A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity.  That post sprang from an argument before the JPML, but we can riff on it today as we examine a short and lovely decision from the Northern District of New York.  We have all suffered through opinions in which judges (or their clerks) painstakingly flog possible outcomes, arguments, and counter-arguments before finally reaching their decisions. And as (once again) McConnell recently pointed out, the result has been some spectacularly bad preemption decisions.  But Olmstead v. Bayer Corp., 2017 WL 3498696 (N.D.N.Y. Aug. 15, 2017), arising in the relatively clear jurisprudence surrounding so-called “PMA preemption,” was what we fondly call a “slam-dunk,” and the court treated it accordingly.

In Olmstead, the plaintiff was implanted with an Essure device, an implantable birth control device manufactured by the defendant.  She alleged that, after she was implanted with the device, she experienced months of pain, fatigue, and excessive bleeding culminating in a hospital visit for an episode of severe abdominal pain.  Though an initial ultrasound appeared normal, a subsequent ultrasound allegedly revealed that “one of the coils of the Essure was sticking out of the uterus by about one inch.” Olmstead, 2017 WL 3498696 at *2 (internal punctuation and citation omitted).  The plaintiff sued in state court, asserting claims for negligent misrepresentation, strict liability, failure to warn, and breaches of express and implied warranties.   The defendants removed the case to federal court and moved to dismiss it, arguing that the plaintiff’s claims were preempted by the Medical Device Act (“MDA”).

As the court explained (and as we have discussed in these pages many times before (like here, also in the context of Essure litigation), Class III medical devices like Essure must undergo FDA’s “rigorous” premarket approval (“PMA”) process before they can be marketed to the public. Id. at *1.  Under the MDA, once a Class III device obtains PMA, the manufacturer may not make changes to the device’s design, specifications, or labeling without FDA permission.

The MDA also includes an express preemption clause. Under this clause, as construed by the Supreme Court in Riegel v. Medtronic, 522 U.S. 312 (2008), state laws that impose obligations that are different from or in addition to the requirements of the MDA are expressly preempted. Id. at *3 (citations omitted).  A common-law claim challenging the safety of an FDA-approved medical device survives only if it alleges a parallel violation of federal law for which state law provides a damages remedy.  Id. (citations omitted).

As such, the Olmstead court explained, the plaintiff’s “onerous task” first required her “to identify a parallel federal law upon which she [had] based her state law claims.” Id. at *4.   In response, the plaintiff cited the Current Good Manufacturing Processes (“CGMPs”) described in 21 CFR § 820.1 et seq..  But she failed to explain how the defendants had violated the CGMPs, which, in any event, were intended “to serve only as an umbrella quality system providing general objectives medical device manufacturers must seek to achieve.” Id. (internal punctuation and citations omitted).  The court emphasized, “Since these regulations are open to a particular manufacturer’s interpretation, . . . allowing a suit to continue on the basis of the CGMPs would necessarily impose standards that are ‘different from, or in addition to’ those imposed by the MDA – precisely the result that the MDA provision seeks to prevent.”  Id. (internal punctuation and citations omitted).

Thus, the court held, because the plaintiff had “failed to identify a single parallel federal statute or regulation related to any of her claims,” the MDA expressly preempted the suit as a matter of law. Id. The court commented that it ordinarily would have allowed the plaintiff to amend her complaint to “attempt to allege a plausible claim that [was] not preempted.” Id. But, in yet another layer of certainty, the court held that New York’s three-year statute of limitations barred the plaintiff’s claims.

Nothing but net. And we are told that this is the twenty-fourth time that an Essure suit has been dismissed or narrowed on preemption grounds.  Short, sweet, and correct – hard to beat that.  We will keep you posted on further developments.

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

We post a lot about preemption. We post a lot about PMA preemption. That’s because thanks to Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) and Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), almost all claims brought against pre-market approved medical devices are either expressly or impliedly preempted. What remains is a “narrow gap” through which a PMA medical device claim must fit in order to withstand a preemption challenge. And as demonstrated by our Device Preemption Scorecard which now has 336 entries – the gap just keeps getting narrower.

There are still a few claims that continue to squeeze by as “parallel violation” claims – misrepresentation claims come to mind – but they tend to fail on pleadings grounds and/or tend to be the more difficult of the claims to prove (with elements like reliance often being the sticking point). And a few courts have allowed some claims to slip through that we think should have crashed on the shoals. One word, Stengel. Even these, however, remain in the minority.

But all of this defense-friendly case law hasn’t stopped plaintiffs from still trying to thread the needle. We’ve seen some creative pleading in recent years and PMA complaints have become more upfront with allegations of alleged parallel violations. Fortunately most courts haven’t been persuaded by the use of “magic words” to create a parallel claim. It’s not enough to say the claim violates federal law. If we are talking about a duck, you better show that what you have looks like a duck, swims like a duck, and quacks like a duck. Otherwise, it’s no duck. It’s a preempted claim. Plaintiffs in Gates v. Medtronic, Inc., slip op., No. 1:15-cv-00726-RP (W.D. Tex. Jun. 29, 2016) didn’t have a duck.

Continue Reading Post-Recall Negligence Claims Preempted

For the second time in a week we are considering a former professor at our law school, though this occasion swims in sorrow. Before he became a Justice on the Supreme Court, before he became a Judge on the DC Circuit, Antonin Scalia taught at the University of Chicago Law School. Many of the eulogies we are hearing this week highlight things about Scalia that remind us of how well he fit in with that remarkable faculty: the relentless intellectual jousting, where arguments but not the arguers were skewered. There must not have been much lounging in a faculty lounge with Scalia, Posner, Epstein, Easterbrook, Sunstein, Stone, et al. (We cannot overstate our disappointment at reading Epstein’s complaint that when Barack Obama taught at the law school the future president displayed little enthusiasm for the robust intramural debates taking place all around him).

When the pundits discuss Scalia’s legacy, they usually emphasize his decisions on guns or flag-burning, or his sharp dissents in cases  involving the death penalty or gay rights. Not all of those opinions were to our liking.  But defense drug and device law nerds will always have a soft spot in our hearts for Justice Scalia’s opinion in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), where he held that most tort claims against PMA devices are expressly preempted by a federal statute. The decision is logical. The writing is clear. (It is not surprising that Scalia has co-authored books with Bryan Garner that urge lawyers to be more direct, concrete, and muscular in their writing.)

Let’s honor Scalia in a way he would have liked – by saluting his logic and his prose in the Riegel decision. But let’s first offer a prologue by way of considering Scalia’s concurrence/dissent in the Cipollone (1992) case. That case was about preemption of tort claims against cigarette manufacturers. The court’s opinion was authored by Justice Stevens and was a Brunswick stew.  Some of it made sense and some of it was squirrelly.  As with so many Stevens decisions, things that at first blush seem relatively sensible become muddy once you wrestle with the real-life consequences down the road. Stevens held some things preempted and some things not, but good luck figuring that out once you’re down to actual cases. By contrast, Scalia’s opinion in Cipollone is crisp and intelligible. One thing he was especially crisp on was the silliness of the presumption against preemption. As Scalia reasoned, the issue is what was the Congressional intent, as manifested by the plain words of the statute. There is no need to indulge in any presumption in making out that intent. Moreover, a presumption against application of a doctrine that can arise in the absence of any Congressional pronouncement whatsoever, such as conflict preemption, makes no sense.

Continue Reading Remembering Scalia, Remembering Riegel

Today is National Grammar Day. Before anyone of our posts goes online, it dashes thorough a gauntlet of reviewers.  Those reviewers collectively possess just the right amount of neurotic fastidiousness to ensure that what emerges is mostly correct and at least intermittently coherent.  Some of us pretend to actually know Strunk & White by heart.  Still, errors occasionally evade the dragnet of dorks. In honor of National Grammar Day, we have festooned today’s post with enough errors to keep all of you grammar cops busy.  We do this as a matter of principal.

But there are no errors in the case under review.  We have a rare favorable medical device decision out of the Seventh Circuit. The case is called Kallal v. Ciba Vision Corporation Inc., 2015 U.S. App. LEXIS 2987 (7th Cir. Feb. 24, 2015).  Mind you, the Seventh Circuit is one court we think the world of. Any court that is home to legal luminaries like Posner, Easterbrook, Wood, et al. must be fairy formidable.  But the Seventh Circuit is also home to the hideous Bausch precedent.  Perhaps you remember Bausch.  Its hard to forget.  The Seventh Circuit permitted a plaintiff to vaguely state a parallel claim which lacked substance under both federal and state law.  TwIqbal pleading requirements impacted the case not at all.  Irregardless of the Supreme Court’s instruction that lame cases should be dismissed before subjecting defendants’ to expensive discovery, the Bausch court elevated the plaintiff’s desire for discovery into something sacramental.

But Kallal is much better than that is. The plaintiff claimed that defective contact lenses had hurt his eyes.  The plaintiff did not have alot of evidence. The company had recalled some of it’s contact lenses.  Courageously (after Bausch) the district court held that the plaintiff’s claims were preempted nonetheless, and that the parallel claim could not save the case.  The plaintiff argued that his suite fit inside of the Riegel exception because the company failed to list ion permeability as a “material characteristic” in its premarket approval list.  The company responded that the FDA did not require them to meet any ion permeability threshold.  The plaintiff did not offer any evidence to the contrary.  In any jurisdiction but Bausch-land, that argument would win the preemption day for the defendant.  And mirabile dictum, it managed to win for the defendant in Kallal.  At least at the lower court’s level.

Continue Reading An Error-free Seventh Circuit Medical Device Case

New Hampshire has always marched to its own flinty tune. It was the first colony to establish a government independent of British authority.  It holds the first presidential primary every four years, insisting that candidates visit waffle shops and bloviate to the amused Yankee locals. You’ve probably seen New Hampshire license plates with the “Live Free or Die” motto.  That motto supplied the title for episodes of both The Sopranos and Breaking Bad.  What other state can make that boast?  And what other state with such a small population can list among its offspring such eloquent luminaries as “Go West Young Man” editor Horace Greeley, “Liberty and Union, now and forever, one and inseparable” Senator Daniel Webster, “And miles to go before I sleep”  poet Robert Frost, and we-can’t-think-of-a-quote President Franklin Pierce?

New Hampshire has played a significant role in American legal history.  Daniel Webster won a case against the Devil.  One of the early major U.S. Supreme Court cases involved Dartmouth College.  We cannot remember what the case was about, though we think it had something to do with Delta House being put on double secret probation.  The Bartlett v Mutual product liability case gave rise to some awful rulings in the New Hampshire federal court before the Supreme Court set things right in what might be our favorite case of the last five years.

In today’s case, Murray  v. Hogan, #226-2013-CV-00600 (New Hampshire App. Ct. Feb. 2, 2015), a New Hampshire court addresses Riegel preemption, as well as the dreaded parallel claim exception.   As far as we can tell, it is the first such decision from the Granite State. (We gratefully tip our cyber cap to David Ferrara at Nutter McClennen for sending the case our way.)  The plaintiffs in Murray brought negligence and products liability claims claiming injuries from a knee replacement gone wrong.  The plaintiffs sued several defendants, including the manufacturer of the artificial knee, as well as the sale rep who was in the operating room and assisted in preparing the artificial knee for insertion.  The artificial knee was a class III medical device, so it comes as no shock that the company moved for summary judgment against all of the plaintiffs’ claims as being preempted by federal law.  Even less of a surprise, the plaintiffs disagreed, arguing that federal preemption does not apply because: (1) the artificial knee did not meet federal regulations, (2) the plaintiffs would like to have some discovery, please, and (3) the company is vicariously liable for the conduct of the sales rep.

Continue Reading New Hampshire Applies Riegel Preemption

This is the time of year when our thoughts start migrating southward.  We can see all those birds’ nests in our suddenly denuded poplar trees.  The driveway is a skating rink of damp leaves.  The baseboards in our home now gurgle from the operation of an ancient oil heating system.

Over the last two weeks our posts leaned against a pair of intemperate blasts from a Vermont federal court.  The results were dreary and/or indecipherable.  Thus, it is with some relief that we bask in the warm glow of a nice, straightforward decision from the happiest place on Earth, the federal court in Orlando.  In Stanifer v. Corin USA Ltd, Inc., 2014 U.S. Dist. LEXIS 158587 (M.D. Fla. Nov. 10, 2014), a hip resurfacing system was implanted into the body of the plaintiff during a right hip arthroplasty procedure.  Subsequent failure of the system allegedly caused the plaintiff to suffer a revision left total hip arthroplasty and surgical removal of the system.  The plaintiff filed a lawsuit in state court seeking to recover “damages and losses” from the defendants based on state law strict liability claims for breach of warranty, manufacturing defect,  and design defect.  After removal of the action to federal court, the defendants moved to dismiss the claims based on federal preemption.

The hip system was a class III device, and therefore subject to the PMA process and the attendant federal preemption.  After the Supreme Court’s decision in Reigel, a plaintiff injured due to use of a Class III PMA device can escape preemption only by asserting a “parallel” state law claim.   As readers of this blog likely know, we think of the parallel claim exception as something crazy and made-up, like a fairy tale or a Johnny Depp movie.  Luckily, the Stanifer case is governed by the law of the Eleventh Circuit, a place that knows how to deal with such things. The Stanifer court embraced Eleventh Circuit precedent to the effect that plaintiffs cannot effectively state a “parallel claim” absent allegations that the defendant violated a “particular federal specification.”  Ah – we are far from the windy incoherence of Vermont (or Chicago – the Bausch case still stands as the babbling zenith of parallel claim doofus-prudence).

Continue Reading Far from Dumbo: M.D. Fla. Gets “Parallel Claim” Case Right

Time travel is on our mind today.  We should hasten to add that it is not a topic that usually absorbs us – otherwise we might squander what little credibility we have with our serious-minded readers. But a trio of things prompted us to think about time-travel.  First, we will (soon, we promise) be discussing a nice TwIqbal case that came out more than a year ago and somehow managed to evade our DDL radar screen.  Second and third are a couple of things we heard from a couple of clients.  In one instance, in a litigation even more far-fetched and meritless than usual, with no science or logic to support the plaintiffs’ allegations, we commiserated with a company executive over a bushel of stupid emails written by low-level employees who stated opinions contrary to those of the company or anybody in it with knowledge or authority.  Still, those self-indulgent emails propped up the litigation and the possibility of settlement-extortion.  The executive wished he could climb into a time machine and smack four or five employees on their noggins before they authored the offending emails.  The litigation would disappear.  It would be like the fading photos in Back to the Future.  But talk about self-indulgent; it’s not as if the time machine idea helps us put together a litigation plan.  Plus, the time machine scenario has very little traction with judges and juries.

We also heard something from an in-house lawyer that made us think of time travel.  This in-house lawyer is someone who, as far as we can tell, is pretty much always the smartest person in the room and who has unerring judgment on all things legal, political, and aesthetic.  So when he told us that we ought to take a peek at the 2013 film About Time, we headed for our local Redbox to rent the movie.  As always, his recommendation was right on.  About Time did just so-so with the critics and the audience, and its marketing message was almost completely confined to the fact that it was directed by the same guy who directed Love, Actually.  But it is good, actually.  It is a funny and clever film about a family where the men, and only the men, have the capacity to travel backwards in time to times and places they actually were in their lifetimes.  (Thus: no ability to park a bullet in Hitler’s head, or to stay the hand of George Eliot and stop her from writing those boring books inflicted on generations of hapless high school students.)  As in Groundhog Day, the hero uses the great power of time travel to get a girl.  Maybe there really is no higher use for time travel.  As in The Butterfly Effect, there are unforeseen and unfortunate consequences to time-travel.  Bill Nighy, who is incapable of looking or sounding uninteresting, is in it (just as he was in Love, Actually).  Unlike most films, you won’t rue devoting two hours to watching it, muttering that you’ll never get that time back.   When we think of the best all-time time-travel movies, we must now include About Time, along with the aforementioned Back to the Future and Groundhog Day, as well as The Terminator, Time After Time, Bill and Ted’s Excellent Adventure, Twelve Monkeys, and the 28 minute French film that inspired Twelve Monkeys, La Jette.

And now on to our little time-capsule case, Swisher v. Stryker Corp., 2013 U.S. Dist. LEXIS 185998 (W.D. Okla. March 14, 2013). The plaintiff claimed injury from a hip implant.  He asserted a negligence per se claim, alleging that he sustained a cascade of health problems requiring additional surgeries, all proximately caused by the defendants’ violation of various regulations promulgated by the FDA.  The plaintiff was trying to avail himself of the “parallel claim”  exception to Riegel preemption.  The defendant filed a motion to dismiss under Rule 12(b)(6), arguing that the complaint was bereft of facts demonstrating how specific FDA regulations were violated and how such violations caused the injuries.

The court agreed with the defendant, applied TwIqbal, and dismissed the case.  The court reasoned that “more is required to make out a parallel claim than conclusory statements that a defendant violated multiple regulations.”  Swisher, 2013 U.S. Dist. LEXIS 185998 at *7. Actually, this plaintiff offered more than most parallel-claiming plaintiffs offer, but it was still not enough.  The plaintiff alleged that he was diagnosed with abnormally high levels of chromium and cobalt in his bloodstream, that the cup and cap components of the hip implant system were made of those two alloys, that microscopic metallic particles rubbed off from the metal surfaces of the cap and cup components, and that such rubbing off resulted from the defendants’ violation of PMA specifications and applicable Good Manufacturing Practices (GMPs).

The court held that the allusion to PMA specs and GMPs was “too conclusory to state a claim.” Id. at *8.  The complaint did not specify the manufacturing defect, nor did 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 did it state how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.  In other words, the plaintiff supplied incantations, not facts.

Swisher is an important case because, as the court acknowledges, different courts sit on different points along the spectrum as to how many facts are needed to state a parallel claim.  Swisher is at the more rigorous end of the spectrum, so we like it just fine.  Going back in time to retrieve the Swisher case will not help us attain romantic love, save the life of civilization’s savior, or even permit us to put on a school presentation where Abe Lincoln tells us to “party on, dudes,” but it is another piece of ammo that helps us terminate parallel claim cases.

We like Riegel preemption because the oscillations of state tort juries should not supplant FDA regulation of medical devices. We like Twombly and Iqbal because plaintiffs should plead sensible facts before turning on the million dollar discovery machine. We do not much like the parallel claim exception to Riegel because its origin is muddy, its application messy, and its effect nasty. We really do not like courts that fail to apply TwIqbal rigorously, because they are lazy and they treat litigation as an expensive game that necessarily culminates in settlement, however bereft of merit the case might be. Accordingly, we have often expressed our ardent dislike for the Seventh Circuit’s Bausch opinion, because it makes the parallel claim exception available to almost any plaintiff willing to insert the words “violation of FDA regulation” somewhere in the complaint, no matter how vague, empty, or nonsensical.  And just as accordingly, we like any case that rejects Bausch or interprets it in a way that cabins its ruinous consequences. That is to say, we very much like the recent case of Smith v. St. Jude Medical et al., 2013 U.S. Distr. LEXIS 3622 (D. MD. March 14, 1013). But we do not like the facts of Smith much, because we have reached that stage of life where nothing upsets us so much as sad things happening to children. The facts of Smith are sad indeed.
The plaintiffs sued St. Jude and Lifewatch Services, Inc. after their three-year old daughter died of heart failure.  Here are the plaintiffs’ allegations:
  • In late 2005, doctors implanted a St. Judge pacemaker in a baby girl. Because of the girl’s condition, the ventricular threshold for the pacemaker was higher than normal.  That increased threshold meant that the expected battery life of the pacemaker was halved  from four years down to two years. In late 2007, the doctor told the plaintiffs that the pacemaker would signal when the battery had reached a level of depletion and required replacing. The doctor assured the parents that once the signal occurred, there still would be plenty of battery life remaining to allow for replacement of the pacemaker without any danger. 
  • In November of 2008, the doctor told the plaintiffs that the pacemaker battery had a remaining useful life of about nine months. He also ordered monthly telephone interrogation of the pacemaker by Lifewatch, another defendant in the case.
  • During a medical appointment on May 11, 1009, the doctor predicted that the battery replacement likely would occur in September. When the plaintiffs arrived home from this appointment, they received an urgent message from the doctor. He explained that he had forwarded the latest interrogation results to a St. Jude company representative. Based upon that conversation, the doctor now believed that the remaining battery life on the pacemaker was much shorter than he had thought. The doctor requested to see the girl in early June to schedule an elective battery replacement.
  • Sadly, on May 27, 2009, the girl died following a cardiac incident. The plaintiffs pacemaker stopped working due to a dead battery.

We are about to get to the legal stuff, but it is hard not to linger on those facts for a bit, and grieve for the extinction of a young life and the despair of those parents.
The plaintiffs’ lawsuit contained several legal theories.  The plaintiffs claimed that St. Jude and Lifewatch acted negligently.  They also asserted claims for breach of warranty and misrepresentation against St. Jude. The court ultimately granted St. Jude’s motion to dismiss after applying TwIqbal pleading standards and federal preemption. The court concluded that the plaintiff’s claims for negligent manufacturing and implied warranty “appear to lie squarely within the scope of claims found to be preempted in Riegel.” Smith, 2013 U.S. Dist. LEXIS 36227 at *9.  In an effort to evade federal preemption, the plaintiffs’ argued that they had established a parallel violation of federal regulations. The problem is that the complaint only hinted at such a violation in the vaguest terms.  There was no specific allegation of a violation of FDA regulations in the complaint, other than a conclusory allegation that the pacemaker did not meet “FDA standards for reserve battery capacity.” Id. at *10.  The complaint did not indicate what, if any, “FDA standards for reserve battery capacity” were in place. Id.  Moreover, the plaintiffs alleged “no deviation from the prescribed PMA manufacturing process that would explain the alleged failure to meet the FDA standards.”  Id.  Instead, Without any factual allegations in support, the plaintiffs allege “that the Defendant St. Jude had a duty that required the sales and servicing support technicians….to advise Dr. Salim that the St. Jude model 5380 had a history of premature battery failure.” The complaint is devoid of factual allegations supporting any such history. There is no allegation that the manufacturing of the pacemaker deviated in any way from the process approved by the FDA, other than the conclusory allegation that St. Jude negligently failed “to manufacture a pacemaker that met FDA specifications for reserve battery capacity.” The fact that the St. Jude pacemaker allegedly failed does not itself establish a deviation from the FDA-approved standards.
Not surprisingly, the plaintiffs’ lawyer sought refuge in Bausch, which is the appellate case that permitted the vaguest, most conclusory allegations to set up a parallel violation.  But the Smith court distinguished Bausch, characterizing Bausch in such a way as to make it sound almost reasonable:  “In Bausch, however, the plaintiff did not simply rely on conclusory allegations of a failure to comply with FDA requirements, but was able to cite to an FDA investigation into the approved device, an FDA product recall and a warning letter bearing a causal relationship to plaintiff’s alleged injuries, and to a factual statement by the FDA suggesting that the device in question had not been manufactured in accordance with regulatory standards.” Id. at *13. 
The plaintiffs’ other claims against St. Jude fared no better.  The plaintiffs contended that St. Jude was liable for breach of express warranty and negligent misrepresentation arising out of information allegedly provided by a St. Jude representative to the doctor. But TwIqbal again compelled dismissal because the complaint did not include any “specific allegations regarding the content of what St. Jude may have communicated to the doctor.”  Id. at *14.  The complaint merely alleged that St. Jude gave express and implied warranties that the pacemaker battery had several months of battery capacity left sufficient to allow replacement on an elective basis sometime after June 2, 2009.  That allegation is insufficient for several reasons.  To the extent the plaintiffs were complaining of communications between St. Jude and the doctor, the “learned intermediary” doctrine barred the claim. To the extent the plaintiffs alleged that the doctor “was acting as St. Jude’s agent in conveying information to them, they provide no factual allegations to support any agent/principal relationship.” Id. at *16.  Moreover, it “is implausible to suggest that a product manufacturer would ask a doctor to serve as its agent in communicating with that doctor’s own patients, where the law requires no such direct communication.”  Id.  In any event, “even assuming the St. Jude representative gave the doctor an estimate regarding battery capacity, the fact that an FDA-approved battery allegedly failed does not nothing to establish that St. Jude deviated from FDA-approved standards.”  Id. at *17.  Further, St. Jude’s alleged representations to the doctor happened almost four years after implantation of the device. Such representations “could not, therefore, have been part of the ‘basis of the bargain,’ and no express warranty claim is viable.” Id. at *18.  Finally, the plaintiff’s complaint suggested that St. Jude had a duty to provide ongoing follow-up medical care and treatment to the baby girl. But, as in many states, Maryland imposes special requirement on medical malpractice claims.  The plaintiffs defined St. Jude not as a “health care provider,” but as a “health care medical products manufacturing, sales, service, and consulting institution.” The plaintiffs did not adequately allege “facts to support any duty owed by St. Jude, a products manufacturer, to provide ongoing medical care.”  Id. at *19.
We have often heard that hard cases make bad law.  Sometimes a sad case can make good law.

Although trial court judges mostly get things right, every once in a while a trial court judge will issue an opinion that just plain stinks. We aren’t simply talking about any old decision in favor of a plaintiff suing a drug or device company. We recognize that some trial court decisions against our clients are legitimate matters of disagreement or, worse, compelled by precedent. The descriptive term “stinks” is a legal term of art meaning that the trial court has thumbed its nose at the decisions of higher courts. We discussed a prior example of this phenomenon here.

Another example of real stinker of a decision is Hofts v. Howmedica Osteonics Corp., 597 F. Supp. 2d 830 (S.D. Ind. 2009). We named Hofts one of the worst prescription drug/device decisions of 2009, and we ranted about it here. Hofts skunked two Supreme Court decisions at once: it refused to dismiss claims that were clearly preempted under Riegel v. Medtronic and lacked the specific facts required by Twombly.

In a properly functioning marketplace of ideas, when a judge puts a stinker of a decision like Hofts out in market, the other judges will turn up their noses and not buy it, and that is exactly what has happened to Hofts. See Ilarraza v. Medtronic, Inc., ___ F. Supp.2d ___, 2009 WL 5245630, at *7 (E.D.N.Y. Dec. 28, 2009); Funk v. Stryker Corp., 673 F. Supp.2d 522, 528-29 (S.D. Tex. 2009); Horowitz v. Stryker Corp., 613 F. Supp.2d 271, 283 n.5, 284 n.6 (E.D.N.Y. 2009); Covert v. Stryker Corp., 2009 WL 2424559 at *13 (M.D.N.C. Aug. 5, 2009); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 2009 WL 1361313, at *3 (D. Minn. May 12, 2009) (all criticizing or disagreeing with Hofts).

The latest example is Anthony v. Stryker Corp., 2010 U.S. Dist. LEXIS 31031 (N.D. Ohio March 31, 2010). Anthony is a fairly typical post-Riegel device claim. Anthony had his hip replaced with a hip prosthesis called the “Trident System,” but the Trident System allegedly caused him pain and had to be removed. He sued Stryker, claiming that the Trident System was defective, unsafe, etc. To get around Riegel, which held that state law cannot impose requirements different from or in addition to federal requirements, Anthony inartfully tried to assert a parallel violations claim, that is, a claim that his hip was made in violation of federal requirements. His complaint alleged that Stryker deviated from “manufacturing performance standards.” When Stryker moved to dismiss, his response to the motion referred to FDA warning letters issued to Stryker for certain violations at its facilities, including practices not in conformity with Current Good Manufacturing Practice requirements of the FDA.

The court was not persuaded because those violations were not connected to his allegedly defective hip implant. The court first pointed out that Anthony had not mentioned the FDA or its regulations (or, presumably, the violation letters) in his complaint. But since that defect could be remedied by amending the complaint, the court went on to the heart of the matter: “Anthony also did not plead any facts that would lead this court to plausibly infer that Stryker’s noncompliance with FDA regulations led to his injury.” Id. at *10. The warning letters did not help Anthony because he did not allege that his injuries were caused by the violations specified in the warning letters. Id. at *12. In a nice turn of phrase, the court concluded: “Without more detailed factual allegations, Anthony’s complaint does not cross the critical threshold that distinguishes the speculative from the plausible.” Id.

Anthony tried to salvage his claim by urging the court to follow the analysis in Hofts. Perhaps at any earlier point in the life of this decision as precedent, that suggestion would have required a careful review of the reasoning in Hofts to show why it was wrong. By now, however, other judges had reviewed Hofts and said that it stinks, and the Anthony court could simply rely on their unfavorable reviews: “the cases relied upon in this court’s opinion are found to be more persuasive than the Hofts analysis with regards to the pleading standards in Twombly.” Id. at *13 (citation and quotation marks omitted). The court found that Anthony’s claims were preempted and dismissed the complaint with prejudice.

And that is the life cycle of a bad trial court decision. It first draws rants from people like us and favorable notices from the plaintiffs’ bar, which tries to use it. The decision then enters the marketplace as precedent, and other judges test it and write thorough negative reviews. These reviews make the odor readily apparent to other judges, who won’t even go near it and turn up their noses in a sentence or two. Eventually, the stench will become so bad that even plaintiffs’ lawyers will shy away from it (anybody remember “enterprise liability”?). We hope that will happen soon to Hofts.

Professor Ben Zipursky (Fordham) just published a guest post over at Torts Prof Blog ruminating about why the Supreme Court found preemption in the context of medical devices that had undergone premarket approval in Riegel v. Medtronic, but did not find preemption in the context of prescription drugs on the facts of Wyeth v. Levine. That’s an interesting post, and we commend it to you.

We have a couple of reactions to the post, one general and one specific.

First, the general: As you know, we’re big believers in preemption at this blog, and we think the Supreme Court should have found preemption in both Riegel and Levine. And we’re still optimistic that courts will find preemption in the context of drugs that have regulatory histories more compelling than the Phenergan involved in Levine.


But, in the spirit of conversation, let’s think for a minute about whether Congress could reasonably have wanted to create a world in which preemption existed for certain medical devices, but not for drugs. We think it could have, for three reasons.

The first reason is historical accident. States were not regulating drugs very much in 1962, when Congress revamped the drug laws. But by 1976 that had changed, and states were regulating medical devices at the time Congress revamped the device laws – most notably California, which in 1970 enacted a law requiring its own premarket approval of medical devices. The Medical Device Amendments followed close on the heels of the Dalkon Shield controversy, which prompted states to act. With state regulation in the offing, Congress could reasonably have focused on the need for preemption in 1976 in a way that never occurred to it in 1962. This is particularly true with the most cutting edge, and highest risk/highest benefit devices, which after 1976 has to be premarket approved – the type of device at issue in Riegel. Had this been on Congress’ radar screen in 1962, it might have done the same thing with PMA drugs.

The second reason for Congress to have distinguished between drugs and devices is grounded in policy. Historically, drug companies have been large. Bringing a new drug to market can take ten years and cost a billion dollars; drug companies have to be big. But historically, device companies were smaller. An orthopedic surgeon could step out into his garage, gin up a valuable implant with the tools he had on hand, and then start a small device company. These smaller companies have fewer resources to withstand the double jeopardy of first running the gauntlet of the FDA’s approval maze, and then being second-guessed under the disparate laws of the 50 states. Don’t get us wrong – we think such double jeopardy shouldn’t be tolerated in either case, but we’re not Congress. Perhaps Congress thought that large drug companies did not need the protection of preemption as much as small device companies did. In fact, the Senate said as much back in 1976, mentioning that its consideration was informed by the importance of the small innovative manufacturer in the invention and development of new medical devices.

The third reason is also grounded in policy. The useful life of a drug can be very long. Penicillin was discovered decades ago, but still serves a purpose, and thus is regularly prescribed. And, back in 1962, before Hatch-Waxman, drugs received patent protection for a long time, so drug companies could sell drugs profitably for many years. The useful lives of medical devices are frequently much shorter. It would be uncommon for a medical device invented today to remain state-of-the-art a decade from now. Perhaps Congress thought that drug companies, which could earn profits on their products for a long time, needed the protection of preemption less than device companies, whose products are not profitable for as long.

That’s our general reaction to Zipursky; here’s the specific.

We don’t think that the difference between Levine and Riegel can be explained by calling Levine a “warning” case and Riegel a “design” case. For one thing, Levine did not say anywhere that design defect claims involving prescription drugs would be preempted. And we’re not as confident as Prof. Zipursky that Levine should be considered a true “warning” case. After all, plaintiff never did offer an alternative warning in Levine and argued primarily that the drug should not have been used at all for that particular indication. 129 S. Ct. at 1194. Nor did Riegel hold that warning claims involving PMA medical devices escaped preemption – quite the contrary. Riegel specifically held warning claims were preempted. 128 S. Ct. at 1011 (“the MDA would pre-empt a jury determination that the FDA-approved labeling for a [device] violated a state common-law requirement for additional warnings”).Having litigated a lot of device cases in our lives, we don’t agree with Prof. Zipurski that “most” device cases involve design defects. Certainly more do than in the drug area, since it’s hard to conceptualize how in most drug cases one would change the “design” of a product and still have the same drug. But let’s face it, design defect cases are hard – in most places a plaintiff has to have an alternative design that arguably works better, or at least more safely. That’s expensive evidence to obtain, if it can be done at all. Warning claims are much easier to bring, since it’s easy and cheap to second-guess a label. Thus, even in the device area, we’d say that there are still substantially more warning than design defect cases.As litigators, we tend to take what courts say at face value. Since Levine and Riegel don ‘t purport to draw distinctions between warning and design claims, we’re not prepared to read in such a distinction. But if we were inclined to psychoanalyze the Court, we would look more to Riegel as involving an off-label use, and Levine involving a labeled use. We could see the Court (although, of course, neither opinion says so) being less inclined to permit liability where a defendant’s product caused injury while being used in a way inconsistent with its FDA-approved labeling, and more inclined to permit liability where the product was being used for an intended purpose, but nevertheless resulted in injury. But again, that’s only rank speculation unsupported by anything in either opinion – and we think there should be preemption in either case, as long as the FDA considered the risk in question and made a decision about what the label should say about that risk.But then again, maybe the most relevant distinction is between law professors, who are paid to think about such things, and us practicing lawyers, who aren’t.