Jury awards $10 million in compensation and $25 million in punitive damages for negligent design of Prolift transvaginal mesh and failure to warn of danger.
Chicago, ILOn the advice of her doctor, Barbara Kaiser had Prolift pelvic mesh implanted in 2009 to treat her pelvic organ prolapse. She then began to suffer from low pelvic pain. It was only years later that she learned that this was likely a transvaginal mesh complication. Her doctor never told her about this and he, himself, claims to have not been aware of all of the risks, including the danger of severe and irreversible injury to his patients.
On March 8, the jury awarded Ms. Kaiser $35 million. That included a whopping $25 million penalty to J&J and its subsidiary, Ethicon, for a policy of deception that put profits before patient welfare.
Edward A. Wallace of Wallace Wexler doesn’t see an anomaly in the verdict. While acknowledging the likelihood of an appeal, he told LAS, “The punitive damages are rationally related to the compensatory damages, and they are supported by the evidence.”
Wallace further told LAS, “These verdicts that are now coming in on a consistent basis will finally inform Johnson & Johnson that they can’t simply release a medical device without supporting safety data and with no idea about how they will affect these women for the rest of their lives.”
Disastrous transvaginal mesh complications
Women who suffer from pelvic organ prolapse may choose surgery to treat serious symptoms that do not improve with more conservative treatment. One method of repairing the pelvic floor involves implantation of transvaginal mesh.
Sometimes the remedy can be worse than the problem. Frequently reported complications include infection, pain, urinary problems, vaginal scarring and recurrence of prolapse and/or incontinence. Another complication cited by the FDA is erosion, in which the mesh gradually dislodges from the vaginal wall where it was implanted and moves into the surrounding tissue and organs. Mesh removal involves complicated surgery, is often unsuccessful and may increase a woman’s risk of additional complications or symptoms.
Truth be told, the injury often doesn’t stop with the woman in pain. Families and communities may be affected by the powerful person who is ill and no longer comes downstairs. Bad medicine is a stone cast in the water that rocks family and community far from the center.
Why such secrecy?
Anecdotal evidence abounds, and international studies suggest caution in the use of transvaginal mesh. So why is this still a common medical practice in the US?
Profit motive looms large in the realm of popular reporting. The story will undoubtedly continue to unfold. Edward Wallace remains sanguine about the prospects for women and families who have been injured.
The Kaisers were represented by Tom Plouff, Jeff Kuntz of Wagstaff Cartmell LLP and Ed Wallace of Wexler Wallace LLP.
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