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Third Circuit Confirms That Alleged Defect in “Simple” Component of More Complex System Must Be Proven by Expert Testimony When Facts Surrounding Defect Claim Are Beyond Common Knowledge

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A plaintiff who alleges that a product is defective usually has to offer expert testimony in support of that allegation.  This should come as no surprise for complex products – if it took a team of scientists and engineers to bring the product to market, then a lay jury should not be asked to evaluate an alleged defect in that product without the aid of expert testimony.  But what if a plaintiff alleges a defect in the design of a relatively simple, more familiar component of a complex product?  The Third Circuit recently addressed that question in an opinion that, although nonprecedential and in some respects peculiar to New Jersey law, illustrates how a court should approach the issue.

In Kuhar v. Petzl Co., 2022 WL 1101580 (3d Cir. Apr. 13, 2022), Plaintiff fell and injured himself while using a safety harness that he had purchased as part of a kit seven years earlier.  He alleged that the fall occurred because a bolt attached to the carabiner of the safety harness had snapped due to a design and/or “indeterminate” or manufacturing defect.  In support of his claims, Plaintiff proffered a metallurgical and materials sciences expert who identified two alleged design defects – a “sharp profile change” and “sharp threads on the bolt” – and machining grooves that the expert deemed a manufacturing defect, some combination of which he claimed had caused the accident.  But some of the expert’s defect and causation opinions were “net opinions” – New Jersey parlance for “ipse dixit” opinions – and were excluded for lack of supporting data.  Other opinions were excluded because the expert failed to define his terms or explain his reasoning.  The Third Circuit agreed with the district court that the expert’s opinions lacked both reliability and fit, and affirmed its exclusion of all of the expert’s opinions.

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Ninth Circuit Asks California Supreme Court to Clarify the Causation Standard Applicable When the Learned Intermediary Doctrine Applies

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How demanding is the causation standard in a California failure to warn claim when a learned intermediary testifies that he would have read and incorporated more stringent warnings if they had been available? Is the plaintiff required to show that the stronger warning would have altered the physician’s decision to prescribe the product? Or may the plaintiff establish causation by showing that the physician would have communicated the stronger warnings to the patient and that a prudent person in the patient’s position would have declined the treatment as a result?

The Ninth Circuit isolated this undefined causation standard in Himes v. Somatics, LLC, and certified the question to the California Supreme Court. After confirming that the learned intermediary doctrine is alive and well in California and that a failure to warn claim cannot survive when the learned intermediary does not read the warnings at all, the Ninth Circuit stopped short of defining the causation standard that applies when a learned intermediary does read the warnings.

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Ninth Circuit Affirms Exclusion of Expert and Resulting Summary Judgment in In re: Incretin-Based Therapies MDL

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Early last year, the In re: Incretin-Based Therapies MDL court held that the plaintiffs’ warnings claims were preempted, excluded plaintiffs’ general causation experts, and granted summary judgment to all defendants on dual preemption and causation grounds. In re: Incretin-Based Therapies Prods. Liab. Litig., 524 F. Supp. 3d 1007 (S.D. Cal. 2021). For context, that was the second time the defendants won summary judgment; the Ninth Circuit had reversed an earlier preemption victory in an opinion that predated the Supreme Court’s decision in Albrecht. In re Incretin-Based Therapies Prods. Liab. Litig., 721 F. App’x. 580 (9th Cir. 2017). Now, however, the Ninth Circuit has affirmed summary judgment as to one defendant (Novo Nordisk A/S (“Novo”)). In re: Incretin-Based Therapies Prod. Liab. Litig., 2022 WL 898595 (9th Cir. Mar. 28, 2022).

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Cybersecurity Safeguard Implemented by Superior Court of New Jersey for OUS Web Traffic

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Last year, we explored the Federal Judiciary’s new safeguards and procedures to protect sensitive court records in light of the SolarWinds Orion cybersecurity breach.  Now, as a result of increased hostilities between Russia and the United States, the New Jersey Judiciary is taking steps to ramp up cybersecurity by blocking web traffic from outside the United States.

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Another Brick in the Wall: The District Court Finds Preemption in Fosamax Case After Remand From the Supreme Court

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We have written before about the Supreme Court’s impossibility preemption decision, Merck Sharpe & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (Albrecht) (here, here, here, and here), highlighting some open questions and uncertainties that might come into play on remand. Albrecht held that impossibility preemption is a question of law for the court, not for the jury, “elaborated” on the “clear evidence” standard arising from Wyeth v. Levine, 555 U.S. 555 (2009) (Wyeth), and remanded to the Third Circuit for determination of the preemption issue. That court in turn remanded to the District of New Jersey and further directed the district court “to determine the effect of the FDA’s Complete Response Letter and other communications with Merck on the issue of whether the agency actions are sufficient” to find preemption.

We predicted that the decision on remand would be “interesting” and opined that the case for preemption was “strong.” We now have that decision, In re Fosamax (Alendronate Sodium) Prod. Liab. Litig., 2022 WL 855853 (D. N.J. Mar. 23, 2022) (Fosamax), and we were right on both counts.

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Eastern District of Pennsylvania Issues Lone Pine Order in Zostavax MDL

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Multidistrict litigation is often criticized for enabling plaintiffs to file meritless cases and then hide in large inventories, hoping to be swept up in a settlement (whether global or otherwise) before the case is meaningfully probed through discovery.  Traditional tools such as plaintiff profile sheets and early screening orders represent a partial solution, as they can help identify cases with more obvious flaws such as those that are clearly time-barred or lack proof of product use.  But some issues, such as critical gaps in causation, are beyond the reach of the limited case-specific discovery permitted for most cases in an MDL.  Enter the Lone Pine order, a case management order by which a court requires all plaintiffs to produce evidence establishing specific elements of their claim.

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