Once again we undertake our annual task of sorting through the worst decisions of the year in prescription medical product liability litigation. These are the true superspreaders of litigation against our clients, extending the contagion of non-socially distanced litigation tourism and other infectious forms of attorney-solicited lawsuits far and wide, to the detriment of almost everyone else. These cases only go to show that there is no vaccine yet against FDA second-guessers, science-denying experts, and novel liability theories. Nor have preventive measures against forum shopping yet proved sufficiently efficacious.
In this vein, we note that not since the mass vaccination litigation of the 1960s has it been possible to produce a vaccine against the emergence of a new contagion without an accompanying grant of tort immunity to keep the ever broadening pandemic of product liability litigation at bay. The extraordinary speed with which COVID-19 vaccines may well have positive correlation with the broad tort immunity conferred by the PREP Act. This year's decisions only further demonstrate the need for such litigation countermeasures to be expanded to protect other examples of life- and health-saving drugs and medical devices.
One thing for certain: a lot of the names frequently found on the right side of the "v." are heavily involved in research and development of vaccines and other products to reduce the impact of COVID-19 on our society. We somehow doubt that any similar contributions will be forthcoming from AAJ, Public Citizen, or any other name representing the other side of the "v." Instead, they will be doing everything they can to circumvent, criticize, collaterally attack and otherwise burden the efforts of everyone trying to combat the current pandemic.
That's what they do, and unfortunately, the rest of this blogpost demonstrates that they are very good at it.
And now, we present our fourteenth annual description of the ten worst prescription medical product liability litigation decisions. Occasionally, we get hit with eleventh-hour significant decisions (like the giant lump of coal California gave us on December 22, 2017 (innovator liability decision, T.H. v. Novartis, 407 P.3d 18 (Cal. 2017), that became our second #1 worst decision that year. Barring some similar catastrophe – unlikely, but this is 2020, after all − we're not planning on any more unpleasantness this year. If any of these legal nemeses is yours, we sympathize, having been in that position ourselves (see 2013-2). The only positive thing we can say is wait till next week, when we review our top ten best decisions.
- Hammons v. Ethicon, Inc., ___ A.3d ___, 2020 WL 6155256 (Pa. Oct. 21, 2020). The judiciary of Bexis' home town of Philadelphia, PA, along with the Pennsylvania Supreme Court itself, is currently the nation's #1 Judicial Hellhole according to ATRA, and this case is one of the reasons why. In Hammons, the Pennsylvania Supreme Court signaled – no, broadcast – that the litigation tourist welcome mat remains out in the Keystone State to any plaintiff from anywhere in the country. Hammons reached this result by bluntly refusing (or "openly defied" in ATRA's description) to follow the United States Supreme Court's holding in BMS ( 2017+1) that "[w]hat is needed [for specific personal jurisdiction] is a connection between the forum and the specific claims at issue." Instead, Hammons explicitly relied on the lone dissent in BMS, and chose not to follow the "specific claims" limitation imposed by BMS, "absent further clarification from the High Court." Thus, an Indiana plaintiff with no connections to Pennsylvania could sue there because the defendant contracted out one step of the manufacturing process to an independent Pennsylvania company, even though that company was immune from suit and plaintiff was not claiming that the claims she pursued had anything to do with that aspect of the manufacturing process. Any plaintiff from any state similarly could claim the same generalized contacts, which is precisely what has happened in this (pelvic mesh) litigation in Philadelphia. One can only hope that Hammons' blatant disregard of controlling Supreme Court precedent will be brought to the attention of the only court now able to do anything about it. We hammered Hammons here.
- Russell v. Johnson & Johnson, ___ S.W.3d ___, 2020 WL 6390218 (Ky. Oct. 29, 2020). This is one of the most cringeworthy decisions we've ever seen from a state high court. After Riegel ( 2008+1), broad investigational device exemption ("IDE") preemption was uniformly recognized, until 2020, because the IDE process was part and parcel of the FDA premarket approval process Riegel had held preempted basically all claims save "parallel" violation cases (which were waived in Riegel). Russell essentially refuses to follow Riegel. Like Hammons (just discussed), Russell preferred a Supreme Court dissent over the majority's supposedly controlling holdings. "Justice Ginsburg's Riegel dissent provides insight. . . ." Riegel had held that "requirements" as used in the FDCA's preemption clause included state common law. Russell, relying on Black's Law Dictionary, "limited" preemption to "state standards and regulations" – not state claims and causes of action. But even after having gone rogue from Riegel, Russell doesn't make sense. No "requirements" meant that should have been the end of the case, nonetheless, Russell turned to parallel claims. But prior Kentucky Supreme Court precedent (not acknowledged in Russell) rejects negligence per se for violation of any law not passed by the Kentucky legislature. Russell holds, "Even if we assume medical devices with the [IDE] are able to qualify for federal preemption, Kentucky's parallel tort claims are allowed; the federal preemption would only restrict the state standard that applies to the device." Other than "no preemption," we still don't know what that means. Finally, Kentucky's "bare-bones, notice pleading" doesn't require that parallel violation claims even be pleaded; "couched in general and conclusory terms" are hunky dory. This is another case that could use United States Supreme Court review of its open defiance, this time on preemption issues. We ripped Russell here.
- Kaiser v. Johnson & Johnson, 947 F.3d 996 (7th Cir. 2020). Another "heads, plaintiff wins, tails defense loses" pelvic mesh decision, this time from Indiana. In Pelvic Mesh litigation, the FDA doesn't exist, unless the plaintiff wants it to, so it doesn't matter what design the defendant used, and a design defect can be found without plaintiff having to advance any alternative design – or so Kaiser reads Indiana law. In a rare case where a "consumer expectation" test would have benefited the defendant (plaintiff's surgeon testified he was well aware of all the product's relevant risks), it doesn't apply – because, negligence. Kaiser also creates a circuit split with Yates ( 2015+1) by allowing plaintiffs to claim that an FDA-cleared design should never have been submitted or marketed in the first place. The FDA existed only to the extent that it supposedly made a statement in 1988 (over 20 years before plaintiff's surgery) about insufficient evidence of "long-term biocompatibility" in connection with a possible downclassification that never happened. So the FDA does exist in pelvic mesh cases, when plaintiffs seek to mischaracterize its actions. Thirty million dollar verdict, including $10 million in punitive damages, affirmed. We criticized Kaiser's abdication here.
- Mize v. Mentor Worldwide LLC, 265 Cal. Rptr.3d 468 (Cal. App. 2020). Another putrid preemption decision from a state court, but since it's an intermediate appellate court, it doesn't rank as high – though Mize is still quite rank. Mize combined questionable reasoning, with the state's absurdly lax pleading standard to allow investigational device-related claims (Mize is so sloppy we had to look elsewhere to ascertain the product's FDA pedigree) to survive that almost every other court (save Russell, above) have found preempted. A prior published California appellate decision had found extensive IDE preemption. Mize didn't even cite it. While Mize relies on Lohr, it similarly ignores the more recent Riegel ( 2008+1) decision. It's easy to reject preemption if one ignores controlling precedent. By allowing preemption without even a "parallel claim" fig leaf, Mize became a minority of one. Conversely, when anti-preemption caselaw was impaired (Coleman, for its reliance on the overruled Stengel ( 2013-2) – by Conklin ( 2018+4)), Mize shrugged off the impairment. In one sentence, Mize also blew off overwhelming "non-California" precedent holding that FDCA-based negligence per se claims are preempted since the FDCA is necessarily a critical aspect of such a claim. Mize goes on to find an FDA reporting violation, concerning death cases, even though the plaintiff didn't die, adding a causal non sequitur to its selective non-use of precedent. And as to pleading causation Mize basically said, because of California's lax pleading requirements, nothing is required. We made mincemeat of Mize here.
- In re Bard IVC Filters Products Liability Litigation, 969 F.3d 1067 (9th Cir. 2020) ("Booker"). Booker started out with such promise – that the defense could finally get a court to examine express preemption in a post-Safe Medical Devices Act §510(k) clearance case on a full record, and thus demonstrate that, unlike the early 1980s device clearance process before the Supreme Court in Lohr, the post-1990 version employed the same "reasonable evidence of safety and effectiveness" standard that Riegel ( 2008+1) found preemptive and in fact imposed device-specific requirements. But after being unable to get the trial court to budge off the Lohr equals no preemption position, the defendant lost by winning. The jury found in the defendant's favor on design defect and imposed liability only for supposedly inadequate warnings. That allowed the Booker court to "assume without deciding" that SMDA "special controls" imposed by the FDA "were legally binding," but still reject preemption. Warning-related special controls were a lot more limited, imposed by reference to FDA guidance documents written for the relevant "class" of device. Booker winds up on our list by imposing very specific specificity. FDA requirements for a "class" of device were not preemptive; only requirements unique to the "particular" device. That is nowhere found in the relevant preemption clause. There were warning requirements in one of the guidances that were so particularized, but they involved aspects "not relevant" to the warnings at issue in Booker. Wouldn't they still trigger the preemptive "in addition to" statutory language? Not according to Booker – it moved the goalposts by creating up a new "relevance" hoop for preemption "in addition to" the particularity gloss imposed by Lohr. That got Booker on the list. We rate it this high (low?) because it also mangled Georgia law on punitive damages, neutering what is (in real Georgia courts) one of the strongest compliance defenses to punitive damages in the country. Booker thus illustrates much of what is wrong with current MDL practice: inability to obtain timely interlocutory appellate review of critical rulings such as preemption, manipulation of state law as merely another settlement tool, and pressure to affirm whatever verdicts emerge from "bellwether" trials, given the amount of judicial time and resources expended in MDLs. We blasted Booker here.
- Risperdal & Invega Cases, 263 Cal. Rptr.3d 412, 427 (Cal. App. 2020). Trial court finding of implied preemption reversed. Although there were no new or previously undisclosed studies that could qualified as "newly acquired information," a study author's deletion of a single table between the draft and final version of that study meant that the FDA didn't have that information. That could be newly acquired information and also enough to suggest that the FDA hadn't been "fully informed," which defeated preemption. One chart. Not only that, but the court ignored a statement in an FDA brief that the agency had all necessary information because the FDA defending itself in litigation was supposedly within the scope of its delegated authority. The FDA had also denied a citizen's petition filed by the same plaintiff's lawyer, stating that "there was no evidence that [the drug] was unsafe or anything else that warranted revoking the pediatric indication of the drug." That, too, was ignored because: (1) the missing chart and (2) FDA rejected extreme demands by counsel for removal from the market or black box labeling, not the mere label change at issue in the litigation. We ranted and inveighed against Risperdal & Invega here.
- Gremo v. Bayer Corp., 469 F. Supp.3d 240 (D.N.J. 2020). This second round of gadolinium litigation is a textbook example of why preemption is proper, since the FDA has explicitly found that the no serious risk from the condition (retention) about which the plaintiffs complain. And our 2020 posts are replete with preemption dismissals. But plaintiffs thrive on finding some court somewhere credulous enough to let even the most obviously meritless claims get by a motion to dismiss. Gremo is that case for this product. The FDA itself has determined that current science cannot establish a causal association between gadolinium and the adverse side effects that plaintiffs claim in case like Gremo. But plaintiffs aren't going plead that, so Gremo denies preemption but declining to judicially notice this undisputable fact. Because warnings survive, so does warranty. Plaintiff's "design" claim – that defendant should have made a different FDA-approved product with a different chemical structure, was a facially preempted "stop selling" claim, but analogizing to refrigerators (which require no governmental approval of any design), Gremo finds nothing more than an alternative design. In an equally bad finish, Gremo simply ignores New Jersey law preempting punitive damages under the state's product liability act. We griped about Gremo here.
- Gross v. Coloplast Corp., 434 F. Supp.3d 245 (E.D. Pa. 2020). For over 75 years, the Pennsylvania Supreme Court has rejected strict liability in product liability cases involving prescription medical products. Since Pennsylvania adopted Restatement §402A in 1966, it has done so by applying comment k to §402A across the board to all such products. Although beginning with drugs, the Supreme Court extended the rationale to medical devices in Cafazzo, as did an intermediate appellate decision, Creazzo. Indeed, one of our qualms about advocating adoption of the otherwise pretty defense friendly Third Restatement was its lack of a comment k equivalent. We discussed this all last year, in response to first ill-advised departure from this rule, Schrecengost ( 2019-8). Gross repeats all of the mistakes of that prior case: (1) misapplying Erie to expand tort law in the teeth of contrary state appellate authority; (2) ignoring Cafazzo and refusing to follow Creazzo; (3) relying on dictum in Tincher – ironically the very case the retained §402A, and thus comment k − when in fact that case expressly recognized the prescription medical product exception from strict liability, and (4) construing medical devices as somehow different from prescription drugs when nothing in Pennsylvania law, or either of the Restatements, justifies a distinction. There were some other similar rulings in 2020, but Gross is the worst of the lot. We thought Gross was just gross here.
- In re MDL 2700 Genentech Herceptin (Trastuzumab) Marketing & Sales Practice Litigation, 960 F.3d 1210 (10th Cir. 2020). This case more or less squeaks onto our bottom ten by virtue of reversing the decision we had named as seventh best in 2019. But the reversal was not nearly as bad as the district court decision had been good. That's because to defeat preemption the Tenth Circuit got way down into the weeds of this particular product, which was a prescription biologic sold in bulk in both liquid and solid forms. Indeed, the court agreed that, had the change plaintiffs were seeking to how the product was distributed been a "major change," the need for prior FDA approval would have required preemption. However, this was an economic loss case, so product safety and effectiveness were not at issue. Because the product had to be converted to liquid form before use, it was a "liquid" for purposes of the relevant FDA regulation, and that changed how doses were calculated, allowing plaintiffs to skirt preemption. That's not a defense to preemption we're likely to see in a personal injury case. Still a decision that reverses a top ten opinion on the merits deserves bottom ten placement. We hectored Herceptin here.
- In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2020 WL 7418006 (D.N.J. Dec. 18, 2020). This late-breaking addition to our bottom ten refuses to preempt any claim in this primarily economic loss MDL involving allegedly contaminated drugs. VSI starts out on the wrong foot by asserting that Levine ( 2009-1) is the "latest, single-most on-point" implied preemption decision. We recommend some more current preemption-related CLE, given that Albrecht ( 2019+1, 2019-6), is both more recent and more on point (it spent several pages revising Levine), and that Bartlett ( 2013+1) and Mensing ( 2011+1) are also several years more recent than Levine. VSI then purported to apply a "presumption against preemption" from Levine that was abandoned in Albrecht's revisions. That alone probably would not have put VSI on the list, but the decision also ignored well over a dozen contrary New Jersey state and federal decisions applying Buckman broadly to all claims attacking submissions to the FDA, and instead following the Desiano minority view narrowly limiting Buckman to "fraud on the FDA." Another lump of coal was VSI's erroneous application of the same preemption presumption to the express preemption clause of the Drug Supply Chain Security Act, despite the Supreme Court having abolished such presumptions in 2016. We haven't blogged about this one yet, given it was only decided last week.
There you have it. This year's litigation superspreaders. We'll also give a dishonorable mention to Collett v. Olympus Medical Systems Corp., 437 F. Supp.3d 1272 (M.D. Ga. 2020) (blogged about here), a lousy personal jurisdiction/stream of commerce case which had been tagged as our #10 worst until we read VSI.
After all this, we're ready to take off our personal protective equipment, take a disinfectant shower, change our masks, and wash our hands twice – everything short of injecting bleach (we don't plan on becoming the other side's clients). These countermeasures are necessary to avoid contaminating the much more pleasant work coming up, next week's review of 2020's top ten best drug/device decisions.
This article is presented for informational purposes only and is not intended to constitute legal advice.