Obtryx II

Obtryx II latest version of Obtryx

At this hour the jury has the case of Tyree v Boston Scientific (2:12-cv-08633) filed in federal court in West Virginia.  

Four women have had their cases consolidated in this federal proceeding.  All were implanted with the Obtryx Midurethral sling to treat incontinence. Their trial has entered its third week in federal court in Charleston, where 67,000 cases are consolidated against seven mesh manufacturers.

The women claim the Obtryx was defectively designed and manufactured and the company was negligent in marketing the defective product.

Boston Scientific argues its mesh implants were properly designed and that doctors were given complete information about their use and the potential for risks.

Robert Adams, Shook Hardy

Bloomberg reports company lawyer Robert Adams says plaintiffs are trying to “demonize the mesh like it’s some kind of dangerous product.”

The case is being heard before U.S. District Judge Irene Berger. The plaintiffs include Jacquelyn Tyree, Carol Campbell, Jeanie Blankenship and Chris Rene Wilson.  All women were treated for incontinence with the Obtryx transvaginal mesh, a ribbon of polypropylene mesh placed under the urethra.

Boston Scientific, a Massachusetts-based company is facing 23,000 defective product lawsuits over its family of pelvic mesh products, some of which have been quietly removed from the market.

One week ago in a federal courtroom in Miami, Boston Scientific suffered another loss when a jury of nine decided its Pinnacle Pelvic Mesh Repair Kit was defectively designed and awarded four plaintiffs $27.6 million.

Pinnacle Pelvic Floor Repair kit

Pinnacle Pelvic Floor Repair kit

Both cases are part of the same consolidated multidistrict litigation and some of the same experts appeared at both trials.

The plaintiffs claim Boston Scientific rushed to market its pelvic mesh products without proper testing, said plaintiffs’ attorney Scott Love (Clark, Love Hutson) during closing arguments after lunch Wednesday afternoon. The company was “desperate to sell more slings and protect its business,” the same argument made to the Miami jury over the Pinnacle product.

 

Miami Pelvic Mesh Trial 

The Tyree trial mimics the same plaintiffs’ arguments before the jury even using some of the same expert witnesses. See Mesh News Desk coverage from Day One. 

The first bellwether trial to test legal theories, the Miami trial of Enghnayem Dortes, Nunez and Betancourt, showed jurors that the mesh degrades over time, is not inert and can fold, migrate, shrink and become hardened like plastic. The Material Data Safety Sheet shown jurors warns against using the raw polymer resin, that makes up the polypropylene, in any implantable medical device.

A jury award  of $26.7 million was announced Thursday, November 13.

Expert witnesses in the Tyree case included Peggy Pence, Jimmy Mays and Dr. Bruce Rosenzweig. Dr. M. Tom Margolis appeared by videotape for the plaintiffs in both cases.

Meanwhile, the company says complication complaints about the Obtryx were less than one percent.

The Obtryx II remains on the market while the Pinnacle was removed in May, 2011. The FDA issued an IMMEDIATE RECALL and a letter announcing the 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.”

 

Courtroom Victories and Losses so Far for BSC

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

In the trial of Maria Cardenas, the jury decided that BSC 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.

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  Obtryx mesh sling case 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.

The Tyree case is the second bellwether filed in a federal court to test legal theories in hopes of determining a settlement amount.

 

Boston Scientific

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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