The Biomaterials Access Assurance Act of 1998 and Corporate Supplier Liability: Who You Gonna Sue?

Abstract

The DuPont Company spent $26 million litigating more than 650 lawsuits over implants used to treat temporomandibular joint syndrome (TMJ) after DuPont had supplied a raw material to the medical device manufacturer. The Biomaterials Access Assurance Act of 1998 (BAAA) was enacted with the aim of preventing suppliers, such as DuPont, from becoming entangled in this type of product liability litigation. This note explores the legitimacy of BAAA and the relative impact it may have on businesses that supply raw materials or component parts to medical device manufacturers. Part II overviews provisions of BAAA, while also discussing common law doctrine that protects component part suppliers from liability and pertinent Food and Drug Administration regulations. Part III reviews the TMJ implant litigation that helped spur Congress' enactment of BAAA. Part IV examines the purported need for BAAA and examines procedural nuances of the Act. Part V concludes that, in theory, BAAA is a legitimate attempt to codify well-established common law. As a result, the BAAA may afford biomaterials suppliers a comfort level that will allow them to safely reenter the market and achieve the Act's purported goal: to prevent a shortage of raw materials, thereby preventing a shortage of life-saving medical devices.