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:


Clearing the Weeds: The Ninth Circuit Confirms that There is Not (And Never Has Been) a Presumption of Admissibility in Its Case Law Addressing Rule 702

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The judge overseeing the In re Roundup Products Liability Litigation MDL once remarked that “When you [consider] Ninth Circuit law, you come away with a pretty strong feeling that the Ninth Circuit is more tolerant of shaky expert opinions than other circuits.”  But that was before the 2023 amendments to Federal Rule of Evidence 702, and appellate courts around the country have gradually been addressing how the amendments impact pre-amendment case law. The Ninth Circuit recently joined the ranks in a way, affirming that same judge’s exclusion of an expert’s causation opinion while harmonizing Ninth Circuit case law with the purposes of the 2023 amendments. The opinion is Engilis v. Monsanto Company, — F.4th —, 2025 WL 2315898 (9th Cir. 2025), and the headlines may come as a surprise to some.

The case-specific underpinnings of the holding are relatively straightforward. The plaintiff alleged that he developed cancer due to exposure to a product manufactured by the defendant. His expert, however, had failed to consider the plaintiff’s obesity as a potential cause of the cancer when conducting the differential etiology that formed his specific causation opinion. He tried to get around this omission by claiming that the plaintiff was not obese, and the plaintiff argued that this was a disputed fact because his plaintiff’s fact sheet was marked “negative” for obesity.  However, the expert failed to cite any medical records indicating that the plaintiff was not obese and did not engage with records that showed he was obese. Translated to Rule 702 terms, any opinion that the plaintiff was not obese was not “based on sufficient facts or data.”  So, the expert argued that obesity is not a risk factor for the kind of cancer at issue and thus did not need to be considered. But his report cited no support for that proposition, which he manufactured at the hearing on the defendant’s Rule 702 motion. The Ninth Circuit agreed with the district court that these issues rendered the expert’s specific causation opinion inadmissible.

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Defective Logic: Why Recall Evidence Falls Short in Court

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In product liability litigation, plaintiffs often treat a product recall as though it is conclusive proof that the product is defective or that its warnings are inadequate. Some plaintiffs even cite clearly inapplicable recalls — for example, lot-specific recalls spurred by a manufacturing or labeling issue that did not impact the unit that the plaintiff received — in an effort to bolster their case before a court or in settlement discussions. Federal Rule of Evidence 407’s prohibition on the use of recall evidence to prove those points seems to do little to quell the enthusiasm. Of course, Rule 407 is grounded in part on “a social policy of encouraging people to take, or at least not discouraging them from taking, steps in furtherance of added safety.” Fed. R. Evid. 407 advisory committee’s note. But Rule 407 is not the only grounds on which recall evidence can (and should) be excluded.

For example, in Pecan Trust v. Nexus RVs, LLC, 2025 WL 1503940 (N.D. Ind. May 27, 2025), the plaintiffs sued the manufacturers of an RV and certain component parts alleging, among other things, that a defect in the brake pressure switch represented a fire risk. In support of that claim, they pointed solely to a safety recall for the part due to a possible fire risk and an expert witness who, based on the recall alone, concluded that the issue might pose a fire risk. The parts manufacturer moved for summary judgment, and the court granted the motion as to the breach of warranty claim after concluding that the plaintiffs had not proffered sufficient evidence of a defect. As the court noted: “That a recall has occurred may be evidence of certain things—namely as a subsequent remedial measure—but it cannot show a product defect. In reality, products subject to a recall might have a defect or might not, as a recall implements a safety campaign to ensure that none do or will manifest one.” (internal citations omitted). And, as the court noted in the specific context of the warranty claim, the fact that the plaintiffs had never presented the RV for work under the recall posed a second, equally problematic obstacle to their claim.

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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.

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