Category: Manufacturing Defect

California Supreme Court Rejects Duty to Innovate

Share

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.

Continue reading “California Supreme Court Rejects Duty to Innovate”

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

Share

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.

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

In Case You Missed It: Faegre Drinker on Products — Fall 2025

Share

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

Share

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.

Continue reading “NY Federal Court Ruling Strengthens FDA Preemption for Class III Device Manufacturers”

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

Share

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.

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

Plaintiff’s Half-Baked Attempt to Prove Defect and Causation With Photographs of Moldy Bread Shows the Knead for Expert Testimony

Share

A picture may be worth a thousand words, but that doesn’t make the camera an expert witness. Product liability actions usually require expert testimony to prove defect and causation. Pictures, like other documents, can be central to an expert’s opinion on those points. But as a plaintiff in the Eastern District of Pennsylvania recently learned, pictures alone are insufficient. Defect and causation still require an expert’s testimony — even in cases involving products as simple as a loaf of bread.

In Kovalev v. Lidl US, LLC, 2024 WL 4642982 (E.D. Pa. Oct. 31, 2024), the plaintiff alleged that he became ill after consuming bread sold and/or baked by the defendants. He claimed to have bought eight loaves initially and experienced abdominal pain and difficulty breathing after spending two days eating the first loaf. He claimed to have thereafter discovered that the loaf was “extensively contaminated with dangerous disease-causing toxic mold.” He took pictures. Later, the plaintiff ate from a second loaf and developed nausea, vomiting, abdominal pain/cramps, general malaise, and respiratory issues “for days.” Once again, he allegedly inspected the bread after eating it and “discovered various-colored mold.” And once again, he took pictures. (As an aside, if we became ill after eating a loaf of bread and then discovered “extensive” mold on it, we would spend the foreseeable future carefully checking all our bread for mold before digging in. We might do so simply because we have read this case. But we digress.) Three months later, the plaintiff purchased four more loaves of bread from another of defendants’ stores. He claimed that while eating that bread he discovered “a large piece of black substance” inside it. Once again, he took pictures. Because he did not know what the substance was or whether he had consumed part of it, he claimed to be “severely traumatized” and afraid of developing future “cancer or damage to his organs,” “suffer[ing] a physical impact,” and losing his “enjoyment of life.”

Continue reading “Plaintiff’s Half-Baked Attempt to Prove Defect and Causation With Photographs of Moldy Bread Shows the Knead for Expert Testimony”