Johnson & Johnson is settling a series of legal claims and lawsuits alleging that a discontinued surgical device harmed women by spreading an undetected hidden cancer, according to court documents and lawyers with knowledge of the settlements.
An estimated 100 cases have either been filed—or readied for lawsuits—against J&J’s Ethicon unit related to power morcellator, a device used in uterine fibroid surgery and hysterectomies. A consolidated litigation is underway in a Kansas City, Kansas federal court, the Wall Street Journal reports.
The power morcellator is used in uterine fibroid surgeries and hysterectomies. The device is inserted via a small incision. The morcellator’s rapidly spinning blades cut tissue into tiny pieces that can be removed through the incision. But if the uterine tissue contains cancerous cells—which are virtually impossible to detect prior to surgery—the procedure can spread the cancer throughout the abdomen, where it rapidly becomes more aggressive and this sharply reduces the woman’s long-term survival chances.
Of the 100 or so claims, J&J has settled nearly 70 over the past few months, according to an attorney involved. Individual settlements vary by case, but so far have ranged from $100,000 to roughly $1 million, according to the WSJ. Talks are reportedly ongoing to settle other morcellator claims. The amounts in individual settlements are confidential and they vary depending on such factors as the woman’s age, her medical condition, and whether she has children, according to people familiar with the settlements. Lawyers for the plaintiffs are pushing for cases to move quickly because many of the women are seriously ill.
The power morcellator was routinely used before April 2014, when the U.S. Food and Drug Administration (FDA) warned women undergoing fibroid surgeries that they have a 1 in 350 chance of harboring cancer that cannot reliably be detected prior to surgery, according to the WSJ. Although the morcellator has not been banned—as some have called for—many hospitals have restricted its use to carefully screened patients and a number of health insurers have decided they will no longer cover routine use of the morcellator in fibroid surgery and hysterectomies.
J&J said the company discloses overall litigation expenses in its regulatory filings, but does not break out morcellator litigation costs separately. A company spokesperson declined to comment on the settlements. The company suspended sales of its morcellator in April 2014 and withdrew it from the market in July 2014.
Dr. Hooman Noorchashm, husband of a woman who has brought suit because morcellator surgery worsened her cancer, lamented that settlements would prevent a public airing of all the facts about morcellators, the WSJ reports. “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,” he said.
The U.S. Government Accountability Office is in the midst of a probe of why the device remained on the market for two decades before the FDA warned it can spread uterine cancer. The FDA has said it plans to fully cooperate with the investigation.