As you’ve probably noticed from the nigh-inescapable television commercials for plaintiff’s law firms, controversy over pelvic mesh inserts, which are pieces of mesh used in surgeries to return pelvic organs to their correct position, has spurred a landslide of cases across the country.  Tens of thousands of cases have been aggregated in a multi-district litigation before Judge Joseph Goodwin in the U.S. District Court for the Southern District of West Virginia, while thousands of cases remain before various state courts.  Responding to the filings in the Philadelphia Court of Common Pleas, the Philadelphia court’s Complex Litigation Center created a mass tort program for the pelvic mesh litigation this past February. So far, over 850 cases have been filed in the Philadelphia court. However, a recent ruling by the Center’s coordinating judge, Judge Arnold New, may vitiate the court’s jurisdiction over the cases. Moreover, the ruling raises interesting questions about the extent of raw-material and component-part immunity under the federal Biomaterials Access Assurance Act.

Alleging that pelvic mesh implants were defectively designed, manufactured and marketed, hundreds of plaintiffs brought claims in Philadelphia against Pennsylvania-based Secant Medical, the supplier of the mesh used in the implants, as well as the manufacturers and sellers of the implants, including Boston Scientific, Ethicon, and C.R. Bard.  Secant moved to be dismissed from the action, arguing that it was entitled to immunity under the Biomaterials Access Assurance Act (BAAA).  The BAAA was passed by Congress in 1998, after the legislature observed that suppliers of raw materials and component parts for biomedical devices were being sued for defects in the end product, and that even though these suppliers had “very rarely been held liable,” they were withdrawing from the market in part because of litigation costs. 21 USC § 1601(7)-(8).  In response to this problem, the legislature passed the BAAA to “assure the continued supply of materials for lifesaving medical devices.” 21 USC § 1601(17). The statute applies to all suppliers of raw materials and manufacturers of components for biomedical implants, other than suppliers of silicone gel and envelopes used in breast implants. 21 USC § 1602(2)(D)(iii). Under the act, the supplier is not liable for any harms allegedly caused by the end product (other than commercial loss or loss of value of the end product) as long as the supplier was not the manufacturer or seller of the end product, and the materials or parts it supplied met the contractual specifications. 21 USC § 1603(b)-(c), 1604(a).

As is so often the case in statutory interpretation, the devil is in the definitions.  The statute defines a “component part” as “a manufactured piece of an implant,” whether or not it has significant non-implant value or applications. 21 USC § 1602(3). The BAAA considers an entity to be a manufacturer of the end-product if they were registered or required to register with the Secretary of the Food and Drug Administration (FDA) under the Food, Drug, and Cosmetic Act (FDCA). 21 USC § 1604(b). The Act also invites agency regulation into BAAA immunity by empowering the FDA secretary, upon notice and opportunity for hearing, to declare that an entity was in fact required to register under the FDCA and is therefore not entitled to immunity. Id.

At oral argument over the applicability of BAAA immunity in the Philadelphia cases, mesh-manufacturer Secant argued that it was entitled to immunity because its mesh was only a component of the implant.  Secant emphasized that it delivered the mesh to the implant-manufacturers in large rolls that the implant-manufacturers then modified, including by cutting and sterilizing. Plaintiffs maintained Secant should not be entitled to supplier-immunity because “[f]undamentally, the mesh is the only thing that is implanted.” They argued that BAAA immunity only applies to suppliers of materials that are integrated into products that contain a number of other components, such as hip implants.

Judge New found Secant’s arguments more persuasive, ruling that Secant was entitled to BAAA immunity because it was not a manufacturer of the end product.  As it is the practice of the Court of Common Pleas to only release a memorandum of opinion if the case is appealed, we can only speculate at this time on what basis Judge New ruled. However, the case raises the interesting issue of what constitutes a “component” in a product that has fewer moving parts than something like a hip implant or pacemaker.  Adopting the Philadelphia mesh plaintiff’s interpretation of the BAAA would not only be unworkable but would undo the entire purpose of the BAAA. As noted above, the statute defines a component as “a manufactured piece of an implant.” Attempting to restrict this definition based on the arbitrary line-drawing that the plaintiffs suggested–such as how many other pieces there are or what percentage of the product the component represents–would mire component-manufacturers and raw material-suppliers in litigation over a product that they did not design or sell, the very unpredictability and expense that Congress sought to alleviate through the BAAA.

The dismissal of Secant from the Philadelphia mass tort litigation also throws a wrench in plaintiff counsels’ attempt to keep the cases in front of what is generally considered a plaintiff-friendly jury pool. Secant was the only Pennsylvania-based defendant, which means the remaining defendants have a strong case for removal to the multi-district litigation in federal court. However, the possibility that plaintiffs will appeal Secant’s dismissal may keep the pelvic mess mass tort program in Pennsylvania courts a while longer.