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| Ethicon's Morcellex Sigma Tissue Morcellator |
Johnson & Johnson ($JNJ) wants to put litigation to rest over its power morcellator devices, and it wants to do it quickly. To accomplish this goal, the company is settling a number of suits claiming that its product, which J&J has since pulled from the market, harmed women by spreading cancer.
About 100 cases have either been filed or prepared for lawsuits against J&J's Ethicon unit over the company's laparoscopic power morcellator device, which plaintiffs claim spread undetected tumors. Of those 100 claims, J&J has settled almost 70 over the past few months, Paul Pennock, a plaintiff lawyer and co-lead counsel on the steering committee for consolidated litigation in a Kansas City, KS, federal court told The Wall Street Journal.
It's difficult to estimate exactly how much J&J will shell out to settle the cases. Some of the company's settlements have ranged from $100,000 to about $1 million, a person familiar with the matter told the newspaper. It's safe to say that J&J will likely spend many millions to lay the claims to rest.
J&J declined to comment to FierceMedicalDevices about its recent settlements.
The New Brunswick, NJ-based company is also in talks to resolve other morcellator claims, lawyers with knowledge of those talks told the WSJ. Meanwhile, J&J still faces separate morcellation cases pending in state courts.
J&J's legal saga over its morcellator devices dates back a few years to when regulators began looking into alleged problems with the products. In 2014, the FDA warned against power morcellators. The agency estimated that about one in 350 women with fibroids also have uterine sarcoma, and that using morcellators on those patients can spread cancerous tissue in the abdomen and pelvis.
J&J subsequently suspended sales of its related devices. A few months later, the company pulled its power morcellator products from the global market. J&J's move was partly influenced by an FDA panel meeting, which recommended upgrading the devices' safety labels to reflect increased risks.
"Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk," J&J spokesman Matthew Johnson said at the time.
In November 2014, the FDA slapped power morcellators with a "black-box" warning--its strongest caution--and recommended against using the tools in the "majority" of women undergoing a hysterectomy. But the agency stopped short of banning morcellators altogether, saying the devices' benefits may outweigh the risks in some cases.
European device outfits Karl Storz GmbH, Richard Wolf GmbH and LiNA Medical also make power morcellators, but J&J has been the most widely scrutinized for issues tied to its devices.
Some lawyers for the plaintiffs are applauding J&J's move to settle cases over morcellator devices. "You certainly don't always see a company step up and take responsibility this early on. That's something we think is appropriate," Pennock said, as quoted by the WSJ.
But the plaintiffs themselves are more wary. Settlements could mean that less attention is drawn to the issue, and that history could repeat itself. "Each one of these cases is an opportunity to create a public record about what went wrong--both ethically and at a regulatory level--so nothing like it happens again," Hooman Noorchashm, a doctor and husband to Amy Reed, an anesthesiologist who went public with health issues tied to morcellator devices, told the newspaper.
- read the WSJ story (sub. req.)