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Bard Request to Exclude Internal Memos From Avaulta Vaginal Mesh Injury Trial Denied

Jan 16, 2014

A federal judge has ruled that device maker, C.R. Bard, must include internal memos concerning its now-recalled Avaulta pelvic mesh product in a bellwether product liability trial.

C.R. Bard asked Judge Joseph Goodwin of the U.S. District Court for Southern Western Virginia to exclude six internal memos authored by Bobby Or, head of Bard's Advanced Surgical Concepts division, according to The memos were written in 2008 and 2009 and involved a number of choices and materials that might be utilized to create new pelvic mesh products.

According to Bard, the memos should be excluded as evidence in the jury trial because they were written after the patient involved in the litigation was implanted with its Avaulta Plus mesh device "and are therefore not relevant to Plaintiff's design defect claim," according to court documents, reported. The device maker cited a federal provision under which introduction of evidence that shows that steps were taken to resolve a defect that would have prevented a prior injury was barred, according to

Bard also argued for the memos’ exclusion as the documents referred to steps that might be taken after the patient received the Avaulta Plus device and indicated that the documents might prejudice the jury, which might delay the trial, according to court records, 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, wrote.

The judge also found that the device maker did not provide sufficient specifics concerning the possibility of jury prejudice, according to "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," Judge Goodwin wrote. The jury trial is scheduled to begin January 10th, according to the court.

The device maker recently agreed to settle another case brought over serious injury claims involving its vaginal mesh products. That settlement was reached prior to trial. The patient claimed that the Bard vaginal mesh implant led to her internal problems, which included urinary problems, according two people familiar with the negotiations and speaking anonymously, according to a prior report.

That case was the second vaginal mesh case Bard settled since it was ordered to pay $2 million to a woman who brought a lawsuit alleging that the Avaulta device caused her injuries. This case was also the first to be tried in federal court. In 2012, a California state court jury found C.R. Bard liable for a woman’s injuries, also tied to Avaulta devices, which represented the first case tried in United States court, according to

Avaulta implants were pulled in 2012 after the U.S. Food and Drug Administration (FDA) ordered transvaginal mesh device makers to study adverse health reactions that include organ damage, infection, and pain tied to the devices. reported. Device makers such as Johnson & Johnson, Endo Health Solutions Inc., and Boston Scientific Corp. are facing similar claims over their transvaginal mesh devices and, while many cases have been consolidated before Judge Goodwin for pretrial processing, others have been filed in state courts in New Jersey, Missouri, and California, according to

The agency reported that the most common complications associated with these devices may include bleeding; bleeding; dyspareunia (pain during sexual intercourse); exposure, extrusion, or protrusion (mesh erosion through the vagina); infection; organ perforation; pain; and urinary problems.

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