Jim Waldenberger, Kline Specter
Mesh Medical Device News Desk, June 12, 2018 ~ During the opening arguments, an attorney for Ms. Martinez says the company knew its products would cause the pain suffered by Ms. Martinez.
Jim Waldenberger of Kline Specter, one of two attorneys representing Ana and Jose Martinez of Nevada, conducted the opening statement to the group of 15 jurors May 30,in a Woburn, Mass courtroom. The trial accuses Boston Scientific of launching two defectives meshes to the market- the Pinnacle Pelvic Floor Repair system and the Obtryx used to treat incontinence.
Since Ms. Martinez was implanted with both meshes in December 2010, “they have left her vagina scarred and deformed, which has basically created two problems for Ana," said Waldenberger in his opening statement to jurors.
Wikimedia Commons, Jurors
That has led to pain with sexual intercourse and with groin pain. She will have these problems for the rest of her life and Ana now has involuntary leaking of urine, he said. Both of these problems are permanent and were caused by the Pinnacle and Obtryx products.
The material that makes the meshes is called polypropylene and it’s heavyweight and not adaptable to a woman’s body, said Waldenberger. Boston Scientific didn’t evaluate, test or determine in any way how these products would react in a woman’s body. They launched them on the market to be competitive with their competitors, jurors were told.
“I want you to ask yourselves, when you hear the evidence, as to whether or not Boston Scientific took responsibility to provide a safe product for the people who need help with the conditions that I’ve just described.”
Martinez had a cystocele, a form of pelvic organ prolapse, treated with the Pinnacle, used for pelvic organ prolapse (POP). And she had stress urinary incontinence, treated with the Obtryx.
Boston Scientific bought its raw polypropylene (PP) material from the Chevron Phillips petroleum company. The raw material came with a warning:
Marlex from China
Urologist, Dr. Michael Margolis will appear at trial, so will Dr. Scott Guelcher, a biomedical engineer. He plans to tell the jury that PP is not suitable for implantation in the human body, it is suitable for carpet backing and automotive products. When implanted in the body, it recognizes PP as a foreign substance and the body attacks it. Excessive scarring then occurs which contracts the mesh causing it to tighten, become brittle and hardened taking nerves with it that cause pain.
The foreign body reaction in Martinez' body from the Obtryx PP implant, caused mesh shrinkage and obstructed her urethra. Pinnacle caused chronic infections, vaginal scarring and erosion into the vaginal wall. The mesh had to be clipped away. It eroded again, the jury was told.
With chronic infections and discharge she underwent a surgery by Dr. Sheldon Freedman in October 2011 to cut out as much Pinnacle mesh as he could. Unfortunately, he had to remove part of her vagina as well, causing it to be disfigured. It’s called a vaginectomy.
Pinnacle Pelvic Floor Repair Kit
Waldenberger continues reminding the jurors there were no clinical trials for these products. Instead, they were rushed to the market to keep up with competitors, even as some within the company, internal documents show, suggested testing should be conducted to see what effects the mesh has in a woman’s body.
The testing that did occur was on rats in the early 2000s.
Boston Scientific took the polypropylene (PP) material, extracted it down to a liquid and ran lab tests, by injecting the liquid into mice to look for cancer; they injected it into guinea pigs to see if they were allergic; and injected into other mice to see if there were mutations. Mesh was implanted under the belly skin of rabbits. The testing took days to weeks.
Even without the testing, “They did know of the dangers of polypropylene products,” he said.
Numerous reports have surfaced about Boston Scientific (BSC) and its search for new PP resin after its supplier said it would no longer sell PP to BSC. Most recently, 60 Minutes outlined the plan to smuggle counterfeit PP from China even though the company could not verify its authenticity.
Since late 2012, it is presumed that BSC transvaginal meshes are made from the PP that came from China. Because she was implanted earlier, the Chinese mesh question will not be entered into this trial.
One year ago, Boston Scientific announced it planned to settle more than 37,000 cases without admitting fault. A class action lawsuit filed in Charleston, West Virginia, alleged BSC was involved in racketeering for the smuggling of PP resin and filed a RICO (Racketeer Influenced and Corrupt Organizations Act) claim.
Those charges of which are usually reserved for organized criminal activity. The class action, headed by Teresa Stevens is reported to be in settlement discussions through Mostyn Law of Houston.
Boston Scientific had 26,000 product liability claims filed in multidistrict litigation in Charleston, WV, the second highest number behind Ethicon (Johnson & Johnson). Still on the market are its incontinence devices, Advantage Fit, Advantage, Lynx, Obtryx II and Solyx Single incision sling.
Also BSC is one of the few companies still selling products for pelvic organ prolapse since they now must go through the more rigorous premarket approval. They include the Uphold Lite, Upsylon Y mesh and Xenform Soft Tissue Repair Matrix.
The first transvaginal mesh marketed in the U.S. in 1999 was Boston Scientific's ProteGen TVM, though it was recalled by the FDA three years later when it failed and led to injuries.
In 2014 and 2015, the company lost two jury trials with eight plaintiffs (4 each) totaling $27 million (Pinnacle trial) and $19 million in the Obtryx trial. ###
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