BOSTON SCIENTIFIC LOSES ITS FIRST FEDERAL TRIAL AND IS ORDERED BY A FLORIDA JURY TO PAY FOUR VICTIMS OF ITS VAGINAL MESH PRODUCTS A TOTAL OF $26.7 MILLION

Boston Scientific Loses First Federal Trial Over Mesh

Jurors in federal court in Miami deliberated about four hours yesterday before finding Boston Scientific officials defectively designed their Pinnacle pelvic-organ implants and failed to properly warn doctors and their patients about the device’s risks, Joseph Osborne, a lawyer for one of the women, said in an interview.

The verdict is the first in a federal case against Boston Scientific over the Pinnacle inserts and the first to combine more than one plaintiff’s claims.

“Boston Scientific better start giving serious consideration to doing a global settlement of these vaginal mesh cases,” Carl Tobias, who teaches product-liability law at the University of Richmondin Virginia, said in a phone interview. “This verdict reinforces the substantial liability they are facing and it’s growing with each verdict.”

Four Awards

Jurors awarded Amal Eghnayem, Osborne’s client, more than $6.7 million. The panel also awarded Margarita Dotres and Mania Nunez, two other women who got Pinnacle implants, more than $6.7 million each. Juana Betancourt, the final woman in the group, was awarded more than $6.5 million, Osborne said. The panel awarded only compensatory damages, he added.Female-Patient-Doctor

Kelly Leadem, a Boston Scientific spokeswoman, said the company disagreed with the jury’s findings that the Pinnacle inserts suffered from design flaws and that company officials didn’t warn about the implants’ risks.

“We believe we have strong grounds to overturn the verdict on post-trial motions and on appeal,” she said in an e-mailed statement.

“The evidence we presented showed that the company completely mishandled this product, and I think the jury’s damage award reflects that,” Osborne said.

The women’s lawyers argued yesterday that Boston Scientific officials ignored internal calls for more testing of the pelvic-organ implant and hurried the device along to counter competitors’ products.

In September, a state court jury in Texas ordered Boston Scientific to pay $73 million in damages to a woman who blamed one of its incontinence implants for her constant pain. That verdict was cut to $34.6 million by the trial judge. The company has won other cases that have gone to trial in state court in Massachusetts.

23,000 Suits

The Natick, Massachusetts-based company, the second-largest maker of heart-rhythm devices, faces more than 23,000 suits over its vaginal implants in U.S. state and federal courts, as well as in Canadian and U.K. courts, according to filings with the U.S. Securities and Exchange Commission. Boston Scientific pulled Pinnacle from the U.S. market in 2011.

Many of the cases against Boston Scientific have been consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia. Others have been filed in state courts in Delaware,New Jersey, Missouri, Texas and California.

Goodwin, who’s overseeing all the vaginal-mesh suits filed in federal courts against Boston Scientific, presided over the trial of the four women’s claims.

Substandard Materials

Women contend the inserts are made of substandard materials and often erode once they are implanted, causing pain and organ damage, and making sex uncomfortable.

The women’s lawyers presented evidence showing the mesh used in the Pinnacle insert hadn’t been approved for use within the human body by the company that made it.

Boston Scientific’s lawyer told jurors in the Miami case the mesh used in the inserts has been relied upon for years by doctors and engineers properly designed the devices.

“There’s no such thing as a risk-free surgery,” Hildy Sastre, one of the company’s lawyers, told jurors. “Because somebody develops a complication, which they’ve been clearly warned of, that doesn’t mean there’s a defect with the product.”

Boston Scientific is expected to face closing arguments Nov. 17 in another multi-plaintiff trial in federal court in West Virginia.

The Florida case is Eghnayem v. Boston Scientific Corp., 14-cv-24061, U.S. District Court, Southern District of Florida (Miami).

To contact the reporter on this story: Jef Feeley in Wilmington, Delaware at jfeeley@bloomberg.net

To contact the editors responsible for this story: Michael Hytha at mhytha@bloomberg.net Andrew Dunn, Peter Blumberg

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Bard Settles Second Bellweather Vaginal Mesh Case

Bard settles second bellwether mesh case after plaintiff verdict in first trial

Female-Patient-Doctor

By Courtney L. Davenport

Following a plaintiff verdict in the first transvaginal mesh bellwether trial in a federal MDL against C.R. Bard, Inc., the device maker settled the second bellwether case shortly after jury selection. About 4,400 suits are pending in that MDL, and about 25,400 federal suits are pending in MDLs against other mesh manufacturers. (In re C.R. Bard, Inc., Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187 (S.D. W. Va. Aug. 23, 2013).)

Last month, a jury awarded Donna Cisson and her husband $2 million, including $1.75 million in punitive damages, against Bard after transvaginal mesh implanted to treat pelvic organ prolapse (POP) eroded, causing bleeding, pain during intercourse, and bladder spasms and requiring additional surgeries. The Cissons alleged Bard defectively designed the mesh and failed to warn doctors when it learned of the risks.

Less than two weeks later, Bard settled with Wanda Queen and her husband for an undisclosed amount. Queen’s specific injuries were not disclosed in the complaint, but attorneys said that despite six corrective surgeries, her injuries are permanent.

Harry Bell of Charleston, W. Va., coliaison counsel in the MDLs, said the Cisson verdict may have prompted Bard to settle with the Queens because Queen’s case was even more egregious. But he does not know what impact the positive resolutions will have on the two remaining bellwether suits or the other MDL plaintiffs.

“From the perspective of the manufacturer, how’s it going to look to the public to have two adverse verdicts back to back and with the verdict amounts increasing? They made the decision they couldn’t take that risk,” he said. “Whether Bard makes the decision to settle [the others], one never knows. Bard has to be considering settlement considering the cases it is losing.”

Transvaginal mesh is surgically implanted in the vagina or abdomen to treat POP—in which the bladder, bowel, or other pelvic organs protrude into the vagina—and stress urinary incontinence. But shortly after it became popular in the late 2000s—in 2010 alone, mesh was implanted in 300,000 women—the FDA started receiving reports of serious injury when the mesh eroded, scraping tissue and protruding into the vagina or other organs, causing chronic pain, incontinence, infection, pain during intercourse, and other problems. Sufferers often require multiple surgeries to remove all of it. In 2011, the FDA warned that serious complications are “not rare” and advised that transvaginal mesh should not be used to treat POP, because it had not proved to be more effective than safer alternatives.

Thousands of mesh recipients and their families sued Bard; Johnson & Johnson subsidiary Ethicon, Inc.; American Medical Systems, Inc.; Boston Scientific Corp.; Coloplast Corp.; and Cook Medical, Inc. The suits allege the manufacturers did not test the defectively designed mesh before putting it on the market, nor did they properly train physicians. Federal MDLs were established against each defendant. State lawsuits are also pending against many of them, and at least two plaintiffs have obtained jury verdicts.

In July 2012, a California state court jury awarded Christine Scott—who suffers fecal incontinence and chronic pain and cannot have sexual relations after mesh eroded into her colon and vagina—and her husband $3.61 million against Bard. (Scott v. C.R. Bard, Inc., No. S-1500-CV-266034 (Cal., Kern Co. Super. July 24, 2012).) Earlier this year, a New Jersey court jury awarded Linda Gross and her husband $11.11 million against Ethicon. Gross underwent 18 surgeries to remove eroded mesh and permanently suffers such severe pain in her legs and pelvis that she cannot sit comfortably, be active for more than a few minutes, or have sexual intercourse. (Gross v. Ethicon, Inc., No. Atla-L-6966-10 (N.J., Atlantic Co. Super. Feb. 25, 2013).)

Bard asked that the court stay the other bellwether trials or certify an interlocutory appeal of an order in Cisson that excluded evidence of the FDA 510(k) device-approval process and the FDA’s decision not to recall Bard’s mesh devices. The judge has denied the request, holding that “I remain unconvinced that Bard is likely to succeed on the merits of any appeal related to the 510(k) issue” and that Bard will not be irreparably injured by waiting for the outcome of the remaining bellwether trials, the first of which is set to begin Oct. 8.