One of the standards used to determine liability in a personal injury case is whether or not the defendant knew, or should have known, that the cause of action would cause harm to the plaintiff. Another standard is whether or not the defendant failed in its duty to warn the plaintiff(s) about the hazards product or circumstances that led to the defendant's injuries.
One of the defendants in the current lawsuits over pelvic mesh products is C.R. Bard, which designed, marketed and distributed a number of of these devices. They were manufactured at Bard's own facility as well as two European companies, Sofradim Production and Tissue Sciences Laboratories.
According to the complaint:
“Defendants’ Pelvic Mesh Products contain monofilament polypropylene mesh and/or collagen. Despite claims that polypropylene is inert, the scientific evidence shows that this material...is biologically incompatible with human tissue and promotes a negative immune response in a large subset of the population implanted with Defendants’ Pelvic Mesh Products” .
Do you think perhaps C.R. Bard's researchers should have known about that?
Polypropylene is a form of plastic that is used for many purposes – including automotive parts, containers and packaging (such as plastic shopping bags), some types of fabrics (used for rope and clothing), plastic wrap and more. It is classified as a thermoplastic, meaning that it can be heated and molded into many useful shapes and materials. It is also recyclable; polypropylene containers are identified by the number 5 within the triangular symbol and the letters “PP.”
As you may know, these pelvic mesh products were approved under 501(k) Clearance, which allows a manufacturer of medical devices to bypass the usual FDA approval process if it can be demonstrated that the devices is “substantially similar” to a device already on the market.
The questions surrounding the safety of these devices have been well covered on many websites. The FDA began receiving complaints in 2005, only three years after mesh devices had been approved (mesh has been used for over fifty years to treat hernias). Over the next three years, the FDA received a thousand reports of “adverse events” associated with mesh devices. A public health notice was finally issued in 2008 in which the FDA acknowledged that perhaps these complications were not so rare as was previously thought.
In November of that same year, medical researchers at the University of Alberta published an article in the journal Science reporting that chemicals from polypropylene laboratory equipment were leaching into medical experiments, affecting the outcomes. This raised serious questions about the use of polypropylene in food-grade packaging.
What are these chemicals? One of them is called DiHEMDA, an ammonium salt that is considered a “biocide” (yes, that literally means “life-killer”). The other substance is called oleamide. Although there is a natural form oleamide produced by the human body, what gets leached out of polypropylene is a synthetic industrial lubricant.
The effects of these chemicals on human tissues are not fully known, though they do appear to have effects on the nervous system.
IN RE: C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation. U.S. District Court for the Southern District of West Virginia, Charleston Division, MDL. No. 2187. Available at http://www.wvsd.uscourts.gov/mdl/2187/pdfs/FinalMasterComplaint.pdf .
McDonald, G. Reid, et. al. “Bioactive Contaminants From Disposable Laboratory Plasticware.” Science, vol. 322 no. 5903 (7 November 2008).
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