An interesting legal question has come up in a vaginal mesh lawsuit recently. It has to do with whether or not a third party that manufacturers one component of the device should share liability with the primary manufacturer that assembled and sold the final product.
The devices that are the cause of action in a Pennsylvania vaginal mesh lawsuit are pelvic slings manufactured, marketed and sold by defendants Boston Scientific (which recently prevailed in a vaginal lawsuit that was heard earlier this summer) and Johnson & Johnson subsidiary Ethicon. These are made from a mesh manufactured by Secant Medical LLC.
Secant sells large rolls of this material to medical device manufacturers such as the defendants in the present case. This mesh can then be used for any number of purposes, including the treatment of hernias (the original purpose for the the mesh), a pelvic sling, or anything else. The implication is that Secant simply sold the mesh to end-users, and had no control over how that product was ultimately used.
Attorneys for Secant argue that the defendant in this vaginal mesh lawsuit should be released from the litigation prior to discovery (the process during which each party has the opportunity to examine all pertinent evidence in the case before the trial). They cite a provision of federal law, known as the “Biomaterials Access Assurance Act” (21 U.S. Code § 1604 (b) (1)), which specifically states that:
“A biomaterials supplier may, to the extent required and permitted by any other
applicable law, be liable for harm to a claimant caused by an implant if the biomaterials
supplier is the manufacturer of the implant.”
The question here is whether or not Secant manufactured the entire device – as argued by the plaintiff's counsel – or simply a component of it. Using hip implant litigation as a precedent, the defense argues that the mesh material manufactured and sold by Secant to Boston Scientific and Ethicon was “part of a more complicated system,” similar to a hip replacement. On the other hand, the plaintiff argues that, while their clients did in fact cut, sterilize and modify the material specifically for use as a vaginal mesh, the mesh itself is the only component of the device that caused the injury.
It's an important distinction - and a complex one as well. If the judge in this case determines that the mesh was simply a component, Secant could well be dismissed from the suit. If, not the other hand, he rules that the mesh material by itself constitutes a device on its own, the company will face liability along with its customers.