Boston Scientific's Pinnacle Pelvic Mesh Kit on Trial in Miami Federal Court

Jane Akre
November 3, 2014
Pinnacle Pelvic Floor Repair kit

Pinnacle Pelvic Floor Repair kit

The first of nearly 15,000 federal lawsuits facing mesh manufacturer Boston Scientific (BCS) will begin November 3 in a federal court in Miami.

It is also the first of the thousands of cases consolidated cases against seven manufacturers to have more than one plaintiffs’ case heard at a time. In this case, four women who were implanted with the Boston Scientific Pinnacle Pelvic Mesh Kit will have their cases heard by the Miami jury.

The logistics for such a case were still being worked on a week before its start.

This will be the first case since an unprecedented $73.5 million loss for the company in a Dallas courtroom in September.

The four plaintiffs appearing in U.S. District Court Miami are - Eghnayem, Dortes, Nunez and Betancourt (Eghnayem v Boston Scientific 2:13-cv-07965).

Judge Goodwin

Judge Joseph R. Goodwin, Charleston, WV

Judge Joseph R. Goodwin, Charleston, WV

Judge Joseph Goodwin will preside while his courtroom in Charleston, WV will be the site of another defective product case against Boston Scientific. In that case, four women will have their cases heard at one time. They claim the Obtryx Mid-Urethral sling they received to treat stress urinary incontinence was defective.

The product liability claims against seven manufacturers were consolidated nearly three years ago when there were 2,500 lawsuits. Today there are 68,000 filed in one U.S. District Court in Charleston, West Virginia under Judge Goodwin.

Consolidating cases is one means Judge Joseph Goodwin is employing to move cases through the courts more quickly after a long lag during much of 2014.

The plaintiffs have a common question of fact- is the Pinnacle Pelvic Mesh Kit defective in its design? Were the instructions that accompanied the kits defective or insufficient to instruct doctors about the potential dangers?

Boston Scientific Trials So Far

This Miami trial is the first of nearly 15,000 filed in federal court. Known as a bellwether, the four early cases against BCS will test legal theories and see how juries will respond.

Boston Scientific had two successful outcomes earlier this year in a Massachusetts courtroom.

In the trial of Maria Cardenas, the jury decided that BCS provided adequate warnings about its Obtryx product. The jurors were not allowed to see the Material Safety Data Sheet during the proceedings, which carried a warning the polypropylene plastic was not to be used to make medical devices. Background here.

In July the Pinnacle Pelvic Floor Repair Kit trial of Diane Albright was won by Boston Scientific in Middlesex Co. in Massachusetts, where Boston Scientific is headquartered. See background story here.

An unprecedented $73.5 million jury award in the Martha Salazar v. Boston Scientific broke the Boston Scientific winning streak last September in a Dallas courtroom. That jury award has since been reduced by half due to caps on awards in Texas.

Salazar v Boston Scientific (DC 12 14349). Martha (Rodriguez) Salazar et al (Feliz Salazar, husband) v Jorge Lopez, MD et al (Boston Scientific) filed over the Obtryx® Transobturator Mid-Urethral Sling (MUS) System story here and here.

Boston Scientific

Based in Marlborough, Massachusetts, Boston Scientific was founded in 1979 and develops, markets and manufacturers medical devices for various specialties including cardiovascular and surgery. Boston Scientific (BSC) makes coronary stents, balloon catheters, implantable defibrillator systems, pulmonary treatments and has a division for chronic pain, vascular surgery and women’s health. Its 2012 revenue was $7.25 billion.

DrugWatch has a nice background on Boston Scientific here.

As of October 31, there were 14,418 Boston Scientific cases filed in federal MDL. The company’s June 10-Q report (June 30, 2014) says it is facing 23,000 product liability cases in the U.S. Canada and the UK.

Michael Mahoney is the present Chief Executive Officer. Mahoney joined BSC after a sales job with Johnson & Johnson where he worked in the DePuy division that sold defective metal-on-metal hips which were later recalled. See background story here

The WSJ reports Mahoney was poached from J&J as part of the long time competition between BSX and J&J.

Like pelvic mesh, the ASR XL acetabular hip replacement entered the market through the Food and Drug Administration’s 510(k) clearance to sell process.

Pinnacle Mesh

The Pinnacle Pelvic Floor Repair Kit is no longer on the market in the U.S.

On May 10, 2011, Boston Scientific sent an “URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED” letter to all affected customers concerning its Class 2 recall for the Pinnacle Pelvic Floor Repair Kit because ‘the device may exhibit low tensile strength between the needle and suture and led to needle detachment during mesh leg placement.”

Boston Scientific still sells a number of mid-urethral slings for the treatment of incontinence including:

Advantage Fit (transvaginal mid-urethral sling)

Lynx – transvaginal mid-urethral sling

Obtryx II (transobturator mid-urethral sling)

Solyx (single-incision sling system).

The ProteGen was the first mesh sling to be manufactured by any mesh maker but it was pulled from the market in 1999. That did not stop other companies from naming it as a “predicate device” on which to base their own mesh products. #

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