Thursday, November 20, 2014
C.A. Upholds Judgment in State’s First Vaginal Mesh Suit
Panel Says Evidence Supported Finding of Liability for Faulty Design
By KENNETH OFGANG, Staff Writer
A judgment for more than $3 million in favor of a woman who claims her life was ruined because of the faulty design of a vaginal mesh product was affirmed yesterday by the Fifth District Court of Appeal.
Ruling in what was reportedly the first vaginal mesh suit filed in any state court—there are a number of federal cases pending—the court said there was substantial evidence that C.R. Bard, Inc. failed to take reasonable care in designing Avaulta Plus, which it marketed between 2007 and 2012.
Because the jury did not specify which of the plaintiff’s theories it relied on, Justice Herbert Levy explained, the sufficiency of the evidence of negligent design made it unnecessary to rule on whether the manufacturer was also negligent in failing to train doctors regarding use of the product or in understating the dangers. The trial judge had previously thrown out claims of fraud and strict liability.
The jury found Bard’s negligence 60 percent responsible for Christine Scott’s injuries and her surgeon—who was not sued—40 percent responsible. It assessed damages of $5 million in favor of Scott and $500,000 on her husband’s loss-of-consortium claim, which were reduced by 40 percent to account for the surgeon’s degree of fault.
In 2009, Scott sued Bard over the device, which had been implanted the previous year to treat pelvic organ prolapse and urinary incontinence. She and her doctors testified that she subsequently needed more surgeries and experiences daily pain, mesh erosion in the vagina and rectum, fecal incontinence, nerve damage and depression, among other complications
Bard took Avaulta Plus off the market in 2012, after the FDA asked it and other manufacturers to conduct additional trials. Bard insisted that the product was safe, but said it no longer needed to produce it because better products had become available.
A former runner, Scott says her fitness, her health and her marital relations were ruined by the product, and started a website called Mesh Gone Wrong. Attorneys for Bard have expressed sympathy for her plight, but claim her injuries are not related to the product.
Justice Herb Levy, writing yesterday for the Court of Appeal, said that while medical device manufacturers are not subject to strict products liability, they can be held liable for negligence.
In concluding that the Scotts presented sufficient evidence of negligent design, Levy cited expert testimony that Avaulta Plus is more dangerous than other vaginal mesh products.
Dr. Donald Ostergard, an expert in urogynocology, testified that features unique to Avaulta Plus caused Scott to suffer an infection, which led to mesh erosion, which led to Scott’s loss of control of the anal sphincter.
“From this evidence, the jury could decide whether Bard acted as a reasonably careful medical device manufacturer when it designed Avaulta Plus,” the justice said.
In an unpublished portion of the opinion, Levy said Bard failed to show it was prejudiced by comments about the actions of other manufacturers or about other cases. Kern Superior Court Judge William D. Palmer gave adequate cautionary instructions, and it is presumed that jurors followed them, the justice said.
The case is Scott v. C.R. Bard, Inc., 14 S.O.S. 5195.
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