Mesh Medical Device News Desk, March 21, 2018 ~ C.R. Bard, of Murray Hill, New Jersey has been the defendant in a number of transvaginal mesh trials. Here is what some of the evidence from those past trials has shown.
While MND is not in the courtroom this week for the McGinnis trial in Bergen Co, New Jersey, the evidence presented in this product liability case is reminiscent of other product liability trials conducted against C.R Bard.
Courtroom View Network is covering the trial and live feeds are available with a subscription here.
Mary McGinnis was implanted with a Bard Avaulta Support system to treat pelvic organ prolapse (POP) and also the Align transobturator sling to treat stress urinary incontinence (SUI).
Donna Cisson has the same meshes implanted in her.
Cisson sued C.R. Bard of Murray Hill, New Jersey, in July 2013, contending that the Bard Avaulta mesh used to treat pelvic organ prolapse (POP) was defective in design. She was represented by Henry Garrard of Blasingame Burch Garrard.
After a mistrial, the case of Cisson v. C.R. Bard began in July 2013 with Lori Cohen defending Bard. She is the same attorney representing Bard again in the McGinnis trial.
Your editor watched as Cohen made herself known during the Cisson jury selection, smiling, greeting and shaking hands with almost everyone on the defense half of the courtroom.
According to Law 360 when Cohen walks into a courtroom, she owns it.
“Her ability to befriend everyone, from the bailiff to the opposition’s witnesses, coupled with her focus on out-preparing the competition, have led to 55 straight trial victories and landed her a spot among Law360’s Top Female Trial Attorneys.”
However, Henry Garrard marred Cohen’s record and won the Cisson trial with his client being awarded $250,000 in compensatory damages and $1,750,000 punitive damages.
Since Cisson is from Georgia, the state was entitled to 75% of the punitive damages under state law.
Material Safety Data Sheet (MSDS)
Garrard opened the trial with the Material Safety Data Sheet.
The MSDS accompanies raw materials that workers come in contact with during the manufacturing process.
Enclosed in the MSDS was a warning the resin is not to be used in medical devices that are permanently implanted in the human body.
The evidence showed Bard knew about the warning and didn’t want supplier Phillips Sumika to know that’s exactly what it was doing.
Evidence showed emails from Roger Darois, VP of Research for Bard Davol who wrote about supplier Phillips Sumika:
“IMPORTANT.. these suppliers will likely not be interested in a medical application due to product liability concerns.” It was important the PP resin be purchased “through a 3rd party, not the resin supplier to avoid a supply issue once the medical application is discovered.”
As a diversion, Bard created a wholly-owned subsidiary Red Oak Sales Company that purchased resin from Phillips Sumika “without creating suspicion about its use.”
“We need to keep this proprietary,” writes Darois.
“Assuring an ongoing supply of PP is critical to achieving the 2008 revenue and there is currently insufficient inventory on-hand at Secant to accomplish this.”
Secant is a textile manufacturer.
Eve Sherrer was implanted with both a Boston Scientific pelvic mesh and a Bard Align.
Represented by Tom Cartmell in the December 2015 trial in Kansas City, Missouri he told jurors a medical device manufacturer must make sure its device is reasonably safe before it is sold. To do that adequate testing is required, especially if this is a permanent implant. And there should be adequate warnings about the risks and dangers associated with the device.
Cartmell told jurors heavyweight and small pore mesh was first used in the 1960’s for hernia repair. After seeing the potential for expansion, manufacturers were in a race to re-purpose hernia mesh to be used in women and placed transvaginally, that is, through the vagina.
Johnson & Johnson was first with its TVT, marketed in the U.S. in 1998, and soon other “sling in a box” products were developed.
After C.R.Bard purchased the rights to the Uretex mesh, actually a knockoff of TVT, the company began selling it in 2002. But it was considered small pore mesh, less than 1 cm and could produce a hardened scar plate that contracted and encapsulated nerves.
Bard knew this but did nothing to make a larger pore pelvic mesh of 3 cm or more.
Doctors, who are considered the end users of transvaginal mesh, were not told the mesh had a potential to shrink from 30 to 50%, due to scarring. They were not told about the MSDS and its warning not to use the raw polypropylene resin for implantable medical devices.
At the Sherrer trial, Lori Cohen of Greenberg Traurig said the Align is the “Gold Standard” for pelvic mesh products.
Sheerer lost her case at the hands of the jury. ###
MND, Bard Opening Arguments in Federal Transvaginal Mesh case, July 9, 2013
MND, May 23, 2013, C.R. Bard Lawsuits: Rulings Reveal Company Secrets
MND, June 13, 2017, C.R. Bard’s Pelvic Mesh Removed from the Market
Materials Safety Data Sheet
Bard Exhibit #200-1 Marlex Mesh MSDS
MND, July 29, 2013, Bard Faces Plaintiff After Mistrial in First Federal Case Against Transvaginal Mesh