Food and Drug Administration (FDA) Archives - Faegre Drinker on Products

Subject: Food and Drug Administration (FDA)

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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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.

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Defective Logic: Why Recall Evidence Falls Short in Court

In product liability litigation, plaintiffs often treat a product recall as though it is conclusive proof that the product is defective or that its warnings are inadequate. Some plaintiffs even cite clearly inapplicable recalls — for example, lot-specific recalls spurred by a manufacturing or labeling issue that did not impact the unit that the plaintiff received — in an effort to bolster their case before a court or in settlement discussions. Federal Rule of Evidence 407’s prohibition on the use of recall evidence to prove those points seems to do little to quell the enthusiasm. Of course, Rule 407 is grounded in part on “a social policy of encouraging people to take, or at least not discouraging them from taking, steps in furtherance of added safety.” Fed. R. Evid. 407 advisory committee’s note. But Rule 407 is not the only grounds on which recall evidence can (and should) be excluded.

For example, in Pecan Trust v. Nexus RVs, LLC, 2025 WL 1503940 (N.D. Ind. May 27, 2025), the plaintiffs sued the manufacturers of an RV and certain component parts alleging, among other things, that a defect in the brake pressure switch represented a fire risk. In support of that claim, they pointed solely to a safety recall for the part due to a possible fire risk and an expert witness who, based on the recall alone, concluded that the issue might pose a fire risk. The parts manufacturer moved for summary judgment, and the court granted the motion as to the breach of warranty claim after concluding that the plaintiffs had not proffered sufficient evidence of a defect. As the court noted: “That a recall has occurred may be evidence of certain things—namely as a subsequent remedial measure—but it cannot show a product defect. In reality, products subject to a recall might have a defect or might not, as a recall implements a safety campaign to ensure that none do or will manifest one.” (internal citations omitted). And, as the court noted in the specific context of the warranty claim, the fact that the plaintiffs had never presented the RV for work under the recall posed a second, equally problematic obstacle to their claim.

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Loper Bright & Corner Post Review: Supreme Court’s Overturning of Chevron Doctrine Spells Uncertainty for Food Industry Regulations

On June 28, 2024, the U.S. Supreme Court overturned the Chevron doctrine of agency deference in its Loper Bright Enterprises v. Raimondo decision. The doctrine takes its name from a 1984 Supreme Court case, Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc, 467 U.S. 837 (1984), which announced a bright-line rule governing whether a regulation promulgated by an executive branch agency, like FDA or USDA, was enforceable based on the scope of statutory authority Congress delegated to the agency. Chevron held that if a court concluded that a statute was silent or ambiguous as to an issue (Step One), then the court must defer to an agency’s permissible construction of the statute in the regulations it promulgated (Step Two). In overturning Chevron deference, Loper Bright announced that courts “must exercise their independent judgment in deciding whether an agency has acted within its statutory authority.”

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