Tort Pandemic Countermeasures − The Ten Best Prescription Drug/Medical Device Decisions of 2020

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.

1. 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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3. 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.
4. 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.
5. 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...