Pharmaceutical

Bard must include memos about poor design, injuries in transvaginal mesh lawsuit

vaginal mesh sling Bard must include memos about poor design, injuries in transvaginal mesh lawsuitA federal judge has ruled that medical device manufacturer C.R. Bard cannot exclude from a bellwether trial against the company internal memos written by an employee warning that transvaginal mesh products have been associated with serious adverse effects and should be redesigned.

The lawsuit was filed by Carolyn Jones, who alleges that Bard’s Avaulta vaginal mesh, also known as a bladder sling, used to treat stress urinary incontinence and pelvic organ prolapse, was poorly designed and caused her to suffer serious injuries.

U.S. District Judge Joseph Godwin denied Bard’s request to exclude internal memos from its employee Bobby Orr, then-head of the company’s advanced surgical concepts division. In a memo written in 2008, Orr informed executives that transvaginal mesh could cause serious injuries and he proposed ways the devices could be redesigned.

Bard argued that the memos were not relevant to Jones’ lawsuit because plaintiffs would have to show that the defect existed while the product was still under the company’s control. Bard claimed that the memos were actually written after the Jones’ mesh was manufactured and implanted in the plaintiff.

Judge Godwin ruled that the memos do touch on the possibility that the devices were defectively designed and that the company knew or should have known of the risks whether or not it had an alternate design. After all, scientific journals that Orr referenced in the memos had been published before Bard began selling its mesh product implanted in Jones.

Jones’ case is the fourth bellwether case scheduled for federal litigation. The first resulted in a $2 million judgment in favor of the plaintiff. The second bellwether was settled on the first day of trial. The third bellwether case was dropped by the plaintiff just weeks before the trial was to take place.

Source: Law 360