An Olympus (TYO:7733) subsidiary agreed to settle a lawsuit filed over the power laparoscopic morcellator used in a gynecological surgery.
Plaintiffs Betty and Elvis Dobson alleged that the Olympus KS PlasmaSORD used in Betty’s 2010 hysterectomy spread myxoid leiomyosarcoma cells in her abdomen and pelvis. Power morcellators use small, rotating blades to break up large tissue masses into fragments and are commonly used to remove benign uterine fibroids in women. Although the FDA approved morcellators in 1995, it wasn’t until 2013 that the late Dr. Amy Reed exposed the risk after undergoing a hysterectomy at the Boston hospital where she worked as an anesthesiologist.
The Dobson lawsuit alleges that Olympus should have known of the risk, citing a 1991 patent application that “describes the potential for laparoscopic power morcellators to disseminate and implant malignant tissue fragments in the body,” according to court documents.
“Plaintiff suffers from physical injury, some or all of which are permanent and/or may be fatal, and the plaintiff may suffer in the future from other diseases or conditions that have not yet been diagnosed,” the lawsuit alleges.
But in a May 30 letter, the parties asked Judge John Milton Younge to dismiss the case.
‘”[T]he parties reached a settlement agreement in the above-referenced matter and therefore request that the case be marked settled on the docket,” according to the documents. Terms of the settlement were not disclosed.
In April 2014 the FDA issued a warning about the cancer risk from morcellation and convened an advisory panel to consider their use in fibroid removal. The agency’s Obstetrics & Gynecology Devices committee failed to come to a clear consensus on the cancer risk from laparoscopic power morcellators, despite outraged testimony from dozens of attendees; in November of that year the FDA ordered so-called “black box” warnings for the devices. In September 2015, the Government Accountability Office said it would investigate potential safety and regulatory issues with the morcellators; legislators later called for the FDA to open a criminal probe into several deaths associated with morcellators.
The furor prompted Johnson & Johnson (NYSE:JNJ) to recall its morcellators in July 2014, after pulling them from the market in April of that year. J&J is now looking to settle 100s of product liability and wrongful death lawsuits brought over the Ethicon devices.