Medical device companies could be at greater risk of lawsuits for ethylene oxide (EtO) exposure after Sterigenics and its parent company Sotera Health were ordered to pay hundreds of millions of dollars to a plaintiff who developed cancer while living by a sterilization facility emitting the gas, Needham analysts wrote.
In a Friday note to investors, the analysts listed companies like Medtronic, Abbott Laboratories, Boston Scientific and Becton Dickinson as device makers with EtO sterilization facilities. The analysts wrote that device companies could become the target of future lawsuits due to an “increased aggressiveness” from attorneys following the Sterigenics loss.
“We expect attorneys to target communities near [EtO] facilities with ads for lawsuits,” the analysts wrote. “Since breast and blood cancers are relatively common, we worry that attorneys could have success in finding additional people willing to file more lawsuits against companies with [EtO] facilities.”
They added that it's “not clear which, if any, of these facilities are facing litigation due to [EtO] emissions.”
A jury recently awarded $363 million to 70-year-old Sue Kamuda, who developed breast cancer after living close to a medical device sterilization facility run by Sterigenics. Sterigenics, Sotera and Griffith Foods, Sotera’s corporate predecessor, were all ordered to pay damages.
Sotera, which is facing over 1,000 EtO lawsuits, is likely to appeal the case, and it's possible that the damages are “significantly reduced” through appeal or a settlement, according to the Needham analysts. But they added that the case has “nonetheless brought significant attention to [EtO] litigation.”
EtO is a gas that’s used to sterilize billions of medical devices every year, but it is also classified as a human carcinogen by the Environmental Protection Agency.
The Sterigenics lawsuit follows stricter regulation of EtO emissions due to possible cancer risks. In 2019, the Food and Drug Administration held a two-day panel to address the risks EtO facilities presented to surrounding communities and explore other sterilizing options. At the time, FDA officials warned about the potential of a medical device shortage if EtO capacity was limited due to sterilizing facilities being shut down.
The EPA recently posted a list of EtO sterilization facilities that pose a risk to nearby communities, including sites run by Medtronic, Edwards Lifesciences and BD.
In the Friday report, Needham listed companies with EtO facilities and which ones the EPA highlighted where the cancer risk is at or above the level of 100 additional cancer cases per million people exposed.
Medical Device Companies with EtO Sterilization Facilities
| Company | Number of EtO facilities | Number of over 100 additional cases/million exposed* |
| Abbott Laboratories | 3 | 0 |
| Alcon | 1 | 0 |
| Becton Dickinson | 4 | 2 |
| Boston Scientific | 3 | 0 |
| Edwards Lifesciences | 1 | 1 |
| Johnson & Johnson | 2 | 0 |
| LivaNova | 1 | 0 |
| Medtronic | 6 | 1 |
| Sotera Health | 8 | 0 |
| Steris | 8 | 0 |
| Stryker | 2 | 0 |
SOURCE:Needham, U.S. Environmental Protection Agency
*As of July 27, 2022, the EPA's risk assessment has shown that cancer risk due to EtO emissions from this facility is at or above the level of 100 additional cancer cases per million people exposed.
