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.

Read the full article on the Faegre Drinker website.

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

For companies operating nationwide, rules governing where they can be sued are consequential — especially in high-exposure toxic tort litigation. Toxic tort cases often involve claims over exposure to substances like asbestos, lead paint, pesticides, pharmaceuticals or industrial pollution and frequently target out-of-state corporations whose products or activities reach far beyond their corporate home base. Illinois’ enactment of SB 328, which amends the Illinois long-arm statute and Business Corporation Act of 1983, raises the stakes in these cases even more, conferring general jurisdiction over companies who register or merely transact business in Illinois.

Consent by registration statutes have been one of the most hotly debated legal questions in the general jurisdiction arena. General jurisdiction is a court’s authority to hear all claims against a defendant, regardless of where the alleged conduct took place. General jurisdiction is reserved for the forums where a defendant is “at home.”1 For corporations, this is usually the corporation’s place of incorporation or principal place of business.2 Yet some argue that simply registering to do business in a state should also open the door to being sued there, even if the dispute has little to no tie to that forum.

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In Case You Missed It: Faegre Drinker on Products — Summer 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.

Tort Reform Is Top of Mind in 2025: Legislative Updates in Georgia, South Carolina, Louisiana and Arkansas

By Elizabeth A. Wurm, Jenna Seiler & Elizabeth C. Christen

Some states that are home to “Judicial Hellhole” venues, often known for producing nuclear verdicts, have rallied for successful tort reform. In the most recent state legislative sessions, Georgia, South Carolina, Louisiana and Arkansas implemented tort reform bills which may serve to neutralize the nuclear verdicts coming out of their courts.

 

Message Received — Delaware Follows Federal Rule of Evidence 702

By Eric M. Friedman & Emma DeLaney Strenski

The Delaware Superior Court took the mass tort world by surprise with its refusal to exclude the plaintiffs’ experts’ causation opinions in the Zantac litigation. But the Delaware Supreme Court granted the defendants’ request for interlocutory appeal and has reversed the Superior Court’s decision and remanded for further proceedings.

 

ChatGPT As Your New Testifying Expert Under Proposed Federal Rule of Evidence 707? Maybe Not.

By Nikolas G. Spilson & Eric M. Friedman

Tools that can reduce the time and cost of litigation have long been in high demand by both clients and counsel. But the tool must be fit for its purpose, and tools that generate evidence or other outputs that will be submitted to the court must pass judicial scrutiny. One of the newer fights concerns the admissibility of machine-generated “expert” opinions.

Causation Conundrums: Implications of Georgia Supreme Court’s Interpretation of Statute of Repose in Long-Term Product Use Cases

When does the statute of repose clock start ticking on a product liability claim involving long-term repeat use of many individually purchased units of a product? According to the Georgia Supreme Court’s decision in Burroughs v. Strength of Nature Global, LLC, __ S.E.2d __, 2025 WL 2918923 (Ga. Oct. 15, 2025), the short answer is that the statute of repose starts anew for each individual unit. But, as Burroughs itself illustrates, that answer creates serious problems that may require the state’s legislature to intervene.

The Burroughs plaintiff alleged she developed uterine fibroids as a result of using chemical hair relaxers manufactured by the defendants repeatedly over nearly two decades. Specifically, she claimed she began using the products in 1995 at the age of six and used them six to eight times per year through 2014 (with one brief hiatus). She developed uterine fibroids in 2018 and filed suit in 2022. The defendants moved to dismiss the plaintiff’s strict liability claims on the basis that they were barred by the statute of repose. Georgia’s product liability statute of repose requires actions to be commenced within 10 years of “the date of the first sale for use or consumption of the personal property causing or otherwise bringing about the injury.” OCGA § 51-1-11(b)(2) (emphasis added). The trial court denied defendants’ motion. The court of appeals reversed, holding the plaintiff’s initial purchase of the first unit of the defendants’ products was a “first sale” that triggered the statute of repose and barred her filing an action more than 10 years later.

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

Even “[a] supremely qualified expert cannot waltz into the courtroom and render opinions” unless those opinions pass muster under Federal Rule of Evidence 702. Clark v. Takata Corp., 192 F.3d 750, 759 n.5 (7th Cir. 1999). As a recent case from the Eastern District of North Carolina illustrates, this principle is at play not only when critiquing an expert’s methodology, but also the expert’s expertise.

In Williams v. Sig Sauer, Inc., — F. Supp. 3d —, 2025 WL 2643400 (E.D.N.C. Sept. 8, 2025), the plaintiff was an “enforcer” for his motorcycle club who “protect[ed]” and “monitor[ed]” the club members. He alleged that his pistol discharged and injured him while he was adjusting his position on his motorcycle. In support of his product liability claims against the manufacturer of the pistol, he proffered two expert witnesses: a gunsmith and a mechanical engineer. The defendant moved to exclude both experts and filed a motion for summary judgment.

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