We’re tired – Tired of blatant lying about COVID-19 and the vaccines that can stop it. Tired of miserable, selfish people who won’t take basic, proven health precautions to combat COVID-19, endangering not only themselves, but everyone else as well. We’re tired of obstructionist politicians who cynically seek to prolong the pandemic for political ends. Closer to the Blog’s roots, we’re tired of ever expanding multi-district litigation that everyone knows is out of control and nobody lifts a finger to rein in. We’re tired of weak to non-existent support for the defense perspective at the American Law Institute, Emory Institute programs, and the like. And we’re sick and tired of judicial triumphalism running amok, ignoring traditional common-law limitations and prescribing more tort liability as the cure for just about every societal problem.
So we’re not trying to be funny, or cute, this year. Every year we present the ten worst prescription medical product liability litigation decisions – this is our fifteenth annual installment. While it’s not unheard of that an eleventh-hour catastrophe (like the late December innovator liability decision, T.H. v. Novartis, 407 P.3d 18 (Cal. 2017)), to cause a belated amendment to our list, we’re crossing our fingers that 2021 has seen enough unpleasantness. So here, without adornment, are 2021’s bottom ten. If you were involved in any of these legal fiascos, we sympathize, since we’ve been there (see 2013-2). Just buck up and wait till next week, when we’ll present our top ten best decisions.
- In re Bair Hugger Forced Air Warming Devices Products Liability Litigation, -1) (8th Cir. 2021). The Eighth Circuit’s reversal of summary judgment in Bair Hugger was one of the worst Rule 702 expert admissibility decisions in years – at least since the Ninth Circuit’s Wendell decision (2017-9), and probably beyond. As a consequence of this misguided decision, one of the least meritorious MDLs we’ve ever seen – see our description of its origin as a business shakedown here – was resuscitated, thus resurrecting (at the time) nearly 5,000 bogus case. Bair Hugger is a poster child for why we need the currently pending amendment to Rule 702. Under Rule 702 the proponent of expert testimony is supposed to establish four things by a preponderance of the evidence: qualifications, factual basis, reliable methods, and reliably applying those methods to the facts. The standard of appellate review is abuse of discretion. But not in the Eighth Circuit after Bair Hugger. The Rule 702 requirements were added in 2000. But Bair Hugger is replete with reliance on pre-2000 language about the “liberal thrust” and “flexibility” of that Rule and how “factual basis,” now one of the four elements proponents are supposed to prove as prerequisites to admissibility, merely “goes to the credibility of the testimony, not the admissibility.” As the current amendment points out in the accompanying committee notes, such statements are “incorrect.” Under Rule 702 as amended in 2000, the sufficiency of the basis for an expert’s opinion is not a “weight” issue. Nor did Bair Hugger respect the abuse of discretion standard. Viewing the obsolete “liberal thrust” proposition as creating “an intriguing juxtaposition” with the abuse of discretion standard, Bair Hugger effectively re-weighed the evidence as it saw fit. It concluded that the gaps in the expert opinions weren’t really as wide as the district court found, nor was the dearth of supporting science really as extreme. Bair Hugger also ignored general acceptance of the opinion (which the Supreme Court has repeatedly held to be a proper factor), because the opinions were subject to “scientific research and debate.” That can be said of almost any cockamamie idea. We sympathize with the district judge in Bair Hugger, who faithfully fulfilled the required “gatekeeper” role, only to get reversed by a backward-looking appellate panel. We hope the defendant in Bair Hugger can wait out the judiciary’s amendment procedure, and then refile essentially the same opinion under the amended Rule 702. We backhanded Bair Hugger here.
- Hamer v. Livanova Deutschland GMBH, 994 F.3d 173 (3d Cir. 2021). Multidistrict product liability litigation, as currently practiced, is a constantly metastasizing cancer on the judicial branch of the federal government. Nobody even bothers to deny anymore that a large percentage of cases filed in MDLs – anywhere between 25% and 40% − are simply bogus. Either the purported plaintiffs can’t show they ever used the product, or they can’t show that they have the injury(ies) being litigated in the MDL. Since many of the Federal Rules of Civil Procedure, such as Rules 8 through 12 are either ignored altogether or deemed inapplicable to “plaintiff-specific” issues in MDLs, there is no good, or universally accepted, way of separating the wheat from the chaff. So completely unvetted claims pile up in massive numbers in MDLs and facilitate their conversion from what Congress intended as an inexpensive means of conducting pre-trial processes, into their current role as a hideously expensive settlement engine. Hamer illustrates the time, effort, expense – and ultimate futility of attempting to weed out meritless claims under the current MDL system. The district court running the MDL imposed a form of “Lone Pine” order, better late than never, only after the defendants had agreed to settle. That order required the plaintiffs to come forward with evidence of injury and causation. Plaintiff Hamer sat on his hands, and after 11 months of back and forth, his case was eventually dismissed. Only after being threatened with dismissal, did the plaintiff do anything, and what he did wasn’t to comply with the order. Rather, he claimed for the first time that his case didn’t belong in the MDL at all, and sought to escape the MDL and to pursue an individual claim in the transferor court. Unfortunately, the Third Circuit fell for this ruse. Looking at the factual vacuum caused by plaintiff’s failure to comply with the Lone Pine order, the Hamer court speculated that, maybe, plaintiff could establish a different injury outside of the MDL, reversed the dismissal, and instead ordered the case remanded. In so doing it rendered useless more than a year’s worth of defense compliance efforts, as well as incentivized other plaintiffs to ignore any and all MDL disclosure orders. We hit Hamer hard here.
- Blackburn v. Shire U.S., Inc., 18 F.4th 1310 (11th Cir. 2021). As we reported here, the district court in Blackburn dismissed the plaintiff’s “picky” warning claim (involving allegedly better monitoring language) because the prescribing doctor neither read the warnings before prescribing the drug nor followed the existing monitoring recommendations. On top of that, the plaintiff was also non-compliant; missing an appointment, contacting the prescriber only to get refills, and never following up on a referral after moving to a different city. So, even if the prescriber would have told him something different, there was no basis for inferring that the plaintiff would have followed his doctors’ orders. The Eleventh Circuit saw things differently. It excused the physician’s failure to read the warnings, with his testimony that he was “already familiar” with the labeling. Perhaps, in some nebulous way, his prescribing had been influenced by having reviewed the warnings at some undefined time in the past. Exactly what the prescriber would have done differently isn’t exactly clear. Moreover, the prescriber’s interest in avoiding liability for filling prescriptions for over a year without ever seeing the plaintiff, was merely a “credibility” issue and not something that prevented plaintiff from drawing favorable inferences from that testimony. “Self-serving statements” may defeat summary judgment. Similarly, Blackburn allowed plaintiff to skate on his own persistent failure to see either his existing or subsequently referred physician. Having recast the causation record, Blackburn then invited, through certification, the Alabama Supreme Court to make two pro-plaintiff changes to Alabama learned intermediary law. First, does the duty to warn go beyond accurately describing the risks, and require the manufacturer defendant also to tell the doctor how to mitigate those risks. We’ve blogged elsewhere that the duty to warn does not extend to telling doctors how to practice medicine. Even though both the Alabama Supreme Court (in the otherwise execrable Weeks (2014-1) decision) and a prior Eleventh Circuit panel (in a case called Toole) had both stated that warning duties were “limited” to “advis[ing] the prescribing physician of any potential dangers,” Blackburn saw fit to create an opportunity to change the law. Second, can the plaintiff establish causation by asserting that a different warning would have caused the prescriber to do something short of not prescribing the product at issue? Once again Weeks seemed to answer that question in a pro-defense way, holding that “the patient must show that, but for the . . . warning, the prescribing physician would not have prescribed the medication to his patient.” Nonetheless, Blackburn found that issue open, citing pre-Weeks federal case, and invited the Alabama Supreme Court to change the law in a plaintiff-friendly direction. We blasted Blackburn here.
- In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2021 WL 222776 (D.N.J. Jan. 22, 2021). To err is human. But such errors get magnified a thousand-fold when they occur in a large MDL. The Valsartan MDL currently counts over 1,000 plaintiffs. We’ve complained repeatedly about MDLs ignoring state law in order to create novel causes of action in violation of the limits that federalism imposes on the ability of federal judges to predict state law under the Erie doctrine. Valsartan is a particularly egregious example, and occurred despite repeated Third Circuit reaffirmations that under the Erie doctrine federal courts may not expand state-law tort liability. Not a single state in the nation allows a claim for express warranty based on nothing more than the name of a drug, but that didn’t stop Valsartan from doing so. Valsartan went off on this unprecedented legal tangent in a transparent attempt to pressure generic manufacturers to settle, since any claim that would require changes to the warnings, designs, manufacturing processes, or availability of generic drugs is federally preempted. This ginned up theory also eliminates reliance as an element of express warranty – again in direct contravention of every state’s law we’ve encountered, by rationalizing that calling generic valsartan “valsartan” “necessarily left plaintiffs no choice but to rely” on that statement. However, the manufacturer likewise has no choice under federal law but to use the name of the corresponding innovator product. This federal requirement necessarily preempts Valsartan’s newly invented express warranty theory, however, because no generic manufacturer may sell its product in any other way, which is the same as a “stop selling” claim preempted under Bartlett (2013+1). For ignoring state law on a massive scale in order to prevent defendants from relying on preemption, Valsartan makes our list as the worst district court decision of 2021. We vilified Valsartan here.
- Gaetano v. Gilead Sciences, Inc., 2021 WL 1153193 (D.N.J. March 26, 2021), and Johnson v. Gilead Sciences, Inc., ___ F. Supp.3d ___, 2022 WL 4439246 (E.D. Mo. Sept. 28, 2021). Both of these awful decisions credited the same theory: that the manufacturer of a pioneering drug that helped lift the death sentence that an AIDS diagnosis used to be could be liable for not abandoning that drug in favor of an allegedly “safer” drug that ultimately was not approved by the FDA until almost ten years later. A more stark example of “no good deed goes unpunished” is hard to imagine. Both Gaetano and Johnson allowed the same novel “state law” theory that a defendant can be liable merely for seeking FDA approval of a drug, and later marketing pursuant that drug, just because in hindsight a later developed drug was in some way allegedly “better” or “safer.” We who lived through the worst of the existential terror that was the AIDS epidemic are simply disgusted. Had the defendant delayed development of the drug that these cases attack so as to investigate supposedly “safer” alternatives, many thousands of lives would have been lost. The Supreme Court in Bartlett (2013+1) correctly preempted “stop-selling” claims due to their inherent conflict with the FDA’s authority over drug approval. This “never start selling” theory is, if anything, worse because it deters submission of potentially safe and effective drugs to the FDA ab initio. Whenever a “safer” drug gets approved, these plaintiffs claim, every prior drug for treating the same condition becomes “defective.” No precedent in either state supports such a claim. Even putting Bartlett aside, the bogus pre- versus post-approval distinction these cases followed should have been preempted directly under the Mensing (2011+1) independence principle because FDA approval is a necessary causal element for both the drug in that these plaintiffs took and the later drug they claim was safer. These cases not only embraced that theory, but expanded it to warnings. However, “approval” necessarily turns on the actions of the FDA, and thus cannot stand under Mensing. A combination of the repulsive factual basis for these cases and the distortions of preemption required to allow them to proceed (along with there being two essentially identical cases) make these our combined fourth worst drug/device decision of 2021. We made our displeasure with these decisions known here and here.
- In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 2021 U.S. Dist. Lexis 100041 (D. Md. May 17, 2021). Even though the defendant ultimately won this particular case – on case-specific grounds – we include this Birmingham Hip decision among our bottom ten because of its flat refusal to follow Erie v. Tompkins and restrict state law causes of action in an MDL to those actually recognized by the state in question. Once again, as with Valsartan (above), an MDL judge resorts to making up state law to avoid a defendant’s otherwise rock-solid preemption argument. The plaintiff was suing under North Carolina law, and as our 50-state survey of failure-to-report claims demonstrates, no North Carolina court, either in the FDCA or any other context, has allowed any cause of action for failure to comply with any sort of mandatory reporting statute. Still, Birmingham Hip refused to dismiss the claim, choosing to follow Lohr while ignoring the directly-on-point, and more recent, Riegel (2008+1) decision. Instead it ruled that a supposedly “parallel” failure-to-report claim didn’t have to be “parallel” at all. Birmingham Hip is thus the apotheosis of a defendant suffering from pro-plaintiff “MDL treatment” in order to increase settlement pressure through greater liability exposure. As long as a state has a generic failure to warn claim, as all states do, that’s enough for a “parallel” failure-to-report claim in the Birmingham Hip Then this lawless decision immunized itself from possible mandamus review by granting summary judgment on case-specific causation grounds. We beat the heck out of Birmingham Hip here.
- Munson v. C.R. Bard, Inc., ___ F. Supp.3d ___, 2021 WL 4261595 (N.D. Miss. Sept. 20, 2021) (not blogged about). We never got around to blogging about Munson, but it is the evil twin of the excellent Nelson v. C.R. Bard, Inc., ___ F. Supp.3d ___, 2021 WL 3578874 (S.D. Miss. Aug. 6, 2021), that we blogged about here. Nelson held that Mississippi law does not recognize product warning claims predicated on not revealing that other, competing products are supposedly “safer” in some way. Adequate warnings about risks were enough. Compared to Nelson, however, Munson resembles a bowl of mush, rejecting what it called a “one size fits all” approach rejecting a comparative risk warning duty. How does one even determine what “relative” risk is? Companies do not have access to other manufacturers’ adverse event reporting, and the FDA’s public adverse event reporting system (“MAUDE,” for devices) is so notoriously subject to biases that the FDA states that: “MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.” Instead of hewing to existing Mississippi law, under which that state’s supreme court had held expert testimony about safer alternative products did not prevent adequacy as a matter of law, Munson “conducted its own research,” and the resultant opinion is notably lacking in Mississippi citations (most being disagreed with or distinguished), and frequently lacking any citations at all. Instead of any rule useful in deciding future cases, Munson leaves litigants guessing when and to what degree this vague comparative warning duty applies beyond not being “automatically barred.”
- Dan Abrams Co. LLC v. Medtronic Inc., 850 F. Appx. 508 (9th Cir. 2021). This case would have ranked much higher had it been published, but any appellate decision allowing a private plaintiff to pursue a claim based on fraud on the FDA is bad enough. In Dan Abrams, the plaintiff got around Buckman by suing under a federal statute, the False Claims Act. But the supposed “false” claims were imaginary and a figment of the alleged fraud on the FDA. Nor was anyone harmed. The suit in Dan Abrams was over a product that was undisputedly (1) safe; (2) effective; and (3) used in accordance with accepted medical practice. Unfortunately, Dan Abrams didn’t care about all that. Instead, it reasoned that, since the plaintiff “claims that [defendant] knew that [the off-label use in question] posed different questions of safety” – not that anything was actually unsafe – “to its previously approved devices,” then if the defendant had “disclosed that the devices were intended for [the cleared] use,” then “the FDA may have required Class III approval.” That’s illogical. All off-label uses necessarily present “different questions of safety” under the FDCA. Otherwise, they wouldn’t have been off-label to start with. It’s also bad policy, since the FCA (or any other legal theory) should not be used to allow the pecuniary interests of private individuals to be a basis for the second-guessing of FDA decisions to allow products onto the market. We disparagingly analyzed Dan Abrams here.
- In re Fluoroquinolone Products Liability Litigation, 517 F. Supp.3d 806 (D. Minn. 2021) Still more MDL madness, albeit this time in an MDL that’s largely run its course. Like the Valsartan and Birmingham Hip result-oriented expansions of state law discussed above, the decision in Fluoroquinolone predicted state adoption of a disfavored and expansive liability theory – innovator liability. As we’ve laid out at length, innovator liability is almost universally rejected, particularly in federal court. In Fluoroquinolone, the Erie-ignoring order was only about one plaintiff in one state, which makes it less awful in a practical sort of way. One wonders why anyone would think that Illinois would follow California into non-manufacturer product liability. The Illinois Supreme Court has consistently given the back of its hand to such theories, already rejecting both market share liability and public nuisance, and only recently it cited to tort conservatism in rejecting both medical monitoring and consent-based personal jurisdiction. Fluoroquinolone purported to distinguish market share liability on the basis of plaintiff identifying the entity “responsible for” wrongful conduct. That misunderstands market share liability, which is based on multiple manufacturers all purportedly engaging in wrongful conduct. All the other Illinois authority contrary to the result in Fluoroquinolone is simply ignored, in particular the intermediate appellate holding that rejected duties to warn about other products specifically in the prescription drug context. We flayed Fluoroquinolone here.
- This entry is from the non-RS side of the blog. In re Allergan Biocell Textured Breast Implant Product Liability Litigation, ___ F. Supp.3d ___, 2021 WL 1050910 (D.N.J. March 19, 2021). Yes, Biocell is an MDL-wide ruling, and yes, it also involved the novel failure-to-report theory invoked as a preemption dodge. But Biocell isn’t as bad as the other two more highly (lowly?) ranked decisions of the same ilk. That’s because Biocell did not blindly hold that all plaintiffs get to take advantage of a theory that, under Erie, federal courts have no right to predict. At least Biocell conducted a legitimate state-by-state analysis, and as we discussed at length here, concluded that in many instances individual states would not adopt failure to report. Nevertheless, Biocell squeaks into our bottom ten because, no matter how poorly reasoned or in the minority – any prior adverse reporting-related decision sufficed for Biocell to predict reporting-based liability. Also, an on-point decision of the relevant appellate court (Third Circuit), holding that failure-to-report claims involving airplanes and the FAA was preempted under Buckman was never discussed, nor were the significant number of state-law non-FDA failure-to-report decisions, which as we discussed here, almost uniformly reject such claims. Beyond failure to report, Biocell would not apply the federal rules – particularly Rule 8 and TwIqbal – to any plaintiff specific issue. It did not treat plaintiffs’ global “manufacturing” claims for what they were: disguised design claims attacking processes shared by each and every of the devices at issue. Nonetheless, unlike the worse-ranked MDL decisions, Biocell was not a total loss, so it ends up at the bottom of our bottom ten. We (well, some of us) discussed the blemishes of Biocell here.
Glad that’s over. This year’s worst prescription medical product liability decisions are bad enough, but we suppose it could have been worse. We have only four appellate lumps of coal in our stockings this year, and one of them is non-precedential.
While we limit eligibility for our best/worst decisions to decisions involving prescription medical products, we would be remiss if we didn’t at least offer a dishonorable mention to cases not involving such products that will nevertheless complicate our defense of our FDA-regulated clients. These are Ford Motor Co. Montana Eighth Judicial District Court, 141 S. Ct. 1017 (U.S. March 25, 2021) (making specific personal jurisdiction harder to defeat in cases not involving forum shoppers) (discussed here); Maglioli v. Alliance HC Holdings LLC, 16 F.4th 393 (3d. Cir. 2021) (bad on PREP Act immunity) (discussed here); Hardeman v. Monsanto Co., 997 F.3d 941 (9th Cir. 2021) (bad on preemption, admission of expert testimony, and punitive damages) (discussed here); and Johnson & Johnson v. Fitch, 315 So.3d 1017 (Miss. 2021) (bad on preemption) (not discussed because we don’t do the other side’s research for them).
Now it’s time for us to decompress and get ready for something we like a lot better − next week’s presentation of the top ten best drug/device decisions of 2021.