Category: Design Defect

In Case You Missed It: Faegre Drinker on Products — Winter 2026

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Catch up on the latest developments of interest for product manufacturers. Here’s a quarterly compilation of the most popular blog posts on Faegre Drinker on Products.

Instruction Malfunction: Pennsylvania Superior Court Vacates $1B Verdict Due to Faulty Jury Instructions

By Sophia M. Landress & Benjamin R. Grossman

Preserving objections to jury instructions can be the difference between paying a significant judgment or making a plaintiff prove their case again at trial. The appellate panel held that the trial court ought to have instructed the jury properly about the crashworthiness doctrine, rather than only instructing the jury on the standard strict liability doctrine.

A Win for the Gig Economy: First Appellate Ruling on Florida’s TNC Statute Affirms Independent Contractor Protections

By Traci T. McKee, Dona Trnovska Gilliland, & Andrew J. Koehler

The TNC Statute generally shelters transportation network companies (TNCs) from vicarious liability for drivers’ actions if certain conditions are met. Abner v. Lyft Fla., Inc. not only reinforces a textual reading of the legislature’s independent contractor structure but also sets a high bar for negligent hiring claims.

Instruction Malfunction: Pennsylvania Superior Court Vacates $1B Verdict Due to Faulty Jury Instructions

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Preserving objections to jury instructions can be the difference between paying a significant judgment or making a plaintiff prove their case again at trial.

In October 2023, a Philadelphia jury handed down a mammoth $980 million verdict for the plaintiff in Amagasu et al. v. Mitsubishi Motors North America et al., due to an allegedly defective seat belt. The verdict included $800 million in punitive damages. Amagasu et al. v. Fred Beans Family of Dealerships, et al., No. 1594 EDA 2024 (Pa. Super. Ct. Dec. 22, 2025). The presiding judge increased the compensatory portion of the verdict, pushing the total award past $1 billion.

Continue reading “Instruction Malfunction: Pennsylvania Superior Court Vacates $1B Verdict Due to Faulty Jury Instructions”

Significant Drug & Device Developments of 2025

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As we welcome the new year, it is time to reflect on some of the most significant legal developments in the drug and device space in 2025.

1. Navigating a New Skepticism in Science

Not long ago, the average American likely could not name the U.S. secretary of health and human services. Yet, following this year’s change in administration and major shakeup in the regulatory landscape, skepticism in science has become the elephant in the room for anyone working in the drug and device sphere. Practitioners should start thinking about how to present scientific evidence to juries in 2026 as the old norms may no longer apply.

Read the full article on the Faegre Drinker website.

NY Federal Court Ruling Strengthens FDA Preemption for Class III Device Manufacturers

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A recent preemption decision out of the Southern District of New York offers encouraging news for medical device manufacturers. In Wieder v. Advanced Bionics LLC, 2025 WL 3237257 (S.D.N.Y. Nov. 20, 2025), the magistrate judge has recommended that most of the state law claims asserted against a cochlear implant manufacturer be dismissed as preempted by federal law under the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetics Act (FDCA). While this is not a final decision yet, should the report and recommendation be adopted, it will be a welcome decision for device manufacturers because it reaffirms that state law claims challenging the safety or effectiveness of a pre-market approved (PMA) medical device are broadly preempted.

Weider involved allegations against the manufacturer of a Class III PMA cochlear implant. The plaintiffs alleged the device, which was implanted in their young child, was defectively manufactured and designed, citing issues with a silicone seal and alleging the manufacturer knew of a design flaw that was revealed by a company-backed clinical study. The manufacturer moved to dismiss the case in its entirety, arguing that federal preemption barred the claims or, alternatively, that the claims were inadequately pleaded.

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Nothing Shocking Here – Eleventh Circuit Affirms Defense Win in Electroconvulsive Therapy Case

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When a case involves electroconvulsive therapy (ECT), one might think it originated out of the Twilight Zone. Despite the misrepresentation of such therapies in popular media, modern ECT serves as a valuable option for patients with certain severe mental health conditions who have tried other therapies without success. Although ECT is far safer today than it was when the stigma attached to it was formed, it still carries risks such as confusion, memory loss, and some physical side effects. One need not enter another dimension to envision why a plaintiff might claim damages arising from those risks. Much like Rod Serling’s anthology, the Eleventh Circuit recently closed the door on one such episode.

In Thelen v. Somatics, LLC, — F.4th —, 2025 WL 2749888 (11th Cir.), the plaintiff suffered from depression and mental health issues so severe that he attempted to take his life numerous times in numerous ways. During a two-year span, he received 95 ECT treatments to address his conditions. He was later diagnosed with a neurocognitive disorder that caused severe memory loss.

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Defining the Limits of Lay Testimony in Complicated Products Cases

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“So when is a question too complicated for the jury?” That is the question the Third Circuit sought to answer recently in Slatowski v. Sig Sauer, Inc., ___ F. 4th ___, 2025 WL 2178533 (3d Cir. 2025), reversing a district court’s grant of summary judgment despite affirming its exclusion of the plaintiff’s causation experts. Ironically, the Third Circuit’s analysis of when an expert opinion is required is itself so nuanced that it may require expert interpretation. Upon close inspection, the Slatowski panel’s holding is not nearly as broad as the headings might suggest.

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