Johnson & Johnson Hit With $35M Verdict in Pelvic Mesh Case
A federal jury in northern Indiana hit Johnson & Johnson with a $35 million verdict in a lawsuit over an "unreasonably dangerous" pelvic mesh implant, a team of lawyers has announced.
March 09, 2018 at 05:45 PM
3 minute read
The original version of this story was published on National Law Journal
Photo: Alexander Tolstykh/Shutterstock.com
A federal jury in northern Indiana hit Johnson & Johnson with a $35 million verdict in a lawsuit over an “unreasonably dangerous” pelvic mesh implant, a team of lawyers has announced.
After two weeks of trial, the nine-person jury in U.S. District Court for the Northern District of Indiana on Friday rendered its verdict against J&J and its subsidiary, Ethicon, for the manufacture, marketing and recruitment of physicians to install the Prolift mesh device intended for repairing prolapsed pelvic organs.
In a statement released Friday, the lead attorney for plaintiffs Barbara and Anton Kaiser, Thomas O. Plouff of Costello McMahon Burke & Murphy, said, ”Ethicon defended an indefensible product and the jury stood up for Barb Kaiser. They were asked to send a message to Ethicon to deter future wrongdoing and they did, a company that sold a medical device without doing any clinical testing and caused thousands of women to suffer painful complications from mesh in their pelvic area.”
Plouff was aided in the case by Jeff Kuntz of Wagstaff & Cartmell in Kansas City, Missouri, and Edward Walllace of Wexler Wallace in Chicago.
The verdict breaks down to $10 million for compensatory damages and $25 million for punitive damages.
The lawsuit claimed Ethicon used polypropylene, a material that is incompatible with human flesh, which causes the body's immune system to attack the device and degrade it, leading to “severe adverse reactions.”
The FDA clearance process for the marketing of the drug did not require Ethicon to prove the safety or efficacy of its mesh, the complaint said, and therefore the safety of the mesh was never reviewed by the government.
“At all times relevant to this action, defendants intentionally, recklessly and/or negligently concealed, suppressed, omitted, and misrepresented the risks, dangers, defects, and disadvantages of the pelvic mesh products and advertised, promoted, marketed, sold and distributed the pelvic mesh products as a safe medical device when, in fact, defendants knew that the pelvic mesh products were not safe for their intended purposes and that the pelvic mesh products would cause, and did cause, serious medical problems, and in some patients, catastrophic and permanent injuries,” the complaint said.
The defendants claimed in their answer to the complaint that the companies were not at fault for the alleged injuries.
Additionally, court papers said, “At all relevant times, the warnings and instructions accompanying the products at issue were governed by and conformed with applicable federal statutes, rules and regulations; therefore, warnings and instructions relating to the products were presumptively adequate.”
J&J spokeswoman Mindy Tinsley said J&J and Ethicon continue to stand by their product.
“Ethicon intends to appeal this verdict as we believe it contradicts the evidence that the product was properly designed and that the company appropriately informed surgeons of pertinent complications,” she said in an email.
“Pelvic organ prolapse is a serious and debilitating condition with limited treatment options,” she continued. “Scientists from around the world who have conducted and reviewed independent research on pelvic mesh agree it is an important treatment option for some women. All surgeries to treat pelvic organ prolapse have risks. While we empathize with those who have experienced complications, many women with pelvic mesh see an improvement in their day-to-day lives.”
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