Early last week, the United States Food and Drug Administration proposed reclassifying transvaginal mesh inserts as “high-risk” medical devices. If that proposal takes effect, it would result in mesh makers being required to take additional — and costly — steps to ensure the safety of their products prior to their gaining market approval.
Currently a lesser exaction is placed on manufacturers, with approval based on satisfying FDA officials that a proposed product is similar to others that have already been approved and are on the market.
A new FDA rule would be far more stringent than that, with mesh manufacturers being required to engage in clinical studies that prove the safety and efficacy of the their products.
One day following the FDA’s announcement, Ireland-based Endo International PLC announced that it was settling approximately 20,000 product liability lawsuits alleging that various mesh implants made by the company have caused organ damage and brought about other complications in women.
Media reports indicate that the company will pay about $830 million to settle those suits. Following their resolution, Endo will still be involved in more than 23,000 other filed complaints that have been consolidated in a West Virginia federal court.
Reportedly, harmed plaintiffs in Ohio and elsewhere who have settled with Endo will receive payments of about $40,000 on average.
A number of other medical device makers also have transvaginal mesh products on the market, and one product liability expert says that Endo’s move could signal “a wave of similar settlements” in the near future.
Any Ohio resident or other person across the country who suffers personal injuries through the use of defective medical devices has recourse to legal remedies that will help to compensate for pain and suffering. An experienced product liability attorney can provide candid and confidential information, as well as advocate aggressively on a client’s behalf.
Source: Bloomberg, “Endo to pay $830 million to resolve vaginal-mesh suits,” Jef Feeley, May 1, 2014