Patterns Emerge After First Federal Vaginal Mesh Trial


After a second attempt, a couple who sued Bard over Avaulta transvaginal mesh injuries finally had their day in court, resulting in a $2 million verdict. Cisson v. Bard went to trial early last month, but ended in a mistrial. The jury took 12 hours to reach a unanimous decision after a two-week trial.

Bard currently faces of thousands of mesh injury cases. The Cisson case was the first to go to trial in federal court and was watched closely to gauge what’s to come in future cases.

Another Victory Against Avaulta

Although the Cisson verdict is the first to be reached in federal multidistrict litigation (MDL) assigned to the U.S. District Court for the Southern District of West Virginia, it’s not the first Avaulta mesh verdict in the United States. In 2012, a California jury awarded $5.5 million in a case filed by Christine Scott and her husband.

That award included $5 million for Mrs. Scott’s medical expenses, pain and suffering, and other damages, as well as $500,000 for her husband’s loss of consortium claim. The jury found both the manufacturer and the plaintiff’s doctor at fault, with Bard responsible for $3.6 million of the verdict. Plaintiffs’ lawyers had asked for $11 million in damages.

According to a report by Bloomberg, the Scotts’ attorney said that the California jury “seemed to focus on evidence we produced showing that Bard didn’t properly test the product before putting it on the market.” According to the verdict sheet, the jury determined that Bard knew or should have known that surgeons conducting pelvic floor repair “would not realize the potential risks” of the implant. But Bard didn’t warn them.

Concerns about Bard’s testing and failure to warn about risks also persuaded the Cisson jury to deliver another blow to the manufacturer.

Emerging Pattern of Juror Discontent Over Failure to Test and Warn

Before deliberating, jurors were instructed to determine the facts based on the evidence presented and to apply those facts to the law as the judge gave it.

During the course of the trial, both sides presented evidence regarding the factual allegations in the case.
Plaintiffs in the Avaulta mesh lawsuits allege that Bard:

  • Knew of the risks associated with the product, but failed to inform doctors;
  • Did not perform  clinical tests or studies to identify Avaulta mesh risks;
  • Did not study how to remove the mesh product;
  • Marketed and sold the mesh despite knowing it was made of a plastic material that wasn’t designed to be permanently implanted  in humans; and
  • Did not tell medical professionals that Avaulta transvaginal mesh was not appropriate for human use.

The Cissons, in particular, alleged that the implant caused bleeding, pain, bladder spasms and painful sexual intercourse and also required several surgeries to remove the mesh. In addition to hearing the plaintiffs’ testimony about how Avaulta mesh disrupted their lives, the jury also heard extensive testimony and saw other evidence from both sides about how mesh implants are designed to work in the body and about Bard’s testing and marketing efforts.

Bard’s trial strategy was to persuade the jury that it “complied with industry standards.” But plaintiffs pointed to evidence, including internal Bard memos and a seven-hour videotaped deposition by a former executive in the division that developed and marketed Avaulta mesh products. The evidence suggested the manufacturer ignored safety concerns and did not properly test its Avaulta line in humans. Based on the verdict, it also provided an effective foil to Bard’s strategy.

The jury awarded $250,000 in compensatory damages because it found that Avaulta’s design was defective and that Bard failed in its duty to warn. The amount includes physical and mental pain and suffering, as well as future suffering. The jury did not award damages for the loss of consortium claim. But notably, Mr. Cisson testified during trial he was more interested in his wife’s suffering and did not want compensation.

The jury was previously instructed that, in order to find Bard liable for defective design, it had to determine that the manufacturer didn’t exercise “reasonable care” in designing the implant. Under the law, making such determinations involves balancing the “inherent risk of harm” of a product against the “utility and benefits” of its design. On this issue, the jury likely felt that Bard could have done more to avoid the danger like test and study its use in humans and or consider an alternate design  (e.g., extending porcine coating to the ends of the mesh).

The jury was also instructed that although Bard had no duty to warn Mrs. Cisson directly, it did have a duty to warn her doctor. The underlying theory is that doctors are “learned intermediaries” and need adequate information to weigh their patients’ needs against any medical risks. According to the jury instructions, Bard had a duty to provide Mrs. Cisson’s doctor with “an adequate warning of the product’s potential dangers” and to “adequately communicate” that warning. The jury found that Bard failed in this duty and caused Ms. Cisson’s injuries.  In this case, Mrs. Cisson’s doctor would not have prescribed an Avaulta implant if Bard had provided an adequate warning.

After returning the compensatory damages award, the parties had another opportunity to address the jury on the issue of punitive damages. The jury apparently heeded advice from the MDL’s lead plaintiffs’ counsel, Henry Garrard, to “get the attention” of Bard executives.  It ordered Bard to pay $1.75 million in punitive damages. The judge had previously instructed the jury that it could award punitive damages if it determined that “Bard’s actions showed willful misconduct, malice, fraud, wantonness, oppression, or that entire want of care that would raise the presumption of conscious indifference to consequences.”

During the punitive damages phase, Garrard also pointed out Bard’s failure to accept responsibility. Bard continues to take this stance. Bloomberg reports that the company continues to deny responsibility for Mrs. Cisson’s injuries. And according to American Lawyer Litigation Daily, Bard vice president Scott Lowry says that the company “will appeal, and continue to vigorously defend against all other lawsuits regarding this product.”

Bellwether Trials Continue

Co-lead plaintiff’s counsel Fred Thompson III is “cautiously optimistic” about future cases. According to American Lawyer Litigation Daily, Thompson sees a pattern in the two multimillion-dollar state cases and now the first MDL case. He says that juries seem to recognize that “these are important cases and that the liability and causation are there.”

Meanwhile, bellwether trials continue in the MDL. The next trial — Queen v. Bard — is scheduled to begin today. Each trial is unique, and the outcome will depend on the individual circumstances of the cases, such as the specific economic losses each plaintiff suffered. But since the allegations are similar, they will likely include the internal memos, corporate testimony and other evidence that proved persuasive during the Cisson trial.

More trial victories could encourage settlements among the thousands of pending cases. Still, it’s unlikely that Bard will admit liability even if it eventually settles most of the cases.

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