Goldberg Segalla partner Karen Cullinane wrote an article that was published in September’s issue of The Brief Case, a publication of the Defense Research Institute.

The article, titled “Does EtO’s Recent Regulatory Battle Victory Mean It Will Win the War?,” explores the evolving regulatory and litigation landscape surrounding ethylene oxide (EtO) – a highly effective but potentially cancer-causing sterilizing gas widely used in medical device manufacturing.

In July, the Trump administration issued an executive order in granting a two-year extension to over 30 EtO-using sterilization facilities, delaying compliance with stricter emissions rules enacted under the Biden administration.

“The current administration’s view is that the final rules are too onerous and put Americans at risk by creating burdens for commercial sterilizers that could result in shortages of essential medical devices,” Karen says. “It also argued that the technology needed to comply with the final rules does not exist in a ‘viable form.’”

Despite regulatory relief, litigation persists, as six plaintiffs filed a federal lawsuit against Eastman Chemical Company in July, alleging cancer caused by exposure to EtO emissions.

“Given the recently completed EtO rulemaking process took the lion’s share of a decade, it seems unlikely the new EPA, despite its zeal for deregulation, would be able to shepherd another round of rulemaking in the three years remaining in this administration,” Karen says. “This delay, coupled with EtO lawsuits failing to abet – and even potentially increasing since the EPA will not require EtO facilities to comply with less forgiving emissions standards any time soon – may just end up a fleeting battle win in the overall EtO war.”

READ THE FULL ARTICLE HERE (subscription required)

MORE ABOUT GOLDBERG SEGALLA’S KAREN CULLINANE:

Karen focuses her practice on complex asbestos litigation, toxic tort matters, mass torts, product liability cases, and general commercial litigation, representing national and international entities including chemical, manufacturing, and mining companies. Her legal experience includes successful precedent-setting motion practice ranging from precluding evidence and dismissing cases on dispositive motions to obtaining directed verdicts on punitive damages.