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“How EtO Plants Can Avoid Lawsuits, Cope With Stricter Regulation”: Karen Cullinane in Medical Design & Outsourcing


“How EtO Plants Can Avoid Lawsuits, Cope With Stricter Regulation”: Karen Cullinane in Medical Design & Outsourcing

March 3, 2021
Karen Cullinane

“Given the thousands of individual personal injury lawsuits and class actions already pending against EtO sterilization plants throughout the U.S., any given plant’s first priority is to preempt or diminish the costs of litigation,” Goldberg Segalla’s Karen Cullinane writes in an article for Medical Design & Outsourcing. “First, EtO plant officials should learn what the neighboring community is like and what its needs are. Doing so makes it easier to eliminate immediately identifiable risks.”

In the article, Karen, a partner in Goldberg Segalla’s Toxic Tort and Environmental Law groups, discusses steps that ethylene oxide (EtO) plants can take to minimize legal exposure, efficiently manage litigation, and be in compliance with new federal regulations. She also talks about how the EtO industry can be prepared for stronger federal and congressional oversight by being involved in the regulatory process.

“For instance, throughout 2020, there were a number of question-and-answer presentations, committee hearings, and public comment sessions about new EtO regulations,” Karen writes. “These are not only opportunities to participate in developing new regulations and compliance measures, but can help industry efforts to educate both regulators and the American public about the life-saving value of medical devices, particularly in the shadow of COVID-19, and the difficulty in finding an alternative sterilizing agent as effective as EtO. It is critical for industry players to communicate what is practically feasible so the federal government can consider this before enacting new EtO regulations. These actions can also help EtO entities to develop a better idea of which new or modified regulations are most likely and to prepare best business practices and compliance and safety plans.”


How EtO Plants Can Avoid Lawsuits, Cope With Stricter Regulation,” Medical Design & Outsourcing, March 1, 2021


Karen Cullinane focuses her practice on complex asbestos litigation, toxic tort matters, mass torts, product liability cases, and general commercial litigation. Karen represents 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.