The controversy surrounding power morcellators and cancer may ultimately result in better monitoring of medical devices. Earlier this month, the U.S. House of Representatives passed the 21st Century Cures bill, which among other things, calls for the inclusion of “unique device identifiers” in electronic health records as a means to better track patient harm.
“What happened with the power morcellator should never be allowed to happen again,” Rep. Mike Fitzpatrick, (R., Pa.), the amendment’s sponsor, said at a hearing of the House Rules Committee just before the bill passed the full House on July 10th.
The 21st Century Cures bill, which boosts federal funding for medical research and changes drug approvals, is still far from becoming law. According to The Wall Street Journal, a similar bill has yet to be introduced in the U.S. Senate, though that could occur before the end of the year. However, it’s unclear as to whether any Senate bill would include similar provisions regarding unique device identifiers.
It should also be noted that the U.S. Food & Drug Administration (FDA) is already working to implement a rule that would require unique identifiers on medical device labels. However, Rep. Fitzpatrick told The Wall Street Journal that the inclusion of the amendment in the 21st Century Cures bill “adds pressure” to encourage the FDA to implement the requirements as quickly as possible.
Power morcellators are used in minimally-invasive hysterectomies and myomectomies to shred tissue into small pieces so that it can be removed via a small abdominal incision. Since April 2014, the FDA has issued two warnings regarding the potential for uterine morcellation to spread and upstage undetected uterine sarcoma cells, an occurrence which can greatly reduce a woman’s chance for long-term survival. In its most recent warning, the FDA specifically cautioned against the use of power morcellators in the vast majority of women who require hysterectomy or myomectomy.
The FDA cleared the first power morcellators for sale over two decades ago, through its 510(k) clearance program which does not require device manufacturers to conduct human clinical trials. Early on, the agency was aware of their potential to spread undetected cancer cells beyond the uterus. However, the true magnitude of the risk only became apparent over the last two years. While it was initially thought that only around 1 in 1,000 women who require fibroid surgery actually have undiagnosed uterine sarcoma, the FDA now says that the rate is closer to 1 in 350.
Court records indicate that more than 20 morcellator lawsuits are currently pending in U.S. courts, all of which were filed on behalf of women who allegedly experienced the spread of undiagnosed uterine cancer following morcellation. One case, which was scheduled to go to trial in Pennsylvania this November, recently settled for an undisclosed amount. And in June, a group of plaintiffs asked the U.S. Judicial Panel on Multidistrict Litigation to consolidate all federally-filed morcellator cancer cases in a single court for the purposes of coordinated pretrial proceedings.
Bernstein Liebhard LLP represents the victims of defective medical devices, and our attorneys are offering free legal reviews to victims of uterine cancer that may have been spread by a power morcellator. If you would like to learn more about filing a uterine morcellation lawsuit, please to arrange a consultation today.