United States: Rotten Tomatoes − The Worst Prescription Drug/Medical Device Decisions Of 2018

Last Updated: January 3 2019
Article by James Beck

When we're trying to decide whether to see a movie, one place we turn for advice is the Rotten Tomatoes website. We visited the site recently to see what those purveyors of overripe fruit had to say about "The Favourite," which attracted our attention with an interesting trailer that preceded "The Crimes of Grindelwald."  Hint – the reviewers liked it much better than the movie we had seen – maybe we will, too.  While on the site we noticed a feature, "24 Worst Movie Remakes," which listed the most negative "Tomatometer" scores subtracting the remake from the original. Of the 24, thankfully, we've only seen one.

We thought about that when compiling this year's bottom ten worst drug/medical device product liability decisions of 2018.  We sure don't want any remakes of these!  Of course, here, there's little positive to subtract from to start with.  These clunkers start out with such awful scores that it's hard to imagine much worse – we wish.   Unfortunately, this marks our twelfth year of doing this, so we've previously reviewed 110 (actually 111 – 2017 had two worsts) other similarly bad decisions. So yes, actually we can imagine worse.

Anyway, let's stop imagining things and get on with the dreary job of discussing the ten worst prescription medical product liability litigation decisions of 2018. If any of these fiascos were yours, feel free to cry on our shoulders.  It's not like it's never happened to us (for instance, see 2013-2), so we know what it can be like.  But don't worry, we'll all feel less depressed next week, when we say "Happy New Year" with our best decisions – no rotten tomatoes needed.

Here goes nothing:

  1. Rafferty v. Merck & Co., 92 N.E.3d 1205 (Mass. 2018). Last year's extra number one worst case ( 2017-1A) was a state supreme court's recognition of the liability uber alles theory of innovator liability. This purely result-oriented claim is contrary to the most fundamental precepts of product liability, since liability does not follow a defendant's profit from the sale of the product as a "cost of doing business," but rather follows the path of least legal resistance – given that product liability claims against generics are preempted − from the generic drug to the original innovator drugmaker that actually lost profits due to generic competition. Because innovator liability is so potentially dangerous – imposing liability for the 90% of the market that is generic on the 10% that is branded – a similar decision by the Massachusetts Supreme Court takes home the number one spot again this year. Innovator liability is sought only because of preemption of direct generic claims, and Rafferty quite frankly admitted that the cause of action it created was a preemption dodge. Unlike last year's case, Rafferty concealed its tort radicalism with a fig leaf. Instead of negligence, Rafferty required "recklessness" on the part of the defendant as a prerequisite to innovator liability. While trumpeting this scienter requirement as "circumscribing" liability "for public policy reasons," Rafferty actually gutted the limitation by choosing a dumbed-down definition of recklessness that really amounts to little more than negligence. We don't doubt that plaintiffs will easily plead recklessness, and thereby jack up the prices of other drugs, since by definition the defendant didn't sell the one that hurt anyone. After Rafferty, generic drug plaintiffs get a unique second bite at the apple that no other product liability plaintiffs enjoy when the real manufacturer is for any reason judgment-proof. For deliberately tossing aside decades of product liability principles so that generic drug users can have someone – the wrong someone – to sue, Rafferty is the biggest judicial rotten tomato of 2018. We ripped Rafferty here.
  2. Campbell v. Boston Scientific Corp., 882 F.3d 70 (4th Cir. 2018). We hate consolidated, multi-plaintiff trials almost as much as we hate innovator liability. Consolidated trials are such a favorite tool of settlement-bludgeoning MDL judges, that we have adopted the hard line of "just say no" to MDLs – and even more to having any trials at all in any MDL. The law used to reject multi-plaintiff consolidations as virtually inherent abuses of judicial discretion, but MDLs have the deleterious effect of sacrificing legal principle to settlement. Last year it was the Eghnayem ( 2017-2) decision from the Eleventh Circuit allowing 4 plaintiffs to be tried together. This year's decision means that now two Courts of Appeals have sanctioned this deliberately prejudicial procedure. If anything, Campbell is worse, because the jury, plainly unable to keep the cases straight, returned almost identical verdicts for each of four plaintiffs. Identical verdicts used to be a Due Process red line, but not in Campbell. After Campbell, it looks like MDLs may freely sacrifice the American legal tradition of separate trials to whatever judges want to do in the name of efficiency. Because that's simply not right, Campbell is the second worst decision of 2018 and a poster child for why the "pre-trial" restriction in the MDL statute should be enforced according to its terms. We criticized Campbell here.
  3. Hammons v. Ethicon, Inc., 190 A.3d 1248 (Pa. Super. 2018). Pennsylvania is well on its way towards being a national personal jurisdiction outlier. Hammons is one reason why. To start with, Hammons was the only decision we were aware of in the entire country – and that includes other Pennsylvania decisions that should have been binding – holding that a defendant, not the plaintiff asserting jurisdiction, bore the burden of proof of proving lack of personal jurisdiction. Beyond that, the Court sandbagged the defendant, resting its jurisdictional decision on "evidence" that had not even been considered when the issue was decided at the trial court level (later introduced for non-jurisdictional purposes at trial). Finally, Hammons based personal jurisdiction on contacts with Pennsylvania that were not relevant to the theories of liability that the non-resident, litigation tourist plaintiff was pursuing, making a mockery of any sort of causal relationship in the context of the post-BMS "arising from"/"relating to" test for specific personal jurisdiction. Thus, Pennsylvania now has the dubious distinction of having unconstitutionally expansive appellate decisions on both general and specific jurisdiction. "Grasping" and "exorbitant" jurisdictional theories, you've got a friend in Pennsylvania. We hammered Hammons here.
  4. Godelia v. Doe 1, 881 F.3d 1309 (11th Cir. 2018). Godelia continued the Eleventh Circuit's string of lousy decisions from last year (see 2017-2, 2017-7, and 2017-8). The court reversed a finding of PMA preemption where the plaintiff offered only a warning letter that did not even involve the type of problem that the plaintiff's decedent encountered. Godelia's excuse was that the warning letter was "not all-inclusive." Godelia completes the Eleventh Circuit's descent from one of the strongest to one of the weakest TwIqbal jurisdictions, allowing an allegation of "violation of the federal regulations noted above" (previously described as "not all-inclusive") to plead a parallel manufacturing defect claim. Vague regulatory allegations were okay, as long as the FDA said the regulations were violated in the warning letter, and so were purely speculative causation allegations. As long as the plaintiff alleged a manufacturing defect, warranty, or misrepresentation claim, PMA preemption was defeated, even if the claim wasn't actually based on the alleged FDCA violations. Warranty claims, which usually fail Florida's privity requirements where prescription medical products are involved, survived because of alleged oral statements by sales representatives. That the device required a prescription does not require dismissal for lack of privity where direct contacts with a sales rep are alleged. And, of course, the court doubles down on Mink's ( 2017-8) deliberate misapplication of Florida negligence per se legislative intent requirement. We didn't post on Godelia before, but it was indeed God awful.
  5. In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, 888 F.3d 753 (5th Cir. 2018). Wait a minute. The court reversed a half-billion dollar verdict and roasted plaintiffs' counsel for improper conduct. How could this case be on the bottom ten list? The answer lies in the court's grant of only a new trial. The Pinnacle Hip decision also made a number of legal rulings that range from questionable to atrocious. The most serious error the court made was refusing to apply established Texas law that comment k precludes strict liability across the board. Pinnacle Hip ignored – really ignored − a half dozen prior decisions (including one of its own) on this issue. Even if there wasn't any precedent (which there was) expanding state-law liability where the state courts have not is not the job of a federal court sitting in diversity. Another flaw was allowing plaintiffs to offer a different product as a purported alternative design. The Fifth Circuit used to be good on this, but allowing an alternative design claim that the product shouldn't have been composed of what the FDA allowed it to be made of really pushes the boundary. Two oddball liability theories also received a green light: "nonmanufacturer seller" and "negligent undertaking." We also don't like allowing "objective" evidence (that is, paid expert testimony on what a "reasonable" physician would have done) to substitute for what the plaintiff's prescriber actually did in evaluating warning causation under the learned intermediary rule. Finally, the court also rejected a preemption argument – but frankly it wasn't the right preemption argument, so we don't take off many points there. We pummeled Pinnacle Hip for these deficiencies here.
  6. In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 300 F. Supp.3d 732 (D. Md. 2018). The worst trial court decision of 2018 came from an MDL. No surprise. One of our objections to MDLs is their bending over backwards to let questionable claims continue, in pursuit of settlement leverage against defendants. BHR was propelled higher (lower?) on our list since the contortions in this case were aimed against PMA preemption, perhaps our favorite defense (and certainly the strongest). Anything that so much as contained a whiff of an FDCA violation became an unpreempted parallel claim, so what began as a Supreme Court waiver comment has just about swallowed Riegel's preemptive rule in this MDL. BHR also distinguished Buckman into almost nothingness – if an FDCA violation is not a "critical" element of a negligence per se claim, it becomes hard to see what would be. PMA products have largely avoided MDLs since Sprint Fidelis, but BHR appears determined to be exception. We bashed BHR here.
  7. Stange v. Janssen Pharmaceuticals, Inc., 179 A.3d 45 (Pa. Super. 2018). Our second bottom ten case from Pennsylvania affirmed a half-million dollar Philadelphia verdict for gynecomastia – a "condition" that another court this year found not "serious" as a matter of law. No wonder Philadelphia attracts litigation tourists from all over the country. The litigation tourist in Stange was from Wisconsin. That's enough to knock Stange a notch or two, since out of state decisions screwing up other states' laws rarely get much attention from the affected states' judges. The chief Pennsylvania law goof in Stange was on expert witnesses – applying a "novel" science limitation that was eliminated by the Pennsylvania Supreme Court in an asbestos case called Betz. On top of this, the court reversed the Philadelphia mass tort judge's holding that New Jersey law applied to punitive damages, since the defendant was headquartered there, and that's where all corporate conduct would have happened. New Jersey has a statute that precludes punitive damages for FDA-approved products. The court sent the case back to the trial court for a comparison with Wisconsin law even though ( as we discussed here) a prior ruling by the same court – binding under Pennsylvania appellate practice – had already determined that the law of the corporate domicile applies to punitive damages choice of law issues. As that prior decision involved a Pennsylvania-domiciled defendant, Stange really applied the choice of law rule, "heads, plaintiffs win; tails, defendants lose." That alone would qualify for this list. Stange is indeed strange, as we pointed out, here.
  8. A.F. v. Sorin Group USA, Inc., ___ F. Supp.3d ___, 2018 WL 4680022 (S.D.N.Y. Sept. 28, 2018). A.F. comes in at number eight on our list because it ignores the role of federal courts sitting in diversity jurisdiction, and also because (unlike the decisions that follow) it's published. As is so often the case with federal decisions embracing novel liability theories, A.F. is a preemption case. The theory that survived dismissal – failure to report adverse events to the FDA – is an ill-concealed preemption dodge. But that didn't stop A.F. What makes the case worse is (as we discussed here) New York courts have affirmatively rejected tort liability based on a variety of claims based upon alleged failures to make reports to governmental agencies. Failure to report claims are not a matter of first impression in New York. Not only that, but the same FDA-related claim had been rejected by another New York court not long before. A.F. is on our list because it ignores both Erie principles and existing New York law. We explained the awfulness of A.F. here.
  9. Sumpter v. Allergan, Inc., 2018 WL 4335519 (E.D. Mo. Sept. 11, 2018). Sumpter is another court-assisted preemption dodge case. This time the dodge is "manufacturing defect." In what way did the device fail to meet specifications? The complaint doesn't say, and the court doesn't care – as evidenced by its reliance on one of the most widely reviled (and not just by us) PMA preemption decisions, Hofts ( 2009-5). As long as the product departed from its "intended result," that's enough. A plaintiff can "extrapolate" from the alleged injuries. That amounts to res ipsa loquitur, and a rather loose sort, at that. But Sumpter's worse than that. Res ipsa loquitur only allows inference of a "defect"; Sumpter uniquely allowed the plaintiff to get by with an inference of FDCA violation from the mere fact of an alleged device failure. Missouri has become the opposite of the "Show Me State." Sumpter is more like "don't need to show me anything." We discussed how Sumpter is septic here and here.
  10. Tryan v. Ulthera, Inc., 2018 WL 3955980 (E.D. Cal. Aug. 17, 2018). The Tryan decision got preemption wrong on so many levels that we didn't know what to make of it. The claims themselves were farcical. Plaintiffs weren't even injured. They claimed only that they were told the device was "approved" rather than "cleared," and wouldn't have purchased it had they known it was a 510(k) device. Thus, Tryan was through and through a private claim for violations of the FDCA. Without the FDCA, the plaintiffs' claimed distinctions would never have existed. Thus, it's a private action totally dependent on the FDCA and barred by that act's prohibition against private enforcement. But Tryan got sidetracked on express preemption – not an issue – and never recovered. Tryan reasoned as if there were a "parallel claim" exception, but no such thing exists in implied preemption. "Mirroring" the FDCA only makes implied preemption stronger, since the FDCA precludes private enforcement (except for an exception only relevant to food). The result? A class action alleging that "FDA approved" and "FDA cleared" are so different that otherwise uninjured consumers should receive damages. Tryan is thus a travesty, as we explained here.

That's our bottom ten, and that's quite enough as far as we're concerned. Time for a shower, to feel clean again, and for some egg nog to get back in the holiday spirit. Our spirit will be back next week, as we award legal Oscars instead of rotten tomatoes when we review the ten best drug/device decisions of 2018.  Finally, we've heard it said that there is no war on Christmas, but there is a war on Thanksgiving – and Christmas has won.  In that spirit, we wish everyone Happy Holidays.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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James Beck
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