The first federal transvaginal mesh lawsuit trial resumed this week in the U.S. District Court for the Southern District of West Virginia, after ending in a mistrial last month. The jury found manufacturer, C.R. Bard, guilty of failure to warn and found the transvaginal mesh product defective.
The jury awarded plaintiff Donna Cission $1.75 million in punitive damages on top of $250,000 in compensatory damages.
The case, Cisson v. C.R. Bard, is one of over 23,000 transvaginal mesh lawsuits filed in the Southern District of West Virginia. The case was the first of four bellwether trials concerning the Avaulta transvaginal mesh device manufactured by C.R. Bard.
Transvaginal mesh, also known as pelvic mesh, is a surgically-implanted device used for the treatment of gynecological issues such as pelvic organ prolapse and stress urinary incontinence. The mesh is made of a synthetic material, usually polypropylene.
Mesh products were approved under the Food and Drug Administration’s (FDA) 510(k) expedited approval process. The 510(k) process allows for drugs and products that are deemed similar to existing FDA-approved products to enter the market as FDA-approved, without extensive trials or testing.
In 2011, the FDA issued heightened warnings for the use of transvaginal mesh products, and recommended that pelvic organ prolapse be reclassified to prevent further approvals of pelvic mesh products through the 510(k) expedited process.
Ms. Cisson, the plaintiff in Wednesday’s trial, alleged that the implant she received, made from a resin-based plastic, was unfit for use in humans. According to a Bloomberg report, C.R. Bard used a plastic material developed by a Chevron Phillips Chemical Co. unit to produce hernia-repair mesh.
The report states that Chevron Phillips internal e-mails and documents show the supplier officially issued a warning that the material should not be permanently implanted in people. Plaintiffs allege the same mesh was used in their transvaginal devices.
“The problem with mesh devices is that they’re made of a synthetic polypropylene… What will actually happen is that the polypropylene will react to the body… it will stretch, it will creep, it will shrink… it starts eroding through organs, it starts affecting the vaginal cavity… It will cause pain, it will cause urinary issues… the mesh can actually eat through the walls of organs. As you can imagine, this is a very painful experience,” stated Robert Price, an attorney with the Levin, Papantonio law firm who practices in the areas of bad drug and defective medical device litigation.