A federal jury in a bellwether injury lawsuit re-trial this week arrived at a $250,000 injury judgment against  transvaginal mesh device maker, C.R. Bard. This Bard case, the first to come before West Virginia’s Federal multi-district litigation (MDL) court, was declared a mistrial last month after testimony revealed the mesh product had been removed from the market, a disclosure which ran afoul of the court’s pre-trial instructions. This time the jury made it to a verdict, which declared C.F. Bard’s Avaulta pelvic mesh device to be defective, and determined that Bard failed to warn about the mesh’s defects.

The jury in the retrial, which began on July 29 and lasted six weeks, awarded the plaintiff $250,000 in compensatory damages, then later added an additional $1.75 million in punishment damages. Though the punitive portions of these damage awards are seldom collected by plaintiffs, the amount in this case clearly indicates that the jury felt the company knew about problems with the Avaulta product, yet failed to properly disclose them to the plaintiff. The jury deliberated for 12 hours over two days. Judge Joseph Goodwin of the U.S. District Court for Western Virginia presided.

Transvaginal mesh devices were approved to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), conditions most commonly caused by weakened pelvic muscles. Transvaginal mesh devices are supposed to help correct these conditions by providing additional strength to the pelvic walls. These mesh devices were approved through an FDA fast-track process known as 510(k), which requires no formal review for safety or efficacy; consequently, the 510(k) route has drawn criticism for being used to gain clearance for transvaginal mesh and other controversial devices.

This is the first federal lawsuit to come to trial that alleged the device harmed a patient. Myriad companies – including Boston Scientific, Endo Health Solutions, Cook Medical, and Johnson & Johnson’s  Ethicon subsidiary – face more thant 4,000 federal lawsuits related to transvaginal mesh devices.

“The jury award reflected the surgeries the woman suffered post implant and the problems she had pre-implant,” said attorney David Matthews, whose firm of Matthews & Associates, along with Freese & Goss – of Dallas, Texas; Jackson, Miss.; and Mobile, Ala. – will try five mesh cases in the next year.  The firms’ five trial cases, however, all concern mesh slings used for stress urinary incontinence (SUI), as opposed to the mesh which was used, in this West Virginia case, to treat pelvic organ prolapse (POP).

The difference in the types of mesh could be important for trial outcomes. The distinction was made somewhat clear in June 2011 when the FDA announced that it would like to see more testing of the transvaginal mesh used for POP; but the agency essentially seemed to agree with manufacturers that the slings being used for SUI did not require further testing, that slings were the “gold standard” for SUI treatment. Whether the slings’ risks outweigh their benefits and whether the women who have been slinged were properly warned of the dangers in the event of the sling’s failure will be determined in the courts.

The FDA has stated that complications linked to transvaginal mesh implants are “not rare” and warned that use of such devices may actually be more harmful when compared to alternative methods for treating POP. The FDA also recently reported that the most common complications associated with transvaginal mesh may include:

• Exposure, extrusion, or protrusion (mesh erosion through the vagina)
• Pain
• Infection
• Bleeding
• Pain during sexual intercourse (dyspareunia)
• Organ perforation
• Urinary problems

Related

• Pelvic Mesh Lawsuit