Another year bites the dust.  We have just about made it through 2023, and while we have compiled our annual top ten best prescription medical product liability litigation decisions, we have the same sense with these as we did with last week’s bottom ten – in 2023 the favorable (as well as unfavorable) results from our product liability sandbox were rather overshadowed by impactful decisions elsewhere  Eligibility for our top (or bottom) ten lists requires that the decision:  (1) involve a prescription medical product, or OTC drug, and (2) have a plaintiff asserting liability for something purportedly wrong with that product.

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both.  In 2023, these include United States ex rel. Polansky v. Executive Health Resources, Inc., 599 U.S. 419 (U.S. 2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) (here); Quishenberry v. UnitedHealthcare, Inc., 532 P.3d 239 (Cal. 2023) (rejecting any express anti-preemption presumption in Medicare case) (here); Baker v. Croda Inc., 304 A.3d 191 (Del. 2023) (no medical monitoring in Delaware) (here); Brown v. Saint-Gobain Performance Plastics Corp., 300 A.3d 949 (N.H. 2023) (same, in New Hampshire) (here); In re E. I. du Pont de Nemours & Co. C-8 Personal Injury Litigation, 87 F.4th 315 (6th Cir. 2023) (huge certified PFAS class action dismissed for lack of standing) (here); Torrey v. Infectious Diseases Society of America, 86 F.4th 701 (5th Cir. 2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) (here); National Association of Wheat Growers v. Bonta, 85 F.4th 1263 (9th Cir. 2023) (First Amendment likewise bars Prop 65 from compelling product manufacturer to add scientifically questionable cancer warning) (here); In re Kirkland, 75 F.4th 1030 (9th Cir. 2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) (here); Carson v. Monsanto Co., 72 F.4th 1261 (11th Cir. 2023) (en banc) (no presumption against preemption; “force of law” of agency ruling a non-issue in express preemption) (here); In re Ford Motor Co. F-150 & Ranger Truck Fuel Economy Marketing & Sales Practices Litigation, 65 F.4th 851 (6th Cir. 2023) (Buckman preemption barred MDL asserting fraud on EPA), cert. denied, 144 S. Ct. 332 (2023) (here); Sanofi Aventis U.S. LLC v. United States Department of Health and Human Services, 58 F.4th 696 (3d. Cir. 2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) (here).  All of these decisions should come in handy in the future, and a lot of them seem more significant than what follows here.

But that doesn’t in any way mean that our top ten decisions aren’t also significant, particularly since they are directly applicable, and not merely analogous, to the arguments we make in defense of our prescription medical product clients.  This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert.  They excluded bogus expert testimony under Fed. R. Civ. P. 702 (don’t say Daubert), both before and after the new, more muscular version of Rule 702 debuted on December first.  They applied the learned intermediary rule, another of our favorite defenses.  They blew out nuclear verdicts.  They rejected novel liability theories and even trimmed large numbers of cases in our increasingly dysfunctional and lawless federal multi-district litigation system (which has grown to 80% of the total federal docket).  They may even do more than one of these.  So here they are, our 2023 top ten prescription medical product liability decisions

1. In re Zofran (Ondansetron) Products Liability Litigation, 57 F.4th 327 (1st Cir. 2023).  Zofran demonstrated, yet again, that where applicable, preemption is the strongest defense our clients have.  Dismissal of an entire MDL unanimously affirmed.  Plaintiffs were trying to turn this drug into the next Bendectin, with bogus birth defect claims attacking a common off-label use.  Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing (2011+1) independence principle, but off-label use did not really figure in Zofran’s analysis.  Instead, Zofran turned mainly on animal studies – three Japanese studies that were not “newly acquired information” that could avoid preemption.  Plaintiffs lost because those studies were old news – the FDA reviewed that same type of information (same species, doses, and risks) five times thereafter and each time found no scientific support for a teratogenicity warning.  There was nothing new or different about them.  Further, none of those three studies showed any statistically significant increased risk – which was why there was nothing new.  No other study did, either.  Nevertheless, plaintiffs found some paid expert who opined that the three studies were “newly acquired information.”  That opinion was “likely inadmissible” as an improper legal opinion.  Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted.  At bottom, plaintiffs were improperly seeking to have courts second-guess the FDA’s methods and conclusions.  Zofran also “presumed,” but did not directly hold, that:  (1) newly acquired information was a prerequisite to the CBE unilateral warning change option; (2) newly acquired information was a legal conclusion; and (3) a litigation opinion could not be such information.  In the end, however, the three studies didn’t matter, because Zofran also held as a matter of law that the record contained “clear evidence” that the FDA would not have permitted the warning plaintiffs wanted.  The FDA’s five reviews of teratogenic risk all came to the same conclusion.  The most recent of those occurred during the litigation itself, thus “the FDA was also fully informed of plaintiffs’ contentions and the opinions of plaintiffs’ experts,” and still didn’t require a warning.  That demonstrates the importance of the FDCA amendment that authorized the FDA to act on information, no matter what the source, that warrants a warning change.  The FDA said there was insufficient data, so plaintiffs’ claims to the contrary were necessarily preempted.  We predicted Zofran as the 2023 zenith here.
2. Center for Environmental Health v. Perrigo Co., 305 Cal. Rptr.3d 587 (Cal. App. 2023), review denied (Cal. June 21, 2023).  A favorable preemption ruling also holds down our number two slot.  California’s notorious Proposition 65 has produced a super abundance of two things – boilerplate cancer warnings and litigation.  Prop 65 warnings also put the lie to the premise of the so-called “heeding presumption,” because if Californians heeded all those warnings, they could not buy or do anything.  In CEH, the plaintiff tried to extend the scope of Prop 65 to over-the-counter drugs, to no avail.  Specifically, they sought to require cancer warnings for purported breakdown products of ranitidine.  As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac (2022+4) MDL opinions.  Legally the State of California – or, more accurately, a private litigant purporting to exercise state powers – has no such power, because warnings on OTC drugs must be approved by the FDA.  OTC drugs also have an express preemption provision, but it contains an exception for Prop 65.  Thus, CEH turned on implied impossibility preemption, specifically an application of Mensing (2011+1) independence principle.  The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65.  The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law.  Indeed, even the weird alternatives the plaintiff advocated, such as “point of sale” signs and DTC advertising (assuming these were Prop 65 remedies at all), were still FDA-regulated labeling.  Express and implied preemption operate independently (see Buckman), thus the express Prop 65 saving clause was irrelevant.  We cackled over CEH here.
3. Cates v. Zeltiq Aesthetics, Inc., 73 F.4th 1342 (11th Cir. 2023), cert. denied, 2023 WL 8532103 (U.S. Dec. 11, 2023).  In Cates the plaintiff encountered an unusual – so unusual as to be called “paradoxical” − but known, adverse reaction.  The device labeling specifically mentioned it.  The prescribing cosmetic surgeon knew about it.  Plaintiff knew about it, too, since he signed an informed consent document mentioning it.  But there are more personal injury suits per capita in Florida than anywhere else, so of course plaintiff sued anyway.  And lost.  And lost again on appeal in Cates.  Not surprisingly, the warning was adequate as a matter of law.  Further, “adequacy” is an objective standard, that neither a plaintiff’s self-interested testimony nor equivocal health care provider testimony can touch.  Plaintiff also brought a design defect claim.  While the Eleventh Circuit could have saved itself some ink by following Florida law (Cavanaugh (2020+9)) precluding use of the consumer expectation in prescription medical device cases, it did the next best thing, holding that plaintiff’s design claim failed under both the consumer expectation and risk/utility tests for such defects.  First, a known and warned about adverse reaction is not a design defect at all.  Second, plaintiff could not make out a risk/utility design defect because he had no alternative design to offer.  Third, and most critically in this particular case, the consumer expectation standard is also objective, and the relevant consumer is the physician, given Florida’s adoption of the learned intermediary rule.  These propositions once again put the manufacturer’s warnings front and center.  Since the injury at issue was indisputably a “known side effect” of the device, plaintiff’s consumer expectation version of design defect also failed.  Once again, the test is objective, so a nurse’s purported misunderstanding of the risk did not create an issue of fact.  “We evaluate an ‘objective’ medical provider’s expectations, not” any “particular” person’s.  Moreover, even if the learned intermediary rule did not limit the “consumer” to the prescribing physician, the numerous mentions of this adverse reaction – including in an informed consent document that plaintiff signed – placed it “well within the range of side effects that [defendant’s] messaging would lead a reasonable consumer to expect.”  Plaintiff’s subjective expectation didn’t create an issue of fact either.  That plaintiff didn’t think he would be one of the unlucky few did not create any legitimate expectation of perfection.  While the opinion could have been shorter, and perhaps even sweeter, all the “even ifs” resulted in favorable, precedential (in federal court) rulings on a greater range of design defect-related issues.  We complimented Cates here.
4. In re Acetaminophen-ASD-ADHD Products Liability Litigation, ___ F. Supp.3d ___, 2023 WL 8711617 (S.D.N.Y. Dec. 18, 2023).  Our best expert admissibility/Rule 702 (and best trial court) decision of 2023 was issued earlier this month, shortly after the Rule 702 amendments went into effect.  Acetaminophen excluded all five of the plaintiffs’ MDL causation experts, which should eventually result in the dismissal of all 500 or so autism claims.  While the five excluded experts were all well-credentialed, their science was, in a word, terrible.  They stuck their heads in the sand to ignore blatant selection bias and numerous confounding factors in the published human data, while relying on a single statistically significant result in a multi-endpoint study that the study’s own authors thought was probably the result of random chance.  Nor could animal studies salvage their multiple epidemiologic failures.  To reach their pre-ordained causation opinions, plaintiffs’ experts coined a new word, never before seen in any Rule 702 decision – “transdiagnostic” − and after the number Acetaminophen did on it, that word will probably never be seen again.  Acetaminophen correctly viewed the experts’ “transdiagnostic approach” as an epidemiological equivalent to the political practice of flooding the zone with irrelevant and confusing material.  These opinions in search of a rationale (one expert had a prior contrary publication) did not become admissible via cherry-picking among research concerning multiple different diagnoses; that was “not generally accepted.”  Plaintiffs’ experts also unsuccessfully advanced the usual p-side mush – “weight of the evidence” and Bradford-Hill – that some decisions (before the latest Rule 702 amendments) had allowed.  Not here.  Even if those “flexible” methods might sometimes be reliable, the way these experts applied them was not.  Also of interest is Acetaminophen’s discussion of the FDA’s five reviews of the purported “risk” between 2015 and 2023, all of which ended the same way: that due to “limitations and inconsistent findings,” the science was “unable to support a determination of causality.”  While these five FDA findings (the last in response to the MDL court’s invitation for the FDA to participate directly in this litigation) were nails in these experts’ Rule 702 coffins, they would also support reversing this MDL’s prior adverse preemption decision (2016-10).  We could go on and on, since Acetaminophen was 148 pages long, but simply listing some adjectives used to describe the excluded opinions will have to do for now:  “obfuscate,” “result-driven,” “misrepresented,” “troubling,” “conclusory,” “incomplete,” “wholesale failure,” “highly questionable,” “misleading,” “skates over,” “unbalanced,” “result-driven,” “suspect,” and “alarming.”  Those criticisms are just of the first of the five experts.  Thus, Acetaminophen is not only thorough, but pungently entertaining as well.  We adulated Acetaminophen here.
5. Onglyza Products Cases, 307 Cal. Rptr.3d 480 (Cal. App. 2023), review denied (Cal. July 26, 2023).  Until Acetaminophen came along, Onglyza was our best decision of the year on expert admissibility.  Onglyza affirmed exclusion of the plaintiffs’ two general causation experts, an M.D. and a biostatistician, for not following any reliable methodology, as required by California’s Sargon decision.  His opinion was based on a risk that was one of multiple secondary endpoints in a single study that the authors cautioned was “unexpected,” may be a “false positive,” and that further investigation was needed.  Several follow-up studies did not find any association with that risk.  Nonetheless, the FDA required a label update, and litigation ensued.  In light of all the other research that had followed, the M.D. expert was properly excluded for giving undue and overwhelming weight to the one positive study when that study itself questioned that outcome.  And when an expert has nothing else, there are always the Bradford/Hill factors to misapply − or to ignore altogether.  The claimed association wasn’t “strong,” and other studies certainly weren’t “consistent.”  Thus, the expert couldn’t just disregard contrary human epidemiology and resort to animal studies that he wasn’t even competent to evaluate.  This cherry-picking evidenced a “shifting, results-based methodology” that wasn’t a real methodology at all.  Nor was there any “analogy,” since studies of other drugs in the same class actions had found nothing.  Nor any “plausible” mechanism, again since the study’s authors couldn’t explain the result, and no other study offered one.  With the M.D. expert properly sent packing, summary judgment was appropriate.  The other, biostatistical, expert did not (and wasn’t qualified to) offer a causation opinion.  Last, and least, Onglyza rejected any basis for allowing plaintiffs to proceed without any expert causation testimony at all.  All of those circled back to the one outlier study that could not alone support causation – even with an expert.  Having made a decision to offer only this bozo of an expert, plaintiffs were not entitled to a do over either.  We honored Onglyza here.
6. Hrymoc (actually McGinnis) v. Ethicon, Inc., 297 A.3d 1245 (N.J. 2023).  In Hrymoc, the New Jersey Supreme Court overturned an abusively obtained $68 million verdict in a pelvic mesh case because the trial court abused its discretion in excluding evidence of §510(k) clearance offered by the defendants.  Wait a minute – a state high court, demise of a nuclear verdict on an evidentiary issue that has been hotly contested nationwide?  Why isn’t Hrymoc rated higher than #5?  Patience, all will be explained.  First, the good news about Hrymoc is what the court did in Hrymoc itself.  The case was governed by North Carolina substantive law, and NC rejects strict liability altogether.  Negligence requires an evaluation of a defendant’s reasonableness, and all relevant NC authority includes relevant regulatory compliance in that mix.  Strike one.  Plaintiffs also grossly overreached, making the lack of any clinical trials for the particular device a centerpiece of their pitch to the jury.  But §510(k) clearance, which defendants could not mention, does not require such data.  Strike two.  Plaintiffs’ own litigation strategy thus opened the door to compliance evidence.  Strike three − $68 million is out.  That’s the good stuff.  What’s not so hot is Hrymoc’s statement that, under New Jersey law, “510(k) evidence is generally inadmissible” because of the same bogus Lohr-based elimination of any difference between preemption and admissibility that unfortunately has tainted pelvic mesh litigation generally (e.g., Cisson (2016-2)).  If compliance isn’t preemptive in a medical device case, then these cases conclude it isn’t admissible at all.  Hrymoc was tried in late 2017.  The next year, the New Jersey Supreme Court held, in an Accutane case, that henceforth all New Jersey mass torts will be governed exclusively by New Jersey law.  That makes Hrymoc a one-off exception from a general exclusion of §510(k) evidence.  Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence.  Given PMA preemption, this statute now applies to nothing.  So, there are good, even excellent, parts of Hrymoc that wipe out a nuclear verdict and penalize plaintiffs for making phony demands for clinical trials in §510(k) cases.  But the bad parts of Hrymoc detract from its favorable result and preclude any higher ranking.  We hemmed and hawed over Hrymoc here.
7. Alcozar v. Orthopedic & Sports Medical Center, 219 N.E.3d 195 (Ind. App. 2023).  We’ve had a special hostility to claims that assert FDCA violations as purported state-law “negligence per se” actions ever since some of us spent years developing defenses to such claims in the Bone Screw litigation.  While we believe that all such claims should now be preempted, given Buckman’s holding that the FDCA prohibits private enforcement, there are a variety of other defenses short of preemption.  Alcozar demonstrates one of them – improper assertion of purported FDCA “violations” that do not, in fact, exist, because the plaintiff interpreted an FDA regulation in some bizarre way that the FDA has not.  Plaintiffs in Alcozar asserted negligence asserted “violations” of a largely parallel Indiana “little FDCA” statute as their means of claiming some sort of state-law basis.  Alcozar didn’t buy it, since the particular regulations did not even apply to the clinics and health care providers that plaintiffs were targeting.  Instead, Alcozar held that the regulations at issue concerned “a completely different scenario” and “made no sense” in the context that plaintiffs sought to apply them.  Specifically, “it would be nonsensical to require directions for patient use for a drug that is injected into the patient by a doctor in a clinical setting.”  Adequate directions for use were something given to doctors by manufacturers, not by doctors to anyone else.  Further, as the regulations did not pertain to these defendants, their alleged violation could not possibly have been causal of the plaintiffs’ claimed injuries.  Alcozar thus demonstrates two of several the non-preemption defenses to FDCA-based negligence per se:  failure to prove a violation, and lack of causation by the claimed violation.  We applauded Alcozar here.
8. In re Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation, ___ F. Supp.3d ___, 2023 WL 5807340 (D. Mass. Sept. 7, 2023).  Better late than never.  The G/N MDL was created in 2013 and mostly settled in 2016.  But seven years after settlement, opt-out G/N plaintiffs remained.  Our #8 decision sought to clean up the leftovers, and ultimately dismissed thirteen opt-out plaintiffs on a variety of useful grounds.  The linchpin of the plaintiffs’ claims in this MDL was an internal corporate memo that concluded, under certain conditions, a particularly dangerous adverse event could occur.  But it was an MDL.  Frantic attorney solicitation led to the filing of numerous claims that did not conform to the conditions set out in the memo.  Presumably, the claims that fit the memo settled.  These were dismissed, because all of the experts that the plaintiffs engaged adhered slavishly to the parameters of the memo, meaning no causation for anyone else.  After the settlement, of course, counsel abandoned these leftovers, not wanting to invest in new experts.  First, the memo required that plaintiff’s blood tests show a certain ratio.  Ten plaintiffs didn’t.  They had no expert testimony supporting causation, so the defendant won summary judgment.  They had no warning causation case, either, because their own experts had testified that, at the blood levels they exhibited, no doctor would change their treatment.  Second, and even more basically, eleven plaintiffs didn’t have expert testimony that they ever had the conditions at issue in the MDL.  Same result – no causation.  Third, the MDL experts only targeted one of the two products in the MDL’s name.  Five plaintiffs only used the other product.  Same result – no causation.  Fourth, the defendant vigorously reacted to the memo.  It sent “several memoranda” to the plaintiffs’ prescribers alerting them to the emergent risk in extensive detail.  Those warnings were adequate as a matter of law, since they specifically warned of exactly what plaintiffs claimed happened.  Moreover, the underlying adverse reactions involved chemical imbalances that all physicians in the relevant specialty had known about since medical school.  So G/N additionally rejected any duty to warn the medical community, generally, about risks that any competent specialist could be expected to know and understand.  Useful propositions all, but why did it take a decade to ween out all of the plaintiffs whose cases lacked basic facts?  MDLs need early vetting. We gave G/N a hand here.
9. M.T. v. Walmart Stores, Inc., 528 P.3d 1067 (Kan. App. 2023), review denied (Kans. Aug. 25, 2023).  FDCA preemption is a powerful defense to prescription medical product liability litigation.  But it pales in comparison to express preemption under the Public Readiness and Emergency Preparedness (“PREP”) Act, which was designed to protect from litigation everyone involved in responding to a formally declared public health emergency.  COVID-19 was such a health emergency, and the PREP Act is why, despite an appalling degree of antivaxx agitation out on the hustings, there has been next to no actual product liability litigation concerning COVID-19 vaccines.  These vaccines are the epitome, indeed the apotheosis, of a “covered countermeasure” against the COVID-19 pandemic.  M.T., the first state appellate decision concerning the PREP Act and COVID-19 vaccination, makes that proposition crystal clear.  The plaintiff in M.T. must be a piece of work.  The suit was over her own daughter telling plaintiff to pound sand and getting vaccinated over plaintiff’s noisy antivaxx beliefs.  Not surprisingly, the daughter suffered no injury at all from being vaccinated.  Plaintiff’s claim against the pharmacy and its employee who administered the vaccine were a hodgepodge of invasion of privacy, “parental right of control,” battery, and informed consent claims, brought under the questionable auspices of the state’s (Kansas) consumer protection statute.  Every last one of these claims was PREP Act preempted.  Overcoming plaintiff’s intentional vagueness, M.T. took judicial notice that the vaccine was precisely that – and therefore a PREP Act covered countermeasure.  That meant both the pharmacist and the pharmacy where the vaccine was administered “covered persons” under the act.  Preemption did the rest.  Plaintiff’s complaints about “consent” related to the vaccination.  Preemption.  The breadth of preemption encompasses claims alleging both positive acts and omissions.  Plaintiff’s repeated attempts to raise nursing home jurisdictional cases failed because the only the scope of regular preemption was at issue.  The PREP Act’s broad express preemption language allowed no exclusion for either “intentional torts” or purported constitutional claims based on parental rights.  “The text of the Act is unambiguous” and preempts “all claims causally related to the administration by a covered person of a covered countermeasure.”  Good-bye and good riddance.  We mightily trumpeted M.T. here.
10. Kampmann v. Procter & Gamble Co., ___ F. Supp.3d ___, 2023 WL 7042531 (C.D. Ill. Oct. 24, 2023).  Kampmann made our list because it gave the back of the hand to a novel liability theory involving over the counter (“OTC”) drugs.  The plaintiffs’ bar has been giving OTC drugs increasing attention for a variety of reasons, so rejection of heretofore unprecedented liability was a welcome development.  The theory was similar to the awful Center for Inquiry decision from last year (2022-5), but fortunately reached a diametrically opposite result.  Kampmann attacked a so-called “Daytime Convenience Pack” because one of the two separate items packaged together allegedly deceived consumers that it could independently treat the common cold.  Thus, the claim was another variation on the mere proximity of products to one amounted to an actionable representation that they both did same thing, when the actual labeling not only made no such claims – but stated exactly the opposite, in all capital letters.  Kampmann rejected plaintiff’s primary argument that mere juxtaposition of two products could be an implied misrepresentation.  Juxtaposition was not an actual communication.  To the extent plaintiff alleged an omission, the express disclaimer overcame it.  Nor could plaintiff privately enforce the FDCA, so an attempt to rely on an FDA proposed rule to create their unprecedented duty also came to naught.  Finally, the throw-away claim for injunctive relief was thrown away.  Plaintiff’s counsel “has been advised on multiple occasions, by courts throughout the country,” that a plaintiff who is already aware of a alleged deception, can’t be injured by it and thus lacks standing to seek an injunction.  We gave kudos to Kampmann here.

So, there you have it.  Those decisions are our top ten picks as the best drug/medical device – and, yes, vaccine − decisions of 2023.  If any of these are your cases, the Blog congratulates you.  If not, we wish you better luck next year.

We’re not finished, however.  We like celebrating favorable precedent, so we also present our annual list of runners up, consisting of what we consider the next ten most favorable decisions of 2023.

Honorable Mentions:  (11) In re Bair Hugger Forced Air Warming Devices Products Liability Litigation, ___ F. Supp.3d ___, 2023 WL 5541638 (D. Minn. July 10, 2023) (here).  No doubt terrified that the court would look favorably on a renewed Rule 702 expert exclusion motion, after the judiciary toughened up that rule as of December 1, 2023, plaintiffs attempted to recuse the judge – and got their heads handed to them.  (12) Kelley v. C.R. Bard, Inc., 2023 WL 2565853 (N.D. Ga. March 17, 2023), reconsideration denied, 2023 WL 3032063 (N.D. Ga. April 21, 2023) (here).  Georgia law requires admission of evidence of regulatory compliance, that includes §510(k) FDA clearance, which means that the Fourth Circuit got Georgia law wrong in Cisson (2016-2).  (13) McGee v. Johnson & Johnson, ___ F. Supp.3d ___, 2023 WL 4765454 (W.D. Pa. July 26, 2023) (here).  Recognizing that Stengel (2013-2) has been overruled and concluding, after detailed analysis that Pennsylvania would not impose liability for purported failure to report adverse events to the FDA.  (14) Jankowski v. Zydus Pharms USA, Inc., 2023 WL 4700651 (3d Cir. July 24, 2023) (here).  Dismissal of dozens of plaintiffs affirmed on grounds of generic preemption, and particularly no duty to send Dear Doctor letters diverging from the FDCA’s sameness requirement.  (15) In re Zantac (Ranitidine) Products Liability Litigation, 343 F.R.D. 347 (S.D. Fla. 2023) (here).  Plaintiffs’ attempt to avoid filing fees for some 58,000 “registry claimants” by suing with massive, multi-plaintiff complaints soundly rejected for precedential and practical reasons.  (16) Daniels-Feasel v. Forest Pharmaceuticals, Inc., 2023 WL 4837521 (2d Cir. July 28, 2023) (here).  The Second Circuit affirms expert exclusion (three experts) and summary judgment in six consolidated cases by rejecting those experts’ “weight of the evidence” opinions for cherry-picking and misapplication of Bradford/Hill.  (17) In re Tasigna (Nilotinib) Products Liability Litigation, 2023 WL 6064308 (Mag. M.D. Fla. Sept. 18, 2023) (here).  We’ve always believed that MDL plaintiffs should be subject to the same rigorous ediscovery obligations as defendants are; Tasigna did just that.  (18) In re Bard IVC Filters Products Liability Litigation, 81 F.4th 897 (9th Cir. 2023) (here).  We don’t care all that much, but this is the first published appellate decision that MDL p-side “participation agreements” are enforceable even in the signatories’ non-MDL cases.  (19) Klinker v. Johnson & Johnson, 2023 WL 358923 (E.D. Cal. Jan. 23, 2023) (here).  Plaintiff lost both on learned intermediary causation (prescriber testimony) and on design defect (his own expert’s vague testimony).  (20) Costa v. Johnson & Johnson, 2023 WL 2662903 (D.R.I. March 28, 2023) (here).  Thorough analysis adds Costa to the list of cases predicting that Rhode Island will adopt the learned intermediary rule.

Our 2022 collection of cases also features these near misses – another group of  well-earned victories, all in federal district court: Garcia v. Sanofi Pasteur Inc., 2023 WL 6387171 (E.D. Cal. Sept. 29, 2023) (enforcing Vaccine Act preemption) (here); United States ex rel. Krahling v. Merck & Co., 2023 WL 8367939 (E.D. Pa. July 27, 2023) (summary judgment against a long-lasting (13 years) FCA claim that was really a product liability claim, finding all plaintiff’s allegations immaterial) (here); Novotney v. Walgreen Co., ___ F. Supp.3d ___, 2023 WL 4698149 (N.D. Ill. July 20, 2023) (OTC preemption precluded plaintiff from disputing FDA’s product monograph) (here); Hawkins v. SSM Health CARE Corp., 2023 WL 4363901 (E.D. Mo. July 6, 2023) (FDCA violations “throughout” complaint established federal question jurisdiction over purported negligence per se claim) (here); Thelen v. Somatics, LLC, 2023 WL 3947945 (M.D. Fla. June 12, 2023) (excluding general causation opinion as ipse dixit under Rule 702) (here); In re Proton Pump Inhibitor Products Liability Litigation, 2023 WL 3173373 (D.N.J. May 1, 2023) (dismissing numerous MDL plaintiffs for not bothering even to serve the defendant) (here); Brashear v. Pacira Pharmaceuticals, Inc., 2023 WL 3075403 (S.D. Ohio April 25, 2023) (warning claim preempted that would have required change to drug “highlights”; design claim also preempted) (here); Rivers v. Nice Recovery Systems LLC, 2023 WL 2525209 (D.R.I. March 15, 2023) (no personal jurisdiction where plaintiff obtained prescription from out-of-state physician) (here).

Looking to the future, the only still outstanding appeal in our 2023 top ten is in G/N (1st Cir. #23-1820).  As indicated above, unsuccessful appeals were taken from four other of our top ten decisions.  An appeal has been filed (11th Cir. #23-13892) in the Thelen case that produced one of our “see also” cases this year, but since that case went to trial, the issues could be much different.  From our best/worst of 2022, certiorari petitions were denied in People v. J&J (2022-2), and Blackburn (2022-10), as was a further appeal in Amiodarone (2022+2) so those are all final.  Due to the complexity of the Zantac MDL, it took a while just to obtain the requisite final appealable orders, but appeals from several Zantac orders (2022+4, 2021+10, and 2021+18) are now pending (we think).  The Zostavax win (2022+10) that resulted in dismissal of over 1,000 plaintiffs for failure to comply with an MDL Lone Pine order has also been appealed (3d Cir. #23-1032).

Of the learned intermediary rule cases we mentioned last year, Himes (here) remains pending in the California Supreme court, as does Muhammad in the Illinois Supreme Court.  The two others produced unpublished, non-citable appellate decisions.  Rennick v. Teleflex Medical, Inc., 988 N.W.2d 680 (Wis. 2023) (mem.); Doring v. Apyx Medical Corp., 2023 WL 5156763 (Colo. App. Aug. 10, 2023) (mem.).  We assume from last year that appeals from the Fosamax (2022+5) and Huntington (2022+8) remain pending – they sure haven’t been decided yet.  We also skimmed over a couple of earlier years of our top/bottom ten lists.  We didn’t see any other decision, pro or con, that involved any further appellate review.

Looking to the future, we know that the quasi-generic preemption appeal to the Fifth Circuit in Taxotere (Hickey v. Hospira) remains pending.  Appeals asserting dormant Commerce Clause as a defense to registration-based general jurisdiction, as suggested by the concurrence in Mallory v. Norfolk Southern Railway Co., 600 U.S. 122 (2023), are beginning to percolate through the Pennsylvania courts, and may see appellate action as soon as late 2024.  Some other pending prescription medical product-related appeals we’re watching are In re National Prescription Opiate Litigation, 2023 WL 826311 (Ohio Nov. 29, 2023) (accepting public nuisance appeal), Gilead Sciences, Inc. v. Superior Court, No. A165558 (Cal. App. 1st Dist.) (duty to innovate), and Shears v. Ethicon, Inc. in the West Virginia Supreme Court of Appeals concerning alternative design in an medical device case.

Finally, on the administrative front, the most significant development of 2023 is the completion of the amendments to Fed. R. Evid. 702 (here), which became effective in December 2023.  Also of significance, at least to us, was the FDA’s proposal to loosen restrictions on so-called “off-label promotion” by regulated manufacturers.  It’s long overdue, but welcome nonetheless.

We’re not aware of any pending national legislation with any significant chance of passage that would impact on prescription medical product liability litigation.  A couple of significant, and unfortunate, state legislative changes occurred during 2023.  In Michigan, the longstanding presumption of non-defectiveness enjoyed by FDA-approved products was repealed.  See 2023 Mich. Legis. Serv. P.A. 285 (S.B. 410).  In California, the legislature sort of overruled the holding in Kline v. Zimmer (2022+6), that defense experts need not testify to “reasonable medical certainty” since defendants don’t bear the burden of proof.  We say “sort of” because the new provision provides that it “does not preclude a witness testifying as an expert from testifying that a matter cannot meet a reasonable degree of probability in the applicable field, and providing the basis for that opinion.”  Cal. Evid. C. 801.1(b).  That’s a big exception, since that’s what most defense experts giving such testimony are trying to establish – that plaintiffs can’t meet their burden.

See you in 2024.