Failure to Warn Archives - Faegre Drinker on Products

Category: Failure to Warn

Third Circuit Confirms Correlation Still Does Not Prove Causation

A recent Third Circuit decision is a useful and quotable reminder that temporal correlation is not enough to prove causation.

Causation is an indispensable element of any product liability action. It is the same in pharmaceutical third-party payor (TPP) class actions, where it is often the element most likely to defeat class certification. Unsurprisingly, plaintiffs often employ creative workarounds in an effort to sidestep obvious causation problems. In In re Avandia Marketing, Sales Practices and Products Liability Litigation, — F.4th —, 2026 WL 2093904 (3d Cir. July 21, 2026), the Third Circuit made clear that there are no shortcuts.

According to the plaintiff TPPs, the defendant pharmaceutical manufacturer had marketed the medication at issue as not only treating diabetes but offering cardiovascular benefits too. The plaintiffs claimed that the promotional campaign caused physicians to prescribe the medication at inflated rates, forcing the plaintiffs to reimburse prescriptions they would not otherwise have covered.

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

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 — Fall 2025

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.

Register to Do Business, Register to Be Sued? Illinois’ New Jurisdictional Trap for Toxic Tort Litigants

By Elizabeth C. Christen, Jenna Seiler, Natalie Abdou & Bryan D. Pasciak

For companies operating nationwide, rules governing where they can be sued are consequential — especially in high-exposure toxic tort litigation. Illinois’ enactment of SB 328 raises the stakes in these cases even more, conferring general jurisdiction over companies who register or merely transact business in Illinois.

Close, But Not Quite: Eastern District of North Carolina Excludes Experts Whose General Expertise Does Not Enable Specific Opinions Offered

By Eric M. Friedman

Even “[a] supremely qualified expert cannot waltz into the courtroom and render opinions” without passing muster under Federal Rule of Evidence 702. Clark v. Takata Corp. (7th Cir. 1999). A recent case from the Eastern District of North Carolina shows this principle is at play not only when critiquing an expert’s methodology, but also the expert’s expertise.

No Defect, No Negligence: Lessons from Rudzinskas v. Retractable Technologies, Inc.

By Alena Markley

A summary judgment from the Southern District of Georgia shows the critical role of defect evidence (or lack thereof) in negligence claims involving medical devices. In Rudzinskas, allegations that a medical device malfunctioned were not sufficient evidence to survive summary judgment on negligent manufacturing and failure-to-warn claims.

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

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

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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