Boston Scientific Pinnacle Mesh Trial Results in $26.7M Verdict for Four Women

A federal jury in Miami has found that Boston Scientific should pay a total of $26.7 million to four women who suffered debilitating and disfiguring injuries due to a complications with their Pinnacle vaginal mesh. 

The verdict is the first to come back following the start two consolidated Boston Scientific mesh trials that began earlier this month, with a separate case continuing in West Virginia involving four other women who experienced problems after receiving the Boston Scientific Obtryx mesh.

The Miami trial was a combined trial involving four Boston Scientific Pinnacle mesh lawsuits brought by Amal Eghnayem, Margarita Dotres, Mania Nunez, and Juana Betancourt.

During eight days of testimony, the plaintiffs presented evidence to the jury that suggested Boston Scientific employees expressed concerns about the safety of the Pinnacle mesh before it was released, calling for more testing to be completed. However, Boston Scientific allegedly ignored the concerns and promoted the product for use in women without warning about the risk that the mesh may erode through the vagina, cause infections or other severe complications.

The jury deliberated for only about four hours yesterday afternoon before determining both that the devices were defective and that the company failed to adequately warn about the potential vaginal mesh complication risks. Each of the women was awarded about $6.5 million in compensatory damages.

Vaginal Mesh Bellwether Cases and Settlements

The two consolidated Boston Scientific trials in Florida and West Virginia are part of a “bellwether” program in the federal court system, where more than 70,000 similar lawsuits are pending against various different manufacturers, also including C.R. Bard, Johnson & Johnson’s Ethicon division, American Medical Systems (AMS), Neomedic and Cook Medical.

In the federal court system, the claims have been consolidated before U.S. District Judge Joseph R. Goodwin as part of an MDL, or Multidistrict Litigation, which is centralized in the Southern District of West Virginia for coordinated discovery and pretrial proceedings. Judge Goodwin is overseeing claims filed against other manufacturers as well.

According to the latest case list (PDF) provided by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on October 15, there currently more than 14,000 Boston Scientific mesh lawsuits, 9,800 Bard Avaulta mesh cases, 21,600 Ethicon mesh lawsuits, 18,800 American Medical Systems (AMS) mesh lawsuits, 1,700 Coloplast mesh lawsuits, 259 Cook Medical mesh lawsuits and 67 Neomedic mesh lawsuits.

All of the complaints involving similar claims that women experienced severe and debilitating problems after receiving products used to repair pelvic organ prolapse or female stress urinary incontinence, alleging that the manufacturers failed to adequately research the design or warn women or the medical community.

The federal bellwether Boston Scientific trials started only a few weeks after a Texas state court jury awarded $73.4 million to one woman who experienced problems with the company’s Obtryx mesh, including $50 million in punitive damages that were designed to punish the manufacturer for their actions in the design, manufacture and sale of the product.

The Texas verdict was subsequently reduced to $34 million under Texas state caps on punitive damages, but likely still sent a strong message to Boston Scientific and other manufacturers of similar products.

These early trial dates were scheduled to help the parties gauge the relative strengths and weaknesses of these cases, and evaluate how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. While the outcomes are not binding on other cases, they may influence eventual vaginal mesh settlement agreements to resolve lawsuits without the need for thousands of individual trials to be scheduled throughout the country.

In October, Endo International announced that it has agreed to settle “substantially all” transvaginal mesh lawsuits against it’s American Medical Systems (AMS) subsidiary, reportedly agreeing to pay about $1.6 billion in settlements.

According to a recent report by the Boston Business Journal, Boston Scientific has set aside nearly $1 billion so far to cover costs associated with the transvaginal mesh litigation. However, there have been no reports involving the settlement of large numbers of cases by Boston Scientific.

Given the lack of progress made by Boston Scientific, Ethicon and C.R. Bard toward resolving the entire litigation, Judge Goodwin has indicated that he plans to speed up the pace of trials for vaginal mesh lawsuits, ordering that hundreds of individual cases be prepared for trial next year.