Mesh Medical Device News Desk, October 21, 2017 ~ The trial of four women, implanted with Boston Scientific’s Pinnacle mesh, was held in a Miami court November 2014 before Judge Goodwin, displaced temporarily from his Charleston, WV court, while another mesh trial took place there.

Each of the four women was awarded compensatory damages in excess of $6 million.

Last week, the mesh trial jury verdict of $27 million against Boston Scientific (BSC) was upheld by the Eleventh Circuit Court of Appeals from the Southern District of Florida.

The case was Eghnayem, Dortes, Nunez and Betancourt, (Eghnayem v Boston Scientific 2:13-cv-07965). All four women had been implanted with the Pinnacle pelvic mesh, used to treat pelvic organ prolapse (POP). All four women had complications including pain, infection, mesh erosion, dyspareunia and mesh shrinkage.

Ms. Eghnayem, art by Akre

Originally filed in the Southern District of West Virginia in multidistrict (MDL) litigation, the case consolidating the plaintiffs and was transferred to the Southern District of Florida for trial.

On November 13, 2014, after an eight-day trial, the jury found for each of the plaintiffs on four claims, deciding that the Pinnacle Pelvic Mesh Repair Kit was defectively designed, that its instructions to physicians were also defective, that the company was negligent, and failed to warn patients about the dangers of the Pinnacle.

The plaintiffs were awarded different amounts of compensation ranging from $6.5 million to $6.8 million each.

Boston Scientific immediately filed to overturn the judgment, which was denied, then to appeal the verdict.

See Mesh New Desk coverage here and here.

 

THE APPEAL

Boston Scientific claimed there were errors in the verdict, that the four women should not have been tried together, that the exclusion of the Food and Drug Administration’s clearance of Pinnacle through the 510(k) was omitted from the evidence, and that Eghnayem did not prove her claims.

Initially, Boston Scientific appealed the judgment in all four of the plaintiffs but later focused solely on the case of Amal Eghnayem, dismissing the three others.

Publishing the U.S. District Court decision October 19, 2017, Judge Judge Stanley Marcus wrote:

“After thorough review, and having had the benefit of oral argument, we can discern no error in the district court’s rulings, and accordingly we affirm the judgment.”

In upholding the jury verdict, the 11th Circuit supported the decision of Judge Joseph Goodwin, of the Southern District of West Virginia to allow the jury verdict and to deny the company’s request for a judgment in its favor. Judge Goodwin heads the federal court in Charleston, WV where the multidistrict pelvic mesh litigation is centered and more than 104,000 cases have been filed.

Boston Scientific had tried to sever the four cases claiming they were different.

A district court may consolidate multiple actions that involve a “common question of law or fact,” wrote Marcus, and that decision is “purely discretionary.”  The different jury awards showed that jurors considered each plaintiff individually, says the decision.

BSC wanted jurors to hear that the FDA cleared its Pinnacle mesh, hoping some form of an FDA acknowledgement might influence the jurors, but the appellate panel said the 510(k) is “not a safety regulation, approval under that process cannot show that BSC performed sufficient testing or complied with applicable safety regulations.”

Besides, this is not a case about federal regulatory compliance and other courts have also rejected including the 510(k) evidence under Rule 403 (Bard 4th Circuit 2016).

The long and short of it is that the district court properly exercised its broad discretion in consolidating these actions and refusing to admit FDA evidence, and the contested fact questions were properly presented to the jury,” Marcus concluded.

Rebecca Mercier Vargas

The warnings in the IFU (Instructions for Use) do not “even remotely suggest that removal might be impossible,” wrote Marcus, referring to a failure to warn.

Daniel Rogers of Shook Hardy & Bacon in Miami spoke for Boston Scientific at oral arguments in May. Rebecca Vargas of Kreusler-Walsh Compiani & Vargas in West Palm Beach argued for the women, including her client Amal Eghnayem.

Rogers has filed a notice that Boston Scientific has reached a tentative settlement with the last of the four women.

THE 2014 MIAMI TRIAL

Dr. Vladimir Iakovlov, Pathologist

During the eight-day trial, the four women claimed painful intercourse, pain, incontinence, infections and mesh exposure after being implanted with the Boston Scientific polypropylene plastic mesh used to treat pelvic organ prolapse (POP).

Dr. Dennis Miller, was presented on videotape.  As the inventor of the Pinnacle, he benefited as a Boston Scientific consultant and preceptor and trained other doctors on the Pinnacle.

Dr. Dennis Miller, urogynecologist

In all, 25 witnesses were called for the plaintiffs to testify about the Pinnacle design, its chemical characteristics and potential dangers.

Pathologist, Dr. Vladimir Iakovlov, (see MND story here)  brought his microscope into the courtroom to show slides of what happens to the polypropylene material as it undergoes oxidative degradation and mesh erosion.  He explained the foreign body response, incited by the presence of mesh, causes inflammation.

What results is scar tissue that encapsulates the mesh as the body tries to distance itself from the invader. See a study he authored in 2013: Mesh is Not Inert.

Scar tissue, also called fibroblasts, move into the mesh holes and cement it into place, making treatment very difficult, said expert, Dr. Tom Margolis.

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 the abdomen of rabbits.

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.

BOSTON SCIENTIFIC

Obtryx II

Meanwhile, during the same November 2014 time period, the trial of four other women was underway in Charleston, West Virginia.

Jacqueline Tyree, and the others, claimed their Boston Scientific Obtryx Mid-Urethral sling used to treat stress urinary incontinence, was defective.

They were awarded more than $18 million by the Charleston jury.

Boston Scientific is one of seven mesh manufacturers facing product liability cases filed over their proprietary mesh products. As of today, there are 25,274 cases pending in the MDL court with 15,811 listed as closed, which may mean they are in the process of being settled.
Last May, BSC announced it would settle 37,000 of its outstanding cases. See MND story here.

Maria Cardenas,  August 18, 2014

Boston Scientific Trials So Far

The Eghnayem Miami trial was the first federal bellwether for Boston Scientific, designed to gauge how juries would respond to the evidence and the relative value of the cases.

Boston Scientific had two successful outcomes earlier in 2014 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 raw polypropylene plastic material was not to be used to make medical devices. Background here.

In July 2014, Boston Scientific was successful in its Pinnacle Pelvic Floor Repair Kit trial filed by Diane Albright and heard 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 2014 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.

Pinnacle Mesh

Pinnacle Pelvic Floor Kit

The Pinnacle Pelvic Floor Repair Kit, cleared by the FDA 510(k) process to market in 2007, is no longer on the market in the U.S.

The polypropylene mesh implant was cleared based on it being “substantially equivalent” to another device already on the market.

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 lead 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).

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