House legislation has recently been introduced in an effort to prompt quicker action by federal regulators to remove dangerous medical devices from the market.
Two bipartisan bills are expected to ease the process for patients who have suffered due to faulty devices to sue the makers of these devices, according to Cincinnati.com. Introduction of the bills occurred earlier this month; one, the Medical Device Guardians Act of 2016, would mandate physicians to tell the U.S. Food and Drug Administration (FDA) about issues manufacturers’ devices may cause patients. The Medical Device Guardians Act would cover existing and future devices.
One such example that prompted the move is the power morcellator. Power morcellators have been routinely used in minimally invasive fibroid surgery and are constructed with “high-speed blades that cut tissue,” making the process of removing fibroid tissue easier through small incisions, wrote Cinncinati.com.
The bill’s sponsors say that it was the problems presented with use of these power morcellators, including the devices once made by Ethicon, that directly led to their proposal, Cinncinati.com noted. Only hospitals and device makers must provide this information to the FDA under current law. Patient advocates argue that this law leads to significant under-reporting and, Cinncinati.com pointed out that, today, physicians must advise the FDA about prescription drug adverse effects via an online database.
U.S. Representatives Louise Slaughter (Democrat-New York) and Michal Fitzpatrick (Republican-Pennsylvania) co-introduced the legislation after they were each approached by constituents who provided very persuasive accounts about how power morcellators led “otherwise treatable cancers to spread.” Representative Slaughter said, “What should been a routine procedure has ended with a death sentence.” She has asked the Government Accountability Office (GAO) to investigate why the FDA approved the power morcellator, which chops the uterus and/or fibroids, which may be hosting malignant cancers that have not spread. Once diced, the cancer has the opportunity to spread.
Johnson & Johnson suspended sales of Ethicon’s power morcellator in April 2014, withdrawing the device from the market in July 2014. J&J, the parent company of Ethicon, has settled in excess of 100 legal claims and lawsuits associated with the morcellators potentially cancer-spreading risk, co-lead counsel for a consolidated lawsuit against J&J told the Wall Street Journal, Cinncinati.com reported.
The second bill would enable the maker of the permanent sterilization system, Essure, to be held liable for patient harm. Essure has been tied to the deaths of at least four women.
“All of us share a similar sad story,’’ said Frank Interlichia. Mr. Interlichia’s wife died as a result of a morcellator procedure. He was speaking to some two-dozen patient advocates who traveled from all over the country to be there when the announcement of the proposed bill was made. He told the group that it was his now-deceased wife’s burning wish “to make sure this never happens to anyone else.’’
