We’ll get to today’s case in a moment, but first, a few words about SCOTUS and expiration dates.

 
One hundred and one years ago tomorrow saw the birth of Lewis Powell, who served as a United States Supreme Court Justice from 1972 to 1987.  Powell succeeded Hugo Black.  More interesting, considering current events, is that Powell was succeeded by Anthony Kennedy. Whether Judge Brett Kavanaugh succeeds Justice Kennedy is a matter of some some controversy.  One reason for that controversy is that Justice Kennedy was often a swing vote.  In a prior post, we recounted our one close encounter with Anthony Kennedy.  He impressed us as a smart jurist who was determined to do the right thing.  Still, it must have seemed somewhat vexing to SCOTUS litigants that everything likely turned on the predilections of one Justice.  The other eight Justices often seemed predictable, almost a done deal.  But Justice Kennedy, at least on some issues, was the wild card.  We have no evidence that Justice Kennedy purposely positioned himself as the swing vote, or that he reveled in his inflated importance, but his importance as a swing vote was undeniable.
 
We have also seen no evidence that Justice Kennedy patterned himself after his predecessor, but it is remarkable how similar they were in locating themselves right at the center of the Court.  Justice Powell was often a swing vote.  If our affirmative action jurisprudence is a bit of a mess, some of the blame for that must go to Justice Powell, whose controlling opinion in the 4-1-4 landmark Bakke decision created a slippery standard that sprung from Powell’s idea of the perfect academic affirmative action program – the Harvard College admissions system.  Even back in 1978, it was pretty obvious that the Harvard system was not quite the holistic, individual-respecting scheme that Powell portrayed. (The legal defense of U.Cal Davis Medical School’s affirmative action program was entrusted to the great Archibald Cox.  During oral argument, Justice Blackmun asked whether the set-aside seats could be compared to athletic scholarships.  Cox replied, “Well, I’m from Harvard … “ – laughter intervened – “I don’t know whether that’s our aim, but we don’t do it very well.”)  Given the current lawsuit challenging Harvard admission policies, the Bakke compromise and its progeny seem even more fragile.  

The story of how Powell came to be appointed to the High Court was told in Bob Woodward’s book, The Brethren. (We hear Woodward has another book out.)  President Nixon was politically hobbled in 1972.  In trying to fill an earlier SCOTUS vacancy, Nixon had two of his selections rejected by the Senate.  Powell was an interesting choice.  He was from Virginia, which fit in with Nixon’s southern strategy.  But Powell would not fit into what we now consider the usual mold.  He had never been a judge. (Black had been a senator, not a judge.  Chief Justice Warren had also been a politician.  Douglas headed the SEC. It used to be acceptable for Justices not have to have a judicial track record.  Why the change?). Powell was a corporate lawyer. He represented the tobacco industry. He was a leader in the ABA.  He wrote a famous memo about how corporate America should deal with a hostile media.  There were plenty of reasons why Nixon would have liked Powell.  But there was one important reason why Powell would be acceptable to Senators who weren’t enamored with Nixon: Powell was 64 years old.  Woodward reported that a Senator waved a cigar and told Powell why he would be confirmed: “We think you’re going to die.”  (Powell himself was not all that fired up to join SCOTUS.  He had turned down an earlier offer.  He did not think he had the constitutional law chops of a Douglas, Black, or Brennan.  Plus, he was not eager for the huge pay cut.)

Recently John Oliver’s Last Week Tonight show argued for eliminating life tenure for judges.   Oliver supported a proposal for staggered 18 year terms.  (Powell served 15 years on SCOTUS.)  Every four year presidential term would include an opportunity to appoint at least two SCOTUS justices.  The system would permit reasonable turnover.  It would avoid the dangers of a gerontocracy.  It might somewhat reduce the temperature of SCOTUS confirmation hearings, since there wouldn’t be a multigenerational impact at stake.  Such a change would require a constitutional amendment.  Spoiler alert: it won’t happen.  But while we’re just dreaming, we have another reason for cuddling up to this idea.  When presidents harbor the hope of appointing a Justice who will support certain policies/rules for thirty years, that means they will select relatively young people.  That elevate-them-when-they-are-young approach also offers the advantage of proffering someone with a limited paper record and a limited target area for skeptical senators. Thus, instead of a SCOTUS appointment being the capstone of a long, distinguished career, it is more and more conferred on jurists in mid-career.  As we slouch toward dotage, we less and less like the idea of such important jobs going to juveniles.  Frankly, we hate seeing presidents and Supreme Court Justices younger than ourselves.  It is an annoyance almost as painful as being forced by some website to enter our birth year in a drop down menu, and scrolling down and down.  And down. 
[Quick quiz: Which Supreme Court Justice served the longest term?  Answer below.]

Why are we pondering these issues at this moment?  Obviously, the ongoing Kavanaugh kerfuffle is top of mind.  We also find ourselves ruing life tenure when we read a judicial decision that seems gruesomely wrong-headed.

And now we get to today’s case.  
 
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In Sumpter v. Allergan Inc., 2018 WL 4335519 (E.D. Mo. Sept. 11, 2018), the plaintiff brought suit over ruptured silicone breast implants.  The implants were premarket approval (PMA) medical devices.  As the Sumpter court acknowledges, the Medical Device Amendments Act “preempts claims challenging the safety and effectiveness of … PMA devices.”  Federal law dislodges any state laws (including via jury verdicts) that are “different from, or in addition to, any requirement applicable under [federal law].”  In the face of this rather clear preemption, the plaintiff in Sumpter ditched her design defect and failure to warn claims.  All that was left was the claim for manufacturing defect.  And here begins the Sumpter court’s descent into sheer awfulness.  As a preliminary matter, the Sumpter court tells us that, “[g]enerally, manufacturing defect claims that allege the ‘manufacturer failed to adhere to the specifications imposed by a device’s PMA’ are not preempted at the pleading stage.”  That quote is from the 2009 Hofts decision out of the Southern District of Indiana.  More than once, this blog has derided Hofts for its mangling of Riegel and Twombly and Iqbal.  Hofts made our list of the ten worst decisions of 2009.  Most courts that have considered Hofts have rejected it.  But not the Sumpter court.  If anything, Sumpter manages to multiply Hoft’s errors.  First, the plaintiff, as is all too typical, never comes close to specifying what the manufacturing defect was.  Second, the Sumpter court’s standard for assessing what constitutes a manufacturing defect is altogether wrongheaded.  A manufacturing defect happens when the product is out of spec from its design. Something about the particular product is different from a product that is manufactured correctly.  Maybe something is in there that shouldn’t be, or something is missing.  Or a component was flawed.  But that is not the Sumpter court’s test.  No, the Sumpter court concludes that a claim for manufacturing defect will lie when plaintiffs say that the products differed from the “intended result.”  What does that mean?  Presumably, a case was brought because someone was injured.  That is never the “intended result.”  Does “intended result” end up requiring a perfection that exists nowhere in the law, on any assembly line, in any product portfolio, or, indeed, on our planet? Moreover, the mere existence of a malfunction cannot, by itself, give rise to an inference that the manufacturer violated the FDCA.  Where is there any basis to invoke the infernal Riegel “parallel violation”?  Through the Sumpter looking-glass, every product liability case contains a manufacturing defect claim destined for a jury.  
 
The closest the plaintiff came to articulating a semi-specific manufacturing defect claim was an allegation of “material fatigue.”  Was there any hint in the case that the materials in the implants at issue were in any way out of spec, or different from the norm?  Nope.  Rather, the plaintiff “extrapolated from the injuries” that “there must have been a manufacturing defect.”  Goodbye TwIqbal.  Goodbye whatever is the relevant state law on manufacturing defect.  Hello, new-fangled res ipsa loquitur theory, even though the Sumpter court never uses those magic Latin words.  Under the Sumpter court’s reasoning, once one claims injury from a product, there’s a manufacturing defect that is immune from a motion to dismiss.  (Unless, one supposes, one is in an outlier case where the product was intended to inflict injury.  And then, surely, there is another legal claim at hand.)  The Sumpter court has defectively manufactured a tort claim that, by all rights, should be dismissed based on well-established, clear SCOTUS precedent.
 
The only consolation is that, as we have pointed out many times before, manufacturing defect claims are hard to win.  The odds are long against the likelihood that the plaintiff will ever demonstrate a true manufacturing defect.  Then again, erroneous jury instructions could wreak havoc in favor of even an empty claim, and how can we predict that won’t happen?
 
Justice Powell once said that history “teaches us tolerance for the human shortcomings and imperfections which are not uniquely of our generation, but of all time.”  Tolerance, indeed.  Plus, unlike with SCOTUS, the Sumpter court might some day get reviewed by a higher court.  And then there is the highest authority of all: the DDL blog ten-worst list at the end of this year.  
[Answer to question:  William O. Douglas sat on the High Court for 36 years and 211 days.  He was confirmed at the age of 40.  The judge we clerked for had clerked for Douglas, and could never utter WOD’s name without a growly follow-up along the lines of “…that bastard.”  Apparently Douglas, while being brilliant and charismatic, was not always very nice.]

Just two days ago, Bexis lowered the boom on the Third Circuit’s recent decision in Cottrell v. Alcon Labs, ___ F.3d ___, 2017 WL 4657402 (3d Cir. Oct. 18, 2017).   In a 2-1 decision, the Cottrell court permitted the plaintiffs to proceed on the notion that making eye drop drips bigger than they have to be is a consumer protection violation.  To Bexis’s eyes, that decision was blind to the lack of standing, the absence of any “substantial economic injury,”  and the FDA’s non-approval of eye drop drips of the “smaller” size plaintiffs claim it is somehow illegal not to make under state law.  It turns out that there is someone else out there even more unhappy with the Cottrell decision than Bexis: the defendant.  Now we have the defendant’s Petition for Rehearing and Rehearing En Banc,  https://www.druganddevicelawblog.com/wp-content/uploads/sites/30/2017/11/Cottrell-rehearing-petition.pdf which makes an insightful and compelling case for undoing the panel’s decision.

 

Two preliminary matters are worthy of comment before we tell you what the Petition said. First, we have been so unkind about the Third Circuit’s error in the Fosamax case that we managed to attract the attention of the excellent CA3 blog.   In that blog, the author wondered whether our dissection of Fosamax was perhaps a bit more violent than necessary.  The author also wondered whether we were coming close to accusing the court of bad faith.  Yes to the former, but definitely No to the latter.  As we told the CA3 blog, we took issue with what we saw as bad reasoning, but never-ever thought there was any bad faith.  (The CA3 blog was generous enough to print our disclaimer.  Thanks for that.)  By and large, we are mighty proud of our home circuit.  We know several of the judges, and every one of them is honorable, hard-working, and much smarter than we are.  Sometimes we are not going to agree with the court’s decisions.  Luckily for us we work in a profession and live in a country where debate and criticism are allowed.  Second, succeeding on a petition for rehearing and rehearing en banc is not easy.  When we clerked for Ninth Circuit Judge William Norris, it seemed there was a presumption against such petitions.  Who wants to admit they were wrong?  And yet we remember one time our judge was on a panel where things strayed from the norm.  Another member of the panel (who will remain unnamed) loved to decide cases before oral argument and draft a memorandum disposition rather than a bench memorandum.  This judge prided himself on having almost no backlog.  He pushed for deciding a particular contract dispute via a mere memorandum disposition, not a published opinion, because he saw the issues as being too obvious and insignificant for the Federal Reporter.  And so a memo dispo issued.  But then the losing party filed a petition for rehearing that was not only insistent, but it made a lot of sense.  We met with our Judge in his chambers to talk it over.  The telephone rang.  It was the third member of the panel, who began by saying, “Bill, I think maybe we got one wrong.”  The two judges confabbed, and then set about persuading the third to change his mind and change the outcome.  It took some arm-twisting, but in the end, justice was done.  A mistake led to a proud moment.  By the way, the Ninth Circuit Judge who called our Judge was Anthony Kennedy.  He is now on the U.S. Supreme Court.  So whenever we hear criticisms of Justice Kennedy for fence-sitting, or for grounding some of his opinions in “the right to define one’s own concept of existence, of meaning, of the universe, and of the mystery of human life” or, much worse, international law, we recall his extraordinary integrity and modesty, and how he was supremely interested in getting things right.

 

Back to the Cottrell Petition. The main points in favor of revisiting the Third Circuit’s decision are that it is contrary to Finkelman v. National Football League, 810 F.3d 187 (3d Cir. 2016), it “radically expands Article III standing,” and that it directly conflicts with Eike v. Allergan, Inc., 850 F.3d 315 (7th Cir. 2017).  Moreover, the plaintiff’s inherently speculative theory of injury in fact was rejected by federal courts in Massachusetts and Missouri.  (When a court comes out with a more pro-plaintiffy position than courts in Massachusetts and Missouri, that’s really saying something.)  That theory was also rejected by the district court in Cottrell.  And then the Third Circuit reversed that rejection.  

 

Remember that the Cottrell plaintiffs did not claim that the medications caused them physical harm or were ineffective in treating their eye conditions, or that the defendants misrepresented or omitted any information about the medications or the number of doses expected.  Rather, the plaintiffs simply insist that smaller eye drops would have cost them less.  How is that any different from the Third Circuit’s earlier, controlling Finkelman case, where the plaintiffs had purchased two Super Bowl tickets on the resale market for $2,000 each, and contended that the National Football League had violated New Jersey’s ticket law by not offering at least 95% of tickets to the general public and instead withholding most tickets for league insiders?  The plaintiff in Finkelman alleged that the NFL’s conduct had caused him injury by reducing the supply of tickets, thereby driving up the cost of tickets on the resale market.  The Third Circuit in Finkelman held that the plaintiff lacked standing because the injury was wholly speculative.  Sure, maybe the NFL’s withholding of tickets increased prices on the resale market, but “it might also be the case that it had no effect on the resale market,” and indeed tickets might even have been more expensive in plaintiff’s hypothetical resale market, as members of the general public may have greater incentives than league insiders to resell at high prices.  (We have to admit that, as residents of Philadelphia, where the local team has the best record in the entire NFL, the availability of Super Bowl tickets is a much, much bigger issue to us right now than the size of eye drops.)

The Petition makes the point that, just as in Finkelman, other market effects might have produced a result very different from what the plaintiffs theorized.  In Cottrell, the plaintiffs essentially presumed that the defendants price their products solely according to volume, such that “changing the eyedropper size would not change the price of the medicine, while extending the useful lifespan of each bottle, driving down [the plaintiffs’] aggregate costs.” But it is just as likely that use of smaller drops would prompt use of different sized containers, or that smaller drops would result in a higher price – because of more doses – for the same container.  Who knows?  All we do know is that the allegations of the complaint do not “affirmatively and plausibly” add up to an “injury” caused by the defendant’s conduct.  

The Petition nicely captures the absurdity of the Third Circuit’s analysis, under which consumers suffer Article III injury from “unfairness” whenever they “walk into a supermarket and buy a product — from toothpaste, to ketchup, to deodorant, to hairspray — so long as they can then conceive of a way that the product might be dispensed more efficiently.”  The Petition also nicely exposes the weakness in the Third Circuit’s effort to distinguish away the Seventh Circuit decision in Eike.  According to the Cottrell majority, Eike “seemed to begin its standing analysis with a determination that the plaintiffs had ‘no cause of action.’” But while it is true that the Seventh Circuit did (correctly) conclude that the plaintiffs had “no cause of action,” the Seventh Circuit also separately held that there was no Article III injury, without ever suggesting a causal connection between the two.  Eike, 850 F.3d at 318.  The Seventh Circuit got it fundamentally right when it held that the fact that a seller does not sell the product that you want, or at the price you’d like to pay, is not an actionable injury; “it is just a regret or disappointment.” 

As residents in, and fans of, the Third Circuit, the Cottrell decision certainly is cause for “regret and disappointment.” We called this post a “second look” at the eye-drop litigation.  It is the second look we have taken at the Cottrell case.  We hope that the Third Circuit takes a second look.      

 

 

With new grass on the field, the 2019 baseball season is underway and optimism springs eternal.  Here in Philadelphia, the Phillies have actually around the top of the NL east for the first time since, umm…., last year actually.  But this year, having added possibly the best player and best catcher in the league, it’s not smoke and mirrors.  We won’t wonk you out with stats, but in 2019 (unlike 2018) the Phillies have a significantly positive runs/runs allowed ratio.  If only the pitching holds up.

Speaking of one, two, three, yer out, consider the recent developments in Covidien mesh litigation.  Specifically, consider three recent wins:  Nowell v. Medtronic, Inc., ___ F. Supp.3d ___, 2019 WL 1434971 (D.N.M. March 29, 2019); Kennedy v. Covidien, LP, 2019 WL 1429979 (S.D.N.Y. March 29, 2019); and Barnes v. Medtronic, PLC, 2019 WL 1353880 (E.D. Mich. March 26, 2019).  Apparently emboldened by settlements in the Vaginal Mesh litigation, the other side’s funders have turned their solicitation machine on all mesh products indiscriminately, and this sort of scattershot litigation is the result.  But here, three different complaints, in three different states in three different parts of the country were all dismissed on the pleadings in less than a week.

Let’s take a look.

Starting with the oldest (a relative term), Barnes alleged grossly negligent design, grossly negligent manufacture, breach of implied warranty, and fraud.  2019 WL 1353880, at *1.  Since mesh is a Class II device, under the questionable decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), Medtronic’s preferred preemption defense isn’t widely available.  Didn’t matter.  There’s more than one way to win a motion to dismiss.  Probably due to some quirk in Michigan law, plaintiff didn’t just allege a design defect, but rather a “grossly” negligent design.  Whatever that quirk was, the allegation didn’t help the plaintiff much.  As in most places, Michigan requires more for design claims than second-guessing the defendant’s design – there must an alternative design.  Id. at *2.  But the plaintiff in Barnes alleged only a non-mesh surgical procedure and two completely different types of mesh.  Id.  We’ve said it before.  An alternative design is a different way to make this product, not being forced to make something else.  Or, as Barnes put it, “In jurisdictions requiring plaintiffs to prove the existence of a safer alternative design, a design for a different, albeit similar, product will not suffice, even if it serves the same purpose.”  Id. at *2 (citation and quotation marks omitted).

Plaintiff’s theory alleges that all polyester hernia meshes are unacceptable.  Her proposed alternatives are alternative treatment methods or alternative types of mesh, not alternative production practices or designs for polyester hernia mesh. . . .  Plaintiff’s design defect claim cannot succeed by categorically challenging the safety of polyester mesh and pleading only alternative categories of products as alternative production practices.

Id.

Plaintiff in Barnes also tried to use a version of res ipsa loquitur to salvage manufacturing and implied warranty claims.  That didn’t work either.  “The manufacturer did not implant the mesh into Plaintiff’s abdomen.  At least one surgeon had to open the sealed, sterile packaging” and that “could easily have affected the integrity of the mesh implant.”  Id. at *3.  In the face of an alternative cause, res ipsa loquitur evaporated.  Case dismissed.

In Kennedy, similar claims failed similarly.  Plaintiff claimed no alternative design need be pleaded, even though New York (like Michigan) required that element before a defendant could be liable.  Lose.  2019 WL 1429979, at *3 (enforcing “the general requirement that an alternative design must be pleaded, even if it is not fully developed”).  “[A]lleging that the product should not be used at all is insufficient to satisfy the feasible alternative design element.”  Id. at *4.  Manufacturing defect?  Plaintiff didn’t come close to alleging one – directly or through circumstantial evidence.  Id.  Warning defect?  The complaint was word salad:

Plaintiff’s claim for failure to warn cannot survive the present dismissal motion because it does not identify how the warnings were inadequate or insufficient. . . .  Plaintiff has failed to provide factual support for his conclusory assertion that Defendant’s warnings did not adequately caution physicians and patients concerning the risks associated with [the product].

Id. at *5 (citation omitted).  As we’ve pointed out, New York federal courts have tended to be good on TwIqbal.

Kennedy picks up speed, knocking down the plaintiff’s remaining claims like a row of dominoes.  Negligence?  Fails just like strict liability.  Id.  Implied warranty?  “Plaintiff has not alleged or argued a factual basis for concluding that the product was not minimally safe for its expected purpose.”  Id. at *6.  Express warranty?  “Plaintiff does not identify a specific warranty made by Defendant that he relied on.”  Id. Fraud and misrepresentation?  There wasn’t any.  “[T]he advertising material incorporated into the Complaint appears to have disclosed the risks of the conditions that Plaintiff has allegedly suffered.”  Id. at *7.  Consumer fraud.  Plaintiff made it all about him.  “Plaintiff has not pleaded sufficient facts to establish that Defendant’s conduct was consumer-oriented.”  Id.  Unjust enrichment?  Absent a defect or a misrepresentation, “there is no equitable basis for a requiring restitution.”  Id. at *8.

Two down.

But Nowell is the biggest and baddest of the lot (and the one that will be published).  Nowell has no fewer than 89 separate headnotes, but one has to wade through 22 Westlaw pages of “D said; P said” before getting to the first one.  Why is it the baddest – that is to say, the best?  Well, check out our learned intermediary rule “head count” post.  New Mexico is one of the states where the supreme court has never spoken, and in the past one pro-plaintiff court tried to say the rule didn’t apply.  Nowell went our way.  To paraphrase (badly) Carl Sagan, absence of state high court precedent is not precedent for absence of the learned intermediary rule.  “[S]ilence on the part of the state means only that it has not had occasion to review the matter, not that it disagrees with the federal court’s interpretation of state law.”  2019 WL 1434971, at *44 (citation and quotation marks omitted).

Pursuant to the learned-intermediary doctrine, the prescribing physician acts as a learned intermediary between a prescription drug manufacturer and the ultimate user, and the manufacturer satisfies its duty to warn by providing adequate warnings to the prescribing physician.  The learned intermediary doctrine states that once a manufacturer warns a doctor about a drug’s inherent dangers, it has fulfilled its legal duty to provide a warning. . . .  [A] plaintiff cannot prevail against a prescription drug manufacturer in a failure to warn case where the manufacturer warned the “learned intermediary” of the drug’s inherent risks.  The overwhelming majority of jurisdictions to address this issue apply the learned intermediary doctrine to define a pharmaceutical company’s duty to warn of risks associated with the use of a prescription drug.

Id. at 40 (citations and quotation marks omitted).  That’s not all, there several more pages of learned intermediary rule discussion, going through every favorable New Mexico case known to man (or at least to Bexis).  Id. at *40-47.  Further supporting the learned intermediary rule is the worlds longest footnote, number 25, which includes:

[M]edical device manufacturers may use the learned-intermediary doctrine in failure-to-warn cases.  Numerous courts have allowed medical device manufacturers to use the learned-intermediary doctrine to defend against failure-to-warn claims.  See, e.g., . . . James M. Beck, Anthony Vale, Drug and Medical Device Product Liability Deskbook §2.03 n.51 (noting that courts within every federal circuit apply the learned-intermediary rule to medical devices). . . .  The Court has not found any case that does not apply the learned-intermediary doctrine to medical devices, and the Court does not think that the Supreme Court of New Mexico would be the sole entity to refuse to apply the learned-intermediary doctrine to such products. . . .

[T]he learned-intermediary doctrine applies to [plaintiff’s] failure-to-warn claims.  Accordingly, the Defendants had a duty to warn only [her] treating physicians of the [device’s] risks.  Argument that the Defendants owed or breached a duty to warn [plaintiff] directly is therefore irrelevant.  In reaching its conclusion that the learned-intermediary doctrine would apply to surgically-implanted medical devices in New Mexico, wide-spread national recognition of the doctrine’s value encourages the Court.  See Headcount: Who’s Adopted the Learned Intermediary Rule?, Drug and Device Law, (last visited March 17, 2019) (collecting cases and statutes, and noting that “all 50 states and two other jurisdictions … have precedent supportive of the learned intermediary rule”).

That’s right, Nowell quoted both Bexis’ book and the Blog in its learned intermediary rule discussion.  That’s a first, as far as we know.  Yet another reason to appreciate Nowell.

Turning to plaintiff’s retinue of claims, the New Mexico statute of limitations barred plaintiff’s warranty, negligence, and strict liability claims.  Id. at *49-51.  Then, turning to the kind of issues we follow more closely, the complaint in Nowell gets thoroughly TwIqballed.  Causation is not adequately alleged.  Plaintiff does not even allege that she had any of the laundry list of “common injuries caused by hernia surgeries” contained in the complaint.  Id. at *52.

The Court construes only three allegations in the Amended Complaint as representing facts germane to [plaintiff’s] negligence claim. . . .  Taken together, these facts — even read liberally — fall short of adequately alleging that the Defendant’s mesh was a proximate cause of [plaintiff’s] later injuries. . . .  [N]othing in the Amended Complaint endeavors to explain why the Defendants’ mesh is a likely, let alone proximate, cause of [plaintiff’s] injury.

Id. at *53 (citations omitted).

Nowell also held that product defect was inadequately pleaded.  The complaint “includes a litany of conclusory allegations regarding the mesh’s failure rates and tendency to cause injury, but, again, does not present a defect that could lead to the mesh’s failure and resultant injury.”  Id. at *54.  To complete the triple play of failure to plead any of the elements of strict liability, she didn’t plead any alternative design either.

[Plaintiff] has not alleged that, when she underwent her surgery, an alternative mesh existed which lacked the design defect and therefore would have prevented her injuries.  Although the Amended Complaint states that “[s]afer and more effective alternatives to hernia mesh exist,” it merely alleges surgical techniques alternative to the use of hernia mesh altogether . . ., but not alternative designs to the Defendants’ mesh. . . .  [A] design-defect claim will not stand if the only alternative is an outright ban. . . .  [Plaintiff’s] failure to allege a feasible design alternative is a further basis on which the Court will dismiss her strict liability claims.

Id. at 55 (citations and quotation marks omitted).

The warning claims also failed in Nowell.  “[M]any of the risks that [plaintiff] mentions are precisely the risks that the FDA considers attendant to all hernia repairs surgeries.”  Id.  Warning causation also went unalleged.  “[Plaintiff] does not allege that any of the above warnings would have prevented [her surgeon] from using the Defendants’ mesh to repair [her] hernia.”  Id.

Just as plaintiff had failed to plead defect adequately, she also failed to plead a lack of merchantability for implied warranty purposes.  “[T]hese conclusory allegations amount to naked assertions devoid of the factual enhancement necessary to bridge the gap between possible and plausible.”  Id. at 57 (citations and quotation marks omitted).  Finally, punitive damages were dismissed for failure to plead “scienter.”  Id. at *58.  Ultimately, “[i]n the end, the Amended Complaint does no more than say that [plaintiff] had a mesh implant, and, years later, had an infection.”  Id. at 57 n.27.

So that’s one, two, three strikes you’re out at the old ball game.  We certainly hope things stay “the old ball game.”  A right to these kinds of early dismissals are precisely what defendants are deprived of in multidistrict litigation.

We’re inaugurating a new feature today.  It’s sort of half way between our scorecards, which we keep up to date (as best we’re able) with both favorable and adverse decisions on a particular subject, and our usual defense-side cheerleading that hails defense wins and excoriates our losses.

What we’re going to start is something we call “cheat sheets.” These will be lists of cases, similar to scorecards.  We intend to update them like we do with the scorecards.  Only, in accordance with our general philosophy that we don’t believe in doing the other side’s research for them, these will only include cases that have pro-defense outcomes on the particular issue.  This will allow us to extend our scorecard research tool (which we use ourselves, quite often) to more subject areas.

The first of these is going to address Twombly/Iqbal pleading decisions in drug/device product liability cases (that means Rule 8, not Rule 9(b)).  For short we’re going to be calling that “TwIqbal” from now on.  That nifty little turn of a phrase is one of the things we learned at the recent PLAC spring conference.  So without further ado here’s our inaugural TwIqbal cheat sheet:

  1. In re Bausch & Lomb Inc., 2007 WL 3046682 (D.S.C. Oct. 11, 2007).  All claims TwIqballed (technically only “Twomblyed,” since Iqbal wasn’t decided yet) due to:  failure to plead facts concerning damages (device).
  2. Parker v. Howmedica Osteonics Corp., 2008 WL 141628 (D.N.J. Jan. 14, 2008).  Express warranty claim TwIqballed due to:  failure to plead any facts establishing the nature of the warranty (device).
  3. Sykes v. Bayer Pharmaceuticals Corp., 548 F. Supp.2d 208 (E.D. Va. Feb. 12, 2008).  Gross negligence claim TwIqballed due to:  failure to plead any facts supporting the adjectives (vaccine).
  4. Heck v. American Medical Systems, Inc., 2008 WL 1990710 (D. Md. April 30, 2008).  All product liability claims TwIqballed due to:  unsubstantiated labels, and legal conclusions; failure to plead elements of strict liability, negligence, or warranty; and failure to distinguish between manufacturing, design, and warning defects (device).
  5. Stratford v. SmithKline Beecham Corp., 2008 WL 2491965 (S.D. Ohio June 17, 2008).  Statutory product liability claims TwIqballed due to:  failure to plead with reference to the proper sections of the statute.  Express warranty claim TwIqballed due to: failure to plead any facts establishing the nature of the warranty (drug).
  6. Wolicki-Gables v. Arrow International, Inc., 2008 WL 2773721 (M.D. Fla. June 17, 2008).  All product liability claims TwIqballed due to: failure to plead product identification (device).
  7. Adkins v. Cytyc Corp., 2008 WL 2680474 (W.D. Va. July 3, 2008).  Negligence claim based upon conduct of sales representative TwIqballed due to:  failure to plead facts of representative’s negligent conduct or causation (device).
  8. Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008).  Express warranty claim TwIqballed due to:  failure to specify the language that constituted the warranty (device).
  9. Bailey v. Janssen Pharmaceutica, Inc., 288 Fed. Appx. 597 (11th Cir. July 29, 2008).  Warning claims TwIqballed due to:  failure to plead facts concerning how the warning to the prescribing physician was inadequate.  Negligence claims TwIqballed due to: failure to plead separate claims against separate defendants (device).
  10. Simmons v. Stryker Corp., 2008 WL 4936982 (D.N.J. Nov. 17, 2008).  Express warranty claim TwIqballed due to:  failure to plead any facts establishing the nature of the warranty (device).
  11. Horowitz v. Stryker Corp., 613 F. Supp.2d 271 (E.D.N.Y. Feb. 20, 2009).  Manufacturing claims TwIqballed due to:  failure, in a preemption case, to plead how the defendant’s manufacturing process violated FDA regulations (device).
  12. Delaney v. Stryker Orthopaedics, 2009 WL 564243 (D.N.J. March 5, 2009).  Manufacturing defect claims TwIqballed due to:  failure, in a preemption case, to plead how the defendant’s manufacturing process violated FDA regulations.  Express warranty claim TwIqballed due to:  failure to specify the language that constituted the warranty (device).
  13. Sherman v. Stryker Corp., 2009 WL 2241664 (C.D. Cal. March 30, 2009).  All product liability claims TwIqballed due to:  failure to plead facts concerning product identification (drug).
  14. In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2009 WL 1921902 (D. Minn. July 1, 2009).  All claims TwIqballed due to:  vague and conclusory allegations that fail to establish standing (device).
  15. Pennsylvania Employees Benefit Trust Fund v. Astrazeneca Pharmaceuticals LP, 2009 WL 2231686 (M.D. Fla. July 20, 2009).  Express warranty claims TwIqballed due to:  failure to plead any facts supporting direct communication between plaintiff and defendant or proximate cause (drug).
  16. Frey v. Novartis Pharmaceuticals Corp., 642 F. Supp.2d 787 (S.D. Ohio July 23, 2009).  Design and manufacturing claims TwIqballed due to:  formulaic pleadings of defect and causation (drug).
  17. Lewis v. Abbott Laboratories, 2009 WL 2231701 (S.D.N.Y. July 24, 2009).  Design claim TwIqballed due to:  failure to plead facts establishing a feasible alternative design. Warning claims TwIqballed due to:  failure to plead inadequate warnings to doctors under the learned intermediary rule.  Manufacturing claims TwIqballed due to:  failure to plead a deviation from intended result.  Implied warranty claim TwIqballed due to:  failure to plead an actionable defect (drug).
  18. Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009).  Parallel violation claims TwIqballed due to:  failure, in a preemption case, plead an FDCA violation involving the plaintiff’s device, anything beyond formulaic conclusions, or facts supporting proximate cause (device).
  19. Williams v. Cyberonics, Inc., 654 F. Supp.2d 301 (E.D. Pa. Sept. 10, 2009).  Express warranty claim TwIqballed due to:  failure to plead facts establishing any express statement (device).
  20. Ivory v. Pfizer Inc., 2009 WL 3230611 (W.D. La. Sept. 30, 2009).  Design claim TwIqballed due to:  failure to plead facts establishing a feasible alternative design (drug).
  21. Dittman v. DJO, LLC, 2009 WL 3246128 (D. Colo. Oct. 5, 2009).  All claims TwIqballed due to:  failure to plead product identification (drug).
  22. Williams v. Allergan USA, Inc., 2009 WL 3294873 (D. Ariz. Oct. 14, 2009).  Parallel violation claim TwIqballed due to:  failure to plead any supporting facts (device).
  23. Gilmore v. DJO, Inc., 663 F. Supp.2d 856 (D. Ariz. Oct. 15, 2009).  All claims TwIqballed due to:  failure to plead any facts, and failure to specify what products were at issue (device).
  24. Mohr v. Targeted Genetics, Inc., 2009 WL 4021153 (C.D. Ill. Nov. 18, 2009).  Strict liability and wrongful death claims TwIqballed in experimental drug case due to:  failure to plead any specific facts beyond bare legal conclusions (drug).
  25. Funk v. Stryker Corp., 673 F. Supp.2d 522 (S.D. Tex. Dec. 1, 2009).  “Information and belief” allegations TwIqballed where facts were public information.  Affirmed on other grounds 631 F.3d 777 (5th Cir. 2011) (device).
  26. Combs v. Stryker Corp., 2009 WL 4929110 (E.D. Cal. Dec. 14, 2009).  All claims TwIqballed due to:  failure to plead product identification (drug).
  27. Gomez v. Pfizer, Inc., 675 F. Supp.2d 1159 (S.D. Fla. Dec. 21, 2009).  Negligence claims TwIqballed due to:  failure to plead individualized allegations against multiple defendants.  Strict liability claims TwIqballed due to:  failure to plead individualized allegations against multiple defendants, failure to plead anything more than bare legal conclusions, and failure to plead what category of defect is claimed (drug).
  28. Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582 (E.D.N.Y. Dec. 28, 2009).  Manufacturing defect claims TwIqballed due to:  failure, in a preemption case, to plead more than unsupported violations of general FDA regulations, and failure to plead causation (device).
  29. Gonzalez v. Bristol-Myers Squibb Co., 2009 WL 5216984 (D.N.J. Dec. 30, 2009).  Negligent misrepresentation claim TwIqballed due to: failure to plead anything beyond conclusory allegations (drug).
  30. Wendell v. Johnson & Johnson, 2010 WL 271423 (N.D. Cal. Jan. 20, 2010).  Negligence, negligence per se, strict liability, wrongful death, and express and implied warranty claims TwIqballed due to:  failure to plead anything beyond the conclusory legal elements (drug).
  31. Krywokulski v. Ethicon, Inc., 2010 WL 326166 (M.D. Fla. Jan. 21, 2010).  Negligence claim TwIqballed due to:  failure to plead facts establishing a duty, and failure to plead facts separately as to each defendant (device).
  32. Haskins v. Zimmer Holdings, Inc., 2010 WL 342552 (D. Vt. Jan. 29, 2010).  Product liability claims TwIqballed due to: failure to plead product identification (device).
  33. Washington v. Wyeth, Inc., 2010 WL 450351 (W.D. La. Feb. 8, 2010).  Product liability claims TwIqballed due to:  failure to plead product identification (drug).
  34. In re Heparin, 2010 WL 547322 (N.D. Ohio Feb. 9, 2010).  Product liability claims TwIqballed due to:  failure to plead facts establishing proximate cause (drug).
  35. Timmons v. Linvatec Corp., 263 F.R.D. 582 (C.D. Cal. Feb. 9, 2010).  Product liability claims TwIqballed due to:  failure to plead product identification (drug).
  36. Mitchell v. Proctor & Gamble, 2010 WL 728222 (S.D. Ohio March 1, 2010).  Product liability claims TwIqballed due to:  failure to plead causation (drug)
  37. Heisner v. Genzyme Corp., 2010 WL 894054 (N.D. Ill. March 8, 2010).  Parallel violation claims TwIqballed due to:  failure, in a preemption case, to plead anything more than formulaic allegations.  Negligence per se claim TwIqballed due to: failure, in a preemption case, to plead any facts establishing causation (device).
  38. Lemelle v. Stryker Orthopaedics, 698 F. Supp.2d 668 (W.D. La. March 15, 2010).  Redhibition claim TwIqballed due to:  failure, in a preemption case, to plead a parallel FDCA violation claim or causation (device).
  39. Adams v. I-Flow Corp., 2010 WL 1339948 (C.D. Cal. March 30, 2010).  All claims TwIqballed due to:  failure to plead facts concerning product identification (drug and device).
  40. Anthony v. Stryker Corp., 2010 WL 1387790 (N.D. Ohio March 31, 2010).  Manufacturing defect claims TwIqballed due to:  failure, in a preemption case, to plead how the alleged FDCA violations caused injury (device).
  41. In re Fosamax Products Liability Litigation, 2010 WL 1654156 (S.D.N.Y. April 9, 2010).  All product liability claims TwIqballed due to:  failure to plead facts concerning product identification (drug).
  42. Tyler v. Bristol-Meyer Squibb, 2010 WL 1664967 (D. Neb. April 23, 2010).  Warning claims TwIqballed due to:  failure to plead inadequate warnings to doctors under the learned intermediary rule (drug).
  43. Peterson v. Breg, Inc., 2010 WL 2044248 (D. Ariz. April 29, 2010).  All claims TwIqballed due to: failure to plead product identification (drug and device).
  44. Daughtery v. I-Flow, Inc., 2010 WL 2034835 (N.D. Tex. April 29, 2010).  All claims TwIqballed (although TwIqbal not cited) due to:  failure to plead sufficient causal link to establish standing (drug and device).
  45. Dean v. DJO, LLC, 2010 WL 1999295 (D. Or. May 17, 2010) & Flint v. DJO, LLC, 2010 WL 1999302 (D. Or. May 17, 2010).  Two identical opinions.  Civil conspiracy claims based upon alleged FDCA violations TwIqballed due to:  an agreement to “sell” a product and “make a profit” was insufficient because there was no allegation that the purpose of the agreement was to cause harm to the plaintiff.  Leave to amend was denied as futile (device).
  46. In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2010 WL 2346624 (D.N.J. June 9, 2010).  RICO allegations that third party payers were injured by off-label promotion TwIqballed due to:   failure to plead that drugs were actually ineffective or unsafe, as opposed to unproven; failure plausibly to allege fairly traceable direct injury necessary for standing.  Mere volume of purchases is insufficient to state that plaintiff must have been injured by statistical prevalence of off-label use.  Specific purchases must be connected to specific acts.  Tortious interference claim inadequately pleaded (drug).
  47. In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2010 WL 2464746 (D.N.J. June 9, 2010).  Consumer fraud claim TwIqballed due to:   failure to plead any nexus between the alleged misconduct and the plaintiff’s prescriber.  Incorporation by reference of allegations made in other proceedings does not suffice, where plaintiff has not pleaded injury to himself (drug).
  48. Kester v. Zimmer Holdings, 2010 WL 2696467 (W.D. Pa. June 16, 2010), second motion granted, 2101 WL 4103553 (W.D. Pa. Oct. 18, 2010).  Negligence claims TwIqballed due to:  failure to plead facts concerning product identification or the applicability of the discovery rule tolling the statute of limitations.  Express warranty claim TwIqballed due to: failure to plead any facts establishing the nature of the warranty (drug).
  49. Steen v. Medtronic, Inc., 2010 WL 2573455 (N.D. Tex. June 25, 2010).  Strict liability, negligence, and warranty claims TwIqballed due to:  failure to support legal conclusions with factual allegations.  Res ipsa was not plausibly pleaded because the plaintiff’s surgeon, not the defendant, allegedly implanted the product that later dislodged (device).
  50. Vice v. Sgalrato Medical, Inc., 2010 WL 2942652, slip op. (W.D. La. July 21, 2010).  Plaintiff’s pleading of the discovery rule/fraudulent concealment as a defense to the statute of limitations TwIqballed due to:  failure to support legal conclusions with factual allegations (drug).
  51. In re Actimmune Marketing Litigation, 2010 WL 3463491 (N.D. Cal. Sept. 1, 2010).  California consumer fraud claims TwIqballed due to:   formulaic pleading of reliance by prescribing physicians.  Missouri consumer fraud claims TwIqballed due to:   failure to plead reliance upon illegal activity (drug).
  52. Bass v. Stryker Corp., 2010 WL 3431637 (N.D. Tex. Aug. 31, 2010).  Parallel violation claims in PMA device case TwIqballed due to:  unelaborated allegations that make no attempt to relate the alleged violations to the PMA or the product.  Plaintiff failed to plead what regulation the defendant violated (device).
  53. Gelber v. Stryker Corp., 752 F. Supp.2d 328 (S.D.N.Y. Sept. 14, 2010).  Parallel violation claims in PMA device case TwIqballed due to:  failure to plead “device-specific” violation or a “cognizable link” to the plaintiff’s injuries.  Express warranty claim TwIqballed due to failure to plead the warranty or how it was breached (device).
  54. Forslund v. Stryker Corp., 2010 WL 3905854 (D. Minn. Sept. 30, 2010).  All product liability claims in medical device case TwIqballed due to failure to plead defect (device).
  55. Maness v. Boston Scientific, 751 F. Supp.2d 962 (E.D. Tenn. Nov. 4, 2010).  Product liability claims against non-PMA medical device TwIqballed for failure to plead facts establishing:  (1) the product was defective and/or unreasonably dangerous, (2) the defect existed at the time the product left the manufacturer’s control, and (3) the plaintiff’s injury was proximately caused by the defective product.  Pleading injury from a product is not enough, nor is merely pleading the legal conclusion “defective.”  Plaintiff must plead a specific problem with the product.  Pleading a recall is insufficient without facts tying it to the plaintiff’s injuries.  TwIqbal applies to complaints filed in state court and removed to federal court (device).
  56. Bishoff v. Medtronic, Inc., 2010 WL 4852650, slip op. (N.D.W. Va. Nov. 22, 2010).   Parallel violation claims in PMA device case TwIqballed due to:  failure to plead “how or why” there was noncompliance with FDA regulations.  Express warranty claim TwIqballed due to no allegations establishing that the defendant had warranted that its “product met safety standards exceeding the requirements of the PMA process” (device).
  57. Adams v. Stryker Pain Pump Corp., 2010 WL 4909564, slip op. (D. Minn. Dec. 1, 2010).  All claims TwIqballed despite “liberal construction” of pro se prisoner complaint.  Strict liability:  no facts pleaded why device was unreasonably dangerous for its intended use.  Failure to warn:  no facts pleaded (1) that defendant promoted the device for the intended use in question, (2) no facts pleaded that the defendant gave a warning to plaintiff’s surgeon, (3) no facts pleaded that the defendant had reason to know its device was dangerous for the intended use (device).
  58. Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. Jan. 25, 2011) .  TwIqbal dismissal affirmed.  In a manufacturing defect claim involving PMA preemption, plaintiffs must plead how the manufacturing process failed, how it deviated from FDA specifications, and the the causal connection between the violation and the plaintiff.  Affirming Funk v. Stryker Corp., 673 F. Supp.2d 522 (S.D. Tex. Dec. 1, 2009) (device).
  59. Rojas v. Qualitest Pharmaceuticals Inc., 2011 WL 334671 (E.D. La. Jan. 28, 2011).  All claims in prescription drug case TwIqballed due to failure to plead product identification (drug).
  60. Cohen v. Guidant Corp., 2011 WL 637472, slip op. (C.D. Cal. Feb. 15, 2011).  Violation claims in PMA device case TwIqballed due to:  failure to plead more than “boilerplate” violation and failure to plead causation.  Plaintiff failed to plead any injury because his device had not failed (device).
  61. Johnson v. Moog, Inc., 2011 WL 719600 (E.D. Tex. Feb. 22, 2011).  All claims TwIqballed due to:  Pleading only that unknown “defendants” committed actions, failure to plead product identification (device).
  62. Llado-Carreno v. Guidant Corp., 2011 WL 705403 (S.D. Fla. Feb. 22, 2011).  All claims TwIqballed due to:  failure to plead more than “boilerplate” violation and failure to plead causation. Plaintiff failed to plead any injury because his device had not failed and no physical harm is claimed.   Warranty claims did not allege what warranty was (device).
  63. Nimtz v. Cepin, 2011 WL 831182 (S.D. Cal. Mar. 3, 2011), dismissed with prejudice, 2011 WL 2160181 (S.D. Cal. June 1, 2011).  Manufacturing, design, and warning claims TwIqballed due to:  failure to plead more than “legal conclusions” concerning the elements of the causes of action.  There is no allegation how the product was inadequately designed or manufactured.  To state a plausible claim for failure to warn, a complaint should at least identify which danger was not warned against, that the danger was substantial, that the danger was not readily recognizable to an ordinary consumer, that the manufacturer knew or should have reasonably known of the danger, and causation (device).
  64. Ironworkers Local Union 68 v. AstraZeneca Pharmaceuticals, LP, 634 F.3d 1352 (11th Cir. 2011). All claims TwIqballed due to:  failure to allege injury (drug).
  65. Bloom v. Depuy Orthopaedics, Inc., 2011 WL 1135753 (D. Md. March 25, 2011).  All claims TwIqballed due to:  failure to plead anything more than a malfunction, failure to plead which of several components was defective, whether the defect was in design or manufacture, or how a non-defective product would have worked differently.  A failure to obtain approval claim did not allege what should have been approved and how.  Warranty claims did not allege what warranty was (device).
  66. White v. Stryker Corp., 818 F. Supp.2d 1032 (W.D. Ky. March 25, 2011).  Violation claims in case TwIqballed due to:  failure to plead violation of device-specific GMP regulation, and failure to plead causation.  Neither a particular regulation nor the nature of the violation was pleaded (device).
  67. Rhynes v. Stryker Corp., 2011 WL 2149095 (N.D. Cal. May 31, 2011).  Punitive damages claims TwIqballed due to:  failure to plead facts establishing heightened intent required for such damages (device).
  68. McFarland v. APP Pharmaceuticals, LLC, 2011 WL 2413797 (W.D. Wash. June 13, 2011).  All claims TwIqballed due to failure to identify the product’s manufacturer (drug and device).
  69. Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595 (W.D. Tex. June 23, 2011).  Product liability claims TwIqballed due to:  failure to allege defect or that the prescriber relied on inadequate warnings (drug).
  70. Singleton v. Eli Lilly Co., 2011 WL 2621067 (E.D. Cal. June 29, 2011).  All claims TwIqballed due to failure to identify the product’s manufacturer (drug).
  71. King v. Pfizer Pharmaceutical Co., 2011 WL 3157305 (D. Md. July 25, 2011).  FDCA violation claims TwIqballed for not involving the product plaintiff took (drug).
  72. O’Brien v. Intuitive Surgical, Inc., 2011 WL 3040479 (N.D. Ill. July 25, 2011).  All claims TwIqballed due to failure to plead causation (device).
  73. Rollins v. Wackenhut Services Inc., 802 F. Supp.2d 111 (D.D.C. Aug. 10, 2011).  All claims TwIqballed due to:  failure to plead more than “legal conclusions” concerning the elements of the causes of action.  The plaintiff’s own allegations defeat a suicide warning claim.  Plaintiff pleaded no facts to bring a comment k case (drug).
  74. Mills v. Bristol-Myers Squibb Co., 2011 WL 3566131, slip op. (D. Ariz. Aug. 11, 2011).  All claims TwIqballed due to:   the failure of plaintiff’s “generic boilerplate” allegation to tie the defendants’ conduct to the plaintiff.  No allegations of prescribing physician reliance.  No allegations how the warning was inadequate (drug).
  75. Tillman v. Taro Pharmaceutical Industries Ltd., 2011 WL 3704762 (N.D. Ill. Aug. 17, 2011).  All claims TwIqballed due to:   pleading only formulaic elements of claims.  The contents of the claimed express warranty are not alleged (generic drug).
  76. Salvio v. Amgen, Inc., 810 F. Supp.2d 745 (W.D. Pa. Aug. 18, 2011).  All claims TwIqballed due to:  failure to plead more than “legal conclusions” concerning the elements of the causes of action.  The judicially noticed package insert eliminates any possible warning claim.  Failure to plead alternative design eliminates any possible design claim.  Claims for strict liability, warranty, testing and marketing not recognized by state law dismissed (drug).
  77. Leonard v. Medtronic, Inc., 2011 WL 3652311 (N.D. Ga. Aug. 19, 2011).  All claims TwIqballed due to: failure to plead more than “conclusory statements and formulaic recitations.” Parallel violation claims TwIqballed for failure to specify what was violated, how it was violated, or how the violation allegedly injured plaintiff (device).
  78. Baldwin v. Zimmer, Inc., 2011 WL 3652411 (S.D. Ohio Aug. 19, 2011). All claims TwIqballed due to: failure to identify any specific defects or failures, and pleading only legal conclusions (device).
  79. Henderson v. Sun Pharmaceuticals Industries, Ltd., 809 F. Supp.2d 1373 (N.D. Ga. Aug. 22, 2011).  All claims TwIqballed due to:  failure to identify the defendant that manufactured the product, and failure to allege FDCA violations that involved the plaintiff’s product (generic drug).
  80. Patterson v. Novartis Pharmaceuticals Corp., 451 Fed. Appx. 495 (6th Cir. Aug. 23, 2011). Product identification allegation TwIqballed due to: use of “and/or” to create ambiguity concerning the product used (drug).
  81. Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197 (W.D.N.Y. Sept. 13, 2011).  Parallel violation claims TwIqballed due to failure to plead the nature of the violation (device).
  82. Younker v. Ohio State University Medical Center, 2011 WL 4558922 (S.D. Ohio Sept. 29, 2011).  All product liability claims TwIqballed due to failure to allege any specific product defect (device).
  83. Cardenas v. Abbott Laboratories, 2011 WL 4808166, slip op. (N.D. Ill. Oct. 7, 2011).  All claims TwIqballed due to failure to allege any facts about plaintiffs beyond their state of residence and that they took the drug “several times” (drug).
  84. Mills v. Bristol-Myers Squibb Co., 2011 WL 4708850 (D. Ariz. Oct. 7, 2011).  “Information and belief” allegations TwIqballed due to the allegations not being within the defendant’s sole knowledge.  Reliance on a study TwIqballed due to the plaintiff not having the same characteristics as the study subjects.  Warning defect claim TwIqballed due to failure to plead any facts (other than on information and belief) that an adequate warning would have changed the plaintiff’s prescriber’s treatment (drug).
  85. Currier v. Stryker Corp., 2011 WL 4898501 (E.D. Cal. Oct. 13, 2011).  Manufacturing claim TwIqballed due to failure to allege how device deviated from intended design.  Implied warranty claim TwIqballed due to vague allegations concerning “defendants” (device).
  86. Hammonds v. Boston Scientific, Inc., 2011 WL 4978369 (W.D. Okla. Oct. 19, 2011).  All claims TwIqballed due to failure to allege that a product defect (device).
  87. Esposito v. I-Flow Corp., 2011 WL 5041374 (E.D. Pa. Oct. 24, 2011).  All claims TwIqballed due to failure to plead facts concerning product identification (device).
  88. Rhynes v. Stryker Corp., 2011 WL 5117168 (N.D. Cal. Oct. 27, 2011).  Violation claims TwIqballed due to failure to plead the nature of the violation (device).
  89. Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420 (W.D. Pa. Nov. 10, 2011).  Express warranty claim TwIqballed due to:  failure to plead the warranty or how it became part of the basis of the bargain (device).
  90. Tierney v. AGA Medical Corp., 2011 WL 7400469 (D. Neb. Nov. 18, 2011).  Violation claims TwIqballed due to failure to plead the nature of the violation (device).
  91. In re Fosamax Products Liability Litigation, 2011 WL 5903623 (D.N.J. Nov. 21, 2011).  Manufacturing defect claim TwIqballed due to:  failure to plead nature of the defect.  Violation claim TwIqballed due to:  failure to link violation to product plaintiff took (drug).
  92. Callaway v. American Medical Systems, Inc., 2011 WL 7724268 (W.D. La. Dec. 8, 2011).  All claims TwIqballed due to:  Failure to allege that the defendant manufactured the product, failure to describe any particular defect, and failure to how the undefined defect caused injury (device).
  93. Erickson v. Boston Scientific Corp., 846 F.Supp.2d 1085 (C.D. Cal. Dec. 12, 2011).  Violation claims TwIqballed due to failure to plead the nature of the violation (device).
  94. Fullington v. PLIVA, Inc., 2011 WL 6153608 (E.D. Ark. Dec. 12, 2011).  All unpreempted claims TwIqballed due to: pleading only formulaic elements of claims (generic drug).
  95. Polk v. KV Pharmaceutical Co., 2011 WL 6257466 (E.D. Mo. Dec. 15, 2011).  All claims TwIqballed due to failure to plead any injury (drug).
  96. Del Valle v. PLIVA, Inc., 2011 WL 7168620 (S.D. Tex. Dec. 21, 2011).  Unpreempted failure to update warning claims TwIqballed due to failure to plead facts supporting the allegations (generic drug).
  97. Grinage v. Mylan Pharmaceuticals, Inc., 840 F. Supp.2d 862 (D. Md. Dec. 30, 2011).  Possibly unpreempted claim claim for failure to use alternative means of communication due to failure to allege causation under the learned intermediary rule.  Implied warranty claims TwIqballed due to failure to plead any facts (generic drug).
  98. Coney v. Mylan Pharmaceuticals, Inc., 2012 WL 170143 (S.D. Ga. Jan. 19, 2012).  Unpreempted failure to update warning claims TwIqballed due to failure to plead facts supporting the allegations (generic drug).
  99. In re Pamidronate Products Liability Litigation, 842 F. Supp.2d 479 (E.D.N.Y. Jan. 30, 2012).  All unpreempted claims TwIqballed due to:   pleading only formulaic elements of claims (generic drug).
  100. Deese v. Immunex Corp., 2012 WL 463722 (S.D. Miss. Feb. 13, 2012).  All claims TwIqballed due to:   pleading only formulaic elements of claims.  Warning claims TwIqballed due to failure to allege causation under the learned intermediary rule.  Express warranty claim TwIqballed due to: failure to plead the warranty or how it became part of the basis of the bargain (drug).
  101. Salvio v. Amgen, Inc., 2012 WL 517446 (W.D. Pa. Feb. 15, 2012). Package inserts mentioned in the complaint may be judicially noticed. In negligent failure to warn claim, a plaintiff must plead facts indicating that the physician did not receive the package insert. A design defect claim must plead an alternative design, not an alternative product (drug/biologic).
  102. Viserta v. St. Jude Medical, Inc., 2012 WL 667814 (D.S.C. Feb. 29, 2012).  Violation claims TwIqballed due to failure to plead the nature of the violation. Violation claims TwIqballed for failure to allege causation from the violation (device).
  103. Bowman v. Wyeth, LLC, 2012 WL 684116 (D. Minn. March 2, 2012).  Unpreempted failure to update claims TwIqballed due to failure to plead facts supporting the allegations (generic drug).
  104. In re Darvocet, Darvon and Propoxyphene Products Liability Litigation, 2012 WL 718618(E.D. Ky. March 5, 2012).  Unpreempted failure to update claims TwIqballed due to failure to plead facts supporting the allegations (generic drug).
  105. Bartlett v. Pfizer, Inc., 2012 WL 718782 (D.R.I. March 5, 2012).  All claims TwIqballed due to failure to allege causation.  Violation claims TwIqballed for failure to allege causation from the violation (drug).
  106. Gross v. Stryker Corp., 858 F. Supp.2d 466 (W.D. Pa. March 14, 2012).  Negligence and res ipsa loquitur claims TwIqballed because they are too vague to establish what standard of care was breached.  Violation claims in PMA medical device case TwIqballed due to failure to plead the nature of the violation.  Broad references to federal regulations are insufficient to establish the duty element of a negligence state law claim which would parallel a violation of federal law.  Plaintiff must allege what regulations are violated and how.  Pleading res ipsa loquitur requires plaintiff to rule out other causes of injury, including medical malpractice.  Rejecting Hofts.  Express warranty claim TwIqballed due to:  failure to plead any facts establishing the nature of the warranty or how it became part of the basis of the bargain (device).
  107. Reed v. Pfizer Inc., 839 F. Supp.2d 571 (E.D.N.Y. March 14, 2012).  Package inserts mentioned in the complaint may be judicially noticed.  Warning claims TwIqballed due to failure to plead what the warning was or how it was inadequate, particularly since the precise risk was in fact warned of.  Design claims TwIqballed due to failure to plead any alternative design.  Manufacturing and express and implied warranty claims TwIqballed due to failure to allege any specific product defect (drug).
  108. Metz v. Wyeth LLC, 872 F. Supp.2d 1335 (M.D. Fla. March 28, 2012).  Negligence per se claim TwIqballed due to:  failure to identify the allegedly violated regulation or that the violation was causal (drug).
  109. Cooley v. Medtronic, Inc., 2012 WL 1380265 (E.D. Ky. April 20, 2012).  Unpreempted claims TwIqballed due to:  failure to allege any specific manufacturing defect (device).
  110. Eckhardt v. Qualitest Pharmaceuticals Inc., 858 F. Supp.2d 792 (S.D. Tex. April 30, 2012).  Unpreempted claims TwIqballed due to:  failure to allege any specific manufacturing defect (generic drug).
  111. Hammarlund v. Stryker Corp., 2012 WL 12868486 (S.D. Cal. July 16, 2012). Violation claims TwIqballed for failure to allege causation from the violation (device).
  112. Aucoin v. Amneal Pharmaceuticals, LLC, 2012 WL 2990697 (E.D. La. July 20, 2012).  All claims TwIqballed due to:  formulaic pleadings of all counts.  Express warranty claim TwIqballed due to failure to plead existence of any statement (generic drug).
  113. Lilak v. Glaxosmithkline, LLC, 2012 WL 4443961 (D. Colo. July 23, 2012).  Negligence per se claims TwIqballed due to:  failure to identify violated enactments, failure to specify how the statute was intended to protect the plaintiff (drug).
  114. Lilak v. GlaxoSmithKline, LLC, 2012 WL 4478972 (D. Colo. July 23, 2012). Negligence per se claims TwIqballed due to: failure to identify violated enactments, failure to specify how the statute was intended to protect the plaintiff (drug).
  115. Lilak v. Astrazenca Pharmaceutical-US, Inc., 2012 WL 4444347 (D. Colo. July 23, 2012). Negligence per se claims TwIqballed due to: failure to identify violated enactments, failure to specify how the statute was intended to protect the plaintiff (drug).
  116. Ali v. Allergan USA, Inc., 2012 WL 3692396 (E.D. Va. Aug. 23, 2012).  Violation claims TwIqballed for failure to allege the violation or causation from the violation (device).
  117. In re Prempro Products Liability Litigation, 2012 WL 3985752 (E.D. Ark. Sept.11, 2012).  TwIqbal requires that claims of off-label promotion who, what, when, and where of the claimed promotion.  How the plaintiff’s doctor relied on the promotion so as to affect the plaintiff must be pleaded specifically.  Boilerplate reliance allegations will be dismissed (drug).
  118. Buckley v. DJO Surgical, 2012 WL 4849368 (S.D. Cal. Oct. 11, 2012).  Product liability claims TwIqballed due to:  failure to specify defect (device).
  119. Bowdrie v. Sun Pharmaceutical Industries Ltd., 2012 WL 5465994 (E.D.N.Y. Nov. 9, 2012).  Strict liability, warranty, negligence per se, and fraud claims TwIqballed due to:  failure to allege a factual basis for allegations of FDCA violations (generic drug).
  120. Rollins v. Wackenhut Services, Inc., 703 F.3d 122 (D.C. Cir. Dec. 28, 2012).  Design and manufacturing defect claims TwIqballed due to: formulaic pleadings.  Warning defect claim TwIqballed due to:  the risk at issue having a black box warning.  Off-label promotion and other allegations TwIqballed due to:  lack of relevance to this plaintiff’s claims.  TwIqbal applies to judgments on the pleadings under Rule 12(c) (drug).
  121. Harris v. Eli Lilly & Co., 2012 WL 6732725 (N.D. Ohio Dec. 28, 2012).  Express warranty claim TwIqballed due to failure to plead existence of the representation or how it was relied upon.  Boilerplate allegations of falsity and reliance must be disregarded (drug).
  122. Aaron v. Novartis Pharmaceutical Corp., 2013 WL 790009, slip op. (W.D. Ky. March 4, 2013).  All claims TwIqballed due to:  formulaic pleadings.
  123. Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808 (S.D. Tex. March 12, 2013).  All claims TwIqballed due to: formulaic pleadings.  Warning claims TwIqballed due to:  failure to plead facts establishing warning causation under the learned intermediary rule and failure to plead facts establishing an exception to the Texas presumption of adequate warnings due to FDA approval.  Warranty claims are TwIqballed due to:  failure to state the warranty (device).
  124. Watson v. Bayer Healthcare Pharmaceuticals, Inc., 2013 WL 1558328, slip op. (E.D. La. April 11, 2013).  All actual LPLA claims TwIqballed due to:   formulaic pleadings.  Neither the nature of the defect or causation is pleaded.  As to warnings, plaintiff also failed to plead having the conditions allegedly not warned about (device).
  125. Goldin v. Smith & Nephew, Inc., 2013 WL 1759575 (S.D.N.Y. April 24, 2013).  Manufacturing defect claim based on circumstantial malfunction TwIqballed due to failure to allege how alternative causes are ruled out.  Design defect claim TwIqballed due to failure to allege substantial risk or alternative design.  Alleging a recall is insufficient to allege a design defect.  Warning claim TwIqballed due to failure to allege how the warning was defective and how the physician relied on the defect.  Implied warranty claim TwIqballed due to failure to allege defect as previously described.  Express warranty claims are TwIqballed due to failure to state the warranty.  Other claims TwIqballed due to:   formulaic pleadings (device).
  126. Knoppel v. St. Jude Medical, Inc., 2013 WL 3803612 (C.D. Cal. May 7, 2013).  All claims TwIqballed due to failure to specify product defects or state how they caused injury.  Warranty claim TwIqballed due to failure to allege privity (device).
  127. Kwasniewski v. Sanofi-Aventis U.S., LLC, 2013 WL 2558283 (D. Nev. June 8, 2013).  All claims TwIqballed due to:   failure to plead causation.  Warning claim TwIqballed due to failure to allege what the warnings were, who received them, and how the warning was inadequate (drug).
  128. Bertini v. Smith & Nephew, Inc., 2013 WL 6332684 (E.D.N.Y. July 15, 2013).  All claims TwIqballed due to: to formulaic pleadings.  The nature of the defect is not stated.  Merely pleading a recall without defect or causation allegations is insufficient.  No alternative design pleaded. Rejecting loose Bausch pleading standard.  Negligence allegations came “from some form book” (device)
  129. In re Pradaxa Products Liability Litigation, 2013 WL 3791509 (S.D. Ill. July 18, 2013).  Class action allegations TwIqballed due to formulaic pleadings (drug).
  130. Batchelor v. Pfizer, Inc., 2013 WL 3873242 (N.D. Ala. July 25, 2013).  All claims TwIqballed due to:   to formulaic pleadings and failure to plead nature of injury and when plaintiff took the drug.  Warning claim TwIqballed due to failure to plead inadequacy as to treating physician and how warnings were inadequate.  Negligence claim TwIqballed due to failure to plead duty violated.  Negligence per se claim TwIqballed due to failure to identify what provision violated and how.  Warranty claim TwIqballed due to failure to plead what made product unmerchantable (drug).
  131. Ball v. Takeda Pharmaceuticals America, Inc., 2013 WL 4040395 (E.D. Va. Aug. 8, 2013).  Most claims (those not dismissed on the merits) TwIqballed due to:  formulaic pleadings that fail to specify the defect and lumping defendants together.  Negligence per se claims TwIqballed due to failure to identify the enactment violated (drug).
  132. Marsar v. Smith & Nephew, 950 F. Supp.2d 1228 (M.D. Fla. Aug.14, 2013).  All claims TwIqballed due to:   indiscriminate incorporation by reference; lumping differently situated defendants together; and repetitive and irrelevant and redundant factual allegations.  Design defect claim TwIqballed due to lack of description of defect.  Negligence claim TwIqballed due to no facts how defendant knew or should have known of defect.  Warranty claim TwIqballed due to formulaic pleadings (device).
  133. Scianneaux v. St. Jude Medical, S.C., 961 F. Supp.2d 808 (E.D. La. Aug. 19, 2013).  All claims TwIqballed due to:   formulaic pleadings.  All claims except express warranty TwIqballed due to failure to plead claims under exclusive product liability statute.  FDCA violation claims TwIqballed due to failure to plead what regulation was violated and how.  A recall does not establish a violation.  Warranty claims TwIqballed due to failure to plead what the warranty was and how it was violated (device).
  134. Kennedy v. Pfizer, Inc., 2013 WL 4590331 (W.D. La. Aug. 28, 2013).  Manufacturing defect claim TwIqballed due to failure to state how the product was not what the manufacturer intended to make.  Design defect claim TwIqballed due to failure to plead how the product was defective or caused injury.  Warning defect claim TwIqballed due to failure to plead the defect, causation, or who prescribed the product.  Express warranty claim TwIqballed due to failure to plead what was false about the defendant’s promotion (drug).
  135. Bueno v. St. Jude Medical Inc., 2013 WL 12142536 (C.D. Cal. Sept. 24, 2013).  All parallel claims TwIqballed due to:  failure to plead the nature  of the injury so that causation by the violation could be evaluated (device).
  136. McPhee v DePuy Orthopedics, Inc., 2013 WL 5462762, slip op. (W.D. Pa. Sept. 30, 2013).  All unpreempted claims TwIqballed due to:  failure to allege what FDCA violations were violated, or how, and failure to plead what the express warranty was and how it was violated (device).
  137. Bradley v. Baxter Healthcare Corp.,  2013 WL 5952060 (W.D.N.C. Nov. 6, 2013).  All unpreempted claims TwIqballed due to: failure to allege what FDCA violations were violated (device).
  138. Bergstresser v. Bristol-Myers Squibb Co., 2013 WL 6230489 (M.D. Pa. Dec. 2, 2013).  Warning claims TwIqballed due to failure to plead causation.  No facts support an allegation that a different warning would have affected the prescriber’s conduct so as to alter the result (drug).
  139. Simon v. Smith & Nephew, Inc., 990 F. Supp.2d 395 (S.D.N.Y. Dec. 3, 2013).  Strict liability design claims fail to plead any alternative design.  Alleging that the defendant “could have manufactured a different product altogether . . . does not itself make out a plausible claim of a design defect.”  Negligence and warranty design claims TwIqballed due to formulaic pleadings.  Pleading a recall does not plead a defect (device).
  140. Christison v. Biogen Idec, Inc., 2013 WL 6834371 (D. Utah Dec. 26, 2013).  Warning claims TwIqballed due to formulaic pleadings.  Plaintiff must plead what information made the warnings inadequate at the time the drug was taken and how adequate warnings would have affected the prescriber’s decision (drug).
  141. Witt v. Howmedica Osteonics Corp., 2013 WL 6858395 (S.D. Fla. Dec. 30, 2013).  All claims TwIqballed as “shotgun” pleadings due to indiscriminate incorporation by reference.  Design defect claim TwIqballed due to failure to plead what component of a “complex” product was defective and how.  Warning defect claim TwIqballed due to failure to address the product’s warnings.  Negligence claim TwIqballed due to formulaic pleadings and failure to plead facts about alleged lapses of due care (device).
  142. Wells v. Allergan, Inc., 2014 WL 117773, slip op. (D.S.C. Jan. 13 2014).  Parallel violation claim in PMA preemption case TwIqballed due to failure to plead the particular defect, the regulation violated, or causation as to any claimed FDCA violation (device).
  143. Poll v. Stryker Sustainability Solutions, Inc., 2014 WL 199150 (D. Ariz. Jan. 17, 2014), post-Stengel warning claim asserting failure to submit adverse events to the FDA TwIqballed due to failure to identify the unreported information or the nature of the adverse events, or to identify any FDA action supporting the non-reporting allegations (device).
  144. Hawkins v. Medtronic, Inc., 2014 WL 346622, slip op. (E.D. Cal. Jan. 30, 2014).  Failure to report claims TwIqballed due to failure to plead causation.  There is no showing the timing of late reports influenced the plaintiff’s treatment.  Violation claims TwIqballed due to failure to identify the enactments violated.
  145. Kashani-Matts v. Medtronic, Inc., 2014 WL 819392 (C.D. Cal. Feb. 14, 2014).  Parallel claims in PMA medical device preemption case TwIqballed due to: failure to plead any supporting facts.
  146. Starks v. Coloplast Corp., 2014 WL 617130, slip op. (E.D. Pa. Feb. 18, 2014).  All unpreempted claims TwIqballed.  Parallel violation claim TwIqballed as boilerplate.  Express warranty claims TwIqballed due to failure to plead the warranty, how it was made, how it became part of the basis of the bargain, or how it was directed to plaintiff.  Contract claims TwIqballed due to failure to plead how a sales brochure was a contract (device).
  147. Kitchen v. Biomet, Inc.,  2014 WL 694226 (E.D. Ky. Feb. 21, 2014).  All unpreempted claims TwIqballed. Parallel violation claim in PMA preemption case TwIqballed because nature of the claimed violation was not specified (device).
  148. Plumlee v. Pfizer, Inc., 2014 WL 695024 (N.D. Cal. Feb. 21, 2014).  Allegations of delayed discovery TwIqballed.  Case dismissed on statute of limitations grounds (drug).
  149. Swisher v. Stryker Corp., 2014 WL 1153716 (W.D. Okla. March 14, 2014). Negligence per se allegation asserted as parallel claim in PMA preemption case TwIqballed due to failure to state how FDA regulations were violated and how the violations caused injury (device).
  150. Burkett v. Smith & Nephew GMBH, 2014 WL 1315315, slip op. (E.D.N.Y. March 31, 2014).  Parallel violation claims in PMA preemption case TwIqballed due to failure to state what FDA regulations were violated and how the violations caused injury (device).
  151. Dilley v. C.R. Bard, Inc., 2014 WL 1338877 (C.D. Cal. April 3, 2014).  Manufacturing defect claims TwIqballed due to formulaic pleadings.  Warning defect claims TwIqballed due to failure to identify the allegedly defective warnings (device).
  152. Vasquez v. Gloucester County, 2014 WL 1599499 (D.N.J. April 21, 2014).  Design defect claims TwIqballed due to failure to plead an alternative design.  Punitive damages claim TwIqballed due to failure to plead any New Jersey exception that would allow a claim against an FDA-approved product (device).
  153. Williamston v. Medtronic, Inc., 2014 WL 2042004 (W.D. La. May 15, 2014).  Parallel violation claims in PMA preemption case TwIqballed due to failure to state how the alleged violation corresponded to any state-law defect and for failure to plead causation.  Plaintiffs not entitled to discovery until TwIqbal is satisfied (device).
  154. Miller v. Pfizer, Inc., 2014 WL 2155020 (N.D. Ala. May 22, 2014).  All claims TwIqballed due to failure to plead how the defendant’s warnings were inadequate.  Although not attached to the complaint, drug warnings alleged to be inadequate were properly before the court on a motion for judgment on the pleadings under the incorporation by reference doctrine (drug).
  155. Smith v. Medtronic, Inc., 2014 WL 2547813, slip op. (W.D. La. June 4, 2014).  Parallel violation claims in PMA preemption case TwIqballed due to conclusory allegations.  Plaintiff failed to plead how the defendant promoted the product off-label to her physician or how such promotion caused her injuries (device).
  156. Arnold v. Alphatec Spine, 2014 WL 2896838 (S.D. Ohio June 26, 2014).  TwIqballed due to Allegations against all defendants TwIqballed due to failure to plead allegations against different defendants separately.  All claims TwIqballed due to conclusory assertions and the rambling, disorganized, and undecipherable nature of the complaint.  Particularity is not the same as prolixity (device).
  157. In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. June 27, 2014).  A parallel misbranding claim requires pleading of the new and scientifically significant information in the hands of the defendant that was not before the FDA.  Allegations based on “information and belief” TwIqballed due to a plaintiff’s belief not providing a plausible basis for anything (generic drug).
  158. Lirette v. Depuy Mitek LLC, 2014 WL 3341358, slip op. (W.D. La. July 7, 2014).  All claims TwIqballed due to formulaic pleadings (device).
  159. Dimieri v. Medicis Pharmaceuticals Corp., 2014 WL 3417364 (M.D. Fla. July 14, 2014).   All claims TwIqballed due to formulaic pleadings. Warning defect claims TwIqballed due to failure to plead physician involvement required by learned intermediary rule (drug).
  160. McElroy v. Amylin Pharmaceuticals, Inc., 573 F. Appx. 545 (6th Cir. Aug. 5, 2014).  All claims TwIqballed due to failure to plead causation of plaintiff’s injuries (drug).
  161. Cordova v. Smith & Nephew, Inc., 2014 WL 3749421 (E.D.N.Y. July 30, 2014).  Unpreempted express warranty claim TwIqballed due to formulaic pleadings (device).
  162. Kennedy v. Pfizer, Inc., 2014 WL 4093065, slip op. (W.D. La. Aug. 15, 2014).  All claims TwIqballed due to formulaic pleadings.  Manufacturing defect claim did not allege how product deviated from specifications.  Design defect claim did not allege alternative design or how risks outweighed benefits.  Warning defect claim did not allege causation under learned intermediary rule.  Express warranty claim did not allege the warranty (drug).
  163. Carlson v. Medtronic Inc., 2014 WL 11514911 (S.D. Miss. Aug. 28, 2014).  Possibly unpreempted manufacturing defect claim TwIqballed due to vagueness. Complaint did not identify allegedly violated regulation, state how the product deviated from FDA requirements, or allege how the violation caused plaintiff’s injury (device).
  164. Rodman v. Stryker Sales Corp., 2014 WL 5002095 (S.D.N.Y. Oct. 7, 2014).  All claims TwIqballed due to failure to plead defect or causation.  “Including but not limited to” does not plead a specific defect.  Pleading a remote in time recall does not plead defect.  Affirmed 604 F. Appx. 81 (2d Cir. May 21, 2015) – plaintiff failed adequately to allege how his device was defective and how any defect caused his injuries (device).
  165. Lirette v. Depuy Mitek LLC, 2014 WL 5445777 (W.D. La. Oct. 20, 2014).  Manufacturing defect claim TwIqballed due to formulaic pleading (device).
  166. Lindler v. Mentor Worldwide LLC, 2014 WL 6390307, slip op. (D.S.C. Oct. 23, 2014).  Express warranty claim TwIqballed due to formulaic pleading (device).
  167. Mallory v. Biomet, Inc., 2014 WL 6890740 (M.D. Ala. Dec. 4, 2014).  All claims TwIqballed due to formulaic pleadings.  A broken device without more does not state a claim (device).
  168. Becker v. Smith & Nephew, 2015 WL 268857 (D.N.J. Jan. 20, 2015).  All claims barred as formulaic pleadings failing to establish the elements of product liability claims under the NJ product liability statute.  Manufacturing defect must plead deviation from intended result.  Design defect must specify defect and address risk utility factors.  Warning claim must state nature of inadequate warning, that the risk was known to exist and was not obvious, and causation.  The warranty language for an express warranty is not pleaded.  Dismissed a second time, 2015 WL 4647982 (D.N.J. Aug. 5, 2015), violation claims TwIqballed due to failure to specify violated enactments; express warranty TwIqballed due to formulaic pleadings (device).
  169. Shells v. X-Spine Systems, Inc., 2015 WL 736981 (W.D. Okla. Feb. 20, 2015).   All claims TwIqballed due to formulaic pleadings.  The complaint does not even allege what the medical device is or who manufactured it.  “Probably” is not enough.  The nature of the alleged defect is not specified (device).
  170. Lonon v. Globus Medical, Inc., 2015 WL 1032861 (S.D. Ga. March 9, 2015).  All claims TwIqballed due to formulaic “shotgun” pleading.  The type and model of the product must be identified.  How the product was defective is not pleaded.  The type of warranty is not specified (device).
  171. Jackson v. St. Jude Medical Neuromodulation Division, 2015 WL 1456650, slip op. (M.D. Fla. March 30, 2015).  All claims, including purported “parallel” claims in PMA preemption case TwIqballed due to formulaic pleadings (device).
  172. Mendez v. Shah, 94 F. Supp.3d 633 (D.N.J. March 30, 2015).  Express warranty TwIqballed due to formulaic pleadings (device).
  173. Morton v. Allergan, Inc.,  2015 WL 12839493 (D.N.J. April 2, 2015).  All unpreempted claims TwIqballed due to formulaic pleadings.  Express warranty claim did not state terms of warranty.  Manufacturing defect claims stated no facts (device).
  174. Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. April 21, 2015).  Warranty claims TwIqballed due to formulaic pleadings (device).
  175. Williams v. CIBA Vision Corp., 2015 WL 1903429 (S.D. Miss. April 27, 2015).  Parallel violation claims TwIqballed due to:  failure, in a preemption case, plead an FDCA violation other than with formulaic conclusions.   Plaintiff’s unsupported “belief” is insufficient (device).
  176. Mercado v.  Bayer Healthcare Pharmaceuticals, Inc., 2015 WL 3545238, slip op. (N.D. Ill. June 5, 2015).  All claims, including express warranty, TwIqballed due to formulaic pleadings (device).
  177. Clements v. Sanofi-Aventis, U.S., Inc., 111 F. Supp.3d 586 (D.N.J. June 11, 2015).  Parallel violation claims TwIqballed due to failure to specify the violation or causation.  Express warranty claims TwIqballed due to formulaic pleadings, including failure to state what the alleged warranty said (device).
  178. Doe v. AstraZeneca Pharmaceuticals, LP, 2015 WL 4661814, slip op. (E.D. La. Aug. 5, 2015).  All non-preempted claims TwIqballed due to formulaic pleadings.  Warning claims must plead the specific adverse effect allegedly not adequately warned of and why the warning was inadequate.  Express warranty must plead the specific promise or representation and how the product failed to conform.  John Doe complaints are not allowed (drug).
  179. Ortiz v. Allergan, Inc., 2015 WL 5178402 (S.D.N.Y. Sept. 4, 2015).  Parallel violation claims TwIqballed due to:  failure to plead factual basis for claims of violation of GMPs, and lack of support by any FDA action.  Warranty claims also inadequately pleaded (device).
  180. Blair v. Medtronic, Inc., 2015 WL 5728050 (N.D. Cal. Sept. 30, 2015).  All claims TwIqballed due to formulaic pleadings.  Form state-court complaint was “epitome” of “threadbare” pleading barred under Rule 8 (device).
  181. Nevolas v. Boston Scientific Corp., 2016 WL 347721 (W.D. Okla. Jan. 28, 2016).  Parallel violation claims TwIqballed due to:  vague pleading of violations of multiple, generally-applicable FDA regulations.  Confidentially of PMAs does not excuse conclusory pleading.  Dismissed with prejudice for same flaws after amendment, 2016 WL 1532259 (W.D. Okla. April 15, 2016) (device).
  182. Tsavaris v. Pfizer, Inc., 2016 WL 375008 (S.D. Fla. Feb. 1, 2016).  Design defect claim TwIqballed due to formulaic pleadings.  Warning claim TwIqballed due to failure to plead what was in the existing warning and why that was inadequate or exactly how the warning should have been rewritten.  Plaintiff failed to plead how dual compliance with state and federal law was possible to avoid preemption (drug).
  183. Ellis v. Smith & Nephew, Inc., 2016 WL 7319397 (D.S.C. Feb. 16, 2016).  Parallel violation claims TwIqballed due to: failure to plead the nature of the violation or causation.  Express warranty claim TwIqballed due to formulaic pleadings.  Plaintiff not entitled to discovery (device).
  184. Guidry v. Janssen Pharmaceuticals, 2016 WL 633673 (E.D. La. Feb. 17, 2016).  All claims TwIqballed due to formulaic pleadings.  No facts support a deviation for a manufacturing defect.  Nature of design defect and how it could have been cured not pleaded.  No allegation how warning was inadequate.  No allegation that plaintiff suffered the condition mentioned in an FDA safety announcement.  No allegation of reliance or causation as to warranty (drug).
  185. Felger v. Smith & Nephew, Inc., 2016 WL 8673054 (D. Alaska March 4, 2016).  Parallel violation claims TwIqballed due to:  formulaic pleadings that fail to identify what regulations were violated or whether adverse events were, in fact, not reported (device).
  186. Brazil v. Janssen Research & Development LLC, 249 F. Supp.3d 1321 (N.D. Ga. March 24, 2016).  All claims TwIqballed due to formulaic pleadings and lumping all defendants together.  Lumping all defendants together also precluded any allegations from supporting personal jurisdiction over any of the defendants (drug).
  187. Schmidt v. Boston Scientific Corp., 2016 WL 1274824 (N.D. Ohio March 31, 2016).  Parallel violation claims TwIqballed due to:  failure to identify any allegedly violated regulations (device).
  188. Weddle v. Smith & Nephew, Inc., 2016 WL 1407634 (N.D. Ill. April 11, 2016).  All claims TwIqballed due to:  product identification – failure to identify which of three manufacturer’s implanted products failed (device).
  189. Yosowitz v. Covidien LP, 182 F. Supp.3d 683 (S.D. Tex. April 23, 2016).    Parallel violation claims TwIqballed due to:  failure to identify the allegedly violated regulations, describe the violations, or plead how they were causal (device).
  190. Woods v. Wyeth, LLC, 2016 WL 1719550 (N.D. Ala. April 29, 2016).  Unpreempted failure-to-update claims TwIqballed due to:  lumping differently situated “defendants” together in overly broad causation allegations (generic drug).
  191. Adams v. Stryker Orthopaedics, 2016 WL 2993213 (S.D.N.Y. May 23, 2016).  All claims TwIqballed due to:  failure to allege the product problem claimed to make it defective, whether a defect affected the device the plaintiff received or how a defect caused plaintiff’s injuries (device).
  192. Fleming v. Janssen Pharmaceuticals, Inc., 186 F. Supp.3d 826 (W.D. Tenn. June 6, 2016).  All claims TwIqballed due to:  formulaic pleadings.  Description of how drug works does not plead defect (drug).
  193. Teixeria v. St. Jude Medical S.C., Inc., 193 F. Supp.3d 218 (W.D.N.Y. June 30, 2016).  “Information and belief” allegations TwIqballed where facts were within plaintiff’s control.  Express warranty claims TwIqballed due to failure to plead the specific promise or representation.  Parallel violation claims TwIqballed due to failure to plead causation from FDA actions (device).
  194. Chiasson v. Medtronic Inc., 2016 WL 4191837 (E.D. La. Aug. 9, 2016).  Parallel violation claims TwIqballed due to:  due to formulaic pleadings.  Because of the potential for preemption, courts require greater specificity in pleading parallel claims (device).
  195. Morrison v. Hoffmann-La Roche, Inc., 2016 WL 5678546 (E.D.N.Y. Sept. 29, 2016).  Allegations in briefs but not in the complaint are ignored.  All claims TwIqballed due to:   lumping differently situated defendants together and formulaic pleadings.  Design claims must allege alternative design.  Manufacturing claims must allege deviation from intended result.  Negligence requires allegation of duty.  Express warranty must specify the warranty (drug).
  196. Moore v. C.R. Bard, Inc., 217 F. Supp.3d 990 (E.D. Tenn. Nov. 14, 2016).  All claims TwIqballed due to conclusory pleadings.  Product liability claims must plead what was wrong with the product and how it caused the plaintiff’s injury.  The composition of the product is insufficient.  That injury followed implantation is insufficient.  Manufacturing defect claims must allege the error in production.  Allegations cannot lump differently situated defendants together (device).
  197. Perry v. Boston Scientific Family, 2016 WL 10637082 (D. Minn. Dec. 1, 2016).  All claims TwIqballed due to conclusory pleadings (device).
  198. Weaver v. Ethicon, Inc., 2016 WL 7098781 (S.D. Cal. Dec. 6, 2016).  Parallel violation claims, including failure to report, TwIqballed due to failure to plead causation from FDA actions (device).
  199. House v. Bristol-Myers Squibb Co., 2017 WL 55876 (W.D. Ky. Jan. 4, 2017).  All claims TwIqballed due to:  formulaic pleadings (drug).
  200. Cure v. Intuitive Surgical, Inc., 2017 WL 498727, slip op. (N.D. Ga. Jan. 31, 2017).  All claims TwIqballed due to:  due to formulaic pleadings (device).
  201. Mikesell v. St. Jude Medical, Inc., 2017 WL 9565366 (Mag. N.D. Ind. Feb. 2, 2017).  Parallel violation claims TwIqballed due to conclusory pleadings.  Adopted 2017 WL 655862 (N.D. Ind. Feb. 17, 2017) (device).
  202. Lawrence v. Medtronic, 2017 WL 826963 (C.D. Cal. Feb. 27, 2017).  Parallel violation claims TwIqballed due to conclusory pleadings.  Parallel claims, including failure to report, must plead the actual violation and causation (device).
  203. Agee v. Alphatec Spine, Inc., 2017 WL 5706002 (S.D. Ohio March 27, 2017), aff’d, 711 F. Appx. 791 (6th Cir. Feb. 22, 2018).  All claims TwIqballed due to:  prolix and confusing pleadings that make it difficult to formulate a responsive pleading (device).
  204. Aston v. Johnson & Johnson, 248 F. Supp.3d 43 (D.D.C. March 31, 2017).  Common-law warning claims TwIqballed due to conclusory pleadings.  Plaintiffs failed to plead contents of warnings, inadequacy, timing of use of drug, timing of injuries, warning causation, injury, or injury causation.  Express warranty claims TwIqballed due to failure to state the warranty (drug).
  205. Webb v. Stryker Corp., 2017 WL 1406899 (W.D. Pa. April 20, 2017).  Negligent design and manufacturing claims TwIqballed due to:  due to conclusory pleadings – failure to specify which component was defective or how manufacturing process went wrong.  Failure to allege causation – claimed propensity to loosen could not have caused infection (device).
  206. Rincon v. Covidien, 2017 WL 2242969 (S.D.N.Y. May 22, 2017).  All claims TwIqballed due to:  due to formulaic pleadings.  Belated facts stated in briefing did not substitute for proper pleading (device).
  207. Lussan v. Merck Sharp & Dohme Corp., 2017 WL 2377504 (E.D. La. June 1, 2017).   All claims TwIqballed due to:  due to formulaic pleadings.  Manufacturing claims must identify a deviation from the defendant’s specifications and plead causation.  Warning claims must identify risks not disclosed to the prescribing doctor, and how the omission was causal.  Express warranty claims must identify the warranty, state how it was untrue, and include facts indicating reliance (drug).
  208. Bigsby v. Davol, Inc., 2017 WL 2472274 (S.D. Ind. June 8, 2017).  All claims TwIqballed due to:  due to formulaic pleadings (device).
  209. Jeffries v. Boston Scientific Corp., 2017 WL 2645723 (D. Md. June 20, 2017).  All claims TwIqballed due to failure to allege causation.  Design, manufacturing, and implied warranty claims TwIqballed due to failure to allege a defect.  Warning claims TwIqballed due to failure to allege what warnings were defective and how (device).
  210. Golden v. Brown, 2017 WL 3272368 (Colo. Dist. June 27, 2017).  Colorado follows TwIqbal.  All claims TwIqballed due to failure to allege product identification.  Recall-based claims TwIqballed due to failure to allege that plaintiff had the recalled product.  Parallel violation claims TwIqballed due to failure to allege what regulations were violated.  Failure to report claims TwIqballed due to failure to allege what was not reported or causation.  Express and implied warranty claims TwIqballed due to formulaic pleadings (device).
  211. Freed v. St. Jude Medical, Inc.,  2017 WL 4102583 (D. Del. Sept. 15, 2017).   Parallel violation claims TwIqballed due to conclusory pleadings.  No specific violations alleged.  No basis for alleging “adulterated” device.  Documents attached to briefs cannot be considered (device).
  212. Sich v. Pfizer Pharmaceutical, 2017 WL 4407930 (D.N.J. October 4, 2017).  All claims TwIqballed due to:  due to formulaic pleadings.  Neither the nature of any defect nor the terms of any warranty are alleged (drug).
  213. Griffin v. Medtronic, Inc., 2017 WL 4417821 (N.D. Ill. Oct. 5, 2017).  All claims TwIqballed due to:  due to formulaic pleadings.  Complaint lacked any description of defect or causation, including prescriber causation under learned intermediary rule.  “[T]he allegations of undisclosed warnings are too vague to establish that [defendant] failed to disclose anything to [plaintiff’s] doctors that they did not already know.”  Warranty claims required the warranty language and how product was unmerchantable (device).
  214. Wright v. Howmedica Osteonics Corp., 2017 WL 4555901 (M.D. Fla. Oct. 12, 2017).  All claims TwIqballed due to:  due to formulaic pleadings.  A recall does not equal a defect.  Warning claims must plead causation.  Affirmed by 741 F. Appx. 624, below (device).
  215. Martin v. Medtronic, Inc., 2017 WL 4574160 (E.D. Cal. Oct. 13, 2017).  Parallel violation claims TwIqballed due to:  failure, in a preemption case, to plead an FDCA violation involving the plaintiff’s device, and failure to allege any adverse events that were not reported.  Express warranty claims fail to plead the terms of the warranty or reliance (device).
  216. Cerniglia v. Zimmer, Inc., 2017 WL 4678201 (D.N.J. Oct. 17, 2017).  All claims TwIqballed due to:  due to formulaic pleadings (device).
  217. Ideus v. Teva Pharmaceuticals USA, Inc., 2017 WL 6389630, slip op. (D. Neb. Dec. 12, 2017).  Warning claim (the sole claim remaining) TwIqballed due to:  failure, in a preemption case, to plead any facts establishing that information relevant to the claim was “newly acquired” after the product’s approval, so that it would qualify for the CBE exception to preemption (generic drug).
  218. Owen v. Dr. Reddy’s Laboratories, 2017 WL 6820197 (W.D.N.C. Dec. 13, 2017).  All claims TwIqballed due to:  due to formulaic pleadings (generic drug).
  219. Douse v. Boston Scientific Corp., 2017 WL 9672522, slip op. (M.D. Fla. Dec. 18, 2017).  All claims TwIqballed due to:  due to formulaic pleadings (device).
  220. Smith v. Medtronic, Inc., 2018 WL 921986 (D. Kan. Jan. 12, 2018).  Recall based claim TwIqballed due to failure to plead that the recall applied to the plaintiff’s product (device).
  221. McGuire v. NorthBay Medical Center, 2018 WL 453736 (E.D. Cal. Jan. 16, 2018).  All claims TwIqballed due to:  due to formulaic pleadings.  Defendant joined in obviously irrelevant claims.  No pleading of specific product, nature of defect, causation, or nature of warranty (device).
  222. Black v. Covidien, PLC, 2018 WL 573569 (W.D.N.Y. Jan. 26, 2018).  All claims TwIqballed due to:  formulaic pleadings.  Causation not adequately alleged as to design or warning defects (device).
  223. Bell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 928237 (W.D. Pa. Feb. 15, 2018).  All claims TwIqballed due to:  formulaic pleadings.  Description of how drug works does not plead defect.  Roles of each defendant not pleaded.  How and why the product was defective not pleaded.  Alternative design and causation not pleaded (drug).
  224. McGee v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 1399237 (N.D. Ala. March 20, 2018).  All claims TwIqballed due to:  formulaic pleadings.  Much of the complaint simply “spews legal conclusions.”  Warning claim, in order to avoid preemption, must plead what newly acquired information was not warned of (drug).
  225. Tutwiler v. Sandoz, Inc., 726 Fed. Appx. 753 (11th Cir. April 9, 2018).  Dismissal affirmed because warning claim TwIqballed due to failure to plead causation under the learned intermediary rule.  Plaintiff must plead, in more than a conclusory fashion, why an adequate warning would have caused the treating physician not to prescribe the drug (generic drug).
  226. Blanchard v. Merck & Co., 2018 WL 8244568 (M.D. Fla. May 21, 2018).  All claims TwIqballed due to failure to plead separate allegations against differently situated defendants (drug).
  227. Bell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 2447788 (W.D. Pa. May 31, 2018).  All claims TwIqballed due to:  formulaic pleadings.  What new information the defendant learned that should have changed the warning not pleaded.  Nor what a revised warning should have said, nor causation.  No alternative design pleaded, only different products (drug).
  228. Oden v. Boston Scientific Corp., 330 F. Supp.3d 877 (E.D.N.Y. June 4, 2018).  All claims TwIqballed due to:  due to formulaic pleadings.  Design claims must plead nature of defect and a feasible alternative design.  A different product cannot be an alternative design.  Manufacturing defect claim must allege what deviated from specifications.  Warning claim failed to identify how or why the warnings were inadequate.  Plaintiff’s actual injuries not alleged so cannot be matched against warnings.  Prescriber-specific facts must be alleged to establish causation by inadequate warning.  Language, reliance, and breach of express warranty must be alleged.  Implied warranty fails when defect claims fail.  Particular purpose warranty must plead a particular purpose other than the product’s ordinary purpose.  Causation not pleaded for consumer protection claim (device).
  229. Weaver v. Ethicon, Inc., 737 F. Appx. 315 (9th Cir. June 12, 2018).  Affirming all claims being TwIqballed.  Manufacturing defect claim TwIqballed due to failure to plead use of recalled product or nature of defect.  Failure to report TwIqballed due to failure to plead a causal failure to report.  Prescriber had access to one allegedly unreported incident and used the product anyway, and the plaintiff’s own incident could not possibly be causal (device).
  230. Pellegrin v. C.R. Bard, 2018 WL 3046570 (E.D. La. June 20, 2018).  All claims TwIqballed due to:  due to formulaic pleadings.  Warning claim must plead causation, including that the prescriber would not have prescribed.  Design claims must plead nature of defect and a feasible alternative design (device).
  231. Quashie v. Olympus America, Inc., 315 F. Supp.3d 1329 (N.D. Ga. June 19, 2018).  All claims TwIqballed due to failure to plead separate allegations against differently situated defendants (device).
  232. Proffitt v. Bristol-Myers Squibb Co., 2018 WL 3318893, slip op. (S.D.W. Va. July 5, 2018).  Warning claims TwIqballed due to failure to plead how the warnings were inadequate or what an alternative should say (drug).
  233. Wright v. Howmedica Osteonics Corp., 741 F. Appx. 624 (11th Cir, July 5, 2018).  Dismissal of all claims being TwIqballed affirmed due to:  due to formulaic pleadings.  Complaint must state nature of defect.  Affirming 2017 WL 4555901, above (device).
  234. Murphy v. Boston Scientific Corp., 2018 WL 4870700 (Mag. M.D. La. July 12, 2018).  Parallel claims TwIqballed due to:  formulaic pleadings.  Plaintiff failed to plead any specific defect that violated any particular FDA requirement and failed to plead causation.  Express warranty also not pleaded.  Adopted as to TwIqbal issues; rejected on not giving plaintiff a chance to amend, 2018 WL 6046178 (M.D. La. Nov. 19, 2018) (device).
  235. Quintana v. B. Braun Medical, Inc., 2018 WL 3559091 (S.D.N.Y. July 24, 2018).  All claims TwIqballed due to:  due to formulaic pleadings.  Design claims must plead nature of defect and cannot rest on res ipsa.  Warning claim must state how warning was inadequate and how it affected prescriber’s conduct in a causal fashion.  Express warranty must plead reliance and a product defect.  Learned intermediary precludes reliance needed for negligent misrepresentation.  Consumer fraud failed to plead reliance or causation (device).
  236. Bryant v. Thoratec Corp., 343 F. Supp.3d 594 (S.D. Miss. July 30, 2018).  Manufacturing defect claim TwIqballed due to:  due to formulaic pleadings.  No causal connection to plaintiff’s injury.  Allegation that discovery will establish nature of violations insufficient (device).
  237. Dendinger v. Covidien LP, 2018 WL 4462579 (E.D. La. Sept. 18, 2018).  All claims TwIqballed due to:  due to formulaic pleadings (device).
  238. Tears v. Boston Scientific Corp., 344 F. Supp.3d 500 (S.D.N.Y. Sept. 29, 2018).  All claims TwIqballed due to:  due to formulaic pleadings.  Design defect claims must identify a defect and an alternative design.  Manufacturing defect claims must identify how the product diverged from the defendant’s intended result.  A warning claim mist indicate how the warning was inadequate when the warning mentions that risk that the plaintiff encountered.  Express warranty claim failed to allege how the statements advanced as warranties were not true.  Implied warranty claims were same as strict liability.  No particular purpose different from the device’s intended use was alleged (device).
  239. Winkler v. Medtronic, Inc., 2018 WL 6271055 (D. Md. Nov. 15, 2019).  All claims TwIqballed due to failure to plead any facts establishing a parallel claim in a PMA preemption case.  Plaintiff given one last chance to plead a proper parallel claim.
  240. Broge v. ALN International, Inc., 2018 WL 6308194 (N.D. Cal. Dec. 3, 2018).  All claims TwIqballed due to:  due to formulaic pleadings.  Warning claim must allege risk known at time of manufacture and prescriber causation under learned intermediary rule.  Manufacturing defect claim must allege deviation from specifications.  A general reference to every conceivable form of communication cannot plead negligent misrepresentation.  No pleading that warranty was breached (device).
  241. Knoles v. Teva Pharmaceuticals United States, 2019 WL 295258 (N.D. Cal. Jan. 23, 2019).  All claims TwIqballed due to failure to plead any facts establishing product identification.  Lumping defendants together and use of “and/or” pleading is improper (device).
  242. Calloway v. Coloplast Corp., 2019 WL 2169222 (Mag. W.D. La. Feb. 5, 2019), adopted, 2019 WL 2166539 (W.D. La. May 17, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  Design claims must allege an alternative design.  Warning claims must allege what was not warned about, and causation through the physician under the learned intermediary rule.  Warranty claims must allege the language of the warranty (device).
  243. Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir. March 26, 2019).  In a warning case, plaintiff must plead the “newly acquired evidence” on which the claim for a different warning rests, or the warning claim will be preempted (drug).
  244. Kennedy v. Covidien, LP, 2019 WL 1429979 (S.D.N.Y. March 29, 2019).  All claims TwIqballed.  Design claims must plead an alternative design, and not never using product.  Manufacturing defect claims cannot be mislabeled design claims.  Warning claim must allege how the warnings were inadequate or insufficient.  Express and implied warranty claims TwIqballed due to formulaic pleadings.  Unjust enrichment claims fail for not alleging a defective product (device).
  245. Nowell v. Medtronic, Inc., 372 F. Supp.3d 1166 (D.N.M. March 29, 2019).  All claims TwIqballed due to:  failure to plead causation.  Product liability claims TwIqballed due to failure to plead defect, alternative design, or causation.  Warning claims TwIqballed due to failure to plead that the surgeon would have acted differently or that a different warning would have prevented injury. Warranty claims TwIqballed due to failure to plead lack of merchantability.  On appeal at 19-2073 (10th Cir.).
  246. Peniston v. Medtronic, Inc., 2019 WL 1894745 (D.N.J. April 29, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  The complaint provides almost no factual allegations whatsoever.
  247. In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2019 WL 2137427 (E.D. Pa. May 2, 2019).  All claims in all MDL complaints TwIqballed due to:  boilerplate pleading leading to “allegations that are absurd on their face as to every plaintiff” (vaccine).
  248. Aguilar v. B Braun Medical Inc., 2019 WL 2173777 (M.D. Fla. May 20, 2019).  All claims in all MDL complaints TwIqballed due to:  “shotgun” pleading.  Plaintiff may not lump together allegations against different defendants.  Plaintiffs may not incorporate multiple counts by reference (device).
  249. Cantwell v. De La Garza, 2019 WL 2166541 (W.D. Okla. May 17, 2019).   All claims, including implied warranty of fitness, TwIqballed due to:  due to formulaic pleadings.  FDCA-based negligence per se requires pleading of specific particular statute or regulation that provides the duty allegedly violated (device).
  250. Grzanecki v. Smith & Nephew, Inc., 2019 WL 2297452 (N.D. Ill. May 30, 2019).  All claims TwIqballed due to:  due to formulaic pleadings. Manufacturing defect clam must plead how the product deviated from specifications.  Design defect must plead nature of defect and causation.  Warning defect must plead how warning is defective and causation under the learned intermediary rule (device).
  251. Carpenter v. Boston Scientific Corp., 2019 WL 3322091 (N.D. Tex. July 24, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  Design defect claims must plead an alternative feasible design.  Manufacturing defect claims must plead a deviation from the manufacturer’s intended design in the particular product, not a defect of the entire product line.  Warning defect cases must plead how the warnings are inadequate and that they were received by the plaintiff’s treating physician (device).
  252. Jacob v. Mentor Worldwide, LLC, 393 F. Supp.3d 912 (C.D. Cal. Aug. 1, 2019).  Parallel violation claims TwIqballed due to:  failure, in a preemption case, to plead any actual adverse events that were not reported. Manufacturing claims failed to specify the violated regulation, how any regulation was violated, or causation.  On appeal, No. 19-56391 (9th Cir.).
  253. Vieira v. Mentor Worldwide, LLC, 392 F. Supp.3d 1117 (C.D. Cal. Aug. 1, 2019).  Parallel violation claims TwIqballed due to:  failure, in a preemption case, to plead any actual adverse events that were not reported. Manufacturing claims failed to specify the violated regulation, how any regulation was violated, or causation.  On appeal, No. 19-56394 (9th Cir.).
  254. Dubroc v. Bristol Myers Squibb, 2019 WL 3756469 (M.D. La. Aug. 8, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  Design defect claims must plead an alternative feasible design.  Warning claims must allege how the learned intermediary would have acted differently with an adequate warning.  Express warranty claims must allege the terms of the warranty and how it became the basis of the bargain (reliance).
  255. Heaton v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 4060097 (S.D. Ind. Aug. 28, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.
  256. Green v. Covidien LP, 2019 WL 4142480 (S.D.N.Y. Aug. 30, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  Plaintiff’s complaint made allegations about the wrong product.  An alternative design must be pleaded to establish a design defect.  Manufacturing defect claims must plead how the product deviated from the intended result.  Pleading injury is a non sequitur.  Injury as circumstantial evidence of malfunction is defeated by the injury being warned about.  A warning claim cannot be pleaded solely with respect to injuries that were actually warned of.
  257. Cavanaugh v. Medtronic, PLC, 2019 WL 6768107 (D. Md. Sept. 25, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  Alleging malfunction alone does not state a plausible claim under any theory.
  258. Meredith v. Medtronic, Inc., 2019 WL 6330677 (S.D. Iowa Oct. 25, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  Plaintiff must plead the elements of a product liability action under the Iowa statute.  Design defect claims must allege how the required alternative design would have prevented injury.  Manufacturing defect claims must plead a deviation from the intended result.  Warning claims must allege what warnings were given and how they were insufficient.
  259. Hindermyer v. B. Braun Medical, Inc., 419 F. Supp.3d 809 (D.N.J. Oct. 30, 2019).  All claims TwIqballed due to:  due to formulaic pleadings.  Plaintiff must plead the elements of a product liability action under the NJ statute.  Design defect requires pleading a feasible alternative design.  Manufacturing defect claims must plead a deviation from the intended result.  Warning claim must plead a failure to warn about a risk the the plaintiff actually suffered.  Warning defect and express warranty claims must pertain to risks the plaintiff actually suffered.
  260. Winkler v. Medtronic, Inc., 2019 WL 6052702 (D. Md. Nov. 15, 2019).  Parallel violation claim TwIqballed in PMA preemption case due to:  due to formulaic pleadings.  Merely stating that the device generally violated some non-specific FDA “standards” is insufficient.  A recall alone does not plead an FDA violation, or causation.
  261. Allo v. Allergan USA, Inc., 2020 WL 32439 (E.D. La. Jan. 2, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.  Manufacturing defect claim must allege what standards were deviated from and the nature of the deviation.  Warning claim must allege how the warning was inadequate.  Express warranty claim must allege the language of the warranty and how it was breached.  Redhibition claim must allege must allege the relevant industry standards and how the product did not comply.
  262. Marshall v. Smith & Nephew, Inc., 2020 WL 362803 (D. Minn. Jan. 22, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.  Where preemption is possible, a claim is not plausible and must be dismissed where it does not allege the  FDA classification and relevant approval process of the device.  Plaintiff must also allege his condition, the outcome for which his implant was intended, other potential factors leading to his symptoms and revision surgery, and causation.  Warning claim must allege defendant’s knowledge of the risk, what warnings were or should have been issued (by and to whom), and how such a hypothetical warning would have changed the course of events.
  263. Oliver v. Covidien LP, 2020 WL 564957 (E.D. La. Feb. 5, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.  Warning causation, requires pleaded facts that a proper warning would have changed the prescriber’s decision to use the product.  Design defect requires pleading a safer alternative design.  Express warranty claims must identify the warranty.  Manufacturing defect claims must allege the relevant product standard and the nature of the deviation from it.
  264. Boris v. Atrium Medical Corp., 2020 WL 589440 (S.D.N.Y. Feb. 6, 2020), Cosh v. Atrium Medical Corp., 2020 WL 583826 (S.D.N.Y. Feb. 6, 2020), and Bustamante v. Atrium Medical Corp., 2020 WL 583745 (S.D.N.Y. Feb. 6, 2020).  Three identical opinions for TwIqbal purposes.  All claims TwIqballed due to:  due to formulaic pleadings.  Design claim must plead alternative design.  Where injuries are common, circumstantial proof unavailable and plaintiff must specify the manufacturing defect.  Warning claim must specify the inadequate warning language.  Negligent misrepresentation, consumer protection, and express warranty claims fails to plead either the false statements or reliance.  Implied warranty must plead facts why product is not reasonably fit for its intended purpose.  Remaining claims fall with the others.
  265. Taylor v. Medtronic, Inc., 2020 WL 886118 (N.D.N.Y. Feb. 24, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.  Warning claim must allege how the warning was inadequate and causation.  Design defect requires pleading a feasible alternative design not avoiding use of product altogether.  Manufacturing defect claims must plead a deviation from the intended result.  Express warranty claim must allege the language of the warranty.  Implied warranty fails where no valid product defect is pleaded.
  266. Bartlett v. Pfizer, 2020 U.S. Dist. Lexis 31040 (W.D. Ky. Feb. 24, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.  Plaintiff fails to plead causation.
  267. Saltis v. Nuvasive, Inc., 2020 WL 4689787 (D. Vt. March 13, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.
  268. Fischer v. Boston Scientific Corp., 2020 WL 2300138 (C.D. Cal. March 25, 2020).  All claims dismissed.  Warning claim TwIqballed due to:  failure to identify the implanting physician was, the warning the physician received, how those warnings were inadequate, and what injuries resulted.
  269. Green v. W. L. Gore & Associates, Inc., 2020 WL 1666790 (D. Idaho April 3, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.  Neither defect nor causation are properly pleaded.  An alleged recall is not tied to plaintiff’s case.  Nature of warning’s alleged inadequacy is not pleaded.
  270. Burgess v. Pfizer, Inc., 2020 WL 1812010 (E.D.N.C. April 9, 2020).  Warning (only claim brought) TwIqballed due to:  failure to allege newly acquired information sufficient to avoid preemption.  Warning claims also require pleading that defendant knew or should have known of dangers not included in its warning label, and that the warning label played any role in the prescriber’s decision to prescribe, plaintiff’s decision to take it, and that a different label plausibly would have changed these decisions.
  271. Cofresi v. Medtronic, Inc., ___ F. Supp.3d ___, 2020 WL 1887862 (W.D. Tex. March 30, 2020).  All claims TwIqballed.  Design defect must state an alternative design that is not a different product.  Manufacturing claim challenged the design, not a unit-specific defect.  Warning claim must state how the warning was inadequate and “must identify what [the] surgeon was warned or what the surgeon reviewed in order to allege” causation.  Punitive damages and gross negligent claims are conclusory.  Loss of consortium must plead a marriage at the time of product use.  Express warranty is totally conclusory.
  272. Kahler v. Merck Sharp & Dohme Corp., 2020 WL 2745667 (W.D. Wash. May 27, 2020).  All claims TwIqballed due to:  due to formulaic pleadings.  Unclear what type of defect plaintiff alleged.  As to warnings, plaintiff failed to plead that the product was not reasonably safe or causation.
  273. Batiste v. Stryker Corp., 2020 WL 3451690 (M.D. La. June 24, 2020) (applying Louisiana law).  All claims TwIqballed due to:  due to formulaic pleadings.  Manufacturing defect must plead some deviation from a manufacturer specification.  Design defect must plead an alternative design. Warning defect must plead what the nature of the defect is and how it caused injury.  Express warranty claim must allege how that alleged warranty was false.
  274. Miles v. Boston Scientific Corp., 2020 WL 3871329 (S.D. Tex. July 9, 2020).  Warning claims TwIqballed due to failure to identify the warning her doctor received, to allege how it was inadequate, and to allege how any failure caused injury.

After Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), was decided, we decided it was time to retire our old device preemption scorecard. The big question, whether PMA device manufacturers are protected by preemption, was resoundingly answered “yes.”

But since then, we’ve said repeatedly that we don’t expect plaintiffs to just fold their tents and go away – and they haven’t. Rather, we expect the other side to look for loopholes in Riegel – even if we don’t think there are any – especially in the area of so-called “parallel” claims.

Anyway, it’s been six months since Riegel was decided, and the decisions addressing such arguments are starting to pile up. So we’ve decided to resurrect and revamp our device preemption scorecard with special emphasis on what Riegel “loophole” arguments are made and how courts decide them. So here goes (drumroll, please), the new and updated druganddevicelaw device PMA preemption scorecard:

  1. Strini v. Edwards Lifesciences Corp., 2008 WL 820192 (Mag. N.D.N.Y. March 26, 2008). Heart valve prosthesis case.  Preemption issues cannot be decided in context of a discovery motion. “Parallel” violation claims might escape preemption.
  2. Stevens v. Pacesetter, Inc., 2008 WL 2637417 (D.S.C. April 1, 2008).  Device not stated, but probably some sort of pacemaker.  No “parallel” violation claims pleaded; action preempted in its entirety.
  3. Despain v. Bradburn, 282 S.W.3d 814 (Ark. April 10, 2008). Plaintiff’s claims preempted against manufacturer of hearing device. No manufacturing defect claim pleaded.
  4. O’Shea v. Cordis Corp., 2008 WL 3139428 (Fla. Cir. May 19, 2008), mandamus denied, 24 So.3d (Fla. App. 2009). Drug eluting coronary stent.  Off-label use does not preclude preemption where the defect (in design claim) or risk (in warning claim) is common to both on- and off-label use. True “parallel” violation claims, including off-label promotion are not preempted. Express warranty claims are not preempted. Fraud claims amounting to fraud on the FDA are preempted under Buckman. Unfair trade practice claims are preempted.
  5. Troutman v. Curtis, 185 P.3d 930 (Kan. June 20, 2008). Plaintiff barely pleaded, and entirely failed to prove, any unpreempted “parallel” violation claims against manufacturer of suturing device.
  6. Adkins v. Cytyc Corp., 2008 WL 2680474 (W.D. Va. July 3, 2008). Novasure endometrial ablation device.  A claim based on the activities of defendant’s on-site representative escapes preemption as not regulated by the FDA.
  7. Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008). Taking judicial notice of FDA PMA for defendant’s adhesion barrier device. Plaintiff failed to plead any unpreempted “parallel” violation claims either before or after FDA approval. Express warranty claims are unpreempted but inadequately pleaded. Leave granted to amend.
  8. Mattingly v. Hubbard, 2008 WL 3895381 (Ky. Cir. July 31, 2008). Plaintiff failed to prove any unpreempted “parallel” violation claims involving Targis microwave device. Negligent failure to train claims are preempted as “in addition to” the FDA’s requirements imposed upon the device.
  9. McCutcheon v. Zimmer Holdings, Inc., 586 F. Supp.2d 917 (N.D. Ill. Aug. 6, 2008). Violation claims involving information the manufacturer of a knee implant provided to the FDA are preempted by Buckman. No evidence supports post-approval claims, even if they could be unpreempted. Riegel overrules contrary anti-preemption precedent. Congressional legislation to overturn Riegel is of no significance until it is passed.
  10. Purcel v. Advanced Bionics Corp., 2008 WL 3874713 (N.D. Tex. Aug. 13, 2008). FDA filed suit against manufacturer of cochlear ear device for violating Good Manufacturing Practices requirements. Plaintiff’s strict liability and implied warranty claims that manufacturer sold adulterated product not preempted under Riegel.  Renewed motion denied, Purcel v. Advanced Bionics Corp.slip op. (N.D. Tex. June 24, 2010).
  11. Clark v. Medtronic, Inc., 572 F. Supp.2d 1090 (D. Minn. Aug. 18, 2008). Doctrine of res ipsa loquitur cannot be invoked to show that a device that failed had necessarily been manufactured improperly. Allegations about information withheld from FDA are preempted by Buckman, and would be an improper private right of action to enforce the FDCA. All claims in case involving an implantable cardioverter-defibrillator, including consumer protection, and breach of unspecified warranties, are preempted.
  12. Kavalir v. Medtronic, Inc., 2008 WL 4087950 (N.D. Ill. Aug. 27, 2008). Preemption motion to dismiss denied because available information did not conclusively establish that the  implantable cardioverter-defibrillator in question had PMA approval.
  13. Walker v. Medtronic, Inc., 2008 WL 4186854 (S.D.W. Va. Sept. 9, 2008). Preemption motion denied without prejudice in infusion pump case. Plaintiff could amend complaint to allege “parallel” FDCA violations, but the issue would be rejoined after discovery concerning the defendant’s evidence that it was in full compliance.
  14. Carson v. Depuy Spine, Inc., 2008 WL 7258800, order (C.D. Cal. Sept. 17, 2008). Summary judgment on preemption grounds granted against all claims spinal disc implant case. Allegations of off-label promotion as “parallel” claim failed: (1) because mere sales rep presence during an off-label surgery isn’t promotion, and (2) for lack of evidence of reliance or causation.  Affirmed 365 F. Appx. 812 (9th Cir. 2010).
  15. Rollins v. St. Jude Medical, Diag Division, Inc., 2008 WL 11395511 (Mag. W.D. La. Sept. 25, 2008).  Motion to dismiss granted in part and denied in part in Angio-Seal case.  All claims based on FDCA compliant acts are preempted.  Claims alleging violations not preempted.  Failure to train and report escape preemption only if violations occurred.  Failure to report the plaintiff’s incident could not possibly be causal.
  16. Parker v. Stryker Corp., 584 F. Supp.2d 1298 (D. Colo. Oct. 22, 2008). Motion to dismiss on preemption grounds granted in hip implant case. Plaintiff failed to plead any facts supporting “parallel” claims. Preemption cannot be avoided by reference to adulteration and misbranding because there is no private right of action under the FDCA. Express warranty claims involving product labeling are preempted.
  17. Rollins v. St. Jude Medical, 583 F. Supp.2d 790 (W.D. La. Oct. 20, 2008). Motion to dismiss plaintiff’s claim that defendants failed to abide by FDA reporting requirements granted in part and denied in part in Angio-Seal case. Plaintiff conceded that all claims were preempted except failure to manufacture/package in accordance with FDA specifications, failure to train, and failure to abide by reporting requirements. Noncompliance claims not preempted. Manufacturing defect claim based on product recall not preempted. Failure to train claim preempted to the extent of FDA compliance. Failure to report claim dismissed for lack of causation.
  18. Link v. Zimmer Holdings, Inc., 604 F. Supp.2d 1174 (N.D. Ill. Nov. 26, 2008). Summary judgment granted against all claims concerning total knee replacement prosthesis. No factual dispute as to compliance with FDA requirements. Rejected loopholes: fraud on the FDA (preempted), post-approval defect (relies on dissent; no proof); congress might change the statute (hasn’t).
  19. Lake v. Kardjian, 22 Misc.3d 960, 874 N.Y.S.2d 751 (N.Y. Sup. Dec. 17, 2008). Summary judgment granted against all claims concerning Targis transurethral microwave therapy system. Plaintiff failed to identify any specific statement exceeding FDA-approved warnings that could qualify as an unpreempted express warranty. Post approval failure to report claims are preempted either as fraud on the FDA or prohibited private FDCA violation claims.
  20. Huber v. Howmedica Osteonics Corp., 2008 WL 5451072 (D.N.J. Dec. 31, 2008). Motion to dismiss denied against complaint alleging solely a claim for express warranty in total hip replacement litigation. The court considered itself bound by pre-Riegel Third Circuit precedent. The question whether express warranty claims are preempted was certified to the Third Circuit. Huber v. Howmedica Osteonics Corp., 2009 WL 2998160 (D.N.J. March 10, 2009), but no appellate decision ever occurred.
  21. In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. Jan. 5, 2009), reconsideration denied, 2009 WL 294353 (D. Minn. Feb. 5, 2009), leave to amend complaint denied, 2009 WL 1361313 (D. Minn. May 12, 2009). Motion to dismiss granted against all claims in Sprint Fidelis MDL. Manufacturing defect claims not “parallel” because no specific violations alleged, or allegeable given generality of FDA regulations. Parallel claims do not exist without a specific FDA regulation for state-law claims to parallel. Adulteration claims amount to prohibited private attempts to enforce the FDCA. Negligence per se only supplies a standard of care, and cannot resurrect an otherwise preempted claim. An express warranty of “safety” would require a jury to find a device unsafe, which is preempted. This is an appealable order, motion practice in the district court appears exhausted, and the matter is currently on appeal.
  22. Hofts v. Howmedica Osteonics Corp., 597 F. Supp.2d 830 (S.D. Ind. Jan. 12, 2009). Motion to dismiss denied as to claims “based on theories that [defendant] failed to comply with federal requirements for manufacturing” a hip replacement prosthesis. Surviving claims include those for express and implied warranty and consumer fraud. All non-violation claims had been voluntarily dismissed.
  23. Means v. Howmedica Osteonics Corp., 2009 WL 347407 (S.D. Ind. Feb. 11, 2009), minute order following Hofts in hip replacement prosthesis case.
  24. Blunt v. Medtronic, Inc., 315 Wis.2d 612, 760 N.W.2d 396 (Wis. Feb. 17, 2009). Pre-Riegel ruling in favor of PMA preemption affirmed in implantable defibrillator case. Both PMA and supplemental PMA have equal preemptive effect. Supplemental approval does not diminish the preemptive effect of initial approval.
  25. Horowitz v. Stryker Corp., 613 F. Supp.2d 271 (E.D.N.Y. Feb. 20, 2009). Motion to dismiss granted as to claims involving total hip prosthesis. All claims except manufacturing defect are preempted, including consumer fraud. Warning letters and recalls not involving the device in question do not create parallel claims. A plaintiff must plead how a particular violation caused injury. The manufacturing claim must be more specifically pleaded. Express warranty claims not based on the approved labeling would escape preemption.
  26. Shertzer v. Howmedica Osteonics Corp., 2009 WL 535997 (S.D. Ind. March 3, 2009), minute order following Hofts in hip replacement prosthesis case.
  27. Delaney v. Stryker Orthopaedics, 2009 WL 564243 (D.N.J. March 5, 2009). Motion to dismiss granted in part and denied in part as to claims involving hip prosthesis. Violation claims, even if not preempted under Lohr, are preempted as attempted private FDCA enforcement under Buckman. Express warranty claims are not preempted, but are insufficiently pleaded. Manufacturing defect claims are preempted without specific allegations of a deviation from FDA-approved specifications.
  28. Dorsey v. Allergan, Inc., 2009 WL 703290, slip op. (M.D. Tenn. March 11, 2009). Summary judgment granted as to claims involving investigational breast implants. Riegel applies to Class III devices marketed pursuant to an IDE or its equivalent. FDA approval of both adjunct (equivalent to an IDE) and core studies (an actual IDE) has preemptive effect.
  29. Gortarez v. White Memorial Medical Center, 2009 WL 8710587 (Cal. Super. March 23, 2009).   Summary judgment granted as to claims, including failure to train physicians, involving a laser and shaft unit.  Training requirements were part of the PMA approval.  Fraud on the FDA claims are preempted by Buckman.  No parallel claims were alleged.
  30. Mitaro v. Medtronic, Inc., 23 Misc. 3d 1122(A), 886 N.Y.S.2d 71, 2009 WL 1272398 (N.Y. Sup. April 9, 2009) (unreported). Motion to dismiss granted against almost all claims, including consumer fraud, in implantable cardiac defibrillator case. Manufacturing defect claim could be a parallel violation claim. Negligence per se claim is preempted both as restating other preempted claims and as attempted private FDCA enforcement. Express warranty claim preempted only to the extent it relies upon FDA-approved statements. Claims predicated on false statements to the FDA are preempted under Buckman. A product recall does not vitiate preemption.  The Appellate Division affirmed in a one-paragraph opinion, Mitaro v. Medtronic, Inc., 73 A.D.3d 1142, 900 N.Y.S.2d 899 (N.Y.A.D. May 25, 2010).
  31. Heisner v. Genzyme Corp., 2009 WL 1210633 (N.D. Ill. April 30, 2009). Motion to dismiss granted as to all claims in anti-adhesive surgical barrier case. Negligence per se claims related to events that post-dated plaintiff’s injuries and thus couldn’t possibly be causal. All other claims are preempted. Express preemption claims based on FDA-approved language are preempted.
  32. Miller v. DePuy Spine, Inc., 638 F. Supp.2d 1226 (D. Nev. May 1, 2009). Granting summary judgment against all claims in a spinal implant disc case, including express warranty because the claimed warranty concerned aspects of device safety and effectiveness. Plaintiff had no evidence to support allegations of violation of FDA manufacturing standards. Allegations of fraud on the FDA are preempted under Buckman and as they are a prohibited attempt at private FDCA enforcement, would not constitute negligence per se under Nevada law.
  33. Mullin v. Guidant Corp., 114 Conn.App. 279, 970 A.2d 733 (Conn. App. May 12, 2009), affirming Mullin v. Guidant Corp., 2008 WL 2785498 (Conn. Super. April 8, 2008). All claims, including manufacturing defect and express and implied warranties, are preempted in action involving implantable defibrillator. Plaintiff did not plead anything that could be considered a “parallel” violation claim. Preemption does not deprive a court of subject matter jurisdiction.  The Connecticut Supreme Court declined to review the case.  292 Conn. 921, 974 A.2d 722 (2009).
  34. Mitchell v. Howmedica Osteonics Corp., 2009 WL 10720098 (S.D. Ind. May 22, 2009). Motion to dismiss denied in action involving hip implant.  Following Hofts, above, 597 F. Supp.2d 830.
  35. Riley v. Cordis Corp., 625 F. Supp.2d 769 (D. Minn. June 5, 2009). Judgment on the pleadings granted as to all claims in drug eluding stent case. A “parallel” claim involves conduct “forbidden” by the FDCA. Even a claim involving prohibited conduct may be impliedly preempted as an improper private FDCA action under Buckman. To escape Buckman, a claim must rely on traditional state tort theories. Preemption applies to off-label uses. A combination of a drug and a device will be treated as a device for preemption purposes where the FDA has regulated the product as a device.  The device cannot be divided into components.  Allegations that the FDA is poorly run do not defeat preemption. Allegations of promoting off-label use escape preemption only if, in addition to violating the FDCA, the promotion failed to warn of risks in violation of the common law. All other warning related claims are preempted. Fraud claims must be specifically pleaded. Express warranty claims based upon the device’s label are preempted. Manufacturing defect claims must allege a violation in the particular device at issue. Any claims not dismissed with prejudice must be repleaded. This case is reportedly on appeal in the Eighth Circuit at No. 09-2870.
  36. Bencomo v. Guidant Corp., 2009 WL 1951821, slip op. (E.D. La. June 30, 2009). Summary judgment on preemption granted against express warranty claims involving embolism capture system. Alleged contradiction between patient material and product labeling could not support a claim where the language in both sets of material were FDA approved. A claim dependent upon the falsity of FDA approved language cannot be a parallel claim.
  37. Colombini v. Westchester County Health Care Corp., 24 Misc.3d 1222(A), 899 N.Y.S.2d 58, 2009 WL 2170230 (N.Y. Sup. July 6, 2009). Summary judgment granted against all claims in action involving an MRI device. That the device had been downclassified to Class II did not eliminate preemption, as the device was initially PMA approved. Plaintiffs could not point to any FDA design requirement that defendant violated, therefore there was no viable parallel claim.
  38. Prudhel v. Endologix Inc., 2009 WL 2045559 (E.D. Cal. July 9, 2009). Motion to dismiss granted in part in aortic stent case. Alleged express warranty of safety was preempted. Alleged parallel claims are preempted when they impose greater requirements on compliant manufacturers. Parallel claims that require “more than mere noncompliance” are not preempted. A manufacturing defect claim, involving product recalls, survives preemption. Strict liability, negligence, and implied warranty claims are preempted.
  39. Cenac v. Hubble, 2009 WL 10678961 (E.D. La. July 31, 2009), motion to dismiss denied on all claims in SynchroMed medication pump case.  However, since plaintiffs failed to plead any unpreempted parallel claim, they must file an amended complaint doing so.
  40. Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009). Motion to dismiss granted against all claims in ceramic total hip replacement case. Finding broad preemption of state tort claims that “incidentally” regulate medical devices. Parallel violation allegations can escape express preemption, but are subject to implied preemption. Rejects argument that preemption may only be decided on summary judgment. Rather than vitiating the preemption defense, allegations of fraud on the FDA are themselves preempted. FDA warning letters issued after plaintiff’s surgery, and thus not relating to the product implanted in plaintiff cannot support an unpreempted parallel claim. To plead an unpreempted parallel violation claim requires alleging a specific federal requirement, how it was violated, and how the violation caused this plaintiff’s injury. Express warranty and consumer fraud claims are too vaguely pleaded to escape preemption.
  41. In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, 2009 WL 2600517, slip op. (M.D. Ga. Aug. 24, 2009). Motion to dismiss granted against punitive damages claim asserted under New Jersey law because fraud on the FDA exception to the statutory ban on punitive damages against FDA-approved products is barred by preemption under Buckman.  Cautionary note:  this opinion was vacated on state-law grounds (whether the product was covered by the statutory ban in the first place) in In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, 2009 WL 4280829 (M.D. Ga. Nov 24, 2009).
  42. William Beaumont Hospital v. Medtronic, Inc., 2009 WL 2849546 (E.D. Mich. Aug. 31, 2009). Motion to dismiss granted in part. All claims based on alleged inadequacy of warnings are preempted in case concerning pain pump refill kits. Contribution claims based upon the negligent distribution of an incorrect free sample that was not in fact the same device as represented are not preempted.
  43. Williams v. Cyberonics, Inc., 654 F. Supp.2d 301 (E.D. Pa. Sept. 10, 2009). Summary judgment granted against all claims in two cases involving vagus nerve stimulation devices. Unknown manufacturing defects inferred from alleged device malfunction were preempted because proof of a failure to manufacture the device to comply with FDA design requirements was shown.  Affirmed memorandum, 388 F. Appx. 169 (3d Cir. July 30, 2010).
  44. Musembi v. DePuy Spine, Inc., 2009 WL 106938061 (D. Nev. Sept. 21, 2009). Summary judgment granted against all claims, including express warranty in case involving artificial invertebral disc.  No mention of any parallel claims.  No collateral estoppel by pre-Riegel decisions.
  45. Mansoor v. American Medical Systems, Inc., 2009 WL 10693227 (D. Nev. Nov. 19, 2009).  Summary judgment granted against all claims in case involving urinary control system.  No mention of any parallel claims.
  46. Williams v. Allergan USA, Inc., 2009 WL 3294873 (D. Ariz. Oct. 14, 2009). Summary judgment granted against all claims in ruptured breast implant case involving IDE device. Claims of lack of valid consent are factually false. No pleaded facts support any violation claim. That PMA approval occurred only after the plaintiff’s device was implanted does not prevent preemption, since essentially the same device was approved. A non-waiver clause in an informed consent form does not override preemption.
  47. In re Medtronic Sprint Fidelis Leads State Court Litigation, 2009 WL 3417867, slip op. (Minn. Dist. Hennepin Co. Oct. 20, 2009). Motion to dismiss granted against all claims in state court Sprint Fidelis litigation. Express warranty and consumer fraud claims preempted. Purported “parallel” claims dismissed because: (1) they are disguised private attempts to enforce the FDCA, which are impliedly preempted under Buckman; (2) there is no parallel state law claim for failure to follow the conditions of an FDA PMA; (3) there is no federal requirement to submit a CBE (it’s strictly voluntary); (4) claims challenging the sufficiency of a defendant’s submissions to the FDA are disguised fraud-on-the-FDA claims; (5) plaintiffs’ design claims would impose rigid specificity that FDA regulations do not; (6) nothing in the FDA’s regulations requires withdrawal of a device because an allegedly “safer” model was later approved; (7) there is no obligation to submit a PMA supplement immediately after learning of problems with an existing device; (8) certain alleged violations were not causally connected to any plaintiff’s injuries; (9) adulteration claims are disguised private attempts to enforce the FDCA; negligence per se claims are disguised private attempts to enforce the FDCA; (10) a statute that does not authorize a private cause of action cannot be the basis of a negligence per se claim under state law; and (11) the regulations subject to plaintiff’s negligence per se claims are only administrative requirements and do not prescribe standards of care owed to any individual.
  48. Williams v. Endologix, Inc.slip op., 2009 WL 3554581 (Ky. Cir. Oct. 30, 2009). Summary judgment granted against all claims in some kind (aortic stent?) of PMA device litigation, except claims “premised upon” FDCA violations, which the court considered parallel claims.
  49. McQuiston v. Boston Scientific Corp., 2009 WL 4016120, slip op. (W.D. La. Nov. 19, 2009). Summary judgment granted against all claims in a drug eluting stent case involving a combination device. Express warranty claim preempted. Plaintiff did not plead a “parallel violation” claim.
  50. Hayes v. Howmedica Osteonics Corp., 2009 WL 6841859 (D.N.J. Dec. 15, 2009) (bench opinion).  Motion to dismiss granted against all claims, including express warranty, in ceramic total hip prosthesis case.  No violation claims were properly pleaded.  A 2006 recall cannot be causally relevant to a device implanted in 2003.  Twiqbal bars speculative parallel violation claims.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.  The New Jersey punitive damages exception is preempted as based upon fraud on the FDA.  Rejecting Hofts.
  51. Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582 (E.D.N.Y. Dec. 28, 2009).  Motion to dismiss granted against plaintiff’s sole “negligence per se” claim involving a medication pump.  The allegedly violated Good Manufacturing Practices were too “vague and open-ended” to constitute a non-preempted parallel violation claim because they “would necessarily result in the imposition of standards that are different from or in addition to those imposed by the FDCA.”
  52. Risavich v. Heart Rhythm Consultants, 2010 WL 9585790 (N.Y. Sup. Feb. 1, 2010).  Summary judgment granted against all claims in action involving an implantable cardiac defibrillator.  Both PMA and supplemental PMA have equal preemptive effect.  Plaintiff failed to plead a parallel claim with specificity.  Implied warranty claims are preempted.
  53. Banner v. Cyberonics, Inc., 2010 WL 455286 (D.N.J. Feb. 4, 2010), summary judgment granted on all claims in action involving a vagus nerve stimulator.  A claimed that a device is a “lemon” because it malfunctioned in unspecified ways does not establish any FDA violation. There was no dispute that the device was manufactured according to FDA specifications.
  54. McGuan v. Endovascular Technologies, Inc., 182 Cal. App.4th 974, 106 Cal. Rptr.3d 277 (Cal. App. Feb. 9, 2010), affirming Johnson v. Endovascular Technologies, Inc., 2008 WL 3139424 (Cal. Super. May 19, 2008), and McGuan v. Endovascular Technologies, Inc., 2008 WL 3139418 (Cal. Super. May 19, 2008).  Summary judgment affirmed against all claims in case involving an endograft device.  Claimed “parallel” violation claim was really a preempted fraud on the FDA claim.  The defendant’s guilty plea did not establish the exception to Buckman because the FDA reapproved the device after the alleged fraud and the guilty plea did not require removal of the device from the market.
  55. Rankin v. Boston Scientific Corp., 2010 WL 672135 (E.D. Ky. Feb. 19, 2010), summary judgment granted on all claims in action involving a balloon catheter.  An allegation that the product failed under normal use does not establish a violation of FDA regulations.
  56. Heisner v. Genzyme Corp., 2010 WL 894054, slip op. (N.D. Ill. March 8, 2010).  Dismissing with prejudice a complaint that had been amended three times (see above for two earlier dismissals).  The device CBE requirements, being voluntary, could not be parallel to a post-sale duty to warn.  A failure to report adverse events to the FDA was not “defect” as required by strict liability.  Negligence per se claims involving post-injury events could not possibly be causal.
  57. Wheeler v. Depuy Spine, Inc., 706 F. Supp.2d 1264 (S.D. Fla. March 9, 2010), summary judgment granted on almost all claims in action involving off-label use of an artificial spinal disc.  Non-violation-related product liability claims are preempted.  Claims seeking to enforce the FDCA, that defendant “permitted” off-label use, and that defendant withheld adverse reaction reports were all preempted under Buckman.  A hearing will be held on express warranty claims, which are vulnerable to both preemption and non-preemption defenses.  Express warranty claim later dismissed on non-preemption grounds, 740 F. Supp.2d 1132.
  58. Lemelle v. Stryker Orthopaedics, 698 F. Supp.2d 668 (W.D. La. March 15, 2010), motion to dismiss granted on all claims involving total hip prosthesis.  Preemption of product liability claims was conceded.  Redhibition is equivalent to a breach of implied warranty and it preempted.
  59. Yost v. Stryker Corp., 2010 WL 1141586 (M.D. Fla. March 23, 2010), motion to dismiss granted against all claims involving hip prosthesis.  Plaintiffs pleaded no violation claims, so all tort claims were preempted.  Express warranty were inadequately pleaded.
  60. Anthony v. Stryker Corp., 2010 WL 1387790 (N.D. Ohio March 31, 2010), motion to dismiss granted on all claims involving total hip prosthesis. Generalized manufacturing defect allegations that do not mention FDCA violations cannot be recast as parallel violation claims. No causal link pleaded between FDA warning letters and device implanted in plaintiff.
  61. Adams v. I-Flow Corp., 2010 WL 1339948 (C.D. Cal. March 30, 2010), motion to strike claim that defendants failed to warn the FDA stricken as a fraud on the FDA claim preempted by Buckman.
  62. Lewkut v. Stryker Corp., 724 F. Supp.2d 648 (S.D. Tex. April 16, 2010), motion to dismiss granted on all claims involving total hip prosthesis.  A component of the system, which had originally received §510(k) clearance, was later included in the PMA and thus has PMA status for preemption purposes.  All claims, including manufacturing defect and consumer fraud, are preempted.  Plaintiff’s claim that his device was “adulterated” because a component was recalled for GMP issues is preempted under 21 U.S.C. §337(a) because adulteration claims are improper private enforcement of the FDCA.  Reconsideration denied, Lewkut v. Stryker Corp., 2010 WL 2542215 (S.D. Tex. June 21, 2010).
  63. Cenac v. Hubbell, No. CV 09-3686, 2010 WL 11537934 (E.D. La. April 16, 2010), motion to dismiss denied on all claims in SynchroMed medication pump case.  However, plaintiffs have still failed to plead any unpreempted parallel claim, and must file an amended complaint doing so.   All claims except those based on FDCA violations are preempted.  The GMPs at issue impose no specific requirements, and are too vague to support an unpreempted parallel claim.  Dismissed on subsequent motion, 2010 WL 4174573, below.
  64. Franklin v. Medtronic, Inc., 2010 WL 2543579 (Mag. D. Colo. May 12, 2010), adopted, 2010 WL 2543570 (D. Colo. June 22, 2010), summary judgment granted on all claims involving implantable defibrillator. Failure to recall claim was not a parallel claim because recall under the FDCA is a voluntary remedial action. Express warranty claims are preempted. FDA regulatory claim was conclusory under TwIqbal, and an improper attempted private FDCA cause of action.
  65. Van Dyke v. Howmedica Osteonics Corp., 2010 WL 8490858, tr. at 22-30 (D. Mont. May 14, 2010), motion to dismiss granted on all claims involving total hip prosthesis.  Express warranty claims and consumer fraud claims based on FDA-approved labeling are preempted.  Claims asserting a right to sue for FDCA violations are preempted by Buckman.
  66. Phillips v. Stryker Corp., 2010 WL 2270683 (E.D. Tenn. June 3, 2010), motion to dismiss denied as to “parallel” violation claims in total hip prosthesis case where a device recall applied to the plaintiff’s device.   A component of the system, which had originally received §510(k) clearance, was later included in the PMA and thus has PMA status for preemption purposes.  The public FDA record is subject to judicial notice.  Manufacturing defect theories based upon a claimed FDCA violation that formed the basis for the recall of the plaintiff’s device adequately states an unpreempted claim.  Reconsideration denied, 2010 WL 4238594 (E.D. Tenn. Oct. 21, 2010).
  67. Huber v. Medtronic, Inc., 2010 WL 4602686 (Cal. Super. June 4, 2010), summary judgment granted against all claims involving implanted PMA device.  No parallel claims alleged.
  68. Kallal v. Ciba Vision Corp., 2010 WL 2330365 (N.D. Ill. June 9, 2010), motion to dismiss granted in part on claims involving Optix contact lens.  All design and testing claims are preempted.  A parallel violation claim was sufficiently pleaded.  Plaintiff’s pleading that the violated standard was FDA-imposed was sufficient; defendant’s argument that the standard was only internal will not be decided on motion to dismiss.  There is a reasonable inference that a product purchased shortly before a recall was covered by the recall; it was not necessary to plead product identification numbers.  Remaining violation claim later dismissed on summary judgment because plaintiff could not prove a violation or causation, see below 2013 WL 328985.
  69. Howard v. Sulzer Orthopedics, Inc., 382 F. Appx. 436 (6th Cir. June 16, 2010) (unpublished), order preempting negligence per se claim in knee prosthesis case reversed.   While the FDA Good Manufacturing Practice plaintiff claims was violated could be read two different ways, other FDA materials suggest that a specific duty was imposed, therefore the regulation was enforceable.
  70. Steen v. Medtronic, Inc., 2010 WL 2573455 (N.D. Tex. June 25, 2010), motion to dismiss granted on all claims, including express and implied warranty, involving an Adapta pacemaker.  No parallel violation claim alleged.
  71. Poole v. Hologic, Inc., 2010 WL 3021528 (W.D. La. July 29, 2010), judgment on the pleadings granted on all claims, including express and implied warranty, involving a “controlled endometrial ablation system.”  No parallel violation claim alleged.
  72. Raleigh v. Alcon Laboratories, Inc., 403 Ill. App.3d 863, 934 N.E.2d 530 (Ill. App. Aug. 6, 2010), affirming summary judgment order preempting all claims in intraocular lens case.  No parallel violation claim alleged.  Further appeal denied, 942 N.E.2d 461 (Ill. 2010).
  73. Gow v. Medtronic, Inc., 2010 WL 3643754 (Ky. Cir. Aug. 26, 2010), summary judgment granted against all claims involving implantable infusion pump, including express preemption and consumer fraud.  Plaintiff fail to plead violation of FDA requirements with any detail and does not identify what was violated.  An FDA recall did not affect PMA approval.
  74. Aaronson v. American Medical Systems, 2010 WL 3603618 (E.D.N.Y. Sept. 7, 2010), motion to dismiss denied in case involving penile implant.  It was unclear at the pleading claim whether the device was actually a PMA device. Limited discovery on the device’s regulatory status is allowed and, if it is a PMA device, plaintiff has 14 days to file a more specific complaint.  Dismissed for failure to file amended complaint, 2012 WL 1712378.
  75. Gelber v. Stryker Corp., 752 F. Supp.2d 328 (S.D.N.Y. Sept. 14, 2010), motion to dismiss granted on all claims involving a total hip prosthesis.  Preemption extends to express warranty and consumer fraud claims.  Plaintiff fail to plead violation of FDA manufacturing requirements with any detail.  Rejecting “lax” pleading standard of Hofts.  Plaintiff must plead a “device-specific” violation and causation by the violation.  Later decision dismissing most claims, 788 F. Supp.2d 145, see below.
  76. Sanders v. Advanced Neuromodulation Systems, Inc., 44 So.3d 960 (Miss. Sept. 30, 2010), summary judgment affirmed on all claims involving a spinal cord stimulator.  Preemption was not defeated by the manufacturer’s unsuccessful attempt to have the device downclassified to Class II.  The FDA did not misinterpret its regulations in deciding that the device was Class III and requiring premarket approval.
  77. Bagumyan v. Medtronic, Inc., 2010 WL 4009891 (Cal. App. Oct. 14, 2010) (unpublished), summary judgment affirmed on all claims involving a Sprint Fidelis pacemaker lead. Supplemental PMA approval is equally preemptive as initial approval. The PMA process cannot be re-examined to test the quality of the FDA’s actual review.  Parallel requirements arguments fail for lack of any citation to anything allegedly violated.  Affirming 2008 WL 8071256 (Cal. Super. Dec. 29, 2008).
  78. In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200 (8th Cir. Oct. 15, 2010), summary judgment affirmed on all claims involving the Sprint Fidelis MDL.  With respect to parallel claims, express preemption under Riegel and implied preemption under Buckman create only a “narrow gap” for state-law claims.  Failure to warn claims not alleging any violation of FDA regulations are not “parallel” claims and are preempted.  Even if additional warnings were allowed they were not required; thus the claim is “different from or in addition to” and is preempted.  Levineinvolving implied preemption, is inapposite.  There is no federal requirement that unmodified products be removed from the market when a modified device is approved.  Claims that the defendant provided the FDA with insufficient information or withheld adverse event reports are private enforcement barred by Buckman.  Absent “concrete” allegations of FDCA violations, design defect claims are preempted.  General allegations of failure to comply with FDA Good Manufacturing Practices are too vague to escape preemption, and are a “frontal assault” on the FDA’s risk/benefit conclusion.  Express warranty claims based on “safety and effectiveness” would require a jury to find a device unsafe, creating a preempted conflict.
  79. Scoggins v. Boston Scientific Corp., 2010 WL 8911977, slip op. (Mass. Super. Oct. 18, 2010), summary judgment granted in part and denied in part in action involving drug eluting stent.  Off-label use does not preclude preemption.  Design defect claims are preempted.  Manufacturing defect claims that also allege FDCA violations escape preemption.  Attacks on off-label promotion allowed by the FDCA safe harbor are expressly preempted.  Most warning claims are preempted, unless plaintiff can show a reporting violation that also violates state common law.  A parallel claim for illegal off-label promotion that is also false escapes preemption.   Express warranty and consumer fraud claims based on FDA-approved statements are preempted, but any other statements are not.
  80. Cenac v. Hubble, 2010 WL 4174573, slip op. (E.D. La. Oct. 21, 2010), motion to dismiss granted on all claims in SynchroMed medication pump case.  GMPs and certain other regulations are too vague to support a “parallel” violation claim.  Allegations of post-PMA adverse event reporting violations are preempted fraud on the FDA claims.  Express and implied warranty claims are preempted.  Dismissed on subsequent motion, 2010 WL 4174573, below.
  81. Cornwell v. Stryker Corp., 2010 WL 4641112 (D. Idaho Nov. 1, 2010), motion to dismiss granted on all claims in Trident total hip implant case.  A component of the system, which had originally received §510(k) clearance, was later included in the PMA and thus has PMA status for preemption purposes.  Plaintiff should have modified allegations concerning the applicability of a product recall once the facts were clear, but Rule 11 sanctions will not be imposed.  A product recall not involving the product at issue cannot form the basis of a “parallel” violation claim.  An adulteration claim is a prohibited private FDCA right of action.
  82. Bishoff v. Medtronic, Inc., 2010 WL 4852650, slip op. (N.D.W. Va. Nov. 22, 2010), motion to dismiss granted on all claims in pacemaker lead case.  Manufacturing defect/negligence per se claims were improperly pleaded because they didn’t identify “how or why” there was a regulatory violation.  Express warranty claims were improperly pleaded.  Implied warranty for a particular purpose claims were preempted.
  83. Norks v. Endovascular Technologies, Inc., 2010 WL 4681417 (Cal. App. Nov. 19, 2010) (unpublished), summary judgment affirmed (2008 WL 5267875) against all claims in case involving an endograft device.  Riegel applies to investigational devices.  Plaintiff did not plead any parallel violation claims.  Fraud on the FDA claims were preempted, thus an amendment was properly denied as futile.
  84. Robinson v. Endovascular Technologies, Inc., 190 Cal. App.4th 1490, 119 Cal.Rptr.3d 158 (Cal. App. Nov. 19, 2010), summary judgment affirmed (2008 WL 5267874) against all claims in case involving an endograft device.  Riegel applies to investigational devices.  Plaintiff did not plead any parallel violation claims.
  85. Burgos v. Satiety, Inc., 2010 WL 4907764 (E.D.N.Y. Nov. 30, 2010), summary judgment granted on all claims, including breach of warranty, in investigational gastric stapling system device case.  IDE devices are subject to FDA supervision that’s identical to PMA for preemption purposes.  Blanket reference to violation of unspecified statutes and regulations cannot suffice to state a parallel violation claim.  Plaintiff can amend.  Motion to dismiss (2011 WL 1327684) and summary judgment (2013 WL 801729) later granted against all claims, see below.
  86. Warren v. Howmedica Osteonics Corp., 2010 WL 5093097 (E.D. Mo. Dec. 8, 2010), motion for reconsideration denied, 2011 WL 1226975 (March 29, 2011), claims based solely on FDCA violations survive preemption in Trident total hip implant case.  The court follows Hofts with respect to pleading and allows violation claims without pleading causation.
  87. Barnes v. Howmedica Osteonics Corp., 2010 WL 11565343 (N.D. Ala. Dec. 14, 2010), summary judgment granted on all claims in case involving hip implant.  Implied warranty preempted.  Parallel claim inadequately pleaded.  A recall does not establish an FDCA violation.  Vague regulatory claim would also be impliedly preempted.
  88. Pardo v. Medtronic Inc., 2010 WL 5300847 (E.D. La. Dec. 15, 2010), summary judgment granted on all claims in case involving brain stimulation device.  Terse order is unclear which claims are barred as preempted and which are barred for other reasons.  Off-label use does not defeat preemption.
  89. Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. Dec. 23, 2010), reversing Bausch v. Stryker Corp., 2008 WL 5157940 (N.D. Ill. Dec. 9, 2008), manufacturing-related claims based solely on FDCA violations survive a motion to dismiss on the basis of preemption in Trident total hip implant case.  Violation claims related to FDA GMPs are sufficiently specific, at the pleading stage, to escape preemption.  The claims are not impliedly preempted because as pleaded there is no conflict with the federal regulations.   Before a plaintiff has discovery, it is not necessary to plead specifically what regulation was violated and how, as to do so may be impossible.
  90. Couvillier v. Allergan, Inc., 2011 WL 8879258, slip op. (Mag. W.D. La. Jan. 20, 2011), adopted, 2011 WL 8879259 (W.D. La. Feb. 9, 2011), motion to dismiss granted against all claims involving breast implant.  No parallel claims mentioned.
  91. Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. Jan. 21, 2011), reversing Hughes v. Boston Scientific Corp., 669 F. Supp.2d 701 (S.D. Miss. Nov. 12, 2009).  All warning and design product liability claims were properly dismissed as preempted.  Violation claims that paralleled traditional state warning and negligence per se claims were not preempted under Riegel.  A formal FDA finding of violation is not required to avoid preemption.  Unexplained FDA silence is not equivalent to approval.  Because the plaintiff’s violation claims paralleled existing state tort claims, there was no preemption under Buckman.
  92. Funk v. Stryker Corp., 631 F.3d 777 (5th Cir.  2011), affirming Funk v. Stryker Corp., 673 F. Supp.2d 522 (S.D. Tex. Dec. 1, 2009), dismissal of all claims against hip implant as preempted is affirmed.  Dismissal of violation claims based upon res ipsa loquitur are implied preempted.  Plaintiff failed to plead any other violation claim with sufficient specificity.  It was proper to take judicial notice of FDA PMA documents.
  93. Cafferty v. Cayuga Medical Center, 2011 WL 541809 (N.D.N.Y. Feb. 8, 2011), motion to dismiss granted against all claims against intraocular lens.  Without any positive allegation of a violation of FDA regulations, a manufacturing defect claim is preempted.  Res ipsa loquitur cannot establish a regulatory violation.
  94. Cohen v. Guidant Corp., 2011 WL 637472, slip op. (C.D. Cal. Feb. 15, 2011), motion to dismiss granted against all claims involving pacemaker.  Plaintiff pleaded only boilerplate FDA regulations as a parallel claim with no attempt to plead that they caused him injury.
  95. Timberlake v. Synthes Spine, Inc., 2011 WL 711075 (S.D. Tex. Feb. 18, 2011), summary judgment granted against all claims, including express warranty, involving artificial intervertebral spinal disc.  Plaintiff’s fraud on the FDA claim was impliedly preempted by Buckman.  Plaintiff had no evidence to establish a causal violation claim.
  96. Nimtz v. Cepin, 2011 WL 831182 (S.D. Cal. March 3, 2011), motion to dismiss granted against all claims involving pacemaker. Plaintiff did not allege a parallel violation claim.
  97. Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296 (11th Cir. March 8, 2011), summary judgment affirmed against all claims against spinal pain pump system.  Plaintiff failed to plead the elements of a parallel claim with any specificity.  Plaintiff is not entitled to any inference of defect due to the loss of a critical component because a defect was not the most probable cause of injury with other causes not ruled out.  Claims against sales representative dismissed under same rationale.  Affirming 641 F. Supp. 2d 1270 (M.D. Fla. July 22, 2009).
  98. Carrelo v. Advanced Neuromodulation Systems, 777 F. Supp.2d 303 (D.P.R. March 8, 2011), summary judgment granted against some claims against impulse generator.  Plaintiff’s claim that he did not receive any of the FDA-approved warnings concerning the device is not preempted because it does not seek any changes in the approved warnings.  Manufacturing defect claims are preempted because a failure does not equal a violation and because plaintiff does not tie a subsequent recall to the device at issue.  Design defect claims are preempted.
  99. White v. Stryker Corp., 818 F. Supp.2d 1032 (W.D. Ky. March 25, 2011), motion to dismiss granted against all claims involving hip implant.  Plaintiff failed to plead the elements of a parallel claim with any specificity.  Plaintiff neither pleaded a violation of a device-specific FDA requirement, nor that any violation pertained to the implanted device.
  100. Warren v. Stryker Corp., 2011 WL 1226975 (E.D. Mo. March 29, 2011), motion to dismiss denied in part against parallel violation claims involving hip implant.  Allowing plaintiffs to use discovery to determine which particular PMA specifications defendants may have violated.
  101. Knight v. St. Jude Medical, 2011 WL 1230815 (W.D. Mich. March 31, 2011), motion to dismiss granted against all claims involving internal cardiac defibrillator except allegations that manufacturer’s representative was aware of the malfunctioning of the particular device and failed to warn the treating physicians.  Adopting 2011 WL 1230819 (Mag. W.D. Mich. Jan. 11, 2011).  Summary judgment granted against remaining claims, 2012 WL 5878804 (W.D. Mich. Nov. 21, 2012).
  102. Schwartz v. Mulhall, 2011 WL 10989741 (N.Y. Sup. April 12, 2011), summary judgment granted against all claims involving penile prosthesis.  Claims were indistinguishable from Riegel.  No parallel claim mentioned.
  103. Godfrey v. Advanced Neuromodulation Systems, Inc., 2011 WL 7768092 (W.D. La. April 4, 2011), summary judgment granted against all claims involving implantable pulse generator.  A manufacturing defect claim predicated on violation of FDA regulations would not have been preempted, but plaintiff alleged only deviations from the manufacturer’s own standards, and the latter claim is preempted.  Design and express warranty claims are preempted.
  104. Burgos v. Satiety, Inc., 2011 WL 1327684 (E.D.N.Y. April 5, 2011), motion to dismiss granted against most claims involving IDE stomach stapling device.  Negligent manufacturing claim is dismissed as it does not allege a parallel violation claim.  Regulatory claim involving record-keeping fails because plaintiff claims injury from the device, not from faulty records.  Vague allegations of failure to comply with IDE survive motion to dismiss and will be the subject of “cabined” discovery.  Summary judgment (2013 WL 801729) later granted against remaining claims, see below.
  105. Gelber v. Stryker Corp., 788 F. Supp.2d 145 (S.D.N.Y. April 18, 2011), motion to dismiss granted against all but two claims involving hip implant.  Manufacturing-based parallel claim survived preemption because an FDA warning letter specified the nature of the claimed violation.  Failure to warn and failure to report claims are preempted.  Information dating from after the plaintiff’s surgery could have no plausible causal effect.  Claims concerning failure to identify and correct device problems are preempted.  Claims concerning failure to control a nonconforming product are preempted.  Claims alleging failure to develop practices and procedures are preempted.  Express warranty claims based upon statements beyond what the FDA required are not preempted.  Other express warranty claims are dismissed either as preempted or as inadequately pled.  Implied warranty claims escape preemption only to the extent they incorporate unpreempted manufacturing claims, but are barred by the statute of limitations.
  106. Kinetic Co. v. Medtronic, Inc., 2011 WL 1485601, slip op. (D. Minn. April 19, 2011), motion for judgment on the pleadings granted against all but one claim brought by third-party payer concerning recalled implantable cardiac defibrillator.  Express warranty and consumer fraud claims are preempted.  Allegations of misrepresentations to the FDA are preempted private attempts to enforce the FDCA.  Having not pleaded any warning-related claims that come close to surviving preemption, plaintiff is not entitled to discovery “to fish for claims of which it is not aware.”  Claim based on alleged promise to pay for certain expenses has nothing to do with the FDA and is not preempted.
  107. Llado-Carreno v. Guidant Corp., 2011 WL 6223409 (S.D. Fla. May 16, 2011), motion to dismiss granted in case involving an implantable cardiac defibrillator.  A conclusory violation claim cannot defeat preemption.  Any violation claim must state specifically what regulation was violated.
  108. Walsh v. Abbott Vascular, 2011 WL 2038572 (E.D. Cal. May 23, 2011), summary judgment denied in case involving a perclose device.  Defendant failed to establish that the Class III device was in fact the one used in the plaintiff’s surgery.
  109. Wilhite v. Howmedica Osteonics Corp., 833 F. Supp.2d 753 (N.D. Ohio June 20, 2011), summary judgment granted against all claims in case involving hip implant.  The complaint does not contain parallel violation requirements.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.
  110. DeLeon v. Johnson & Johnson, 2011 WL 2618957 (S.D. Tex. July 1, 2011), motion to dismiss granted against all claims in case involving an artificial spinal disc.  No parallel violation claim asserted.
  111. Purchase v. Advanced Bionics, LLC, 896 F. Supp.2d 694  (W.D. Tenn. Aug. 4, 2011), summary judgment granted in part and denied in part in case involving cochlear implant that had been recalled and as to which the FDA had brought and settled administrative proceedings against the defendant. Claims based on:  (1) failure to submit PMA, (2) failure to identify a change in a report to the FDA, and (3) adulteration based on (1) and (2)  are preempted.  PMA approval and reporting requirements are administrative, not safety, requirements.  Failure to submit claims are disguised fraud on the FDA claims.  Claims of deviation from PMA supplement manufacturing/design requirements and failure to test a modified device are not preempted.  All other GMP claims are too vague and general to support a parallel negligence per se claims.
  112. Norton v. Independence Technology, LLC, 2011 WL 3584491 (E.D. Cal. Aug. 15, 2011), motion to dismiss granted against all claims in case involving a motorized, stair-climbing wheelchair.  No parallel violation claim asserted.
  113. Austin v. Medtronic, Inc., 2011 WL 13228412 (N.D. Tex. Aug. 18, 2011),motion to dismiss granted against all claims in case involving pain pump.  No parallel claim pleaded.  No entitlement to discovery.
  114. Leonard v. Medtronic, Inc., 2011 WL 3652311 (N.D. Ga. Aug. 19, 2011), motion to dismiss technically denied due to plaintiff’s request to amend complaint.  All claims, including express and implied warranty, as pleaded are preempted.  A conclusory violation claim cannot defeat preemption.  Any violation claim must state specifically what regulation was violated, how the violation occurred, and how the violation was causal.  Rejecting Hofts.  A negligence per se claim that merely alleges an FDCA violation is an impliedly preempted private right of action.  A parallel claim cannot be based on the learned intermediary rule, since the rule’s duties are not identical to FDA regulations, and are thus not “genuinely equivalent.”  FDA-approved statements cannot serve as a basis for breach of express warranty or fraud.  An unjust enrichment claim contingent upon preempted claims is likewise preempted.
  115. Horn v. Boston Scientific Neuromodulation Corp., 2011 WL 3893812 (S.D. Ga. Aug. 26, 2011), summary judgment granted against all but one claim involving spinal cord stimulator.  Implied warranty is preempted.  Plaintiff’s negligence per se claim is preempted because it only alleges non-specific violations of broad, generic quality system regulations.  An express warranty claim based on a promise of a five-year battery life, was not preempted.  That promise is not a preempted general promise of safety.
  116. Hanna v. Kaiser Foundation Hospitals, 2011 WL 10621777 (Cal Super. Sept. 13, 2011), demurrer sustained against all claims involving unstated device.  No parallel claims asserted.  Leave to amend parallel claims permitted
  117. Malbroux v. Jancuska, 2011 WL 3816104 (W.D. La. Aug. 29, 2011), motion to dismiss granted against all claims involving penile prosthesis.  Preemption under Riegel includes devices approved under product development protocols.  No FDCA violation claim alleged.
  118. Haynes v. Cyberonics, Inc., 2011 WL  903238 (N.D. Ga. Sept. 6, 2011), summary judgment granted against all claims, including an express warranty claim, involving vagal nerve stimulator.   Plaintiff did not have evidence of any violation of FDA regulations that could serve as the basis of a parallel claim.
  119. Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197 (W.D.N.Y. Sept. 13, 2011), motion to dismiss granted against all claims involving hip implant.  No parallel violation claims asserted in the original complaint.  Leave to amend denied.  Amended violation claims were generic and did not specify what federal regulations were violated, or how.  Rejecting Hofts (plaintiff lifted his amended allegations verbatim from Hofts).  Plaintiff’s amended express warranty claim, asserting generalized safety promises, was also preempted.
  120. Rhynes v. Stryker Corp., 2011 WL 5117168 (N.D. Cal. Oct. 27, 2011), motion to dismiss granted against all claims involving hip implant. Plaintiff failed to plead what FDA requirements were violated, or how.  General allegations about FDA “warnings” were insufficient.
  121. Tierney v. AGA Medical Corp., 2011 WL 7400469, slip op. (D. Neb. Nov. 18, 2011), motion to dismiss granted against all claims involving septal occluder.  FDA documents concerning the device are subject to judicial notice.  Claims alleging an allergy to an FDA-approved ingredient are preempted.  Plaintiff will be permitted to amend to allege factually supported violation claims concerning design or manufacture.  Plaintiff is not entitled to discovery beyond publicly available documents.  Motion to amend denied, 2012 WL 395545 (D. Neb. Feb. 7, 2012), plaintiff belatedly pleaded an amended failure to report claim that has nothing to do with the facts of his injury.
  122. Bentzley v. Medtronic, Inc., 827 F. Supp.2d 443 (E.D. Pa. Nov. 29, 2011), motion for summary judgment granted against all claims involving an insulin delivery system, except express warranty.  The entire system underwent PMA or a PMA supplement.  Preemption relates to a device as a whole, not its component parts.  A recall of a related, but different product, does not affect preemption.  Plaintiff has no evidence of violations of FDA manufacturing, doctor’s prescription, or warning requirements.  A plaintiff who had not yet been implanted with a device when it was recalled, and who received FDA-approved post-recall warnings, was not within the scope of the recall.
  123. Bush v. Thoratec Corp., 837 F. Supp.2d 603 (E.D. La. Nov. 29, 2011), motion to dismiss granted (with leave to amend) against all claims involving a ventricular assist system.  The limited savings clause in §360h(d) does not defeat express preemption under §360k.  An attempted parallel claim that the defendant’s failure to report to the FDA resulted in a less strict voluntary recall is preempted under Buckman because it turns upon speculation about what the FDA might have done.  Claims alleging breach of disclosure duties owed to the FDA are preempted.  Almost all remaining claims dismissed, 2012 WL 2513669 (E.D. La. June 28, 2012), see below.
  124. Haile v. Kaiser Permanente Medical Group, 2011 WL 13151488 (Cal.Super. Nov. 29, 2011), demurrer granted against all claims involving implantable defibrillator.  No parallel claim pleaded.
  125. Callaway v. American Medical Systems, Inc., 2011 WL 7724268 (Mag. W.D. La. Dec. 8, 2011), adopted, 2012 WL 1354573 (W.D. La. Jan. 24, 2012), motion to dismiss granted against all claims involving a penile prosthesis.  The complaint is utterly devoid of factual content suggesting an unpreempted claim.
  126. Erickson v. Boston Scientific Corp., 846 F. Supp.2d 1085 (C.D. Cal. Dec. 12, 2011), judgment on the pleadings granted against all claims involving several pacemakers.  PMA and product development protocol supplements are equivalent to PMA and are preemptive.  Parallel violation claims must allege specifically what was violated.  A product recall does not vitiate preemption.
  127. Duggan v. Medtronic, Inc., 840 F. Supp.2d 466 (D. Mass. Jan. 10, 2012), summary judgment granted against all claims involving insulin delivery system.  The entire system underwent PMA or a PMA supplement.  Preemption relates to a device as a whole, not its component parts.  Preemption is governed by the scope of the FDA’s approval letter, not reassessment of the PMA.
  128. Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. Jan. 25, 2012), affirming grant of summary judgment on all claims in action involving spinal pain pump.  The claimed violation did not involve any aspect of the device that was mandatory.  The only mechanism for creating a binding performance requirement is through creation of an FDA performance standard.  Treating non-binding standards as if they were binding creates a different standard and is therefore preempted.   Affirming 2010 WL 4822135 (S.D.W. Va. Nov. 24, 2010).
  129. Gillman v. Boston Scientific Corp., 2012 WL 892239 (Mag. D. Or. Jan. 27, 2012), approved, 2012 WL 882788 (D. Or. March 13, 2012), motion to dismiss granted against most claims involving spinal cord stimulator.  No parallel violation claim is alleged.  Negligent misrepresentation that there were trained doctors available in the state to which plaintiff was moving did not involve an FDA-approved statement and escaped preemption.  However, there was no special relationship to support that claim.
  130. Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. Jan. 31, 2012), affirming in part and reversing in part grant of motion to dismiss on all claims in a knee replacement case.  PMA approval is a legal conclusion and should not be taken as true on a motion to dismiss.  Judicial notice of PMA status from publicly available FDA documents is proper.  The entire device system was PMA approved, not just some components.  Plaintiff successfully stated a parallel claim based on alleged FDCA manufacturing violations that paralleled state manufacturing defect claims.  Plaintiff alleged what FDA standards were violated, that the violation affected the device actually implanted, specifically alleged the violation, and alleged how the violation could have caused the particular injury that the plaintiff suffered.  The preliminary nature of an FDA warning letter did not matter for purposes of pleading.  A formal finding by the FDA is not a prerequisite.  The general nature of some FDA regulations becomes specific when the particular PMA is approved.  A claim can be based on a manufacturer’s failed to satisfy a standard required by the FDA in its approval of the PMA for the device.  Plaintiff cannot make a claim based on a manufacturer’s failure to do something different than what the FDA approved.  Since the FDA found a violation, there is little chance that litigation would produce a different reading of the standard than the FDA.  A FDA violation based negligence claim is not a purely FDCA-based claim violating Buckman where state law provides an equivalent manufacturing defect theory.  Even if negligence per se is not available, the violation could be evidence of simple negligence.  The manufacturing violation-based claim survives whether sounding in strict liability, negligence, or warranty.  All warning and “marketing” claims are preempted.  Express warranty claims are preempted.  Affirming and reversing 2010 WL 3431637 (N.D. Tex. Aug. 31, 2010).
  131. Viserta v. St. Jude Medical, 2012 WL 667814 (D.S.C. Feb. 29, 2012), motion to dismiss granted against all claims involving cardiac defibrillator leads.  Plaintiff’s attempt to plead a parallel manufacturing claim fails for lack of any specificity as to what standards were violated how.  Adverse event reports, are not linked to anything relevant to this plaintiff.
  132. Gross v. Stryker Corp., 858 F. Supp.2d 466 (W.D. Pa. March 14, 2012), motion to dismiss granted against all claims involving artificial hip prosthesis.  A product recall is not an admission of regulatory violations.  Negligence and res ipsa claims are preempted.  Violations of FDA regulations are too vaguely pleaded.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.  Warranty claims based on FDA-approved labeling are preempted.  Non-device specific good manufacturing practices relied on by plaintiff are too vague to serve as a parallel claim.
  133. Cameron v. Boston Scientific Corp., 2012 WL 1592535 (N.D. Ohio April 12, 2012), summary judgment granted against all claims involving thermal ablation device. Plaintiffs have no evidence to support any parallel claim.  Adopted 2012 WL 1592532 (N.D. Ohio May 4, 2012).
  134. Cooley v. Medtronic, Inc., 2012 WL 1380265 (E.D. Ky. April 20, 2012), motion to dismiss granted against all claims involving implantable cardiac defibrillator, including express warranty, fraud, and emotional distress.  Plaintiff did not assert any parallel claims.
  135. Hinkel v. St. Jude Medical, Inc., 869 F. Supp.2d 739 (E.D. La. April 23, 2012), summary judgment granted against all claims involving an implantable spinal pulse generator, including express warranty under LPLA.  FDA standards are not the same as the LPLA.
  136. Lowe v. Medtronic, Inc., 2012 WL 3656468, slip op. (C.D. Cal. May 9, 2012), motion to dismiss granted against all claims involving implantable defibrillator.  Failure to report claims are impliedly preempted by Buckman.  Parallel claims inadequately preempted due to failure to plead the violation or causation with specificity.  A warning letter and a recall do not establish a parallel claim.
  137. Cline v. Advanced Neuromodulation Systems, 914 F. Supp.2d 1290 (N.D. Ga. June 15, 2012), motion to dismiss granted in part and denied in part in case involving implantable pulse generator.  An express warranty of battery life, beyond the FDA-approved labeling, was not preempted.  Vague allegations of violations of good manufacturing practices were inadequate to plead a parallel claim.  Motion to amend allowed, 2012 WL 7009687 (N.D. Ga. Nov. 7, 2012), see below.  Most claims preempted, 2014 U.S. Dist. Lexis 56669 (N.D. Ga. March 31, 2014), see below.
  138. Reuter v. Medtronic, Inc., 2012 WL 3635955, slip op. (New Jersey Super. Law. Div. June 18, 2012), summary judgment granted against all claims involving a pacemaker.  No parallel claim alleged.  Motion to amend to add negligence claim based on presence of a technician denied, since the technician could not advise the physician on medical procedures.
  139. Bush v. Thoratec Corp., 2012 WL 2513669 (E.D. La. June 28, 2012), motion to dismiss granted against all claims involving a heart pump except post-sale duty to warn-based claim predicated on non-compliance with FDA regulation regarding contents of recall letter.  Vague regulations can support violation claims at the pleading stage.  A prior FDA finding of violation is not required. Whether the claimed violation is genuinely parallel can only be decided on summary judgment.
  140. Hammarlund v. Stryker Corp., 2012 WL 12868486 (S.D. Cal. July 16, 2012), motion to dismiss granted against all claims involving hip implant.  No parallel claim sufficiently pleaded.  First amended complaint dismissed, 2013 WL 12095239 (S.D. Cal. March 20, 2013), plaintiff failed to allege that recall included her device.  Second amended complaint allowed in part, 2014 WL 12515349 (S.D. Cal. Jan. 9, 2014), plaintiff could assert an unpreempted failure to report claim.
  141. Phillips v. Medtronic, Inc., 2012 WL 3641487, slip op. (Mass. Super. July 10, 2012), motion to dismiss granted against all claims involving spinal pain pump.  Alleged FDA regulatory violations could not be causal because they did not involve risk of the injuries plaintiff alleged.  While negligent pharmacovigilence claims paralleling federal regulations are not expressly preempted, they are impliedly preempted under Buckman.
  142. Steiden v. Genzyme Biosurgery, 2012 WL 2923225 (W.D. Ky. July 17, 2012), motion to dismiss granted against all product liability claims involving Synvisc-One but denies as to parallel claim, allegations of adulteration, supported by immediate injury were sufficiently specific to state an unpreempted claim.  Plaintiff did not have to state specifically how FDA regulations were violated.
  143. Weston v. Kim’s Dollar Store, 399 S.C. 303, 731 S.E.2d 864 (S.C. Aug. 8, 2012), grant of partial summary judgment affirmed in litigation concerning colored contact lenses.  Express preemption provisions should be construed broadly.  Colored contact lenses are PMA medical devices.   All claims based on warning, labeling, design, marketing, or misbranding were properly dismissed as preempted.  Defendant conceded that a negligent manufacturing claim may survive preemption as a parallel claim.  Affirming as modified 684 S.E.2d 769 (S.C. App. July 15, 2009).
  144. Cornett v. Johnson & Johnson, 211 N.J. 362, 48 A.3d 1041 (N.J. Aug. 9, 2012), grant of motion to dismiss affirmed against most, but not all, claims involving a drug eluting stent.  Failure to warn claims are preempted.  FDA non-disclosure claims, both pre-approval and post-marketing failure to report, are preempted fraud-on-the-FDA claims, as they require proof of fraud against the agency.  Off-label use did not go through the FDA’s regulatory process, therefore failure to warn claims not involving agency fraud that pertain to off-label uses are not preempted.  Warning claims based on legal (safe harbor) off-label promotion are preempted.  Express warranty claims survive preemption to the extent based on statements not subject to FDA approval.  All other express warranty claims are preempted.  Affirming as modified, 998 A.2d 543 (N.J. Super. A.D. July 23, 2010).
  145. Mayen v. Tigges, 2012 WL 3553378 (N.Y. Sup. Aug. 17, 2012) (in table at 36 Misc.3d 1231(A), 959 N.Y.S.2d 90), motion to dismiss granted against all claims involving knee implant, including express and implied warranty.  Request for discovery denied.
  146. Ali v. Allergan United States, 2012 WL 3692396 (E.D. Va. Aug. 23, 2012), motion to dismiss granted against all claims involving stomach band, including express and implied warranty.  Plaintiff must allege what federal regulations were violated, and how the violation caused injury.  Plaintiff must allege Initial failure of PMA did not establish anything.  Recall was non-causal unless the device in question was recalled due to the risk at issue.  Disagrees with Hofts.  Request for discovery denied.  Currently on appeal.
  147. Delfino v. Medtronic, Inc., 2012 WL 12925029 (Minn. Dist. Aug. 29, 2012), motion to dismiss granted against all claims involving an implanted defibrillator.  Parallel claims insufficiently pleaded.  A recall does not infer a violation.  Affirmed 2019 WL 2415049 (Minn. App. June 10, 2019), below.
  148. Hawkins v. Medtronic, Inc., 909 F. Supp.2d 901 (S.D. Ohio Sept. 24, 2012), motion to dismiss granted in part and denied in part in case involving implantable pulse generator.  Vague allegations of FDCA violations in design, warning, manufacturing, and implied warranty cannot be held entirely preempted on motion to dismiss.  Ignoring TwIqbal pleading standards in favor or earlier “precise contours” language in Lohr.  Negligent handling claims have no FDCA equivalent and are dismissed as preempted.  Express warranty not preempted because it does not require finding that any FDA-approved statements are untrue.  Fraud claims would require finding FDA-approved statements are untrue and are preempted.  Failure to report claims are preempted by BuckmanInterlocutory certification denied, 2012 WL 6059361 (S.D. Ohio Dec. 6, 2012),
  149. McClelland v. Medtronic, Inc., 2012 WL 5077401, slip op. (M.D. Fla. Sept. 27, 2012), motion to dismiss granted against all claims involving an implanted pacemaker.  Documents in the FDA public record are judicially noticeable.  Under Florida law, the violation of a statute can only give rise to civil liability if the statute indicates an intention to create a private cause of action.  The FDCA explicitly bars private rights of action.  All non-parallel violation claims are preempted under Riegel.  There is no FDCA requirement that a manufacturer contact doctors or patients directly, without FDA involvement, concerning alleged device defects.  There is no parallel in Florida common law to an FDCA violation claim, so parallel violation claims do not state a claim under state law.  Claims based on FDCA disclosure requirements are impliedly preempted.  Renewed motion granted (see below).
  150. Killen v. Stryker Spine, 2012 WL 4482371 (Mag. E.D. Pa. Sept. 28, 2012), motion to dismiss granted in part and denied in part in case involving an investigational cervical intervertebral device.  Preemption under Riegel applies to IDE devices.  Plaintiff pleaded parallel violation claims as well as could be expected without discovery.  The express warranty claim is preempted as pleaded but may be amended to specify any non-FDA-approved statement upon which the claim is based.  Fraud claims are preempted to the extent they involve FDA-approved statements, but not as to follow-up medical care.  Adopted 2012 WL 4498865 (W.D. Pa. Sept. 28, 2012).
  151. Tillman v. Smith & Nephew, Inc., 2012 WL 6681698 (N.D. Ill. Nov. 1, 2012).  Taking judicial notice of FDA PMA for defendant’s hip resurfacing system.  Plaintiff did not plead any parallel claims, only preempted claims concerning “defects.”  Plaintiff must replead facts establishing a parallel claim or suffer dismissal.
  152. Cline v. Advanced Neuromodulation Systems, 921 F. Supp.2d 1374 (N.D. Ga. Nov. 7, 2012), motion to amend complaint to add parallel claim granted in case involving spinal cord stimulator.  Warning letter provided specific regulatory violations and causation was adequately pled.  Unidentified regulations or vague GMPS would not have been sufficient.  The claim is not impliedly preempted because it parallels a manufacturing defect claim.  Most claims preempted, 2014 U.S. Dist. Lexis 56669 (N.D. Ga. March 31, 2014) see below.
  153. Hesik v. Boston Scientific Corp., 2012 WL 12897111 (D.S.C. Nov. 16, 2012), motion to dismiss denied in action involving defibrillator.  Only an unpreempted parallel claim is alleged, and it is sufficiently pleaded   Later decision see below, 2014 WL 5644699.
  154. Raborn v. Albea, 2012 WL 6600475 (La. Dist. Dec. 7, 2012), exception of no cause of action (motion to dismiss?) granted against all claims involving bone growth stimulator.  Claims involving alleged off-label use are preempted as imposing different requirements than the FDA.  Claims involving off-label promotion are also preempted as private enforcement under Buckman.
  155. Littlebear v. Advanced Bionics, 896 F. Supp.2d 1085 (N.D. Okla. Dec. 19, 2012), summary judgment granted in part and denied in part in case involving cochlear implant that had been recalled and as to which the FDA had brought and settled administrative proceedings against the defendant.  Claims that defendant did not meet a specific moisture level are preempted because the PMA did not impose such a requirement.  A GMP regulation to evaluate suppliers is too vague to support a parallel claim.  Fraud and consumer protection claims are preempted; there is no FDA regulation requiring disclosure.  Failure to obtain supplemental PMA claims are impliedly preempted under Buckman.  This is not a safety requirement and there is no private right to enforce the FDCA.  Claims alleging deviation from PMA requirements are not preempted.  Negligence per se claims are attempts to enforce the FDCA and are preempted.
  156. Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. Jan. 10, 2013) (en banc),  motion to dismiss affirmed in part and reversed in part in case involving PMA pain pump.  All claims not involving “parallel” violations of the FDCA were properly held preempted.  Presumption against preemption applies.  A claim for failure to warn a third party (the FDA) about reportable adverse events is an unpreempted parallel claim under Riegel. Since the claim does not involve the FDA’s pre-market approval process it is preempted under Buckman.  Reversing 2010 WL 4483970 (N.D. Ariz. Nov. 9, 2010).
  157. Sons v. Medtronic Inc., 915 F. Supp.2d 776 (W.D. La. Jan. 14, 2013),  motion to dismiss granted against all claims in case involving pacemaker.   Claims for design defect, manufacturing defect, failure to warn, negligence, and strict liability are preempted.  No parallel claim alleged.  Even if a claim for failure to train isn’t preempted, it does not state a claim because the manufacturer is not responsible for the practice of medicine.
  158. Simmons v. Boston Scientific Corp., 2013 WL 12130261 (C.D. Cal. Jan. 14, 2013), motion to dismiss granted against all claims in case involving implantable cardiac defibrillator.  Vague GMPs cannot be basis of a parallel claim.  Failure to report claim improperly pleaded.  Failure to recall claim preempted where FDA never ordered recall.  Negligence per se preempted.
  159. Desai v. Sorin CRM USA, Inc., 2013 WL 163298 (D.N.J. Jan. 15, 2013), motion to dismiss granted against all claims in case involving cardiac defibrillator.  Judicial notice may be taken of the FDA website’s list of PMA approvals.  Claims for negligence, defective design, and failure to warn are preempted.  Allegations of deviations from FDA standards for design and manufacture are conclusory.  A failure does not establish an FDCA violation.  Discovery may not be based on vague allegations.
  160. Kallal v. Ciba Vision Corp., 2013 WL 328985 (N.D. Ill. Jan. 28, 2013), summary judgment granted in case involving contact lenses.  Lenses were not subject to recall.  Fact of adverse reaction does not establish a defect or an FDCA violation.  Plaintiff failed to establish a violation of an FDA requirement, as opposed to an internal corporate specification.
  161. Thomas v. Alcon Laboratories, 116 F. Supp.3d 1361 (N.D. Ga. Jan. 29, 2013), motion to dismiss granted against all claims in case involving contact lens.  FDA PMA may be established by judicial notice.  Express and implied warranty claims based on general safety allegations are preempted.  Violations of vague GMPs cannot be parallel claims due to differing interpretations of such regulations.  The parallel claim was also inadequately causally related to the plaintiff’s device.
  162. Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206 (W.D. Okla. Feb. 6, 2013), motion to dismiss granted against all claims in case involving bone growth stimulator.  Off-label use does not limit express preemption under Riegel.  Alleged illegal promotion does not make all the plaintiff’s claims “parallel.”  Fraudulent inducement, misrepresentation, constructive fraud, and negligence claims are expressly preempted to the extent they seek changes to device labeling, marketing, design, or manufacturing.  These claims are impliedly preempted under Buckman to the extent they depend on alleged off-label promotion.  Off-label use and promotion are inherently FDCA-based concepts, thus tort claims based thereon are in substance claims violating the FDCA, which the statute forbids.  Allegations of false statements to physicians, whether or not involving off-label promotion, are inadequately pleaded.  Failure to warn, design defect, and negligence claims are preempted.  Warranty claims involving journal articles and opinion leaders allege that the product was not safe or effective, and are preempted.  Discovery is unnecessary.  Affirmed by 784 F.3d 1335 below.
  163. Gale v. Smith & Nephew, 989 F. Supp.2d 243 (S.D.N.Y. Feb. 13, 2013), motion to dismiss granted in part and denied in part in case involving hip resurfacing system.  Design, warning and manufacturing defect claims preempted.  Express and implied warranty claims preempted.  Fraud on the FDA claims brought as a consumer fraud claim are probably preempted, but are not pleaded sufficiently to state a claim.  Post sale duty to warn claim preempted.  Negligent conduct of recall claim not preempted.  Failure to comply with PMA reporting requirements not preempted.  Ruling on amended complaint, see below.
  164. Lamere v. St. Jude Medical, Inc., 827 N.W.2d 782 (Minn. App. Feb 19, 2013), summary judgment affirmed in case involving mechanical heart valve.  Allegedly violated GMPs were too vague to support a parallel manufacturing defect claim.  Plaintiff did not indicate how alleged violations were causal.  A manufacturing defect claim unrelated to any alleged FDCA violation was preempted.  Affirming, 2012 WL 3635953, slip op. (Minn. Dist. Jan. 18, 2012) and 2011 WL 10550518 (Minn. Dist. Feb. 7, 2011).
  165. Anderson v. Boston Scientific Corp., 2013 WL 632379 (S.D. Ohio Feb. 20, 2013), motion to dismiss granted in case involving spinal cord stimulator.  All claims are based on state law defects, not any violation of the FDCA.  Negligence claim concerning actions of sales representative fails to plausibly allege causation.
  166. Gray v. Stryker Corp., 2013 WL 633120 (S.D. Ind. Feb. 20, 2013), motion to dismiss denied in case involving hip implant.  Judicial notice may be taken of the FDA approvals on the agency’s website.  Manufacturing defect claims are only preempted if the defendant complied with FDA requirements.  Plaintiff is suing about the same recalled device as in Bausch and has adequately pleaded violation claims of a similar nature.  Pleading the specific regulations violated is not required.
  167. Burgos v. Satiety, Inc., 2013 WL 801729 (E.D.N.Y. March 5, 2013), motion for summary judgment granted against remaining manufacturing defect claim in case involving investigational stomach stapling system. Plaintiff lacked any evidence of how the device violated FDA regulations.  In the absence of any evidence of a violation, plaintiff could not create a question of fact from a spoliation inference, even if such an inference were proper.  A settlement offer is not evidence of a violation.  A product-related injury does not support an inference of a violation.
  168. Sadler v. Advanced Bionics, Inc., 929 F. Supp.2d 670 (W.D. Ky. March 8, 2013), summary judgment granted in part and denied in part in case involving cochlear implant that had been recalled and as to which the FDA had brought and settled administrative proceedings against the defendant.  Failure to obtain PMA supplement did not render either the device or the component unapproved.  Negligence per se failed on state law grounds.  Fraud, fraudulent omission, and misrepresentation either sought preempted label changes or involved the FDA and were preempted under Buckman. A design claim based on deviation from the relevant supplemental PMA survived preemption, but other design claims were preempted.  Failure to obtain supplemental PMA claims are impliedly preempted under Buckman.  A GMP regulation requiring testing under actual or simulated use conditions was sufficiently specific to survive preemption as a parallel claim; all other GMPs were too vague.  Claims that defendant should have conducted life cycle testing are preempted because the PMA did not impose such a requirement.  Other Negligence claims follow the strict liability analysis.
  169. Smith v. St. Jude Medical Cardiac Rhythm Management Division, 2013 WL 1104427 (D. Md. March 13, 2013), motion to dismiss granted in case involving pacemaker.  All claims, including express and implied warranties, were preempted or inadequately pleaded.  Parallel claims were inadequately pleaded and unlike Bausch did not allege any action taken by the FDA.
  170. Smith v. Depuy Orthopaedics, Inc., 2013 WL 1108555, slip op. (D.N.J. March 18, 2013), summary judgment granted against all claims in case involving PMA knee implant.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.  Parallel violation claim not pleaded with requisite particularity.  Preemption requires specific requirements and cannot be defeated with vague allegations of FDCA violations.  Express warranty preempted because it involves FDA-approved statements.  Fraud is subsumed by state product liability statute.  Affirmed 552 F. Appx. 192 (see below).
  171. Lasalle v. Pappas, 2013 WL 1130726 (E.D. La. March 18, 2013), motion to dismiss granted in case involving unidentified device.  All of plaintiff’s claims are not only preempted, but also fail under TwIqbal.  Plaintiff is not entitled to discovery to look for possible “parallel” claims.
  172. Kubicki v. Medtronic, Inc., 2013 WL 1739580 (D.D.C. March 21, 2013), motion to dismiss granted in part and denied in part in case involving insulin pain pump.  Fraud, consumer fraud, and misrepresentation claims are insufficiently pleaded.  Mixed in with preempted claims are various allegations of FDCA violations.  Because these claims may reasonably be understood to assert violations, they survive preemption.  Nothing more is required at the pleading stage.  Express warranty claims may also survive preemption to the extent they are based on advertising or some other non-FDA-approved communication.
  173. Simmons v. Boston Scientific Corp., 2013 WL 1207421, slip op. (C.D. Cal. March 25, 2013), motion to dismiss granted against all claims in case involving implantable cardiac defibrillator.  All non-parallel claims preempted.  Parallel claims were inadequately pleaded.  Plaintiff pleaded no facts supporting a Stengel failure to warn the FDA claim.  No deviations from FDA-approved design were pleaded.  GMPs were too generic to support manufacturing-related violation claims.  A product recall does not establish a violation.  Since this was plaintiff’s third amendment, no further leave to amend was appropriate.  Defendant was awarded costs.
  174. Stokes v. I-Flow Corp., 2013 WL 1715427 (M.D. Fla. April 8, 2013), motion to dismiss granted against all claims in case involving pain pump.  A claim that a defendant failed to comply with the FDA’s rejection of a marketing use is an attempted private FDCA cause of action under Buckman.  Design and warning claims differ from FDA requirements and are preempted.  Plaintiff’s negligence claim does not parallel any FDA regulation.  Reporting obligations are owed to the FDA, not to the medical community.
  175. Messner v. Medtronic, Inc., 2013 WL 1655218 (N.Y. Sup. April 9, 2013) (in table at 39 Misc.3d 1213(A), 975 N.Y.S.2d 367), motion to dismiss granted in part and denied in part in case involving porcine heart valve.  Claims based on defective design, negligence, implied warranty improper labeling preempted.  Parallel claims based on improper manufacturing, including related warning and express warranty claims, not preempted.
  176. Lipscomb v. Depuy Orthopaedics, Inc., 2013 WL 12136500 (M.D.N.C. April 11, 2013), motion for summary judgment granted against all claims in case involving knee implant.  No parallel claims asserted.
  177. Elmore v. Smith & Nephew Inc., 2013 WL 1707956 (N.D. Ill. April 19, 2013), motion to dismiss denied in case involving hip implant.  Only parallel claims were pleaded.  Defect claims based on failure to follow GMPs are parallel.  Common-law claims based on FDA violations are not preempted so long as the same conduct would result in independent liability.  Reconsideration denied, 2013 U.S. Dist. Lexis 101085 (N.D. Ill. July 1, 2013)
  178. Knoppel v. St. Jude Medical, Inc., 2013 WL 3803612 (C.D. Cal. May 7, 2013), motion to dismiss granted against all claims, predominantly design claims, in case involving cardiac defibrillator.  All claims that require a different design or manufacturing process than what the FDA approved are preempted.  No parallel claims alleged.
  179. Kaiser v. Depuy Spine, Inc., 944 F. Supp.2d 1187 (M.D. Fla. May 14, 2013), motion to dismiss granted against all claims in case involving artificial spinal disc.  Allegations that the defendant failed to design, test, manufacture, market, sell, promote, label, and/or distribute the device in accordance with FDA requirements failed under TwIqbal.  Plaintiff failed to allege that the defendant violated any applicable FDA performance standard; the violation plaintiff claimed was not an FDA performance standard.  State law does not allow pursuit of parallel claims based on FDA violations.
  180. McClelland v. Medtronic, Inc., 944 F. Supp.2d 1193 (M.D. Fla. May 16, 2013), motion to dismiss granted against the only remaining claim in case involving an implanted pacemaker. Failure to report adverse event claims are preempted. To the extent the alleged duty is owed to the device user, it is expressly preempted. There is no FDCA duty to inform patients of adverse events. To the extent the alleged duty is owed to the FDA, it is preempted as private FDCA enforcement. Prior decision discussed above.
  181. Pinsonneault v. St. Jude Medical, Inc., 953 F. Supp.2d 1006 (D. Minn. June 18, 2013), motion to amend denied in large part in case involving pacemaker leads.  Failure to report adverse event claims are preempted.  A state law post-sale duty to warn product users is not the same as a duty to report adverse events to the FDA.  FDA adverse event reports are not necessarily public and available to users.  No state recognizes a tort cause of action for failure to report to a federal agency.  Because there is no recognized state-law parallel, the reporting claims are also preempted under Buckman as improper private FDCA causes of action.  An express warranty of “safety” is preempted because no non-FDA-approved labeling statements are specified.  Certain factual amendments may not be futile because their causal relevance to the plaintiffs’ injuries cannot be determined on the pleadings.
  182. Lederman v. Howmedica Osteonics Corp., 950 F. Supp.2d 1246 (M.D. Fla. June 19, 2013), motion to dismiss granted against against all claims in case involving hip implant.  Manufacturing defect claims are preempted unless alleged as parallel claims.  Plaintiff’s parallel claim pleading is insufficient.  He fails to explain how FDA warning letters relate to his device, manufactured three years before the letter.  Plaintiff must specify how the device violated a particular FDA regulation.  Plaintiff has leave to amend.
  183. Wendt v. Bernstein, 2013 WL 3199361 (Ill. Cir. June 24, 2013), motion to dismiss granted against all claims in case involving a bone growth stimulator. Allegations concerning off-label promotion and use are not parallel to any FDA regulation, but rather are improper private attempts to enforce the FDCA.  Plaintiff given leave to amend.
  184. Otis-Wisher v. Fletcher Allen Health Care, Inc., 951 F. Supp.2d 592 (D. Vt. June 25, 2013), motion to dismiss granted against against all claims in case involving a bone growth stimulator.  All non-FDA-related claims are preempted.  Allegations that fail to identify the alleged regulatory violations cannot defeat preemption.  Allegations solely concerning off-label promotion and use are not parallel claims because there is no FDA regulation barring such activity.  Aff’d mem., No. 14-3491, 616 F. Appx. 433 (2d Cir. June 9, 2015).
  185. McBride v. Medtronic, Inc., 2013 WL 3491085 (W.D. La. July 10, 2013), motion to dismiss granted against against all claims in case involving an infusion pump.  Taking judicial notice of FDA PMA.  A manufacturing defect claim asserting deviation from the manufacturer’s specifications is not a parallel claim and is preempted.  Under the exclusive state statute, claims for negligence per se are subsumed.  Therefore, there is no state-law basis for asserting parallel claims.  All failure to warn claims are preempted.
  186. Gavin v. Medtronic, Inc., 2013 WL 3791612, slip op. (E.D. La. July 19, 2013),  motion to dismiss granted in part and denied in part in case involving an infusion pump.  Preemption applies to off-label uses.  Preemption depends on FDA approval, not how the device was ultimately used.  PMA preemption applies to off-label use of a component of a product system separately from the rest of the system.  The component remains PMA approved.  Claims that defendant should have warned about off-label uses vary from FDA approved warnings and are preempted.  A claim based on failure to report adverse events survives express preemption.  Various causes of action dismissed under exclusive state statute.  Express warranty claims attacking FDA-approved labeling are preempted, and nothing else is pleaded.  Implied warranty claims are preempted.  State law does not recognize claims based on violations of federal regulations.  Off-label use and promotion are purely FDA-related concepts, so claims based on such allegations are impliedly preempted under Buckman.
  187. Eggerling v. Advanced Bionics, L.L.C., 958 F. Supp.2d 1029 (N.D. Iowa July 24, 2013), summary judgment granted in part and denied in part in case involving cochlear ear device.  Preemption is not an appropriate subject for collateral estoppel.  Failure to obtain PMA supplement did not render either the device or the component unapproved.  Parallel claims based on broad administrative GMPs are preempted.  Design and manufacturing claims based on deviation from the relevant supplemental PMA is not preempted.  A GMP regulation requiring testing under actual or simulated use conditions was sufficiently specific to survive preemption as a parallel claim.  Claims that defendant should have conducted life cycle testing are preempted because the PMA did not impose such a requirement.
  188. Houston v. Medtronic, Inc., 957 F. Supp.2d 1166 (C.D. Cal. July 30, 2013), motion to dismiss granted against against all claims in case involving an infusion pump.  Taking judicial notice of FDA PMA.  PMA preemption applies to off-label use of a component of a product system separately from the rest of the system. The component remains PMA approved.   Off-label use occurs “with respect to” a device, so claims concerning such use are within the scope of express preemption.  Claims concerning warnings, including post-sale warnings, about off-label use are preempted as in addition to the warnings the FDA requires.  What the FDA merely permits, state law cannot make mandatory.  Design defect claims are preempted.  Off-label use claims exist solely because of the FDA’s labeling requirements, and are therefore impliedly preempted as attempts to enforce the FDCA.  All other parallel claims do not state what was violated, and are inadequately pleaded.  Allegations of false off-label promotion would state an unpreempted parallel claim, however the claims are not pleaded with particularity under Rule 9(b).  An express warranty claim alleging false statements not constituting labeling would not be preempted, but is inadequately pleaded.  Renewed motion to dismiss granted in part and denied in part – see below.
  189. Harris v. Medtronic, Inc., 2013 WL 4011624 (Cal. Super. Aug. 1, 2013), demurrer with leave to amend granted against all claims in case involving a bone growth stimulator.  The fraud claim must be repleaded to avoid fraud on the FDA and product labeling.  Warning claims cannot be based on FDA-approved labeling.  Design defect claims cannot be based on off-label use.  PMA covers devices, not uses.
  190. Lawrence v. Medtronic, Inc., 2013 WL 4008821 (Minn. Dist. Aug. 7, 2013), motion to dismiss granted against against all claims in case involving a bone growth stimulator.  Claims requiring labeling about off-label use are expressly preempted.  Claims, including consumer fraud, are impliedly preempted under Buckman to the extent they depend on alleged illegal off-label promotion.  The label is an FDA concept.  All non-off-label claims would require changes to FDA-approved aspects and are expressly preempted.  Fraudulent off-label promotion claims are not preempted, but are not pleaded with particularity.
  191. Halsey v. Smith & Nephew, Inc., 2013 WL 12226936 (D. Vt. Aug. 13, 2013), motion to dismiss granted against against all claims in case involving a hip implant.  All of plaintiff’s claims impose liability in the absence of any violation of the FDCA.  Later motion 2014 WL 12717702, below.
  192. Dawson v. Medtronic, Inc., 2013 WL 4048850 (D.S.C. Aug. 8, 2013), motion to dismiss granted against against all claims in case involving a bone growth stimulator.  There is no state claim for off-label promotion.  Off-label promotion is not necessarily illegal; the only statutory prohibition has ceased to be effective.  Claims are impliedly preempted under Buckman to the extent they depend on alleged illegal off-label promotion.  Failure to warn, design defect, negligence, strict liability, warranty, fraud, negligence per se, and misrepresentation claims that would require changes to FDA-approved warnings or labels are expressly preempted.  Violation claims cannot be based on information provided to the FDA.
  193. Scianneaux v. St. Jude Medical, S.C., 961 F. Supp.2d 808 (E.D. La. Aug. 19, 2013), motion to dismiss granted against against all claims in case involving an implantable cardiac defibrillator.  Taking judicial notice of documents on FDA website.  Plaintiff failed to plead an unpreempted violation claim.  A recall does not defeat preemption.
  194. Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. Aug. 21, 2013), motion to dismiss granted in part and denied in part in case involving a bone growth stimulator.  Taking judicial notice of device labeling.  While off-label use claims can be expressly preempted, off-label promotion claims are not.  The FDA does not review off-label promotion; it is essentially unregulated.  Applying presumption against preemption.  Claims based on the fact of off-label promotion would be impliedly preempted.  Parallel claim analysis is not necessary for claims involving off-label promotion.  Negligence per se claims are preempted under Buckman.  Tort claims not concerning off-label promotion are preempted under Riegel, except for failure to report adverse events, which are not preempted.
  195. McDonald-Lerner v. Neurocare Associates, P.A., 2013 WL 7394926 (Md. Dist. Aug. 29, 2013), motion to dismiss denied in case involving a bone growth stimulator.  The FDA does not review off-label uses or statements, therefore there is no preemption of claims alleging off-label promotion.  All claims are parallel.  Truthful off-label promotion should be illegal.  Overruled by McCormick, see below.
  196. Alton v. Medtronic, Inc., 970 F. Supp.2d 1069 (D. Or. Sept. 6, 2013), motion to dismiss granted in part and denied in part in case involving a bone growth stimulator.  Judicial notice taken of adjudicative facts in documents, including FDA documents.  Off-label promotion does not necessarily violate the FDCA, but is only evidence; disagreeing with Ramirez.  Off-label promotion does not eliminate preemption.  Fraud, negligence, and strict liability claims based on introduction of a misbranded device by virtue of off-label promotion survive both express and implied preemption.  Other warning claims that would impose additional labeling obligations are preempted.  Design defect claims are preempted.  Express warranty claims are preempted to the extent based on FDA-approved statements, but not where based on off-label statements.
  197. Gale v. Smith & Nephew, Inc., 2013 WL 9874422 (S.D.N.Y. Sept. 13, 2013), motion to dismiss amended complaint granted in part and denied in part in action involving hip prosthesis.  Manufacturing defect claim based on vague FDA GMPs preempted.  Claims that device was labeled for the wrong size parallel FDA regulations and survive.  Failure to warn physicians about adverse events is preempted, since the FDCA does not require such warnings.  Allegations of failure to report adverse events are not preempted.  See above for prior ruling.
  198. Kraushaar v. Coloplast Corp., 2013 WL 12154726 (Cal.Super. Sept. 17, 2013), demurrer overruled in action involving a penile prosthesis.  Refusing to take judicial notice of FDA documents.  Defendant failed to prove that the device was PMA approved or that it satisfied FDA specifications.
  199. Stout v. Advanced Bionics, LLC, 2013 WL 12133966 (W.D. Pa. Sept. 19, 2013), summary judgment granted in part and denied in part in case involving cochlear implant that had been recalled and as to which the FDA had brought and settled administrative proceedings against the defendant.  Lack of a PMA supplement did not negate the PMA, and claim for failure to seek a supplement is barred as private FDCA enforcement.  Failure to test preempted where tests not FDA required.  Violation of vague GMPs preempted.  Negligence per se based on un-pre-approved design changes survives as a parallel claim.
  200. Suckow v. Medtronic, Inc., 971 F. Supp.2d 1042 (D. Nev. Sept. 20, 2013), motion to dismiss granted against all claims in case involving implantable cardiac defibrillator.  Plaintiff failed to plead a parallel violation claim.  Supplemental PMA is preemptive.  Strict liability and express warranty claims are preempted.
  201. Bueno v. St. Jude Medical Inc., 2013 WL 12142536 (C.D. Cal. Sept. 24, 2013), motion to dismiss granted against all claims in case involving implantable cardiac defibrillator leads.  Failure to plead the nature of injury renders causation of any parallel claim implausible.
  202. Knoppel v. St. Jude Medical, Inc., 2013 WL 12116393 (C.D. Cal. Sept. 24, 2013), motion to dismiss granted in part and denied in part in case involving an implantable defibrillator.  Manufacturing defect and warning claims based on failure to report to FDA survive preemption.  Negligence per se survives preemption.  Reporting claim fails to allege causation.  Res ipsa claim preempted.
  203. Weber v. Allergan, Inc., 2013 WL 11310512 (D. Ariz. Sept. 25, 2013), motion to dismiss granted against all claims in case involving breast implants.  Plaintiff pleaded no parallel claims.  Reversed, 621 F. Appx. 401 (9th Cir. Oct. 23, 2015), plaintiff should have been given a chance to plead parallel claims.  Subsequent decision, 2018 WL 9817168, aff’d, 940 F.3d 1106, below.
  204. McPhee v DePuy Orthopedics, Inc., 2013 WL 5462762, slip op. (W.D. Pa. Sept. 30, 2013), motion to dismiss granted against against all claims in case involving knee implant.  Plaintiffs fail to plead a parallel claim alleging manufacturing violations.  Plaintiffs fail to plead how regulations were violated.  The cited GMP regulations are too general to form the basis of a violation claim.  Implied warranty claims are preempted.  Express warranty claims are not preempted, but are insufficiently pleaded.
  205. Eidson v. Medtronic, Inc., 981 F. Supp.2d 868 (N.D. Cal. Oct. 3, 2013), motion to dismiss granted in part and denied in part in case involving a bone growth stimulator. Judicial notice taken of documents on FDA website.  All claims challenging labeling are preempted.  Use of fewer than all components of device system did not defeat preemption.  Fraud and negligence claims based on alleged untruthful off-label promotion survive both express and implied preemption.  Warning claim based on failure to report adverse events is not preempted, but claim is dismissed with leave to amend for failure to plead causation.  Negligence claim alleging illegal off-label promotion is impliedly preempted as an FDCA violation claim.  See below for decision on amended claims
  206. Medtronic, Inc. v. Malander, 996 N.E.2d 412 (Ind. App. Oct. 11, 2013), affirming denial of summary judgment in case involving implantable cardiac defibrillator.  Plaintiff’s sole remaining claim, concerning statements made by a company technician during surgery were not preempted because it did not involve FDA-approved statements on labeling.
  207. Bradley v. Baxter Healthcare Corp., 2013 WL 5952060 (Mag. W.D.N.C. Oct. 18, 2013), adopted without separate opinion, 2013 WL 5952060 (W.D.N.C. Nov. 6, 2013) motion to dismiss granted against against all claims in case involving gelfoam.  All claims seek to change or add to federal requirements.  A general allegation of violating “good manufacturing practices” was insufficient to state a parallel claim.
  208. Chao v. Smith & Nephew, Inc., 2013 WL 6157587, slip op. (S.D. Cal. Oct. 22, 2013), summary judgment granted in part and denied in part in case brought by physician involving total hip replacement.  Design defect claim preempted.  Claim of violation of FDA training requirements for physicians is a parallel claim and not preempted, but a violation may not have occurred.
  209. Brown v. DePuy Orthopaedics, Inc., 978 F. Supp.2d 1266 (M.D. Fla. Oct. 24, 2013), motion to dismiss granted against all claims in case involving knee implant.  Warning and design claims are preempted.  A parallel claim based on an FDA warning letter fails because for lack of causal nexus, given an unexplained two-year gap between the time of the FDA inspection and the manufacture of plaintiff’s device.   The parallel claim is also impliedly preempted, as it amounts to an attempted FDCA private right of action.  There is no analogous state law action because Florida law does not permit actions to enforce FDA requirements.
  210. Cook v. Coe, 2013 WL 6154562, slip op. (Cal. Super. Nov. 18, 2013), demurrer (motion to dismiss) granted against all claims in case involving a bone growth stimulator.  Preemption is not defeated by a presumption.  Any claims that would change the FDA-approved warnings are preempted.  Claims alleging promotion of off-label uses and failure to seek a supplemental PMA are preempted as attempts to enforce the FDCA.  Misrepresentation about off-label use would not be preempted, but are inadequately pleaded.
  211. Kashani-Matts v. Medtronic, Inc., 2013 WL 6172234, slip op. (C.D. Cal. Nov. 22, 2013), motion to dismiss granted against all claims in case involving a bone growth stimulator.  All warning claims preempted.  Design defect claims preempted.  Fraud claims based on FDA-approved warnings are preempted.  Fraudulent misrepresentations in the context of off-label promotion would not be preempted, but are inadequately pleaded.  Amended complaint dismissed see below.
  212. Simon v. Smith & Nephew, Inc., 2013 WL 6244525, slip op. (S.D.N.Y. Dec. 3, 2013), motion to dismiss granted against all claims in case involving a hip replacement system.  Taking judicial notice of FDA website documents.  Claims based on a physician’s mixing components of different PMA-approved systems are preempted.  A voluntary recall does not establish a parallel violation claim.  A different product is not an alternative design.  Preemption extends to all components of a PMA system.  Implied warranty claims preempted for similar reasons.  Reconsideration  denied, 2014 WL 1257780 (March 26, 2014).
  213. Frederick v. Smith & Nephew, Inc., 2013 WL 6275644 (N.D. Ohio Dec. 4, 2013), motion to dismiss denied in case involving a hip replacement system.  The complaint does not clearly establish the PMA status of all the components allegedly used, so preemption cannot be determined at this time.
  214. Comella v. Smith & Nephew Inc., 2013 WL 6504427, slip op. (N.D. Ill. Dec. 11, 2013), motion to dismiss granted in part and denied in part in case involving a hip replacement system.  Claims that the defendant failed to advise the FDA after approval about product dangers is an unpreempted parallel claim.  Claims that the defendant failed to warn the public are preempted.  Failure to report adverse event claims are not agency fraud claims preempted under Buckman.  The claims are sufficiently pleaded under Bausch.
  215. Ford v. Mentor Worldwide, LLC, 2013 WL 12420090 (E.D. La. Dec. 17, 2013), motion to dismiss granted against all claims in case involving an unidentified product.  Plaintiff did not oppose.
  216. Ledet v. Medtronic, Inc., 2013 WL 6858858, slip op. (S.D. Miss. Dec. 30, 2013), motion to dismiss granted against all claims in case involving a bone growth stimulator.  Off-label use does not affect PMA preemption because the analysis does not depend on use of the device.  Fraud claims based on labeling are expressly preempted.  Fraud and negligence claims based on off-label promotion are impliedly preempted as attempts to enforce the FDCA.  Warning, design, warranty, and negligent misrepresentation claims are expressly preempted.
  217. McDonald v. Lester E. Cox Medical Centers, 2014 WL 58773, slip op. (Mo. Cir. Jan. 2, 2014), summary judgment granted against all claims in case involving a implantable cardiac defibrillator.  All claims are preempted.  Plaintiff failed to establish any facts providing a basis of liability on the conduct of the defendant’s sales representative.  There is no proof of any representations that would qualify as express warranties.
  218. Wells v. Allergan, Inc., 2014 WL 117773, slip op. (D.S.C. Jan. 13, 2014), motion to dismiss granted against all claims in case involving injectable gel dermal fillers.  During PMA, the FDA evaluates everything about the device, from labeling to safety, preempting all claims except “parallel” violations.  Plaintiff failed to plead defect, violation, or causation as to any violation claim.  Plaintiff is not entitled to discovery.
  219. Smith v. Depuy Orthopaedics, Inc., 552 F. Appx. 192 (3d Cir. Jan. 14, 2014), summary judgment affirmed against all claims in case involving PMA knee implant.  PMA supplements are equally preemptive.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.  Plaintiff does not need discovery to know that all the components were incorporated into a PMA.  Affirming 2013 WL 1108555.
  220. Morris v. Rotolo, 2014 Mass. Super. Lexis 220 (Mass. Super. Jan. 15, 2014), motion to dismiss granted against all claims against manufacturer in case involving hydrothermal ablator.  Plaintiff failed to plead any parallel claims.  Merely pleading that the defendant violated unspecified regulations is insufficient.
  221. Poll v. Stryker Sustainability Solutions, Inc., 2014 WL 199150 (D. Ariz. Jan. 17, 2014), motion to dismiss granted in part and denied in part in case involving hip implant.  Judicial notice taken of documents on FDA website.  Failure to submit adverse event reports can be the basis of a warning claim surviving preemption, however the claim is inadequately pleaded.  Strict liability and warranty claims based on FDA-approved labeling are preempted.
  222. Coleman v. Medtronic, Inc., 223 Cal. App.4th 413, 167 Cal. Rptr.3d 300 (Cal. App. Jan. 27, 2014), review accepted by the California Supreme Court – opinion vacated and uncitable.
  223. Bohnenstiehl v. Wright Medical Group, Inc., 2014 WL 319652 (E.D. Mo. Jan. 29, 2014),  motion to dismiss granted in case involving femoral implant against express and implied warranty claims.  Preemption not mentioned with respect to other claims.
  224. Hawkins v. Medtronic, Inc., 2014 WL 346622, slip  op. (E.D. Cal. Jan. 30, 2014), motion to dismiss granted against all claims in action involving bone growth device.  Off-label use does not trump PMA preemption.  All PMA components are protected by preemption.  Off-label promotion does not trump PMA preemption.  Defective warning claims preempted.  A new “intended use” would require changes to PMA labeling.  Off-label promotion can be the basis of a parallel claim.  Failure to report claims are insufficiently pleaded.  Claims affecting the PMA label are preempted.  Fraud and misrepresentation claims concerning off-label promotion are not preempted, but are insufficiently pleaded.  Off-label promotion is a disguised FDCA claim, whereas negligent failure to warn is a traditional state law claim.  Negligent warning claims that would alter PMA warnings are preempted.
  225. Rodriguez v. American Medical Systems, 2014 WL 429431 (S.D. Tex. Feb. 4, 2014), summary judgment against all claims in penile prosthesis case.  Preemption under Riegel applies to devices approved under a product development protocol.  A parallel claim cannot be assumed from the fact that plaintiff was injured.  Affirmed, see below.
  226. Halsey v. Smith & Nephew, Inc., 2014 WL 12717702 (D. Vt. Feb. 4, 2014), motion to dismiss granted in part and denied in part in case involving hip implant.  Plaintiff adequately pleaded a parallel manufacturing defect claim based on an FDA recall.  State law claims, including warnings, untethered to this claimed violation are preempted.  The FDA ordered neither warnings nor a recall.  Earlier motion 2013 WL 12226936, above.
  227. Scovil v. Medtronic, Inc., 995 F. Supp.2d 1082 (D. Ariz. Feb. 7, 2014), motion to dismiss granted against most claims in action involving bone growth device.  Off-label promotion claims preempted because only the FDA can enforce its prohibition.  Design and manufacturing claims based on risks of off-label use are preempted.  Any warning claim concerning off-label uses is in addition to the label and therefore preempted.  Disagreeing with Ramirez.  All negligence claims are preempted except marketing involving off-label promotion.  Fraud and consumer fraud claims involving off-label promotion are not preempted.  Warranties were disclaimed.
  228. Kashani-Matts v. Medtronic, Inc., 2014 WL 819392 (C.D. Cal. Feb. 14, 2014), motion to dismiss amended complaint granted in action involving bone growth device.  Vague statements that the device’s labeling did not meet FDA requirements were insufficient to state parallel claims.  “Magic words” are not enough.
  229. Starks v. Coloplast Corp., 2014 WL 617130, slip op. (E.D. Pa. Feb. 18, 2014),  motion to dismiss granted against all claims, including implied warranty, in action involving penile implant.  Judicial notice taken of FDA documents.  A subsequent PMA takes precedence over an earlier 510k approval of some components for preemption purposes.  Parallel claims cannot be boilerplate.  Express warranty claims are inadequately pleaded.
  230. Kitchen v. Biomet, Inc.,  2014 WL 694226 (E.D. Ky. Feb. 21, 2014), motion to dismiss granted against all claims, in action involving knee implant.  All non-parallel claims, including express and implied warranty, are preempted.  Parallel claim allegations are insufficiently pleaded.
  231. Harris v. Medtronic, Inc., 2014 WL 866063 (Cal. Super. Feb. 27, 2014).  Demurrer granted in part and denied in part in action involving bone growth device.  Failure to report adverse event claims are not preempted.  Failure to warn and fraud claims based on off-label promotion are preempted.  FDA regulations about off-label promotion are not genuinely equivalent to any state-law claim.  Negligence per se claims concerning off-label promotion are not preempted.  Fraud claims concerning statements made to the FDA are fraud on the FDA claims and are preempted.  Fraud claims based on  affirmatively false off-label promotion are not preempted.  Genuine equivalence not present liability could exist under the state law without a violation of federal law.
  232. Marse v. Medtronic, Inc., 2014 WL 987829 (Minn. Dist. March 12, 2014), renewed motion to dismiss granted against remaining claims for fraud and constructive fraud in action involving bone growth device. Plaintiffs have failed to make out a fraudulent off-label promotion claim that survives preemption. Affirmed in part and reversed in partAngeles v. Medtronic, below.
  233. Schuler v. Medtronic, Inc., 2014 WL 988516, slip op. (C.D. Cal. March 12, 2014), motion to dismiss granted against all claims in action involving bone growth device.  All claims would require additional disclosure.  Off-label promotion is not barred by federal law and cannot give rise to a parallel claim.
  234. Seeberg v. Medtronic, Inc., 2014 WL 1102740 (Minn. Dist. March 12, 2014), renewed motion to dismiss denied against remaining claims for fraud and constructive fraud in action involving bone growth device. Plaintiffs pleaded sufficient facts about fraudulent off-label promotion and agency to survive preemption. Plaintiffs did not plead sufficient facts to support a claim based on medical articles.
  235. Younkin v. Medtronic, Inc., 2014 WL 1102738 (Minn. Dist. March 12, 2014), renewed motion to dismiss denied against remaining claims for fraud and constructive fraud in action involving bone growth device. Plaintiffs pleaded sufficient facts about fraudulent off-label promotion and agency to survive preemption. Plaintiffs did not plead sufficient facts to support a claim based on medical articles.
  236. Swisher v. Stryker Corp., 2014 WL 1153716 (W.D. Okla. March 14, 2014), motion to dismiss granted against negligence per se claims in action involving hip resurfacing system.  Conclusory statements that the defendant violated multiple regulations are not sufficient to plead a parallel claim.  Causation and the nature of the violation are required.  Motion to dismiss amended complaint denied, as claims now sufficiently pleaded, 2014 WL 12160770 (W.D. Okla. June 17, 2014).
  237. Hayter v. Medtronic, Inc., 2014 WL 8165507 (Cal. Super. March 14, 2014), demurrer sustained in part and overruled in part in action involving bone growth device. Fraud and warning claims based on false off-label promotion or failure to report are not preempted.  Other design and warning claims are.  Express warranty based on voluntary statements about off-label uses are not preempted.  Design defect claims preempted.
  238. Bertini v. Smith & Nephew, Inc., 8 F. Supp.3d 246 (E.D.N.Y. March 17, 2014), motion to dismiss granted against all claims in action involving hip replacement system.  Judicial notice taken of FDA approval/clearance documents.  Where components of a PMA approved device and a 510k cleared device are mixed, preemption could be complex.  Focusing on the system as a whole, the only defects that could be causal are those relating to the PMA components.  While mixing components was off-label, preemption is not concerned with how devices are used.  Off-label use is not a defect.  Failure to warn is not parallel to claims about violating reporting requirements.  FDA reporting requirements do not require warnings directly to doctors or patients.  No reliance was alleged with respect to off-label promotion.  Consumer expectation-based implied warranty claims are preempted.
  239. Mead v. Medtronic, Inc., 2014 WL 1102737 (Minn. Dist. March 19, 2014), renewed motion to dismiss granted against remaining claims for fraud and constructive fraud in action involving bone growth device.  Plaintiffs have failed to make out a fraudulent off-label promotion claim that survives preemption.
  240. Davenport v. Medtronic, Inc., 2014 WL 1102736 (Minn. Dist. March 19, 2014), renewed motion to dismiss granted against remaining claims for fraud and constructive fraud in action involving bone growth device. Plaintiffs have failed to make out a fraudulent off-label promotion claim that survives preemption.  Affirmed in part and reversed in partAngeles v. Medtronic, below.
  241. Starovasnik v. Medtronic, Inc., 2014 WL 1102742 (Minn. Dist. March 19, 2014), renewed motion to dismiss granted against remaining claims for fraud and constructive fraud in action involving bone growth device. Plaintiffs have failed to make out fraudulent off-label promotion or agency claims that survive preemption.  Affirmed in part and reversed in partAngeles v. Medtronic, below.
  242. Beaudry v. Medtronic, Inc., 2014 WL 1102741 (Minn. Dist. March 19, 2014), renewed motion to dismiss denied against remaining claims for fraud and constructive fraud in action involving bone growth device.   Plaintiffs pleaded sufficient facts about fraudulent off-label promotion and agency to survive preemption.  Plaintiffs did not plead sufficient facts to support a claim based on medical articles.
  243. Herron v. Smith & Nephew, Inc., 7 F. Supp.3d 1043 (E.D. Cal. March 21, 2014), motion to dismiss granted in part and denied in part in action involving hip resurfacing system.  Allegations of a mislabeled component adequately state a parallel claim.  Other undefined or jargon-filled allegations are dismissed.  Claims asserting that the FDA did not do its job are preempted.  Much of the complaint is too vague to determine if parallel claims are being made, and must be repleaded.
  244. Schouest v. Medtronic, Inc., 13 F. Supp.3d 692 (S.D. Tex. March 24, 2014), motion to dismiss granted in part and denied in part in action involving bone growth device.  Preemption extends to all components of a device system, whether or not used together.  All claims that seek to have the defendant do more than the FDA has required are preempted.   The FDA does not define nor explicitly ban, off-label promotion.  Claims including express warranty based on false off-label promotion are not preempted.  Warning and implied warranty claims about off-label use are preempted.  Design claims are preempted.  Mere off-label promotion claims are preempted by Buckman.  If plaintiff can identify a state law duty to report adverse events, such a claim would not be preempted.  Amended complaint dismissed with prejudice see below.
  245. McConologue v. Smith & Nephew, Inc., 8 F. Supp.3d 93 (D. Conn. March 24, 2014), motion to dismiss granted in part and denied in part in action involving hip replacement system. Blanket preemption rejected in light of parallel claim exception.  A device not manufactured in accordance with a PMA remains a “device intended for human use,” and preemption applies.  A manufacturing defect claim predicated on failure to follow PMA standards survives preemption as does misrepresentation and implied warranty claims predicated on the manufacturing defect.  Independent state law claims are not parallel and are preempted.  Warning and design claims preempted.  Testing claims TwIqballed.
  246. Blankenship v. Medtronic, Inc., 6 F. Supp.3d 979 (E.D. Mo. March 25, 2014), motion to dismiss granted against all claims in action involving bone growth device.  Taking judicial notice of FDA approvals and supplements.  Making what is permissive into something mandatory is preempted.  General references to violating GMPs fail to establish a parallel claim.  Violations of the PMA would state a parallel claim.  Off-label promotion is prohibited by federal law but not unlawful under traditional state law.  Manufacturing defect and negligence claims based on off-label promotion are preempted as imposing different requirements.  Demands for warnings about off-label uses are preempted.  Failure to file adverse event report claims are preempted.  Design defect claims seeking anything other than what the FDA required are preempted.  Off-label promotion only exists by virtue of the FDCA.  Negligence per se is not based independently tortious conduct.  Non-disclosure of facts about FDA approval is not a state-law tort.  A claim of fraudulent off-label promotion would not be preempted, but is inadequately pleaded.
  247. Burkett v. Smith & Nephew, 2014 WL 1315315, slip op. (E.D.N.Y. March 31, 2014), motion to dismiss granted against all claims in action involving hip replacement system. A PMA supplement supports preemption.  Violation allegations involving vague GMPs do not support preemption.  Nor was causation pleaded between the alleged violation and the plaintiff’s injury.  Design and warning claims preempted, in negligence as well as strict liability.  Fraud express/implied warranty, and consumer protection claims inadequately pleaded to escape preemption.
  248. Simoneau v. Stryker Corp., 2014 WL 1289426, slip op. (D. Conn. March 31, 2014), motion to dismiss granted in part and denied in part in action involving hip replacement system.  In light of FDA warning letters and product recalls, claims alleging manufacturing defects are parallel and not preempted.  Allowing reliance at pleading stage on general GMPs.  Recalls were pleaded to involve components implanted specifically in plaintiff.  Warning and design based claims are preempted.  Failure to report claims are not parallel.  Federal law does not require warnings to plaintiff or her doctors.  State law does not require warnings to the FDA.  Express warranty claims inadequately pleaded.
  249. Cline v. Advanced Neuromodulation Systems, 17 F. Supp.3d 1275 (N.D. Ga. March 31, 2014), motion to dismiss granted in part and denied in part in action involving a spinal cord stimulator.  Strict liability claims are preempted because, whether or not a “duty” is involved, they would require changes in the device triggering the express preemption clause.  The battery life claim is preempted because there is no FDA performance standard to that effect.  A design validation claim is preempted because there is no showing that the defendant’s validation was contrary to FDA regulations.  Several FDA violation claims fail because they lack any causal connection to the failure plaintiff alleged.  One parallel claim based on a recall has a sufficient causal relationship and thus survives preemption as a parallel claim.
  250. Houston v. Medtronic, Inc., 2014 WL 1364455, slip op. (C.D. Cal. April 2, 2014), motion to dismiss granted in part and denied in part in action involving bone growth device.  Preemption applies to devices, not uses of devices or promotion of uses of devices.  FDA requirements extend to off-label use and promotion.  Ramirez is wrongly decided.  Failure to report claims to the FDA are not preempted. Fraudulent promotion of off-label use can escape preemption.  Plaintiff pleaded his physician’s exposure to fraudulent promotion with sufficient particularity.  Express warranty is not preempted and is adequately pleaded.
  251. Brady v. Medtronic, Inc., 2014 WL 1377830, slip op. (S.D. Fla. April 8, 2014), motion to dismiss granted in action involving bone growth device.  Preemption does not turn on how a device is marketed.  Fraud claims against FDA-approved labeling are preempted.  Fraud claims involving off-label promotion are not preempted, but not pleaded with particularity.  Negligent warning and design claims are preempted.  Negligence claims based on illegal promotion are preempted as attempts to enforce the FDCA.  Express warranty claims not involving FDA labeling may not be preempted, but are not properly pleaded.
  252. Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp.3d 1021 (D. Haw. April 10, 2014), motion to dismiss granted in action involving bone growth device.  Documents on FDA website judicially noticed.  All claims challenging contents of FDA-approved label are preempted.  Off-label promotion claims can be preempted (rejecting Ramirez).  Design and off-label promotion claims preempted, except fraud.  Fraud, concealment, and misrepresentation claims not preempted, but inadequately pleaded.  Failure to report claims inadequately pleaded.  Express warranty claims outside the label not preempted but inadequately pleaded.
  253. Eidson v. Medtronic, Inc., 40 F. Supp.3d 1202 (N.D. Cal. May 13, 2013).  Renewed motion to dismiss granted in part and denied in part.   Claims alleging affirmatively fraudulent off-label promotion are not preempted.  Failure to warn claims based on overpromotion and deceptive off-label promotion are expressly preempted, but claims alleging failure to report adverse events to the FDA are not.
  254. Williamston v. Medtronic, Inc., 2014 WL 2042004 (W.D. La. May 15, 2014), motion to dismiss granted in action involving implantable cardiac defibrillator.  Parallel claims not pleaded where the violation of allegedly parallel regulations did not articulate a defect with any specificity. Nor was causation alleged.  Nor was the nature of the allegedly parallel state-law cause of action.
  255. Reed v. Medtronic, Inc., 2014 WL 1930221 (Cal. App. May 15, 2014) (unpublished), summary judgment reversed because plaintiff should have been allowed to amend complaint.  Plaintiff did not appeal entry of summary judgment against all prior product liability claims.  A claim that an employee of the defendant negligently programmed a device is not a requirement “with respect to a device,” as it does not challenge any aspect of the device.  Such a claim is not a parallel claim because no violation is involved.
  256. Malonzo v. Mentor Worldwide, LLC, 2014 WL 2212235 (N.D. Cal. May 28, 2014), motion to dismiss granted in action involving breast implants.   Plaintiff concedes that all her pleaded claims were preempted, but failed to allege an adequate parallel claim.  Failure to report adverse events alleged only an FDCA violation.
  257. Hornbeck v. Medtronic, Inc.,  2014 WL 2510817 (N.D. Ill. June 2, 2014), motion for judgment on the pleadings denied in action involving bone growth device.  All plaintiffs’ claims involve FDCA violations, so they are parallel claims.  By promoting off-label use the defendant removed itself from the protection of preemption.  Because the FDA only approved the components for use together, preemption cannot apply to components used separately.
  258. Johnson v. Hologic, Inc., 2014 WL 2581421, slip op. (E.D. Cal. June 6, 2014), judgment on the pleadings granted against all claims in action involving a mammography machine.  Documents on FDA website judicially noticed.  No parallel claims were pleaded.
  259. Franzese v. St. Jude Medical, Inc., 2014 WL 2863087 (E.D.N.Y. June 23, 2014), motion to dismiss granted in action involving implantable cardiac defibrillator.  PMA documents judicially noticed.  Parallel claims alleging violations of vague GMPs are preempted.  Nonspecific adulteration claims are preempted.  Design defect claims are preempted.  A warning letter issued three years after manufacture does not establish causation.  Express and implied warranty claims based on FDA-approved labeling are preempted.  Negligence claims preempted for same reasons as strict liability.  Negligent misrepresentation claims inadequately pleaded.
  260. Pinsonneault v. St. Jude Medical, Inc., 2014 WL 2879754 (D. Minn. June 24, 2014), summary judgment granted in large part in action involving implantable cardiac defibrillator.  A manufacturer’s purely internal manufacturing specifications do not become FDCA requirements simply because the FDCA requires manufacturers to have such specifications.  None of plaintiff’s alleged manufacturing defects violate any actual FDCA requirement so plaintiffs have no parallel unpreempted claims.
  261. Dunbar v. Medtronic, Inc., 2014 WL 3056026, slip op. (C.D. Cal. June 25, 2014), motion to dismiss granted in part and denied in part in action involving bone growth device. Warning and design claims expressly preempted.  There is no traditional tort claim for off-label preemption, so negligence and negligence per se claims based on such allegations are impliedly preempted.  Express warranty claims are not preempted, but are inadequately pleaded on basis of the bargain and notice grounds.
  262. Mendez v. Shah, 28 F. Supp.3d 282 (D.N.J. June 27, 2014), motion to dismiss granted in part and denied in part in action involving bone growth device.  Preemption does not depend on using all of the approved components.  Claims alleging false off-label promotion are not preempted.  Subsequent opinion, 94 F. Supp.3d 633, below.
  263. Edwards v. Ethicon, Inc., 30 F. Supp.3d 554 (S.D.W. Va. July 8, 2014), summary judgment denied in action involving vaginal mesh.  That a device system had one component that was PMA approved did not support preemption where the system as a whole was cleared as substantially equivalent under §510k.
  264. Huskey v. Ethicon, Inc., 29 F. Supp.3d 736 (S.D.W. Va. July 8, 2014), summary judgment denied in action involving vaginal mesh. That a device system had one component that was PMA approved did not support preemption where the system as a whole was cleared as substantially equivalent under §510k.
  265. Highfield v. Perard, 2014 WL 3773976, slip op. (Pa. C.P. Clarion Co. July 16, 2014), preliminary objections granted against third-party complaint in action involving thermal ablation device.  A failure to maintain/inspect claim would impose extra requirements to the PMA process and is preempted.  There is no private right to enforce the FDCA.  Alleging violation of non-device-specific GMPs is insufficient to state a parallel violation claim.  General violation claims do not provide a causal nexus between the violation and the alleged injury.
  266. Waltenburg v. St. Jude Medical, Inc., 33 F. Supp.3d 818 (W.D. Ky. July 21, 2014), motion to dismiss granted in part and denied in part in action involving implantable cardiac defibrillator.  Specifically pleaded manufacturing defects in violation of GMPs are not preempted.  FDA requirements are in both PMA and supplemental PMAs.  Failure to report to FDA warning claim not preempted.
  267. Martin v. Medtronic, Inc., 32 F. Supp.3d 1026 (D. Ariz. July 23, 2014), motion to dismiss granted in action involving bone growth device.  Judicial notice taken of FDA approvals. Preemption applies to off-label uses, rejecting Ramirez.  Misrepresentation can be a parallel state duty in cases of untruthful off-label promotion.  Fraud claims based on FDA-approved labeling are preempted.  Fraud claims based on untruthful off-label promotion are not preempted but are inadequately pleaded.  Warning claims based on off-label promotion are preempted.  Failure to report adverse events to the FDA is not preempted, but plaintiffs fail to allege how such a failure caused them injury.  Design defect claims preempted.  Negligence claim based on off-label promotion impliedly preempted.  Express warranty claim based on untruthful off-label promotion not preempted but warranty must be pleaded.  Second complaint dismissed, see below.
  268. Thibodeau v. Cochlear Ltd., 2014 WL 3700868 (D. Ariz. July 25, 2014), motion to dismiss granted in part and denied in part in action involving cochlear implant.  An unexplained list of 30 allegedly violated regulations is conclusory and cannot defeat preemption.  Negligence per se is impliedly preempted as directly based on an FDCA violation.  All warning-based claims, including express warranties, are preempted.  Allegations of failure to warn the FDA are not preempted.
  269. Scanlon v. Medtronic, Inc., 61 F. Supp.3d 403 (D. Del. July 28, 2014), motion to dismiss granted in action involving bone growth device. Judicial notice taken of FDA approvals and other documents.  Motion for discovery denied.  Off-label promotion claims preempted, and are not parallel claims.  Warning and negligence preempted as adding requirements.  No federal requirement to seek label change.  Misrepresentation claim preempted where label complied with FDCA.  False promotion and failure to report would not exist apart from FDCA and are implied preempted.
  270. Huggins v. Medtronic, Inc., 2014 WL 4262211 (Colo. Dist. July 28, 2014), motion to dismiss denied in action involving bone growth device.  Everything is a parallel claim.
  271. Cordova v. Smith & Nephew, Inc., 2014 WL 3749421 (E.D.N.Y. July 30, 2014), partial motion to dismiss (all but manufacturing claims) granted in action involving hip implant.  Warning, design, and implied warranty claims are preempted.  Express warranty based on manufacturing defect would not be preempted, but is inadequately pleaded.
  272. Blankenship v. Medtronic, Inc., 2014 WL 3818485 (E.D. Mo. Aug. 4, 2014), motion to dismiss denied in action involving bone growth device against repleaded fraud claims concerning off-label promotion.  Fraud claims adequately pleaded.
  273. Zaccarello v. Medtronic, Inc., 38 F. Supp.3d 1061 (W.D. Mo. Aug. 6, 2014), motion to dismiss granted in part and denied in part in action involving in action involving bone growth device.  Design, manufacture, and warning claims preempted.  Express warranty, fraud, and consumer fraud escape preemption to the extent based on false off-label promotion, but express warranty and fraud are inadequately pleaded.  Improper promotion and negligence per se impliedly preempted as disguised FDCA causes of action.
  274. Roberts v. Stryker Corp., 2014 WL 12911070 (W.D. Ky. Aug. 7, 2014), motion to dismiss granted in part and denied in part in action involving in action involving hip implant.  Some GMPs cited by plaintiffs are sufficiently specific in establishing a duty to support a parallel claim, others are too vague. Warning claims preempted because Kentucky does not recognize any failure to report claim.
  275. Vitale v. Medtronic, Inc., 2014 WL 3893294, slip op. (C.D. Cal. Aug. 8, 2014), motion to dismiss granted in action involving bone growth device.  All claims are expressly or impliedly preempted.
  276. Arthur v. Medtronic, Inc., 2014 WL 3894365, slip op. (E.D. Mo. Aug. 11, 2014), motion to dismiss granted in part and denied in part in action involving in action involving bone growth device.  Judicial notice given to FDA documents.  Off-label promotion is subject to misbranding, which is an FDA requirement.  Design, warning, and warranty claims expressly preempted.  Negligence claims based on off-label promotion impliedly preempted as private FDCA actions.  The concept of “off-label” is a creature of the FDCA.  Fraudulent misrepresentation and express warranty claims involving false off-label promotion are not preempted, but inadequately pleaded.
  277. Gall v. Stryker Orthopaedics, 2014 WL 12614471 (C.D. Cal. Aug. 14, 2014), motion to dismiss granted part and denied in part in action involving hip implant.  All claims other than those based on a Stengel failure to report theory preempted.
  278. Toubian v. Boston Scientific Corp., 2014 WL 12607702 (C.D. Cal. Aug. 19, 2014), motion to dismiss granted part and denied in part in action involving implantable defibrillator.  Parallel manufacturing claim based on GMPs survives preemption and is adequately pleaded.  GMPs need not be specific.
  279. Arvizu v. Medtronic, Inc., 41 F. Supp.3d 783 (D. Ariz. Aug. 25, 2014), motion to dismiss granted part and denied in part in action involving in action involving bone growth device.  Judicial notice given to FDA documents.  Off-label promotion does not negate preemption.  FDA approves devices, not uses.  Fraud involving FDA-approved statements is preempted, but fraudulent off-label promotion is not.  Warning claims other than failure to report are preempted.  Design defect preempted.  Truthful off-label promotion claims preempted because not state-law duty to refrain from such promotion.  Express promotion not preempted, but inadequately pleaded.
  280. Carlson v. Medtronic Inc., 2014 WL 11514911 (S.D. Miss. Aug. 28, 2014), motion to dismiss granted against all claims in action involving pain pump.  Parallel manufacturing defect claim inadequately pleaded.
  281. Tansey v. Cochlear Ltd., 2014 WL 4829453 (E.D.N.Y. Sept. 26, 2014),  motion to dismiss granted in part and denied in part in action involving cochlear implant.  Manufacturing defect claims are parallel and not preempted.  Design defect claims are preempted. Warning claims rely on an FDA recall occurring more than a year later, which fails to plead causation.  Failure to inspect claims are TwIqballed.  Related negligence claims follow the defect allegations.
  282. McCormick v. Medtronic, Inc., 101 A.3d 467 (Md. App. Oct. 7. 2014), dismissal of all claims affirmed in part and reversed in part.  Allegations of misrepresentations (fraud, misrepresentation, consumer fraud, express warranty) made in the context of off-label promotion are neither expressly or impliedly preempted.  Rejects Ramirez.  All claims that challenge the FDA-approved warnings or design of a PMA device are preempted.  Failure to disclose information in the course of the approval process are impliedly preempted.  Pure off-label promotion claims, not depending on falsity are impliedly preempted.  Both are seeking to enforce the FDCA.  Strict liability is preempted.  Breach of warranty is preempted to the extent based on FDA labeling, otherwise it is not.  Plaintiffs failed to plead fraud with particularity.
  283. Sluss v. Medtronic Sofamor Danek USA, Inc., No. BC 496524, slip op. (Cal. Super. Oct. 15, 2014), demurrer granted in part and overruled in part in action involving in action involving bone growth device.  All claims preempted except for those relating to negligent off-label promotion and failure to report adverse events.  Strict liability off-label promotion is preempted as are all design claims and warnings not concerning off-label promotion.
  284. Anderson v. Medtronic, Inc., 2014 WL 5528664, slip op. (Minn. Dist. Oct. 16, 2014), motion to dismiss granted against all claims in action involving bone growth device.  Fraud and constructive fraud based on false off-label promotion are inadequately pleaded because they rely on generalized fraud on the market allegations.  All other claims are preempted, including negligence, strict liability, express and implied warranty, several consumer fraud/trade practices statutes, and unjust enrichment.
  285. Lindler v. Mentor Worldwide LLC, 2014 WL 6390307 (D.S.C. Oct. 23, 2014), motion to dismiss granted against all claims in action involving breast implants.  All claims preempted, except express warranty, which is inadequately pleaded.
  286. Hesik v. Boston Scientific Corp., 2014 WL 5644699 (D.S.C. Nov. 4, 2014), summary judgment granted in part and denied in part in action involving defibrillator.  All claims dismissed except for alleged 5-year express warranty, which is arguably beyond anything required by the FDA.  Violations of vague FDA regulations cannot escape preemption as parallel claims.  Implied warranty claims are preempted.  Earlier decision see above 2012 WL 12897111.
  287. Stanifer v. Corin USA Ltd., 2014 WL 5823319 (M.D. Fla. Nov. 10, 2014), motion to dismiss granted against all claims in action involving hip resurfacing device.  Only parallel claims escape preemption and plaintiff did not plead any.  Judicial notice of FDA approval is proper.  Request for pre-complaint discovery is denied.
  288. Farrand v. Stryker Corp., 2014 WL 11514684 (S.D. Iowa Nov. 12, 2014), summary judgment granted in part and denied in part in action involving hip implant.  “Not strong enough” claim preempted.  Warning, testing, and warranty claims preempted.  “Marginal” manufacturing defect parallel claim based on warning letter survives preemption as pleaded, to the extent it alleges only violations of FDA standards.
  289. David v. Medtronic, Inc., 2014 WL 12626709 (Cal. Super. Nov. 18, 2014), demurrer sustained against all claims in action involving bone growth device.  Judicial notice taken of official FDA acts. All plaintiff’s claims may be preempted, but they are too vaguely pleaded to dismiss with prejudice.  Fraud on the FDA is preempted.
  290. Cales v. Medtronic, Inc., 2014 WL 6600018 (Ky. Cir. Nov 21, 2014), motion to dismiss granted against all claims in action involving bone growth device.  Off-label use does not oust preemption.  Preemption does not depend on using all of the approved components.  The FDA approves devices, not uses.  Parallel claims must involve a substantially equivalent state-law theory.  Neither off-label promotion nor failure to report are parallel claims.  They have no equivalent state liability theories.  Private enforcement of the FDCA is impliedly preempted.  Fraud is not properly pleaded.  Without pleading physician-specific reliance, plaintiff is alleging improper fraud on the market.  All claims attacking FDA-approved labels and design are preempted.  Without pleading physician-specific causation, failure to report claims do not allege any state law claim, and are dismissed.  Any warranty created by off-label promotion must become part of the basis of the bargain to avoid preemption.  Reconsideration denied  2015 WL 4081908 (Ky. Cir. July 1, 2015)
  291. Martin v. Medtronic, Inc., 63 F. Supp.3d 1050 (D. Ariz. Nov. 24, 2014), motion to dismiss granted against all claims in action involving bone growth device.  All claims previously dismissed as preempted are again dismissed.  Failure to report claims dismissed for failing to plead causation.  Fraud is sufficiently pleaded, with reliance on a specified article and the author’s agency by specified financial ties.  Other promotional allegations insufficiently pleaded.  Allegations of reliance upon unspecified medical literature are not enough.  General allegations about product safety dismissed as fraud on the market.  Express warranty inadequately pleaded.  Entire complaint dismissed as prolix and redundant with leave to amend.  Subsequent history:  Entire complaint dismissed with prejudice because of plaintiff’s repeated pleading prolixity.  2015 WL 1477903 (D. Ariz. April 1, 2015)
  292. Pitkow v. Lautin, 2014 WL 11351492, slip op. (N.Y. Sup. N.Y. Co. Dec. 9, 2014), summary judgment granted against all claims against injectable body sculpturing device). Preemption applies to products promoted for off-label use.  No parallel state-law claim alleged.  All claims about off-label promotion also preempted under Buckman.  Affirmed 29 N.Y.S.3d 805 (N.Y. App. Div. May 12, 2016).
  293. Hernandez v. Stryker Corp., 2014 WL 7044171, slip op. (W.D. Wash. Dec. 11, 2014), motion to dismiss granted against all claims in action involving total hip implant.   Vague references to “adulteration” and FDA warning letters do not plead sufficient facts to establish a parallel claim.  Causation fails because plaintiff fails to link letters to her claim.  The allegedly violated GMPs do not specify any steps that the defendant was required to take.  Express warranty claims based on FDA-approved labeling are preempted.
  294. Brook v. Sanofi Aventis LLC, 2014 WL 7272243 (S.D. Ohio Dec. 18, 2014),  motion to dismiss denied in action involving cosmetic injection.  Citing Bausch, the court refuses to decide any preemption issue without discovery into whether a parallel claim exists.
  295. Rodriguez v. American Medical Systems, 597 F. Appx. 226 (5th Cir. Dec. 31, 2014), summary judgment affirmed against all claims in penile prosthesis case.  Plaintiff could not create a factual dispute about the device’s PMA approval.  Plaintiff failed to plead a plausible parallel claim.  Affirming 2014 WL 429431, above.
  296. Johnson v. Hologic, Inc., 2015 WL 75240 (E.D. Cal. Jan. 5, 2015), judgment on the pleadings granted against all amended claims in action involving a mammography machine.  Plaintiff failed to plead a viable parallel claim.  An failure to report adverse events cannot possibly be causal where the event in question is the one that injured the plaintiff.
  297. Morton v. Medtronic, Inc., 2015 WL 12778750 (Mag. D. Minn. Jan. 5, 2015), adopted 2015 WL 12780468 (D. Minn. Feb. 19, 2015), motion to dismiss granted against all claims in action involving implantable defibrillator.  All state-law claims, including manufacturing defect and express/implied warranty preempted.  No parallel claims alleged.
  298. Beavers-Gabriel v. Medtronic, Inc., 2015 WL 143944 (D. Haw. Jan. 9, 2015), motion to dismiss remaining claims of amended complaint denied in action bone growth device.  False off-label promotion claims are not preempted and are adequately pleaded.  Failure to report claims are not preempted under Stengel.
  299. Tone v. Studin, 2015 WL 725420 (N.Y. Sup. Jan. 20, 2015), summary judgment granted against all claims in action involving injectable body sculpturing device. Preemption applies to products promoted for off-label use.  No parallel state-law claim alleged.  All claims about off-label promotion also preempted under Buckman.  Affirmed 51 N.Y.S.3d 548 (N.Y. App. Div. March 29, 2017).
  300. Garross v. Medtronic, Inc., 77 F. Supp.3d 809 (E.D. Wis. Jan. 21, 2015), motion to dismiss denied in action involving bone growth device.  Fraud claims based in false off-label preemption are not preempted.  Negligence and strict liability claims based on failure to report adverse events, or failure to seek approval of promoted indications are parallel claims and are not preempted.  Judicial notice given to FDA-approved warnings.
  301. Wright v. Medtronic, Inc., 81 F. Supp.3d 600 (W.D. Mich. Jan. 23, 2015), motion to dismiss granted against most claims in action involving bone growth device.  Federal law does not explicitly ban off-label promotion.  Off-label promotion does not defeat preemption because preemption applies to devices, not uses.  There is no state-law duty to refrain from off-label promotion.  Design and warning claims preempted.  Fraudulent promotion is not preempted and, as amended, is adequately pleaded.  Express warranty is not preempted, but was disclaimed.
  302. Thorn v. Medtronic Sofamor Danek, USA, Inc., 81 F. Supp.3d 619 (W.D. Mich. Jan. 23, 2015), motion to dismiss granted against all claims in action involving bone growth device.  Federal law does not explicitly ban off-label promotion.  Off-label promotion does not defeat preemption because preemption applies to devices, not uses.  There is no state-law duty to refrain from off-label promotion.  Any duty to provide truthful information to the FDA is preempted by Buckman.   Design and warning claims preempted.  Express warranty is not preempted, but was disclaimed and inadequately pleaded.  Affirmed on procedural grounds, 2015 U.S. App. Lexis 22582 (6th Cir. Dec. 15, 2015)
  303. Holland v. Frey, 2015 WL 606105 (Cal. Super. Jan. 26, 2015), demurrer denied in action involving “Precision SCS” device.  While a malfunction claim would be preempted, plaintiff is suing only over what a sales representative allegedly said about the malfunction.  Sales representative conduct is not subject to preemption.
  304. Buccelli v. Mayer, 2015 WL 398594, slip op. (Fla. Dist. Jan. 28, 2015), motion to dismiss granted against all claims in action involving bone growth device.   All claims whatever theory challenging FDA approved design and labeling are expressly preempted.  Fraudulent off-label promotion claims are insufficiently pleaded.  No allegations specific to plaintiff’s surgeon.  Warning claims based on off-label promotion are expressly preempted.  Negligent marketing claims grounded in off-label promotion are impliedly preempted under Buckman.  Express warranty claims are not preempted, but do not plead any warranty that became the basis of the bargain.
  305. Murray v. Hogan, 2015 WL 609599, slip op. (N.H. Super. Feb. 2, 2015), summary judgment/motion to dismiss granted in part in action involving knee implant.  All plaintiff’s direct liability claims against the defendant are preempted.  Plaintiff granted leave to attempt to plead a parallel claim.  Vicarious liability claims based on sales rep conduct in the operating room are not preempted.
  306. Kennedy v. Naka, 2015 WL 1486985 (N.Y. Sup. Feb. 11, 2015), summary judgment granted against all claims in action involving artificial heart valve, except express warranty, which was inadequately pleaded.
  307. Millman v. Medtronic, 2015 WL 778779, slip op. (D.N.J. Feb. 24, 2015), motion to dismiss granted against all claims in action involving deep brain stimulator.  All claims, including warranty, are preempted.  Fraud claim based on sales rep statements inadequately pleaded, but would not be preempted.
  308. Scovil v. Medtronic Inc., 2015 WL 880614 (D. Nev. March 2, 2015), motion to dismiss amended complaint granted in part in action involving bone growth device.   Parallel manufacturing defect claim inadequately pleaded.  Failure to report claim not preempted.  Negligence and fraud claims not preempted to the extent based on illegal off-label promotion.  Implied warranty claims dismissed on state law grounds.  Express warranty improperly pleaded.
  309. Teixeria v. St. Jude Medical, Inc., 2015 WL 902616 (Mag. W.D.N.Y. March 3, 2015), motion to dismiss granted in part in action involving implantable defibrillator.    Manufacturing defect claims paralleling a recall and FDA warning letter survive preemption.  More general negligence claims are preempted to the extent they assert duties beyond FDA requirements. Warning and design-based warranty claims preempted.  Misrepresentation preempted because FDA regs do not require any communication with doctors or patients, except warning labels.  Warranty claims based on the same manufacturing defect theory and on vaguely alleged direct statements are not preempted.  Adopted in part and rejected in part, 2016 WL 3547932, below.
  310. Jones v. Medtronic, Inc., 89 F. Supp.3d 1035 (D. Ariz. March 6, 2015), motion to dismiss granted with prejudice against all claims in action involving bone growth device.   Vague claims about unspecified devices are inadequately pleaded.  Plaintiff’s fraud claim escapes preemption but is inadequately pleaded.  Off-label promotion does not defeat preemption, rejecting Ramirez.  Preemption bars assertion of state-law duties based on off-label promotion that differ from FDA warning requirements.  Design defect claims preempted.  Affirmed in part and reversed in part, 2018 WL 3912167 below.
  311. Michajlun v. Bausch & Lomb, Inc., 2015 WL 1119733 (S.D. Cal. March 11, 2015), motion to dismiss granted in part in action involving intraocular lens.  Warning-related claims based on advertising that paraphrased FDA-approved labeling preempted.  Failure to report not reported and sufficiently causal.  Consumer fraud claims preempted as requiring different labeling.  UCL “unlawful” action claims predicated on FDCA violations are impliedly preempted under Buckman.
  312. Byrnes v. Small, 60 F. Supp.3d 1289 (M.D. Fla. March 18, 2015), motion to dismiss granted against all claims in action involving bone growth device.  All warning and design claims preempted.  Failure to report claims impliedly preempted as private FDCA enforcement.  No state-law reporting duty exists.  False off-label promotion claims (fraud, misrepresentation) not preempted, but inadequately pleaded.  Ramirez rejected.  All negligence theories preempted.  See below for ruling on repleaded complaint
  313. Schouest v. Medtronic, Inc., 92 F. Supp.3d 606 (S.D. Tex. March 20, 2015), motion to dismiss amended complaint granted with prejudice against all remaining claims in action involving bone growth device.  There cannot be a parallel claim for for failure to report adverse events to the FDA because no such state law duty exists.  Express warranty and consumer fraud claims inadequately pleaded.  Fraud and misrepresentation theories inadequately pleaded.
  314. Mendez v. Shah, 94 F. Supp.3d 633 (D.N.J. March 30, 2015), motion to dismiss granted against all remaining claims in action involving bone growth device.  Manufacturing defect claim must identify allegedly violated FDA requirement.  Off-label warning claim preempted. Prior decision, 28 F. Supp.3d 282, above.
  315. Jackson v. St. Jude Medical Neuromodulation Division, 2015 WL 1456650, slip op. (M.D. Fla. March 30, 2015), motion to dismiss granted against all claims in action involving neurostimulation device.  Negligence, strict liability and warranty all preempted.  Plaintiff’s general allegations cannot be the basis for a parallel claim.  A parallel claim would fail because Florida state law does not recognize claims based on FDCA violation. Private violation claims are impliedly preempted under Buckman.
  316. Brady v. Medtronic, Inc., 2015 WL 11181971 (S.D. Fla. March 30, 2015), motion to dismiss denied in action involving  bone growth device.  Allegations of fraudulent off-label promotion are neither expressly nor impliedly preempted.
  317. Shuker v. Smith & Nephew PLC, 2015 WL 1475368 (E.D. Pa. March 31, 2015), motion to dismiss amended complaint granted in action involving knee implant.  Use of PMA components with 510k components does not deprive the PMA components of preemption.  Off-label combination of components did not create a new non-approved and non-preempted device.  Off-label use does not render preemption inapplicable.  All plaintiff’s generalized claims preempted.  Express warranty and false off-label promotion not preempted but inadequately pleaded. Timing renders any failure to report claim implausible.  Second dismissal, see 2016 WL 5461900, below.
  318. Morton v. Allergan, Inc.,  2015 WL 12839493 (D.N.J. April 2, 2015), motion to dismiss granted against all claims in action involving stomach band.  All claims not based on parallel violation claims, including express warranty, are preempted.  Manufacturing defect claims asserting parallel claims were inadequately pleaded.
  319. Dwyer v. Boston Scientific Corp., 2015 WL 3384894 (Mass. Super. April 2, 2015), motion to dismiss denied in case involving defibrillator. Parallel claims for manufacturing defect not preempted where defendant admitted failure in letter and violations of GMPs alleged.  Manufacturing defects violating nonspecific GMPs are permissible.  No other claims alleged.
  320. Hafer v. Medtronic, Inc., 99 F. Supp.3d 844 (W.D. Tenn. April 13, 2015), motions to dismiss granted against all claims in multiple actions involving bone growth device.  Allegations of illegal off-label promotion do not displace preemption, rejecting Ramirez.  Claims attacking off-label promotion are impliedly preempted under Buckman as private FDCA enforcement.  “Off’-label” is purely federal.  Preemption affects devices, not uses or specific components.  Physician off-label mixing of non-PMA components does not affect preemption, nor were the non-PMA components alleged to be defective or to have caused harm.  Warning, design and implied warranty claims preempted.  Failure to report adverse events was preempted private FDCA enforcement.  False off-label promotion wasn’t preempted, but was not pleaded to establish prescriber-specific reliance.  Express warranty wasn’t preempted.
  321. Angeles v. Medtronic, Inc., 863 N.W.2d 404 (Minn. App. April 20, 2015), affirming in part and reversing in part dismissal of all claims in action involving bone growth device.  Preemption is not precluded by off-label use.  It is not essential that all components of a system be used.  Off-label use can be standard of care.  Rejecting Ramirez and Hornbeck.  Off-label promotion claims are preempted unless they further allege that false information was conveyed.  No state law duty to refrain from off-label promotion.  A failure to report claim would not be preempted, but must be sufficiently pleaded, including causation.  Design-related claims preempted.  Breach of voluntarily made express warranties are not preempted, if not based on FDA-approved labeling.  Fraud inadequately pleaded.  Superseding StarovasnikMarse, and Davenport, above.
  322. Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. April 21, 2015), dismissal of all claims affirmed in action involving bone growth device.  All strict liability, negligence, warranty, and misrepresentation claims are preempted unless parallel federal duties exist that are at least as broad as the state-law claims.  No parallel design or warranty claims are advanced.  Warning-related claims are not parallel because plaintiff’s off-label promotion claims go beyond warnings, and exceed the scope of federal requirements.  Plaintiff cannot force revision of a warning where federal regulations preclude preclude revision.  Plaintiff fails to identify any parallel federal requirement that the defendant violated.  Neither off-label use nor off-label promotion preclude preemption.  Preemption is tied to devices, not uses.  Congress did not write the statute to limit preemption to labeled uses.  Riegel found preemption in an off-label use situation.  Warranty and fraud not pleaded with specificity.  Affirming 921 F. Supp.2d 1206, above.
  323. Williams v. CIBA Vision Corp., 100 F. Supp.3d 585 (S.D. Miss. April 27, 2015), motion to dismiss granted against all claims in action involving intraocular lens.  Plaintiff failed to allege any specific facts how the device in question actually deviated from applicable FDA manufacturing requirements.  Without a viable parallel claim the action was preempted.
  324. Anderson v. Medtronic, Inc., 2015 WL 2115342, slip op. (S.D. Cal. May 6, 2015), motion to dismiss granted against all claims in action involving bone growth device.  Off-label promotion does not vitiate preemption, rejecting Ramirez.   FDA regulates such promotion.  No state law claims for off-label promotion.  It is impliedly preempted as a disguised FDCA violation claim.  Off-label promotion claims would require different warnings and are expressly preempted.  Plaintiff did not attempt to plead a failure to report claim.  Warranty and fraud claims inadequately pleaded for lack of prescriber-related allegations.  Negligence per se claims are impliedly preempted.
  325. Caton v. Stryker Sustainability Solutions, Inc., 2015 WL 12426110 (C.D. Cal. May 12, 2015), motion to dismiss granted against all claims in action involving hip implant.  Adequately pleaded manufacturing defect claims were parallel.  Failure to report information to FDA survived preemption, provided plaintiff pleaded:  (1) causation; (2) a duty to report the information at issue; and (3) that defendant actually had received adverse incidents that were not reported.
  326. McAfee v. Medtronic, Inc., 2015 WL 3617755, slip op. (N.D. Ind. June 4, 2015), motion to dismiss granted in part and denied in part in action involving defibrillator.  All failure to warn claims preempted except parallel claim for failure to report to FDA.  Failure to report to physicians is preempted as not parallel.  Negligent design and manufacture claims preempted.  Res ipsa claims preempted.  Reconsideration granted and motion granted, 2016 WL 2588807 (N.D. Ind. May 5, 2016), plaintiff failed to plead causation for reporting-based claim.
  327. Clements v. Sanofi-Aventis, U.S., Inc., 111 F. Supp.3d 586 (D.N.J. June 11, 2015), motion to dismiss granted against all claims in action involving injectable facial sculpting material.  All claims permitted by state product liability statute are preempted except parallel claims, which are inadequately pleaded.  Off-label promotion claims must be specifically pleaded, and may be preempted anyway.
  328. Leroy v. Medtronic, Inc., 2015 WL 4600880 (N.D. Fla. July 29, 2015), motion to dismiss granted against all claims in action involving implantable defibrillator.  Judicial notice taken of public FDA records.  A voluntary recall does not preclude preemption.  Parallel claim inadequately pleaded.
  329. Becker v. Smith & Nephew, Inc., 2015 WL 4647982 (D.N.J. Aug. 5, 2015), motion to dismiss granted against all claims in action involving hip implant.  Judicial notice taken of PMA status.  Plaintiff may not plead vague FDCA violations and fill in the blanks through discovery.  Express warranty claims must state the warranty.  Only non-FDA approved warranty language could escape preemption.
  330. Seedman v. Cochlear Americas, 2015 WL 4768239 (C.D. Cal. Aug. 10, 2015), motion to dismiss granted in part and denied in part in action involving cochlear implant.  Manufacturing defect claim survives as parallel claim and is adequately pleaded.  Design defect, negligent misrepresentation, and implied warranty preempted.  Conclusory failure to report claim allowed.  A catch-all negligence per se claim survives as to manufacturing defect, but everything else is preempted.
  331. Spier v. Coloplast Corp., 121 F. Supp.3d 809 (E.D. Tenn. Aug. 17, 2015), motion to dismiss granted against all claims in action involving penile prosthesis.  Plaintiff did not attempt to plead a parallel claim.  Express warranty also inadequately pleaded.
  332. Williams v. Smith & Nephew, Inc., 123 F. Supp.3d 733 (D. Md. Aug. 18, 2015), motion to dismiss granted in part and denied in part in action involving hip implant.  Design and implied warranty preempted.  Warning claim alleging failure to report adverse events not preempted as parallel to post-sale duty to warn.  Manufacturing defect claim not preempted.  Express warranty only preempted as to FDA-approved statements.  Failure to conduct studies impliedly preempted as FDCA enforcement.  Manufacturing defect claim insufficiently pleaded.
  333. Riddell v. Howmedica Osteonics Corp., 2015 WL 5167039 (S.D. Miss. Sept. 3, 2015), motion to dismiss granted in part and denied in part in action involving knee implant.  Non-preempted manufacturing parallel claim adequately pleaded.  Design and warranty claims preempted or inadequately pleaded.  Uncertain if preemption sought as to warning claims.
  334. Latimer v. Medtronic, Inc., 2015 WL 5222644, slip op. (Ga. Super. Sept. 4, 2015), motion to dismiss granted against all claims in action involving bone growth device.  FDA labels subject to judicial notice. No presumption against preemption in a PMA preemption case.  Off-label promotion does not vitiate preemption, rejecting Ramirez.  PMA based on devices, not uses, and not off-label promotion.  Preemption does not vary by component.  No state law claims for off-label promotion.  Off-label is FDA concept.  It is impliedly preempted as a disguised FDCA violation claim.  Warning, design, fraud and consumer fraud by omission, express and implied warranty expressly preempted.  Design defect impliedly preempted as impossible under Bartlett.  Failure to report claim inadequately pleaded, and nonexistent under state law.  Reporting does not encompass journal articles.  Implied warranty claims also impliedly preempted.  Affirmative fraud inadequately pleaded.
  335. Ortiz v. Allergan, Inc., 2015 WL 5178402 (S.D.N.Y. Sept. 4, 2015), motion to dismiss granted against all claims in action involving breast implant.  Manufacturing-related FDCA violations and warranty claims conclusorily pleaded.
  336. Gall v. Stryker Orthopaedics, 2015 WL 12803805 (Cal. Super. Sept. 17, 2015), judgment on the pleadings granted in part and denied in part in action involving hip implant.  Design, manufacturing, warning, and testing claims preempted, except for failure to report.  Warranty claims preempted to the extent based on FDA-approved statements.  Fraud claims preempted by Buckman “regardless to whom those representations were made.”  See below for subsequent opinion.
  337. Marmol v. St. Jude Medical Center, 132 F. Supp.3d 1359 (M.D. Fla. Sept. 24, 2015), motion to dismiss granted against all claims in action involving pacemaker lead.  Judicial notice taken of FDA website documents, but not their contents.  Manufacturing defect claim not parallel because state law does not recognize FDCA-based negligence per se.  For the same reasons a failure to report-based warning claim also cannot be parallel.  In the absence of state-law duty to make reports to a government agency, plaintiff’s claim is an improper private attempt to enforce the FDCA.
  338. Humana Inc. v. Medtronic Sofamor Danek USA, Inc., 133 F. Supp.3d 1068 (W.D. Tenn. Sept. 25, 2015), motion to dismiss granted against almost all claims in third-party payer action involving bone growth device.  Express and implied warranty and fraud by omission claims preempted.  All other claims, except some federal Medicare claims dismissed for various non-preemption reasons.
  339. Stanfield v. Boston Scientific Corp., 166 F. Supp.3d 873 (S.D. Tex. Sept. 30, 2015), motion to dismiss granted against all claims in action involving pacemaker.  Judicial notice taken of FDA PMA.  PMA supplements and product development protocols are equally preemptive.  No parallel claim pleaded.
  340. Wood v. Medtronic, Inc., 2015 WL 5793602, slip op. (W.D.N.Y. Oct. 2, 2015), motion to dismiss granted against all claims in action involving bone growth device.  Fraud and manufacturing defect inadequately pleaded.  All other claims preempted.
  341. Allen v. Zimmer Holdings, Inc., 2015 WL 6637232 (D. Nev. Oct. 30, 2015), motion to dismiss granted against all claims in action involving a hip prosthesis.  Devices originally cleared as drugs prior to the Medical Device Amendments are treated as having PMA.  A subsequent reclassification to Class II does not affect preemption, which is determined as of the time of FDA approval.  All components of a PMA device enjoy PMA preemption.  Plaintiff did not allege any parallel claims.
  342. Conklin v. Banner Health, 2015 WL 10688305 (Ariz. Super. Oct. 30, 2015), motion to dismiss granted against all claims in action involving an infusion pump.  Warranty claims preempted.  Failure to report claim failed to allege causation.  Negligence per se alleging FDCA violations impliedly preempted as private FDCA enforcement.  Affirmed  ___ P.3d ___, 2018 WL 6613311, below.
  343. Byrnes v. Small, 142 F. Supp.3d 1262 (M.D. Fla. Nov. 9, 2015), motion to dismiss granted against almost all claims in amended complaint action involving bone growth device.  Fraudulent omission claims are preempted, but allegations of affirmatively false off-label promotion escape preemption as parallel claims.  All negligence claims that are sufficiently pleaded are preempted.  Express warranty claims insufficiently pleaded.  Prior opinion 60 F. Supp.3d 1289, above.
  344. Ward v. St. Jude Medical, Inc., 2015 WL 12516628 (S.D. Fla. Nov. 9, 2015), motion to dismiss granted against all claims in action involving defibrillator.  Plaintiff pleaded no parallel claims, merely mentioning a recall and unspecified violations is insufficient.
  345. Mink v. Smith & Nephew, Inc., 145 F. Supp.3d 1208 (S.D. Fla. Nov. 19, 2015), motion to dismiss granted against all claims in action involving hip prosthesis.  A list of allegedly violated FDCA regulations, without facts supporting how they were allegedly breached or how the breach was causal, is insufficient to plead a parallel violation.  Contract claim and misrepresentation claims pertaining to plaintiff’s participation in a post-marketing clinical trial were preempted by FDA post-marketing requirements.  No parallel claim exists because Florida law does not require post-surgical monitoring.  Buckman preempts any claim that plaintiff was dropped from the study to avoid FDA reporting requirements.  Reversed in part, 2017 WL 2723913.
  346. Lyles v. Medtronic, Inc., 2015 WL 9997860 (Mag. W.D. La. Nov. 23, 2015), adopted, 2016 U.S. Dist. Lexis 6924 (W.D. La. Jan. 20, 2016), motion to dismiss granted against all claims in action involving bone growth device.  Judicial notice taken of FDA documents.  All warning claims preempted.  Statutory exclusivity means all informational claims are warning claims.  Reconsideration denied, 2016 U.S. Dist. Lexis 59775 (W.D. La. May 4, 2016). Motion for relief from judgment denied, 2016 WL 4540870 (W.D. La. Aug. 31, 2016).  On appeal at
  347. Funke v. Sorin Group USA, Inc., 147 F. Supp.3d 1017 (C.D. Cal. Nov. 24, 2015), motion to dismiss granted against all claims in action involving bioprosthetic heart valve.  Failure to report adverse events inadequately pleaded.  Judicial notice taken of FDA adverse event database that shows reports contrary to plaintiff’s allegations.  No duty to report foreign adverse events prior to PMA.  State reporting duties not parallel to FDA requirements are preempted.  Plaintiff’s manufacturing defect allegations are really a preempted design defect claim.  Negligence and misrepresentation claims also preempted.
  348. Marion v. Smith & Nephew, Inc., 2015 WL 7756063 (D. Utah Dec. 1, 2015), motion to dismiss granted against all claims in action involving hip prosthesis.  No parallel claim pleaded.  Implied preemption eliminates remaining arguments.  Second opinion on amended complaint below.
  349. Pearsall v. Medtronics, Inc., 147 F. Supp.3d 188 (E.D.N.Y. Dec. 7, 2015), motion to dismiss granted against all claims in action involving implantable cardiac defibrillator.  Manufacturing defect claims asserting violation of vague GMPs are preempted.  State law does not require submission of PMA supplements, so no parallel claim can exist.  That purely federal claim is further preempted as attempted private enforcement of the FDA.  Failure to report claims are not parallel.  Filing adverse event reports with FDA is not the same as warning doctors of risks.
  350. Raab v. Smith & Nephew Inc., 150 F. Supp.3d 671 (S.D.W. Va. Dec. 15, 2015), motion to dismiss granted in part and denied in part in action involving hip implant.  Plaintiff had two surgeries, the first with a PMA system, parts of which were replaced in the second surgery with non-PMA components of another system.  A valid parallel claim cannot challenge the FDA’s regulatory process or FDA requirements imposed under that process.  Parallel manufacturing defect claims may be stated for violations of general GMPs as negligence per se or under a malfunction theory.  Design defect claims are preempted.  Warning/marketing claims alleging off-label promotion of the mixing of Class III and Class II components from different systems are preempted because no facts establishing FDCA violations or any parallel state duty are alleged.  Off-label use is not a violation.  Preemption not asserted against claims solely involving the non-PMA components.
  351. Smith v. St. Jude Medical, 2015 WL 9094383 (S.D. Miss. Dec. 16, 2015), motion to dismiss granted against all claims in action involving neurostimulator.  Pro se complaint did not make any parallel claim.  Extensive judicial notice of FDA-related documents.
  352. Day v. Howmedica Osteonics Corp., 2015 WL 13469348 (Mag. D. Colo. Dec. 24, 2015), motion to dismiss granted against all claims in action involving cervical disc system.  Product was IDE device in a clinical trial.  CMP violations cannot serve as parallel claims because IDE devices are exempt from them.  FDA Warning letter did not involve the device.  All information-based claims including express warranty preempted.
  353. Grubbs v. Synthes, 2016 WL 360610 (M.D. Fla. Jan. 19, 2016), motion to dismiss granted against all claims in action involving knee implant.  No parallel claims alleged.  Plaintiff did not establish that the device had been recalled.
  354. Gall v. Stryker Orthopaedics, 2016 WL 7011530 (Cal. Super. Jan. 19, 2016), judgment on the pleadings granted in part and denied in part in action involving hip implant.  Judicial notice taken of various FDA documents.  Manufacturing defect and failure to report warning claims not preempted.  Duty to test preempted as different from FDCA.  See Earlier opinion, above.
  355. Nevolas v. Boston Scientific Corp., 2016 WL 347721 (W.D. Okla. Jan. 28, 2016), motion to dismiss granted against all claims in action involving spinal cord stimulator.  Plaintiff failed to plead parallel claims.  Alleged violations of non-specific GMP regulations do not state parallel claims.  Confidential PMAs do not justify vague pleadings.  Amended complaint dismissed 2016 WL 1532259 (W.D. Okla. April 15, 2016), violations still too vague.  On appeal No. 16-6127 (10th Cir.)
  356. Money v. Johnson & Johnson, 2016 WL 368128 (N.D. Cal. Feb. 1, 2016), judgment on the pleadings granted against all claims in action involving contact lenses.  No parallel claims pleaded.
  357. De La Paz v. Bayer Healthcare LLC, 159 F. Supp.3d 1085 (N.D. Cal. Feb. 2, 2016), motion to dismiss granted against all claims in action involving implantable contraceptive.  Violation claims must be causal.  Adulteration is not necessarily a design or manufacturing defect.  Negligent training preempted by FDA approval of training manuals.  Manuals judicially noticed.  Failure to report claim noncausal.  Implied warranty preempted.   Express warranty and fraud claims involving FDA-approved statements preempted; rest inadequately pleaded.
  358. Morris v. Greenky, 2016 WL 10703473 (N.Y. Sup. Feb. 9, 2016), motion to dismiss granted against all claims in action involving hip prosthesis.  Generally applicable FDA GMPs are too vague for their violation to serve as the basis for a parallel claim.
  359. Ellis v. Smith & Nephew, Inc., 2016 WL 7319397 (D.S.C. Feb. 16, 2016), motion to dismiss granted against all claims in action involving hip implant.  Parallel claims did not allege either the violation or causation.  A recall does not defeat preemption.  Express and implied warranty and consumer fraud preempted.  Failure to report preempted as private FDCA enforcement.  Plaintiff not entitled to discovery.
  360. Medali v. Bayer Healthcare LLC, 2016 WL 2348545 (Cal. Super. Feb. 16, 2016), demurrer granted against all claims in action involving implantable contraceptive.  Plaintiff did not plead any parallel claim, and must replead.
  361. Felger v. Smith & Nephew, Inc., 2016 WL 8673054 (D. Alaska March 4, 2016), motion to dismiss granted against all claims in action involving hip implant.  All claims are preempted except possibly parallel claims involving manufacturing defects or failure to report, but those claims are insufficiently pleaded.
  362. Mink v. Smith & Nephew, Inc., 169 F. Supp.3d 1321 (S.D. Fla. March 14, 2016), renewed motion to dismiss granted against all claims in action involving hip prosthesis.  While plaintiff’s parallel claim allegations might plausibly allege a violation of the FDCA, they fail under express preemption to state a parallel claim and under implied preemption, both because Florida does not allow FDCA-based negligence per se claims.  A contract claim, involving plaintiff’s termination from a post-marketing clinical trial, cannot be a parallel claim because the termination is not alleged to have violated any regulation.
  363. Thompson v. St. Jude Medical, Inc., 2016 WL 1089978 (S.D. Ind. March 21, 2016), motion to dismiss granted against all claims in action involving defibrillator.  Although plaintiff references a recall, no specific FDA regulatory violation is identified.  Nor did plaintiff plead how any violation caused injury or even how the device was defective or malfunctioned.
  364. McLaughlin v. Bayer Corp., 172 F. Supp.3d 804 (E.D. Pa. March 22, 2016), judgment on the pleadings granted in part and denied in part in action involving implantable contraceptive.  Rejects attorney general argument that PMA preemption requires subject matter specific FDA regulations.  Negligent training claim based on violation of FDA training requirements not preempted, but inadequately pleaded.  Same for negligent risk management.  Same for express warranty.  Same for negligent manufacturing.  Negligent entrustment claim preempted.  Express warranty not preempted.  Fraudulent concealment impliedly preempted as private FDCA enforcement.  Fraud not preempted, except as to FDA-approved statements, but not specifically pleaded.  Misrepresentation survives under lesser pleading standards.  Failure to report not preempted.  Subsequent decision, see below.
  365. Morgan v Medtronic, Inc., 172 F. Supp.3d 959 (S.D. Tex. March 23, 2016), motion to dismiss granted against all claims in action involving spinal pain pump.  Judicial notice of FDA approval documents.  No parallel claim asserted.  Express warranty claim expressly preempted.
  366. Ward v. St. Jude Medical, Inc., 2016 WL 1208789, slip. op. (S.D. Fla. March 28, 2016), motion to dismiss granted against all claims in action involving implantable defibrillator.  No parallel claims alleged, and they would be preempted in any event as attempts to privately enforce the FDCA because Florida does not recognize such claims under state law.
  367. Schmidt v. Boston Scientific Corp., 2016 WL 1274824 (N.D. Ohio March 31, 2016), motion to dismiss granted against all claims in action involving implantable defibrillators.   Plaintiff failed to plead a parallel claim with boilerplate that failed to identify allegedly violated regulations.
  368. Brandt v. Medtronic, Inc., 179 F. Supp.3d 967 (D. Nev. March 31, 2016), motion to dismiss granted against all claims in action involving gastric device.  Taking judicial notice of FDA documents.  PMA preemption applies to devices cleared under the FDA’s humanitarian device exemption.  All warning and design claims preempted.  Fraud on the FDA allegations impliedly preempted.  Plaintiff allowed to replead a possible failure to report parallel claim.
  369. Frere v. Medtronic, Inc., 2016 WL 1533524 (C.D. Cal. April. 6, 2016), motion to dismiss granted against all claims in action involving infusion pump.  Taking judicial notice of FDA documents.  Alleged parallel claims are not alleged to be causal.  Adulteration and misbranding claims are impliedly preempted as private FDCA enforcement.  Express warranty claims preempted and inadequately pleaded.  Implied warranty, fraud, and consumer fraud preempted.  Failure to train preempted because no allegations that FDA-required training not provided.
  370. Yosowitz v. Covidien LP, 182 F. Supp.3d 683 (S.D. Tex. April 23, 2016), motion to dismiss granted against all claims in action involving embolization device.  Taking judicial notice of FDA documents.  Parallel claims insufficiently alleged.  Express and implied warranty preempted.  A recall does not revoke a PMA.  FDCA violation claim impliedly preempted as private FDCA enforcement.
  371. Glennen v. Allergan, Inc., 202 Cal. Rptr.3d 68 (Cal. App. April 29, 2016), grant of demurrer against all claims affirmed.  Failure to train claim preempted because no allegation that FDA required surgeon training that was not provided.  General GMPs do not mandate surgeon training since the FDA does not regulate the practice of medicine.  Since there is no state law duty to train surgeons, claim is also impliedly preempted as private FDCA enforcement.
  372. Money v. Johnson, 2016 WL 3055875 (N.D. Cal. May 31, 2016), judgment on the pleadings granted in part and denied in part in action involving contact lens.  Manufacturing defect and implied warranty claims based on claimed manufacturing violations survive preemption as parallel claims also supported under state law.  General GMP claims would be preempted.  Battery claim preempted.
  373. Lutz-Cummings v. Medtronic, Inc., 2016 WL 3082314 (Minn. Dist. May 31, 2016), motion to dismiss granted against all claims in action involving infusion pump.  Plaintiff’s violation claims involved only general GMPs and were therefore not parallel claims.  Post-sale duty to warn and failure to train claims preempted.  Failure to report claim fails to plead causation.  No state-law duty to refrain from off-label promotion so that claim impliedly preempted as private FDCA enforcement.
  374. Frere v. Medtronic, Inc., 2016 WL 9455137 (C.D. Cal. June 1, 2016), motion to dismiss granted in part and denied in part in action involving pain pump.  Non-violation claims preempted.  Violation claims, including failure to report,  not preempted.  Express and implied warranty claims preempted.  Negligence per se and consumer fraud impliedly preempted as private FDCA enforcement.
  375. Potolicchio v. Medtronic, Inc., 2016 WL 3129186 (E.D. Tenn. June 2, 2016), judgment on the pleadings granted against all claims in action involving infusion pump.  Parallel claims must plead causation.  Violation claims relating to a different version of the product cannot be causal.  No state-law duty to report to FDA.  On appeal, No. 16-6069 (6th Cir.).
  376. Laverty v. Smith & Nephew, Inc., 197 F. Supp.3d 1026 (N.D. Ill. June 23, 2016), partial judgment on the pleadings denied in action involving hip implant.  Plaintiff’s warning claim based on allegations of failure to report adverse events to the FDA was a parallel claim.  Report claim was not disguised FDCA enforcement.
  377. Gates v. Medtronic, Inc., 192 F. Supp.3d 704 (W.D. Tex. June 29, 2016), motion to dismiss granted against all claims in action involving defibrillator lead.  FDA regulates post-recall communications, so claim attacking post-recall statements is preempted.
  378. Teixeria v. St. Jude Medical S.C., Inc., 193 F. Supp.3d 218 (W.D.N.Y. June 30, 2016), motion to dismiss granted against all claims in action involving implantable defibrillator.  Express warranty preempted, whether or not volunteered.  Sales rep warranties not pleaded.  Warning letter claim could not be causal.  Disapproving information and belief pleading.  Approving in part and disapproving in part 2015 WL 902616 above.
  379. LaFountain v. Smith & Nephew, Inc., 2016 WL 3919796 (D. Conn. July 18, 2016), motion to dismiss granted in part and denied in part in action involving hip implant.  All claims except failure to report and express warranty preempted.  Express warranty improperly pleaded.  Claims solely involving 510k cleared component not preempted.  Fraud on the FDA and off-label promotion claims impliedly preempted.
  380. Stiltner v. Medtronic, Inc., 2016 WL 4005471 (Minn. Dist. July 25, 2016), motion to dismiss granted against all claims in action involving pain pump.  Parallel claims based on warning letters or failure to report adverse event must plead device- and plaintiff-specific causation.  Vague GMPs cannot be the basis of a parallel claim.  Warranty and consumer protection claims are preempted claims seeking additional warnings.
  381. Norman v. Bayer Corp., 2016 WL 4007547 (D. Conn. July 26, 2016), motion to dismiss granted against all claims in action involving contraceptive device.  Parallel claims based on FDA actions did not plead causation, because no facts tie the FDA actions to the plaintiff’s device.  Buckman preemption of failure to report claim.  No parallel state claim exists.  Negligence per se is private FDCA enforcement.  Misrepresentation and express warranty preempted for attacking FDA-approved statements.
  382. Marion v. Smith & Nephew, Inc., 2016 WL 4098608 (D. Utah July 27, 2016), motion to dismiss granted in part and denied in part in action involving hip implant.  Failure to report claim presented as negligence per se survives.  No state-law argument against negligence per se in opinion.  Claims of misstatement in PMA process barred as fraud on the FDA claim.  Manufacturing defect preempted as not parallel.  Warning and implied warranty preempted.  Express warranty and several other claims inadequately pleaded.
  383. Skinner v. St. Jude Medical, Inc., 2016 WL 4054931 (W.D. La. July 27, 2016), motion to dismiss granted against all claims in action involving heart valve.  Parallel claim not alleged.
  384. Nagel v. Smith & Nephew, 2016 WL 4098715 (D. Conn. July 28, 2016), motion to dismiss granted against all claims in action involving hip implant.  In cases involving device components subject to mixed levels of FDA approval, PMA preemption applies to all claims that implicate a PMA component.  Only claims entirely divorced from PMA components escape preemption.  Off-label use is legal and does not affect preemption.  Strict liability, negligence, misrepresentation and warranty claims all preempted.
  385. Lance v. Bayer Essure, Inc., 2016 WL 4417248, slip op. (Cal. Super. Aug. 2, 2016), demurrer sustained in part and overruled in part in action involving contraceptive device.  Failure to report adverse event claims are not preempted.  All other warning claims preempted.  Advertising-related claims survive because similarity to FDA-approved labels cannot be decided on demurrer.  Manufacturing and training claims are inadequately pleaded.
  386. Aemisegger v. Medtronic, Inc., 2016 WL 6079941 (Ill. Cir. Aug. 17, 2016), partial motion to dismiss granted in action involving pain pump.  Manufacturing claims may allege violations of non-specific GMPs.  Parallel claims based on an FDA recall must allege causation.  Plaintiff’s injuries could not possibly have been caused by the issue over which the recall occurred.
  387. Weaver v. Ethicon, Inc., 2016 WL 4430855 (S.D. Cal. Aug. 22, 2016), motion to dismiss granted against all claims in action involving self-absorbing surgical matrix.  No parallel claims alleged.  Second motion granted, see below.  Third motion granted in part, see below.
  388. Crissi v. Johnson & Johnson Vision Care, 2016 WL 4502038 (E.D.N.Y. Aug. 22, 2016), judgment on the pleadings granted in action involving extended wear contact lenses.  No parallel claim pleaded.  All relevant promotional materials were FDA approved.
  389. Richardson v. Bayer Healthcare Pharmaceuticals Inc., 2016 WL 4546369 (D. Idaho Aug. 30, 2016), judgment on the pleadings granted in part and denied in part inaction involving contraceptive device.  All claims except failure to report preempted.
  390. White v. Medtronic, Inc., 2016 WL 4539494 (E.D. Pa. Aug. 31, 2016), motion to dismiss granted in part and denied in part in action involving pain pump.  Express warranty not preempted as a voluntary action.  Manufacturing defect not preempted as parallel claim.
  391. Blair v. Medtronic, Inc., 2016 WL 9149503 (N.D. Cal. Sept. 12, 2016), motion to dismiss granted against all claims in action involving neurostimulator.  Judicial notice taken of premarket approval FDA documents.  All negligence, warranty, and strict liability claims preempted.  No parallel claims pleaded.
  392. Aaron v. Medtronic, Inc., 209 F. Supp.3d 994 (S.D. Ohio Sept. 22, 2016), motion to dismiss granted against all claims in action involving bone growth device.  Judicial notice taken of PMA and approved labeling.  Rejects Bausch pleading standard.  PMA component used off-label entitled to full PMA preemption.  Off-label use does not vitiate preemption.  Failure to report does not state a claim and is preempted as not parallel to any state-law claim.  Design claim preempted and inadequately pleaded.  Express warranty involves safety/effectiveness, so is preempted; also inadequately pleaded.  Parallel claims for failure to report and illegal off-label preemption have FDCA violations as a “critical element” and are impliedly preempted.  Fraud inadequately pleaded under 9(b).
  393. Lane v. Boston Scientific Corp., 2016 WL 5369596 (N.D. Ind. Sept. 26, 2016), motion to dismiss denied in action involving spinal stimulator.  Plaintiff’s parallel claims were sufficiently pleaded under Bausch.
  394. Shuker v. Smith & Nephew PLC, 211 F. Supp.3d 695 (E.D. Pa. Sept. 29, 2016), motion to dismiss granted against all claims in action involving hip implant.  Plaintiff’s only parallel claim, for off-label promotion, failed to plead a plausible cause of action, as the document in question could not be construed as off-label promotion.  First dismissal, see 2015 WL 1475368 above.  Affirmed in part and reversed in part below
  395. Mihok v. Medtronic, Inc., 2016 WL 8309087 (Conn. Super. Oct. 20, 2016), motion to strike denied in action involving a pain pump.  Refusing to decide preemption before discovery.
  396. Roberts v. Medtronic, Inc., 2016 WL 6585137 (Minn. Dist. Nov. 4, 2016), motion to dismiss granted against all claims in action involving a pain pump.  Plaintiff failed to plead a parallel claim because violations of vague GMPs are insufficient.  Plaintiff also failed to plead how violations caused injury.  Failure to report and fraud claims also inadequately pleaded to establish a parallel claim.
  397. Weaver v. Ethicon, Inc., 2016 WL 7098781 (S.D. Cal. Dec. 6, 2016), renewed motion to dismiss granted against all claims in action involving surgical packing.  Judicial notice taken of FDA documents.  Parallel claims, including failure to report, pleaded violations and causation in conclusory fashion.  Nature of claim and causation must be pleaded.  Warning claim preempted.  Third motion granted in part, see below.
  398. Vincent v. Medtronic, Inc., 2016 WL 7374271 (N.D. Ill. Dec. 20, 2016), motion to dismiss granted against all claims in action involving a pacemaker lead.  Judicial notice taken of FDA approval and supplemental approvals.  Supplemental approvals are preemptive.  Preemption not lost by late filing of a PMA supplement, resulting in FDA approval after the device’s use in the plaintiff.  Prior FDA requirements remain in place and preempt design, warning, and manufacturing claims.  Claims based on the late filing are Buckman preempted as private FDA enforcement.
  399. Wildman v. Medtronic, Inc., 221 F. Supp.3d 804 (W.D. Tex. Dec. 22, 2016), judgment on the pleadings granted against all claims in action involving a spinal neurostimulator.  No presumption against preemption in express preemption.  PMA supplement is preemptive.  Battery life warranty claim expressly preempted because the warranty’s contents were dictated by FDA approved statements.  Reversed in part, 2017 WL 4926804, see below.
  400. Parra v. Coloplast Corp., 2017 WL 24794 (E.D. La. Jan. 3, 2017), motion to dismiss granted against all claims in action involving a penile implant.  No parallel claims pleaded.  Nature of express warranty not pleaded.
  401. Babayev v. Medtronic, Inc., 228 F. Supp.3d 192 (E.D.N.Y. Jan. 6, 2017), summary judgment granted against all claims in action involving a neurostimulator.  All common-law claims preempted.  Parallel claims inadequately pleaded and lack factual basis.  Express warranty claims inadequately pleaded.  Vague and open-ended GMPs cannot support parallel claims.  Installation GMPs do not apply to manufacturers of implanted devices.  Surgeons are the installers.  Alleged violations are non-causal.
  402. Godelia v. Zoll Services, LLC, 2017 WL 201826 (S.D. Fla. Jan. 18, 2017), motion to dismiss granted against all claims in action involving an external defibrillator.  All common-law claims preempted.  Parallel claims cannot be based on post-incident warning letter involving different risk plaintiff did not suffer.  Fraud and warranty claims preempted as attack on warnings.  Buckman preemption of parallel claims because state law doesn’t recognize them.  Affirmed in part and reversed in part, 881 F.3d 1309 below.
  403. Wolicki-Gables v. Doctors Same Day Surgery Center, Ltd., 216 So.3d 665 (Fla. App. Feb. 15, 2017), grant of summary judgment affirmed against spoliation claim involving spinal pain pump system.  Spoliation claim depended on there being an unpreempted parallel claim.  Parallel claims for violating the FDCA do not exist in Florida.
  404. Silver v. Medtronic, Inc., 236 F. Supp.3d 889 (M.D. Pa. Feb. 21, 2017), motion to dismiss denied in action involving pain pump (other claims dismissed on state law grounds).  Parallel manufacturing defect claim stated by GMP violations from warning letter.  Failure to report warning claim not preempted.  Express warranty not preempted as a voluntary action.
  405. Weaver v. Ethicon, Inc., 2017 WL 680725 (S.D. Cal. Feb. 21, 2017), third motion to dismiss granted against all claims in action involving surgical packing.  Manufacturing defect preempted for not matching FDA enforcement and lack of causation.  No actual failure to report alleged.  Failure to report plaintiff’s own incident cannot be causal.
  406. McLaughlin v. Bayer Corp., 2017 WL 697047 (E.D. Pa. Feb. 21, 2017), second motion to dismiss granted in part and denied in part in action involving implantable contraceptive.  Failure to train claim not preempted to the extent it alleges deviation from PMA-mandated training.  Preempted to the extent duties to monitor, certify, or ensure competence are alleged, which go beyond PMA requirements.  Failure to withdraw from market preempted.  Most fraud claims preempted because they involve FDA-approved statements.
  407. Martin v. Medtronic, Inc., 2017 WL 825410 (E.D. Cal. Feb. 24, 2017), motion to dismiss granted against all claims in action involving pain pump.  Express warranty, warning and fraud expressly preempted.  Duty to train not governed by FDA requirements, therefore expressly preempted.  Manufacturing defect, implied warranty, fraud and consumer fraud all based entirely on FDCA violations and therefore impliedly preempted by Buckman.
  408. Chester v. Boston Scientific Corp., 2017 WL 751424 (D.N.J. Feb. 27, 2017), motion to dismiss granted against all claims in action involving implantable defibrillator.  All claims under NJ product liability statute preempted.  Parallel claim not properly pleaded, and would be expressly preempted for lack of any equivalent state-law claims. Failure to report claim also impliedly preempted as private FDCA enforcement.  No discovery allowed.
  409. Lawrence v. Medtronic, 2017 WL 826963 (C.D. Cal. Feb. 27, 2017), motion to dismiss granted against all claims in action involving pain pump.  Parallel claims must plead the nature of the FDCA violation and causation.  All non-violation claims preempted.  Affirmed at 2020 WL 429769 below.
  410. Warstler v. Medtronic, Inc., 238 F. Supp.3d 978 (N.D. Ohio Feb. 28, 2017), motion to dismiss granted against all claims in action involving pain pump.  Parallel claims must be specifically pleaded.  Plaintiff not entitled to discovery.  Plaintiff’s “manufacturing” claim is really a preempted design claim.  Parallel claims cannot be based on vague GMPs.  Failure to report preempted.  No parallel Ohio common law claim.  PMA supplements preemptive.  Express and implied warranty and misrepresentation preempted.  Reconsideration denied, 2017 WL 3088037 (N.D. Ohio July 20, 2017).
  411. Tufts v. Medtronic, Inc., 2017 WL 1062520 (D.S.C. March 21, 2017), motion to dismiss granted against all claims in action involving pain pump.  All common-law claims preempted.  No parallel claims alleged.
  412. Rand v. Smith & Nephew, Inc., 2017 WL 8229320 (C.D. Cal. April 5, 2017), motion to dismiss granted against all claims in action involving hip implant.  Design, express and implied warranty, fraudulent concealment, and all parallel claims expressly preempted, except for failure to report allegations, which are inadequately pleaded.  Violation allegations involving actions not relevant to plaintiff’s condition are not causal.
  413. Cavender v. Medtronic, Inc., 2017 WL 1365354 (N.D. Ind. April 14, 2017), motion to dismiss granted in part and denied in part in action involving defibrillator lead.  Parallel claims are adequately pleaded under Bausch.
  414. Canary v. Medtronic, Inc., 2017 WL 1382298 (E.D. Mich. April 18, 2017), motion to dismiss granted in part and denied in part in action involving spinal stimulator. Design and warning defect claims preempted.  Manufacturing defect parallel claim based on misreading of GMP.  Fraud claim based on statements of manufacturer’s representative survives preemption.
  415. Paturzo v. Boston Scientific Corp., 2017 WL 8220600 (C.D. Cal. April 21, 2017), motion to dismiss granted against all claims in action involving an implantable defibrillator.  Manufacturing defect claim lists regulations without any connecting facts.  Design, warning, and warranty preempted.  Failure to report preempted for failure to identify any actually unreported events.
  416. Russell v. Johnson & Johnson, Inc., 2017 WL 2261136 (Ky. Cir. May 8, 2017), judgment on the pleadings granted against all claims, including warranty, in action involving a cardiac catheter.  Judicial notice of FDA documents given. Requirements imposed through PMA, PMA supplement, and IDE processes were all specific to devices and thus preemptive.  Plaintiff alleged no parallel claims.  Informed consent, fraud, consumer fraud, and unjust enrichment claims preempted as restating warning claim.
  417. Burrell v. Bayer Corp., 260 F. Supp.3d 485 (W.D.N.C. May 10, 2017), motion to dismiss granted against all claims in action involving contraceptive device.  Failure to report impliedly preempted as private FDCA enforcement, and could not possible be causal because FDA already had the information and did not act.  All other claims, including express warranty and consumer fraud, are expressly preempted.  Rejects Hofts pleading standard.  Vacated on non-preemption grounds 918 F.3d 372 (4th Cir. 2019).
  418. Beardslee v. UCLA Medical Center, 2017 WL 7411062 (Cal. Super. May 16, 2017), demurrer granted against all claims in action involving cardiac assist device.  No parallel claim alleged.  Amended complaint dismissed, see below, 2017 WL 7411060.
  419. Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. June 26, 2017), reversing in part grant of motion to dismiss.  Parallel violation claims are state-law causes of action.  Manufacturing defect and misrepresentation claims are parallel claims and are adequately pleaded.  Plaintiffs need not plead violations specifically.  Failure to report claims involve a duty owed to the FDA that is not a traditional state-law duty and are impliedly preempted.  Misrepresentations about clinical trial were outside what the FDA required, and because they were voluntarily made, not private FDCA enforcement.  Reversing in part 145 F. Supp.3d 1208.
  420. Beardslee v. UCLA Medical Center, 2017 WL 7411060 (Cal. Super. August 10, 2017), demurrer with prejudice granted against all claims in action involving cardiac assist device.  Parallel claim and express warranty allegations were boilerplate.  Implied warranty of safety preempted.  Original complaint dismissed, see above, 2017 WL 7411062.
  421. Olmstead v. Bayer Corp., 2017 WL 3498696 (N.D.N.Y. Aug. 15, 2017), motion to dismiss granted against all claims in action involving contraceptive device.  General GMPs do not support a parallel claim, and in any event plaintiff has failed to plead any violation related to her claims.
  422. Connelly v. St. Jude Medical, Inc., No. 5:17-cv-02006-EJD, 2017 WL 3619612 (N.D. Cal. Aug. 23, 2017), motion to dismiss granted in part and denied in part in action involving implantable cardiac defibrillator.  Parallel manufacturing and design claims adequately pleaded.  Negligence per se impliedly preempted.
  423. Brackin v. Medtronic, Inc., 2017 WL 5957204 (W.D. Tenn. Sept. 14, 2017), motion to dismiss denied in action involving insulin pump.  The evidence did not establish that the product had been pre-market approved.  Alleged GMP violations were sufficiently definite to be actionable.
  424. Ebrahimi v. Mentor Worldwide LLC, 2017 WL 4128976 (C.D. Cal. Sept. 15, 2017), motion to dismiss granted against all claims in action involving breast implant.  Parallel claim alleging improper conduct of FDA-mandated post-marketing clinical trials impliedly preempted by Buckman as private FDCA enforcement.  No analogous state-law cause of action exists.  Subsequent opinions, 2018 WL 2448095 and 2018 WL 6829122, below.  Affirmed, 2020 WL 2510760, below.
  425. Freed v. St. Jude Medical, Inc., 2017 WL 4102583 (D. Del. Sept. 15, 2017), motion to dismiss granted against all claims in action involving neurostimulator.  PMA approval is judicially noticeable.  Preemption extends to all components of a PMA device system.  Parallel claims not pleaded.  Express warranty and adulteration claims preempted.  Subsequent opinion, below, at 2019 WL 418843.
  426. Norabuena v. Medtronic, Inc., 86 N.E.3d 1198 (Ill. App. Sept. 20, 2017), grant of motion to dismiss reversed in action involving bone growth stimulator.  Only claim at issue was false off-label promotion.  State-law warning claim was parallel to adulteration, and therefore not preempted.  No parallel claim for failure to report or adequate directions for use.  Even though not preempted, dismissal was proper for failure to plead physician-specific causation, but dismissal should have been without prejudice.
  427. Golden v. Brown, slip op., 2017 WL 4239015 (Colo. Dist. Sept. 24, 2017), second motion to dismiss granted against all claims in action involving pain pump.  Parallel claims must plead causation.  A recall does not support a presumption of an FDCA violation.  Vague GMPs do not support parallel claims.  Failure to report adverse events to the FDA are not analogous to state-law warning claims.  They are expressly and impliedly preempted.  Express warranty claims are expressly preempted.
  428. Fisk v. Medtronic, Inc., 2017 WL 4247983 (N.D. Ind. Sept. 25, 2017), motion to dismiss granted in part and denied in part in action involving pain pump.  Since a plaintiff need not plead around preemption as an affirmative defense, specific violations and causation need not be pleaded under Bausch.  Manufacturing defect and failure to report claims survive preemption.  Other warning claims dismissed.  Warranty claims dismissed on state law grounds.
  429. Kodger v. Zimmer Biomet Holdings, Inc., 2017 WL 4348997 (N.D. Ohio Sept. 29, 2017), motion to dismiss denied.  Only manufacturing defect claim asserted, and plaintiff alleged violations of specific GMP standards.
  430. Dunstan v. Bayer Essure, 2017 WL 4392046 (E.D. Pa. Oct. 3, 2017), motion to dismiss granted in part and denied in part in action involving implantable contraceptive.  Prior rulings in 172 F. Supp.3d 804, and 172 F. Supp.3d 804, above adhered to.  Negligent misrepresentation preempted where statements approved by FDA, but not as to other statements.
  431. Martin v. Medtronic, Inc., 2017 WL 4574160 (E.D. Cal. Oct. 13, 2017), motion to dismiss granted against all claims in action involving pain pump.  Express warranty preempted as directed against FDA approved statements.  Manufacturing and reporting claims survive preemption but are inadequately pleaded.  Neither claim adequately pleads causation.  Warning letters did not involve plaintiff’s device or were after the fact.  No unreported adverse events are identified.  On appeal at 17-17284 (9th Cir.).
  432. Williams v. St. Jude Medical, S.C., Inc., 2017 WL 11113322 (N.D. Ga. Oct. 19, 2017), motion to dismiss granted in part and denied in part in action involving pacemaker leads.  Manufacturing defect claims survive as parallel claims.  Warning, failure to report, and misrepresentation claims preempted.
  433. Wildman v. Medtronic, Inc., 874 F.3d 862 (5th Cir. Oct. 31, 2017), reversing in part dismissal of express warranty claims in action involving spinal neurostimulator.  Detailed express warranty went beyond language that FDA had approved, and therefore escaped preemption.  While battery life statement was approved by FDA, statements about rest of device were not.  Plaintiff must plead on remand that device failure was caused by a component other than the battery.  Reversing 221 F. Supp.3d 804, above.
  434. Westmoreland v. Medtronic, Inc., 2017 WL 5132669 (E.D. Mo. Nov. 6, 2017), motion to dismiss granted in part and denied in part in action involving an aortic graft.  Negligence claims concerning the conduct of a sales representative during surgery did not involve FDA-regulated and are not preempted.  Plaintiff failed to allege agency.
  435. Laux v. Mentor Worldwide, LLC, 2017 WL 5186329 (C.D. Cal. Nov. 8, 2017), summary judgment against all claims in action involving breast implants.  Vague GMPs cannot be the basis of a parallel claim.  Plaintiff did not specify which GMP was violated.  Affirmed, 786 F. Appx. 84 (9th Cir. Nov. 26, 2019).
  436. Hart v. Medtronic, Inc., 2017 WL 5951698 (D.N.J. Nov. 30, 2017), motion to dismiss granted against all claims in action involving pain pump.  Plaintiff failed to allege a parallel claim.  Express warranty of “safety” preempted.
  437. Moody v. Allergan USA, Inc., 2017 WL 6949742 (W.D.N.Y. Dec. 5, 2017), adopted, 2018 WL 451824 (W.D.N.Y. Jan. 17, 2018), motion to dismiss granted against all claims in action involving gastric band.  Manufacturing defect claims require specific pleading of how product at issue differed from other units.  Consumer fraud claims fail to plead statements not approved by the FDA, or to plead reliance.
  438. Williams v. Bayer Corp., 541 S.W.3d 594 (Mo. App. Dec. 5, 2017), affirming in part and reversing in part grant of motion to dismiss claims involving implantable contraceptive.  Consumer fraud, fraud and express warranty claims preempted where they involve FDA-approved statements.  Failure to report expressly preempted to extent that claimed FDA reaction was removal from market, but not impliedly preempted. Manufacturing-related claims not preempted.  Post-PMA warning claim expressly preempted.  Failure to train claim not preempted to the extent it alleges deviation from PMA-mandated training.  Preempted to the extent training would go beyond PMA requirements.
  439. Bailey v. Medtronic, Inc., 2017 WL 6035329 (S.D. Ind. Dec. 6, 2017), motion to dismiss granted in part and denied in part in action involving defibrillator.  Warranty claims improperly pleaded.  Manufacturing defect claim can be parallel claim.
  440. Gravitt v. Mentor Worldwide, LLC, 289 F. Supp.3d 877 (N.D. Ill. Jan. 11, 2018), motion to dismiss granted in part and denied in part in action involving breast implants.  Claims based on alleged deficiencies in post-marketing studies that did not violate the PMA are expressly preempted.  Claims based on study deficiencies that violated the PMA are impliedly preempted as private FDCA enforcement.  Claims about violations at manufacturing facilities are preempted as not parallel to manufacturing defects.  Failure to report not preempted.  Second motion, 2018 WL 2933609, below.
  441. Weber v. Allergan, Inc., 2018 WL 9817168 (D. Ariz. Jan. 25, 2018), summary judgment granted against all claims in action involving breast implants.  An FDA regulatory violation cannot be inferred from a device malfunction.  Affirmed, 940 F.3d 1106, below.
  442. Kubicki v. Medtronic, Inc., 293 F. Supp.3d 129 (D.D.C. Feb. 5, 2018), summary judgment granted in part and denied in part in action involving insulin pump.  PMA extends to all components of a device system.  Alleged violations of vague GMPs are insufficient to create a parallel claim.  Warning letter did not involve component plaintiff claimed was defective.  Failure to report claim was not parallel to any existing state-law tort and involves speculative causation.  Failure to recall imposes differing requirements.  Manufacturing defect claim not preempted.
  443. Godelia v. Doe, 881 F.3d 1309 (11th Cir. Feb. 8, 2018), affirming in part and reversing in part dismissal of action involving external defibrillator.  Manufacturing defect claim not preempted.  Misrepresentation claim not preempted because it went beyond FDA requirements.  Affirming in part and reversing in part 2017 WL 201826, above.
  444. Shuker v. Smith & Nephew, PLC, 885 F.3d 760 (3d Cir. Mar. 1, 2018), affirming in part and reversing in part dismissal of action involving hip implant.  Refusing to recognize abolition of presumption against preemption in product liability cases.  Off-label use of device components does not preclude preemption.  Preemption is to be evaluated as to each component separately.  All non-parallel claims against PMA component are preempted.  False off-label promotion claim was adequately pleaded and not preempted.  Affirming in part and reversing in part 211 F. Supp.3d 695, above.
  445. Rowe v. Mentor Worldwide LLC, 297 F. Supp.3d 1288 (M.D. Fla. March 2, 2018), motion to dismiss granted in part and denied in part in action involving breast implants.  Failure to report and negligence per se are impliedly preempted as private FDCA enforcement.  Warning and design preempted.  Manufacturing may be unpreempted but must be repleaded.  Misrepresentation fails Rule 9(b).  Warranty fails on state-law grounds.
  446. Mize v. Mentor Worldwide LLC, 2018 WL 1364257, slip op. (Cal. Super. March 13, 2018), demurrer sustained as to all claims in action involving breast implant.  No parallel claims are adequately alleged except failure to report, which cannot possibly be causal because it involves events years after plaintiff’s surgery.  Subsequent opinion, 2018 WL 5085716, below.
  447. In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 300 F. Supp.3d 732 (D. Md. March 26, 2018), motion to dismiss granted in part and denied in part in action involving hip implants.  Design and warning claims preempted.  All parallel claims escape preemption, including negligence per se.
  448. Jones v. Medtronic, Inc., 2018 WL 1462169 (Minn. App. March 26, 2018) (unpublished), grant of motion to dismiss affirmed in part and reversed in part in action involving infusion pump.  Manufacturing defect, failure to report, and warranty claims survive preemption.  Negligence, negligence per se, and consumer fraud claims preempted.
  449. Romer v. Stryker Corp., 2018 WL 1496971 (M.D. Fla. March 27, 2018), motion to dismiss granted in part and denied in part in action involving hip implant.  Negligence per se-based parallel manufacturing defect claim survives preemption.  Strict liability and negligence claims preempted.
  450. In re Essure Product Cases, 2018 WL 1734205, slip op. (Cal. Super. March 28, 2018), summary judgment granted in part and denied in part in action involving contraceptive implant.  Express warranty claims preempted where attacking FDA approved information.  Preemption applies no differently to advertising.  Preemption applies to FDA approved statements, even if the FDA later approves changes to the material.
  451. In re Essure Product Cases, 2018 WL 3602859, slip op. (Cal. Super. March 28, 2018), motion to strike granted in action involving contraceptive implant.  There is no separate cause of action for negligent post-market surveillance, so that cannot be a parallel claim.
  452. Plourde v. Sorin Group USA, Inc., 2018 WL 1542361 (D. Mass. March 29, 2018), motion to dismiss granted in part and denied in part in action involving porcine heart valve.  Failure to report claim survives preemption.  All other claims are preempted.
  453. Rice v. Allergan USA, Inc., 2018 WL 1618036 (N.D. Ala. April 4, 2018), motion to dismiss granted against all claims in action involving gastric band.  All non-parallel claims expressly preempted.  Parallel claim based on permissive regulation expressly preempted because no obligation imposed.  Failure to file CBE warning update expressly preempted.  Failure to report and postmarket surveillance claims impliedly preempted.  Fraud claim too vague to escape preemption.
  454. Delfino v. Medtronic, Inc., 2018 WL 2688420 (Minn. Dist. May 18, 2018), summary judgment granted in action involving implantable cardioverter defibrillator.  None of the alleged defects violated the manufacturing requirements applicable to the device.  Plaintiff misconstrued those requirements.  A PMA does not prohibit anything not specifically allowed.  Such a prohibition is preempted as “in addition to” FDA requirements.  Longevity projections are not PMA performance standards  A device malfunction does not establish an FDCA regulatory violation.  That long after implantation the device was no longer performing to specification does not establish a violation at the time of sale.  Plaintiff’s engineering expert excluded as not qualified to interpret FDA PMA requirements.  Implied warranty claim, asserting that device was not safe or effective, was impliedly preempted.  Affirmed 2019 WL 2415049 (Minn. App. June 10, 2019), below.
  455. Ebrahimi v. Mentor Worldwide LLC, 2018 WL 2448095, slip op. (C.D. Cal. May 25, 2018), motion to dismiss granted against all remaining claims in action involving breast implant.  Technical defects in studies are not adverse events required to be reported to the FDA.  No causation pleaded from alleged failure to report.  Alleged violations of general FDA regulations were too vaguely pleaded.  Plaintiff granted leave to amend. Prior opinion, 2017 WL 4128976, above, subsequent opinion, 2018 WL 6829122, below.  Affirmed, 2020 WL 2510760, below.
  456. Neils v. Steinberg, 76 N.Y.S.3d 921 (N.Y. Sup. June 5, 2018), motion to dismiss granted against all claims in action involving intraocular lens.  Express and implied warranty and negligence claims all would be in different from or in addition to FDA requirements.
  457. Gravitt v. Mentor Worldwide, LLC, 2018 WL 2933609 (N.D. Ill. June 12, 2018), motion to dismiss granted in part and denied in part in action involving breast implants.  Most of plaintiff’s allegations about the conduct of post-marketing studies are not FDCA violations and are expressly preempted.  The others have no common-law equivalent and are preempted as private FDCA enforcement.  No causation where FDA aware of alleged deficiencies and took no action.  Failure to report survives preemption.  Prior opinion, 289 F. Supp.3d 877, above.
  458. Spellman v. Smith & Nephew, Inc., 726 F. Appx. 629 (9th Cir. June 13, 2018), grant of motion to dismiss reversed in action involving knee implant.  Failure to report claims were sufficiently pleaded and escaped preemption.  Plaintiff should have been allowed to amend manufacturing defect allegations.
  459. Benyak v. Medtronic, Inc., 2018 WL 3005915 (Ill. App. June 14, 2018) (unpublished), grant of motion to dismiss affirmed in action involving pain pump.  No presumption against preemption.  Design and manufacturing claims preempted.  No parallel manufacturing claim alleged.  Failure to instruct was a preempted warning claim.
  460. Besse v. Insightec, Ltd, 2018 WL 10703872 (Cal.Super. June 21, 2018), demurrer overruled in action involving ultrasound brain ablation device. The PMA status of the components plaintiff is suing over is not pleaded in the complaint and no judicial notice is established.
  461. Bull v. St. Jude Medical, Inc., 2018 WL 3397544 (E.D. Pa. July 12, 2018), motion to dismiss denied in action involving pacemaker leads.  Plaintiff’s only claim, for negligent warning based on failure to report adverse events to the FDA is neither expressly no impliedly preempted.
  462. Murphy v. Boston Scientific Corp., 2018 WL 4870700 (Mag. M.D. La. July 12, 2018), motion to amend denied in action involving penile implant.  Preemption renders amendment futile.  A product development protocol is as preemptive as PMA.  Parallel claims insufficiently pleaded. Adopted on the merits 2018 WL 6046178 (M.D. La. Nov. 18, 2018), however plaintiff given a chance to amend.
  463. Reed v. St. Jude Medical, 2018 WL 4293146, slip op. (Mag. D. Minn. July 24, 2018), adopted, 2018 WL 4251872 (D. Minn. Sept. 6, 2018), motion to dismiss granted against all claims in action involving heart valve.  No parallel claims alleged.  A malfunction does not establish a violation.
  464. Bryant v. Thoratec Corp., 343 F. Supp.3d 594 (S.D. Miss. July 30, 2018), motion to dismiss granted against all claims in action involving left ventricular assist device.   FDA documents subject to judicial notice.  Recall-related claim preempted for adding to federal requirements.  Failure to report plaintiff’s incident cannot possibly be causal.  Direct to patient warning claim violating learned intermediary rule cannot be a parallel claim.  Warning claims preempted.  Manufacturing defect claims are conclusory.
  465. Ramkelawan v. Globus Medical, Inc., 2018 WL 8368675 (M.D. Fla. Aug. 8, 2018), motion to dismiss denied in action involving cervical artificial disc.  Manufacturing defect claims are parallel to GMP non-compliance and thus are parallel claims.  No other claim asserted.
  466. Jones v. Medtronic, Inc., 745 F. Appx. 714 (9th Cir. Aug. 16, 2018), grant of motion to dismissed affirmed in part and reversed in part in action involving bone growth device.  All claims except failure to report, failure to update, and manufacturing defect preempted.  Fraud and negligence per se preempted.
  467. Gomez v. Bayer Corp., 2018 WL 10612946 (N.J.Super. L.D. Aug. 31, 2018), motion to dismiss granted against all claims in action involving implantable contraceptive.  Failure to warn is expressly preempted.  Failure to report and failure to train are impliedly preempted as not recognized under state law, and thus private FDCA enforcement.  Affirmed 2020 WL 215897, below.
  468. Roemer v. Corin Group, PLC, 2018 WL 4281470 (M.D. Fla. Sept. 9, 2018), motion to dismiss granted against all claims in action involving hip implant.  All claims expressly preempted, except for negligence per se and failure to report, which were impliedly preempted under Buckman as private attempts to enforce the FDCA.
  469. Sumpter v. Allergan, Inc., 2018 WL 4335519 (E.D. Mo. Sept. 11, 2018), motion to dismiss denied in action involving breast implant.  Plaintiff abandoned all claim except manufacturing defect.  Plaintiff allowed to infer both a manufacturing defect and an FDCA violation from the fact of an alleged malfunction.
  470. Bowlen v. Coloplast A/S, 2018 WL 4469319 (W.D. Pa. Sept. 18, 2018), motion to dismiss granted in part and denied in part in action involving penile implant.  Warning claims are sufficiently pleaded as parallel claims.  Design defect claims dismissed.
  471. A.F. v. Sorin Group USA, Inc., 2018 WL 4680022 (S.D.N.Y. Sept. 28, 2018), motion to dismiss granted in part and denied in part in action involving heart valve.  All claims dismissed except failure to report.
  472. Mize v. Mentor Worldwide LLC, 2018 WL 5085716, slip op. (Cal. Super. Oct. 1, 2018), motion to dismiss granted in action involving investigational breast implant.  Failure to report claim is preempted, since it does not involve actual unreported events, but only speculation that more adverse events would have been discovered if studies had been conducted differently.  Prior opinion, 2018 WL 1364257, above.
  473. Shelp v. Allergan, Inc., 2018 WL 5734664 (W.D. Wash. Nov. 2, 2018), motion to dismiss granted in action involving breast implant.  All claims dismissed, including consumer fraud.  No parallel violation claim alleged.  Subsequent opinion, 2018 WL 6694287, below.
  474. Winkler v. Medtronic, Inc., 2018 WL 6271055 (D. Md. Nov. 15, 2019), motion to dismiss denied without prejudice in action involving heart valve assist device.  Plaintiff completely failed to plead any parallel claim, and will be given one more chance to do so.  Discovery is not necessary to plead a parallel claim.  Subsequent opinion, 2019 WL 6052702, below.
  475. Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. Dec. 18, 2018), reversal of grant of motion to dismiss reversed in action involving infusion pump.  Arizona does not recognize claims for failure to report adverse events to the FDA.  Because no parallel state law claim exists, failure to report claims are impermissible attempts at private FDCA enforcement preempted by Buckman.
  476. Ezell v. Medtronic PLC, 2018 WL 6928917 (W.D. La. Dec. 19, 2018), adopted, 2019 WL 97041 (W.D. La. Jan. 3, 2019), motion to dismiss granted against all claims in action involving drug eluding stent.   Judicial notice of FDA approvals.  Parallel claims are not pleaded with sufficient specificity.  Failure to recall claim preempted.
  477. Shelp v. Allergan, Inc., 2018 WL 6694287 (W.D. Wash. Dec. 20, 2018), motion to dismiss granted against all claims in action involving breast implant.  Judicial notice taken of FDA PMA.  Consumer protection claim is really failure to warn.  No parallel claim attempted.  Prior opinion, 2018 WL 5734664, above.
  478. Cashen v. Johnson & Johnson, slip op., 2018 WL 6809093 (New Jersey Super. Law Div. Dec. 24, 2018), motion to dismiss granted against all claims in action involving breast implant.  Statutory product liability, express warranty, and fraud claims preempted.  Other claims abrogated by state law.
  479. Ebrahimi v. Mentor Worldwide LLC, 2018 WL 6829122slip op. (C.D. Cal. Dec. 27, 2018), motion to dismiss granted without leave to amend against all remaining claims in action involving breast implant.  Defendant’s internal laboratory test results did not create any FDA-imposed standard the violation of which could serve as the basis of a manufacturing defect claim.  Other allegations are too general.  Prior opinions, 2018 WL 2448095, and 2018 WL 6829122, above.  Affirmed, 2020 WL 2510760, below.
  480. ASEA/AFSCME Local 52 Health Benefits Trust v. St. Jude Medical, LLC, 2019 WL 318393 (D. Minn. Jan. 24, 2019), motion to dismiss granted against all claims in class action involving cardiac defibrillators.  Third party payors’ concealment allegations sought to add requirements or else sought private enforcement of the FDCA.  Failure to file adverse event reports or fraud on the FDA are all preempted.
  481. Freed v. St. Jude Medical, Inc., 2019 WL 418843 (D. Del. Feb. 1, 2019), motion to dismiss granted in part and denied in part in action involving neurostimulator.  Express and implied warranty claims preempted or inadequately pleaded.  Failure to report and negligent manufacturing claims survive preemption.  Prior opinion at 2017 WL 4102583.
  482. Calloway v. Coloplast Corp., 2019 WL 2169222 (Mag. W.D. La. Feb. 5, 2019), adopted, 2019 WL 2166539 (W.D. La. May 17, 2019), motion to dismiss granted against all claims in action involving penile implant.  No parallel claims alleged.
  483. White v. Medtronic, Inc., 2019 WL 13396132 (Mag. E.D. Mich. Feb. 20, 2019), adopted, 2019 WL 1330923 (E.D. Mich. March 25, 2019), motion to dismiss granted against all claims in class action involving bone growth device.  Off-label use does not affect preemption.  Riegel was an off-label case.  Off-label promotion claims are not parallel to recognized state-law cause of action.  Express and implied warranty claims preempted.  Fraud claim was disguised fraud on FDA claim.  Affirmed 2020 WL 1808606, below.
  484. Westerfield v. Corin Group, PLC, 2019 WL 1233634 (M.D. Fla. March 15, 2019), motion to dismiss granted against all claims in class action involving hip implant.  Design defect and failure to report claims preempted.
  485. Stampley v. Allergan USA, Inc., 2019 WL 1604201 (Mag. W.D. La. March 15, 2019), motion to dismiss granted against all claims in class action involving breast implant.  Plaintiff failed to connect her claims to the violation of any federal device requirement.  Adopted, 2019 WL 1601613 (W.D. La. April 15, 2019).
  486. McNeil-Williams v. Depuy Orthopaedics, Inc., 2019 WL 2339258 (E.D.N.C. May 29, 2019), motion to dismiss granted against all claims in case involving a knee implant.  Failure to update is not recognized as a state-law claim and therefore cannot be a parallel claim.  Rather it is a preempted private attempt to enforce the FDCA.  Warranty claim preempted as a warning claim.  Any attempt to challenge the integrity of FDA device approval would be preempted by Buckman.
  487. Soja v. Medtronic, Inc., 2019 WL 2391609 (E.D. Cal. June 6, 2019), motion to dismiss granted against all claims in class action involving pain pump.  Plaintiff alleged no parallel claims, and it is unclear what they could be.  Related decision, 2019 WL 2396540 – proper to take judicial notice of FDA website material.
  488. Delfino v. Medtronic, Inc., 2019 WL 2415049 (Minn. App. June 10, 2019), summary judgment affirmed against all claims in action involving defibrillator.  Claimed parallel claims involving the PMA submission were factually incorrect.  What is a federal regulation and what violates that regulation are matters of law for the court to decide.  A malfunction does not preclude preemption.  Experts may not opine on issues of law.  Since preemption is an issue of law exclusion of plaintiff’s FDA expert was appropriate.  Affirming 2018 WL 2688420 and 2012 WL 12925029, above.
  489. Womack v. Nevro Corp., 2019 WL 2567982 (M.D. Fla. June 21, 2019), motion to dismiss granted against all claims in action involving spinal cord stimulator.  Parallel claims must identify what FDA requirements were violated.  Alleged violation of unspecified requirements is insufficient.
  490. Jacob v. Mentor Worldwide, LLC, 389 F. Supp.3d 1024 (M.D. Fla. July 17, 2019), motion to dismiss granted against all claims in action involving breast implants.  All non-parallel claims preempted.  Failure to report parallel claim has no state-law counterpart, and is Buckman preempted.  Subsequent opinion, 2019 WL 6766574, below.
  491. Grubbs v. Medtronic, Inc., 2019 WL 3288263 (N.D. Ala. July 22, 2019), motion to dismiss granted in part and denied in part in action involving pain pump.  Warning claim, including failure to report, preempted.  Warranty claims escape preemption to the extent based on FDA violations.
  492. Jacob v. Mentor Worldwide, LLC, 393 F. Supp.3d 912 (C.D. Cal. Aug. 1, 2019), motion to dismiss granted against all claims in action involving breast implants.  No presumption against preemption.  Litigation tourists cannot avoid the substantive law of their state of residence.  Failure to report claim is conclusory, not identifying any actual failures. Other violation allegations were similarly conclusory.  Parallel claims failed to identify what regulations were violated or how.
  493. Vieira v. Mentor Worldwide, LLC, 392 F. Supp.3d 1117 (C.D. Cal. Aug. 1, 2019), motion to dismiss granted against all claims in action involving breast implants.  No presumption against preemption.  Litigation tourists cannot avoid the substantive law of their state of residence.  Failure to report claim is conclusory, not identifying any actual failures. Other violation allegations were similarly conclusory.  Parallel claims failed to identify what regulations were violated or how.
  494. Porter v. Depuy Orthopaedics, Inc., 2019 WL 3979656 (E.D. Va. Aug. 6, 2019), motion to dismiss granted against all claims in action involving knee implant.  Plaintiff failed to plead with any specificity what went wrong with the implant and how that was related to any regulatory violation.  A recall does not establish a causal violation.  Plaintiff’s claims are consistent with a compliant device causing injury.  No unpreempted express warranty claims because no statements exceeded the scope of FDA-approved statements.  Implied warranty of fitness for a particular purpose is necessarily preempted because the FDA approved the device’s intended use.
  495. In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, ___ F. Supp.3d ___, slip op., 2019 WL 3818291 (D. Md. Aug. 14, 2018), motion to dismiss granted in part and denied in part in action involving hip implant.  In a hybrid PMA/510k device system, preemption bars non-parallel claims targeted against PMA components.  Holding applies to strict liability, negligence, warranty, misrepresentation-based, and recall claims.  False off-label promotion claims survive preemption.  Failure to conduct a post-marketing study is impliedly preempted as private FDCA enforcement.  Failure to update and duty to train claims are expressly preempted.  Negligence per se claims are not preempted.
  496. Sharp v. St. Jude Medical, S.C., Inc., ___ F. Supp.3d ___, 2019 WL 3821895 (N.D. Ga. Aug. 14, 2019), motion to dismiss granted against all claims in action involving implantable cardiac defibrillator.  Rejects Bausch “plaintiff needs discovery” rationale.  Plaintiff must plead facts to establish a parallel claim.  Laundry list of allegedly violated regulations failed to plead either how any violation occurred or causation.  Plaintiff failed to plead causation to avoid preemption of manufacturing defect claim.  Recall does not affect preemption.  Failure to report is a preempted fraud on the FDA claim.  Negligence per se is attempted private FDCA enforcement.
  497. Sewell v. Mentor Worldwide, LLC, 2019 WL 4038219 (C.D. Cal. Aug. 27, 2019), motion to dismiss granted against all claims in action involving breast implants.  No presumption against preemption.  Litigation tourists cannot avoid the substantive law of their state of residence.  Failure to report claim is conclusory, not identifying any actual failures. Other violation allegations were similarly conclusory.  Parallel claims failed to identify what regulations were violated or how.
  498. Billetts v. Mentor Worldwide, LLC, 2019 WL 4038218 (C.D. Cal. Aug. 27, 2019), motion to dismiss granted against all claims in action involving breast implants.  No presumption against preemption.  Litigation tourists cannot avoid the substantive law of their state of residence.  Failure to report claim is conclusory, not identifying any actual failures. Other violation allegations were similarly conclusory.  Parallel claims failed to identify what regulations were violated or how.
  499. Brooks v. Mentor Worldwide, LLC, 2019 WL 4628264 (D. Kan. Sept. 23, 2019), motion to dismiss granted against all claims in action involving breast implants.  Negligent pharmacovigilance, failure to report, and several manufacturing defect claims impliedly preempted for lack of parallel state cause of action.  FDCA-based negligence per se not permitted.  Warning claim expressly preempted.  CBE FDA process is voluntary, not mandatory.  Manufacturing defect claims patterned on FDCA rather than common law are expressly and impliedly preempted.
  500. Williams v. Mentor Worldwide LLC, 2019 WL 4750843 (N.D. Ohio Sept. 30, 2019), motion to dismiss granted against all claims in action involving breast implants.  No parallel claims alleged.
  501. Irizarry v. Abbott Laboratories, 2019 WL 5061127, slip op. (E.D. Pa. Oct. 8, 2019), motion to dismiss granted against all claims in action involving blood vessel closure device.  Parallel claims inadequately pleaded.  An appended affidavit is not a pleading.  Nature of any FDCA violation must be pleaded.  No discovery.  No parallel state-law claims identified.
  502. Freed v. St. Jude Medical, Inc., 2019 WL 5102643 (D. Del. Oct. 11, 2019), Motion to dismiss denied against remaining claims in action involving neurostimulator.  Arguments against manufacturing defect claims are temporarily waived.  Duty to report claim is adequately pleaded.
  503. Weber v. Allergan, Inc., 940 F.3d 1106 (9th Cir. Oct. 11, 2019), affirming grant of motion to dismiss against all claims in action involving breast implants.  Statement about device performance in clinical trial was aspirational only and was not an FDA-approved standard.  To make it one was preempted as different from FDA regulation.  That the device malfunctioned was insufficient proof of violation of FDA regulations.  Direct proof of a violation is necessary.  Res ipsa loquitur can establish defect but not an FDA violation.  Affirming 2018 WL 9817168, above.  Cert. denied, 2020 WL 1326110 (U.S. March 23, 2020).
  504. Knoth v. Apollo Endosurgery US, Inc., 425 F. Supp.3d 678 (S.D. Miss. Nov. 8, 2019), motion to dismiss granted in part and denied in part in action involving gastric balloon.  All non-parallel claims preempted.  Manufacturing defect claim not preempted to the extent that it is based on GMP violations.  Design claim preempted.  Warning claim failed on state law grounds.  Express warranty claim based on statements not approved by FDA is not preempted.
  505. Winkler v. Medtronic, Inc., 2019 WL 6052702 (D. Md. Nov. 15, 2019), motion to dismiss granted against all claims in action involving heart valve assist device.  Attempted parallel claim is conclusory.  Merely stating that the device generally violated some non-specific FDA “standards” is insufficient.  Device recall insufficient to establish an FDA violation.  Previous opinion, 2018 WL 6271055, above.
  506. Barone v. Bausch & Lomb, Inc., 2019 N.Y. Misc. Lexis 6423 (N.Y. Sup. Dec. 6, 2019), motion to dismiss denied.  The only claim being asserted, failure to report adverse events, was an unpreempted parallel claim.
  507. Jacob v. Mentor Worldwide, LLC, 2019 WL 6766574 (M.D. Fla. Dec. 10, 2019), motion to dismiss amended complaint granted in action involving breast implants.  All plaintiff’s claims, particularly concerning warnings, were still preempted.  Informed consent was a disguised preempted warning claim.  Failure to maintain records claim impliedly preempted as private FDCA enforcement.  Prior opinion, 389 F. Supp.3d 1024, above.  On appeal, at 20-10132 (11th Cir.).
  508. Walls v. Medtronic, Inc., 2019 WL 6839942 (E.D. Pa. Dec. 16, 2019), motion to dismiss granted against all claims in action involving deep brain stimulators.  No parallel claims pleaded.  Post-sale duty to warn claim would be preempted if it went beyond FDA requirements.  Where plaintiff pleaded an intended use, an off-label promotion claim would not be viable.  Judicial notice proper of FDA documents establishing PMA.
  509. Tinkler v. Mentor Worldwide, LLC, 2019 WL 7291239 (S.D. Fla. Dec. 30, 2019), motion to dismiss granted against all claims in action involving breast implants.  No parallel claim pleaded.  FDCA duty to create procedures not “genuinely equivalent” to state-law warning claim.  Failure to report claims impliedly preempted.
  510. Bayer Corp. v. Leach, 139 N.E.3d 1127 (Ind. App. Dec. 31, 2019).  Partial denial of preemption judgment on the pleadings affirmed in action involving implantable contraceptive.  Parallel manufacturing defect claims escape preemption.  Both premised on federal GMP violation and within state statutory definition of manufacturing defect.  Vacated, and later decision, 2020 WL 4811506, below.
  511. Bledsoe v. Medtronic, Inc., 2020 WL 43107 (N.D. Ind. Jan. 3, 2020), motion to dismiss granted in part and denied in part in action involving pain medication pump.  Duty to report runs only to FDA, so warning claims preempted.  Design defect preempted because it would second-guess FDA’s safety and effectiveness determination.  Under Bausch, a manufacturing defect claim escapes preemption even without the violated FDA requirement, or the violation, being specified.
  512. Gomez v. Bayer A.G., 2020 WL 215897, slip op. (N.J. Super. A.D. Jan. 14, 2020), grant of motion to dismiss affirmed against all claims affirmed in action involving implantable contraceptive.  Plaintiff failed to plead a parallel claim with respect to defendant’s warnings or as to any express warranty.  Failure to train and manufacturing defect claims did not allege any parallel claim.  Preemption requires stricter pleading requirements.  Affirming 2018 WL 10612946, above.
  513. Green v. Medtronic, Inc., 2019 WL 7631397 (N.D. Ga. Dec. 31, 2019), motion to dismiss granted against all claims in action involving pain pump.  Manufacturing defect claim preempted where no violated regulation alleged.  Negligence per se dismissed under Buckman because claim cannot exist without FDCA.  Amendment allowed 2020 WL 45777134, below.
  514. Lawrence v. Medtronic, ___ F. Appx. ___, No. 18-55621, 2020 WL 429769 (9th Cir. Jan. 28, 2020), grant of motion to dismiss affirmed against all claims affirmed in action involving pain pump.  Parallel claims properly preempted for failure to identify violation of specific FDA regulation.  Failure to test explanted units properly preempted as “in addition to” FDA requirements that do not mandate any such tests.  Failure to report properly preempted for lack of causation and because all reports actually made.  Failure to report plaintiff’s own incident could not possibly be causal.  Affirming 2017 WL 826963, above.
  515. White v. Medtronic, Inc., ___ F. Appx. ___, 2020 WL 1808606 (6th Cir. Jan. 29, 2020), grant of motion to dismiss affirmed against all claims affirmed in action involving bone growth device.  Preemption applies when components of a PMA device are used separately off-label.  Affirming 2019 WL 13396132 above.
  516. Allo v. Allergan USA, Inc., 2020 WL 814855 (E.D. La. Feb. 19, 2020), motion to dismiss granted in part and denied in part in action involving breast implants.  Manufacturing defect and redhibition claims based on product not meeting FDA thickness standards are permissible parallel claims.  All other claims preempted.
  517. Lewis v. Abbott Laboratories, Inc., 2020 U.S. Dist. Lexis 42635 (M.D. Fla. Feb. 24, 2020), motion to dismiss denied in action involving a defibrillator.  Plaintiff only brought unpreempted manufacturing defect claims.  Fraud dismissed for failure to allege any false statement.
  518. Doe v. Bausch & Lomb, Inc., 443 F. Supp.3d 259 (D. Conn. March 11, 2020), motion to dismiss granted against all claims in action involving intraocular lens.  All warning-related claims expressly preempted, including consumer fraud.  Failure to report claim impliedly preempted as private FDCA enforcement.
  519. Saltis v. Nuvasive, Inc., 2020 WL 4689787 (D. Vt. March 13, 2020), motion to dismiss granted against all claims in action involving pedicle screws.  No FDCA violations pleaded.
  520. Hayes v. Endologix, Inc., 449 F. Supp.3d 676 (E.D. Ky. March. 26, 2020), motion to dismiss granted in part and denied in part in action involving aortic aneurysm graft.  FDCA-based negligence per se had no state-law analog and could not be parallel claims.  Remaining claims were sufficiently specific to avoid preemption.
  521. Webb v. Mentor Worldwide LLC, ___ F. Supp.3d ___, slip op., 2020 WL 1685323 (N.D.N.Y. April, 7, 2020), motion to dismiss granted against all claims in action involving breast implants.  References to vague GMPs and a warning letter involving a different product do not plead a manufacturing defect.  Nothing suggests that this unit was any different from any other.  Warning, design and implied warranty claims preempted.  No express warranty pleaded.
  522. Carter v. Medtronic, Inc., 2020 WL 2319729 (S.D. Ohio May 11, 2020), summary judgment granted against all claims in action involving pain pump.  Manufacturing defect claim fails because res ipsa loquitur cannot establish a regulatory violation.
  523. Ebrahimi v. Mentor Worldwide LLC, 804 F. Appx. 871 (9th Cir. May 15, 2020), dismissal of all claims affirmed in action involving breast implant.  Manufacturing defect preempted.  Plaintiff’s injury was not proof that defendant must have violated some GMP.  Defendant’s data sheet did not create any design specification.  Prior opinions:  2017 WL 4128976, 2018 WL 2448095, and 2018 WL 6829122, above.
  524. Green v. Medtronic, Inc., 2020 WL 4577713 (N.D. Ga. May 1, 2020), motion to amend allowed in part and denied in part in action involving a pain pump.  Manufacturing defect claim patterned after FDA warning letter not preempted on the pleadings.  Negligence per se, including little FDCA act, impliedly preempted.  Express warranty not breached, and otherwise preempted.  Prior decision, 2019 WL 7631397, above.
  525. Diodato v. Mentor Worldwide LLC, 2020 WL 3402296 (D. Md. June 19, 2020), motion to dismiss granted against all claims in action involving breast implants.  A device malfunction is insufficient to infer that the defendant violated FDA regulations.  No particular deviation from any identified FDA manufacturing regulation is alleged.  Same for warning and design claims.
  526. Sullivan v. Boston Scientific Corp., 2020 U.S. Dist. Lexis 137586 (Mag. N.D. Fla. June 23, 2020), adopted, 2020 WL 4430392 (N.D. Fla. July 31, 2020), motion to dismiss granted against all claims in action involving spinal cord stimulator.  No parallel claims alleged.
  527. English v. Bayer Corp., ___ F. Supp.3d ___, 2020 WL 3454877 (W.D.N.Y. June 25, 2020), motion to dismiss granted against all claims in action involving implantable contraceptive.  Failure to train expressly and impliedly preempted.  Failure to report expressly preempted because no parallel state claim exists.
  528. D’Addario v. Johnson & Johnson, 2020 WL 3546750 (D.N.J. June 30, 2020), motion to dismiss granted against all claims in action involving breast implants.  Manufacturing claim failed to tie the alleged defect to violation of any FDA regulation.  Warning claim either challenged approved warnings or asserted fraud on the FDA.
  529. Bayer Corp. v. Leach, ___ N.E.3d ___,  2020 WL 4811506 (Ind. App. Aug. 19, 2020), denial of motion to dismiss affirmed in part and reversed in part in action involving implantable contraceptive.  Negligence per se is impliedly preempted.  Plaintiff cannot, on a failure to report theory or otherwise, require a defendant to make a labeling change that is voluntary under FDA regulation.  Fraud claims based on false statements outside FDA-approved warnings survives on the pleadings.  Manufacturing defect claim not impliedly preempted.  Allegation of negligent conduct of FDA-mandated physician training, or voluntarily self-assumed additional training, is not preempted.  Express warranty claims are voluntarily assumed and not preempted.  Prior decision, 139 N.E.3d 1127, above.
  530. Hill v. Abbott Laboratories, 2020 WL 4820243 (D.S.C. Aug. 19, 2020), motion to amend allowed in part and denied in part in action involving an implantable cardiac defibrillator.  Recall does not establish an FDCA violation, but allows one to be pleaded.  Express and implied warranty and unjust enrichment expressly preempted.  Manufacturing defect and related warning/misrepresentation claims not preempted.
  531. Coghill v. Bayer Corp., 2020 U.S. Dist. Lexis 154092 (E.D. Ky. Aug. 25, 2020), motion to dismiss granted in part and denied in part in action involving implantable contraceptive.  Only claims plaintiff conceded were dismissed.  As to everything else, the record was too unclear to make an affirmative ruling on preemption.
  532. Noel v. Bayer Corp., 2020 WL 5038782 (D. Mont. Aug. 26, 2020), motion to dismiss granted against all claims in action involving implantable contraceptive.  Alleged adulteration could not have caused plaintiff’s injury and thus was not an unpreempted manufacturing defect claim.  Plaintiff cannot invalidate FDA approval.  Claim of duty to submit CBE supplement preempted.  Reporting claims preempted as either beyond what FDA requires or not supported by state law.  Express warranty claims attacking FDA-approved statements are preempted.  Duty to train claims must plead violation of FDCA training duties.  Overpromotion, pharmacovigilence, and consumer fraud claims all preempted.
  533. Conley v. St. Jude Medical, LLC, ___ F. Supp.3d ___, slip op., 2020 WL 5087889 (M.D. Pa. Aug. 28, 2020), motion to dismiss granted against all claims in action involving nerve root stimulator.  Parallel claims cannot be asserted by alleging violations of vague CGMPs.  Express warranty not preempted but inadequately pleaded.  Failure to report and manufacturing defect are preempted.
  534. Hill v. Bayer Corp., 2020 WL 5367334 (E.D. Mich. Sept. 8, 2020, motion to dismiss granted against all claims in action involving implantable contraceptive.  No parallel state law claim for failure to report adverse events to the FDA.  Failure to train preempted to the extent it exceeds FDA requirements, and causation not pleaded to the extent it does not.  Express warranty preempted as to statements approved by FDA.