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Due to the FDA approval process, dozens of mesh devices were cleared for sale because of their similarity to one initial model, Boston Scientific Corporation’s ProteGen, which was voluntarily recalled by its manufacturer after just two years on the market. (Boston Scientific is a defendant in approximately 12,000 of the suits.) While the FDA has expressed concern over the safety of the implants, they remain available.
Mesh Manufacturers Face Allegations
The lawsuits accuse mesh manufacturers of failing to properly test their products for human use and of ignoring research and warnings that suggested they were unsafe. For example, attorneys claim that medical giant Bard secretly ignored warnings from one of its suppliers not to use a certain type of plastic in humans. Plaintiffs in the cases have experienced painful, debilitating side effects that often required multiple revision surgeries. In many cases the side effects are irreversible.
Additionally, Johnson & Johnson may be penalized by the court for improperly losing or destroying documents relevant to the lawsuits, a fact that came to light in December 2013.
Compensation for Transvaginal Mesh Plaintiffs
Plaintiffs in transvaginal mesh lawsuits may be eligible for compensation for medical expenses, lost earnings (past and future), pain and suffering, loss of consortium (loss or degradation of family relationships, e.g. spousal relationships), and emotional distress, as well as punitive damages.
Juries have ruled in favor of the plaintiffs in several cases, and many experts agree that manufacturer liability is relatively clear.
A California woman, Christine Scott, was awarded $3.6 million by a jury in 2012. Scott underwent nine revision surgeries in an attempt to correct damage caused by her Avaulta Plus Biosynthetic Support System, manufactured by Bard. The mesh broke apart and became inextricably intertwined with Scott’s pelvic organs, causing incontinence and severe pain, and preventing Scott from having sexual intercourse with her husband. Scott’s pain was so debilitating she requires painkilling shots just to sit down. Her ordeal led her to contemplate suicide.
In February 2013, a New Jersey jury awarded $11.1 million, including $7.8 million in punitive damages, to Linda Gross, a nurse who underwent 18 unsuccessful revision surgeries after being implanted with Johnson & Johnson’s Prolift system.
Mesh Manufacturers Negotiate Settlements
As of October 2013, five of the six major manufacturers of transvaginal mesh implants are in negotiation to settle more than 30,000 pending lawsuits. The involved manufacturers include Coloplast A/S, Cook Medical Inc., Bard, Endo Health Solutions’ American Medical Systems division, and Boston Scientific Corp. The only major manufacturer not involved in the potential settlement is Johnson & Johnson.
The settlements could eventually draw in as many as 50,000 plaintiffs, and could result in a multibillion dollar payout. Approximately 12,000 cases involving Johnson & Johnson would not be affected.
- Feeley, J. and Voreacos, D. (2013, September 30). Bard, vaginal-mesh makers, said to be in settlement talks. Bloomberg News. Retrieved December 12, 2013.
- Feeley, J. (2013, August 21). Bard settles vaginal-mesh case after $2 million verdict. Bloomberg News. Retrieved December 12, 2013.
- Feeley, J. (2013, August 13). Bard put profits ahead of patients’ safety, lawyer says. Bloomberg News. Retrieved December 12, 2013.
- Feeley, J. (2013, December 4). J&J lost or destroyed vaginal-mesh files, lawyers contend. Bloomberg News. Retrieved December 12, 2013.
- Voreacos, D. and Nussbaum, A. (2012, March 21). J&J marketed vaginal mesh implant without U.S. approval. Bloomberg News. Retrieved December 12, 2013.
- Edelhart, C. (2012, July 23). Bakersfield woman wins $3.6 million in first of trials related to medical device. The Bakersfield Californian. Retrieved December 12, 2013.
- Johnson, L. (2013, February 28). Jury adds $7.8 million in J&J punitive damages. Boston Globe.
- Thomas, K. (2012, June 6). Johnson & Johnson unit to halt urinary implants. The New York Times. Retrieved December 12, 2013.
- Meier, B. (2012, January 5). F.D.A. orders surgical mesh makers to study risks. The New York Times. Retrieved December 12, 2013.
- Zimmerman, R. (2011, November 4). Surgery under scrutiny: What went wrong with vaginal mesh. WBUR. Retrieved December 12, 2013.