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Third Circuit Affirms Lone Pine Order and Ensuing Dismissals in In re Zostavax MDL

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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.

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Ayotte v. National Basketball Association: Plaintiff Can’t Hide the Ball on Communications Between Counsel and Non-Retained Treater Expert

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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.

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Plaintiffs’ Second Bite at the General Causation Apple Fares No Better Than the First in Acetaminophen MDL

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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.

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California Supreme Court Walks Middle Ground on Warnings Causation but Reaffirms Learned Intermediary Doctrine in Himes

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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).)

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Georgia Court of Appeals Confirms “First Sale” as Used in Statute of Repose Refers to Sale of First Unit of Repeatedly Purchased Products

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Georgia’s product liability statute of repose requires actions to be commenced within 10 years of “the date of the first sale for use or consumption” of the product at issue. OCGA § 51-1-11(b)(2) (emphasis added). While the concept of “first sale” is clear and intuitive in the context of a product that may be sold and then later resold, it may be somewhat less clear as applied to a consumable product that is purchased repeatedly over a lengthy period of time. Is the “first sale” of such a product the earliest transaction by which the plaintiff ever obtained the product, or does “first sale” merely refer to the initial purchase of each individual unit of the product as opposed to any subsequent resales? The Georgia Court of Appeals recently clarified that it is the former – “first sale,” for purposes of the statute of repose, refers to the “first sale” of any unit of the product to the plaintiff. Thus, subsequent purchases of a new unit of the product do not come with their own fresh repose periods.

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Loper Bright & Corner Post Review: Supreme Court’s Overturning of Chevron Doctrine Spells Uncertainty for Food Industry Regulations

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On June 28, 2024, the U.S. Supreme Court overturned the Chevron doctrine of agency deference in its Loper Bright Enterprises v. Raimondo decision. The doctrine takes its name from a 1984 Supreme Court case, Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc, 467 U.S. 837 (1984), which announced a bright-line rule governing whether a regulation promulgated by an executive branch agency, like FDA or USDA, was enforceable based on the scope of statutory authority Congress delegated to the agency. Chevron held that if a court concluded that a statute was silent or ambiguous as to an issue (Step One), then the court must defer to an agency’s permissible construction of the statute in the regulations it promulgated (Step Two). In overturning Chevron deference, Loper Bright announced that courts “must exercise their independent judgment in deciding whether an agency has acted within its statutory authority.”

To read the full article, visit the Faegre Drinker website.