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A jury in state court in Massachusetts rejected a plaintiff's claims that Boston Scientific's Pinnacle vaginal-mesh implant caused her injuries, in the first of more than 12 000 lawsuits to go to trial contending that the device eroded, causing organ damage and pain. Jurors found that Boston Scientific properly designed the Pinnacle mesh and adequately warned the plaintiff about the implant's risks.
Earlier this month, Boston Scientific announced that second-quarter net income dropped 97 percent to $4 million, partly due to $267 million in litigation-related charges linked to its transvaginal surgical mesh product. Company spokeswoman Denise Kaigler said "we are pleased with the outcome" of the case, adding "patient safety is of utmost importance to Boston Scientific and we dedicate significant resources to deliver safe, high-quality products." The plaintiff's lawyer indicated that the next vaginal-mesh trial in Massachusetts is set for August 11, while the first of the federal cases is scheduled for November 3.
According to people familiar with the matter, Boston Scientific and other producers of vaginal inserts including Johnson & Johnson and C.R. Bard had talks earlier this year about settling suits over the products. Many of these cases have been consolidated before US District Judge Joseph Goodwin in Charleston, West Virginia, for pretrial information exchanges, while other suits have been filed in state courts in Delaware, New Jersey, Massachusetts, Missouri and California.
In July 2012, a jury in California ruled that C.R. Bard must pay $5.5 million in damages over claims that the company's Avaulta Plus vaginal implant caused incontinence and chronic pain, in the first lawsuit over the device to go to trial. Meanwhile, a jury in New Jersey last year decided that Johnson & Johnson must pay $7.76 million in punitive damages in addition to compensation of $3.35 million to a woman who claimed she suffered injuries from the company's Gynecare Prolift vaginal mesh implant. Earlier this year, a US district judge threw out a lawsuit claiming that Johnson & Johnson's TVT Retropubic sling was defectively designed, the first trial ruling related to the vaginal mesh implant.
The FDA recently issued two proposed orders that if finalised would reclassify surgical mesh for transvaginal pelvic organ prolapse from a moderate-risk to a high-risk device and require companies to submit a premarket approval application.
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