Nearly two dozen new lawsuits were filed against Sterigenics this week over its now-shuttered ethylene oxide (EtO) sterilization plant in Willowbrook, Ill., according to a law firm representing some of the plaintiffs.
That brings the total of such lawsuits to nearly 75, noted Chicago personal injury lawyer Antonio Romanucci, court-appointed lead counsel from among five firms involved in the litigation. Plaintiffs in the new cases include individuals and families who claim that they or their family members became seriously or terminally ill following exposure to EtO, which the plant used to sterilize medical devices and the Environmental Protection Agency considers a carcinogen.
Oak Park, Ill.-based Sterigenics’ troubles continue to mount. Yesterday, a judge in Fulton County, Ga., heard arguments in a case that seeks to rescind an Aug. 7 consent order allowing Sterigenics to upgrade emissions controls for the sterilant gas at an Atlanta plant. Plaintiffs in that case contend that the federal Environmental Protection Agency (EPA)nnotified Georgia environmental officials in August or September of 2018 of elevated EtO levels near the plant, and that neither agency notified the public. Had the public been notified, they would have contested parts of the consent order, the lawsuit says.
Plaintiffs in the Illinois cases are linking EtO exposure to leukemia, lymphoma, breast cancer, miscarriages and other medical conditions. Despite being coordinated for pre-trial and discovery purposes, each case will be tried individually.
“The magnitude of this case is evident by the growing number of families that have been devastated over the last three decades by Sterigenics’ negligence, and we will not rest until we secure justice for the wrongdoings of this company in our community,” Romanucci said in a news release.
“Consistent with the previous complaints, these claims lack merit and Sterigenics will vigorously defend against them,” a Sterigenics spokesman told Medical Design & Outsourcing in an email. “As acknowledged by the DuPage County Court, Sterigenics consistently complied with applicable regulations regarding ethylene oxide emissions. In fact, the company historically outperformed what the law requires in controlling its emissions.”
Illinois state officials closed the Willowbrook plant in February and Sterigenics decided in September not to reopen it. Work to upgrade emissions controls at the Atlanta plant are continuing since the company temporarily shut it down Aug. 26. The plant remains closed as the upgrades proceed, according to the company.
The stakes are high for the industry, healthcare systems and the public. The Sterigenics Willowbrook plant closure sent hospitals scrambling for alternative sources of critical devices. Although no major device shortages have ensued, the FDA and the industry have issued dire warnings about that possibility.
EtO is used to sterilize about 50% of all devices sold in the U.S. that require sterilization — more than 20 billion medical devices per year, according to the FDA. It is a preferred sterilant for devices made from certain polymers (such as plastic or resin), metals, or glass, and devices that have multiple layers of packaging or hard-to-reach crevices, because it has better penetration properties than other methods and is unlikely to damage products during the process.
Meanwhile, the FDA is seeking alternatives to EtO and has also asked for public input on emissions reduction technology. But some industry experts contend that even if a viable alternative were found, it would take 10 years for medtech companies to validate the processes to FDA standards for all the devices now sterilized by EtO.
The EPA is expected to update its EtO regulations by March 2020.