HACKENSACK, N.J. (Legal Newsline) – A jury on April 13 hit New Jersey maker of mesh implant devices C.R. Bard with $35 million in punitive damages in addition to the $33 million in compensatory damages awarded the previous day for the alleged physical damage its mesh device caused a North Carolina woman.
Mary McGinnis had filed a lawsuit against C.R Bard for its Avaulta and Align pelvic mesh devices implanted into her pelvic region in 2009 to support a sagging bladder. Instead the implants allegedly caused tissue inflammation, rigid scarring, intense pain and loss of mobility and had to be removed during subsequent surgeries, causing the woman further harm.
Made of clear polypropylene, the device consists of a small central mesh with attaching arms and comes in a box kit. The implants were first put on the market in 2007.
During a three-week trial, defense attorneys for C.R. Bard attempted to portray McGinnis’ source of pain to be a result of her own long-term arthritic conditions and not the implant. The plaintiff contended the implant was defective and once inside McGinnis’ body contracted, resulting in intense pain.
The eight-member jury agreed with the plaintiff and on April 12, awarded McGinnis $23 million in compensation with another $10 million going to her husband, Tom, for his suffering during the ordeal.
New Jersey Superior Court of Bergen County Judge James DeLuca explained that unlike the compensation award given to the plaintiff for loss and suffering, the punitive phase of the verdict held Friday decided whether to punish C.R. Bard for its actions and to deter the company from making future similar transgressions.
“You decided the compensatory damages and now you must decide the punitive,” DeLuca explained before the vote was taken. “If you decide on punitive damages, you must then decide the amount of the award.”
Streaming video coverage of the trial was provided to Legal Newsline by Courtroom View Network.
The jury verdict was much the same as the compensation vote the day before, 7-1 in favor of a punitive award. An amount of $35 million was levied, approved again by 7-1 vote.
Before the votes were taken, C.R. Bard’s attorney Lori Cohen of Greenberg Traurig said a punitive award was not merited because the company was innocent of willful wrongdoing.
“We respect you and your (compensation) verdict,” she told the jury. “Does this case warrant punitive damages? This is totally different and has an extremely higher burden (of proof). We think it should stop here.”
Cohen said punitive damages were used to punish a party who had acted in an especially outrageous manner. She explained C.R. Bard had not acted with malicious intent.
“You might think they (C.R. Bard) were careless, but to say they were malicious, I don’t think anyone can say any of the folks who worked at C.R. Bard were malicious," she said. "There was never any evidence of intentional wrongdoing.”
Cohen projected a slide with a statement from Adam Silver, vice president of C.R. Bard's medical division, who said, “There are risks associated with doing these procedures with mesh, but we’re always looking at ways to make it better.”
“They (C.R. Bard) thought they had a significant clinical heritage (background information)," Cohen said. "Obviously you (jury) disagree. But again did they do this deliberately? Or do you think they could have done better, that’s what you told them yesterday. They may not have met the standards you wanted for them, but they didn’t do anything intentional.”
Cohen asked the jury if they wanted to encourage or discourage medical companies in seeking future innovation in the medical products field.
She contended C.R. Bard believed in patient safety, complied with industry standards and that the Avaulta and Align products had low complaint rates.
Cohen also disputed the idea the products were “experimental” in nature and said the benefits of the products outweighed the risks.
“If you’re complying with industry standards, you can’t be maliciously doing harm,” she said.
Cohen exhibited a slide that showed C.R. Bard had total sales figures of $1,125,633 for its Align implant and $1,186,677 for the Avaulta.
“We’re not talking about huge sales figures and profits,” she said.
Adam Slater of Mazie, Slater, Katz & Freeman of Roseland, New Jersey, McGinnis’ attorney, portrayed the actions of officials at C.R. Bard to be a deliberate case of ignoring facts and warnings and engaging in deception to generate profits.
“Justice is not just a word - it’s a living, breathing thing,” he said. “You (jury) are actually going to get to speak to the executives of a large corporation that did things wrong and tell them it’s not good enough, they're going to do it the right way.”
Slater said no regret had been heard from company officers.
“I didn’t hear we’ll do things differently,” he said. “What I heard is, We hear you (jury), but we did everything right.”
Slater exhibited a slide stating that C.R. Bard and its subsidiary Davol from 1997 onward tried to ensure that officials of Phillips Sumika Polypropylene Co., a division of Chevron and a supplier of polypropylene resin, wouldn’t find out its materials were being used for medical implant devices. If it did find out, they might withdraw the supply over safety concerns.
“This is the culture of C.R. Bard,” Slater said.
Slater played a tape of Dr. Elizabeth Barbee, the North Carolina gynecologist who performed the implant on McGinnis in 2009 after going through training provided by C.R. Bard. Recorded during a deposition in 2016, Barbee agreed she was not informed of all the potential health risks of the products and called placing a device with an unknown reaction inside someone’s body “irresponsible.”
“The victimization doesn’t just stop with Mary (McGinnis),” Slater said. “They didn’t tell Dr. Barbee the truth.”
Slater said warnings just months before the products went on the market expressing concern that mesh kits lacked enough evidence of risk versus benefit to adequately counsel patients about the possible outcomes of use went unheeded.
“In 2008, they knew the properties of the mesh were causing clinical harm to women,” Slater said. “Yet they kept selling the devices. That’s willful. Mary McGinnis didn’t know she was part of an experiment and Dr. Barbee didn’t know either.”
Slater said C.R. Bard had a $2 billion net worth and had identified the market share for pelvic mesh in 2008 at $225.5 million globally.
“They were chasing this giant market,” he said. “They made tens of millions of dollars on these profits. You need to award enough to punish and deter. Do you want C.R. Bard to say, OK, we got by that one, we’ll be OK. or say, We need to listen and do things right?”