Nicole Berwick

Nicole Berwick counsels clients in product liability and mass torts. She draws on her experience working in the federal court system to develop creative solutions to complex problems and craft persuasive arguments concerning novel issues of law. Nicole serves clients in the health and life sciences, consumer products, and technology industries in individual cases and in multidistrict litigation.

View the full bio for Nicole Berwick at the Faegre Drinker website.

Articles by Nicole Berwick:


Yes, Michigan Applies the Learned Intermediary Doctrine

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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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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

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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.

Continue reading “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”