California Appeals Court Affirms Multimillion Dollar Verdict Against Transvaginal Mesh Device Maker, C.R. Bard, Parker Waichman LLP Comments.

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The $5.5 million verdict was reached in a case brought over C.R. Bard’s Avaulta Plus vaginal mesh implant.

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“We represent many women who have filed lawsuits over alleged injuries associated with transvaginal mesh and continue to provide free consultations for anyone who seeks more information about their rights,” Mr. Falkowitz noted.

A California appeals court has affirmed a $5.5 million verdict against device maker, C.R. Bard Inc. and a gynecologist, finding both responsible for a woman’s injuries associated with a C.R. Bard Avaulta Plus vaginal mesh implant. The case is Christine Scott et al. v. C.R. Bard Inc., case number F066039, in the Court of Appeal of the State of California, Fifth Appellate District.

The jury rejected C.R. Bard’s argument that negligence theories submitted to the jury were erroneous. According to the decision, the jury correctly considered if Bard, which designed the medical device, could face negligence claims even if it was not found to be responsible under strict liability claims. Bard argued that the theory presented, finding it responsible for training physicians on the way in which to properly install the vaginal mesh device and handle potential complications, was not appropriate. The panel also ruled that the device maker’s actions, including its physician training sessions, revealed that the theory was presented properly. “It should have been apparent to Bard that improper training could increase the risk of harm to the physician’s patients,” the panel wrote in its decision. “Accordingly, the theory that Bard undertook to train physicians and thus had a duty to use due care in carrying out such training was properly submitted to the jury.” The plaintiffs lost their bid to shift the gynecologist’s 40 percent share of the verdict to C.R. Bard.

Pelvic mesh devices are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Thousands of women allege in lawsuits that these devices are defective and have also led to severe and, sometimes, permanent and life-altering injuries and pain, according to Parker Waichman LLP.

Transvaginal mesh has been the focus of several multidistrict litigations. Ms. Scott’s case, filed in 2009 over the Bard Avaulta Plus, was the first to reach a verdict. Her allegations involve an array of complications associated with her Avaulta Plus mesh implant, several corrective surgeries, an inability to control her bowels, and the inability to have sexual intercourse with her husband.

In July 2012, a jury found Bard acted negligently toward Ms. Scott and that Bard’s negligence was a key factor in the pain, nerve damage, and incontinence she alleged were associated with her Avaulta Plus implant. The jury leveled a $3.6 million judgment against the device maker, from the total verdict of $5.5 million; the jury assigned 40 percent blame to Ms. Scott’s physician, a defendant in the lawsuit. On appeal, Bard argued the negligent design claim was barred when the jury found it not liable for failure to warn, according to court records. While C.R. Bard is correct that it cannot be held strictly liable for an alleged Avaulta Plus design defect, according to the panel, immunity from strict liability does not bar a negligence claim. “Rather, strict liability focuses not on the conduct of the manufacturer but on the product itself and holds the manufacturer liable if the product was defective,” the panel wrote.

“The panel’s finding places appropriate blame on device makers and helps women allegedly injured by these devices closer to receiving the compensation they deserve,” says Gary Falkowitz, Managing Attorney at Parker Waichman LLP.

Transvaginal mesh devices were approved with little or no clinical testing, a point emphasized in patient lawsuits. A regulatory loophole, commonly known as the 510(k) has enabled device manufacturers to sell these pelvic mesh devices without much clinical evidence to prove their efficacy and safety. The 510(k) process eliminates clinical testing should a device be shown to be sufficiently similar to an older, approved device, and has been the focus of significant controversy in recent months, Parker Waichman LLP indicated.

A June 30, 2014 Securities Exchange Commission (SEC) filing revealed that C.R. Bard, agreed to a settlement of more than 500 of the Avaulta transvaginal mesh lawsuits pending against the firm. In addition to these cases, the device maker faces thousands of lawsuits nationwide. Most were consolidated as part of the federal MDL centralized before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia. Nearly 60,000 federally filed MDLs involving transvaginal mesh, including more than 9,000 filed against C.R. Bard, were brought against an array of transvaginal mesh device makers and are pending.

The cases are:

  •     In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2325)
  •     In re: Boston Scientific Corp., Pelvic Repair System Products Liability Litigation (MDL No. 2326)
  •     In re: Coloplast Corp. Pelvic Support System Products Liability Litigation (MDL No. 2387)
  •     In re: Cook Medical, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2440)
  •     In re: C.R. Bard Inc. Pelvic Repair System Products Liability Litigation (MDL No. 2187)
  •     In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2327)
  •     In re: Neomedic Pelvic Repair System Products Liability Litigation (MDL 2511)

The lawsuits brought against C.R. Bard over its Avaulta transvaginal mesh, as well as actions brought against other transvaginal mesh manufacturers, all similarly allege significant injuries following surgery that utilized vaginal mesh to repair POP or SUI in women. These women also similarly allege that the devices are defective and provide an unnecessary risk of injury, according to Parker Waichman LLP, which has filed a number of lawsuits in the various MDLs being overseen by Judge Goodwin, including against Johnson & Johnson, the parent company of Ethicon; AMS; and Boston Scientific.

“We represent many women who have filed lawsuits over alleged injuries associated with transvaginal mesh and continue to provide free consultations for anyone who seeks more information about their rights,” Mr. Falkowitz noted.

Parker Waichman LLP continues to offer free consultations to victims of transvaginal mesh, pelvic mesh, and vaginal implant injuries.
If you or a loved one experienced complications following mesh-related surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI), please visit the firm's transvaginal mesh injury page at yourlawyer.com. Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).

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