Boston Scientific ($BSX) is among the many devicemakers coping with the fallout over vaginal mesh implants, and the company has now disclosed that it's facing more than 2,500 lawsuits and investigations by attorneys general over the products.
In a regulatory filing, Boston Sci says most of the plaintiffs are suing over fraud, breach of warranty or failure to warn, and that many of the cases have been consolidated into a single federal court in West Virginia. Furthermore, the company found out in October that it is the subject of a civil investigation into its sales practices for the implants, led by the California attorney general and other state offices.
The concerns over vaginal mesh implants came to a head last year as women around the country reported serious adverse events from products made by Boston Sci, Johnson & Johnson ($JNJ), C.R. Bard ($BCR), Covidien ($COV) and others. In January, the FDA ordered the devicemakers to conduct three-year studies on the rates of organ damage and other complications in light of patients' claims.
Since then, the troublesome implants have attracted a wealth of legal attention. J&J is dealing with at least 550 lawsuits over its Gynecare Prolift mesh, and the company was dealt a blow in March with the revelation that it sold the products for three years without FDA clearance. Bard is facing litigation over its Avaulta Plus implant, most recently paying millions in damages to a California woman.
- read Boston Scientific's 10-Q