This month, a federal judge in West Virginia dismissed 149 product liability actions brought against C.R. Bard involving its transvaginal mesh device products after the parties entered into a settlement. The exact terms of the settlement agreement have not been revealed.
The company’s pelvic products are intended to treat women who suffer from pelvic organ prolapse and stress urinary incontinence. Thousands of women reported experiencing severe complications after the device was implanted, however, including cramping, abdominal pain, bleeding, painful intercourse, and more. In many cases, women required additional surgeries to remove the devices, which often migrated out of their original locations, and to repair the resulting internal damage. Although some injuries were addressed through the follow-up procedures, many women are facing long-term or permanent injuries associated with the products.
Thousands of lawsuits have been brought against Bard alleging that the Avaulta product was defective, resulting in the formation of a Multi-District Litigation proceeding, known as MDL No. 2187. An MDL is similar to a class action in that a number of plaintiffs with common injuries and causes of action are grouped together. It differs from a class action, however, in that each plaintiff must still plead and prove his or her individual claim.
Earlier this year in a similar action, an appellate court upheld a verdict against the company regarding its Avaulta mesh product, awarding the plaintiff $2 million. The verdict contained $250,000 in compensatory damages and $1.75 million in punitive damages against Bard. Punitive damages are a category of compensation that is designed to punish a defendant for willful, reckless, or malicious conduct. They also serve as a disincentive to other companies contemplating similar behaviors. Bard, which had recalled the Avaulta device in 2012, appealed the damages award and argued that the court improperly excluded evidence about a 510(k) pre-approval that the company obtained from the FDA. Under the 510(k) process, a company can obtain approval for a medical device if it demonstrates in the application that the device is at least as safe and effective as, or substantially equivalent to, a device that is already approved.
Bard also alleged that the lower court improperly allowed the plaintiffs to submit evidence regarding a Material Safety Data Sheet detailing the dangers associated with polypropylene resin, which is used in the manufacture of Avaulta, and regarding the jury instructions that the lower court judge provided. The Fourth Circuit Court of Appeals rejected each of Bard’s challenges to the lower court ruling and upheld the $2 million verdict against the product manufacturer.
If you or someone you love has suffered injuries as the result of a transvaginal or pelvic mesh product, you may be entitled to compensation. Proudly serving clients throughout Florida, Texas, New York, and California, among other states, our dedicated team of dangerous medical device lawyers is standing by to assist you with gathering evidence, filing your claim, and negotiating with the company responsible for your injuries. We offer a free consultation to discuss your situation, so call us at 312-462-1700 or contact us online to set up your appointment.