It’s that time of year again – time to review drug and medical device product liability litigation during 2022 and select the year’s ten worst decisions. Frankly, it’s not that hard to do – they reek to high heaven, so they are pretty easy to find. What’s harder is finding the motivation to write about decisions that we find profoundly distasteful for one reason or another. It’s fun to write about wins, but not about losses, so watch for decisions we might not have addressed previously.
Whether or not we could stomach bad decisions before, since 2007 we’ve diligently prepared bottom ten annual lists, and we’re not about to stop now. It’s possible that we could have a December depressant at the end of the year (T.H. v. Novartis, 407 P.3d 18 (Cal. 2017), in 2017), but that’s thankfully unusual. Further, we limit ourselves medical product liability litigation (prescription and non-prescription), so Dobbs v. Jackson Women’s Health Org., 142 S.Ct. 2228 (2022) (here and here), doesn’t count, despite its implications for FDCA preemption and telemedicine. Nor does the truly awful Atchley v. AstraZeneca UK Ltd., 22 F.4th 204 (D.C. Cir. 2022), decision that it is TwIqbal “plausible” to sue pharmaceutical companies as accomplices to international terrorism − demonstrating that some litigation is even worse than product liability. We likewise don’t count Pfizer, Inc. v. United States HHS, 42 F.4th 67 (2d Cir. 2022), a profoundly destructive decision that companies trying to help patients pay for lifesaving, but expensive, treatments violate the Anti-Kickback statute (here).
Anyway, without further ado, here our ten lumps of coal for your Christmas stocking. If you had a hand in any of these judicial debacles, we sympathize, since we’ve had to put our own cases on the list before (see, e.g., 2013-2 and 2021-10). A lawyer who never loses isn’t being trusted to litigate hard cases. In any event, the pain is temporary, and next week we’ll present our top ten best decisions.
- Glover v. Bausch & Lomb, Inc., 275 A.3d 168 (Conn. 2022). We despise failure-to-report claims in prescription medical product liability litigation. They’re nothing but preemption dodges – invented “parallel claims” that never existed before, and created solely for the purpose of evading preemption. We’re so opposed to FDCA-based reporting claims that we have prepared, and keep current, a detailed 50-state survey, that even includes analogous non-FDCA-based claims, so all defendants have access to the best legal research to defeat such claims. A lot of good that did us in Glover. Using a indiscriminately expansive rationale, that a the “purpose” of a 1970s era state product liability statute was to “protect anyone . . . injured by a defective product,” Glover ignored both the absence of any express reporting-based claim in the statute, as well as that court’s prior non-product liability precedent rejecting claims for failure to report to a government agency. The FDA could be “the person best able to take or recommend precautions” under the statute, although the obvious causation gap, that FDA would have to do something (perhaps a label change) that might change the prescriber’s treatment, was totally ignored. While ostensibly not deciding preemption issues – and thus avoiding having to deal with the Buckman issue that “critical elements” of such claims are derivative of the FDCA, desire to evade preemption through “parallel claims” oozes from every pore in Glover. We gagged on Glover here.
- People v. Johnson & Johnson, 292 Cal. Rptr.3d 424 (Cal. App. 2022). When is a product liability case not a product liability case? When the same allegations are bundled together and writ large in a consumer protection action brought by a state attorney general, that’s when. Presto, the learned intermediary rule disappears and along with it all issues of individualized causation. Despite contrary testimony by surgeons that actually used the product, supposedly sufficient evidence existed that physicians – generally, not in any particular surgery – were “likely” to be deceived. Moreover, nobody can know ahead of time what a “violation” is or isn’t, since that is determined on an ad hoc, and post hoc, case-by-case basis. Further, the usual safe harbor for compliance with regulatory requirements did not apply, since the device was Class II and thus “only” §510(k) cleared. Since the attorney general had sued, recovery was permitted of statutory damages for every single piece of promotional material ever sent to California, regardless of whether anyone ever saw or was influenced by it, some 200,000 “violations” that added up to some $300 million. That figure was “extrapolated” from advertising material ordered by a single sales representative, with no attempt at reductions for material that was trashed or otherwise never used. The combined rulings were so bad that the defendant has appealed to the United States Supreme Court because the claims were so vague and standardless as to violate Due Process. We panned People v. J&J here.
- Blackburn v. Shire U.S., Inc., ___ So.3d ___, 2022 WL 4588887 (Ala. Sept. 30, 2022). Before Blackburn, Alabama had pursued a standard, mainstream evaluation of learned intermediary rule – limiting the duty to warn to warnings pertaining to product risks and limiting causation to warning changes that would have caused the prescribing physician not to have prescribed that product to that patient. Thus, monetarily motivated plaintiffs were not allowed to make risible claims that they would have disobeyed their doctors’ recommendations – “learned” medical advice that is at the core of the rule – and refused to take recommended medications. No longer. Blackburn continued that court’s pro-plaintiff trend, evidenced in Weeks (2014-1), and relaxed both requirements, holding: (1) prescription drug manufacturers now must not only warn about drug risks (indisputably done in this case), but must further instruct physicians how to practice medicine by telling them how to mitigate those risks, and (2) a plaintiff can prove warning causation with evidence that the prescribing physician would merely have altered some aspect of patient treatment or monitoring, even though still prescribing the same drug. The door is now open in Alabama to a wide range of speculative, contrafactual gaps in defendant’s causation defenses, that had the prescriber only tested for this or told the patient about that, the outcome would somehow have been different – reminding us of the “4,000 holes in Blackburn [Lanca]Shire” about which the Beatles sang. Blackburn was hardly a case in which either issue would actually had made a difference because, as we discussed last year in giving the Eleventh Circuit’s Blackburn (2021-3) certification order a similar thumbs down, the prescribing doctor didn’t read the warnings before prescribing the drug and didn’t follow the monitoring information that the defendant’s labeling did contain. At the same time, the plaintiff was also non-compliant with what the doctor told him to do, missed appointments, and limited the subsequent physician-patient relationship solely to obtaining refills. So the court chose to make new law on what were essentially moot questions. We blasted Blackburn here.
- Nicholson v. Biomet, Inc., 46 F.4th 757 (8th Cir. 2022). Nicholson affirmed a punitive damages verdict against a medical device manufacturer. That’s bad. It did so on blatantly inconsistent reasoning. That’s worse, and enough to land this decision on our bottom ten. In Nicholson, the defendant sought to admit the absence of any contemporaneous MAUDE adverse event reports to contradict plaintiff expert opinions on defect. At the time of the surgery there was only one such report out of some 25,000 total devices that sold by that point. This evidence was excluded due to “critiques concerning the data’s meaning and value” – a reason that defendants often raise. Exclusion was affirmed as “harmless” with respect to design defect because, lack of adverse events did not mean there wasn’t a better alternative design. That was questionable, under Iowa law, since Iowa is a Third Restatement state, and under the Restatement the defectiveness of the design is measures as of the date of sale. What’s much worse, however, is that Nicholson was a punitive damages case, for which Iowa requires “willful and wanton” conduct. That’s defined as “disregard of a known or obvious risk so great as to make it highly probable that harm will follow.” Given that prerequisite for punitive damages, the lack of reported adverse events as of the date of surgery could not possibly be “harmless.” No matter how misbegotten MAUDE undoubtedly is as a basis for a causation opinion, it is still a form of notice – that’s probably all MAUDE has going for it. Without any significant number of reported events, there was simply nothing for the defendant to “disregard” – certainly nothing “known or obvious,” and even more certainly no indication of “highly probable” harm. And there’s more. Nicholson also ruled that an attempt to warn, even if negligent, didn’t preclude punitive damages, and did so on the weird ground that a contrary rule would “defy the purpose of design defect claims.” That might make sense as if the warning had been asserted as a defense to design defect, but it’s simply a non sequitur where the only issue is punitive damages, where even negligent attempts at giving warnings can preclude the existence of the requisite state of mind. Indeed, the Eighth Circuit had reached the opposite conclusion under a different state’s law, in a decision Nicholson didn’t bother to cite. We said “no way” to Nicholson here.
- Center for Inquiry, Inc. v. Walmart, Inc., 283 A.3d 109 (D.C. 2022). This case wins the 2022 booby prize for the most absurd legal theory allowed in a published decision. It would have placed higher overall but for the plaintiff’s underlying proposition – that homeopathic products aren’t efficacious – having considerable merit. So while the plaintiff might have been right on the science, the case itself should have gotten nowhere on duty. It’s another bizarre consumer protection claim, predicated on store shelves “having voices.” The theory that Center for Inquiry allowed was that a retailer made some sort of implicit representation simply by how it organized products on its shelves. DC plaintiffs can now sue for false implications caused by what products are next to what other products. In Center for Inquiry the claim was the placement of homeopathic products alongside FDA-approved over-the-counter products was an implied (mis)representation that the homeopathic products were as efficacious as the OTC products. Apparently, Center for Inquiry is of the view that “reasonable” DC consumers aren’t very bright. There is no claim anywhere that any actual statement, labeled or otherwise, was false or misleading. So retailers are now liable simply for what products they put next to what other products. So what can DC consumers sue over now? Margarine next to butter? Veggie burgers next to meat? OTC drugs next to dietary supplements? Diet soda next to sugary soda? Fiction next to non-fiction? We hope that all this sounds as ridiculous to you as it does to us. We castigated Center for Inquiry here,
- Thacker v. Ethicon, Inc., 47 F.4th 451 (6th Cir. 2022). “Burden of proof? We don’t need no stinkin’ burden of proof.” That’s the bottom line in Thacker. Remarkably, this published appellate opinion, reversing summary judgment in a pelvic mesh case, never once mentioned the burden of proof. The plaintiff alleged various injuries from two different pelvic mesh devices implanted at the same time by the same physician, but her experts didn’t distinguish between those two devices, instead blaming everything on both devices collectively. That was typical lazy MDL plaintiff behavior. Later on, after remand, the defendant received summary judgment because those muddled causation opinions didn’t rise to a prima facie case – what plaintiffs in every product liability case have the burden of establishing. Continuing her desultory, MDL-type pursuit of her claim, plaintiff deposed the implanting surgeon but failed to adduce any testimony that he would have done anything differently – and that even with today’s knowledge, he believed the products were “safe and effective treatment options.” That sort of prescriber testimony has previously been almost universally fatal to caution in learned intermediary rule cases. But ignoring the plaintiff’s burden of proof, Thacker held that plaintiffs had no duty to present causation evidence that doctors would have done something different “when the defendant also has not presented evidence that the doctor would not have changed their mind.” Without admitting it, Thacker thereby flipped the burden of proof, requiring defendants to disprove causation under the learned intermediary rule rather than plaintiffs having to prove it. That’s the equivalent of adopting a heeding presumption (which no Kentucky appellate court has ever done) without saying so. For its pro-plaintiff abuse of the burden of proof, Thacker earned a spot on this year’s bottom ten. We thrashed Thacker here.
- Jacob v. Mentor Worldwide, LLC, 40 F.4th 1329 (11th Cir. 2022). Class III medical devices are subject to broad preemption under Riegel. Jacob allowed a plaintiff to escape a richly justified preemption-based dismissal because . . . the plaintiff was pro se (on appeal she wasn’t even pro se anymore). That’s simply wrong. Pro se status should not entitle a plaintiff in a more favorable result than someone represented by counsel. We counted them up – on 23 prior occasions represented plaintiffs had claims against the same type of Class III product dismissed on preemption grounds. The plaintiff in Jacob alleged nothing warranting a different result. But she received much “less stringent” review. Plaintiff had dismissed her most plausible claim, so that it no longer appeared in the active complaint. Normally amended pleadings supersede former pleadings, but not this time, since she was pro se. Plaintiff didn’t oppose dismissal with any basis for “parallel claims” that could escape preemption, not even alleging FDCA violations, but because she was pro se she was allowed to sandbag the entire trial court proceeding with arguments not made except on appeal. Pro se plaintiffs apparently don’t have to preserve anything. That the district court adopted a defendant’s arguments is enough. Jacob also freed pro se plaintiffs from any obligation to plead facts under TwIqbal. For giving pro se litigants advantages in prescription medical product liability litigation that represented plaintiffs could hardly dream of, Jacob earned a spot in our bottom ten. We junked Jacobs here.
- DeCostanzo v. GlaxoSmithKline PLC, 2022 WL 17338047 (E.D.N.Y. Nov. 29, 2022). This case earned the distinction of the worst trial court decision of 2022 by endorsing the plaintiff’s (and by implication any other plaintiff’s) “end run” past the Vaccine Act’s alternative compensation program, and thus imperiling the Act’s protection of the vaccine industry from the sort of widespread litigation that nearly drove it out of business before the Act was enacted. DeCostanzo green-lighted a class action purportedly representing everyone who took the targeted vaccine because it was allegedly not as effective as advertised – leading to purported “defective immunity” and “receiving a painful injection.” Thus, plaintiff alleged a vaccine-related injury that triggered the requirement to first “exhaust” the Act’s alternative compensation system before they could sue. The plaintiffs never even tried. Instead of a valid “petition” (a term defined in detail by the Act) plaintiff filed little more than a blank sheet of paper containing none of the data that the Act requires. Plaintiff then received four two-month “extensions,” but filed nothing more. She then sought to “withdraw” her petition because she didn’t get a decision by the Act’s 240-day deadline – a decision that her deliberate inaction precluded. The plaintiff should have been non-prossed for gaming the system, but instead DeCostanzo allowed her to leapfrog the Act’s compensation system entirely. Supposedly the “plain language” of the Act’s withdrawal provision permitted this end run. That reasoning is garbage because the same “plain language” specifies what’s supposed to be in a “petition,” and plaintiff utterly failed to submit a “petition” that could be “withdrawn.” If this plaintiff could sabotage her own claim and thus avoid the Act’s compensation system, then so could any other plaintiff. That would destroy the utility of having the alternative and unleash the very torrent of vaccine litigation that the Act was created to prevent. Further, plaintiff’s class action claims were allowed to continue despite asserting only design and warning claims, both of which are facially preempted by the Act and the Bruesewitz decision interpreting it. We demolished DeCostanzo here.
- Bueno v. Merck & Co., ___ F. Supp.3d ___, 2022 WL 4125231 (S.D. Cal. Sept. 9, 2022), and Whaley v. Merck & Co., 2022 WL 1153151 (S.D. Cal. April 12, 2022). These two decisions – both by the same misguided court − seek to clear the way for Californians to pursue innovator liability actions against branded drug manufacturers despite the branded defendants having no relevant jurisdictional contacts with the state. In both cases, the same defendant is being sued despite doing none of the things that would subject it to personal jurisdiction in California under the Bauman (no general jurisdiction) and BMS (no specific jurisdiction) Supreme Court decisions. While the defendant sold its products to other persons in California, at other times and places, it did not sell any drug to the plaintiffs. But under BMS, sales to unrelated third parties cannot establish jurisdiction. Under Ford Motor, sales of the same product can be enough, but that’s not true for innovator liability, which divorced liability from product sales. This defendant never sold anything to these plaintiffs. Bueno and Whaley essentially turned personal jurisdiction on its head, ruling that, because substantive California law allowed warning liability in the absence of any sale, it would “impermissibly ignore binding California . . . precedent” not to allow those warnings – unaccompanied by any sale at all – to create personal jurisdiction. That’s a bootstrap if we ever saw one. It’s simply inconsistent with the concept of personal jurisdiction. Personal jurisdiction does not depend on the validity of the underlying claims. In BMS, all of the dismissed plaintiffs were suing over injuries from drugs that they had taken, which gives them product liability claims (just not in the state where they sued). Therefore, the substantive validity of the claim is in no way a sufficient basis for jurisdiction. Rather, there must be sufficient “minimum contacts” of the defendant that sufficiently relate to the plaintiff’s claim. Having sold the same products (with the same warnings) to unrelated third persons years before wasn’t enough in BMS (which reversed the California Supreme Court), and isn’t enough in innovator liability cases. That California law may be loopy enough to allow innovator liability does not create a jurisdictional basis that meets the requirements of Due Process. Unfortunately, while Ford Motor cautioned that its finding of personal injury did “not mean that anything goes,” these cases do quite the opposite. We bashed Bueno and walloped Whaley here and here.
- Blackburn v. Shire U.S., Inc., 2022 WL 16729466 (11th Cir. Nov. 7, 2022) (unpublished). The Blackburn litigation has the dubious distinction of having both the most bottom-ten decisions all time, three (see 2021-3 and our #3 case, above) and also of being the only individual litigation ever to post two bottom-ten decisions in the same year (the Actos MDL did that in 2014). That’s because in this Blackburn decision, the court made a disastrous mistake. It misread that portion of the FDA’s complex and multi-leveled regulation on NDA supplements that dealt with “changes being effected” (which we call the “CBE” regulation, even though it’s only a subpart of a much larger whole) so as to interpret an example as an exclusion. Because of that misreading, Blackburn got preemption of a particular type of label change – involving “highlights” (which we discussed here) precisely backwards. We disagree with court decisions all the time, but rarely is it a matter of a decision, not only being adverse, but also being flat out wrong. Why is rather complex, like the CBE regulation. Basically, the problem is this: When the FDA created the “highlights” section of labeling, it forbade any changes to highlights without its express prior approval. It amended the CBE regulation to say so, cross-referencing the other regulation concerning highlights. The defendant raised preemption of highlights-based warning claims in Blackburn, citing that section. Blackburn said the defendant was wrong, citing what it called an “exemption” in another part of the overall supplement regulation (§314.70(b)) that referred back to the CBE regulation. However, that “exemption” wasn’t an “exemption” from prior approval at all. Instead, it was “highlights” being listed as an example of something requiring prior FDA approval. All this matters, of course, because under what we call the “Mensing independence principle,” any label change that would require prior FDA approval is subject to preemption because it is impossible to both wait for FDA approval while complying with an immediately applicable state common-law tort duty. The regulatory analysis may be complex but the bottom line is that, in its haste to reject preemption, Blackburn read the relevant regulation backwards. Blackburn’s unusual feature of being flat-out wrong, in addition to being pro-plaintiff is why it made our bottom ten, beating out several other candidates. We belabored the errors in Blackburn here.
For the sake of completeness – and because we forced ourselves to analyze (or re-analyze) still more bad decisions – here are those other candidates, in no particular order: Freeman v. Ethicon, Inc., ___ F. Supp.3d ___, 2022 WL 3147194 (C.D. Cal. Aug. 4, 2022) (here); Doran v. Glaxosmithkline PLC, ___ F. Supp.3d ___, 2022 WL 2104513 (D. Conn. June 10, 2022) (about which we didn’t post); Muhammad v. Abbott Laboratories, Inc., ___ N.E.3d ___, 2022 WL 2253517 (Ill. App. June 23, 2022), appeal allowed, 2022 WL 17364258 (Ill. Nov. 30, 2022) (about which we didn’t post), and Cohen v. Johnson & Johnson, ___ F. Supp.3d ___, 2022 WL 5109167 (W.D. Pa. Oct. 15, 2022) (here).
Good riddance. Once we’ve decontaminated ourselves from our excessive exposure to toxic jurisprudence, we’re ready for something a lot more fun − next week’s presentation of the top ten best drug/device decisions of 2022.