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).
Subject: Causation
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).)
Peer Review Can’t Save “Junk Science” from FRE 702 Judicial Gatekeeping – In re: Roundup Court Excludes Expert Whose Opinions Had Been Published in Peer-Reviewed Literature
When tasked with assessing the admissibility of expert testimony under Federal Rule of Evidence 702, courts often cite the so-called Daubert factors as criteria that guide the inquiry. Among those factors is “whether the [expert’s] theory or technique has been subjected to peer review and publication.” Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993). The Daubert Court observed that, although publication “is not a sine qua non of admissibility,” peer review “increases the likelihood that substantive flaws in methodology will be detected.” But peer review is not coterminous with the Rule 702 inquiry that federal courts are called upon to make, especially with the rise of so-called predatory publishing and journals with relaxed (or absent) peer review processes. As one court recently observed, “a court can’t wave junk science through the Daubert gate simply because it survived some prepublication peer-review process.” In re: Roundup Products Liability Litigation, 2024 WL 3074376 (N.D. Cal. June 20, 2024).
In In re: Roundup, the plaintiff claimed to have developed non-Hodgkin’s lymphoma (NHL) as a result of using the defendant’s herbicide. In support of that claim, he offered a single expert on the issue of whether glyphosate, the active ingredient in the herbicide, can cause NHL in humans. The expert’s opinions were all contained in two peer-reviewed and published articles that the expert had co-authored. But only one of the two—a 2019 meta-analysis of six epidemiological studies addressing the link between glyphosate and NHL, which had been published before the expert became involved in the litigation—grappled with the available epidemiological evidence. The defendant attacked that paper on multiple grounds, and the court agreed that it constituted “junk science” with several flaws each independently justifying its exclusion.
Northern District of Illinois Holds that Seventh Circuit Precedent is Incompatible with Rule 702 as Amended
In explaining the December 2023 amendments to Federal Rule of Evidence 702, the Advisory Committee called out several ways in which “many courts” had “incorrectly” applied Rule 702 and failed to adequately discharge their duty as gatekeepers with regard to expert witness testimony. The import of those comments is that existing precedent on Rule 702 may be “incorrect” and must be re-examined.
A case pending in the Northern District of Illinois serves as a fine illustration of how this re-examination should work in practice. In West v. Home Depot U.S.A., Inc., 2024 WL 1834112 (N.D. Ill. Apr. 26, 2024), the plaintiff alleged that she was injured when portions of a store display fell on her. She offered a trio of experts to opine that her claimed injuries had been caused by the incident, but none of them “were aware of, let alone reviewed, [her] highly salient medical history prior to issuing their causation opinions.” Rather, they were treating physicians who based their opinions solely on their post-incident treatment of the plaintiff.