Bard Inc. Ordered To Pay Damages Of $33M Over Defective Pelvic Mesh

On Thursday, April 12, 2018, a New Jersey state jury ordered C.R. Bard, Inc., maker of medical products, to pay $33 million in compensatory damages for selling a pelvic mesh they knew was unsafe and for failing to warn doctors about its risks.

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After a medical malpractice lawsuit trial that lasted for nearly a month and one full day of deliberations, the jury handed down a verdict in favor of Mary McGinnis and her husband, both plaintiffs in the case. The jury determined that the injuries Mary McGinnis suffered were due to design defects of C.R. Bard’s Avaulta Solo Support System and Align Trans-Obturator Urethral Support System, and awarded compensatory damages of $23 million to Mary and $10 million to her husband. The jury was scheduled to consider potential punitive damages when the trial re-convened on Friday, April 13, 2018.

Mary McGinnis filed the lawsuit in 2011 after the devices were implanted in March 2009. She endured the procedure that implanted the Avaulta Solo device to support her bladder, which included the Align System that was designed to treat stress urinary incontinence, according to court documents. Mary claimed that before the procedure, Bard knew about problems with the pelvic mesh and that her surgeon would not have used it if Bard had warned her about certain risks. She added that the devices caused her to suffer debilitating pain and made her unable to have sexual relations with her husband.

Plaintiffs also claimed that the devices were too heavy and the pore sizes in the mesh were too small, according to a company memo authored by Bard executive Bobby Orr. The memo stated that the “mesh products designed to date are over engineered with regard to strength for the biologic requirements and the pore size results in formation of a scar plate that is rigid and does not integrate well over time with the host tissue.” According to the memo, Orr suggested that the company develop and test a “light weight, large pore mesh for vaginal repair.”

In closing statements in the hernia mesh lawsuit, plaintiffs’ attorney Adam Slater of Mazie Slater Katz & Freeman, LLC, told the jury that the company had blown through “red lights” warnings that their devices were dangerous and yet continued to sell them to the public. According to Slater, “They (C.R. Bard, Inc.) knew that the problems with this mesh material were causing clinical harm to patients before this was ever put into Mary’s body. They knew it was unsafe, and these were among the many red lights.”

Slater added that the surgeon had said that she would not have used the devices on Mary McGinnis if Bard had warned her about the risks.However, Bard’s attorney, Lori G. Cohen of Greenberg Trauriq, LLP, countered during the trial that the products were “safe and effective” and assured the court that they met all requisite standards and requirements for sale to the public.

During her summary to the jury, Cohen asserted that the plaintiffs had not come close to proving that the Bard’s devices were defective or that Bard didn’t adequately warn of the risks nor did they prove that Mary McGinnis’ health issues were due to the devices. She also noted Mary’s significant history of medical problems before the Bard devices were implanted and they did not prove that it was a separate surgical procedure that caused her inability to have sex with her husband.

Cohen countered the claim of the plaintiffs that the devices were too heavy and the pore sizes in the mesh were too small when she said, “… the products are appropriate in terms of balancing to do the work they need to do and to do it safely and properly and they met the requirements to be on the market…”

She also countered Orr’s remarks in the memo saying that a subsequent study disproved his hypothesis about larger pore sizes. In addition, Cohen noted during the trial that Mary had signed an informed consent document before the procedure and added that she was notified by the surgeon of warnings provided to her by Bard of the risks of the devices.

The hernia mesh lawyer for the plaintiffs and defendant also clashed during the trial concerning a material safety data sheet that the supplier issued concerning the raw material used in the mesh device.

The data sheet warned about using “the Phillips Sumika Polypropylene Company material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.” Cohen argued that the warning has nothing to do with the Bard devices.