So, another year has passed. 2022 is in the books and the republic still stands, even if Roe v. Wade (and, soon, Twitter) do not. The COVID-19 pandemic – if not COVID-19 itself, which has instead become endemic – is largely over, except for some probably PREP Act preempted shouting.
For the Blog, the end of the year means that it’s time for our annual celebration of the Drug & Device Law Blog’s top ten decisions of the year. Some of these cases establish important legal principles, such as preemption, Rule 702 expert exclusion (don’t say Daubert), or the learned intermediary rule. Others are important because they affect large numbers of cases gathered in the increasingly dysfunctional federal multi-district litigation system. Some do both. In either event, these decisions make the legal world at least somewhat less dangerous for our clients and (not incidentally) more favorable for us defense lawyers.
In making these choices, we keep our focus on what we do, which is defending product liability litigation involving prescription medical products and OTC drugs. Eligibility for our top (or bottom) ten lists requires that the decision: (1) involve such a product, and (2) have a plaintiff asserting liability for something purportedly wrong with that product. During the year, we discuss a variety of other decisions that have a significant impact on what we or our clients do, but pertain to either different products or different types of claims. In 2022, we’ll give shout-outs to Nemeth v. Brenntag North America, 194 N.E.3d 26 (N.Y. 2022) (an excellent toxic tort causation/expert exclusion case, here); Hayes v. University Health Shreveport, LLC, 332 So.3d 1163 (La. 2022) (health care providers can damn well fire at-will employees who refuse to get vaccinated, here); California Chamber of Commerce v. Council for Education & Research on Toxics, 29 F.4th 468 (9th Cir. 2022) (California’s Proposition 65 is subject to First Amendment restrictions on compelled speech, here); Recht v. Morrissey, 32 F.4th 398 (4th Cir. 2022) (First Amendment does not prevent state regulation of misleading attorney advertising, here); Thornton v. Tyson Foods, Inc., 28 F.4th 1016 (10th Cir. 2022) (food misbranding claims cannot be based on governmentally approved statements, here); several decisions rejecting compelled ivermectin claims; In re Paraquat Products Liability Litigation, 2022 WL 451898 (S.D. Ill. Feb. 14, 2022) (rejection of product-based public nuisance, here); Bell v. American International Industries, ___ F. Supp.3d ___, 2022 WL 16571057 (M.D.N.C. Sept. 13, 2022) (exposing junk science nature of journal article, and accompanying concealment of data, by a mass tort plaintiffs’ expert, here); Quinteros v. InnoGames, 2022 WL 898560 (W.D. Wash. March 28, 2022) (computer code is not a “product,” here).
All should come in handy in the future.
Time to get on with it. Here are 2022’s top ten decisions
- Dearinger v. Eli Lilly & Co., 510 P.3d 326 (Wash. 2022). Our best case of 2022, and our only state high court win of the year, is a decisive defeat for plaintiffs still looking to undo the learned intermediary rule. Not one justice of the Washington Supreme Court was convinced, even on a federal-court certification, which tends to promote expansion of liability by presenting legal questions largely divorced from any broader factual context. First, the passage of a product liability statute that did not mention the rule did not work an implied repeal. Implied repeal of common-law principles is not a thing in Washington, since any repeal must have the support of clear legislative intent. Dearinger batted down that Hail Mary pass. Nor did the existence of “consumer expectation” as a design defect test, create some sort of direct-to-consumer (“DTC”) advertising exception to the learned intermediary rule concerning warnings. The rule exists because physicians are in the best position to explain to patients the risks of the drugs they prescribe. The existence of DTC advertising does not detract from that policy. Such advertisements do not mean that doctors abdicate their independent responsibilities, and if that happens in a particular case, medical malpractice is the proper remedy. Nor does DTC advertising do away with the FDA’s prescription requirements. With the policy reasons for the learned intermediary rule intact, Dearinger rejects any DTC exception. Thus, plaintiffs once again failed to convince a court – any court – outside of New Jersey to adopt an otherwise universally rejected exception. Twenty-three years ago, the New Jersey Supreme Court thought it would start a trend by using product liability to punish drug companies that advertised their products to the public. Rather, Dearinger shows that New Jersey should reconsider its outlier position. We delighted in Dearinger here.
- Amiodarone Cases, 300 Cal. Rptr.3d 881 (Cal. App. 2022). We’ve noticed that the learned intermediary rule is also under concerted attack in California. Despairing of getting any court to reject the rule outright, plaintiffs have come up with various arguments seeking to shrink the scope of the rule into non-existence. Those efforts failed miserably in Amiodarone. Mix that with a favorable preemption ruling, and we have our second best case of the year, notwithstanding its intermediate appellate status. Because it is a generic drug, amiodarone presents preemption problems for plaintiffs. First, the medication guides. As they have elsewhere, plaintiffs try to dodge preemption by claiming medication-guide-related failures, but the learned intermediary rule is incompatible with that duty. Since there is no state-law duty to warn patients directly, California’s Sherman Act (which in some ways mirrors the FDCA) doesn’t help plaintiffs because it exempts FDA-regulated prescription drugs from its labeling requirements. Moreover, given the learned intermediary rule, any duty to give them medication guides is purely federal, which Buckman preemption precludes private plaintiffs from using as the basis of a claim. So plaintiffs attacked the rule, claiming first it was an affirmative defense that, in California, cannot be the basis of a pleading-based motion. Not so. The rule determines who is owed a warning duty. It is not an affirmative defense, and no California case had ever so held. Thus, California plaintiffs must plead and prove it. Nor does the learned intermediary rule vanish merely because a plaintiff claims an inadequate warning. That is every warning case, so this bogus argument would have effectively abolished the rule. Second, it’s California, so there’s an innovator liability angle against the branded manufacturers, but that has problems too, since the only alleged branded misrepresentations were based on FDA warning letters from 1989 and 1992 – thirty-plus years ago. What doctor is going to testify to relying on thirty-year old statements by a different manufacturer in prescribing a drug? Not only that, but those old warning letters had nothing to do with what the plaintiffs claimed were misrepresentations. Maybe plaintiffs would say anything, but that gets back to the learned intermediary rule as well. One final favorable note, the branded defendants were not responsible for statements in medical articles because the plaintiffs’ allegations did not establish that the authors were their agents. We adulated Amiodarone here.
- Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., 48 F.4th 1040 (9th Cir. 2022), is an economic loss product liability case with potentially massive implications. Plaintiff alleged that the defendant’s drug, which was pharmacy compounded, should never have been sold because it required FDA approval as a “new drug,” something it indisputably did not have. These allegations put the court deep into the weeds of the FDA’s regulation of pharmacy compounding regulations as these claims turned on whether or not the defendant’s compounded product was “essentially a copy” of some other FDA approved drug. Plaintiff could not privately enforce the FDCA, but tried to avoid Buckman by claiming that the laws of “several states,” including California, mirrored the FDCA and, as a matter of state law, separately prohibited the sale of non-FDA-approved drugs and under them plaintiff could recover for being “harmed economically because the defendant violated the FDCA.” The Ninth Circuit said no. Nexus was not bringing a “traditional tort law” claim, but rather was trying to launder FDCA-centric claims through purportedly identical state statutory provisions. Plaintiff could not avoid Buckman preemption and exclusive FDA enforcement by asserting violations based solely on FDCA provisions as identical state-law claims. “The plaintiff tried to assert claims under other laws, but they were based on putative violation of the FDCA,” and “a private action brought under [other laws] may not be pursued when . . . [it] would require litigation of the alleged underlying FDCA violation” – unless the FDA had already found a violation. The purported state law violation of FDCA compounding provisions says in substance “comply with the FDCA,” and thus is not a traditional common law tort. Because all of plaintiff’s claims depended on the adjudication of an unresolved FDCA issue, “[t]he plain text of the FDCA leaves that determination in the first instance to the FDA.” Not only is Nexus a useful application of Buckman preemption in and of itself, but it has significant larger implications. In the Farm Fresh Salmon decision we discussed here, the California Supreme Court adopted essentially the same rationale that Nexus flatly rejects. As a result, California courts have become a hotbed of food-related litigation claiming to enforce purportedly “California” food violation claims that, as in Nexus, raise, as state statutory claims, wholesale adoption of FDCA standards. While Nexus does not control state courts, it is binding on all California federal courts, and we think defendants can use its holding to dismiss much, if not all, of the economic-loss food litigation (“non-traditional” claims as in Nexus) that currently chokes those courts. We noodled on Nexus here.
- This entry is from the non-Dechert side of the blog. In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2022 WL 17480906 (S.D. Fla. Dec. 6, 2022). This is unquestionably the best trial court decision of 2022. It entered summary judgment against the entire Zantac MDL because all of the plaintiffs’ causation witnesses flunked the reliability and fit requirements of Fed. R. Civ. P. 702. Zantac is 341 pages long in slip (167 Westlaw pages and 672 Lexis pages), so we can hardly do it justice here. Zantac exposes the numerous fallacies, fudges, and fakes of the plaintiffs’ experts – and of the supposedly “independent” testing laboratory that sparked this entire litigation. That lab literally cooked the product (we’re not kidding − over 266° F) to generate bizarre and ridiculous levels of purported contamination from alleged carcinogenic decomposition products. That was so blatantly bad that plaintiffs hired their own chemical contamination expert rather than use the first lab’s results. That expert also cooked the product (but only to 167° F), and also failed to document what he and his lab actually did, since Zantac found his lab’s logbooks incomprehensible and its protocols both unwritten and routinely manipulated by “manual integrations.” The lab put so much salt (a catalyst of the alleged chemical breakdown) in “artificial stomachs” that it would have killed an actual person. The chemist used novel equipment to conduct chromatography. The Zantac plaintiffs’ epidemiological experts failed to follow recognized rules of statistics. To name a few, cherry-picking of both data and methods, reliance on statistically insignificant results, ignoring confounding factors, contradicting the conclusions of studies they relied on, unfounded extrapolations, resorting to methods they criticized before being paid by plaintiffs, treating diverse populations as comparable, actively avoiding peer review, and finally making the last-resort accusation that every similar product also caused cancer. They also used numerous questionable methodologies, from “weight of the evidence,” through in vivo and in vitro data, through ditching dose-response and threshold dose, through animal studies and regulatory risk assessments (treating a 1 in 100,000 risk per-day exposure rate as equivalent to “more likely than not”), all of which ignored plentiful contrary human epidemiology. Zantac meticulously walks through these experts’ methodological misdeeds, which were complex and numerous. We, however, find the following statement most persuasive: “there is no published conclusion or finding, outside of this litigation, that concludes that [the drug at issue] causes cancer of any kind.” Zantac also rejected each and every legal argument plaintiffs raised to avoid having to prove this or that causation issue. We did our best to summarize Zantac here.
- In re Fosamax (Alendronate Sodium) Products Liability Litigation, 593 F. Supp.3d 96 (D.N.J. 2022). We’ve always considered preemption to be our most powerful defense. It’s not dependent on the merits of any plaintiff’s case and, as we’ve said, “capable of wiping out an entire MDL with a single motion” − without needing 300+ pages (see, above) to do it. That’s what happened in Fosamax. This Fosamax opinion was the remand decision from the Supreme Court’s decision in Albrecht (2019+1,-6), and contrary to what Justice Thomas thought, implied preemption applied and barred the whole thing. With preemption now being a pure question of law, Fosamax entered summary judgment without there being any jury question to consider. Credibility decisions were for the factfinder, which now meant the judge deciding the motion. Plaintiffs asserted their usual litany of post-Albrecht arguments, and lost them all. “Clear evidence” to support preemption did not require a manufacturer actually have requested the FDA to approve the exact label change a plaintiff demands. The implied preemption principles in generic preemption cases (Mensing (2011+1) and Bartlett (2013+1)) apply equally to all analogous implied preemption situations. An extensive record demonstrated that the defendant “fully informed” the FDA about the relevant risk, so preemption was required. Fosamax made quite a few notable pro-defense rulings: (1) The FDA is the sole arbiter of what is material to its decisions, so plaintiffs are not allowed to contradict it. (2) Albrecht required formal, not final, agency action, which here was a complete response letter. (3) Informal FDA communications were not preemptive under Albrecht, but were admissible to inform the meaning of the Agency’s formal decisions. Plaintiffs could not ignore informal FDA communications altogether. (4) Since the FDA is statutorily obligated to respond with a label change, if appropriate, in response to information from any source, the FDA’s decision not to require one in response to the defendant’s submission here, meant that it concluded that no change was necessary. (5) FDA actions receive a “presumption of regularity.” (6) Absent proof of withheld information, an FDA rejection of a proposed warning means that the science did not support the warning. (7) A finding that the FDA was “fully informed” for “clear evidence” purposes also means that no “newly acquired information” supporting a label change existed at that time. (8) Manufacturers are not required to seek futile label changes in the absence of “newly acquired information” to preserve a preemption defense. Such a requirement would improperly encourage overwarning. And so the entire MDL (some 500 remaining plaintiffs) bit the dust. We feted Fosamax here.
- Kline v. Zimmer, Inc., 294 Cal. Rptr.3d 500 (Cal. App. 2022). A second California state court case in our top ten? That’s never happened before. Kline resolved, under California law, a recurring issue regarding expert witnesses – in particular defense-side experts − and the standards of certainty with they must hold their opinions. We have discussed this issue before. Reversing a jury verdict, the court of appeal unanimously held that, because defendants do not have the burden of proving causation, defense causation experts need not testify to the same “reasonable medical certainty” standard required of plaintiffs’ experts. The plaintiff, not the defendant, bore the burden of making out a prima facie case, and thus must present expert testimony that could sustain a finding in the plaintiff’s favor. Here, the defendant medical device manufacturer did not need to show it was more likely than not that a cause identified by its experts resulted in the plaintiff’s injuries – the defendant simply had to cast sufficient doubt on the plaintiff’s theory of liability that the jury could conclude that plaintiff’s theory was not proven. Therefore, it was reversible error for the trial judge to exclude several defense experts because they did not express their opinions to a reasonable certainty. The right of a party without the burden of proof to suggest alternative causes, or the uncertainty of causation, to less than a reasonable medical certainty is “imperative.” Just because an expert’s opinion does not reach the reasonable medical certainty threshold does not render it impermissibly speculative. The trial court’s rigid rule constituted structural error that was per se prejudicial to the defendant, requiring a new trial. We gave kudos to Kline here.
- Nelson v. C.R. Bard, Inc., 44 F.4th 277 (5th Cir. 2022). To paraphrase, the law expects every warning to do its duty. That happened here. Affirming summary judgment in an IVC (inferior vena cava) filter case, the Fifth Circuit determined that the defendant’s warnings were adequate as a matter of law. The instructions for use that accompanied the device warned the implanting surgeon against every injury that the plaintiff claimed to have suffered “in no uncertain terms.” The plaintiff had no “meaningful” response to those warnings. Instead, plaintiff complained that information mentioned in internal company documents was “concealed” by being omitted from the warnings. That argument is contrary to Mississippi law, which requires plaintiffs to base warning defect claims on the text and language of the warnings, not on internal company documents. Thus, plaintiff could not support a verdict with speculative arguments from cherry-picked internal documents. Design defect failed for lack of causation. Plaintiff never identified any cause for the device allegedly tilting after installation, nor did plaintiff have evidence that a simple tilt could have caused the device to fracture and perforate the vein. That’s all good, but still somewhat disappointing, because the district court’s decision (2020+20) contained probably the best and most thoughtful discussion of why “comparative” warning claims – that defendants should warn that competing products had comparatively fewer adverse events – are legally bogus and factually false, since comparative data is not generally available, and voluntary reporting is so subject to error that the FDA says its statistics are invalid for comparative purposes. The Fifth Circuit, however, dodged that issue entirely. If it had affirmed for the same reasons as the district court, Nelson would have moved up several notches. We navigated Nelson here and here.
- City of Huntington v. AmerisourceBergen Drug Corp., ___ F. Supp.3d ___, 2022 WL 2399876 (S.D.W. Va. July 4, 2022). It’s an opioid case, so ordinarily our lips are sealed, but here is an excerpt from a Reed Smith press release: “On July 4, [a] U.S. District Judge . . . handed the three distributors a complete defense victory. [The judge] found that all three had programs in place to meet their opioid responsibilities. He also found that the ‘overwhelming majority’ of doctors were acting in good faith in their prescribing of opioids, and that distributors appropriately responded to good faith prescribing. He rejected the plaintiffs’ legal theory that the distribution of these medicines could establish a public nuisance.” Here is a second public story also discussing the Huntington decision.
- In re Onglyza & Kombiglyze XR Products Liability Litigation, 2022 WL 43244 (E.D. Ky. Jan. 5, 2022). Similarly to Zantac, but in a much smaller MDL, O&K determined that all of the plaintiffs’ experts failed Fed. R. Evid. 702, while three defense experts survived Rule 702 gatekeeping. One, whose methodology plaintiff did not challenge, was qualified as an experienced specialist who routinely prescribed the drug at issue and other similar medications. Plaintiffs’ challenge to the second, mostly that someone else wrote his report, also failed. The third defense expert was also qualified, and was not required to analyze the raw data underlying a study before relying on it. Plaintiff nitpicking about individual studies and other data also did not affect admissibility. By contrast, plaintiff’s expert was a cardiologist who purported to apply Bradford Hill methodology. Whenever we see a Bradford Hill-spouting expert, we roll our eyes, since what passes for “methodology” is merely a mish-mosh of a dozen or so “factors” that supposed “experts” can readily manipulate to produce whatever result they want. Sure enough, this expert was the only person anywhere, in or out of the litigation, to opine that the drug could cause the claimed injury. Equally predictably, he misused the Bradford Hill factors, focusing on only a couple and completely ignoring others, such as “consistency” in the data – that is, except for manufacturing false consistency by ignoring adverse studies for no good reason. The expert also committed the common sin of claiming to rely on studies while ignoring the authors’ conclusions, since the authors recognized that their multi-endpoint study increased the likelihood that the multiple outcomes could include one or more false positives. Finally, the expert’s claimed “analogy” was blatantly cherry-picked, selected not from the same class of drug, but rather from a different class known to cause the outcome at issue. Sure enough, in the wake of this exclusion, summary judgment followed because plaintiffs had no general causation expert, and a new expert that plaintiffs first surfaced more than two years after the MDL expert deadline was not permitted. (O&K, 2022 WL 3050665). We okayed O&K here.
- In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2022 WL 952179 (E.D. Pa. March 30, 2022), and In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2022 WL 17477553 (E.D. Pa. Dec. 6, 2022). A Lone Pine order with teeth issued prior to a settlement in an MDL is a rare bird indeed. That happened in the Zostavax MDL this year, and plaintiffs’ consequent non-compliance cut the heart out of that litigation. The key allegation in the MDL is that the defendant’s vaccine, which used a weakened live varicella virus to confer immunity, could cause the very disease – shingles – against which the vaccine is directed. While plaintiffs (most of them, anyway) alleged that theory of liability, it turns out they can’t prove it without a certain medical test. That’s because just about everybody catches chickenpox as a child, and that so-called “wild” version of the virus stays in the body indefinitely and often re-emerges and causes shingles later in life. The test, which the Zostavax Lone Pine order required plaintiffs to divulge, if anyone had it, is the only way of genetically distinguishing wild, non-vaccine-related virus from the weakened strain used in the purportedly “defective” vaccine. After none of the bellwether plaintiffs had the test, and suffered summary judgment for failure to prove causation (2020+19), the court imposed the Zostavax Lone Pine order, requiring all plaintiffs claiming shingles as their injury to put up or shut up. They had 90 days to comply. Guess what? Not one of the 1189 plaintiffs claiming shingles had taken the test (which had to be administered while the characteristic shingles rash existed). Thus, none of these plaintiffs had admissible proof that the vaccine actually caused their shingles cases, as opposed to the ubiquitous wild varicella virus, because mere ineffectiveness is not a defect. In default of compliance with the Zostavax Lone Pine order, the second Zostavax order dismissed all of plaintiffs’ claims, and again rejected their arguments that they could prove causation through other, unspecified and undisclosed, means. All that’s left in the Zostavax MDL are a few hundred miscellaneous non-shingles claims. We zeroed in on Zostavax here and here.
That’s it. These are our top ten picks as the best drug/medical device – and vaccine − decisions of 2022.
That is not the end, however, as we also present our 2022 annual list of runners up, consisting of what we consider the next ten most favorable 2022 decisions.
Honorable Mentions: (11) Greisberg v. Boston Scientific Corp., 2022 WL 1261318 (3d Cir. April 28, 2022) (unpublished). Enforces the New Jersey “super-presumption” of compliance with FDA regulations in a §510(k) device case, which contrary to plaintiffs’ Lohr-based arguments, supports that presumption. Affirms the grant of a motion to dismiss. Would have ranked significantly higher if precedential (here and here). (12) Arevalo v. Mentor Worldwide LLC, 2022 WL 16753646 (11th Cir. Nov. 8, 2022) (unpublished). Affirmance of Rule 702 exclusion of notorious pelvic mesh “expert” causation witness for an inadequate differential diagnosis. Would have ranked higher if precedential (here). (13) Storment v. Walgreen, Co., 2022 WL 2966607 (D.N.M. July 27, 2022). One of the few courts properly applying PREP Act immunity. Vaccine administration site not liable for injuries to recipient who wandered off and collapsed (here). (14) Pfaff v. Merck & Co., ___ F. Supp.3d ___, 2022 WL 4121406 (E.D.N.Y. Sept. 9, 2022). Preemption of drug warning claim despite the FDA – ten years after plaintiff stopped using the drug – actually adding the risk in question to the label. FDA documents, obtained through FOIA request demonstrated lack of sufficient scientific basis at all relevant times (here). (15) Pietrantoni v. Corcept Therapeutics Inc., ___ F. Supp.3d ___, 2022 WL 16857262 (D. Mass. Nov. 10, 2022). Because the FDA requires submission of adverse event reports without regard to causation, AERs cannot be “newly acquired information” that could support a unilateral CBE supplement, and thus cannot defeat preemption under Albrecht (2019+1,-6). Preemption bars claims against the manufacturer of a form of mifepristone not intended for medication abortions (here). (16) Vesoulis v. ReShape LifeSciences, Inc., 2022 WL 989465 (5th Cir. April 1, 2022) (unpublished). FDCA-based negligence per se is necessarily preempted because negligence per se is not a recognized Louisiana product liability claim. Thus, it is purely a matter of private FDCA enforcement barred under Buckman (here). (17) R.S.B. ex rel. Hammar v. Merck & Co., 2022 WL 3927868 (E.D. Wis. 2022). In another useful post-Albrecht discussion of “newly acquired information,” a plaintiff’s expert’s “litigation-driven” opinion “unsupported by any published research” could not qualify. “Plaintiffs are not entitled to create their own ‘newly acquired information’ through the use of experts” (here). (18) In re Incretin-Based Therapies Products Liability Litigation, 2022 WL 898595 (9th Cir. March 28, 2022) (unpublished). A win is a win is a win, but this unpublished affirmance of summary judgment against an entire MDL based upon lack of scientific proof of causation was a rather disappointing. The Ninth Circuit neither confronted its ugly Wendell (2017-9) causation decision, nor did it even discuss the alternative ground of federal preemption (here). (19) Poozhikala v. Medtronic, Inc., 2022 WL 1076173 (C.D. Cal. April 7, 2022). Neither “information and belief” nor laundry lists of purported FDCA violations could forestall preemption in this PMA device case. Failure-to-report and CGMP violation claims also dismissed (here). (20) Wilkins v. Genzyme Corp., 2022 WL 4237528 (D. Mass. Sept. 14, 2022). Allegations that the defendant had a duty to keep producing its drug in amounts to satisfy the plaintiff class’ demand failed utterly. The lengthy decision slices, dices, and purees drug shortage cases; if this type of litigation were more common, it would surely rate higher (here).
Our 2022 collection of cases also features these near misses – so here is another group of well-earned victories: Reddick v. Medtronic, Inc., 2022 WL 715494 (5th Cir. March 9, 2022) (unpublished) (here); Bradley v. Globus Medical, Inc., 22 Wash. App.2d 1041 (Wash. App. June 30, 2022) (here); In re Smith & Nephew Birmingham Hip Resurfacing Hip Implant Products Liability Litigation, ___ F. Supp.3d ___, 2022 WL 1556099 (D. Md. May 17, 2022) (here); Roshkovan v. Bristol-Myers Squibb Co., 2022 WL 3012519 (C.D. Cal. Jun. 22, 2022) (here); Roncal v. Aurobindo Pharma USA, Inc., 2022 WL 1237888 (D.N.J. April 27, 2022) (here).
As far as further review is concerned, an appeal of the Kline case, above (#6), has already been denied by the California Supreme Court. A certiorari petition in the People v. J&J (2022-2) remains pending. A reargument petition has been filed in the Blackburn (2022-10) appeal. We also went back and reviewed our prior lists of best and worst decisions. Brooks (2021+2) and Bair Hugger (2021-1) both had certiorari petitions denied. The plaintiffs’ appeal from the excellent preemption decision in Zofran (2021+4) remains pending. The same is true for the New Jersey Supreme Court appeal in Hrymoc (2021+8). Numerous appeals in Zantac (2021+10 and 2021+18) remain pending, because of disputes about whether the orders were final and appealable. That won’t be a problem anymore, given the Zantac summary judgment order described above (#4).
We 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 already know that the Mallory personal jurisdiction appeal on the critical general jurisdiction by consent issue will be decided by the United States Supreme Court in 2023. A win for the good guys in Mallory would deprive litigation tourists of their last generalized excuse for suing in their favorite jurisdictions regardless of any relationship to the parties or to the facts. A loss . . . would be too terrible to contemplate, so we’ll burn that bridge should we have to come to it.
Some of the same learned intermediary rule issues in Amiodarone are already before the California Supreme Court in Himes v. Somatics, LLC, No. S273887 (Cal.) (here). Whether to adopt the learned intermediary rule is also currently before the Wisconsin Supreme Court in Rennick v. Teleflex Medical, Inc., No. 2020AP001454 (Wis.) (here). Other learned intermediary rule issues are pending in Muhammad v. Abbott Laboratories, No. 128841 (Ill.), and Apyx Medical Corp. v Doring, No. 2022 CA 1089 (Colo. App.).
We fully expect plaintiffs to appeal the 2022 Amiodarone, Zantac, Fosamax, and Huntingdon decisions. We’re less certain about the O&K and Zostavax decisions, but if plaintiffs want to throw good money after bad, be our guest.
Some other pending prescription medical product-related appeals we’re watching are In re National Prescription Opiate Litigation, Nos. 22-3750/3751/3753/3841/3843/3844 (6th Cir.) (public nuisance); Gilead Sciences, Inc. v. Superior Court, No. A165558 (Cal. App. 1st Dist.) (never start selling liability), a Second Circuit appeal (No. 22-00146) from Daniels-Feasel v. Forest Pharmaceuticals, Inc., 2021 WL 4037820 (S.D.N.Y. Sept. 3, 2021) (here) (Rule 702 expert exclusion), and the interlocutory appeal authorized by In re Taxotere (Docetaxel) Products Liability Litigation, 2022 WL 16923721 (E.D. La. Nov. 14, 2022) (prescription drug preemption).
Finally, on the administrative front, the most significant development of 2022 is the continued progress of the proposal by the Advisory Committee on Civil Rules to amend Fed. R. Evid. 702 (here). In September, the full Judicial Conference of the United States approved the amended rule. That was the last real hurdle. The Supreme Court and Congress also get a say, but in practice they rarely alter amendments to federal rules. Assuming that is the case here, new Rule 702 will become effective in December 2023. We discussed these amendments most recently here.
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 2023.