Ethylene Oxide Regulations In Transition: What You Need To Know

At a Glance

  • In 2024, EPA finalized significant tightening of EtO emissions standards for commercial sterilizers, including new fugitive emissions controls, continuous monitoring requirements, and more stringent point-source standards.
  • The Trump administration has since proposed rescinding key provisions of the 2024 rule, and has granted two-year presidential exemptions to 41 sterilization facilities. Those exemptions are currently being challenged in court.
  • The public comment period on the proposed rollback closed May 15, 2026, drawing over 30,000 comments. A final rule on the proposed rollback is expected later this year, though the timeline could extend.
  • At this time, the 2024 rule remains technically in effect, and state-level EtO requirements continue to apply regardless of federal action. Manufacturers and sterilizers should therefore be planning for multiple regulatory scenarios.

The regulatory landscape for ethylene oxide (EtO) emissions from commercial sterilization facilities is in the midst of a significant transition. The Trump administration has moved aggressively to unwind the US Environmental Protection Agency’s (EPA) 2024 EtO emissions standards for commercial sterilizers, including proposing a substantial rollback of the rule’s core provisions.

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Dissecting the EU’s New Product Liability Directive: The Dawn of US-Style Discovery

The deadline for EU members to implement the new Product Liability Directive is fast approaching before year’s end. For companies doing business in the EU, the new rules bring many changes, including significant disclosure obligations that are an expansion, or altogether new set, of discovery rules that have historically applied in product liability litigation in EU member states. Companies should review the new rules, monitor further developments, and develop internal protocols to be ready if litigation arises under the new rules.​

Read the full article on the Faegre Drinker website

Solving the Culpable Co-Defendant Problem: An Update on Preserving Your Client’s Defenses after a Culpable Co-Defendant Files a Motion for Summary Judgment in California State Court

California appellate courts have recently provided much needed clarity for defendants wishing to preserve the ability to attribute fault to a potentially culpable co-defendant seeking summary judgment. We previously addressed this issue in a 2021 blog post, highlighting the uncertainty facing defense counsel where granting summary judgment to a co-defendant would preclude an empty chair defense. Two published 2025 decisions now confirm that defendants can oppose a co-defendant’s summary judgment motion directly with no cross-complaint required.

This is a rare and tricky situation. Defendants in multiparty litigation often share interests. Opposing a co-defendant’s motion can inflate costs, strain relationships, and ultimately benefit plaintiffs. But sometimes preserving the ability to attribute fault to a co-defendant is necessary to protect your client.

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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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Paraquat MDL Lone Pine Order Creates New Hurdles for Nonsettling Plaintiffs

The multidistrict litigation (MDL) concerning paraquat-based herbicides — In re: Paraquat Products Liability Litigation, MDL No. 3004 (S.D. Ill.) — has become a focal point in mass torts. Thousands of plaintiffs allege that exposure to paraquat caused them to develop Parkinson’s disease (PD). The litigation has featured high-stakes scientific disputes, key defense wins, a master settlement agreement, and now Case Management Order No. 25 (CMO 25, 2026 WL 1707147), a Lone Pine order with important implications for nonsettling plaintiffs and a potential roadmap for effective case management in other MDLs.

In April 2024, the MDL court excluded the plaintiffs’ sole expert on general causation. That ruling left the plaintiffs unable to establish general causation, and the court accordingly granted the defendants’ motion for summary judgment. But that ruling only formally applied to the four bellwether cases; while the bellwether plaintiffs’ inability to establish general causation portended problems for every plaintiff in the MDL, the litigation continued.

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