Boston Scientific faces first federal transvaginal mesh trials

Reuters News
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Posted: Nov 03, 2014 1:03 AM

By Jessica Dye

(Reuters) - Boston Scientific Corp on Monday was set to face its first federal trials in two courts over claims from women who say they were injured by the company’s transvaginal mesh devices.

One, in Charleston, West Virginia, involves allegations from four women over the company's Obtryx device, used to treat stress urinary incontinence. The other, in Miami, concerns women implanted with the Pinnacle, which treats pelvic organ prolapse.

Boston Scientific has been hit with more than 23,000 suits in U.S. state and federal courts over the devices in the six years since concerns were first publicly raised over the devices. Federal cases against it and six other companies have been consolidated before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.

Since then, transvaginal mesh has become one of the most sued-over medical devices in U.S. history. Goodwin has said he'll resort to creative tactics, like grouping similar plaintiffs for trial, to keep the cases from dragging on for decades, as litigation for other mass torts like asbestos and tobacco did.

It won't be easy. Together, the three biggest defendants - Boston Scientific, Johnson & Johnson's Ethicon Inc unit and C.R. Bard Inc - face more than 72,000 claims in federal and state courts, according to the companies' regulatory filings.

The U.S. Food and Drug Administration in April said it was considering requiring the makers of products used to treat pelvic organ prolapse to submit additional safety data to remain on the market.

Plaintiffs say the devices were poorly designed, made from substandard material and can lead to injuries ranging from infection and pain to bleeding and nerve damage.

Ethicon and Boston Scientific have both denied liability and said in statements to Reuters that they believe mesh is an important treatment option. C.R. Bard declined to comment.

The nine cases that have gone to trial so far, against Boston Scientific, Ethicon and C.R. Bard, have produced mixed results, with defendants winning some and plaintiffs others. One company, Endo International’s American Medical Systems, announced recently that it would set aside $1.6 billion to settle “substantially all” mesh claims.

The three trials faced by Boston Scientific in state courts have also led to varying outcomes. Two cases in Massachusetts resulted in wins for the company, while a third in Texas ended with a $73 million verdict for the plaintiff, which was later reduced to $34 million under a state law capping damages.

The group trials starting Monday are part of Goodwin's plan to speed up the cases' progress. He has also ordered Boston Scientific and C.R. Bard to each prepare hundreds of cases for trial in courts across the United States starting as early as next year.

While Goodwin originally scheduled a series of single-plaintiff bellwether, or test, trials for the federal litigation, he scrapped those plans earlier this year and instead consolidated claims from multiple women into a single trial. Doing so, he said, would help save courts' time and resources, and “may facilitate settlement” by giving Boston Scientific and plaintiffs a clearer picture of the strengths and weaknesses of their cases.

While not unprecedented, it is unusual for personal-injury cases involving medical devices to proceed with more than one plaintiff at a time, given that individuals may have different medical histories and product experiences.

Boston Scientific fought vigorously against the consolidated trial plan, saying in court filings that each woman’s issues would be obscured by the group setting and prejudice jurors against the company.

A company spokeswoman, Kelly Leadem, declined to comment specifically on the litigation but said in a statement that Boston Scientific is committed to patient safety.

Several plaintiffs’ lawyers for the women headed to trial Monday did not return requests for comment.

Fidelma Fitzpatrick, an attorney at Motley Rice who has represented plaintiffs in other mesh trials against Boston Scientific and Ethicon, said the outcome from the group trials could help Boston Scientific and plaintiffs move closer to a resolution.

“I think that Goodwin has been working hard to try to find an end game for this litigation,” Fitzpatrick said. “The reality is, one case at a time when you’re trying four or five cases a year against a manufacturer isn’t enough to truly put pressure on the defendants."

(Reporting by Jessica Dye; Editing by Alexia Garamfalvi and Douglas Royalty)