Judge Overseeing C.R. Bard Transvaginal Mesh Litigation Lets Stand $2 Million Verdict, Parker Waichman LLP Comments

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The bellwether case was the first federal lawsuit to reach trial within seven multidistrict litigations brought over the surgical devices used to treat specific gynecological conditions.

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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,”

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, is commenting on activity in a multidistrict litigation (MDL) brought over device maker, C.R. Bard’s, transvaginal mesh product. A West Virginia federal judge is leaving, intact, a $2 million jury verdict in Cisson et al v. C.R. Bard, Inc., case number 2:11-cv-00195, in the U.S. District Court for the Southern District of West Virginia. The case was a bellwether brought over allegations surrounding defects in Bard’s implant devices and was the first federal lawsuit to reach trial within seven MDLs brought over transvaginal mesh used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The plaintiff alleged “significant mental and physical pain and suffering” following a May 2009 surgery in which she was implanted with Bard’s Avaulta Plus Posterior Biosynthetic Support System to treat her POP.

The seven MDLs contain more than 70,000 currently pending cases involving transvaginal mesh including approximately 10,000 in the Bard MDL. The cases have been centralized before Judge Goodwin and 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)

Pelvic mesh devices are used to treat POP and 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.

U.S. District Judge Joseph R. Goodwin also stated that Bard did not prove a miscarriage of justice, denied the device maker a new trial, and refused to find a provision in Georgia’s Tort Reform Act of 1987 unconstitutional. The complaint was originally filed in Georgia and was transferred to the MDL in March 2011. A West Virginia federal jury awarded the plaintiff $1.75 million in punitive and $250,00 in compensatory damages in August 2013. (Cisson et al v. C.R. Bard, Inc., case number 2:11-cv-00195, in the U.S. District Court for the Southern District of West Virginia)

The judge would not sign off on the device maker’s attempt to reduce the punitive damages and indicated that the plaintiff suffered significant physical pain and injury, likely permanent and that evidence demonstrated Bard's "indifference and reckless disregard of the health and safety of Ms. Cisson…. Put simply, the evidence demonstrated that, during the market life of the Avaulta Plus, Bard knew about the risks posed by the product and its complication rates, but time and again, Bard did not act to correct the problems. This longstanding and continuous behavior strongly indicates reprehensibility.” (Cisson et al v. C.R. Bard, Inc., case number 2:11-cv-00195, in the U.S. District Court for the Southern District of West Virginia)

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 years, Parker Waichman LLP indicated.

Bard argued that the Court was in error on a number of points, including allowing evidence regarding a material safety data sheet accompanying the polypropylene resin material used to manufacture the Avaulta Plus transvaginal mesh device. Judge Goodwin found that the sheet, which contains a caution against using polypropylene resin in a permanent medical implant, was admissible and strengthened the plaintiffs’ claims; that the Court did not provide improper jury instruction regarding a question of liability by refusing to state that plaintiffs were mandated to prove causation by expert testimony; and that the Court did not err when it permitted plaintiffs’ allegations concerning Bard’s decision to not perform pre-market clinical testing. The judge noted that the duty to exercise reasonable care includes the duty to test the product. (Cisson et al v. C.R. Bard, Inc., case number 2:11-cv-00195, in the U.S. District Court for the Southern District of West Virginia)

In denying Bard a new trial; however, the judge stated that the Court was not incorrect when it excluded evidence involving the fact that Bard was in compliance with the U.S. Food and Drug Administration’s (FDA) rule mandating device makers advise the agency 90 days prior to marketing a medical device. The judge pointed out that the rule does not cover a product’s safety and efficacy and that introducing that evidence might have significantly increased the likelihood of misleading and confusing the jury. (Cisson et al v. C.R. Bard, Inc., case number 2:11-cv-00195, in the U.S. District Court for the Southern District of West Virginia)

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. “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,” Gary Falkowitz, Managing Attorney at Parker Waichman noted.

If you or a loved one experienced complications following mesh-related surgery involving transvaginal mesh, pelvic mesh, and vaginal implants 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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