Manufacturing Defect

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We recently commented on Sumpter v. Allergan, Inc., 2018 WL 4335519 (E.D. Mo. Sept. 11, 2018), for several reasons – all bad – but one stands out, the ruling that used what’s essentially res ipsa loquitur to wave plaintiff through PMA preemption with a manufacturing defect.  According to Sumpter:

Plaintiffs allege that, due to manufacturing defect, the products . . . [user plaintiff] received were not the products approved by the FDA.  Even though “the precise contours of their theory of recovery have not yet been defined,” the Court holds Plaintiffs’ allegations sufficiently allege that Defendants did not adhere to FDA manufacturing requirements.

Id. at *2.  For this remarkable inference, Sumpter cites only Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which had nothing to do with manufacturing defects as a form of parallel claim.

What Sumpter held is not the law.  Not even close.  While we recognize that manufacturing defect claims in some circumstances can thread the “narrow gap” between express and implied preemption, such allegations cannot do so by mere inference.  “Plaintiffs cannot simply incant the magic words ‘[defendant] violated FDA regulations’ in order to avoid preemption.”  Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011) (citation and quotation marks omitted).

This complaint is impermissibly conclusory and vague; it does not specify the manufacturing defect; nor does it specify a causal connection between the failure of the specific manufacturing process and the specific defect in the process that caused the personal injury. Nor does the complaint tell us how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.

Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011).

To infer an FDCA violation, and therefore an unpreempted manufacturing defect, from the mere fact of a device malfunction demands an “actual guarantee” of safety.  But “the FDA recognizes the device will not always function in accordance with specifications,” so such “additional requirement[s]” are “precluded.”  Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012).  The “FDA approves the process by which a Class III device is manufactured, but it does not guarantee that every device manufactured in that process will work.”  Banner v. Cyberonics, 2010 WL 455286, at *4 (D.N.J. Feb. 4, 2010).  Therefore, “if the FDA approves a manufacturing process and the defendant-manufacturer conforms with it, a device thereby produced that nevertheless does not function as intended does not give rise to liability.”  Id.

For similar reasons, numerous courts have rejected res ipsa loquitur as a basis for inferring FDCA violations in PMA preemption cases.

[Plaintiff] relies, instead, on the doctrine of res ipsa loquitur for the proposition that full compliance would have resulted in a problem-free device.  Res ipsa loquitur does not suffice.  Res ipsa loquitur permits an inference of negligence when there can be no other explanation. . . . If negligence were the only cause of a Class III device’s failure, there would be no need for the MDA’s ongoing reporting requirements. See 21 C.F.R. § 814.84(b)(2). Plaintiff is ultimately wrong when he assumes that premarket approval guarantees the device is completely safe.

Clark v. Medtronic, Inc., 572 F. Supp.2d 1090, 1094 (D. Minn. 2008).  “Because of the general nature of the doctrine of res ipsa loquitur, a fact finder could rule in favor of [plaintiff] without finding that [defendant] violated any federal regulation.  Such a finding would impose requirements ‘different from, or in addition to,’ those in the [device’s] PMA and would thus be expressly preempted.”  Williams v. Bayer Corp., 541 S.W.3d 594, 612-13 (Mo. App. 2017).  Accord McAfee v. Medtronic, Inc., 2015 WL 3617755, at *6 (N.D. Ind. June 4, 2015) (“[t]o the extent [plaintiff] alleges that [defendant] is liable under a theory of res ipsa loquitur . . ., his claims are preempted”); Kallal v. Ciba Vision Corp., 2013 WL 328985, at *3 (N.D. Ill. Jan. 28, 2013) (preempting “argument hints at reliance on the doctrine of res ipsa loquitur”), aff’d, 779 F.3d 443 (7th Cir. 2015); Knoppel v. St. Jude Medical, Inc., 2013 WL 12116393, at *7 (C.D. Cal. Sept. 24, 2013) (“the res ipsa loquitur doctrine is barred by [preemption] because the PMA process does not demand that a product be risk free, but only that its benefits, if manufactured according to specifications, outweighs its risks”); Gross v. Stryker Corp., 858 F. Supp.2d 466, 483 (W.D. Pa. 2012) (“references to federal regulations in his negligence and res ipsa loquitur claims are too vague and general”); Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197, 202 (W.D.N.Y. 2011) (res ipsa claims “are based squarely on Defendants’ purported breach of state tort duties of care,” which “are precisely the type of claims Riegel held are preempted”); Cafferty v. Cayuga Medical Center, 2011 WL 541809, at *5 (N.D.N.Y. Feb. 8, 2011) (“one may not infer a manufacturing defect without creating a duty that adds to, rather than parallels, federal requirements”); Funk v. Stryker Corp., 673 F. Supp.2d 522, 531 (S.D. Tex. 2009), (because “the PMA process does not demand that an innovation be risk free . . . [i]t would follow that one may not infer a defect in the product simply because a patient encountered negative side effects in using it”), aff’d, 631 F.3d 777 (5th Cir. 2011); LeMay v. Eli Lily [sic] & Co., 960 F.Supp. 183, 186 (E.D. Wis. 1997) (parallel claims “proceed only for violations of the FDA regulations” but “res ipsa loquitur could allow recovery for negligence that Congress has preempted,” so plaintiffs “may not rely on the doctrine”).

Therefore, “[t]he fact that the [defendant’s device] allegedly failed does not itself establish a deviation from the FDA-approved standards.”  Smith v. St. Jude Medical Cardiac Rhythm Management Div., 2013 WL 1104427, at *4 (D. Md. Mar. 13, 2013).  In Burgos v. Satiety, Inc., 2013 WL 801729 (E.D.N.Y. March 5, 2013), no inference that an investigational device violated FDA regulations could be inferred from its malfunction, even though plaintiff had been offered a settlement and there were allegations of spoliation (neither of which were present in Sumpter).

Plaintiff has failed to provide any circumstantial evidence, other than the fact that Plaintiff was injured and that she was offered some money, to argue that the . . . device was actually manufactured in a way that violated the IDE.  Plaintiff has not presented any evidence that the . . . device was adulterated, or that it was unreasonably dangerous and unfit for [its] intended purpose to show that the IDE was violated.  Failure to provide any evidence in support of Plaintiff’s claim is fatal and it must be dismissed.

Id. at *7 (citations and quotation marks omitted).  See also Herrnandez v. Stryker Corp., 2015 WL 11714363, at *3 (W.D. Wash. March 13, 2015) (plaintiff could not escape preemption on “conclusory allegations” that explanted device violated FDA regulations); Ali v. Allergan USA, Inc., 2012 WL 3692396, at *11 (E.D. Va. Aug. 23, 2012) (facts that support causation from a malfunction “are not sufficient to link the [malfunction] or [plaintiff’s] injuries to any federal violation . . . in the manufacture of the device”); Anthony v. Stryker Corp., 2010 WL 1387790, at *4 (N.D. Ohio Mar. 31, 2010) (an “attempt to recast generalized deviations from ‘manufacturing performance standards’ as specific violations of federal regulations is insufficient to state a claim”); Rankin v. Boston Scientific Corp., 2010 WL 672135, at *4 (E.D. Ky. Feb. 19, 2010) (“that the [device] allegedly failed during normal use does not override the clear language of §360(a) or the Supreme Court’s ruling in Riegel that the plaintiffs’ claims are preempted by federal law”); Cenac v. Hubbell, 2009 WL 10678961, at *4 (E.D. La. July 31, 2009) (“mere fact that a device malfunctions or produces an adverse result does not plead a violation of federal law”); Delfino v Medtronic, Inc., 2018 WL 2688420, at *8 (Minn. Dist. May 18, 2018) (“the mere fact that a device malfunctioned is not evidence that the device violated any federal requirement”).

Sumpter cited nothing to support its letting the plaintiff slide under TwIqbal on the theory that a device malfunction, without more, is enough to establish not only a product defect, but an FDCA violation.  That’s two bridges too far.  One can only hope that defense counsel will be able to show the trial court the error of its ways soon, without the need for an appellate court to do it for them.

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.]

 

This post comes only from the Cozen O’Connor side of the blog.

The MDL court in the Testosterone Replacement Therapy (“TRT”) litigation recently entered summary judgment in favor of a non-US manufacturer that did not distribute in the US, along with its US subsidiary. The judgment ended efforts to hold those two defendants, Besins Healthcare, S.A. and Besins Healthcare Inc., liable under a series of product liability claims for injuries allegedly caused by the use of AndroGel, a TRT product. In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, 2018 WL 2416239 (N.D. Ill. May 29, 2018).

The court knocked down each of the plaintiffs’ claims in rather short order. Plaintiff’s strict liability and negligent design defect claims fell because plaintiffs had no evidence of a defect. Plaintiffs tried to rely on allegations in the complaint. That doesn’t cut it on summary judgment. Allegations are not evidence:

As the non-moving party, it is plaintiffs’ burden to identify evidence to show why defendants are not entitled to judgment as a matter of law. Because plaintiffs have provided nothing more than quotations from their complaint and from this Court’s order denying the Besins defendants’ motion to dismiss, they have not met their burden.

Id. at *5. A lack of evidence also ended plaintiffs’ manufacturing defect claim: “Plaintiffs present no evidence or argument that AndroGel suffers from a manufacturing defect. Thus the Court considers plaintiffs to have forfeited that negligence theory.” Id. The court entered judgment against plaintiffs’ defect claims.

More interesting was the Court’s rejection of Plaintiffs’ failure to test claim. Plaintiffs relied on an email from an R&D employee at a Besins subsidiary reacting to publications suggesting an association between AndroGel and cardiovascular risks. The employee wrote that “the community should be calling for further study” and that Besins should be “very careful . . . about getting into this discussion” because it might have an “ethical obligation” to conduct such studies as a company that profited from the manufacture of AndroGel. Id. at *2. It’s not surprising that plaintiffs focused on this email.

But they did little else. In fact, plaintiffs’ evidence went no further than the email, which on its own does not establish a failure to test claim. On the other hand, the Besins defendants, who were not distributors of AndroGel in the US, presented actual evidence undermining plaintiffs’ claim. In particular, they relied on the R&D employee’s deposition testimony in which he clarified that Besins did not have the right to conduct testing in the United States. Id. This went unchallenged, and the court found it dispositive:

Plaintiffs have provided nothing to support a contention that the Besins defendants have a duty to conduct safety studies in the United States. To the contrary, the undisputed evidence shows that the Besins defendants cannot do so, and plaintiffs have not attempted to reconcile that evidence with their position.

Id.

The court found other unfixable problems with plaintiffs’ failure to test claim. Plaintiffs presented no evidence that Besins actually failed to test. The R&D employee’s email certainly doesn’t prove that. Plaintiffs also provided no evidence of a proximate causation, making no evidentiary connection between the alleged failure to test and their injuries:

[P]laintiffs have provided no evidence that the Besins defendants’ alleged failure to test proximately caused plaintiffs’ injuries. Plaintiffs’ theory is that the Besins defendants’ failure to adequately test AndroGel caused AbbVie [the company to whom Besins licensed the exclusive right to market and distribute AndroGel in the US] to lack sufficient information about AndroGel’s risks. The alleged failure to test, plaintiffs say, thus “directly contributed to AbbVie’s failure to provide an adequate warning to healthcare providers in the United States.” Plaintiffs, however, do not cite any evidence to support this theory. Their conclusory argument is insufficient to withstand summary judgment.

Id.

The court also rejected plaintiffs’ failure to report adverse reports claim. Plaintiffs described this claim as a failure to report adverse events to other manufacturers, industry experts and the FDA. Having so constructed their claim, however, plaintiffs presented no evidence or argument to establish that the Besins defendants had an enforceable duty to report adverse events to other manufacturers or industry experts. Id. at *6. For their part, the Besins defendants presented evidence that they had no duty to report AndroGel adverse events to the FDA. That responsibility instead fell solely to AbbVie, the company to whom the Besins defendants licensed the exclusive right to market and distribute AndroGel in the US. Id. With no duty, plaintiffs had no claim. Setting that aside, plaintiffs nonetheless presented no evidence that the Besins defendants failed to report any adverse event or that such failure proximately caused their injuries. Id. For all these reasons, the court entered judgment against plaintiffs’ failure to report claim.

The upshot of this opinion appears to be that the non-distributor Besins defendants are our of the Hormone Replacement Therapy MDL.

This post is from the non-Reed Smith side of the blog.

It may be post Mardi Gras season, but we don’t think there is ever a bad time to embrace the motto – “Laissez les bons temps rouler.” Quite literally – “Let the good times roll.” However, don’t try this with your high school French teacher, because after her gasp of horror, she will tell you that the grammatically correct way to get a party started in France is “Prenons du bons temps.” Of course, the Louisiana version is really Cajun French as opposed to France French and with both having so many good things to offer it’s really a matter of preference in a given moment. Like deciding if you’re in the mood for bouillabaisse or crawfish etouffee; a beignet or a croissant; a Hurricane or a Cabernet Franc.

Now that we’ve got you thinking about what’s for dinner, we can narrow our Louisiana focus to just the Louisiana Products Liability Act (“LPLA”) – hoping to whet your legal appetite now. In the case of Pierre v. Medtronic, Inc., 2018 U.S. Dist. LEXIS 67773 (E.D. Lous. April 23, 2018), plaintiff alleged she was injured as a result of defendant’s self-fixating mesh that was used in plaintiff’s abdominal surgery. Plaintiff alleges she suffered an infection and pain following her surgery. Id. at *2. We are jumping to the end of the decision to immediately lop off several of plaintiff’s claims. The court dismissed claims for breach of warranty of fitness for ordinary use, negligence, breach of implied warranty, negligent misrepresentation, and negligent design all on the grounds that they exceed the scope of the LPLA and the LPLA “sets forth the exclusive theories of liability for manufacturers for damage caused by their products.” Id. at *15.

So, what claims does the LPLA allow? Manufacturing defect, design defect, failure to warn, and express warranty. Id. at *5. And on defendant’s motion to dismiss, only half those claims survived. The first claim to survive, unusual for a drug/device case, is for manufacturing defect. That’s because here plaintiff had a specific allegation that the mesh used in her surgery was improperly sterilized which led to her development of an infection. Because plaintiff is challenging a deviation from the standard procedures for this product, she’s stated a claim for a manufacturing defect. But the court was clear that what plaintiff could not do is attack the defendant’s sterilization process generally, only this particular alleged deviation. Id. at *7-8.

Next plaintiff alleged two design defects. First plaintiff alleged that the mesh was defective in that it was made of polyester, a weaker material than used in other mesh products, and that the weaker material required a different method of being secured which ultimately led to causing plaintiff more pain than she would have suffered with a different method of attachment. Id. at *8-9. Since plaintiff alleged a design defect, alleged that that defect was the cause of one of her injuries (pain), and that alternative designs existed, she passed TwIqbal on this claim. Her second design claim, however, did not meet that standard. Plaintiff alleged that the design of the mesh caused her infection by lowering her pH. But missing from this claim is any suggestion of “the existence of a feasible alternative design that would prevent the alleged injury.” Id. at *10.

There was no splitting the baby on plaintiff’s failure to warn claim. It was dismissed in its entirety. As to the alleged failure to warn about infection, plaintiff relies exclusively on a single marketing document. However, plaintiff failed to allege any facts “to plausibly suggest that [plaintiff’s] surgeon relied, or any competent surgeon would rely, on this marketing document when deciding whether to perform surgery.” Id. at *11. A pretty demanding standard when you infer, and we think the court was so implying, that no competent surgeon relies on marketing material to make medical decisions. Moreover, the court pointed out several ways in which the marketing document cites to other documents, most importantly to the “Instructions for Use” of the mesh demonstrating that “Defendants did not rely solely, if at all, on the marketing document to warn users of the risks.” Id. at *12. Not to mention that the risk of infection is a “common surgical complication” most likely already known to plaintiff’s surgeon. Id.

Plaintiff’s second failure to warn claim was based on a failure to warn that the mesh might contract after surgery causing pain. Id. Here plaintiff failed to allege any facts about what warning was provided to plaintiff’s surgeon relying only on a boilerplate statement that defendant didn’t warn. Id. But such an “allegation is too broad to state a claim because it does not identify (1) which aspects of the product warranted a warning and (2) what injuries resulted from the failure to warn.” Id. at *13. Too vague to withstand dismissal.

So too was plaintiff’s breach of express warranty claim. Plaintiff only alleged that defendant warranted the product was safe and fit for its intended use, merchantable, adequately tested, and did not have dangerous side effects. Id. at *14. But a claim that a product is “safe” or “effective” is only a “general opinion” or “general praise,” insufficient to form the basis for an express warranty under the LPLA.

Of the 6 claims brought that were permissible under the LPLA, only 2 survived the motion to dismiss. Not a complete win, but good enough to put in the “good times” category. And if you don’t want to get embroiled in the French debate, we recommend following the lead of Shirley & Lee from 1956 or The Cars from 1978 and just let the good times roll (in English).

Last year’s list of the Ten Worst DDL cases was remarkable because all ten decisions came from appellate courts.  Yikes.  And it is not as if the bad appellate decisions were spread around.  Two came from our home circuit, the Third.  Two came from the reliably problematic Ninth Circuit.  But the ‘winner’ was the Eleventh Circuit, with three terrible opinions.  For defense practitioners, Eleventh Circuit precedents can create something of an obstacle course. 

 

It turns out that good federal district judges in SEC country also can be frustrated with what their appellate brethren hath wrought.  Last week we were sent an interesting example of this: Rowe v. Mentor Worldwide, LLC, No. 8:17-cv-2438-T-30CPT (M.D. Fla. March 2, 2018).  In that case, the plaintiff sued for negligence, strict liability, and breach of warranty arising out of injuries allegedly caused by a silicone gel breast implant. The breast implants are class 3 devices requiring premarket approval from the FDA.  The plaintiff’s implants had ruptured.  The plaintiff asserted that the defendant failed to conduct proper studies and failed to warn about known risks.  The defendant filed a motion to dismiss.  The district court wrote a thorough and well-reasoned opinion, concluding that all of the claims save one must be dismissed.  All of the claims would have been dismissed had it not been for a pesky Eleventh Circuit case that is unsound and inconsistent with other Eleventh Circuit cases.  The district judge acknowledged being stuck, but was none too happy about it.  The Rowe court’s opinion is laid out logically, and we will do our best to track it.

 

Pleadings

 

The court addresses “a growing plague on the justice system, which has wreaked havoc in this case and numerous others: poorly drafted pleadings.” Slip op. at 4. We get an Iqbal name-check.  The Rowe court recognizes the liberalities of notice pleading, but also recognizes that “[t]here is a point, though, where a pleading becomes deficient not because it lacks sufficient allegations to provide notice of claims, but because it buries those allegations among pages of irrelevant and impertinent material.”  Id. at 5  The complaint in this case was 60 pages, with 151 pages of exhibits.  The negligence claim includes “six separate negligence theories that are confusingly interwoven among each other.”  Id. at 5.  In short, the plaintiff “threw every allegation into the Complaint to see what would stick.”  Id. at 6.  But instead of throwing out the complaint wholesale, the court examined the particular causes of action to see which ones, in fact, would stick.

 

Preemption Overview

 

For its preemption analysis, the Rowe court largely relied on the recent Eleventh Circuit decision in Godelia.  That ends up having its ups and downs.  But the general preemption analysis is straightforward enough.  The threshold questions is whether the claims are valid under Florida state law, which governs the case.  If not, those claims are gone.  If so, the next questions is whether those claims are preempted by federal law.

 

Negligence failure to warn 

 

The plaintiff does not allege that the defendant failed to give the warning required by FDA. Therefore, the plaintiff must be seeking to impose a warning requirement that is different from or in addition to federal law.  Such a claim is expressly preempted by statute. Slip op. at 9.

 

Failure to report adverse events 

 

As any even semi-faithful reader of this blog knows, we think this claim is hogwash.  It should fail both on simple causation grounds as well as preemption.  We wrote about this issue earlier this week.  Some of you might know that the Ninth Circuit is a devilishly bad place for defendants on this issue.  But the Rowe court is not in the Ninth Circuit.  Instead, it is Eleventh Circuit law that supplies the framework, and this is one area where the Eleventh Circuit is pretty good, as it sees failure to report claims under Florida law as essentially alleging a claim of fraud on the FDA, which is preempted by Buckman. Slip op. at 10.

 

Failure to comply with federal laws 

 

The claims under this category pertain to alleged breaches of federal requirements and regulations. One example mentioned in the complaint is failure to do required studies.  But Florida law imposes no such requirement. So this claim flunks the preliminary test.  Even if the claim somehow survived that test, it would be impliedly preempted.  Id. at 11.

 

Negligent misrepresentation  

 

The plaintiff offered only the most general allegations of failures to disclose the risks of the implants. The court deemed these allegations to fall far short of Fed. R. Civ. P. 9(b), which requires specificity of fraud allegations.  The plaintiff “never identifies what the misrepresentations were, when they were made, how they were made, where they were made, or who made them.”  Id. at 12. In any event, the misrepresentations seemed to involve what was and was not told to the FDA.  Accordingly, those claims are impliedly preempted under Buckman.  Id. at 13.

 

Negligence per se 

 

Violation of a federal statute does not establish negligence per se if there is no federal private cause of action.  No such federal private cause of action exists here.  The complaint does not state a parallel claim, and is therefore impliedly preempted. Id. at 14.

 

Manufacturing defect 

 

Everything had been gliding along so smoothly up to this point.  Now we hit a rough patch.  The plaintiff alleged deviations from requirements in the device’s PMA, departures from good manufacturing practices, and vague failures to exercise care in the manufacturing process.  The defendant argued that the plaintiff never pointed to any device-specific requirements. It supported its argument by citing Wolicki–Gables (11th Cir. 2011).  The Rowe court agreed that the Wolicki-Gables standard would require dismissal of the complaint.  But recent Eleventh Circuit decisions in Mink and Godelia cut the other way.  “The holdings in Mink and Godelia are directly at odds with Wolicki-Gables and appear to announce a new standard the Eleventh Circuit is directing courts to apply.”  Slip op. at 16-17.  (We listed Mink as the eighth worst DDL case of 2017.  Here is the post where we explained why we think Mink stinks.)  The Rowe court felt stuck.  Under recent rulings, the plaintiff could conceivably state a claim under parallel requirement.  At the same time, the court recognized that the “negligence count is nearly eviscerated by the Court’s ruling on the other theories.”  Id. at 17.  This, just to ensure there really is some there there, the court directed the plaintiff to replead the one surviving claim in an amended complaint. 

 

(This kerfuffle over what to do about competing circuit precedents reminds us of our time clerking on the Ninth Circuit, which is so huge and spread out that, believe it or not, inconsistent holdings proliferate.  What to do?  Assume there was  no en banc decision, which is what it should take to alter circuit precedent.  Does a panel need to follow the earlier or later decisions.  Your instincts might prompt you to conclude that it is always the most recent precedent that controls.  But if the recent decision’s reversal of precedent was improper, maybe even illegitimate, because it did not go the en banc route, should it really command respect?  We wrote a bit on this issue last year, as part of our extended Fosamax mourning period, and argued that the earlier precedent should control and the later deviation deserves no respect.)

 

 

Strict liability – failure to warn 

 

The analysis here is the same as for negligent failure to warn, and so is the result: preempted. Slip op. at 18.

 

Strict liability – manufacturing defect 

 

Remarkably, the result here is different from the negligent manufacturing defect claim.  For some unknown reason, the plaintiff did not ladle any specific federal requirements into this claim. Instead, the plaintiff simply relied on good manufacturing practices.  Not good enough.  Such allegations do not pass muster under either old or new Eleventh Circuit precedent.  Id. at 18.

 

Breach of implied warranty 

 

Plaintiffs constantly toss in warranty claims as an apparent afterthought.  Or maybe it is a no-thought.  The Rowe case is controlled by Florida law, and Florida law requires privity.  That is all perfectly obvious.  Equally obvious is that breast implants are not available for purchase directly by consumers.  The plaintiff pretty much conceded absence of privity and absence of a legal basis for proceeding with this claim, by not responding to the argument.  The court dismissed the warranty claim. 

 

Final scorecard

 

All that is left is the negligent manufacturing defect claim.  That should be a hard one for the plaintiff to win.

 

It occurs to us that good district judges such as Rowe’s are not the only folks who must grit their teeth and do battle with the Eleventh Circuit’s doctrinal wanderings.  Defense DDL practitioners are in the same boat.  We can relate, inasmuch as the Third Circuit (think of Fosamax) has done us few favors lately.  So we commiserate with excellent defense lawyers such as the ones who fought for and won as complete a victory as reasonably possible in the Rowe case.  Congratulations to Dustin Rawlin, Monee Hanna, and Allison Burke of Tucker Ellis, and David Walz of Carlton Fields.

 

 

Happy birthday, Christopher Plummer.   The great Canadian actor turns 88 today, and seems as vibrant as ever.  What a marvelous career Plummer has had.  He is a preeminent Shakespearean actor.  We saw him play Iago to James Earl Jones’s Othello on Broadway 35 years ago.  Of course, most people remember Plummer as Captain Von Trapp in The Sound of Music (1965), a film for which Plummer reserves enormous contempt, referring to it (if at all) as “The Sound of Mucus.” Much more recently, we enjoyed Plummer’s flinty interpretation of Ebenezer Scrooge in The Man Who Invented Christmas.  And there has been abundant publicity over Plummer’s replacement of Kevin Spacey in House of Cards.  It seems a thankless task to succeed someone in such scandalous circumstances.  But we’ll thank Plummer, if only because he supplied a (strained) segue into today’s post, which is about successor liability.

 

More specifically, we have a pro-defense decision on successor liability with respect to a bankrupt medical device manufacturer. The court holds that there is no liability for design and manufacturing claims under either NY or PA law – including PA’s peculiar product line liability theory. The court concludes as a matter of law that product line liability applies only to manufacturers, not to distributors. But there is a fly in the ointment: the court’s conclusion on the failure to warn claim is rather muddled – to the point where that cause of action is not concluded at all.

 

In Deluca v. Portland Orthopaedics Ltd., et al., 2017 U.S. Dist. LEXIS 198962 (E.D.N.Y. Dec. 2, 2017), a husband and wife sued for injuries relating to a failed hip implant. The husband and wife lived in New York. That is where the 2009 implant operation took place. That is also where the injury – the 2012 failure of the implant – took place. The implant was manufactured by Portland, an Australian company that had entered into receivership shortly before the plaintiff’s implant operation and that had sold off its assets before the implant failed three years later. The plaintiffs sued Portland, as well as the Singapore successor company and its manufacturing and distributing affiliates, which were incorporated in Pennsylvania (not something we’d ever recommend doing). The complaint included claims for strict liability (failure to warn, manufacturing defect, and design defect), negligence, and breach of warranty – the usual. Portland never appeared on the case and was dismissed. One presumes it would be judgment-proof. The remaining defendants moved for summary judgment, and their arguments centered around successor liability – or, to be precise, absence of successor liability. The court sensibly held that New York law governs because that is where the injury occurred, but the court also treats us to an analysis under Pennsylvania law, where it arrives at the same destination, albeit via a slightly more complicated route.

 

The successor corporation purchased certain assets of Portland. There was no purchase of stock or any formal merger. Under those circumstances, the successor typically does not acquire prior tort liabilities. That is the law in both New York and Pennsylvania. There are some exceptions to this general rule, but none applies here.

 

New York recognizes four possible exceptions, none of which saved the plaintiffs’ design or manufacturing defect claims:

 

First, the successor did not expressly or impliedly assume prior liabilities. In fact, those liabilities were expressly excluded.

Second, the de facto merger exception does not apply. There was no continuity of ownership, management, or physical locations. In addition, the seller continued to exist, even if only in gossamer form.

Third, the “mere continuation” exception does not apply. Again, the seller lingered, and there was no hint of overlapping owners or managers.

Fourth, there is no evidence that the asset sale was a fraudulent effort to evade liability.

 

Pennsylvania adds another factor – whether the transfer was made without adequate consideration and without provisions for creditors of the selling corporation. That factor also does not apply here. More significantly, or problematically, some Pennsylvania courts have announced a “product line” exception, an extreme pro-plaintiff doctrine left over from the 1980s. The Deluca court is not persuaded that this exception has been endorsed by the Pennsylvania Supreme Court. And remember that the Deluca court has chosen New York law to govern this case. Nevertheless, just in case some appellate court might get dodgy, the Deluca court goes through the motions of measuring the evidence in the case against the product line exception and concludes that it does not help the plaintiffs here. The factors animating the product line exception are pretty fuzzy: (1) whether the purchase of the product line caused the “virtual destruction of the plaintiff’s remedies against the original manufacturer,” (2) does the successor have the ability to assume the original manufacturer’s “risk-spreading role,” and (3) the fairness of requiring the successor to assume responsibility insofar as the successor was enjoying the original manufacturer’s good will.

 

The Deluca court easily dispensed with these factors by pointing to some important facts:

 

  1. Portland’s insolvency preceded the asset sale, and was certainly not caused by it.
  2. The asset sale was not prompted by any scheme to evade product liability claims. At the time of the sale, the problem of implant failures was not on the radar screen.
  3. The purchase agreement explicitly excluded goodwill as well as related liabilities.

 

Further, the Deluca court held that the product line exception could not be used against the defendants who were never involved in manufacturing. Thus, even if someone wanted to shape the gooey product line factors so as to preserve claims against a successor, the distributor defendants would still be off the hook.

 

The plaintiffs requested additional discovery on the successor liability question. The Deluca court refused that request on both procedural and substantive grounds. The procedural problem for the plaintiffs was that they failed to submit a Rule 56(d) affidavit documenting what discovery would be sought and why it wasn’t obtained earlier. The substantive ground was futility. Even from the face of the plaintiff’s’ arguments, it was clear to the court that the request was a mere fishing expedition, with no justification for the delay and no expectation that anything reeled in would make a difference.

 

So far so good for the defense. But the court also kept the failure to warn claim alive, at least for now. New York law recognizes that successor corporations sometimes have an independent duty to warn. That duty arises not from succession of the prior manufacturer’s duties, but from the successors’ relationship with customers. Here, the plaintiffs alleged that a sales representative working for one of the defendants was in a position to provide additional warnings to the treating doctor. We do not know what those warnings would be, and are not sure how they would fit into the chronology of the case. The defendants pointed to the Instructions for Use as containing ample warnings. The Deluca court responded that it is unclear whether the physician received the IFU or whether the warnings were in fact adequate.

 

To our eyes, those questions should not be enough to stave off summary judgment. How could the doctor not have access to the IFU? Is there any suggestion that the defendants did something to make the IFU unavailable? Seems unlikely. How is the adequacy of the warning not an issue of law? And is there any open issue of warning causation? That is, did the plaintiffs proffer any evidence that a different warning – whatever that might be – would have changed the doctor’s mind in such a way as to avoid the alleged injury? On these points, the court’s reasoning is full of holes.  We suspect that the plaintiffs will ultimately be unable to fill those holes with evidence.  Then the defendants will be in a position to borrow a title from the Bard: all’s well that ends well.

 

This post is from the non-Reed Smith side of the blog.

Search for Medtronic on this blog and you’re going to find preemption cases. Lots of preemption cases. Mostly preemption victories for the defense. An overwhelming body of preemption law has been made by Medtronic. They’ve certainly led the charge. So, if we say today’s post is a Medtronic case about a spinal implant, you’re likely thinking more preemption. While that wouldn’t be a bad thing, even here at the DDL blog we can get a little tired of beating the preemption drum (don’t let Bexis know). Everyone once and a while we like to sing a different tune.

After all, if you never flipped over to the B-side, you may have missed some really good music. We’ll now pause to explain B-sides to the iPod generation who may be completely unfamiliar with the old 45-rpm single. The single was meant to showcase an album’s prospective hit on its A-side with an additional song on the B-side. The B-sides were typically throw away tracks. But sometimes, an equally good, and some may argue better, song could be found by flipping the single over. For example, ‘I Am the Walrus’ was on the B-side of the Beatles ‘Hello Goodbye’ (that was a John v. Paul thing). Pearl Jam’s ‘Yellow Ledbetter’ was the B-side of ‘Jeremy’ until radio DJs made it a hit on its own. U2 originally only released ‘The Sweetest Thing’ as the B-side to ‘Where the Streets Have No Name.’ And, perhaps one of the best songs of all time (says this blogger and Sir Paul McCartney) – ‘God Only Knows’ was a B-side. To be fair it was the B-side to the Beach Boys ‘Wouldn’t It Be Nice?’ so isn’t that really like two A-sides?

In the case we’re bringing you today, Medtronic had previously won a motion to dismiss plaintiff’s fraud and consumer protection claims on the grounds of preemption (among other reasons). See our post here.  So, you’ve already heard the A-side.  But following that decision, plaintiff’s design defect and manufacturing defect claims under the Louisiana Products Liability Act (LPLA) remained. So Medtronic moved for summary judgement. As to design defect, plaintiff had to concede that it had no evidence of an alternative design, so that claim was dismissed with prejudice. See Lyles v. Medtronic Sofamor Danek, USA, 2016 U.S. Dist. LEXIS 38550, at *15 (W.D.La. Mar. 23, 2016). On manufacturing defect, plaintiff alleged res ipsa loquitur — welcome to the B-side of this record.  The district court granted summary judgment. See id. at *21-23. Plaintiff appealed. But the Fifth Circuit said the district court got it right.  Like the Stones got it right with ‘You Can’t Always Get What You Want’ on the flip side of ‘Honky Tonk Women’.

Plaintiff had multiple medical device components implanted in his spine to treat his spinal stenosis and cervical cord compression. Lyles v. Medtronic Sofamor Danek, USA, 2017 U.S. App. LEXIS 17534, at *3 (5th Cir. Sept. 11, 2017). X-rays taken within the first day of surgery showed something amiss with one of the implanted plates (experts disagree regarding whether the plate was broken or just misaligned). Id. at *3-4. Plaintiff sought additional treatment and underwent a second surgery, but the plate was not explanted and remains in plaintiff’s spine. Id. at *4-5.

To maintain a manufacturing defect claim under the LPLA, plaintiff has to prove that at the time the medical device left the manufacturer’s control, it materially deviated from its specifications or from other identical products from the same manufacturer. Id. at *9. Plaintiff offered no proof of either the device’s specifications or how the device used in his surgery deviated from those specifications. He relied instead on res ipsa loquitur – arguing that the only reasonable inference that would explain the device breaking was that there was a defect in how it was made. Id. at *10.

The Fifth Circuit does a nice job of explaining both how the doctrine is to be applied sparingly and then discussing those rare situations in which a plaintiff has been allowed and not allowed to use it in the products liability context. See id. at *10-13. In sum, “where there are other potential causes of injury, a plaintiff’s inability to exclude all known potential causes other than a manufacturing defect preclude his reliance on the doctrine.” Id. at *13.

In his opposition to defendant’s motion for summary judgment, plaintiff relied exclusively on two things – the short time between implant and breakage and his expert’s conclusion that he had no other reason for the breakage other than a defect. Id. at *13-15. What plaintiff failed to do was address any of the “multiple potential explanations,” offered by the defendant. Id. at *14. Putting aside for a minute that plaintiff can’t make an argument on appeal that he didn’t make below, his new argument to the Fifth Circuit was that there was no evidence for defendant’s alternative explanations. But plaintiff lost sight of his burden of proof:

[T]o succeed on the theory of res ipsa loquitur, [plaintiff] has the burden of producing evidence excluding other reasonable explanations. Though [plaintiff] argues that there is no evidence for any other cause for the [device’s] breakage, there is no evidence for a manufacturing defect either, which is why he is invoking res ipsa loquitur. The other reasonable explanations for the [device’s] breakage posited by [defendant] are equally as likely as a manufacturing defect. It is [plaintiff] who has the burden to adduce evidence excluding them.

Id. at *15-16. The issue isn’t whether there is evidence to support the other reasonable explanations, but rather what evidence plaintiff has adduced to exclude the other reasonable explanations. Id. at *18.

Further, plaintiff didn’t offer any evidence that any alleged defect existed when the device left the manufacturer’s control. Prior to plaintiff’s surgery, the device was stored at the hospital and any number of people had access to it. Id. at *16-17. The Fifth Circuit concluded that even if the district court had been wrong in not applying res ipsa loquitur, which it wasn’t, plaintiff’s manufacturing defect failed on this ground as well. Id. at *17.

Res ipsa loquitur is definitely a B-side to preemption but don’t overlook the B-sides or you might miss out on a winner.

It’s a fairly well known double standard. If you ask your child why he or she did that rotten, terrible, awful thing and he or she responds “just because” – that’s never good enough. When a parent is faced with the question “why,” however, “because I said so” is a fairly standard, albeit a bit of a crutch, response. If your child happens to have a litigator as a parent, the lesson that “just because” won’t cut it is learned very early. Litigators like to practice their cross-examination skills. Litigator-parents get that opportunity when faced with broken windows, missed curfews, and dented bumpers. DDL Blog litigator-parents not only cross-examine, we TwIqbal (actually seems to work well as a verb). We want supporting facts and they better be sufficient to “nudge” whatever explanation is being offered “across the line from conceivable to plausible.” Ashcroft v. Iqbal, 556 U.S. 662, 680 (2009).

That’s exactly what the judge was looking for in Staub v. Zimmer, Inc., 2017 U.S. Dist. LEXIS 89109 (W.D. Wash. Jun. 9, 2017). Try as he might, however, he couldn’t find it. Plaintiff filed suit in Washington state alleging injury from the implantation of a prosthetic hip. Id. at *1. Following removal to federal court, defendant moved to dismiss.

In Washington, all products liability claims are subsumed under the Washington Product Liability Act (“WPLA”). Id. at *4. The WPLA allows a plaintiff to seek recovery for defective design; failure to warn; defective manufacture; or breach of express or implied warranty. Id. at *4-5. While a plaintiff does not have to specify in the complaint which precise theories he or she is pursuing, the complaint has to “contain sufficient non-conclusory factual allegations to support at least one avenue of relief.” Id. at *5. So, the court combed the Staub complaint to see if it met that basic requirement.

First, the court could find no indication anywhere in the complaint that plaintiff was alleging either failure to warn or breach of warranty. Id. at *5-6. The court was unwilling to read into the complaint claims that plaintiff appears to have failed to assert. As an aside the court pointed out that should plaintiff wish to pursue a failure to warn claim, it may be barred by the learned intermediary doctrine. Id. at *6n3. Perhaps a little foreshadowing?

The WPLA recognizes both the risk utility test and the consumer expectations test as bases for a design defect claim. So plaintiff’s complaint better have support for at least one of these theories. Plaintiff Staub, however, failed to adequately plead either. On risk utility, plaintiff only alleged that the product was “not reasonably safe.” Id. at *7. On consumer expectations, plaintiff only alleged that the device “failed to meet consumer expectations of safety.” Id. at *8. These are the pleading equivalent of “just because.” Parroting back the words of the elements of the claim do not suffice. Nowhere did plaintiff allege how a design element led to his alleged injury, whether there was a feasible alternative design, or how the product didn’t meet expectations. Id. at *7-8.

On his manufacturing claim, plaintiff failed to allege any facts showing that the device at issue deviated in any way from the intended design. Id. at *9. Once again, a bare bones allegation that the product was “defective and unreasonably dangerous” was far from satisfactory. Id. Plaintiff apparently made some attempt to save his manufacturing defect claim by alluding to the fact that the product had been voluntarily recalled. But without any allegations connecting the recall to plaintiff’s alleged injuries, the recall alone offers no support. Id. at *10n5.

Plaintiff is getting a do-over; he has 20 days to file an amended complaint. It’s sort of like, go to your room and when you come back you better having something better than “just because.”

We’ve all had cases where plaintiffs try to use their prescribers and treaters as their experts on everything from failure to warn and causation to design defect and company conduct. Even on the medical aspects of the case, a treater needs to offer more than just an unsupported general conclusion in order to withstand scrutiny under Daubert. But, when a surgeon or an orthopedist, for example, starts to offer opinions on product defects; when he or she has sufficiently wandered away from the parameters of their general expertise; the bar needs to be set even higher. Or, at least the proffered opinion needs to be even more carefully scrutinized. And certainly something more than — gee, I’ve never seen this before – is required.

But – gee, I’ve never seen this before – is all plaintiffs had to offer in Whybark v. Synthes, Inc., 2017 U.S. Dist. LEXIS 67988 (W.D. Ken. May 4, 2017). And that’s why defendants were awarded summary judgment. The case involves a bone screw (a product dear to Bexis and me). Plaintiff had one implanted in his foot to correct an osteoarthritis issue. Id. at *1. Two months after surgery, x-rays revealed that the plaintiff’s bones had not yet fully healed. X-rays taken four months after surgery show the bone still not completely healed and also that the bone screw had fractured. Id.

Kentucky products liability actions are governed by the Kentucky Product Liability Act which allows three potential claims: defective design, defective manufacture, and failure to warn. Id. at *4-5. Plaintiffs abandoned both their design defect and their failure to warn claims. On design defect, the only evidence in the case was that plaintiff’s surgeon testified the product was safe and effective. Id. at *5. Nor did plaintiffs challenge that the package insert contained an adequate warning about the risk of screw fracture. Id. at *6.

Plaintiffs instead decided to place their sole focus on manufacturing defect. The court begins its analysis of the claim by determining that indeed plaintiffs needed expert testimony to support it. Knowledge of the design and manufacture of bone screws is “far outside the realm of common experience” of lay jurors. Id. at *7.   But the only expert proffered by plaintiffs was the implanting surgeon. The surgeon’s only testimony regarding defect was that “he suspected the breakage of the [defendant’s] screw was due to a manufacturing defect because he had never seen a bone screw break after surgery.” Id. at *2. While it’s reassuring to know that the doctor has had such a good track record, that tells us absolutely nothing about whether this particular screw contained a manufacturing defect.

But even before getting to the substance or basis for his opinion, the surgeon’s testimony failed Daubert because he was unqualified on manufacturing issues. The first point was obvious, he had no training, education or experience in manufacturing, metallurgy, or biomedical engineering. Id. at *12. Beyond that though, plaintiff could offer no reason for why the doctor’s clinical experience and personal knowledge of bone screws qualified him to offer an expert opinion on manufacturing defect. Id. The treater/prescriber’s testimony is generally admissible as to care, treatment, prognosis – things he observed, concluded, or formed an opinion on in the course and scope of treatment. Id. This is another reason to challenge a treater/prescriber’s testimony on causation, if not supported by an independent expert report that withstands Daubert. While causation is in the realm of the doctor’s expertise, if it’s not something he opined on during care and treatment, he shouldn’t be allowed to opine on it at trial.

Even though clearly not qualified, the court went on to assess the reliability of plaintiff’s surgeon’s opinion. Here, the doctor failed to state his opinion, such as it was, to a reasonable degree of medical certainty. Id. at *13. That is because he couldn’t. He had done no research. Reviewed no company or manufacturing documents. He could cite no principles to support his conclusion. Id. at *14-15. But, he was well aware that “it is generally accepted in the medical community that bone screws can fracture secondary to fatigue when subject to loads caused by non-union [non-healing].” Id. at *14. So, even though he’d never seen it before, he knew it could happen. As if that wasn’t enough to take the wind from his sails, he also testified that he would “absolutely” defer to a metallurgist on the issue of defect. Id. at *15. As luck would have it, defendants had a metallurgist and he opined that the screw met industry standards and contained no manufacturing defects. Id. at *2.

Finally, plaintiffs attempted to argue res ipsa loquitur – they didn’t need an expert because the circumstantial evidence justified an inference that the screw would not have fractured absent some defect. Id. at *17. But that theory only works if plaintiffs can eliminate “all other reasonable explanations for the accident;” in this case the fracture. But they can’t because plaintiff’s own surgeon and sole expert witness conceded that the non-healing of the bone may have caused the screw to fracture. Id.

This case appears to have been a loser for plaintiffs from the outset. Relying on the treater as a defect expert just sealed its fate. The defense relies on prescribers as learned intermediaries and we don’t go after them unless really forced to. If they step this far outside their expertise, we’re sort of forced to.

Back in October we posted about the Eastern District of Pennsylvania decision McLaughlin v. Bayer Corp, 2016 U.S. Dist. LEXIS 37516 (EDPA Mar. 22, 2016) saying that while we liked the ultimate result – tossing out most of plaintiffs’ claims – some pieces of the decision weren’t as strong as we would have liked. Well, McLaughlin’s back and it’s still not a slam dunk, but plaintiffs’ don’t have too much left of their cases either.

As a reminder, this is actually a decision in 5 cases each alleging injury from plaintiffs’ use of a Class III, PMA contraceptive device, Essure. McLaughlin v. Bayer Corp., 2017 WL 697047, at *1 (E.D.Pa. Feb. 21, 2017). Several of plaintiffs’ original causes of action were dismissed with prejudice, but they were given an opportunity to amend to try to salvage their claims for negligent training, negligent risk management, breach of express warranty, fraudulent misrepresentation, and negligent manufacture. Negligent misrepresentation and failure to warn premised on failure to report survived the first motion to dismiss.

The decision methodically goes through each cause of action.

Negligent Training: In its first decision, the court opined it was possible to state a parallel claim for negligent training, but since plaintiffs failed to specify how defendant’s training deviated from federal training requirements or how those deviations caused plaintiffs injuries, the claim had to be dismissed as insufficiently pled. Id. at *3. In the amended complaint, plaintiffs alleged 6 such failures by defendant. As to 3, the court couldn’t find any federal directive that required defendant to do what plaintiffs alleged it failed to do. So, as to those 3 allegations, the claim was dismissed as expressly preempted. Id. at *4-5. As to the remaining 3 alleged violations, defendant challenged them on causation grounds but was unsuccessful. The court found the complaint sufficiently alleged that because defendant failed to properly train the doctors, the doctors in turn did not properly place the device causing it to migrate and cause plaintiffs’ injuries. Id. at *5. The complaint, however, lacked any specific allegations about the actual doctors who performed plaintiffs’ surgeries. The court didn’t find that fatal at the pleadings stage – that was for discovery. Id. at *6. But if you look at what the 3 bases for the failure train claim are, they appear to all be things plaintiffs could have asked their doctors about before filing these lawsuits. Did the doctor successfully complete 5 preceptorings? Did the doctor read and understand the training manual? Did the doctor successfully complete the simulator training? If the answers to those 3 questions are yes in each case – this claim is over.

Continue Reading PMA Preemption Revisited in Pennsylvania