Day 7: Boston Scientific Case with the Jury!

Jane Akre
November 13, 2014
Pinnacle Pelvic Floor Repair kit

Pinnacle Pelvic Floor Repair kit

At this writing, the case of four mesh-injured patients who claim the Boston Scientific Pinnacle Pelvic Floor Repair Kit is defective is in the hands of the nine-person jury.

The defense wrapped up its case around 2 pm Thursday after two days of testimony to assure jurors the Pinnacle mesh kit was a safe and effective treatment for pelvic organ prolapse (POP) in 2008.

The four women filed defective product claims against Boston Scientific saying the Pinnacle was defective in its design and in its instructions for use. The Pinnacle was voluntarily taken off the market by Boston Scientific in 2011.

All four women were implanted with the Pinnacle to treat POP, a condition where pelvic organs require support to keep them from dropping out of the body.

Court was closed on Tuesday for Veterans Day.

Last September, the case of Martha Salazar v. Boston Scientific resulted in a $73.5 million verdict for Ms. Salazar, which was later reduced to $34 million under Texas tort reform. That number still represents the highest jury award among the dozen or so pelvic mesh cases that have gone to court.

Boston Scientific won its first two cases in state court in Massachusetts. This is the first bellwether case being tried in federal court. A bellwether trial tests legal theories to derive a relative value of a case. The company is facing 23,000 product liability cases concerning its various pelvic mesh products.

The case is Eghnayem v. Boston Scientific Corp, 2:13-cv-07965, filed in the So. District of WV and moved to the Southern District of Florida (Miami).

The women represented are Amal Eghnayem, Margarita Dortes, Maria Nunez and Juana Betancourt.

Here is the testimony that was conducted Day 6 Monday, November 10.

DAY SIX- Boston Scientific Defends the Pinnacle Pelvic Mesh Kit

Monday, November 10, 2014 ~ MIAMI, FL

The plaintiffs finished their case Monday around noon with Maria Nunez on the stand, who was implanted with the Pinnacle repair kit in 2008. Questions about her sex life by defense attorney Hildy Sastre (Shook Hardy & Bacon) caused Ms. Nunez to cry.

Among the jury of nine ( 5 men, 4 women) there are at least six Hispanic individuals. In that culture, intentionally harming the matriarch of the family is frowned upon and could eventually become a factor in this case.

The defense case was wrapped up with a compelling closing about respect for women and the lack of safety testing or any testing of the Pinnacle before it was launched in 2008. The defense reminded jurors that the plaintiff had not proven their case, that some of the women had preexisting conditions and that scientists they brought to testify said the Pinnacle is safe and effective.

Jury Not Told

The 9-person jury (5 men, 4 women) has not been told that the Pinnacle was removed from the market in 2011 because ‘the device may exhibit low tensile strength between the needle and suture and led to needle detachment during mesh leg placement.” See the FDA notice here.

The jury has not been told about the 100,000 product liability cases facing seven mesh manufacturers, Boston Scientific among them.

Monday Day 6: Dr. Stephen Blaylak - Case for the Defense

Dr. Stephen Badylak

Dr. Stephen Badylak

Dr. Stephen Blaylak is a tissue engineer with the McGowan Institute of Regenerative Medicine. He was hired as an expert by Boston Scientific to appear to the jury. Like Dr. Vladimir Iakovlov from Day 4, he was an anatomical pathologist and studies biomaterial science as well as a medical degree.

Links here:

His papers:

Dr. Badylak is also mentioned in WikiPedia under the chapter of Regenerative Medicine.

Stephen Badylak lab website

On the stand Dr. Badylack said that women who receive mesh implants grow new tissue into the mesh - brand new, healthy tissue.

Testimony so far in the case has shown that the normal foreign body reaction in the presence of mesh creates scar tissue that can cause mesh and its surrounding area to shrink, fold, degrade and become inflamed and infected. Dr. Badylack refuted the plaintiff’s claim and said if the foreign body response is not infection or cancer, then it is not a complication.

Dr. Badylak holds over 50 U.S. patents, 200 patents worldwide, has authored more than 225 scientific publications and 20 book chapters. On cross-examination, plaintiff attorney Jim Perdue brought out that Dr. Badylack was hired by Boston Scientific in 2001 and 2002 to story foreign body reaction, in other words, besides being compensated for his appearance at trial and trial preparation, he is a long-time consultant to the company.

Ultimately the jury heard that while Boston Scientific studied different waves, weights and pore size of polypropylene mesh those 2002 studies did not address the Marlex that would eventually be used in the Pinnacle, and did not involve human trials but rather the implantation in rabbits of mesh materials in the abdomen to determine the effect of implantation on the mesh. The rabbits were sacrificed at two weeks, six weeks and 12 weeks so there was no assessment of the long-term effect on the rabbits.

Dr. Stephen Spiegelberg

dr stephen spigelberg

Dr. Stephen H. Spiegelberg is a polymer chemist from the Massachusetts Institute of Technology who previously held a post at Kimberly Clark.

He is now a chemical engineer with the Cambridge Polymer Group in Boston where he consults and tests polymers and their use in medical applications and has done so for almost 20 years.

Link here:

His group tests explanted devices and how they perform for both the legal community and to obtain a patent. One of the components is biocompatibility. He said Boston Science passed all of the tests in bringing the Pinnacle and its Marlex mesh to market.

Earlier in the plaintiffs' case, it was determined that Phillips Sumika, which provides device makers with the raw polymer, added a disclaimer that the materials were not to be used in implantable medical devices. Despite the disclaimer, Dr. Spiegelberg said Boston Scientific had contracted with the company in 2004 to bypass those warning provided the company did the appropriate testing.

Discussing chemical additives to the polymer Dr. Spiegelberg said Boston Scientific added an antioxidant to the polymer. Eventually it becomes a free-radical he said and the antioxidant that slows down the oxidation or mesh and does not fail over time, he insisted.

He too confirmed there was never any animal testing on the Marlex mesh used in the Pinnacle Pelvic Floor Repair Kit before it was marketed in January of 2008.

Spiegelberg had received mesh explants to study for degradation and he called those explants “pristine.” He did not show the actual piece of explanted mesh side-by-side the original mesh for a comparison. Dr. Spiegelberg attempted to discredit Dr. Vladimir Iakovlov and his polarizing images which showed twinkling white particles of mesh in an explant.

Plaintiffs’ attorney Jim Perdue established the doctors’ relationship with Boston Scientific was a long-term one. For 15 years, 5 percent of all of his revenue annually came from Boston Scientific.

With the jury out of the room Wednesday, Judge Joseph Goodwin indicated to the lawyers that the jury has already made up their minds and that he would not restrict the further proceedings including closing arguments which are expected to take place Thursday.

The jury often delivers its decisions before Friday. Judge Joseph Goodwin has instructed them to take their time, preferring it be decided tonight. Any decision on punitive damages will be heard later in a separate haring.

The case went to the jury around 2 pm Thursday. At this writing, the courtroom is in a standby mode. #

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