2021 is almost over. Before 2021 – indeed, before the last half of 2021 – practically nobody other than stargazers had ever heard of “omicron,” unless someone was part of some fraternity or sorority. Now everybody has. The omicron viral variant demonstrates, once again in real time (as had the delta variant before it) that, yes, evolution is a fact, not a theory. The law also evolves, and we hope that, like history, the arc of that evolution ultimately bends towards justice. Chronicling cases that helped that hoped-for trend along, we once again take time for the Drug & Device Law Blog’s top ten decisions of the year. Some cases directly extinguish harmful legal mutations, others provide overriding immunity, and still others limit the scope of infection. All influence the course of future legal events, we think, for the good.
We temper our metaphysical tendencies with the relatively limited scope of our analysis. To make our top (or bottom) ten lists, a case must involve some form of prescription medical product liability litigation. Lots of other decisions occur each year that significantly impact what we do, even though not involving prescription medical products. So, we’ll salute Mallory v. Norfolk Southern Railway Co., ___ A.3d ___, 2021 WL 6067172 (Pa. Dec. 22, 2021) (good on general jurisdiction by consent, here); Normandy v. American Medical Systems, Inc., ___ A.3d ___, 2021 WL 3482928 (Conn. Aug. 9 2021) (good on hospital liability, here); Sardis v. Overhead Door Corp., 10 F.4th 268 (4th Cir. 2021) (good on Fed. R. Evid. 702, here); United States v. Supervalu, Inc., 9 F.4th 455 (7th Cir. 2021) (good on FCA objective reasonableness, here); Judge Rotenberg Educational Center, Inc. v. United States FDA, 3 F.4th 390 (D.C. Cir. 2021) (good on not banning off-label uses, here); Webb v. Trader Joe’s Co., 999 F.3d 1196 (9th Cir. 2021) (good on food preemption, here), Texas Health Huguley, Inc. v. Jones, ___ S.W.3d ____, 2021 WL 5405794 (Tex. App. Nov. 18, 2021) (good on ivermectin litigation, here); and Sullivan v. Holy Redeemer Hospital & Medical Center, ___ A.3d ___, 2021 WL 4344068 (Pa. Super. Sept. 24, 2021) (good on vaccinator liability, here). All should come in handy in the future.
Enough with the introductions. Now, let’s proceed
- State ex rel. Hunter v. Johnson & Johnson, ___ P.3d ____, 2021 WL 5191372 (Okla. Nov. 9, 2021). We can’t discuss this case, but others have. The Product Liability Advisory Council (“PLAC”), told its members: “This is an extremely significant decision which, if followed by other States, could rein in the efforts of Plaintiffs to get around traditional principles of product liability through a sweeping application of nuisance law. The Court’s finding that nuisance law does not apply to the lawful manufacturing, marketing and selling of products is a broad and unequivocal one that should apply with equal force to all products, not just prescription medications. The Court also offers a sound and detailed analysis of the numerous reasons that nuisance law should not apply to the sale of products, which will make it more persuasive authority as similar issues are litigated in other courts throughout the United States.” For other commentary, see: here, here, here and here.
- Brooks v. Mentor Worldwide LLC, 985 F.3d 1272 (10th Cir. 2021). Our best preemption decision of the year. Brooks is an example of breast implant litigation done right. The FDA’s reclassification of breast implants as Class III in response to the original spate of – now scientifically discredited – breast implant litigation brought with it PMA preemption. Brooks affirmed dismissal of all claims on preemption grounds, either express or implied. Between §360k(a) and §337(a), the “narrow gap” could not be threaded. Brooks recognized something we’ve been arguing all along, that FDCA-based negligence per se is necessarily preempted because the FDCA has to be a critical element of any such claim, and there’s no private FDCA enforcement allowed. Warnings also fell. First, there’s no mandatory duty to update FDA-approved labels. Second, as we’ve put a lot of effort into arguing, there is no state-law equivalent to support a “parallel claim” for purported failure to make adverse event reports to the FDA. Nor can there be an unpreempted “manufacturing defect” absent any facts that the particular implant the plaintiff received “differed” both from what the defendant’s design intended and from an FDA-approved product specification. Alleging only general Good Manufacturing Practice violations did not cut it. We burnished Brooks here.
- Albert v. Sheeley’s Drug Store, Inc., ___ A.3d ___, 2021 WL 6062555 (Pa. Dec. 22, 2021). The “in pari delicto” or “wrongful acts” doctrine prevents criminals from becoming plaintiffs. One primary fact pattern is squarely in our sandbox – preventing illegal drug users from suing drug manufacturers or suppliers over injuries caused by their own criminal acts committed in order to obtain possession of controlled substances. We’ve opposed recent efforts in the ALI that have sought to abolish in pari delicto, which precludes liability as a matter of law, and to replace it with a jury question of comparative fault. Thus, Albert’s reaffirmation of the doctrine could not have been better timed. In Albert the Pennsylvania Supreme Court agreed with us (literally, Bexis filed an amicus brief) that, because in pari delicto involved criminal activity, it was not merely another aspect of comparative fault. Albert is powerful evidence refuting those who would green-light criminal plaintiffs by replacing in pari delicto’s bright line rule with a mushy jury issue. Albert thus adds Pennsylvania to the majority view that overdose cases brought by illegal drug users are squarely within the scope of the in pari delicto The doctrine exists “principally because holding otherwise would force courts to condone and perhaps even encourage criminal conduct.” Albert warned litigants that “the judiciary is not tolerant of fraud and illegality,” and that criminal “culpability” can preclude perpetrators from later “seeking common-law redress.” We adulated Albert here.
- In re Zofran (Ondansetron) Products Liability Litigation, ___ F. Supp.3d ___, 2021 WL 2209871 (D. Mass. June 1, 2021). Zofran is our highest ranked district court decision of 2021, not only because of its preemption ruling disposing of an entire MDL, but also because of its procedural approach to establishing preemption post-Albrecht (2019+1,-6). The best way, after Albrecht, to establish “clear evidence” preemption in prescription drug cases is to show that the FDA did reject a label change along the lines of that the plaintiffs were proposing while considering whatever junk science the plaintiffs rely on. Since the FDCA now requires the FDA to respond to “new information” however received, 21 U.S.C. §355(o)(4)(A), the defendant filed its own citizen’s petition during the litigation that did precisely that. Such petitions require a formal response from the FDA. So, when the FDA declined to order a label change the label in response to all that the MDL plaintiffs had to offer, that was “clear evidence” barring the plaintiffs’ claims. For companies confident that the science supports their warning-related positions (comprising most of our clients), Zofran provides the playbook for bringing the FDA’s expertise to bear in mass tort litigation. The substantive preemption rulings in Zofran were excellent as well. Zofran pointed out that, unlike other products, the FDA’s approach to labeling includes prevention of overwarning. Nor could the court ignore the FDA by “assuming” that the FDA had not done what the statute required. Nor was preemption in any way limited to FDA consideration of what a particular manufacturing defendant (that had sold the NDA in the interim) had done. Science is science, whoever presents it, so the preemptive significance of the FDA’s action was the same no matter who prompted it. Finally, the FDA’s decision finding insufficient scientific basis for a label change was necessarily dispositive of that same question for all prior dates, because earlier scientific knowledge could not have been declined in the interim. We offered huzzahs for the dazzling Zofran decision here.
- Salinero v. Johnson & Johnson, 995 F.3d 959 (11th Cir. 2021). Our best learned intermediary rule case of the year. As longtime advocates of the learned intermediary rule, we oppose the other side’s unending attempts to poke holes in the doctrine. One of the worst of supposed learned intermediary “exceptions,” due to the inherently prejudicial nature of its basis, is based upon supposed “financial bias” created by financial ties between the prescribing physician and the defendant. Plaintiffs argue that such ties undermine the rule by compromising physician independence. We explained before why such assumptions are ill founded and that the supposed exception has been almost universally rejected. Still, the other side keeps trying. In Salinero the court flatly rejected arguments that such an exception could exist under Florida law. Basically, Salinero refused to allow a plaintiff, who was dead to rights under the prescriber’s unrebutted testimony, to instead attack the prescriber’s credibility. Enhancing the opinion’s value was its reliance on another of our favorite doctrines – Erie conservatism. “For us to create a wholly new doctrine, virtually out of whole cloth, would work a profound change in Florida’s law. Sitting in diversity, we are Erie bound to follow Florida’s courts,” which have never even hinted at such an exception. We saluted Salinero here.
- Ignacuinos v. Boehringer Ingelheim Pharmaceuticals, Inc., 8 F.4th 98 (2d Cir. 2021). The logic of the Mensing (2011+1) independence principle is ineluctable. “[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.” 564 U.S. at 623-24. Given that decision, any state-law demand for the alteration of a drug (or a device) that the FDA regards as a “major” change is necessarily preempted, because all “major” changes require FDA pre-approval. That’s precisely what Ignacuinos held, and that’s why it makes our top-ten list for this year. This proposition is powerful. It powered the Gustavsen (2018+2) decision to a lofty perch a few years ago. Ignacuinos agreed with Gustavsen. Any common-law demand for what the FDA lists a “major” change, as defined in 21 C.F.R. §314.70(b)(2), is preempted. In so holding, Ignacuinos adopted an argument that we had articulated on the Blog back in 2013. Given the preemptive power of this rationale – implied preemption could just as easily apply to medical devices as to drugs – Ignacuinos makes our list this year. We agreed with Ignacuinos here.
- In re Taxotere (Docetaxel) Products Liability Litigation, 995 F.3d 384 (5th Cir. 2021), and In re Taxotere (Docetaxel) Products Liability Litigation, 994 F.3d 704 (5th Cir. 2021). The Fifth Circuit decided these two related appeals two days apart. The underlying litigation is founded on a presumption that we simply find incredible – that cancer victims would jeopardize their lives by refusing to use the most effective available chemotherapy treatment because they might permanently lose their hair. The first case involved a statute of limitations decision based on plaintiffs defining their “injury” as hair loss persisting for more than six months. That created an objective date for the statute of limitations running, six months plus the applicable statutory period. Given that widespread attorney solicitation in MDL situations dredges up any number of stale cases (these plaintiffs filed their cases more than six years after the passing of pleaded six months of hair loss), a bright line is a wonderful thing, particularly when provided by the plaintiffs themselves. The second case rejected the lenient “MDL treatment” that learned intermediary causation had received in Taxotere. There was nothing “unique” about the physician-patient relationship in chemotherapy cases that would shift the focus from a prescriber’s decision-making to a patient’s. The prescribing oncologist’s testimony that the label change about permanent hair loss wouldn’t have made any difference in his decision regarding what to do to keep cancer from killing this plaintiff was dispositive. We expect that such prescriber testimony will be widespread in this MDL. We trumpeted the Taxotere decisions here.
- Hrymoc v. Ethicon, Inc., 249 A.3d 191 (N.J. Super. App. Div. 2021), appeal granted, 261 A.3d 349, 350 (N.J. 2021). In the Pelvic Mesh MDL, the court disregarded the previous majority rule that FDA regulatory decisions were generally admissible. By misapplying the antiquated Lohr decision to an evidentiary issue to which it did not apply, Pelvic Mesh created a contra-factual world in mesh cases where juries never learned about the FDA’s role in clearing those products. This led to some very (2020-1) bad (2018-1) decisions (2017-2). In device litigation, those decisions converted the FDA’s oversight role into an all-or-nothing proposition – either it’s preemptive or it’s not even admissible. Through this evidentiary sleight of hand, courts essentially repealed state compliance presumption statutes in medical device litigation in numerous states, one of them being New Jersey. But in New Jersey, anyway, thanks to Hrymoc, that’s not the case, at least for now. A unanimous panel recognized that exclusion of FDA device clearance was unduly prejudicial to defendants, reversing two multi-million dollar jury awards. Thus, what the Pelvic Mesh MDL required is reversible error in New Jersey. Hrymoc recognized that, since Lohr, the FDCA had been amended so that the §510(k) process could no longer be fairly characterized as having nothing to do with device safety. Just because it is “less rigorous” than PMA approval does not make §510(k) clearance irrelevant under state evidentiary rules. Further, jurors are not ignorant. They know what the FDA is and expect to hear about in prescription medical product cases. Plaintiffs may not mislead the jury by arguing that state law required pre-clearance actions that the FDA did not without the defendant being able to explain to the jury that the FDA did not require those steps. We hailed Hrymoc here.
- Incretin-Based Therapies Products Liability Litigation, 524 F. Supp.3d 1007 (S.D. Cal. 2021). In another preemption ruling taking down an entire MDL, Incretin dismissed the plaintiffs’ claims that the drugs in question caused pancreatic cancer under both prongs of Albrecht (2019+1,-6). First, the Incretin plaintiffs couldn’t point to any “newly acquired information” that would allow a unilateral label change in the first place. Some of what plaintiffs relied on was not “new,” other material didn’t qualify as “information,” and none qualified as both. The MDL Plaintiffs made no fewer than 16 separate attacks on the information the defendants submitted to the FDA and lost on every single one of them. With plaintiffs unable to raise the pre-Albrecht “fact question” canard, Incretin examined and ruled that, on each issue, the defendants had the better of the argument. In sum, the FDA had been all over the pancreatic cancer issue, and there wasn’t anything worthwhile that the Agency hadn’t already reviewed. Further, that same extensive administrative record was also “clear evidence,” after Albrecht, that the FDA would not approve the warnings the plaintiffs demanded about the purported risk. At best the FDA found the risk “indeterminate,” which did not meet the Agency’s own scientific standards for a warning change. As for what the FDA knew, Incretin cut through that preemption Gordian Knot with the simple logical syllogism – if there was no “new” evidence withheld, then necessarily the FDA was “fully informed.” Moreover, everything the FDA did, including denying a citizen petition, was within the scope of its lawfully delegated powers – including an FDA-authored article in a medical journal. Finally, given the FDA’s obligation to act on information however received (see, Zofran, above), Incretin rejected another of the other side’s favorite anti-preemption arguments, holding that FDA inaction can, under the circumstances in Incretin, support preemption. For its comprehensive rejection of attempts to misuse Albrecht to rolling back implied preemption, Incretin also makes our list. And on top of everything else, Incretin held that the plaintiffs’ expert causation opinions were inadmissible under Fed. R. Evid. 702. One or (usually) more of plaintiffs’ seven purported experts improperly relied upon outdated, incomplete, and cherry-picked data. They changed methodologies in midstream without explanation, applied those methodologies inconsistently, and used unvalidated methodologies. They ignored human epidemiology in favor of animal and in vivo studies. They relied blindly on each other, and their analysis could not be tested or replicated. Their litigation-generated opinions differed from their academic work and were based on information supplied by counsel. Incretin featured all the usual junk science we are accustomed to seeing from the other side, and all seven of the offending witnesses were excluded. We idolized Incretin here.
- In re Zantac (Ranitidine) Products Liability Litigation, 510 F. Supp.3d 1175 (S.D. Fla. Dec. 31, 2020). We bent the rules (by one day) for this one, which was decided on New Year’s Eve, 2020. We may be fast, but we’re not that fast. Besides, our post discussing this Zantac decision was also in 2021. The Zantac MDL has a notably conscientious transferee judge who is ready, willing, and able to tackle tough issues. We’ve blogged about no less than nine separate Zantac MDL decisions. This one is the best of a pretty good lot, primarily because the issue involved, innovator liability, which poses an existential threat to non-generic pharmaceutical manufacturers. The sprawling Zantac MDL includes plenty of plaintiffs who took only or mostly generic versions, and thus would face preemption claims (which they also lost) in suing the defendants that actually manufactured what they took. So they brought innovator liability claims against the brand manufacturers, under the laws of no fewer than (and originally more than) 35 states. In this Zantac opinion, plaintiffs lost – in every single state. An “overwhelming national consensus” rejects innovator liability. It didn’t matter whether the claim was viewed as a “product liability” or a “negligence” claim. This sweeping rejection of a dangerous novel liability theory earns Zantac a spot on our annual best of list. In addition to state law, Zantac also relied on another of our recurring favorites, that under the Erie doctrine, federal courts cannot make up new state tort liability “out of whole cloth.” Plaintiffs from the two jurisdictions (Massachusetts (2018-1) and California (2017-1a)) allowing some form of innovator liability also lost, with Zantac adopting a personal jurisdiction argument first unveiled on this Blog in 2018: because innovator liability does not turn on any activity at all that the defendant conducted in the forum state (but rather on FDA-approved labeling), the plaintiffs from those two states could not establish personal jurisdiction over the branded defendants under minimum contacts analysis. Plaintiffs’ bizarre argument that California and Massachusetts law could apply extraterritorially also failed. We zeroed in on Zantac here.
There you have it, our top ten picks as the best drug/medical device decisions of 2021.
But wait; there’s more. Despite the pandemic, a lot of judges and lawyers did a lot of work during 2021. In many of those cases, that work paid off for the right side of the “v.” To recognize these additional pro-defense decisions, we have our annual list of runners up, the next ten most favorable 2020 decisions.
Honorable Mentions: (11) Connell v. Lima Corp., 988 F.3d 1089 (9th Cir. 2021), was in the top ten until Albert (#3) happened. Cornell reinforces the Biomaterials Access Assurance Act as a powerful defense for suppliers of medical device components by broadly interpreting its scope (bespoke components are protected, not just raw materials) and narrowly interpreting its exceptions (plaintiffs cannot voluntarily create a situation where they are “unlikely to recover full damages” by settling cheap with other defendants) (here). (12) Fajardo v. Boston Scientific Corp., ___ A.3d ___, 2021 WL 5989909 (Conn. Dec. 16, 2021). Excellent state high court alternative design ruling if facing an extremist expert claiming everything using a particular material is defective. Plaintiffs cannot change their tune and argue that a product made of the same material, and therefore defective according to their own expert, is a safer alternative design (too recent for a blogpost). (13) Gall v. Smith & Nephew, Inc., 286 Cal. Rptr.3d 108 (Cal. App. 2021). Relatively rare pro-defense California appellate decision. FDA process violations held not genuinely equivalent to manufacturing defects and failure-to-report claims fail under the learned intermediary rule when the prescriber knows the risk (here). (14) Black v. DJO Global, Inc., 488 P.3d 1283 (Idaho 2021). Manufacturing defect claims dismissed where relevant device was no longer available. Neither res ipsa loquitur nor malfunction theory can substitute for proof of defect where the claimed injury was a known risk of the product (here). (15) Ideus v. Teva Pharms USA, Inc., 986 F.3d 1098 (8th Cir. 2021). Another good learned intermediary rule case, affirming (2019+15). The Nebraska learned intermediary rule extends to medical devices and does not include an exception requiring direct-to-patient warnings for contraceptive products (here). (16) Frei v. Taro Pharmaceutical USA, Inc., 844 F. Appx. 444 (2d Cir. 2021). Dismissals of dozens of amiodarone claims affirmed on TwIqbal grounds, including inadequate pleading of failure to report. It seems sort of obvious that any reporting-based claim must at least identify some actual failure to report, but plaintiffs never learn (here). (17) Carrozza v. CVS Pharmacy, 992 F.3d 44 (1st Cir. 2021). Plaintiff could not pursue product liability claims against a pharmacist who properly filled a prescription. Dismissal of other claims due to plaintiff’s inability to muster admissible expert testimony also affirmed (here). (18) In re Zantac (Ranitidine) Products Liability Litigation, 510 F. Supp.3d 1234 (S.D. Fla. Dec. 31, 2020). The next best of the many Zantac decisions (also on New Years’ Eve 2020) holds that plaintiffs could not evade generic preemption with a boilerplate “misbranding” claim since they could not privately enforce the FDCA. To allow broad, vague misbranding claims would render preemption meaningless (here). (19) In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2021 WL 5631687 (E.D. Pa. Dec. 1, 2021). Summary judgment against all five bellwether plaintiffs after experts excluded for a litany of Rule 702 flaws largely involving differential diagnosis (here). (20) Nelson v. C.R. Bard, Inc., ___ F. Supp.3d ___, 2021 WL 3578874 (S.D. Miss. Aug. 6, 2021). Rejecting any duty to warn of comparative risks between competing products and finding device label adequate as a matter of law. Comparative claims were not allowed under state law and were bad from a policy standpoint (here).
Our 2020 collection of cases concludes with more near misses than usual – there were quite a few good post-Albrecht preemption cases in 2021, prompted by excellent regulatory facts in Pradaxa and gadolinium litigation; you can check them all out on our preemption scorecard – so here are the next tier of victories: Vieira v. Mentor Worldwide, LLC, 845 F. Appx. 503 (9th Cir. 2021), et al. (here); Dunn v. Genzyme Corp., 161 N.E.3d 390 (Mass. 2021) (here); Graham v. Mentor Worldwide LLC, 998 F.3d 800 (8th Cir. 2021) (here); In re Zantac (Ranitidine) Products Liability Litigation, 512 F. Supp.3d 1278 (S.D. Fla. 2021) (here); In re Xarelto (Rivaroxaban) Products Liability Litigation, 2021 WL 2853069 (E.D. La July 8, 2021) (here); Lowery v. Sanofi-Aventis LLC, 2021 WL 872620 (N.D. Ala. March 9, 2021) (here and here); Plourde v. Sorin Group USA, Inc., 517 F. Supp.3d 76 (D. Mass. 2021) (here).
Looking backwards, we reviewed our prior lists of best and worst decisions. Three intermediate appellate decisions from last year, Cavanaugh (2020+9), Steins (2020+10), and Zitney (2020+11), all had review denied by their respective state high courts. Certiorari was denied in Brooks (above). Gayle (2020+18) was summarily affirmed “[f]or substantially the reasons stated by the District Court.” Gayle v. Pfizer, Inc., 847 F. Appx. 79, 80 (2d Cir. 2021). We skimmed over a couple of earlier years of our top/bottom ten lists. Nowell (2019+13) was affirmed, but the only issues appealed were relatively uninteresting state-specific statute of limitations issues. Nowell v. Medtronic, Inc., 2021 WL 4979300 (10th Cir. Oct. 27, 2021) (unpublished, even in F. Appx.). We didn’t see any other decision, pro or con, that involved any further appellate review. Finally, the recurring Pennsylvania issue concerning the applicability of comment k in medical device cases, is no longer on appeal, as the case before the Pennsylvania Supreme Court, Ebert, became part of a global settlement.
Looking forward, from this year’s list, above, we already know that the New Jersey Supreme Court has accepted our eighth best case, Hrymoc, for further review. See Hrymoc v. Ethicon, Inc., 261 A.3d 349-50 (N.J. 2021) (granting four petitions). We’re also aware that all three of the federal district court opinions in his year’s top ten, Zofran, Incretin, and Zantac, are currently on appeal, although the Zantac appeal is limited to Illinois law. Quite a few additional Zantac-related appeals are now pending. Also on tap for 2022, even with the demise of Ebert, we know of three federal court certifications to state supreme courts that could produce significant decisions in 2022: Glover, on failure-to-report claims in Connecticut; Blackburn (2021-3), on learned intermediary rule causation issues in Alabama; and Dearinger, on whether there is a direct-to-consumer exception to the learned intermediary rule in Washington. An interesting appeal is also pending in the oddball case, Atchley v. AstraZeneca UK Ltd., 474 F. Supp.3d 194 (D.D.C. 2020), on whether drug and device manufacturers allegedly providing “free goods and cash payments” to corrupt officials in Iraq could be liable under the Anti-Terrorism Act for how funds thereby generated were supposedly diverted to terrorists.
Finally, on the administrative front, the most significant development of 2021 is the proposal by the Advisory Committee on Civil Rules of the Federal Judicial Conference to amend Fed. R. Evid. 702 to specify that the proponent of expert testimony bears the burden of proving all of that rule’s prerequisites to admission – and also to state in the notes that numerous decisions relying on outdated, pre-2000, and pro-admissibility decisions are wrongly decided. We discussed these amendments (here) and (here). If adopted, the Rule 702 amendments would probably take effect by the end of 2022.
An amendment to Fed. R. Civ. P. 16 to mention early plaintiff vetting as something a judge supervising mass tort litigation can “consider” has been made. That hardly seems worth the effort to us.
Also, as we discussed here, the FDA finally completed work on its long-overdue “intended use” regulatory update. While we’re not familiar with the state of play, both the now-you-see-it, now-you-don’t administrative flip-flops over a “totality of the evidence” test for intended use, and the FDA’s rather labored approach to First Amendment issues involving “off-label promotion,” provide grounds for post-adoption challenges to the FDA’s final rule.
We’re not aware of any pending national legislation with any significant chance of passage that would impact on prescription medical product liability litigation.
See you in 2022.