Mesh News Desk, February 10, 2016, 11:30 am EST ~ Late this morning, a Philadelphia jury found Johnson & Johnson (J&J) made a defective pelvic mesh – the TVT- and awarded Sharon Carlino $13.5 million. The jury found the warnings to her doctor were defective and he said he would never have implanted the transvaginal polypropylene tape he used to treat her incontinence if he had known of its risks.
After listening to the evidence in the two-week trial, the jury awarded Ms. Carlino $3.25 million in compensatory damages for her pain and suffering, $250,000 to Mr. Carlino for loss of consortium and $10 million in punitive damages.
This was the first trial of the TVT, made by the J&J division of Ethicon to go to a jury. A previous trial of the TVT in 2013, Lewis v. Ethicon, was dismissed by Judge Goodwin in a West Virginia federal court following a directed verdict motion by J&J.
According to The Legal Intelligencer, Ethicon attorney Laura Hensley Smith, told jurors J&J was proud of its TVT- the first mesh “sling” to treat stress-related incontinence. It was “revolutionary” and “the gold standard,” terms most mesh manufacturers use to describe their polypropylene implants used to treat prolapse and incontinence. The TVT was approved for sale by the Food and Drug Administration in 1998 in the U.S.
Shanin Specter of Kline & Specter representing Ms. Carlino told jurors the company blindly accepted data from the doctor who developed the TVT. “It was never properly analyzed and verified by anyone.”
Ms. Carlino has the TVT placed during a hysterectomy. She was implanted August 18, 2005, at Jersey Shore University Medical Center by Dr. Andrew Blechman. By 2007 she felt something “sharp” in her vagina where mesh had eroded. After a partial removal surgery, in 2010 she felt the mesh eroding again and had a second removal surgery. By 2012 she felt pain and experienced dyspareunia or painful sex. She had a third surgery, also by Dr. Blechman to revise and remove the mesh.
She has undergone permanent injury, corrective surgery and has experienced mental and physical pain and suffering, financial and economic loss including medical services and expenses, says her complaint. At the same time defendants market their products as safe, effective reliable medical devices that are minimally invasive. Knowing the mesh had problems, J&J nonetheless sold it through “carefully planned, multifaceted marketing campaigns and strategies.”
Attorney Adam Slater who helped the team of Specter and Richard Freese tells Mesh News Desk this is a very important verdict.
“They (Ethicon) rolled out the defense they’ve been using in mid-urethral sling case, after mid-urethral sling cases and this verdict shows those defenses don’t hold any water. The idea that the TVT is the Gold Standard and the professional societies think its the best treatment for women, juries don’t care when they see the truth through the internal documents and deposition testimony. The truth comes out in the courtroom. The other thing this trial shows is that these damages are meaningful to jurors. The defendant manufacturers have completely failed to convince any jury that the injuries caused by this mesh are mild and or acceptable.”
Slater adds that Specter and Freese put in a tremendous effort for their client.
Just last month, J&J made its first settlement offer to 2,000 to 3,000 pelvic mesh sufferers offering $120 million to end their product liability cases. See the story here.
After a disappoint fourth quarter 2015 report on its medical device division, the company said it planned to restructure by eliminating 3,000 jobs. Part of the problem is the enormous cost of litigation in fighting the 42,000 pelvic mesh cases filed against the company.
J&J says it has spent $141 million in total litigation costs in 2015, down from $1.2 billion in defense costs in 2014.
In a December jury trial, a Court of Common Pleas jury found for plaintiff Patricia Hammons, 65 and awarded her $12.5 million – $5.5 million in compensatory damages and $7 million in punitive damages. The jury found the Prolift mesh, used to treat prolapse, was defectively designed and the company failed to warn doctors about its inherent dangers that were well understood. See the story here.
J&J is facing nearly 31,000 cases consolidated in federal court in Charleston, WV in multidistrict litigation, the largest number of any of the six other manufacturers. Thousands of other cases have been filed against the company in state courts and globally.
While J&J quietly removed four of its pelvic meshes from the market in mid 2012, the TVT and its cousin the TVT-O (obturator) remain on the market and are still called the “Gold Standard” by many doctors. However, many doctors who sit at the head of medical societies such as AUGS are preceptors or consultants for device manufacturers.
The U.S. Food and Drug Administration has been slow to react to the thousands of injury reports coming into the agency. After first notifying the public that mesh complications are “rare ” in 2008, the FDA reversed itself by mid 2011 saying mesh complications are “not rare” especially for the larger meshes used to treat a prolapsing uterus and to reinforce a pelvic floor. The agency ordered three year post-approval monitoring of the POP (pelvic organ prolapse) mesh. Just last month, the FDA finally adapted a recommendation of its expert panel in 2011, and reclassified POP mesh as “high risk” or class III which will require clinical trials before it is marketed.
Mesh makers have 30 months to prove the safety and efficacy of their product to the FDA or POP mesh cannot be sold. The reclassification did not extend to mesh used to treat stress urinary incontinence or SUI mesh. It remains “moderate risk” or class II, despite the fact that it is more commonly used than POP mesh and may represent twice the number of cases filed in this product liability litigation. #