HACKENSACK, N.J. (Legal Newsline) – A former C.R. Bard vice president told a jury April 6 that the use of a resin substance in pelvic implant devices had not been communicated to a supplier of the resin because if the supplier found out its resin material was being used for medical purposes, it might prohibit its availability.
“That could be one of the outcomes - it could be difficult to source the material,” said Roger Darois, former vice president of research and advanced technologies at C.R. Bard, during the trial at the New Jersey Superior Court in Bergen County.
Streaming video coverage of the trial was provided to Legal Newsline by Courtroom View Network.
However Darois, today retired, said there had been no wrongdoing.
“You were asked a number of questions about hiding information from Phillips Sumika (Polypropylene Co.) about C.R. Bard’s use of the resin,” said Cliff Merrell of Greenberg Traurig, attorney for C.R. Bard. “Is that an accurate characterization?”
“No,” Darois responded. “Hiding implies something wrong. We actually chose not to remind them (Phillips). We had no reason to contact them that we were still using their resin (for medical), we were buying it from a distributor, there was no way they could prevent us from buying this product legally.”
Phillips Sumika was a Woodlands, Texas-based supplier and marketer of polypropylene resins used for many purposes, including medical implants - particularly those involved in the repair of hernias. The Chevron Phillips website states Phillips Sumika "has permanently shut down its manufacturing facilities and is no longer involved in the production, sale or marketing of polypropylene."
Darois appeared as a witness for C.R. Bard in the lawsuit filed by Mary McGinnis of North Carolina. McGinnis sued C.R. Bard of New Jersey in New Jersey Superior Court over the pelvic mesh implanted into her groin region in 2009 for bladder prolapse. She alleges the device was unsafe and caused inflammation and scar tissue, resulting in intense pain.
The mesh, a spider web-shaped clear polypropylene device with connecting arms that comes in a box kit, had to be removed from McGinnis over subsequent surgeries.
In addition to pain, medical bills and quality of life damage, McGinnis also alleged C.R. Bard went ahead and marketed its Avaulta and Align implant devices beginning in 2007 knowing there were health concerns and without properly warning patients and doctors about possible complications.
Adam Slater of Mazie, Slater, Katz & Freeman in Roseland, New Jersey, attorney for McGinnis projected on a screen a medical caution statement titled "Material Safety Data Sheet" (MSDS), required by the Occupational Safety and Health Administration (OSHA) and that accompanies resin shipments.
The statement read, “Do not use this Chevron Phillips Chemical Co. material (resin) in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”
Another statement advised not to use the material for “Brief or temporary implantation unless provided under an agreement which acknowledges the contemplated use.”
Darois agreed he had written a 2004 email that suppliers would likely not be interested in medical applications of the polypropylene product because of liability concerns. He also later advised company officials “Ensuring an ongoing supply of polypropylene is critical to achieving the 2008 revenue and there is currently insufficient inventory on-hand to accomplish this.”
Shakespeare Monofilaments, a company that had supplied C.R. Bard with polypropylene monofilament for use in hernia and pelvic mesh devices, declined to provide more monofilament because of liability concerns over medical use. Slater said an offer had even been made to indemnify the monofilament producer against potential lawsuits brought by people for harm caused them by the products, but the offer was turned down as well.
“They (Shakespeare) still said 'Nothing doing; we won’t do it under any circumstances,' correct?” Slater asked.
“That’s correct,” Darois said.
Darois indicated the greatest good was to acquire the material so medical implant devices for hernias and pelvic problems could continue to be produced for the people who depended on them. He said the devices had a history of successful use.
“If we can’t get the material, there are a million surgical patches used each year,” Darois said. “Half of the hernias in the U.S. use them. To cut this off would be irresponsible unless we had data. The devices continue to be successfully used even after the caution.”