Uphold, Taranakiobgyn, NZ website

Uphold, Taranakiobgyn, NZ website

MND, October 19, 2015 ~ On Friday, October 16, Boston Scientific (BSC) received a favorable jury verdict in a Statesville, North Carolina courtroom in a product liability trial filed by Martha Carlson, 65.

The case, Ramona Winebarger, et al. v. Boston Scientific Corp., No. 15-57, was heard in the Western District of North Carolina. It was remanded from federal court and multidistrict litigation. The case number is 5:15-cv-00057-RLV-DCK.

While disappointed, especially for our client, this is the first in many upcoming cases set for trial.  We look forward to our next trial which we think will conclusively prove that Boston Scientific marketed an unsafe product that has hurt thousands of American women” said Jeff Larimore of Mueller Law of Austin, Texas.

In 2010, Ms. Carlson was implanted with an Uphold pelvic mesh device to treat pelvic organ prolapse. Today she says she has debilitating, chronic pelvic pain, incontinence and dyspareunia or painful sex.

In its decision, the jury said Ms. Carlson did not prove Boston Scientific acted unreasonably in designing the Uphold device that caused her injuries.  According to the jury in its 12-0 vote, Ms. Carlson did not prove by the preponderance of the evidence that Boston Scientific breached an implied and implied warranty of merchantability.

The case was a defense pick.  Jurors said afterward they did not think that her injuries were related to the mesh and that her injuries were not very significant.

After partial summary judgment in April before Judge Richard Vorhees, of the Western District of N.C., evidence was allowed to be admitted about the 510(k) clearance procedure of the U.S. Food and Drug Administration (FDA) that allows pelvic mesh to make it to market with little scrutiny for safety.  The case was pared down to claims of negligent design, breach of implied warranty of merchantability and punitive damages.

Judge Vorhees also denied her failure to warn claim, meaning the doctor received adequate information from Boston Scientific.

TRIAL BRIEF

According to her trial brief, the polypropylene used to make the Uphold is “impure, non-medical-grade” known as Marlex that “shrinks, hardens, bunches and degrades,” in the body.  The weave is so small that bacteria is entrapped and so are nerves, resulting in pelvic pain.

After a partial removal attempt, Ms. Carlson says the mesh broke apart into small pieces.

Marlex resin is issued by Chevron Phillips. Its Material Safety Data Sheet says it is not to be used in implantable medical devices that come in contact with internal bodily fluids or tissues.

See the Martha Carlson Trial Brief.Uphold mesh from nz site

 

BOSTON SCIENTIFIC CLAIMS

For its part, Boston Scientific said Ms. Carlson’s injuries are not from the Uphold, which is made of Polyform mesh. Made by Proxy Biomedical, Polyform mesh is uncoated monofilament macroporous polypropylene. The company says that mesh is safe and effective and that Ms. Carlson’s pelvic organ prolapse improved after she was implanted.

The company also says there is no reasonable alternative to the Uphold design.

The trial went to the jury October 16, ten days after it began, which returned the verdict on the same day.

Uphold Lite is still on the market.

 

bostonBACKGROUND

The Carlson case was originally filed in multidistrict litigation underway in Charleston, W. federal court where Boston Scientific is facing 19,222 cases facing Boston Scientific alleging defective design and manufacture and a failure to warn.  See the court calendar here. 

The jury in the case of Barba v. BSC issued an unprecedented $100 million award in May. Last week, it was reduced by the Delaware federal judge and BSC was denied a new trial. See story here.

The Los Angeles trial of Sanchez v. Boston Scientific settled just before it went to the jury last May (2:12-cv-05762).  See the story here.

Boston Scientific suffered a $73.5 million jury loss in the September 2014 case of Martha Salazar.  The jury also found Boston Scientific was “grossly negligent” and included $50 million in punitive damages. That amount was later reduced by half due to tort reform.  See story here.  

Last November, the company lost two separate federal trials alleging the company made defective pelvic mesh – one in West Virginia where jurors delivered an $18.5 million verdict to four plaintiffs plus an additional $1 million in punitive damages. See Tyree v Boston Scientific (2:12-cv-08633) The jurors there too concluded the company acted with “gross negligence.”

In a Miami federal court last November, four women injured by the company’s Pinnacle mesh, were collectively awarded $26.7 million. See the story here.

Boston Scientific received favorable jury verdicts twice before, in the Maria Cardenas case in Massachusetts where the jury ruled her Obtryx mesh was not defectively designed, and in the Albright case, also heard in the same Woburn, Mass courtroom over the Pinnacle pelvic mesh.

The Defendant began settling 3,000 cases for $119 million cases earlier this year. See story here.

Pinnacle

Pinnacle

RECALLS 

BSC’s Pinnacle Pelvic Floor Repair kit was recalled by the company in 2011 because of concerns a needle may detach from the mesh during placement.

Boston Scientific’s ProteGen was the first mesh sling to be manufactured and used as a prototype or “predicate” for a generation of meshes to follow.  The company pulled it from the market in 1999 because it had higher than expected rates of erosion and did not perform as intended. See story here.

Even though it was used as the basis for future designs, the FDA has no  process to review the subsequent designs that named ProteGen as its predicate device.  #