The results of preliminary lawsuits against transvaginal mesh manufacturers seems to indicate that the legal tide is turning in favor of women who claim that the devices cause injuries such as pain, bleeding and infection.
Seven mesh device makers, including Boston Scientific, Johnson & Johnson, C.R. Bard and Endo International, are facing thousands of lawsuits over their products, which are used to treat organ prolapse and urinary incontinence in women. In 2010 alone, more than 70,000 mesh devices were implanted in U.S. women.
Boston Scientific—facing more than 24,000 lawsuits (including 14,000 federal lawsuits) over its mesh products such as the Pinnacle and Obtryx—has lost a string of lawsuits since September and been ordered pay a total of nearly $80 million to injured female plaintiffs. The Pinnacle was recalled in 2011 because, according to the FDA, “The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.”
In September, a Texas state court jury ordered Boston Scientific to pay $73 million to a woman who said she suffered nerve damage and constant pain from her Obtryx device. A judge later reduced the award to $34.6 million, although it remains the largest to date. The lawsuit claimed that Boston Scientific designed and marketed a product that it knew was defective.
November saw Boston Scientific dealt two more courtroom defeats. On November 13th, the company was ordered by a federal jury in Miami to pay four plaintiffs compensatory damages totaling $26.7 million, or around $6.5-$6.7 per plaintiff, for injuries suffered from Pinnacle devices. Exactly one week later, a West Virginia jury awarded $18.5 million to four women who'd received Obtryx implants.
About 70,000 federal lawsuits against vaginal mesh manufacturers are pending in the Southern District of West Virginia as part of a multidistrict litigation (MDL). As of November, according to the Judicial Panel on Multidistrict Litigation (JPML), the following seven companies have cases pending against them:
• C.R. Bard, Inc.: 9,884
• American Medical Systems: 18,903
• Boston Scientific: 14,272
• Ethicon, Inc.: 21,774
• Coloplast Corp.: 1,721
• Cook Medical: 259
• Neomedic: 72
MDLs allow numerous civil lawsuits involving one or more common questions of fact to be consolidated for pretrial proceedings. Typically, a few initial MDL cases, known as “bellwether” trials, are tried in order to gauge the value of claims. The West Virginia trial that resulted in a plaintiffs' verdict was one such bellwether, and thus augers well for other women who claim that pelvic mesh makers are responsible for their injuries. Additional multi-million dollar plaintiff verdicts could force Boston Scientific and other manufacturers to reach settlement in the cases pending against them.
Common among the MDL cases are claims that the vaginal mesh inserts contain design flaws and that mesh manufacturers failed to adequately test their devices.
Boston Scientific, Ethicon, and C.R. Bard have all been hit with multi-million dollar mesh suit verdicts. Boston Scientific allegedly has $945 million set aside to handle lawsuit settlement costs, while Endo International announced recently it had reserved $1.6 billion to settle without trial transvaginal mesh cases.
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