It was recently announced a Pennsylvania state jury has awarded a New Jersey woman a $20 million verdict for injuries she suffered after receiving a pelvic mesh implant made by Ethicon, a subsidiary of Johnson & Johnson.
J&J and its Ethicon medical device division has accrued $34.5 million in punitive damages over its transvaginal meshes in the last 15 months.
Peggy Engleman of Cinnaminson, NJ, was awarded $2.5 million compensatory damages and $17.5 million in punitive damages following a three-week trial in Philadelphia Common Pleas Court, the highest amount of punitive damages awarded so far among the transvaginal mesh cases heard in this court.
Originally filed by Stark & Stark in 2013, the suit claimed that a TVT-Secur device manufactured by Ethicon was defective and that the companies failed to warn users of the risks.
Ms. Engleman had the device implanted in 2007 to relieve stress urinary incontinence, but said the device failed within a month and her condition returned. She began to experience pain and discomfort as the mesh started to erode inside her body and had multiple surgeries as a result. However, physicians were unable to remove all the shards of mesh in her abdomen.
The pelvic mesh litigation still has 183 cases pending, with the next one scheduled to go on trial May 22. Two earlier pelvic-mesh verdicts in Philadelphia against Johnson & Johnson/Ethicon resulted in awards of $12.5 million and $13.5 million. Johnson & Johnson also faces tens of thousands of additional lawsuits around the country regarding pelvic mesh implants.
The TVT-Secur (TVT-S) is a polypropylene mesh “hammock” that cradles the urethra to treat incontinence. It is tethered in place with two arms that extend up through the buttocks.
TVT-S was cleared for market in 2006 without any clinical trials through the U.S. Food and Drug Administration’s 510(k) clearance process.
It was removed from the market voluntarily by J&J in mid-2012 along with three other problematic pelvic meshes. The company said it was for financial reasons.
No information was included in this case about the role the Food and Drug Administration plays in clearing transvaginal mesh for market through the fast-track 510(k) approval process.