Category: Design Defect

California Supreme Court Rejects Duty to Innovate

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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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What’s the Catch? Interpreting the “Catch-All” Provision of Pennsylvania’s Unfair Trade Practices and Consumer Protection Law

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The Supreme Court of Pennsylvania recently ruled that a product vendor’s silence is not deceptive when the vendor has no duty to speak.

The “catch-all” provision of Pennsylvania’s Unfair Trade Practices and Consumer Protection Law (UTPCPL) prohibits vendors of goods and services from “[e]ngaging in any other fraudulent or deceptive conduct which creates a likelihood of confusion or of misunderstanding.” 73 P.S. § 201-2(4)(xxi). In March 2026, the Supreme Court of Pennsylvania decided that omissions do not count as “deceptive conduct” under the UTPCPL.

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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.

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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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