Design Defect Standards Archives - Faegre Drinker on Products

Subject: Design Defect Standards

California Supreme Court Rejects Duty to Innovate

On August 3, 2026, the California Supreme Court issued its decision in the closely watched Gilead Tenofovir Cases, No. S283862, — Cal.5th —, 2026 WL 2223748 (Cal. Aug. 3, 2026), rejecting the so-called “duty to innovate.” The court held, in a 6-1 decision, that “a drug manufacturer has no duty of care when deciding whether and when to develop and commercialize an allegedly safer alternative drug” to replace an admittedly nondefective drug. The decision is a significant victory for pharmaceutical manufacturers and carries substantial implications for product liability litigation across industries.

Background

The case arose from a Judicial Counsel Coordination Proceeding comprising more than 30,000 plaintiffs — HIV patients who took Gilead’s tenofovir disoproxil fumarate (TDF). Plaintiffs did not claim TDF was defective; it is undisputedly a life-saving medication. Instead, they alleged Gilead unreasonably delayed bringing an alternative medication, tenofovir alafenamide (TAF), to market, depriving them of a purportedly safer option and allegedly causing kidney, bone, or tooth injuries.

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

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.

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Significant Drug & Device Developments of 2025

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.

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

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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Dismissal of a Broken Chair Claim Shows That Expert Testimony May Be Essential Even for a “Simple” Product

In Mehner v. Furniture Design Studios, Inc., 2023 WL 2351688 (D. Neb. Mar. 3, 2023), the court granted summary judgment on product defect claims by a plaintiff allegedly injured by the collapse of a restaurant chair eight years after the manufacturer delivered it. This well-reasoned decision reminds us that even for fairly simple products, expert proof may be required to establish a defect – and failure to develop the factual predicate in discovery may leave the plaintiff without an opinion (and without a case). It also highlights important limitations in the “malfunction theory” that sometimes allows a plaintiff to proceed without expert proof or identification of a specific defect.

Plaintiff was eating at a restaurant in Omaha when his chair allegedly collapsed. He sued Furniture Design Studios (FDS), which designed, manufactured and sold the chair, asserting strict liability and negligence design defect claims.

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

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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