Johnson & Johnson(NYSE:JNJ) is reportedly looking to settle 100s of product liability and wrongful death lawsuits brought over its now-recalled laparoscopic power morcellators used during surgeries to remove ostensibly benign uterine tumors.
The morcellators, which use a cutting tip to shred and remove uterine tissue, have been implicated in the spread of a lethal cancer that can masquerade undetected as benign fibroids.
The FDA in April 2014 issued a warning about the devices, later convening a special advisory panel to evaluate their continued use in the surgical suite. The watchdog agency estimates that about 0.3% of women undergoing hysterectomy or fibroid surgery are found to have undetected uterine sarcomas, including the deadly leiomyosarcoma. In November of that year, the FDA ordered so-called “black box” warnings for the labels on morcellators, advising doctors that the devices, until recently a mainstay of gynecological surgery, be avoided in nearly all fibroid-removal procedures.
J&J subsidiary Ethicon recalled its morcellators in July 2014, after pulling them from the market in April of that year. Now the healthcare giant is looking to settle some of the estimated 100 cases that have been filed or readied for filing, plaintiffs’ attorney Paul Pennock told the Wall Street Journal. The company has settled about 70 of the cases over the past few months, with amounts ranging from $100,000 to about $1 million, the newspaper reported, citing “a person with knowledge of some recently resolved cases.” A handful of cases are still pending in state courts, according to the journal.
Earlier this year, Rep. Mike Fitzpatrick (R-Pa.) asked the FDA’s Office of Criminal Investigations to open an investigation of several deaths associated with the morcellators, citing FDA regulations requiring hospitals and medical device companies to report any device-related serious injuries or deaths.