According to unsealed court records, CR Bard Inc. sold vaginal-mesh devices made of a plastic that its manufacturer warned was not suitable for human surgical use. Managers at Bard’s Davol unit used a resin-based plastic made by a Chevron Phillips Chemical Co. unit to produce hernia-repair mesh after the material’s supplier officially registered a warning that it shouldn’t be permanently implanted in people, according to e-mails and documents in a lawsuit over Bard’s implants.
In 2004 and 2007 e-mails filed in federal court in West Virginia, a Davol executive warned colleagues not to tell Chevron Phillips or other resin makers that the company was using the material in medical devices placed in humans.
Suppliers such as Chevron Phillips “will likely not be interested in a medical application due to product-liability concerns,” Roger Darois, the Davol executive, said in a March 2004 e-mail. “It is likely they do not know of our implant application. Please do not mention Davol’s name in any discussion with these manufacturers.”
Thousands of women who blame Bard’s Avaulta line of implants for their injuries said the files show Davol officials knew the resin-based mesh wasn’t proper for human implantation and tried to cover up their use of the material.
Bard Mesh Injury Trials
Bard, faces a July 8 trial in Charleston, West Virginia, over claims its mesh device harmed Donna Cisson, 54. Cisson, who lives in Georgia, will use the e-mails in the trial over whether the Avaulta design was defective and Bard failed to warn of the risks. Cisson claims the device caused her pain, bleeding and bladder spasms that required follow-up surgeries.
West Virginia MDL
Judge Goodwin is overseeing 20,000 lawsuits against Bard, Johnson & Johnson, Endo Health Solutions Inc.’s American Medical Systems, Boston Scientific Corp., Coloplast Corp. and Cook Medical Inc. alleging injuries from vaginal mesh implants. All of the mesh lawsuits are consolidated in multidistrict litigation or MDL, in West Virginia. Cisson’s case will be the first against any of those companies to go to trial before Goodwin, who is coordinating the pretrial exchange of information.
3 more bellwether trials involving Bard’s vaginal mesh are scheduled before Goodwin after Cisson’s case. The women allege erosion of the mesh, which is designed to bolster up weakened pelvic muscles and treat urinary incontinence, can cause organ damage and bleeding and make sexual intercourse painful. They said the meshes, pushed in place through vaginal incisions, degrade and shrink over time.
U.S. Food and Drug Administration officials estimate that 300,000 women had pelvic organ prolapse surgery in 2010 and mesh was used in a third of the procedures. Agency data showed more than 250,000 incontinence surgeries for women that year, about 80 percent involving vaginal-mesh implants.
The agency last year ordered Bard, J&J and other mesh makers to make three-year studies of rates of organ damage, infection and painful sex linked to the devices after women’s groups called for their removal from the market.
Sales Stopped and Plaintiffs’ Verdicts Hit Hard
J&J, said last year it would stop selling four lines of vaginal-mesh implants after complaints and lawsuits about the devices. A jury in Atlantic City, New Jersey, decided in February that J&J and its Ethicon unit must pay more than $11 million in damages to a woman who blamed the company’s Gynecare Prolift implant for her injuries.
A California state court jury last year awarded $3.6 million to a woman who blamed Bard’s Avaulta Plus implant for injuring her. The Avaulta mesh, sold in the U.S. since 2005, were pulled off the market last year. A Bard official said in a January 2012 internal e-mail that, in response to the FDA ordering safety studies on vaginal-mesh devices, the company planned to pull Avaulta devices off the market that year.
Key Safety Document
Cisson’s lawyers said that Phillips Sumika, a Texas-based unit of Chevron Phillips Chemical, filed a required safety data document, called a “Material Safety Data Sheet,” with the U.S. Occupational Safety and Health Administration about the Marlex polypropylene used in some Bard hernia and vaginal implants. On the 2007 document’s front page, Phillips Sumika put a “Medical Application Caution” about the product.
“Do not use this Phillips Sumika Polypropylene Co. material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues,” according to the disclosure unsealed in Cisson’s case.
“Do not use this Phillips Sumika Polypropylene Co. 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 Phillips Sumika Polypropylene Co. under an agreement that expressly acknowledges the contemplated use.”
Chemical Reactions Cause Mesh Erosion
The warning stated that the resin-based plastic “may react with oxygen and strong oxidizing agents, such as chlorates, nitrates and peroxides.” According to Cisson human bodies can produce such oxidizing agents and the reaction can cause the mesh to erode.
Despite the warning, Davol officials bought Phillips Sumika’s resin-based plastic from other companies that bought it in their own names, according to Cisson’s lawyers. Davol used the material as the base for hernia-repair and vaginal-mesh devices, the attorneys said in court papers.
Business Professor Slams Bard
Erik Gordon, a University of Michigan business professor, said the Avaulta case shows an abuse of the 510(k) process. According to Gordon, “The alleged conduct is unconscionable how can anyone ever trust a company that knowingly disregards safety warnings from its own supplier and covers up its conduct?”
The judge also unsealed Bard officials’ and medical experts’ pretrial testimony on the lack of human testing of the mesh before the company began selling it in the U.S. in 2005. The mesh was cleared through the FDA’s 510(k) system, which allows medical devices to reach the market without human testing if regulators decide they are similar to products already for sale. JNJ, Bard and other competitors already had vaginal-mesh inserts on the market when the Avaulta Plus insert Cisson received was approved in 2007, according to court filings.
The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 2:10-md-02187, and Cisson’s case is Cisson v. C.R. Bard Inc., 2:11-cv-00195, U.S. District Court, Southern District of West Virginia (Charleston).
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.