Boston Scientific Corp, which was on the losing end of a $73 million verdict in Sept., begins facing its first federal trials in two different courts this week. All claims are from women who believe they have been injured by Boston Scientific’s transvaginal mesh contraptions.
In Charleston, West Virginia, in an unusual arrangement, four women will have their cases heard simultaneously over Boston Scientific’s Obtryx mesh sling, which was installed in them to treat stress urinary incontinence. In Miami, in another unusual arrangement, a trial begins today for several women implanted with the Pinnacle mesh product which was used to treat pelvic organ prolapse.
Boston Scientific faces 23,000 Lawsuits
More than 23,000 women have filed suit against Boston Scientific in U.S. state and federal courts over the plastic contraptions implanted inside them to treat, typically, stress urinary incontinence or pelvic organ prolapse. Federal cases against Boston Scientific and six other mesh makers have been consolidated in the Southern District of West Virginia before U.S. District Judge Joseph Goodwin.
Transvaginal Mesh is thought to contain the largest numbers of litigants for a multi-district litigation court since since the advent of MDL courts in the 1960’s. According to Reuters, Goodwin has said he’ll resort to creative tactics to tackle the big numbers, “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.”
Goodwin has his work cut out for him. The three biggest defendants alone – Boston Scientific, Johnson & Johnson’s Ethicon Inc unit and C.R. Bard Inc – face more than 72,000 claims in state and federal courts, according to the mesh makers’ regulatory filings.
In April, the FDA 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. The transvaginal mesh products were approved on the streamlined 510(k) process, meaning the makers proposed to FDA that the plastic contraptions were substantially similar to predicate products on the market, and the FDA bought that line of reasoning.
Plaintiffs argue that the devices were poorly designed of substandard material, and, most importantly, that the mesh plastic causes nerve damage, bleeding, infection, permanent pain.
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.
Reuters reports that the nine cases that have gone to trial so far, against Boston Scientific, Ethicon and C.R. Bard, have produced mixed results. Plaintiffs have won more than they lost. One company, Endo International’s American Medical Systems, announced it would set aside $1.6 billion to settle “substantially all” of the mesh claims against AMS.
$73 Million Verdict against Boston Scientific
Boston Scientific won two of three against it, but in the trial BS lost, the jury awarded $73 million to a Texas woman, which included $50 million in punitive damages. The jury appeared swayed by testimony that BS had withheld from doctor targets data which showed the company’s mesh had more problems than advertised .
The group trials starting in W. Va. and Miami Nov. 3 are part of Judge Goodwin’s plan to expedite all cases in his charge. Reuters reports that Goodwin has also ordered Boston Scientific and C.R. Bard to prepare hundreds of cases for trial in courts across the United States starting as early as next year.
Goodman said that consolidating claims from multiple women into a single trial would help save the 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.
Goodman’s action is not unprecedented but it is unusual, because individuals in such cases can have vastly different medical histories and products.
Boston Scientific fought hard against the consolidated trial plan. In court filings, BS said that each woman’s issues would be obscured by the group setting and would prejudice jurors against the company.
BS Company spokeswoman Kelly Leadem declined to comment to Reuters specifically on the litigation, but she 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, which is not unusual, given that defense could take anything they say and make legal points, claiming plaintiffs had prejudiced the jury with whatever they may have said.
Houston attorney David Matthews, who represented the woman who won a $73 million verdict against Boston Scientific, said, “I think Judge Goodwin is doing the best he can to expedite the cases. I think he appreciates the importance of working expeditiously but not at the expense of justice. The sheer numbers do seem to call for some creative jurisprudence.”
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