We warned everyone, but there is no sense beating a dead horse (or bear, or whale).  So we’re getting right to the unpleasant business of discussing the bottom ten worst prescription medical product liability litigation decisions of 2024.  And we stress both “product liability” and “litigation.”  Otherwise, we’d have to include Harrington v. Purdue Pharma L.P., 144 S. Ct. 2071 (2024), concerning the scope of bankruptcy releases in a pharmaceutical mass-tort driven Chapter 11 proceeding.  While we discussed Harrington here, as defense lawyers we find something abhorrent about considering a defendant’s bankruptcy as part and parcel of prescription medical product liability litigation.  Other non-prescription medical product cases that we consider both important and adverse include Davidson v. Sprout Foods, Inc., 106 F.4th 842 (9th Cir. 2024), perpetuating the fiction that a state’s in toto mass adoption of FDCA standards makes their enforcement “state law” for preemption purposes (here); Carson v. Monsanto Co., 92 F.4th 980 (11th Cir. 2024), another adverse preemption decision that we discussed here; and In re Natera Prenatal Testing Litigation, 664 F. Supp.3d 995, 1007-08 (N.D. Cal. 2023), predicting (contrary to Erie principles) a consumer protection exception to the learned intermediary rule (here).

Even without obnoxious decisions like those, there’s more than enough judicial road kill and brain worms out there to complete our disagreeable task of compiling the ten worst prescription medical product liability decisions of the year.  We’ve been shoveling the Augean Stables of prescription medical product liability litigation since 2007, assembling this annual list, because who else would do it if we didn’t?  Bad decisions, like good ones, should be recognized as such.  While it’s always possible that an eleventh-hour holiday horror could arise, as happened here and here, late-breaking adverse precedent has so far been thankfully uncommon.

That’s enough prologue.  On to the agony.  Coming up are ten decisions that make us say “ow, ow, ow” rather than “ho, ho, ho.”  If you were on the receiving end of any of these bad boys, believe us, we sympathize since our own cases have made this list before (see, e.g., 2013-2 and 2021-10).  Just keep up the good fight.  Lawyers that never lose aren’t trusted with difficult cases.  Keep in mind that the pain will go away, since next week we’ll be heralding the top ten best decisions of 2024.

1. Gilead Tenofovir Cases, 317 Cal. Rptr.3d 133 (Cal. App. 2024).  Our worst case of the year recognized a pernicious “negligence” theory that created liability for the makers of non-defective drugs for not inventing and obtaining FDA approval of different, allegedly “safer” drugs for the same indication.  Moreover, it did so in the context of drugs that reduced a diagnosis of AIDS from a death sentence to merely a chronic condition.  For those with short memories, before the drug at suit, people were dying of AIDS by the thousands.  Tenofovir now holds that its manufacturer can be liable for getting that drug through FDA approval, instead of one not approved until a decade or so later.  We can’t imagine how many more people would have died in misery had that been the law at the time.  And no state suffered more from the AIDS epidemic than California – talk about biting the hand the feeds (saves) you.  Strict liability was a California invention that made proof of a “defective” product easier than negligence.  An intermediate appellate panel has stood the law on its head, holding that negligence can impose liability “beyond the duty not to market a defective product.”  Tenofovir relied chiefly on a case involving chicken bones in food, rather than California’s extensive precedent involving prescription medical products. We see no way that Tenofovir can possibly be squared with solicitude that the California Supreme Court showed for prescription products in the 1988 Brown case that abolished strict design defect liability for such products.  Now no defect is required at all, only “foreseeability” that a later, safer drug would have been approved by the FDA.  On a clear day, in California, courts (at least this one) can foresee forever.  The decision’s public policy analysis is exemplified by this quotation:  “[m]oral blame is typically found when the defendant benefits financially from its conduct.”  Making a profit is thus declared immoral in California.  This novel “duty to innovate” will do just the opposite – affirmatively impede innovation on both ends of the product cycle.  Liability is a form of deterrence, and the liability recognized in Tenofovir will deter product innovation on both ends.  At the front end, it deters manufacturers fearful of liability from bringing any “first in its class” product to market, since some later related product might, in hindsight (in Tenovofir, two decades after the fact), turn out possibly to be “safer” for some patients in some respect.  On the back end, the same liability will deter manufacturers from releasing improvements that make their products “safer,” because doing so could create hindsight liability for all sales of the original product for whatever injuries the “safer” innovation arguably could have provided.  As of now, any defendant who “knows” of an allegedly safer and equally effective design for a product it currently makes will be compelled to replace its existing, non-defective product with the alternative design, or else face a risk of broad liability.  Thankfully, the California Supreme Court will review.  We trashed Tenovofir here, and tore into it again here.
2. In re Fosamax (Alendronate Sodium) Products Liability Litigation, 118 F.4th 322 (3d Cir. 2024).  This is the second time that a Third Circuit reversal of a preemption summary judgment holding in the Fosamax MDL has earned the dubious distinction of landing high on our annual worst of the worst list (2017-1).  The first Fosamax decision, among other things, found that preemption was a jury question.  That decision was unanimously reversed by the Supreme Court in Albrecht (2019+1) and remanded for the trial court to rule on preemption as a matter of law.  The trial court did, reviewing a long and detailed FDA administrative record, including the FDA’s view of that record as briefed in the Supreme Court, and once again found preemption (2022+5).  Once again, however, the Third Circuit reversed, and its new opinion is equally bizarre.  We’ve always thought of the adversary litigation process as an effective way to uncover the truth.  This Fosamax opinion utilizes a presumption against preemption – increasingly endangered everywhere else – as a means of avoiding the truth.  Fosamax effectively thumbed its judicial nose at the Supreme Court’s Albrecht holding, this time putting said thumb on the scale through that presumption rather than, as in the first time around, through a heightened burden of proof.  The Supreme Court held that subsidiary facts relating to the legal question of preemption are determined by the court.  That meant a “clearly erroneous” appellate standard of review, which the Third Circuit first recognized, and then disregarded, using the same presumption as grounds for reversal.  Further mischaracterizing the Supreme Court’s decision, the Third Circuit panel described it as “emphatically” applying the presumption against preemption, when in fact the opposite was true.  No such presumption is mentioned anywhere in Albrecht. Rather, the Supreme Court spent several pages reformulating its earlier Levine decision, pointedly removing all references to that presumption, which had been so prominent in Levine.  Having utterly misconstrued Albrecht, the Third Circuit then wielded the presumption against preemption as a sword to cut off, and thus reverse, the district court’s detailed analysis of the FDA’s administrative record.  Using the presumption to evade the “clearly erroneous” standard of review, Fosamax held that reliance on the administrative record was simply unnecessary.  If the FDA’s formal determinations were “ambiguous” so as to warrant review of this record, the presumption required an anti-preemption result, notwithstanding anything that the FDA had actually done, and even contrary to what the agency had told the Supreme Court it had done in its amicus brief in Albrecht.  Thus, instead of using a presumption to simplify the fact-finding process, or to fill in blanks (why presumptions exist in the first place), Fosamax used the presumption to avoid looking at the FDA’s administrative record at all.  The presumption controls and actual facts be damned.  Fosamax even disinterred an old Supreme Court chestnut from a non-FDCA field preemption case, the courts “have a duty to accept the reading that disfavors pre-emption.”  Fosamax concluded by telling FDA-regulated defendants’ tough luck, since the FDA can “take its time” but defendants must “at all times” be held responsible for their labeling, whether the FDA would let them change it or not.  That, of course is completely at odds with the Mensing (2011+1) independence principle, but Fosamax also gave Mensing the back of its hand, because generic cases are “different.”  They are not, of course, when implied preemption is at issue, but since Fosamax had already disregarded Albrecht, why stop there?  We flogged the blatantly result-oriented opinion in Fosamax here and here.
3. Himes v. Somatics, LLC, 549 P.3d 916 (Cal. 2024).  In Himes, the highest court of the largest state in the country upset decades of settled precedent concerning learned intermediary causation, and embraced the very dubious factual proposition that, despite their physicians’ recommendations, some mythical “objective” patient would refuse to follow medical advice had a prescription medical product’s labeling said more about whatever risk that became reality to any particular plaintiff.  One of the primary bases for having the learned intermediary rule in the first place is to protect and preserve the physician-patient relationship, so historically plaintiffs failed to establish warning causation as a matter of law where the prescriber would still have prescribed the medication/device notwithstanding whatever aspect of the warning was at issue.  To allow causation theories premised on patient rejection of physician recommended prescriptions is inherently destructive of the physician-patient relationship.  At least the court did not accept the extreme plaintiff position that a plaintiff with dollar signs in his/her eyes could establish a jury submissible causation case with nothing more than their own self-interested testimony that, in hindsight, s/he would have rejected the product “had I only known.”  But the standard that Himes adopted, that “a plaintiff may establish causation by showing that the physician would have communicated the stronger warning to the patient and an objectively prudent person in the patient’s position would have thereafter declined the treatment,” is novel, relies on multiple hypotheticals, and invites speculation on numerous levels.  Consequently, the proposition will be quite difficult definitively to rule in or out, meaning a lot of denied summary judgment motions.  The Himes test is one of those propositions that sounds nice as an academic matter, until one considers issues of proof.  How does one establish how a theoretical “objectively prudent” patient would have behaved?  Does this become yet another field for paid experts to offer predictable paid opinions?  Conversely, with the door open for plaintiffs to argue that their physicians’ advice should have been ignored, it would appear that discovery into how the plaintiff reacted to other warnings concerning other products is now relevant, since defendants are entitled to challenge the credibility of “if I had only known” testimony.  Claims based on refusing prescriptions also tend to devolve into preempted “stop selling” claims, since holding that an extra couple of percent of a serious risk satisfies the Himes standard amounts to a determination that all (or the great bulk of plaintiff-patients) should never have had the treatment at issue.  However these proof issues play out, the purpose and intent of the change is to reduce the availability of summary judgment in warning causation cases.  Himes offered a long list of relevant, but not dispositive “factors” to consider.  The only thing that is certain after Himes is that prescription medical product liability litigation in California will be still more expensive and time-consuming.  We harped on how horrible Himes was here.
4. Providence Health System-Oregon v. Brown, 548 P.3d 817 (Or. 2024).  The vast majority of precedent, which we discussed in this somewhat dated 50-state survey, rejects holding hospitals strictly liable as “sellers” of products.  Indeed, as that post indicates, the trend had been against hospital strict liability, with several states that had initially allowed it changing their minds.  Not so in Oregon.  Ignoring – literally − a decades-long trend, Providence Health held that nothing after 1979 (before Illinois and Missouri switched sides) could even be considered.  Why?  Because Oregon adopted Restatement §402A by statute in 1979.  Thus, in construing the legislature’s intent in adopting the relevant sections of §402A, which are vague and capable of multiple meanings, nothing after 1979 was relevant.  Having made 45 years of interpretive precedent vanish by legal fiat, Providence Health was free to expand liability because that was what §402A in general was intended (when drafted in 1965) to do.  Thus, hospitals in Oregon are now strictly liable as “sellers” of prescription medical products administered in the course of medical treatment.  The decision even ignores subsequent hospital-specific legislation for the same reason.  That is a very disturbing proposition on a number of levels, since much has happened in the product liability field since the year before Bexis started law school.  As the Oregon product liability statute covers a lot of areas, including adoption of most the §402A’s comments, this holding could well put Oregon law in a similar time warp, unable to consider the last 45 years of precedent, on any number of product liability issues.  Indeed, we’ve already commented on a similar problem with the learned intermediary rule in Oregon, arising from the same vague statutory section and the same refusal to consider product liability as it is, and not as it was 45 years ago.  For artificially creating a legal vacuum, and then filling it with expansive strict liability, Providence Health ranks high on our worst decision list.  We pummeled Providence Health here.
5. This entry is from neither the Reed Smith nor the Dechert sides of the Blog.  In re Zantac (Ranitidine) Litigation, 2024 WL 2812168 (Del. Super. June 3, 2024) (“Ranitidine”).  Delaware claims itself to be the legal home of more than a million business entities, including more than two thirds of Fortune 500 companies.  This is in no small part because Delaware has become known as a place where corporations can receive reasonable, fair-minded treatment in court.  This Ranitidine decision, allowing junk science into evidence in a coordinated proceeding of nearly 75,000 cases, threatens the First State’s good reputation.  Over the course of over 300 pages, the trial court adopted virtually every pro-plaintiff position that the federal Zantac MDL (2022+4) rejected when it refused to admit the same theories under the nearly identical federal Rule 702. It’s hard to know where to begin on all the ways that Ranitidine got it wrong, which is why it qualifies as the worst trial court decision (state or federal) of 2024.  The decision permitted unscientific testing, cherry-picked data, litigation-driven reasoning, and plain sloppy science − all based on the outdated and incorrect premise that these challenges merely speak to “weight not admissibility.”  But we have to say that most troubling were the rulings that cut across all experts.  First, Ranitidine permitted general causation opinions based on studies relating to whether NDMA − as opposed to ranitidine, the active ingredient in the defendants’ drugs − causes cancer.  That assumes what the plaintiffs’ experts opine, since NDMA is known to be carcinogenic.  However, no reliable scientific evidence exists to establish that ranitidine has that property.  Second, Zantac failed to require that the plaintiffs’ experts identify any sort of “threshold dose,” that is, the minimum dose where any harm can occur. This is fundamental scientific fallacy, and threshold dose is absolutely critical in a litigation like this, where the substance NDMA is found in air, water, and all manner of foods without causing cancer.  The trial court’s reasoning is exactly the sort that the federal Rule 702 amendments were designed to prevent.  The silver lining is that this opinion was so bad that, since our prior post on this case, the Delaware Supreme Court has done something it rarely does, and has accepted the defendants’ interlocutory appeal.  We hope that court will right this wrong and we’ll see it on next year’s 10 best list.  Some of us rebuked Ranitidine here.
6. Huertas v. Bayer US LLC, ___ F.4th ___, 2024 WL 4703136 (3d Cir. Nov. 7, 2024).  In 2018, the Third Circuit, in a non-prescription medical product decision, rejected standing for product liability plaintiffs seeking money for nothing – alleging only that they didn’t know that the product, which they had used successfully and without any injury or risk of injury, had a concealed carcinogenic contaminant.  That decision held that “buyer’s remorse, without more, is not a cognizable injury,” and denied standing.  Fast forward six years, and Huertas, reversed dismissal of a factually indistinguishable (also involving carcinogen allegations) no-injury class action against a recalled OTC drug on one of the flimsiest attempts at distinguishing otherwise controlling precedent that we’ve ever seen.  The basis of Huertas’ distinction was that, while the prior plaintiffs had not pleaded that the product was “defective,” while the Huertas plaintiff did.  The contaminant in the prior, controlling case was asbestos, however, which under New Jersey law, which Huertas purported to apply, has been held in scores of decisions to be a product defect.  Moreover, easily correctable pleading deficiencies played no part in the reasoning of the prior controlling case.  What mattered in that case, as in Huertas, was the plaintiff class pleaded no purported damages beyond buyer’s remorse.  The Huertas class’ purported damages amounted to, at most, not using a single partial tube of an OTC fungicide.  Huertas thus thumbed its nose at both controlling precedent and the fundamental precept that de minimis non curat lex.  But for some silver linings, Huertas could have ranked higher (lower?) on today’s list.  We heckled Huertas here.
7. Herzog v. Superior Court, 321 Cal. Rptr.3d 93 (Cal. App. 2024), review denied (Cal. Aug. 28, 2024).  A decision we cannot discuss.
8. In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2024 WL 776757 (D.N.J. Feb. 26, 2024).  If it’s Valsartan, you know it has to be bad.  This benighted MDL has previously generated decisions that “graced” our worst of lists for three of the last four years (2023-1, 2021-4, 2020-10) so why should 2024 be any different?  Unfortunately, it’s not, and thus Valsartan breaks a tie and holds the record for most negative appearances on our year-end lists.  Certified product liability class actions have been rarer than hen’s teeth in recent years, but last year’s worst case of all certified no fewer than four of them in one fell swoop with the express intent of forcing the defendants to settle.  Not surprisingly the defendants sought an interlocutory appeal, but unfortunately the Third Circuit denied the petition without explanation.  Subsequent activity uncovered additional grounds (questionable damages experts and unsavory would-be class representatives) why these unprecedented classes should never have been certified, so the defendants moved to decertify.  In denying that motion, Valsartan did something else unprecedented – it asserted that the Third Circuit’s summary order was an “affirmation” of the aforesaid class certifications.  But law of the case doesn’t work that way.  A previous appeal must actually be decided on the merits to be law of the case.  Such a ruling was doubly inappropriate in the class certification context, given that Fed. R. Civ. P. 23(c)(1)(C) expressly provides that “[a]n order that grants or denies class certification may be altered or amended before final judgment.”  The class certification order itself was our worst decision of last year, and for giving a facially invalid reason for refusing to reconsider that order, this year’s Valsartan decision makes this year’s list.  We vented about Valsartan here.
9. Dressen v. AstraZeneca AB, 2024 WL 4666577 (D. Utah Nov. 4, 2024).  The Public Readiness & Emergency Preparedness (“PREP”) Act was written by Congress to facilitate the emergency production of so-called “covered countermeasures” – including vaccines − during public emergencies.  Among other things, the PREP Act was designed to overcome fears of product liability by those asked to manufacture experimental anti-pandemic products at breakneck speed.  Thus, the PREP Act has the most extensive language precluding state (or federal) liability that we have seen in any statute anywhere, including both preemptive and immunity language.  As our PREP Act scorecard demonstrates, until Dressen, no PREP Act-protected vaccine manufacturer had ever lost a dismissal motion in a personal injury case.  Plaintiff claimed that the defendant had violated “contractual” language in the informed consent agreement that she signed when she received the defendant’s vaccine.  However, the language allegedly concerned reimbursement for medical expenses and personal injuries.  So it was really a tort claim poorly disguised as a contract claim.  Even that shouldn’t have mattered, because the broad statutory preemption and immunity language made no distinction between tort and contract claims.  Rather, preclusion of liability turned on whether the “countermeasure” had been “prescribed,” “dispensed,” or “administered,” all of which indisputably occurred in Dressen.  Thus, the claims in Dressen were all within the express terms of the PREP Act’s preemption and immunity language.  So Dressen simply ignored what the statute stated and relied on cases involving would-be “countermeasures” that, due to one defect or another, were never actually administered to anyone.  Then Dressen asserted that the plaintiff’s damages – all personal injury related – were “caused” by the claimed breach of contact rather than the vaccine.  But the but for cause had to be the vaccine’s administration, since without that, the plaintiff’s alleged damages would not have happened.  As a backup, Dressen claimed the statute’s broad preemption language was “absurd,” because without the allegedly breached contract, people would be deterred from getting experimental vaccines, which was supposedly contrary to the basic purpose of the PREP Act.  The only thing “absurd” about Dressen was that rationale.  Nearly 270 million Americans received experimental COVID-19 vaccines authorized under the PREP Act.  Almost none of them had any contract of the sort alleged in Dressen.  They received these vaccines because it was their best available medication for avoiding COVID-19, which killed well over a million Americans.  Finally, the PREP Act did not render any contractual provision “illusory,” as Dressen repeatedly stated.  That plaintiff had the same ultimate recourse that every other vaccinated American had, which was the Countermeasures Injury Compensation Program that the PREP Act also created.  Dressen is an example of spherical error; it is wrong anyway one views it.  We deconstructed Dressen here.
10. Ahmed v. Johnson & Johnson Healthcare Systems, Inc., 2024 WL 693078 (S.D. Ala. Feb. 20, 2024), reconsideration & certification denied, 2024 WL 947447 (S.D. Ala. March 5, 2024).  Ahmed takes the last spot on our bottom ten list because it bizarrely allowed a plaintiff claiming injury from an implanted medical device to get away with having no medical expert, yet still avoid summary judgment on causation.  Ahmed was contrary to Alabama law as stated by both the Alabama Supreme Court, generally, and the Eleventh Circuit (and a half dozen district court decisions), in the specific context of prescription medical product liability litigation.  It was not that the plaintiff in Ahmed did not think about getting medical testimony.  Plaintiff simply failed to call the medical expert she had lined up, who was listed only as a “rebuttal witness.”  So plaintiff avoided summary judgment, despite bearing the burden of proof, without any medical testimony at all – in a case involving the alleged cause of the breakage of a metal weight-bearing implant.  Ahmed let plaintiff skate on basic medical causation point by holding that a broken device case wasn’t  “complex.”  But Ahmed cited nothing for that remarkable conclusion, only distinguishing the defendant’s authority.  The jury, unguided by any affirmative medical testimony could conclude “that the damages over which Plaintiff sues resulted from the [implant’s] failure and not some alternate cause.”  Why?  Pure “temporal relationship.”  That’s just wrong under controlling Eleventh Circuit precedent, and even under the cases that Ahmed cited.  And it’s loud wrong, too, as the defendant’s motions for reconsideration and certification were both denied.  We abhorred Ahmed here.

Finally, we’re done, and not a moment too soon.  Now that we’ve finished with this judicial roadkill, and recovered from excessive exposure to jurisprudential brain worms, we’ll move on to something much more pleasant – our discussion, next week, of the top ten best drug/device decisions of 2024.