Jury Awards $3.27 Million in Bellwether Transvaginal Mesh Lawsuit

Defective Medical Devices
Defective Transvaginal Mesh Verdict

By Zac Pingle, Staff Writer

Recently, the Fourth Circuit Court of Appeals upheld a 2014 verdict that awarded $3.27 million to a plaintiff who suffered from adverse effects after receiving a transvaginal mesh implant. The company that designed and manufactured the defective mesh device, Ethicon, argued to have the Court rescind the verdict based on several arguments.

The Use of Comment K

Ethicon argued that it was not liable for the plaintiff’s injuries based on the language used in Comment K of the American Law Institute’s Restatements. This Comment specifically states, “There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.” However, the Fourth Circuit disagreed with this assertion, seeing that the jury could have reasonably found that Ethicon’s Tension-Free Vaginal Tape-Obturator (TVT-O) design caused the device to be needlessly unsafe, based on expert testimony.

In his testimony, an associate professor of chemical engineering from Vanderbilt University stated, “the body recognizes [the material in pelvic mesh] as a foreign material and… will continue to attack it in this way until it’s removed or destroyed or it’s gone.” A former Ethicon employee also claimed that the polypropylene used in the pelvic mesh may contribute to medical complications, and that another lightweight material could be used to reduce the potential for injury.

Thus, the Court found that, “A reasonable jury could conclude from this expert testimony that Ethicon’s use of a heavyweight quantity of polypropylene mesh in the TVT-O constituted a design defect.”

501(k) Approval

Ethicon’s other main argument was that, since the product was approved by the FDA via the the 501(k) process in 2003, the court which presided over the case in 2014 erred by retracting this evidence. This process allows a company to receive market approval for a medical device if the device is “substantially equivalent” to another device that is currently approved, which also allows the company to skip submission of clinical data of its device. The Fourth Circuit sided with this decision, as the 501(k) process only considers safety based on a previous product, known as a predict.

Since 2014, the FDA has reclassified pelvic mesh devices as a “high risk” product, and is no longer eligible for approval through the 501(k) process.

The Real Danger of Pelvic Mesh Devices

The plaintiff in this case sued Ethicon in 2012, after receiving three different surgeries to correct the issues caused by the TVT-O device. Surgeons found that the device had completely eroded on the right side during the third surgery, and the plaintiff still experiences pelvic pain as a result. The jury awarded the plaintiff $3.07 million in damages, and another $200,000 for loss of consortium.

The Fourth Circuit concluded that the plaintiff “offered sufficient evidence to sustain the jury’s verdict and the district court committed no reversible error. Accordingly, we affirm.”

This case is only one in thousands involving defective pelvic mesh devices that are being used to treat stress urinary incontinence (SUI). The side effects associated with pelvic mesh devices can be debilitating, and include:

  • Severe pelvic pain

  • Fistulas

  • Infection

  • Organ perforation

  • Bleeding

  • Device migration and/or erosion

  • Bruising

  • Pain during sexual intercouse

This case, in particular, has set a precedent to prove liability in pelvic mesh mass tort cases, and many other similar cases are expected to be heard in the near future.

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