Subject: Failure to Warn Standards

Third Circuit Confirms Correlation Still Does Not Prove Causation

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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

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

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A recent summary judgment decision out of the Southern District of Georgia illustrates the critical role of defect evidence (or lack thereof) in negligence claims involving medical devices. As the plaintiff in Rudzinskas v. Retractable Technologies, Inc., No. 4:24-cv-009, 2025 WL 22772490 (S.D. Ga. Sep. 29, 2025) recently learned, allegations that a medical device malfunctioned are not sufficient evidence to survive summary judgment on negligent manufacturing and failure to warn claims.

In Rudzinskas, the plaintiff alleged that on two different occasions, when her husband injected her with vitamin B12 at home, the needles shot off their syringes and became dislodged inside her body (first in her buttock, and a few months later, in her arm). Plaintiff asserted that the syringes were marketed as containing needles that automatically retract from a patient into the barrel of the syringe when the plunger handle is fully depressed. Plaintiff sought medical attention following the alleged incidents. Plaintiff’s physicians confirmed the presence of the first needle and attempted to surgically extract it, but the surgery was unsuccessful. After the second incident two months later, the same surgeon attempted to confirm the presence of the second needle, but did not see it and did not perform surgery. Arising from these allegations, the plaintiff asserted two claims against the defendant for (1) negligent manufacture and (2) negligent failure to warn.

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5 Major Drug and Device Developments of 2022

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As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702 updates that took place this year, which will carry over into 2023?), but provides a brief recap and assessment of five of the most interesting and consequential developments affecting drug and device law in 2022.

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“Alternative Avenues” Argument in Failure-to-Warn Cases Adding an Additional Wrinkle to Medical Device Litigation

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A developing line of cases across the nation may have large implications for medical device manufacturers defending against failure-to-warn claims.  While a treating physician’s failure to read or rely on the manufacturer’s warnings has historically been fatal to a failure-to-warn claim in many jurisdictions (at least those without a “read and heed” presumption), plaintiffs have tried novel “alternative avenues” arguments to make summary disposition of the claim more difficult.

There are two theories under which a failure-to-warn claim may be brought in the products liability context:  a manufacturer with a duty to warn may breach its duty by either (1) failing to provide an adequate warning of the product’s potential risks (the “content theory”) or (2) failing to adequately communicate the warning to the ultimate consumer (the “communication theory”).  Plaintiffs have traditionally pursued failure-to-warn claims in prescription medical device cases under the content theory, with most courts holding that a treating physician’s failure to read or rely on the manufacturer’s warnings in the product’s instruction for use (“IFU”) is fatal to the claim.  See, e.g., Foster v. Ethicon, Inc., 2021 WL 1169473, at *7 (D.S.D. Mar. 26, 2021).

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