Multidistrict litigation is meant to “promote the just and efficient conduct” of actions “involving one or more common questions of fact” by transferring those actions to a single district court “for coordinated or consolidated pretrial proceedings.” 28 U.S.C. § 1407(a). In MDLs involving alleged physical injury or illness caused by a product, one “common question of fact” is general causation. Each plaintiff in the MDL must prove that the product is capable of causing the injury or illness. We think it is usually — if not always — most “just and efficient” to address general causation on an MDL-wide basis as early as practicable. Some courts disagree, testing general causation initially on just a subset of plaintiffs in the MDL; when those efforts fail, other plaintiffs may be permitted to try again, perhaps with new general causation experts. But the plaintiffs’ second attempt to establish general causation often fails to remedy the problems that doomed the first attempt (as we have discussed before), merely amplifying costs for both parties before reaching the same result. The In re Deepwater Horizon BELO (Back-End Litigation Option) Cases litigation, while not formally centralized as an MDL itself, provides another example. In re Deepwater Horizon BELO Cases, 119 F.4th 937 (11th Cir. 2024).
Subject: Multi-District Litigation
In re Taxotere (Docetaxel) MDL Court Rejects Plaintiffs’ Argument that Lone Pine Order is Unfair
We think Lone Pine orders are pretty fair. Lone Pine orders are case management orders that require plaintiffs in multidistrict litigation (MDL) to produce specific evidence without which the plaintiffs cannot make a prima facie case. There is nothing unfair about dismissing a case that is fatally flawed for want of critical evidence that cannot be obtained. Yet Lone Pine orders rarely sit well with plaintiffs who cannot (or do not want to have to) make the showing required of them. Rather than accept their fate, these plaintiffs often attack the Lone Pine order in an effort to delay the inevitable. We discussed one such effort in the In re Zostavax MDL in 2022 and earlier this year. The In re Taxotere (Docetaxel) MDL now provides another example, not only of how plaintiffs attack Lone Pine orders but also of how courts should respond to these unmerited attacks. In re Taxotere (Docetaxel) Prods. Liab. Litig., 2024 WL 4362982 (E.D. La. Oct. 1, 2024).
Third Circuit Affirms Lone Pine Order and Ensuing Dismissals in In re Zostavax MDL
In March 2022, the In re Zostavax MDL court entered a Lone Pine order requiring plaintiffs who claimed to have developed shingles as a result of using the Zostavax vaccine to produce certain test results supporting causation. In December 2022, the court dismissed 1,189 cases for failure to comply with that Lone Pine order. We posted about the Lone Pine order in April 2022 and the dismissal order in December of the same year. Now, on appeal, the Third Circuit has affirmed both the Lone Pine order and the dismissal. In re: Zostavax (Zoster Vaccine Live) Prods. Liab. Litig., 2024 WL 3423709 (3d Cir. July 16, 2024).
Zostavax is a vaccine meant to prevent shingles, a viral infection caused by the varicella-zoster virus (VZV). The vaccine introduces a weakened strain of VZV, triggering an immune response that primes the recipient’s immune system against non-vaccine sources of VZV (i.e., “wild-type strains”). VZV is responsible for both shingles and chickenpox, and it remains in the body for life. As a result, everyone who had chickenpox as a child faces a risk of the virus reactivating and causing shingles in adulthood. A laboratory test (called a “PCR test”) can reliably distinguish between the strain of VZV used in Zostavax and the wild-type strain one would find due to chickenpox infection.
Plaintiffs’ Second Bite at the General Causation Apple Fares No Better Than the First in Acetaminophen MDL
In December 2023, back when the ink was still drying on the amendments to Federal Rule of Evidence 702, the Southern District of New York excluded all five general causation experts proffered by plaintiffs in the In re Acetaminophen MDL whose cases had been selected for trial. We discussed that impressively detailed and painstaking decision here. Observing that all 50 states require proof of general causation in product liability cases and that the plaintiffs now had no experts to carry that water, the court instituted an order to show cause process that led to the dismissal of approximately 550 cases. However, over the defendants’ objections, the court permitted a small handful of new arrivals to the MDL to name their own general causation expert and try again. In yet another impressively meticulous opinion, the court recently doubled down on its Rule 702 “gatekeeping” role and excluded the new plaintiffs’ backup general causation expert in In re Acetaminophen – ASD-ADHD Prod. Liab. Litig., No. 22MC3043 (DLC), 2024 WL 3357608 (S.D.N.Y. July 10, 2024).
The plaintiffs in In re Acetaminophen allege that prenatal use of acetaminophen caused attention deficit hyperactivity disorder (ADHD) and/or autism spectrum disorder (ASD) in offspring. The plaintiffs’ first five proffered general causation experts were excluded in part because the court took issue with the experts’ “transdiagnostic” approach — combining literature of ADHD and ASD into a single analysis — because it merely “obscured limitations in the scientific literature.” The new plaintiffs’ expert — number six overall — sidestepped the “transdiagnostic” issues and sought to opine solely on a supposed link between prenatal acetaminophen use and ADHD. But the court, still mindful of acetaminophen’s critical role as the only pain reliever and fever reducer indicated for use during pregnancy and the FDA’s multiple reviews of its safety, remained vigilant in its Rule 702 obligation.
California Supreme Court Walks Middle Ground on Warnings Causation but Reaffirms Learned Intermediary Doctrine in Himes
As we reported in April, the United States Court of Appeals for the Ninth Circuit certified a question on California’s Learned Intermediary Doctrine in Himes v. Somatics, LLC, 2022 WL 989469 (9th Cir. Apr. 1, 2022). The California Supreme Court has now decided the issue in a way that walks the middle ground. On the one hand, the court rejected plaintiff’s call for recognizing an exception to the learned intermediary rule and reaffirmed the basic rule that a manufacturer’s duty to warn runs to the prescribing physician. On the other hand, the court ultimately lowered plaintiff’s burden of providing warnings causation. The opinion has clear ramifications not only on dispositive motion and trial practice, but on discovery strategies in prescription drug and medical device cases.
The question before the court was whether a plaintiff is “required to show that a stronger risk warning would have altered the physician’s decision to prescribe the product,” or whether a plaintiff may instead establish causation “by showing that the physician would have communicated the stronger risk warning[ ] to the plaintiff, either in their patient consent disclosures or otherwise, and a prudent person in the patient’s position would have declined the treatment after receiving the stronger risk warning.” (Himes v. Somatics, LLC, 16 Cal.5th 209 (2024).)
Lack of “Newly Acquired Information” Defeats Plaintiffs’ Claims in Zofran MDL
Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks – for example, a recent systematic review and meta-analysis concluded that use of ondansetron during pregnancy was associated with a reduced incidence of miscarriage but “was not associated with abnormal pregnancy outcomes,” including a variety of birth defects. Nevertheless, plaintiffs have alleged that Zofran causes birth defects and that the warnings accompanying the drug should have said so. Those claims were dismissed in 2021 when the district court held them preempted, and the First Circuit recently affirmed that decision in In re Zofran (Ondansetron) Products Liability Litigation, — F.4th —, 2023 WL 128570 (1st Cir. Jan. 9, 2023).
Plaintiffs in the Zofran MDL alleged, among other things, that the defendants failed to warn of birth defects observed in certain animal studies. Because such claims implicate the warnings accompanying an FDA-approved drug, they are preempted unless the manufacturer could have unilaterally amended the label through the Changes Being Effected (CBE) regulation. The CBE regulation permits a manufacturer to amend a product’s labeling without prior FDA approval “to reflect newly acquired information” and thereby “add or strengthen” the warnings where there is “evidence of a causal association” between the drug and the subject on which the warnings are being amended.
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