Cardenas V. Boston Scientific Trial Continues

Maria Cardenas, Monday August 18

Courtroom View Network is covering the Massachusetts product liability trial of Maria Cardenas v. Boston Scientific Corp. which ended its first week with the plaintiff resting.

See CVN here.

The trial began Thursday, August 14th with jury selection.

Maria Cardenas vs. Boston Scientific Corp. (12-02912) is being heard in Superior Court of the Commonwealth of Massachusetts, County of Middlesex) over the Obtryx transvaginal tape used to treat stress urinary incontinence (SUI).

Attorneys for Cardenas include Joe Osborne (Babbitt, Johnson, Osborne & Le Clainche PA) as well as Doug Monsour, (Monsour law firm).

Boston Scientific is represented by Eric Anielak, ( Shook, Hardy & Bacon), Susan Murphy (Murphy & Riley PC) and Matthew Keenan (Shook Hardy).

In July, the company won the first bellwether case in Massachusetts, Albright v Boston Scientific in which the plaintiff alleged the Pinnacle mesh was defectively designed and that the doctors using it received inadequate warnings about its risks. Bloomberg has that story here.

This is the second bellwether trial in the state and one of more than 1,000 filed in Massachusetts alleging the transvaginal mesh implants made by the company are defective in their design, their manufacture and their instructions. In federal court in West Virginia, there are almost 14,000 similar cases filed against the company, and 66,000 defective product cases filed against seven manufacturers.

Maria Cardenas

Maria Cardenas, the mother of three children, gave birth to her last child in 2003, a baby over 10 pounds. By 2005 she was experiencing incontinence, which can result from large babies and/or difficult births. As many women do, she let it go for about three years until it got worse.

As a treatment, her surgeon implanted a polypropylene sling manufactured by Boston Scientific. She had the pelvic mesh implanted in 2008. Cardenas now says the implant was defectively designed and injured her permanently.

On Wednesday, Maria Cardenas said she implant permanently damaged her urethra and she continues to have pain and medical complications from the Obtryx mesh, which was partially explanted.

In order to treat the initial undiagnosed pain following her mesh implant, she underwent a hysterectomy but then doctors discovered the mesh had eroded through her urethra. Portions of the sling remain behind in that her surgeon did not believe it could be safety removed. Pelvic mesh is intended to be a permanent implant.

“I’m scared,” she said. “I don’t know if that could have any more complications, what kind of complications…. I just don’t want to go through any more surgeries.”b ~ Maria Cardenas

Prior to surgery Cardenas said she had signed a consent form that warned of complications. When asked if she understood mesh erosion, was one among many other complications. She said she did not recall.

Cardenas' doctor told her that he only had a 1% complication rate, among his patients. "I was just that 1%" she had been told.

The Obtryx transvaginal mesh remains on the market (here).

Witnesses for the Defense

Doreen Rao, engineer Boston SCientific

A Boston Science engineer, Doreen Rao appeared on the stand Tuesday, August 19. Doug Monsour, the attorney for Maria Cardenas, asked Rao, who worked on the company's Pinnacle sling project, her opinion on polypropylene (PP) transvaginal mesh.

Rao believes PP is inert and does not change in the body. She insisted the mesh does not shrink in the body. Instead, the tissues grow around it and cause the mesh to change shape but the mesh itself doesn't shrink, she said. Under questioning she admitted the tissue which encapsulated the mesh does shrink. Shrinkage is thought to occur as nerves can become encapsulated and cause chronic pain.

Dr. Badylak

Another witness for the defense appeared August 20. Dr. Stephen Badylak is a biomaterials expert who had tested PP in animals, specifically implanted the plastic mesh under the skin of rabbits.

He testified there were no biologically significant differences in any measure after the mesh was harvested at various times from the rabbits.

The trial will continue Monday, August 25. @