Federal judge Joseph Goodwin of the U.S. District Court for Southern Western Virginia just ruled that device maker, C.R. Bard, must include company memos involving the Avaulta pelvic mesh device in a bellwether product liability jury trial scheduled to begin January 10th.
Bard requested that six internal memos be excluded; Judge Goodwin denied the request, according to MassDevice.com. The memos were written by the head of Bard’s Advanced Surgical Concepts division, Bobby Or, in 2008 and 2009 and discussed various options and that might be used in the development of vaginal mesh products.
Bard argued that the documents should be excluded as evidence in the jury trial because they were written after the patient underwent surgery for implantation with the Avaulta Plus device “and are therefore not relevant to Plaintiff’s design defect claim,” according to court documents, wrote MassDevice.com. Bard cited a federal provision that indicates that introducing evidence that reveals that measures were taken to correct a defect that would have prevented a serious injury is barred, MassDevice.com, wrote.
Bard’s arguments also included that the documents discussed steps that might be taken after the patient was implanted with the Avaulta Plus device and that those documents might potentially prejudice the jury, which might also delay the trial, according to court records, MassDevice.com reported.
Judge Goodwin denied the request stating that, among other issues, based on Bard’s statement concerning the law, the device maker’s argument indicates that it recognized what is considered a key point in the case—that C.R. Bard should have known that other, feasible options existed no later than when the Avaulta product was launched in 2007, MassDevice.com wrote.
Judge Goodwin also found that Bard provided insufficient information on the potential of jury prejudice, writing that, “Bard has failed to sufficiently articulate why admission of the memoranda would lead to prejudice that is “unfair.” As such, the Orr memoranda should not be excluded,” MassDevice.com reported.
Avaulta implants were pulled from the market in 2012 following a U.S. Food and Drug Administration (FDA) order to all transvaginal mesh device makers to study adverse health reactions, such as organ damage, infection, and pain associated with the mesh devices, Bloomberg.com reported. Johnson & Johnson, Endo Health Solutions Inc., and Boston Scientific Corp. are facing similar claims over their transvaginal mesh devices and, while many such cases have been consolidated before Judge Goodwin for pretrial processing, others have been filed in New Jersey, Missouri, and California, state courts, according to Bloomberg.com.
According to the FDA, the most commonly reported complications associated with transvaginal mesh devices include bleeding; dyspareunia (pain during sexual intercourse); exposure, extrusion, or protrusion (mesh erosion through the vagina); infection; organ perforation; pain; and urinary problems.
Meanwhile, Bard recently agreed to settle another case brought over serious injury claims involving its vaginal mesh products; the settlement was reached prior to trial. The patient alleged that the Bard implant caused her internal problems, including urinary problems, according to two people familiar with the negotiations and speaking on the condition of anonymity, Bloomberg.com reported previously. That case was the second such lawsuit Bard settled since it was ordered to pay $2 million to a woman who brought a lawsuit alleging Avaulta injuries. In 2012, a California state court jury found C.R. Bard to be liable for yet another woman’s injuries, also involving Avaulta devices and representing the first case tried in United States court.
