HAMMOND, Ind. (Legal Newsline) – An Indiana federal judge on Aug. 8 gave a choice to a woman who won a case that alleged the pelvic mesh device made by Johnson & Johnson caused her severe injury. She could submit to a lesser amount of punitive damages or face a new punitive damages trial, the judge ruled.
Judge Philip P. Simon's ruling in favor of Barbara Kaiser is one of thousands of lawsuits J&J and its New Jersey subsidiary Ethicon face over their pelvic implant device, called “Prolift.”
Kaiser sued Johnson & Johnson and Ethicon, a maker of surgical tools and medical closure devices, for the pelvic mesh implant installed into her groin region in January 2009 at the Community Hospital in Munster, Indiana. The device was intended to prop up a sagging bladder.
Instead in September 2011, Kaiser said she learned from her doctor the acute pain she was experiencing in her vaginal area could be caused by the implant.
Prolift is a device made of pre-cut pieces of polypropylene called “Gynecare Gynemesh” manufactured by Ethicon. The mesh has four connecting and securing arms.
On July 13, 2011, the U.S. Food & Drug Administration (FDA) issued a warning about the use of mesh devices that “serious complications associated with surgical mesh for transvaginal repair are not rare.”
The warning further stated it is not clear if transvaginal mesh devices are more effective than traditional non-mesh repairs (sutures) for patients with prolapse conditions, and could subject the patients to greater risk.
Kaiser’s lawsuit of March 28, 2012, alleged mental and physical pain and suffering, permanent injury requiring corrective surgery, financial loss from medical bills and loss of physical relations with her husband and co-plaintiff Anton Kaiser.
The U.S. District Court for the Northern District of Indiana on March 8 awarded the woman $10 million in damages and $25 million in punitive damages after a jury agreed Johnson & Johnson and Ethicon had misled the public about the risks of the mesh implant. The verdict said the companies failed to establish proper safety procedures for removal of the mesh in case of failure and failed to perform adequate research and pre-testing of the device.
The allegations contended the defendants had also provided incomplete, insufficient and misleading training and information on the implantation of the devices to doctors who would install them, to increase sales of the mesh devices.
“Despite defendants’ knowledge of similar catastrophic injuries, complications and conditions caused by their Prolift, the defendants have and continue to manufacture, market and sell the products, while continuing to inadequately warn, label, instruct and disseminate information regarding the product, both prior to and after the marketing and sale of the product implanted into the plaintiff (Kaiser),” the suit read.
Johnson & Johnson contested the verdict and moved to overturn it. The company also sought a new trial or at least a reduction in the damages award.
Judge Simon denied overturning the judgment and a request for a new trial, finding the presentation of the evidence made a judgment in favor of Kaiser reasonable. However, the judge said the punitive damage award had been set too high.
Simon said the jury erred in setting a punitive damage amount based on a percentage of J&J’s $70 billion total net worth, rather than the company’s profits selling the Prolift device in Indiana, calculated at a mere $150,000.
He maintained the $25 million punitive amount was 166 times the relevant amount of profits earned by the defendants J&J and Ethicon. Simon ruled instead for a $10 million punitive award.
Kaiser is to decide if she will accept a reduced punitive amount and receive a total $20 million in damages instead of $35 million. If she refuses, the judge will order a new punitive damages trial.
According to a report by the Saunders & Walker law firm on March 13, Johnson & Johnson and Ethicon still face more than 13,000 mesh lawsuits and 55,000 product liability claims across the country. The two companies have lost more than a half-dozen trials with verdicts from $2.16 million to $20 million.