A Bridge Too Far: Reliance on Malfunction Theory Rejected When the Alleged Failure is a Known Risk of the Product

In some circumstances, a plaintiff lacking direct evidence of an identifiable, specific defect may be permitted to use circumstantial evidence to prove that a product malfunctioned and create a triable inference of a product defect. Some courts may treat proof of a product malfunction as circumstantial evidence of a product defect because a product will not ordinarily malfunction (or perform outside the reasonable safety expectation of the consumer) in the absence of a defect. This circumstantial evidence doctrine, commonly known as the “malfunction theory,” may provide plaintiffs with a pathway to establish a prima facie case of a product defect.

While the malfunction theory sometimes allows plaintiffs to bring a claim for a product defect where the product is no longer available or a specific defect cannot be identified, plaintiffs often attempt to stretch the theory beyond its logical bounds. In a recent case from Idaho, Black v. DJO Global, Inc., the Idaho Supreme Court rejected use of the malfunction theory when the alleged product “failure” (or malfunction) was the occurrence of a known risk, i.e., one that could occur even when the product performs as intended. Black v. DJO Glob., Inc., 488 P.3d 1283, 1288 (Idaho 2021).

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Pennsylvania Medical Device Strict Liability Claims: Relentless Repetition, Clamoring for Review

A Pennsylvania federal court has again asked that the state’s Supreme Court clarify whether, and to what extent, medical device manufacturers are immune from strict liability claims by virtue of the “unavoidably unsafe products” exemption recognized in Restatement (Second) of Torts Sec. 402A cmt. k (“Comment k”)—only this time with a direct certification.

On Thursday, the Third Circuit Court of Appeals certified that question to the Pennsylvania Supreme Court, along with a question about which negligent design defect theory—or theories—a Pennsylvania plaintiff may assert against a medical device manufacturer.  Pet. for Certification of Questions of State Law, ECF No. 50, Ebert v. C.R. Bard, Inc., et al., No. 20-2139 (3d Cir. June 24, 2021) (“Ebert Pet.”).   Last spring, Judge Pappert of the Eastern District of Pennsylvania dismissed Ms. Ebert’s strict liability claim, finding her IVC filter “an ‘unavoidably unsafe product’” under Hahn v. Richter, 673 A.3d 888 (Pa. 1996), and she appealed that order granting summary judgment to the Third Circuit.

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Ninth Circuit Affirms Dismissal of Breast Implant Cases on Preemption Grounds

The Ninth Circuit has confirmed in quadrophonic sound that plaintiffs cannot avoid preemption by relying on vague and speculative allegations to establish a parallel claim.  The court affirmed the dismissal of four lawsuits by plaintiffs claiming they were injured by breast implants on the grounds that their claims are barred by the 1976 Medical Device Amendment to the Food, Drug and Cosmetic Act (MDA).  Sewell v. Mentor Worldwide, LLC, et al., no. 19-56393; Vieira v. Mentor Worldwide, LLC, et al., no. 19-56394; Billetts v. Mentor Worldwide, LLC, et al., no. 19-56398; Nunn v. Mentor Worldwide, LLC, et al., no. 19-56391.

In each case, California plaintiffs alleged their breast implants were defective and caused them to experience fatigue, muscle pain, and migraines.  The district courts dismissed the complaints for failure to state a claim on grounds of preemption, and plaintiffs appealed.

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