Covidien Files $180 Million Allotment For Transvaginal Mesh Litigation

By Jof Enriquez,
Follow me on Twitter @jofenriq

Medical device manufacturer Covidien recently booked a $180 million pre-tax legal charge in the third quarter related to transvaginal pelvic mesh litigation payments.

Currently, Covidien is embroiled in lawsuits against manufacturers of pelvic mesh products due to alleged personal injuries that resulted from the use of those products. According to its filing with the U.S. Securities and Exchange Commission, “two subsidiaries of Covidien have supplied pelvic mesh products to one of the manufacturers named in the litigation and Covidien is indemnifying that manufacturer on certain claims.”

While Covidien did not identify the manufacturer in its filing, C. R. Bard is one manufacturer that receives pelvic mesh products from Covidien. According to Lawyers and Settlements, “about 9,000 of Bard’s Avaulta transvaginal mesh lawsuits are currently pending in a federal multidistrict litigation.”

Covidien’s filing mentions that the company recorded the cost allotment after receiving “additional information regarding the nature of products liability claims and potential exposure based on access to medical records, discussions with plaintiff attorneys and settlements by other manufacturers.” Covidien added that most complaints “allege design and manufacturing claims, failure to warn, breach of warranty, fraud, violations of state consumer protection laws and loss of consortium claims.”

Thousands of lawsuits have been filed by women in numerous federal, state, and overseas courts against several medical device companies in regards to transvaginal mesh, with the patients alleging that they suffered personal injuries during and after implantation.

According to Lawyers and Settlements, Boston Scientific is facing more than 20,000 lawsuits in both federal and state courts in the U.S., 10 in Canada, and three in the United Kingdom. Johnson & Johnson’s subsidiary Ethicon is dealing with over 19,000 vaginal mesh cases in U.S. District Court, Southern District of West Virginia, along with several separate lawsuits in other jurisdictions.

One manufacturer, Endo International Plc, in April settled 20,000 lawsuits for $830 million, according to a Bloomberg report. At around the same time, the U.S. FDA said it was mulling stricter requirements for manufacturers of pelvic mesh devices amid the mounting number of lawsuits.

However, the FDA this month decided against a total ban on transvaginal mesh products for pelvic organ prolapse repair. The agency was acting on a petition filed by the consumer advocacy group Public Citizen who sought a recall of the devices and their reclassification as Class III devices.