Subject: Prescription Drugs

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

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

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

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

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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FDA Finalizes Voluntary Recall Guidance Imploring Companies to Be “Recall Ready”

FDA recently issued final guidance regarding the initiation of voluntary product recalls and its related suggestions on how to be “recall ready.” The guidance – covering voluntary recalls of food, drugs, devices, biological products, cosmetics, and tobacco – emphasizes the importance of a company’s recall readiness at all stages of a product’s distribution chain and provides companies with suggested measures to prepare for and implement voluntary recalls. It also advises companies on best practices for working with FDA to initiate a timely voluntary recall.

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It’s an MDL World: The JPML issues its first orders of the year, creating two new MDLs

Centralization of claims in multidistrict litigation has become the new normal—so much so, that MDL proceedings now comprise more than 50 percent of the federal civil caseload. But has MDL practice in the United States peaked? Only time will tell. While the total number of MDL cases remains high (424,720 cases as of mid-February), the vast majority of these cases are concentrated in just a few of the more crowded MDL dockets. And as the annual MDL statistics in recent years show, the total number of new MDL petitions submitted, and granted, has been in decline. In 2021, for example, the Judicial Panel on Multidistrict Litigation received 33 total MDL petitions, granting only 19—compared with 44 petitions (26 granted) the year before.

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