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Jury: Bard Created Defective Vaginal Mesh Product, Failed to Warn of Dangers

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Jury sits and listens

By Doug Allen

BREAKING NEWS: The jury found Bard guilty of failure to warn and found the vaginal mesh product defective. They awarded $250,000 to Donna Cisson for compensatory damages and will decide punitive damages soon.

CHARLESTON, W.Va. — The jury began deliberations today in the nation’s first federal trial to determine if a transvaginal mesh device was defective and caused permanent injury to a patient, after 45 minutes of detailed instructions from the judge presiding over the case. The jury was sent to the jury room with more than 20,000 pages of documents, which the judge joked would require a call to “American Van Lines to get the exhibits hauled in.”

Cisson v. C. R. Bard is the first of more than 23,000 similar cases pending in the U.S. District Court for the Southern District of West Virginia, in Charleston. The next trial against Bard will begin in the same courtroom on Monday, with two more to follow.

The four men and four women of the jury have heard 11 days of testimony from more than a dozen witnesses. Judge Goodwin told the court last week that he will be unavailable on Thursday and Friday, so a substitute judge will be brought in if the jury returns a verdict before the weekend.

Jury Instructions

Judge Joseph R. Goodwin, who’s been assigned to manage the caseload, began by telling jurors, “It’s my duty to instruct you on the law.” He addressed the jury on instructions, the rules of law to apply, and the guidelines on how to do it.

“You are now judges of the facts,” Goodwin said. “You must decide this case based solely on the facts and the law.”

He told the jury they are not permitted under law to have sympathy or prejudice for either party in the case, and that just because an expert witness had an opinion doesn’t mean they have to accept that opinion. He said the plaintiff had the burden of proof, and it was the jury’s job to determine if the facts presented by the plaintiffs were true or not true.

The jury must decide the facts “by a preponderance of the evidence, not beyond the shadow of a doubt,” which is a lower standard, he said. If it’s more likely true than not true, the fact should be decided in favor; if it’s evenly divided or tilted toward the evidence, the fact is not proven.

Bard should only be found responsible for Cisson’s injuries if her legal team proved a defect in the Avaulta Plus device, the defect existed at the time it left Bard’s control, and the defect in the product was the proximate cause, or most significant factor, of the injury.

“Whether the product is defective is a question of fact decided by you,” Goodwin said.

The Avaulta Plus may be found defective because of its design, and Bard has a duty to exercise reasonable care in choosing the design of the product, he told the jury. He then gave them detailed directions about how to balance the inherent risk of harm from a product compared to its overall utility.

Bard Had a ‘Duty to Inform’

Cisson’s lawsuit alleges negligent failure to warn on Bard’s part, and Goodwin said the question was whether Bard failed to provide adequate warnings of the risks associated with the Avaulta Plus product. If the jury finds that Bard had a duty to inform her implanting physician of the risks associated with Avaulta Plus but failed to do so, and that failure was the proximate cause of Cisson’s injuries, they must find in her favor.

He said Bard’s affirmative defenses were that Cisson assumed the risks of the product, and she failed to mitigate her damages. If the jury believes Bard proved both of those, they must find in favor of Bard.

He also gave detailed instructions on how to determine damages, including punitive damages, which he described as intended to punish, penalize or deter the defendants. To assess punitive damages, Goodwin said there must be “clear and convincing” evidence, which he said was a higher standard than a preponderance of the evidence but a lower standard than the shadow of a doubt.

‘You Are the Judges’

The jury must begin by choosing a foreman, and their verdict must be unanimous. One juror, an operating room nurse, wore scrubs to court today for the first time since jury began hearing testimony more than two weeks ago.

“Feel free to change your minds and opinions,” Goodwin said. “But do not surrender your views or opinions just to reach a verdict.”

He told them if they wondered why certain evidence wasn’t presented at trial to disregard it, because “you got what you got.” He said he would not read back witness testimony and they must rely on their memories and notes to deliberate the facts. He discouraged them from asking any additional questions of the court.

“You are the judges,” Goodwin concluded. “This is a serious matter, and you should take it seriously.”

Closing Arguments

Attorneys for both sides presented dramatic closing arguments Tuesday. The plaintiff’s team spent about an hour summarizing its case, while the defense took about 50 minutes.

Henry Garrard, lead attorney for the plaintiff, began by stressing that when it comes to medical products and care, “trust is a sacred and powerful thing.” He told jurors it’s critical that, “someone, somehow enforces those safety principles … you can feel fair and justified in holding (Bard) accountable.”

Garrard highlighted some of the evidence in the case that supported his clients’ claims, but spent most of his time making an emotional appeal to jurors. He spoke at length about a company’s responsibility for the products it manufactures and markets, and focused on the lack of clinical trials in humans before the launch of the Avaulta Plus and Avaulta Solo devices.

“(They) steamrolled through safety principles,” Garrard said. “Corporations must carefully and safely resolve warning signs that their products may be dangerous. … You need something that tells you (this product) is going to work in a human body.”

During his argument, he used a series of plastic red flags to illustrate each of the opportunities he said Bard had to realize the Avaulta products had safety issues, yet refused to do anything about.

He pointed to witness statements, including communications from doctors concerned about the product, the Material Safety Data Sheet on the polypropylene used to manufacture it, a company-acknowledged lack of data on contraction (or shrinkage) of Avaulta after implantation, and pore size that some said is too small for it to be safe and effective.

“Over and over, Bard memos are saying you’ve got to have (large) enough pore size,” he said. “Yet Ms. Bigby said pore size doesn’t matter. Now that defies logic.”

‘We Have a Few Rats, a Few Rabbits, Some Sheep’

Garrard repeatedly reminded the jury that the only studies Bard conducted on Avaulta products were done on rats, rabbits and sheep, and that even though the lead investigator of one of those studies said the goal was to determine how the products would react in humans, they did not achieve that goal.

“Bard says, ‘We have (studies on) a few rats, a few rabbits, some sheep,’” Garrard said. “They tried to distance themselves from the animal studies. … Those sheep are akin to the wool Bard’s been trying to pull over your eyes in this courtroom.”

In the most dramatic moment of his closing argument, he highlighted testimony by an expert witness for the defense who said that the implantation process involved the uncoated mesh arms of the product “sawing at tissue” in patients. He then showed a graphic video of an actual implantation procedure where the arms were being pulled back and forth in a sawing motion through the vagina, pausing the video for several seconds in front of the jury.

He finished his closing argument talking about plaintiff Donna Cisson.

“Bard said in their opening statement, ‘She’s not hurt; she’s fine now; it all has to do with her back,’” Garrard said. “She’s got 22 inches of this (mesh) left inside her that’s not coming out … but she sucks it up; she takes it; she doesn’t complain. But she’s got to live with it until the day she takes her last breath.”

Donna Cisson held her husband’s hand and wiped tears from her eyes as Garrard concluded his argument.

“The product should have never, ever been out there,” he said. “Bard had bad ideas that led to permanent harm. … Fair justice, that’s all we ask.”

‘They Have to Prove It’

In stark contrast to Garrard’s closing argument, lead defense attorney Lori Cohen presented a point-by-point deconstruction of Garrard’s arguments. She highlighted testimony and evidence in the case supporting Bard’s position, and simultaneously attempted to school the jury in the their duty under the law.

Cohen called Laura Bigby, Bard’s director of research and development, “an incredibly conscientious, detailed, thoughtful leader.” She said the trial was the story of a much-needed medical device that helped thousands of women, and that, for the 100-year-old company, “nothing is more important than patient safety.”

“This was about innovation,” she said. “Doctors said, ‘Help us help our patients.’”

Citing the plaintiff’s burden of proof, she accused the plaintiff’s attorneys of not presenting a valid legal case, and pointed out several technical areas of testimony where the plaintiffs did not present evidence to refute her claims.

“If you throw enough mud against the wall, some of it may stick,” she said. “I could have said nothing this entire trial. … They have to prove it.”

‘Bard Extensively Tested the Avaulta Plus’

Although much testimony was presented to the contrary, Cohen asserted that not having sheaths on Avaulta’s arms was a “non-issue,” and that the pre-market, animal-only clinical trials were sufficient.

“Physicians did not want sheaths on Avaulta,” she said. “Bard extensively tested the Avaulta Plus.”

Cohen repeated “the data does not lie” over and over. The phrase was a quote from an expert witness for the defense earlier in the trial. She also addressed Cisson’s complaints, arguing they were all related to spine abnormalities.

“Ms. Cisson should be relieved,” Cohen said, suggesting treatment for her spine would relieve her pain.

Cohen repeated testimony that Cisson was still being helped by the Avaulta device because the remnants left in her body were still providing support. She also challenged the plaintiff’s argument that Bard should not have made a permanently implantable medical device without knowing how to take it out.

In the most dramatic moment of her closing argument, Cohen said it’s not Bard’s responsibility to know how to remove the device from a woman’s body once it’s implanted.

“Bard does not put it in,” she said. “That’s up to the physician, to know how to take it out.”

Cohen also spent some of her time criticizing attorneys for the plaintiff.

“I never cut (the witnesses) off,” she said. “I never told them to stop talking. … I’m proud of the fact that we gave you everything … full transparency.”

She did not tell the jury that more than 4,000 similar lawsuits are waiting to be tried in the very courtroom in which they sat, or that Bard voluntarily withdrew Avaulta from the market last year rather than conduct additional clinical trials required by the Food and Drug Administration (FDA).

Neither did attorneys for the plaintiff. Goodwin excluded that information from the trial before it started, stating it could be prejudicial to the jury.

‘Facts are Stubborn Things’

Attorney Paul Ferrell, Jr. presented the plaintiff’s rebuttal argument, the final words to the jurors from an attorney in the trial. Ferrell said the defense utilized a strategy of, “deny, deny, then counter-accuse.”

“They deny Avaulta plus was unsafe; they deny Instructions For Use were inadequate,” he said. “Then they counter-accuse (the doctor) of inserting it wrong.”

He said it was clear Cisson had experienced erosion with her device, but Bard denied that too.

“To say otherwise is to speak an untruth,” Ferrell said. “Facts are stubborn things.”

He said Bard made bad choices by having a plan to implant the devices, but no plan to remove them, and that sometimes deeds speak louder than words. He reminded jurors that the doctor who implanted the mesh device in Cisson testified on the stand he was angry the company had not shared full details of the product’s history with him.

“Donna Cisson trusted her doctor, who trusted Bard,” Ferrell said. “Donna Cisson is not a hypothesis; she is a reality.”

Doug Allen is a freelance reporter based in Aspen, Colo. His work has appeared in local and national print and radio outlets, including The Washington Post and Aspen Public Radio.

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