Federal Rules of Evidence 701 and 702 govern the admissibility of lay and expert opinion testimony, respectively, in federal courts. Rule 701(c) helps paint the line between the two, providing that an opinion “based on scientific, technical, or other specialized knowledge within the scope of Rule 702” cannot be admitted as a lay opinion. This requirement was added in the 2000 Amendments to Rule 701 to address what the Advisory Committee described as a risk “that the reliability requirements set forth in Rule 702 will be evaded through the simple expedient of proffering an expert in lay witness clothing.” Given this history, one might expect courts to err toward applying Rule 702 to any testimony that inherently draws on expertise that laypeople do not possess. But, as illustrated by the Sixth Circuit’s split decision in United States v. Betro, — F.4th —, 2024 WL 3811838 (6th Cir. 2024), some courts use a different approach.
Yes, Michigan Applies the Learned Intermediary Doctrine
For decades, both state and federal courts in Michigan have routinely applied the learned intermediary doctrine in products liability cases involving prescription medical products. Under the doctrine, a manufacturer’s duty to warn runs not to a plaintiff but to the plaintiff’s prescribing physician. Although “[e]very state in the country, along with the District of Columbia and Puerto Rico, has adopted the learned intermediary doctrine in some iteration,” Dearinger v. Eli Lilly & Co., 510 P.3d 326, 329 (Wash. 2022) — including courts applying Michigan law — a Michigan federal court recently expressed doubt about the doctrine’s applicability and certified a question to the Michigan Supreme Court. The answer, if the court accepts the question, should be clear — yes, Michigan applies the learned intermediary doctrine.
In Osos v. NuVasive, Inc., No. 23-CV-12331, 2024 WL 3585092 (E.D. Mich. July 30, 2024), the plaintiff alleged injury from an implantable medical device manufactured by the defendant. The defendant filed a motion to dismiss, which among other things argued that the plaintiff’s failure to warn claim was barred by the learned intermediary doctrine because she had not alleged any failure to warn the implanting surgeon. 2023 WL 9322029 (motion to dismiss). The plaintiff did not take issue with the learned intermediary doctrine in general but argued that, because she alleged that the implanting surgeon was an inventor of the product and an agent of the defendant, there was no true “intermediary” between the defendant and the plaintiff. 2023 WL 11081568 (opposition). Thus, according to the plaintiff, the case represented an exception to the learned intermediary doctrine.
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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.
Ayotte v. National Basketball Association: Plaintiff Can’t Hide the Ball on Communications Between Counsel and Non-Retained Treater Expert
Picture a deposition of a plaintiff’s treating physician. Early in the deposition, defense counsel asks the usual questions about the physician’s communications with the plaintiff’s counsel. But the plaintiff’s counsel, claiming that the physician is a non-retained expert whom the plaintiff’s counsel represents in connection with the action, objects on the basis of privilege and instructs the physician not to answer. That can’t be right, but exactly why not? And if such communications are discoverable, then why wouldn’t communications between defense counsel and a corporate defendant’s employee who is designated as a non-retained expert be discoverable as well? A recent order from the Southern District of New York offers clarity.
In Ayotte v. National Basketball Association, 2024 WL 3409027 (S.D.N.Y. Jul. 15, 2024), the plaintiffs designated a treating psychologist as a non-retained expert and claimed he was represented in connection with the action by the plaintiffs’ counsel. Thus, when the defendant sought to discover communications between the plaintiffs’ counsel and the treating psychologist, the plaintiffs argued they were privileged.
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).)