Category: Failure to Warn

Blurry Vision in Two Courts Leads to Denial of Preemption in Intraocular Lens Implant Case

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A recent Second Circuit preemption decision illustrates the importance of a clear-eyed approach to medical device preemption issues.

In Glover v. Bausch & Lomb, Inc., 6 F.4th 229 (2d Cir. 2021), the district court dismissed as preempted a complaint concerning vision loss from defective intraocular lenses implanted during cataract surgery. Plaintiff developed “Z syndrome,” permanently impairing her vision, and sued the manufacturer under the Connecticut Product Liability Act (CPLA) for failing to warn.  She alleged the defendant had failed to report prior Z Syndrome cases to the FDA, as required by the Federal Food, Drug, and Cosmetic Act (FDCA).

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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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Northern District of Illinois Excludes Engineering Expert’s Testimony and Grants Partial Summary Judgment, Fulfilling its Responsibility as Gatekeeper

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For over two decades, dating back to Daubert and the ensuing amendments to Rule 702, federal district courts have been charged to act “as gatekeepers to exclude unreliable expert testimony.” Fed. R. Evid. 702 advisory committee’s note to 2000 amendments. However, some courts have not embraced that role, letting jurors weigh questions about an expert’s qualifications or methodology as though they go to credibility rather than admissibility. Indeed, the Advisory Committee on Evidence Rules proposed an amendment to Rule 702 to address the “pervasive problem” of courts holding that issues of admissibility are questions “of weight for the jury.” See, Sardis v. Overhead Door Corp., 10 F.4th 268, 282-84 (4th Cir. 2021). (quoting Advisory Comm. on Evidence Rules, Agenda for Committee Meeting (Apr. 30, 2021)).

A recent decision out of the Northern District of Illinois, however, provides an excellent example of a court discharging its duty to preclude inadmissible expert opinions. The Plaintiff in Pessman v. Trek Bicycle Corporation, 2021 WL 5769530 (N.D. Ill. Dec. 6, 2021) was injured in a bicycle accident. Plaintiff’s engineering expert opined that the cause of the accident was a crack in the carbon fiber frame of Plaintiff’s Trek bicycle attributable to a design defect. The engineer claimed that carbon fiber frames are prone to cracking and that the crack was mistaken for simple paint chipping by a dealer who had inspected the bicycle several days before the accident, allegedly due to Trek’s failure to train the dealer properly.

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