A recent vaginal mesh trial judge unsealed emails from a C.R. Bard executive which warned colleagues not to tell Chevron Phillips, the manufacturers of resin based plastic, that the company would be utilizing synthetic materials for medical devices placed in humans. Specifically, Chevron Phillips was not made aware that its material would be used in vaginal mesh products for treatment of pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
Tellingly, a Material Safety Data Sheet (MSDS) was filed with the Occupational Safety and Health Administration (OSHA) that specifically stated “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.”
This warning that the material should not be used in the human body or for permanent contact with human fluids shows an enormous disregard for patient safety by the company C.R. Bard. Just as disturbing is the fact that the Bard Avaulta product, as well as its other products, was not tested in humans prior to being approved by the FDA. Bard’s products were approved through a streamlined process entitled 510(K) which allows manufacturers to base their applications for approval on devices that are already on the market. This can lead to devastating consequences because the existing products on the market have often not undergone testing either.
The unsealed court documents demonstrating that C.R. Bard actively attempted to cover up the fact that the material utilized in its mesh products was never intended to be used in the human body has caused outrage. One jury in California State Court awarded a woman $5.5 million in a case regarding Bard’s Avaulta product.
Interestingly, Bard’s products were pulled from the market in 2012. The timing is curious given that the FDA had requested that manufacturers provide additional information regarding adverse events associated with their products. Additionally, the FDA has required manufacturers to perform clinical testing on their mesh products if they wish to continue marketing and selling them. Bard has repeatedly alleged that it was merely making a “business decision” and had nothing to do with recent allegations that its products were defective.
On April 29, 2014, the FDA announced that they have changed the approval process for transvaginal mesh products used for “POP” or pelvic organ prolapse. These products are now considered high risk products and require premarket approval. This means that manufacturers will have to prove the safety and efficacy of the device before it is sold on the market. As mentioned above, these products were previously approved through 510(K) which is a streamlined approval process that only requires manufacturers to show that their products are based on a predicate device. See our blog post about transvaginal mesh approval process here.
It is estimated that Bard is currently facing approximately 4,000 lawsuits related to its defective mesh products. Some of these cases are pending in the MDL court before Honorable Joseph Goodwin and others are in state court consolidations in New Jersey and California.