It should come as no surprise.
The first civil lawsuit against medical device maker C.R. Bard, manufacturer of the Avaulta Transvaginal Mesh, had been going on for little more than a week when it was revealed that the supplier of the plastic material used to manufacture the device had warned the company that their product – polypropylene – was unsuitable for use in the human body.
As far back as 2008, Canadian researchers had determined that toxic chemicals – specifically, quaternary ammonium – was leaching into substances stored in polypropylene containers. It cause mild to serious skin irritation and even burns in the gastro-intestinal lining, and in extreme cases can even result in convulsions and death. The Environmental Working Group has classified polypropylene as a “low to moderate” health hazard. Furthermore, an expert witness, Dr. Anthony Brennan, testified that polypropylene is prone to break down inside the human body, which can result in serious inflammation among other problems. Dr. Brennan was one of several expert witnesses called upon to provide testimony. Naturally, lawyers for C.R. Bard filed motions to exclude much of this expert testimony under the Daubert standard, which allows a judge to limit or throw out expert testimony based on his own opinions of an expert's reliability – regardless of whether or not that judge has any training or experience in the area at the center of the litigation (in this case, medicine and biochemistry).
In the present case, the judge did grant Bard's motion for many of the experts – but found that Dr. Brennan, whose expert report states that he is “knowledgeable about...physical and chemical aging of polymers and nanocomposites,” was indeed “qualified to offer opinions on the design” of the mesh.
As if that weren't bad enough news for the corporate defendant, recently unsealed court records show that an executive at C.R. Bard's Davol division (where the meshes were manufactured) sent emails to other executives, warning them not to say anything to their suppliers about using polypropylene in medical devices to be implanted in patients. In 2004, that executive, Roger Darois, stated that polypropylene suppliers will “not be interested in a medical application due to product-liability concerns.” (Not surprisingly, Darois is now a vice-president at C.R. Bard.)
Naturally, another senior executive at the company, Scott Lowry insists that there was every reason to believe their product was safe.
He had no comment about the emails, however.
Feely, Jeff and David Vorecos. “Bard Used Mesh Plastic Found Unfit for Humans by Supplier.” Bloomberg, 26 July 2013.
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