Day One for Boston Scientific's Pinnacle Mesh Kit
Goodwin, from Charleston WV, was filling a vacancy in another federal judge’s courtroom while his West Virginia court is the scene of another trial pitting four women against Boston Scientific over another of its products product, the Obtryx Mid-urethral sling.
It didn’t help matter that the judge had developed a cold. He occasionally sneezed into a tissue and looked quite miserable.
With 67,000 cases now amassed in West Virginia, consolidated in multidistrict litigation, Judge Goodwin has had no choice but to put together the cases of four women at a time, all with similar questions of fact posed to the nine-person jury.
Did Boston Scientific make and market a defective product and were its instructions to doctors, the end users, inadequate for the women to be planted with the Pinnacle Pelvic Mesh kit.
The jury weighed in loud and clear in September during the last trial in a Dallas courtroom delivering an unprecedented $73.5 million loss for the company.
The morning was spent picking jurors. There would eventually be nine – three black and one white woman and five men, some with Hispanic surnames. Judge Goodwin was the Southern gentleman explaining to the jurors the difference between federal court and their state courts. He also shared a recipe for salsa.
During the selection process, Judge Goodwin was seething when one prospective juror told the courtroom her opinion. Her husband, a doctor, had been sued multiple times and these women were not injured; they were looking for a payday!
“Thank you,” he said dismissing her from jury duty. Later he told the court he wished he could force that woman to watch the trial so she’d know what the issue was all about.
Jim Perdue, of Perdue and Kidd, Houston made the opening statement to the jury.
Plaintiffs Amal Eghnayem, Juana Betancourt, Maria Nunez, and Margarita Dotres sat in the first row on the plaintiffs’ side. Two of the women are Spanish speakers and needed interpreters who quietly spoke into headsets on the other end of the room.
Perdue said the evidence will show that Boston Scientific, like every corporation, has a responsibility not to expose the public to a needless risk in order to sell its products. The proof will show Boston Scientific (BSC) ignored that duty and made the choice not to tell anyone about the risks of the Pinnacle Pelvic Floor Repair kit.
Launched in 2005, documents showed during a meeting in November of that year, BSC green lighted the Pinnacle in order to fast-track it to market.
“BSC is losing market share, let’s make a knockoff of Perigee and let’s get this done quickly” ~ inner office document from Boston Scientific
Perigee is the mesh kit made by competitor American Medical Systems and was considered first in the marketplace. Johnson & Johnson had the Prolift kit for pelvic organ prolapse already on the market. Boston Scientific was last to launch.
Mesh kits are the largest medical device to hold back prolapsing organs, a condition known as pelvic organ prolapse (POP). Pinnacle would eventually have bragging rights- it offered 105% coverage of the pelvic floor, the largest among competitors.
“Speed is A#1” the document continued.
Let’s not go with the biologic material decided the team because it would “increase launch time” and “add complexities.”
Plaintiffs’ attorney, Jim Perdue (Perdue and Kidd) delivered to the jury the opening arguments on behalf of the four women. The Material Safety Data Sheet (MSDS) as front and center as it has been in other mesh cases.
The MSDS contains warnings about chemical preparations so workers and material handlers know how to handle the chemicals with caution. Polypropylene (pp) mesh is a resin polymer which is obtained from various sources and sent to processing plants where it is blended with additives to create resin pellets that are sold to mesh makers.
In this case, the raw material came from Chevron Phillips, a petroleum company. Polypropylene (pp) is a petroleum by-product. The mesh made for Boston Scientific was also known as Marlex, or MarFlex HHM TR-130. It is the same basic polymer used to make the majority of synthetic pelvic mesh and hernia mesh implants.
Perdue showed the jurors the MSDS contains a warning that the polypropylene was not appropriate to put in permanently implanted medical devices.
Specifically it says:
The MSDS says “Do not use this Chevron Phillips chemical material in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues unless the material has been provided directly from chevron Phillips chemical under a contract which expressly acknowledges the contemplated use.”
Chevron Philips was uncomfortable that BSC might be using the mesh for medical applications and Perdue showed a purchase contract from 2006. It said BSC had the responsibility to ensure the pp is suited to the correct application.
Despite the promises by the company, BSC never had time to test the Pinnacle Pelvic Mesh kits before the sold it to the public. Perdue said there were no clinical trials and no animal testing. Only post-market trials were conducted by doctors who were hired by Boston Scientific to conduct sponsored studies.
Molly Craig of Hood Law of Charleston, South Carolina introduced herself to the jury and introduced her team, lawyers from shook Hardy & Bacon of Kansas City, Missouri.
They all needed surgical options, they all needed to have mesh, she insisted.
“Thank goodness there are treatment options for POP. It is a terrible condition.” ~ attorney Molly Craig
The plaintiffs must prove by the preponderance of evidence each claim. Despite the fact that the plaintiffs get to make their case first, Craig asked jurors to consider both sides. “There are both sides of a story before you make a decision.”
The case must move quickly and a videotaped deposition of sales rep Even Brasington was the first witness. Now a WorldWide Marketing VP for BSC, Brasington was shown notes from a national sales meeting in 2010.
“Our #1 goal is to outsmart our competitors and take share. It’s about winning!”
Not a consistent message with #1 in patient safety is it, he was asked by the attorney on the video. Brasington answered that the message at a national sales meeting is to fire up sales reps so they are motivated.
ProteGen was the first Boston Scientific product to ever hit the market. By 1999 it was recalled for not performing as expected but the failure led to a ProteGen Recall Task Force inside the company. BSC would learn lessons from the failure, or at least that was the intention – Test future products before they go to market. Did BSC do that with the Pinnacle? Not prior to launch, said Brasington.
On cross examination, the defense did not do itself many favors. On video, an attorney’s voice off camera asked what marketing does? They uncover clinical unmet needs in the market. How do they do that? By establishing relationships with key market leaders or thought leaders, also known as preceptors. Dr. Dennis Miller’s name was introduced.
A urogynecologist from Wisconsin, Dr. Miller is long known to be a preceptor ofr trainer of other doctors in a consulting capacity for industry. Former with Ethicon (J&J), Miller went to BSC to push the Pinnacle pelvic mesh kit, his own invention of a unique delivery system for the mesh. The VP of marketing agreed Dr. Miller received royalties from BSC due to his patent of the Pinnacle.
Also appearing on videotape Phillip Ratcliff appeared. He was the marketing manager of Women’s health for BSC. By mid 2005, Johnson & Johnson, C.R. Bard and AMS were eroding BSC sales with their synthetic meshes. J&J had the Prolift, AMS had the Apogee and Perigee. Ratcliff’s job would be to fill the holes by developing synthetic mesh to compete.
Develop a “Quick knock-off Perigee with benefits” was the goal identified to “Plug holes in their portfolio” documents showed. Big average selling price and Big margins. What were the margins of cost to price for the Pinnacle? In the 80% range, he answered.
On November 7, 2005 a memo shown on the screen listed the priority, “Speed is #1.”
Three Trials in One day!, Mesh News Desk November 2, 2014
Background on ProteGen
Protegen: the Grandmother of them All