Pharmaceutical

Judge rules $2 million verdict stands against transvaginal mesh maker

vaginal mesh sling Judge rules $2 million verdict stands against transvaginal mesh makerA federal judge denied a mistrial and left intact a $2 million jury verdict against medical device manufacturer C. R. Bard Inc., in a bellwether trial over claims that its transvaginal mesh implant was defective and caused serious injuries. U.S. District Judge Joseph R. Goodwin said the motion stood because the company had not proven a miscarriage of justice.

However, Goodwin also did not find unconstitutional a provision in Georgia’s Tort Reform Act of 1987 that requires product liability plaintiffs to give up 75 percent of their punitive damage earnings to the state. This comes as a blow to plaintiffs Donna and Dan Cisson, who in August 2013 were awarded $1.75 million in punitive damages and $250,000 in compensatory damages by a West Virginia federal jury.

The Cisson case was the first federal suit among seven multidistrict litigation suits to go to trial. All involved allegations of injuries caused by transvaginal mesh. The mesh, also known as a bladder sling, is used to treat stress urinary incontinence and pelvic organ prolapse. Serious injuries have been associated with the implants including erosion, chronic pain, infections, hemorrhaging and disability. Transvaginal mesh is made by numerous manufacturers, many of whom are involved in similar litigation.

In denying Bard’s motion for a new trial, Goodwin supported the court’s decision not to include evidence relating to Bard’s compliance to Food and Drug Administration (FDA) requirements of notifying the agency 90 days prior to marketing the medical device. That, the judge said, does not determine whether or not a product is safe and effective. He also said that introducing that evidence could have been misleading and confusing to the jury.

Bard argued that the court should have allowed evidence involving a material safety sheet that had accompanied the polypropylene resin material used to manufacture the company’s transvaginal mesh. The sheet cautioned against using polypropylene resin in permanent medical devices.

Furthermore, Goodwin said the court was correct to allow plaintiffs’ allegations that the company did not perform clinical tests prior to marketing the implants to ensure their safety and efficacy.

Regarding the Cissons’ motion involving the provision in Georgia’s Tort Reform Act of 1987, Goodwin said the statute legitimizes the state’s interest of deterring conduct that has the potential to harm all citizens, not jut the plaintiffs. Thus, the ruling stands.

The remaining multidistrict litigations involve more than 70,000 lawsuits. An estimated 10,000 are in the Bard MDL.

Source: Law 360