The Perry vs. Ethicon Pelvic Mesh Trial opened Monday, Jan. 26 in Calif. state court in Bakersfield. Coleen Perry is suing Johnson & Johnson and Ethicon after being implanted with pelvic mesh made by Johnson & Johnson subsidiary Ethicon. Mrs. Perry, who had been implanted with the mesh in 2011 to treat stress urinary incontinence, had it removed in 2014, because, she said, it caused her more problems than it solved. See the Petition filed by her attorneys here (Perry Petition).
In opening remarks, Mrs. Perry’s attorneys said the TVT Abbrevo implanted in Mrs. Perry was not reliably or adequately tested, and that the company did not design the product in a reasonably safe manner. The Abbrevo mesh is also a heavyweight mesh, a mesh first used for hernia repair in 1974, that was never designed to be implanted into the vagina.
As part of their claim that Ethicon’s Abbrevo has a faulty design, Mrs. Perry’s attorneys also argued in opening that Johnson & Johnson decided to make a change from mechanical cut to laser cut mesh in 2006; this change, the attorneys posited and will need to prove to the jury, resulted in a stiffened mesh product that can more readily cause erosion than its softer machine cut precursor, and the laser cut mesh does not perform as the mesh was originally intended by the company.
Johnson & Johnson’s TVT Secur, a precursor of Abbrevo, was rushed to the market in the absence of sound clinical data, said Mrs. Perry’s attorneys. Ethicon made two mistakes at that point in the evolution of pelvic mesh: 1.) Ethicon chose not to test the product on women before releasing it to the market. 2.) Ethicon chose not to tell doctors that the new stiffer mesh in Secur was heavyweight laser cut mesh that was stiffer than previous meshes. Instead, the company said this was the same mesh as the older mesh.
By 2008, Ethicon knew Secur was a failure, and in 2010 did a marketing study of 120 doctors around the world which confirmed it was a failure. Nevertheless, the mesh remained on the market and Ethicon continued to promote it to unawares doctors and their women patients.
Ethicon’s chief scientist said Secur mesh was considered heavyweight, and Ethicon’s consultants told the company not to use the heavyweight mesh, the 1974 mesh. Plaintiff’s attorneys will need to present evidence to prove this to support their misrepresentation claim in the trial.
Laser cut mesh was three times (3X) as stiff as machine cut mesh, and Ethicon’s lead engineer Dan Smith, a 30-year man with the company, told Ethicon the mesh was too stiff.
Studies on prolene mesh made of prolene sutures showed that 6-8 years after implantation, the mesh was cracking and the sutures degrading. Polypropylene – plastic – degrades inside of women over time. Ethicon knew as early as the 1990s that prolene does degrade and that degradation causes problems.
TVT and Abbrevo did not go through any approval by the FDA. They were fast tracked by 510k process because Ethicon presented to FDA that the pelvic mesh it intended to implant in women’s vaginas was substantially equivalent to a precursor product, the 1974 plastic the company had been using for hernia repair. Because Ethicon skirted the standard device approval process with 510k, no studies were done on women to see if the transvaginal mesh would work, to prove that the benefits outweighed the risks.
Attorney Kim Schmid of Minnesota opened for the defense.
“TVT is a good and essential product that treats a very serious problem,” she said. Schmid also said that TVT Abbrevo was “the gold standard” for women’s stress urinary incontinence issues. She used the term “gold standard” not less than eight times in her 50-minute opening. She said Abbrevo was “state of the art” technology, and that some risks are universal no matter what the surgery.
Ethicon’s defense attorney said Mrs. Perry signed an informed consent form on March 23, 2011 prior to her surgery. That form included the language to warn Mrs. Perry that she could suffer “pain, mesh erosion, poor healing, additional surgeries.”
Eleven months ago, Mrs. Perry was walking 3 ½ – 4 miles per day. “Life is good!!!” she emailed her doctor. Mrs. Perry suffered a dozen urinary tract infections and many other female pelvic problems, said the defense. She blamed all her problems on the mesh. Mrs. Perry saw a lawyer’s advertisement for transvaginal mesh lawsuit and decided to file one herself. She had her pelvic mesh sling removed (or partially removed) after seeing that lawyer ad and deciding to file a suit.
Defense said polypropylene mesh (defense does not use the interchangeable synonym – “plastic” – as the plaintiff’s side often does) had been used safely and effectively for more than 30 years. Defense gave a brief history of the European Dr. Olmsted, whose “new procedure” in fashioning Johnson & Johnson’s hernia mesh into transvaginal mesh and selling it to the company kicked off the production and sales of women’s transvaginal mesh products.
Defense said the transvaginal mesh Abbrevo sling is just 12 centimeters long, or about 4 3/4″ and less than ½” wide. “Evidence will show it is large pore, lightweight mesh in the context of SUI surgery,” said Schmid, and “TVT-Abbrevo has always used laser cut mesh since it began selling in 2006.
After opening arguments, Mrs. Perry’s attorneys called Dr. Peggy Pence as their first witness. She was expected to give testimony showing the lack of safety testing for the Abbrevo mesh sling, as well as testimony on the lack of proper warnings and whether or not Ethicon exercised a reasonable standard of care in its warnings, or lack thereof.
Stay tuned. . .