Article by: JOE CARLSON, Star Tribune
A jury hit Boston Scientific with $73.5 million in damages this week in one of thousands of suits the device maker faces over an implant intended to treat incontinence.
The verdict in a Dallas court is part of a tsunami of product-defect and failure-to-warn litigation the device industry faces over similar products. Boston Scientific, which had won two similar suits in Massachusetts, has 23,000 more pending against it.
The plaintiff in the Texas case, 42-year-old Martha Salazar, is the first to win an award against the company over alleged defects with its Obtryx sling. Salazar said she suffered nerve damage and persistent pain and infections from the vaginal implant.
“I think it’s a really big case,” said David Matthews, the Houston personal-injury lawyer who represented her in the two-week trial. “A woman’s life was turned upside down because of a device she was using for a minor issue of urinary incontinence.”
Boston Scientific, which has a substantial share of its workforce in the Twin Cities, said in an e-mailed statement that it was disappointed in Monday’s ruling and vowed to appeal.
The company argued at trial that doctors’ continued widespread use of the devices shows that they understand the benefits and risks.
“Devices like the Obtryx serve an important public medical need,” company attorneys wrote in legal filings.
“The prevalence of their usage in the medical community demonstrates that mesh slings are beneficial to patients.”
Seven companies are sued
A total of seven companies are facing lawsuits over alleged defects in vaginal mesh devices, including C.R. Bard and Johnson & Johnson’s Ethicon subsidiary, Reuters reported. Last April, a subsidiary of Dublin-based Endo International agreed t! o pay $8 30 million to settle about 20,000 defect lawsuits without admitting wrongdoing.
The devices are designed to treat incontinence and the shifting of organs from pelvic-floor prolapse, which can occur with age and after childbirth. Mesh slings are supposed to support weakened or damaged internal tissues, and may be removable or permanent.
Salazar accused Boston Scientific of negligence for designing and marketing the flawed Obtryx device even though it had a safer alternative design before January 2011, when her doctor implanted her device. The jury agreed, and awarded Salazar and her husband, Felix, $23.5 million in compensatory damages and an additional $50 million in punitive damages.
The jury verdict form said the Dallas jurors decided that the company’s actions amounted to gross negligence because executives knew of the risk from the product and sold it “with conscious indifference to the rights, safety or welfare of others.”
Company lawyers strongly dispute the strength of Salazar’s evidence at trial. They said she failed to show the device was “unreasonably dangerous” and never proved that the company failed to warn doctors of the risks inherent in the device.
“As conceded by Ms. Salazar’s treating surgeon, Dr. Lopez, the Obtryx is recognized by the medical community as the standard of care,” company lawyers wrote in court filings before the verdict, referring to stress urinary incontinence.
“Given this, no reasonable fact finder could find that Boston Scientific has acted with gross negligence.”
Salazar’s attorney Matthews said that although the company published a study warning of some risks in 2009, it did not tell doctors about the study or change warning labels for the device.
Although he represents several hundred other women with! active cases, Matthews noted that one jury verdict would not necessarily affect other cases.
But he said the volume of complaints from women with the devices should prompt changes at the company.
“They need to seriously reconsider whether the product needs to be on the market or not,” he said.
Joe Carlson • 612-673-4779