Mesh Medical Device News Desk, June 18, 2018 ~ Friday June 15th, a Woburn, Mass. jury came back deciding for Boston Scientific in the 16 day trial of Ana and Jose Martinez.
Jurors decided the Pinnacle and Obtryx pelvic mesh products were not defective and the company did not fail to warn end user doctors about the dangers of the polypropylene meshes.
This was only the fifth win for the medical device maker.
In July 2014, Diane Albright, implanted with a Pinnacle was awarded nothing in the Middlesex County courtroom but she did win a new trial. Maria Cardenas, also in the Mass. courtroom, lost her Obtryx case against Boston Scientific the next month.
Martha Carlson in Statesville, NC also lost her Uphold trial in October 2015 against Boston Scientific as did Eva Sherrer in Kansas City, Mo in February 2016.
Meanwhile, Boston Scientific lost the Martha Salazar case against Boston Scientific in Dallas and was awarded more than $73 million in her Obtryx case. The judge later reduced that award to $34.6 million due tort caps. In Miami, four women who filed a defective mesh cases against Boston Scientific over the Pinnacle mesh they were implanted, were awarded more than $26.6 million (Eghnayem case).
During that same week in November 2014, four plaintiffs filed and won their Obtryx case against Boston Scientific winning more than $18.5 million (Tyree case).
In May 2015, Boston Scientific lost a Pinnacle case filed by Deborah Barba who was awarded $100 million in a Delaware court. The judge later reduced it to $10 million citing a "grossly disproportionate" amount.
See Mesh News Desk story on Trials so Far and outcomes Here.
The following story is taken from the opening statements in Ana Martinez v. Boston Scientific, the product liability trial underway in Middlesex Co. Massachusetts.
“Even without the testing – the clinical testing that they should have done, they did know of the dangers of polypropylene products,” Jim Waldenberger of Kline Specter told jurors at the end of last month in explaining the Ana Martinez v. Boston Scientific case to jurors.
Ca No. 12-3081, Mass Superior Court, Woburn, MA, before The Honorable Thomas Billings.
Jim Waldenberger, Kline Specter
They understood dyspareunia (painful sex) and understood mesh erosion into the vagina. It was all contained in the failure modes effect analysis documents, created by research and development department at Boston Scientific pre-market. Relating to the Pinnacle product, BSC knew the mesh caused excessive inflammation or scarring. Erosion, exposure, dyspareunia, they put it on the market anyway, he said.
Ana Martinez was implanted with two Boston Scientific meshes in December 2010 - one for pelvic organ prolapse (Pinnacle) and another for stress urinary incontinence (Obtryx).
Dr. Dennis Miller
Dr. Peter Rosenblatt at AUGS 2016
The trial promised to show the key opinion leaders, (KOL) ie Dennis Miller, Peter Rosenblatt, who were paid to promote meshes to other doctors. Even among the KOL, mesh was reported back to the company to have increased rates of complications.
Dr. M. Tom Margolis will testify the more mesh in a product, the more foreign body reaction, the more foreign body reaction, the more scarring, the more nerve entrapment – nothing reported back to the company stopped it from selling its mesh medical devices.
Margolis will be brought in to discount the notion by defense that polypropylene (PP) has been used since the 1950’s as a hernia implant product. He will say the vagina has special functions, for example, it needs to move when the bladder fills up, it has to accommodate the rectum. It is not a fair comparison to compare it to an abdominal hernia mesh.
Dr. M. Tom Margolis
Even KOL Peter Rosenblatt reported a 27.9 % erosion rate with the Pinnacle product. That did not stop him from heading the Pelvic Floor Institute training for Boston Scientific at its Boston headquarters.
Waldenberger said Boston Scientific will blame the implanting physician Dr. Kord Strebel, MD (Valley Hospital Medical Center, Las Vegas) for implanting the meshes improperly and it will blame Ana for having sex too early following her implant.
Dr. Kord Strebel, MD, Las Vegas Ob-Gyn
Susan Murphy for Boston Scientific objected to the plaintiff attorney telling jurors what she was going to say. “He’s now degrading and insulting me personally and my clients. It’s inappropriate in an opening statement, and he’s now spent ten minutes saying what I’m going to do, the blame, the shifting, the cherry picking. That’s argument, your Honor. That’s not opening statement, and I object to it.”
After a sidebar the court ruled - Overruled.
Attorney Waldenberger told jurors Ana and Jose are from Nevada and are both 58 years old. They have been married for 38 years. They are from Mexico and they are American citizens. English is their second language. Because of that, there will be an interpreter at trial to standby in case they feel more comfortable with a Spanish translation to the proceedings, that will be conducted in English.
Ana works at a casino as a banquet server and Jose has his own business working with the construction industry. She has to wear pads to her job which is humiliating, embarrassing and depressing. Ana and Jose separated for a period of time because of the strain in their relationship, including a loss of intimacy. They decided to work through their issues and are still together.
Susan Donnelly Murphy
Susan Murphy of Murphy & Riley, Boston then conducted her opening statements to the 15 jurors. She and Jim Keale represent Boston Scientific. She reminded jurors first that the plaintiff has the burden of proof in this case, proving by the preponderance of the evidence every element of its case.
On the Material Safety Data Sheet (MSDS) she told jurors “that same producer of resin for the polypropylene continues to sell to Boston Scientific, knowing the uses to which it was being put.”
The warnings Boston Scientific provided to Dr. Strebel were “fully informative, completely reasonable, and completely adequate.”
She reminded jurors Boston Scientific’s mission was to provide minimally invasive medical devices. And it’s a hometown company, located in Marlborough and in Middlesex County since its founding in 1979.
No surgery is risk-free, she said to the jurors promising to introduce the risks of a surgical non-mesh repair.
“That’s what drew these urogynecologists to say we need something better. We can’t keep repeat operating on patients.”
She promised to introduce Peter Rosenblatt, and Jim Goddard, an engineer for Boston Scientific’s women’s health division. Goddard will say before its put on the market a medical device must pass through teams that evaluate and test these products.
She promised to show jurors peer-reviewed medical literature on the Obtryx and Pinnacle.
She told jurors they would introduce Dr. Spiegelberg, Cambridge Polymer Group and a chemical engineer to discuss the chemical composition of polypropylene.
As promised by plaintiffs’ side, Murphy indicates in her opening statement that Dr. Strebel addressed a 3 cm mesh erosion, which he removed one and pulls it closed, “and that this was, according to Dr. Rosenblatt, probably an inadvisable way to have managed this.”
After you listen to the evidence “you will come to the conclusion that neither the Pinnacle nor the Obtryx was defective.” ###
MND, Doctor Sunshine, What You May Want to Know About Your Doctor's Conflict of Interests, July 4, 2016
MND, Plaintiff Opens in Martinez v. Boston Scientific, June 12, 2018
MND, Martinez Trial - The FDA Debate, June 11, 2018
MND, Martinez Trial, What Jurors Won't Hear, June 2, 2018
MND, Martinez Trial Underway, May 29, 2018