Subject: Causation

Pathologist Stopped Short of Offering Could-Have, Should-Have Opinions

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In personal injury and wrongful death cases, the plaintiff bears the burden of proving medical causation, which almost universally requires testimony from a competent expert.  Some plaintiffs offer testimony from forensic pathologists—also known as medical examiners, or physicians specializing in postmortem cause-of-death determinations—to prove causation.  These forensic pathologists (or the parties proffering their testimony) may push evidentiary boundaries with respect to opinions corollary to their cause of death determinations. While some courts have allowed juries to hear these questionable corollary opinions, relying on cross examination to level the playing field, others have excluded such testimony on the basis of insufficient qualifications or lack of reliable methodology.  Recently, the Southern District of Georgia excluded a forensic pathologist’s opinions on both grounds in a wrongful death action. Although not a product liability case, the court’s well-reasoned holding is sure to affect product cases going forward.

In Griffin v. Coffee County et al., 2022 WL 2045650 (S.D. Ga. June 7, 2022), a man in custody at a county jail in Georgia died from a methamphetamine overdose. His estate brought claims for deprivation of rights and medical malpractice against the jail, the hospital, and various individuals associated with those entities. In support of its claims, the estate proffered testimony from a forensic pathologist who offered opinions about medical treatment.

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Expert’s Failure to Identify Product Defect in Pressure Cooker or Inadequacy in Warnings Leads to Summary Judgment

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It is axiomatic that a plaintiff must offer evidentiary support for each element of her claim in order to survive summary judgment. And a ubiquitous feature of product liability actions is the use of expert witnesses by both sides. These principles are, of course, related – the plaintiff usually must offer expert testimony in order to make a prima facie case, and the defense then attacks that prima facie case through expert testimony. But sometimes a plaintiff loses sight of the connection and, despite retaining an expert, fails to elicit the opinions she needs to make her case. As a recent decision from the Western District of Wisconsin illustrates, it pays for a defendant to carefully evaluate whether a plaintiff has checked all of the necessary boxes.

In Moore v. National Presto Industries, Inc., 2022 WL 1555875 (W.D. Wis. May 17, 2022), Plaintiff alleged that she was injured when she opened her pressure cooker while it was still pressurized, ejecting its contents onto her arm, causing burns. Plaintiff sued the cooker’s manufacturer, asserting strict liability claims for design defect and failure to warn as well as a claim for negligence. Defendant moved for summary judgment on each of these claims.

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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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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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