Obtryx II

Obtryx II

Mesh Medical Device News Desk, September 8, 2014 ~ A Dallas jury has returned a verdict in excess of $73.465 million for Martha Salazar in her product liability trial against Boston Scientific. That award includes $50 million in punitive damages.

See how it breaks down on Mesh News Desk.

Mesh News Desk had court watcher Joleen Chambers in the courtroom and she reported this tonight. At this hour there appears to be no other media coverage. The actual breakdown numbers should be available in the morning.

Salazar filed a product liability lawsuit against Natick, Mass.-based Boston Scientific. DrugWatch has more on the background of the company here.

Dallas District Court Judge Ken Molberg oversaw the trial (#DC 12 14349). Martha Salazar had filed an action against her implanting physician Dr. Jorge Lopez and Boston Scientific.

Dallas Judge Ken Molberg

Dallas Judge Ken Molberg

Salazar was implanted with a Obtryx® Transobturator Mid-Urethral Sling (MUS) System, a polypropylene mesh used to treat incontinence. Dr. Lopez did the 15 minute surgery January 17, 2011. Mrs. Salazar had testified she had SUI (stress urinary incontinence) symptoms only with active exercise or a cough or sneeze.

Salazar claims she was experiencing dyspareunia, pain, irreversible nerve damage to femoral and obturator nerve. Damage to adductor in right leg causes plaintiff to walk with limp. She just had 4th major surgery to remove mesh  recently which took hours.  More dangerous and invasive surgeries are to follow.

Salazar Alleged

– Warnings were inadequate to warn of the nature and extent of possible irreversible, permanent, catastrophic injuries. groin and pelvic pain. Dyspareunia, nerve damage, chronic debilitating UTI,

– The product is defective

– The risks outweigh the benefits.

-BSC did not adequately test the product on humans. Transvaginal implantation is not a sterilized field Bacteria with plastic initiates degradation, erosion, biofilm, shrinkage up to 50%. The middle of the Obtryx mesh is heat treated to make it stronger with no testing.   It becomes stiff and jagged edges form and effectively mechanically saw or dissect the urethra and other soft tissue.

-BSC ignored the MSDS issued by Phillips Sumika

-BSC withheld or concealed clinical trial information about these potential injuries

-the obturator approach is uniquely dangerous and needs more long term study

-BSC did not budget adequately for post-market surveillance and complaint investigation

 

WHAT WENT WRONG FOR BOSTON SCIENTIFIC

Peggy Pence P.h.D

Peggy Pence P.h.D

Chambers, who sat in the 10 day trial, says Boston Scientific played fast and loose with the evidence putting forth hours of studies and at one point claiming they had 2,000 studies that substantiated the safety of the Obtryx transvaginal pelvic mesh. When questioned about the data, the plaintiffs showed the studies were not about the Obtryx and good data, such as randomized controlled trials, were lacking. One study, for example,  only had three Obtryx patients.

Chambers says the evidence made the trial long and boring and what took ten days could have easily been summarized in four days.

The jurors often looked bored at the house of scientific studies. In one registry of data, funded by Boston Scientific, Chambers says according to testimony, the numbers were not going their way so they cancelled the study.

Peggy Pence, a toxicologist/pharmacologist consultant for the plaintiff who has been an expert in the Linda Gross case as well as Carolyn Lewis, testified that call center personnel were not well trained and did not pass on complaints coming in from customers. The call center had a huge backlog of 1,100 complaints that were not dealt with in a timely fashion.

Lawyers for Mrs. Salazar were Tim Goss (Freese and Goss), David Matthews ( Matthews Law), Richard Capshaw and Sheila M. Bossier from Mississippi. The jury of one dozen were about half men and women and racially diverse including white, black and Hispanics. The defense team was headed by Shook Hardy and Bacon, who also have represented the largest tobacco companies as well as the Sedgewick law firm from Dallas. Maria Karos.

Both sides had agreed no discussion of the Food and Drug Administration and its 510(k) process would be introduced. The feeling was it would bog down the proceedings.

One incident may have been significant. On Friday, a staff member of the Boston Scientific team told their photographer to take a picture of a juror who she believed was sleeping.   The judge, Ken Molberg admitted he sometimes closes his eyes but he is actively listening. The photographer was escorted out of the courtroom because it is the judge’s job to take care of his jurors and respect their privacy.

Boston Scientific sells Advantage Fit, Advantage, Lynx, Obtryx, Solyx, slings used to treat incontinence. The company is famous for making the first polypropylene mesh sling for incontinence, the ProteGen, which was removed from the market in 1999 over safety concerns. That did not stop it from being used as the “predicate” or equivalent device the Food and Drug Administration relies on as a basis for approval of new devices. See more here.