The Pennsylvania Superior Court has upheld a $12.8 Million verdict awarded to a woman who suffered painful complications following implantation of a transvaginal mesh device manufactured by Johnson & Johnson’s Ethicon, Inc. subsidiary.
Yesterday’s decision marks the first time the appellate court has considered the U.S. Supreme Court’s recent ruling in Bristol-Myers Squibb v. Superior Court of California, which held that plaintiffs must file product liability lawsuits in jurisdictions where their injuries occurred or where defendants are headquartered.
Plaintiff Patricia Hammons was implanted with Ethicon’s Prolift Kit transvaginal mesh system in 2009. She has since undergone three surgical attempts to remove the mesh due to chronic pain and other complications. A jury in the Philadelphia Court of Common Pleas ruled in her favor over two years ago, after finding that the Prolift Kit was defectively designed and responsible for her suffering.
Hammons is a resident of Indiana. In appealing the verdict, Johnson & Johnson and Ethicon asserted, among other things, that Pennsylvania was an inappropriate jurisdiction for her lawsuit in light of the Bristol-Myers Squibb decision.
However, the Superior Court rejected that argument, noting in its 82-page opinion that Ethicon has “considerably stronger” ties to Pennsylvania in comparison to Bristol-Myer’s connections with California.
“Ethicon supervised the design and manufacturing process of pelvic mesh in Pennsylvania in collaboration with Secant Medical, Inc., a Bucks County company,” the opinion states. “Ethicon also worked closely with an Allentown, Pennsylvania physician, Vincent Lucente, M.D., in developing Prolift. Both of these factors support the exercise of specific jurisdiction over Ethicon in Pennsylvania.”
Since 2008, the U.S. Food & Drug Administration (FDA) has issued several public health alerts regarding serious complications associated with the use of transvaginal mesh implants to treat women suffering from pelvic organ prolapse and stress urinary incontinence. Three years after issuing its first such communication, the agency declared that complications following transvaginal mesh surgery to repair pelvic organ prolapse were not a rare occurrence, a complete reversal of its earlier position.
Most recently, the FDA reclassified transvaginal mesh indicated for pelvic organ prolapse surgery as high-risk medical devices. Among other things, the reclassification prevents such implants from obtaining regulatory clearance through the agency’s 510(k) program, which does not require a new medical product to undergo human clinical trials before coming to market if a manufacturer can show that it is “substantially equivalent” to a previously-approved device.
Since 2008, more than 100,000 plaintiffs have filed transvaginal mesh lawsuits in courts throughout the United States in a bid to obtain compensation for life-changing injuries and complications they claim were the result of defectively designed devices.
A mass tort program underway in the Philadelphia Common Pleas has already tried a half-dozen cases involving Ethicon’s pelvic mesh implants. The most recent concluded last fall, when a Philadelphia jury awarded $57 million in punitive and compensatory damages to a woman who said she had endured chronic pain since receiving TVT-O mesh in 2007.
Damages awarded to other Pennsylvania transvaginal mesh plaintiffs have ranged from $2.16 million to $20 million.