With 2020 mercifully coming to an end, it is once again time for the Drug & Device Law Blog’s top ten decisions of the year. In keeping with COVID-19’s dominance of 2020, we present our top ten in the context of countermeasures against another social ill – the tort pandemic raging across much of the nation. Some of the cases here will keep our clients socially distant from aggregate litigations in superspreader venues where only plaintiffs want to be. Others resemble personal protective equipment, shielding our clients from harmful allegations in conflict with regulatory oversight. Others are more like vaccines, inoculating our clients from dangerous liability theories. Still others more resemble the central attribute of the effort to create COVID-19 vaccines – that science must be respected and the crackpot theories peddled by the other side would do more harm than good.
Next, our annual reminder. Our scope of coverage is limited. Our top (and bottom) ten lists are limited to cases involving prescription medical product liability litigation (relatively broadly defined). Cases are decided each year that significantly impact what we do, even though not involving prescription medical products. So, we’ll salute Rockhind v. Stevenson, 236 A.3d 630 (Md. 2020), adopting Daubert; Berry v. the City of Chicago, ___ N.E.3d ___, 2020 WL 5668974 (Ill. Sept. 24, 2020), rejecting no-injury medical monitoring; Texas Brine Company, L.L.C. v. American Arbitration Association, Inc., 955 F.3d 482 (5th Cir. 2020), in which a third straight court of appeal approved of removal before service; and Exela Pharma Sciences, LLC v. Sandoz, Inc., ___ F. Supp.3d ___, 2020 WL 5535026 (W.D.N.C. Sept. 15, 2020), preempting attempts to second guess FDA product decisions in commercial litigation.
Enough with the introductions. Now, let’s proceed with the protective measures.
- Rios v. Bayer Corp., ___ N.E.3d ___, 2020 WL 2963318 (Ill. June 4, 2020). For decades, litigation tourist plaintiffs looking for generous juries and favorable rulings have flocked to Madison, Cook, and St. Clair counties in Illinois. After Rios it’s time to start mucking out these Augean stables. Rios applied the Supreme Court’s BMS (2017+1) decision the way it was intended, to prevent any plaintiff from anywhere from relying on secondary or immaterial forum “contacts” that had nothing to do with their cases as a basis for personal jurisdiction. 160 out-of-state plaintiffs (suing in Madison County) advocated a “loose and spurious” form of general jurisdiction under the guise of “specific” jurisdiction. They cobbled together supposed forum “contacts” that had nothing to do with their cases − “clinical trials,” us[ing] the state . . . for [a] physician training program,” “orchestrat[ing] a marketing campaign” – even though they weren’t in the trials and were unaffected by either the training or marketing. In stark contrast to our worst case of 2020, Rios refused to allow “specific” jurisdiction to be based on “contacts” so general that any plaintiff from anywhere could assert then. Without the plaintiffs themselves being prescribed, having purchased, or ever using the product in state, no “meaningful” basis for meeting the “arising from”/”relating to” standard for specific personal jurisdiction existed in Rios. “Illinois has no particular interest in resolving claims that did not arise out of or relate to activities that occurred here.” Further, all these “out-of-state plaintiffs could pursue their claims elsewhere.” And since a number of the plaintiffs in fact had filed suit elsewhere, judicial economy also supported dismissal. Cleaning up an earlier mess, Rios also expressly overruled the earlier M. (2016-8) decision which had held that clinical trials established jurisdiction even for non-resident plaintiffs who were never trial subjects. Since Illinois has already rejected general jurisdiction by consent, that means that litigation tourists are now out of personal jurisdiction arguments in Illinois. We rhapsodized about Rios here.
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- Boone v. Boehringer Ingelheim Pharmaceuticals, Inc., 239 A.3d 1175 (Conn. 2020). The Connecticut Supreme Court unanimously affirmed the complete preemption of prescription drug design defect claims. State judges are generally less friendly towards federal preemption of their state’s law than federal courts, so that’s an accomplishment right there. Applying one of our favorites − the “Mensing (2011+1) independence principle” – Boone preempted a rather unusual contention that the defendant should have not have sold an FDA approved product until also getting FDA approval of a supposed “antidote.” This purportedly common-law claim rather explicitly sought to hold hostage an FDA approved drug until a separate, later FDA action approving a different drug. Beyond being contingent on agency action, that claim was further preempted as a “stop selling” claim under Bartlett (2013+1) because the only way to avoid liability under the plaintiff’s theory was not to sell the FDA-approved product at all, pending development of a second drug. The court explicitly rejected plaintiff’s argument (which we see all the time) that Mensing and Bartlett should be limited to generic drugs, and instead agreed with Yates (2015+1) to hold that Supreme Court’s implied preemption analysis was broadly applicable. Also rejected was another common claim from the other side, that Albrecht (2019+1, 2019-6) required all prescription drug implied preemption arguments to jump through the hurdles of the “clear evidence” test. That test only applies if the FDA’s CBE regulation applies and allows unilateral warning revision. CBE Bartlett is not a basis for changing drug design or availability. Finally, the plaintiffs’ claim that it “pre-approval” design defect claims escape preemption was also rejected as another variant of a stop selling claim. We went bonkers for Boone here.
- In re Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), ___ F.3d ___, 2020 WL 7214264 (2d Cir. Dec. 8, 2020). Our best Daubert decision of 2020 was decided earlier this month. Short but oh so sweet, the Second Circuit affirmed in toto In re Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), 387 F. Supp.3d 323 (S.D.N.Y. 2019), which was our 9th best case of 2019. The court properly held that none of the plaintiffs’ experts offered general causation opinions that could withstand any degree of scientific examination. This result seems obvious – the condition at issue is “idiopathic intracranial hypertension,” and “idiopathic” means precisely that cause cannot be determined – but other circuits have been much more hospitable to junk science. Not Mirena. Plaintiffs first argued that the inquiry into their experts’ methods was too rigorous. Mirena court affirmed that Daubert requires a “hard look” at expert opinions and that “an expert’s methodology must be reliable at every step of the way,” emphasizing the necessity of “rigorous examination.” “[N]ot only was it appropriate for the district court to take a hard look at plaintiffs’ experts’ reports, the court was required to do so to ensure reliability.” Then, with almost Shakespearean inconsistency, plaintiffs complained about the trial court considering their experts’ conclusions, as opposed to their methods. Wrong again. Mirena holds that it is entirely proper, as a Daubert factor, to consider that an expert’s conclusions are not generally accepted. Mirena also affirms that support by published studies may be required where the expert’s methods are not otherwise reliable, and rejects differential diagnosis as the sole basis for a general causation opinion. Affirming summary judgment, Mirena also recognizes that “there is a general causation requirement across all states.” We marveled at Mirena here.
- In re Taxotere (Docetaxel) Products Liability Litigation, 966 F.3d 351 (5th Cir. 2020). The passive aggressive approach many MDL plaintiffs and their counsel take towards their obligations to complete “fact sheets” or similar disclosure documents is one to the banes of any MDL defense counsel’s existence. Missed deadlines and incomplete answers abound and require inordinate amounts of work keeping track of deficiencies and notifying plaintiffs repeatedly of their failure to meet their obligations. MDL deficiency proceedings drag on for many months. That’s what happened in Taxotere. After more than four months of inaction, the plaintiff hadn’t done a thing – no submission at all. Only after the MDL court set a hearing did plaintiff make a woefully inadequate submission. After a judicial sanctions warning, followed by yet another round of extensions and deficiencies, the court had finally had enough and dismissed the case with prejudice. Plaintiff appealed and lost, bigtime, in a rare published appellate opinion on this topic. Taxotere is a long overdue reaffirmation of the power of MDL judges to impose the ultimate sanction of dismissal with prejudice on MDL plaintiffs who only want to wait for settlement, while doing nothing. Taxotere rejected plaintiff’s dithering, multi-factor argument in favor of a simple review of the MDL court’s discretion to dismiss – was there a “clear record” of delay, and would “lesser sanctions” suffice. In Taxotere there was extensive delay, which in and of itself demonstrated that no lesser sanction would stop it. No fact sheet; no case. Dismissal sanctions had to be real and enforceable. We touted Taxotere here.
- This entry is from the non-RS side of the blog. Dolin v. GlaxoSmithKline LLC, 951 F.3d 882 (7th Cir. 2020). Again? The Seventh Circuit reaffirms its prior decision that we named as fifth best decision of 2018. The court rejected an argument that Albrecht (2019+1, 2019-6) precluded defendants from ever having “clear evidence” that the FDA would have rejected the warning in question unless the particular defendant itself had unsuccessfully submitted the particular warning to the FDA. Instead, the FDA’s decision to impose classwide labeling on the defendant’s drug that did not contain the language plaintiff advocated sufficed as “clear evidence” of an adverse FDA’s decision − whether or not the particular defendant being sued actually submitted a label change. Albrecht did not repudiate the “would have” rejected standard in Levine (2009-1), but merely clarified it. Rather than overrule or make huge changes to Levine, the principal holding in Albrecht was that preemption is a question of law. The record showed that the FDA had “full information” from the defendant, so preemption was not defeated by the FDA deciding to act more broadly than in a product-specific manner. Classwide labeling is formal enough to be a preemptive FDA action. Thus, the court emphasized the parts of Albrecht we liked and minimized those parts we did not. We (well some of us) discussed Dolin here.
- In re Viagra (Sildenafil Citrate) & Cialis (Tadalafil) Products Liability Litigation, 424 F. Supp.3d 781 (N.D. Cal. 2020). These favorable Daubert decisions should spell the end of another MDL. All of plaintiffs’ general causation experts excluded after a 4-day Daubert hearing. A single medical journal article reporting an “association” was not enough. Association is not causation. Plaintiffs’ experts’ Bradford Hill analysis was result-driven and truncated, relying on a single factor – association – to the exclusion of the other eight factors. Plaintiff’s theory was not supported by any scientist, researcher, regulatory agency, or other qualified person, save their own paid experts. The science was all the other way. Lots of things may be biologically “plausible,” but that doesn’t mean they have any actual scientific support. Science worked. An article found an association and suggested further study. Other scientists took up the challenge, but nothing more significant than the initial association has been found. A very good decision, particularly from a court in the Ninth Circuit. We vouched for Viagra here.
- Keen v. C.R. Bard, Inc., ___ F. Supp.3d ___, 2020 WL 4873634 (E.D. Pa. Aug. 19, 2020) & Keen v. C.R. Bard, Inc., ___ F. Supp.3d ___, 2020 WL 4818801 (E.D. Pa. Aug 19, 2020). Two excellent decisions handed down the same day. These could just as well have been issued as a single opinion, so we consider them together. The first decision is notable for its solid reaffirmation of established Pennsylvania law precluding strict liability in prescription medical product liability litigation. Pennsylvania appellate decisions involving prescription medical product liability litigation are unanimous in rejecting strict liability, and so are vast majority of federal cases that purport to apply Pennsylvania law. Also cites nonbinding jury instructions. The other parts of the opinion, denying summary judgment on other claims, are routine and pale by comparison. The second Keen opinion concerned trial evidence, and rejected the fallacy − adopted primarily in pelvic mesh cases like Eghnayem (2017-2), and Cisson (2016-2) − that evidence of FDA §510(k) clearance is excludable as irrelevant or unduly prejudicial to plaintiffs. This was never the law prior to Pelvic Mesh, and was created not so much from the law, but rather to force settlement. Not anymore, since Keen held that the jury, “after taking into consideration the history of the FDA’s 510(k) clearance of the [product], could determine that [defendant] took reasonable and appropriate steps in its effort to bring [the product] to market.” That’s the right result, since in no other area of tort law is regulatory compliance viewed as an all or nothing (preemption or inadmissibility) proposition. We gave kudos to Keen here and here.
- Cavanaugh v. Stryker Corp., ___ So.3d ___, 2020 WL 5937405 (Fla. App. Oct. 7, 2020). Defense counsel managed an excellent result despite some pretty bad facts in Cavanaugh. The key to the case was misuse of the device by medical personnel who failed to read the defendant’s warnings. The key to the appeal, and why it made our list, is some pretty basic product liability law. As in many states, Florida allows proof of design defect on the basis of either “consumer expectation” or “risk/utility” theories. Defendants, particularly those that manufacture complicated products like medical devices, much prefer the latter to the former, and in Cavanaugh the District Court of Appeal agreed. The consumer expectation test does not logically apply to a prescription-only product about which a “ordinary consumer” would not have any meaningful expectations. These rulings should have lasting impact in Florida. Further, since the appeal came in the context of objections to jury instructions, plaintiff never requested an instruction that the “learned intermediary” was the “consumer” for purposes of measuring consumer expectations. We commended Cavanaugh here.
- (Tie) Stiens v. Bausch & Lomb Inc., ___ S.W.3d ___, 2020 WL 7266398 (Ky. App. Dec. 11, 2020). This late addition to our list reaffirms both the purely federal nature of allegations concerning truthful off-label promotion and the vitality of the state of the art defense in a case where the off-label use at issue was also the medical standard of care. Yes, the defendant engaged in off-label promotion, but plaintiff had no evidence: (1) of any untrue statement, or (2) that the risk was known at the time of the surgery (plaintiff’s expert admitted only extant medical literature was “not germane”). Rather, plaintiff’s surgeon was the first to report the risk. Unknown risks are not foreseeable, as required by the state’s product liability act. Nor did defendant improperly fail to test off-label uses for unknown risks. Drug manufacturers are not legally required to test their products for unknown risks of off-label uses. Nor could plaintiff use that unknown risk gin up a claim over truthful off-label promotion. Assuming that to be an FDCA violation, off-label promotion must be false also to support state-law liability, and the defendant neither knew nor should have known of that risk at the time of the promotion. Following Caronia (2012+7) and Caplinger (2013+9), Stiens held that mere off-label promotion is not a tort claim under state law. We saluted Steins here.
- (Tie) Ridings v. Maurice, 444 F. Supp.3d 973 (W.D. Mo. 2020). 2020 saw quite a few favorable implied preemption cases involving “newly acquired information,” and this was the best of them. Extensive analysis, including a road map of how, procedurally, a court is to approach a preemption motion after Albrecht (2019+1, 2019-6). In Ridings that included a bench trial at which plaintiff had to specify exactly what was supposedly wrong with the defendant’s warning. “Newly acquired information” is separate from, and precedes “clear evidence” in evaluating prescription drug preemption issues. Further, it is the plaintiff’s burden to put the defendant in the “clear evidence” box, so plaintiff must come forward with evidence showing that all the prerequisites of the FDA’s CBE regulation are met, not just newly acquired information but that such information involved a “serious” risk. Good holdings that inconclusive “needs more study” medical articles, foreign warnings, and discontinued patents don’t trigger the CBE regulation. For good measure, Ridings also found clear evidence that the FDA would not allow the warning plaintiff sought based on FDA inaction in the face of all the information being disclosed and considerable back and forth on the precise topic. We rapturously reviewed Ridings (here).
That’s a wrap for our top ten picks as the best drug/medical device decisions of 2020.
But wait; there’s more. Like the 2020 hurricane season, there were a lot more than ten pro-defense decisions worth naming, so here’s our list of runners up, the next ten most favorable 2020 decisions.
Honorable Mentions: (11) Zitney v. Wyeth LLC, ___ A.3d ___, 2020 WL 7040432 (Pa. Super. Dec. 1, 2020). Precedential holding, in hotly contested test case, that no separate duty exists, once a prescription medical product manufacturer has provided adequate warnings with its product, to repeat those warnings in a Dear Doctor letter addressed specifically to a plaintiff’s prescribing physician (here, and here). (12) This space intentionally left blank. (13) Hubbard v. Bayer HealthCare Pharmaceuticals, Inc., ___ F.3d ___, 2020 WL 7550285 (11th Cir. Dec. 22, 2020). Best learned intermediary case of 2020. Prescriber already knew of risk and thought it too small to change anything. Georgia does not have a heeding presumption. Brand new, so no post yet. (14) Almond v. Janssen Pharmaceuticals, Inc., ___ F.R.D. ___, 2020 WL 6545892 (E.D. Pa. Nov. 6, 2020). A nationwide class action involving medical monitoring? No, way. The multiple conflicting state approaches to medical monitoring alone preclude any class, and justify striking the class allegations at the outset (here). (15) Irizarry v. Abbott Laboratories, ___ F. Appx. ___, 2020 WL 6441117 (3d Cir. Nov. 3, 2020). One of the most hotly disputed issues in PMA preemption cases is whether plaintiffs have to plead the nature of the claimed FDCA violation and causation to state a “parallel” violation claim. In Irizarry the Third Circuit came down on the side of enforcing TwIqbal. Would have ranked much higher if precedential (here). (16) Polt v. Sandoz, Inc., 452 F. Supp.3d 557 (E.D. Pa. 2020). Invokes Erie restraint to reject a novel medication guide exception to Pennsylvania’s learned intermediary rule. Negligence per se cannot be used to create new duties not recognized by the common law (here). (17) Henry v. Angelini Pharma, Inc., 2020 WL 1532174 (E.D. Cal. March 31, 2020). A couple of years ago we had the bright idea that personal jurisdiction was a likely defense to innovator liability, since the defendant never sold the product that the plaintiff took, it did not commit any act in the relevant jurisdiction. There were no cases then, but in Henry a California court agreed with our theory and dismissed the case (here). (18) Gayle v. Pfizer, Inc., 452 F. Supp.3d 78 (S.D.N.Y. 2020). Another excellent implied preemption “newly acquired information” decision. A disorganized mass of some 6000 adverse event reports is not such evidence, hence preemption. (here). (19) Conley v. St. Jude Medical, LLC, ___ F. Supp.3d ___, 2020 WL 5087889 (M.D. Pa. Aug. 28, 2020). Dynamite PMA preemption case. Good on parallel claims, specificity of pleading, failure to report adverse events, and applying Albrecht to medical devices (here). (20) In re DePuy Orthopædics, Inc. ASR Hip Implant Products Liability Litigation, 953 F.3d 890 (6th Cir. 2020). A useful appellate reminder that an overseas litigation tourist can’t also sue an overseas defendant, since overseas parties on both sides of the “v.” destroys diversity jurisdiction. Not more highly ranked because this just doesn’t happen all that often (here).
Our 2020 collection of cases concludes with more near misses than usual – there were quite a few good post-Albrecht preemption cases this year; you can check them all out on our preemption scorecard – so here are the next tier of victories: Webb v. Mentor Worldwide LLC, 453 F. Supp.3d 550 (N.D.N.Y. 2020) (here), D’Addario v. Johnson & Johnson, 2020 WL 3546750 (D.N.J. June 30, 2020) (here), and Smith v. Teva Pharmaceuticals United States, 437 F. Supp. 3d 1159 (S.D. Fla. Feb. 4, 2020) (here). Finally, Markham v. Ethicon, Inc., 434 F. Supp.3d 261 (E.D. Pa. 2020), if followed elsewhere, could be a big removal deal (here).
Reviewing our prior lists of best and worst decisions, from this year’s lists, we just discussed the Mirena (2019+9) affirmance above, and mentioned last week, that our #7 best case of 2019 got reversed. In addition, appeals are pending in Nowell (2019+13) and (we think) in Roberto (2019+20). The others appear final, with appeals failing to change the result in Sherman (2019+6), Davis (2019+18), A.Y. (2019-3), and Painters & Allied Trades (2019-4).
We skimmed over a couple of earlier years of our top/bottom ten lists, but found nothing more than the Dolin (2018+5) re-affirmance mentioned above and the Russell (2018+17) and Hammons (2018-3) results mentioned last week.
Looking forward, we’ve already mentioned that the Supreme Court will decide, before the current term ends in June 2021, a couple more (non-drug/device) product liability personal jurisdiction cases – ones that do not litigation tourists. Maybe the decision will provide more clarity about the “arising from”/”relating to” specific personal jurisdiction standard. We’d like to see further review in the United States Supreme Court of both the Hammons (2020-1) and Russell (2020-2) decisions, since in both instances state highest court refused to follow Supreme Court precedent and relied instead on lone dissents, but Supreme Court review is notoriously hard to get. Further, an appeal is also pending in the Ridings case discussed above as our number ten case. Another possibility is that we’ll get lucky, and the Mirena plaintiffs will appeal that case to the Supreme Court. We think Mirena would be an excellent vehicle for pro-defense resolution of some Daubert-related circuit splits.
Finally, on the administrative front, the biggest action we see on the horizon is whether the incoming administration will let stand the recent expansion of PREP Act liability to actors without government affiliations, decisions not to use covered countermeasures and creating an exclusive federal cause of action. The FDA’s restarted attempt to address its obsolete, 1950s-vintage “intended use” regulations will also plod forward.
Legislatively, we don’t expect much that affects our product liability bailiwick. However, that’s not necessarily a bad thing. With Congress closely balanced, we don’t see much likelihood that legislation precluding snap removals will succeed.