Assessing Protections for Biomaterials Suppliers 12 Years After the Biomaterials Access Assurance Act

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The growth of the biomaterials market, which analysts expect to reach $58.1 billion by 2014, shows that biomaterials suppliers have flourished by relying on the Biomaterials Access Assurance Act of 1998 (BAAA), 21 U.S.C. §§ 1601-1606, to forestall product liability litigation, and by resorting to additional legal defenses or extra-legal mechanisms to minimize the costs of such litigation. While more than 12 years have passed since the enactment of the BAAA, its substantive protections remain unclear. Additional legal and extra-legal means of protecting biomaterials suppliers do exist, however, and component suppliers to medical device companies should consider such means to diminish their legal risks.

The BAAA

OVERVIEW

In the scientific literature, a “biomaterial is a nonviable material used in a medical device, intended to interact with biological systems.” The medical use of biomaterials dates back to 1588, when patients with cleft palate first received gold plate implants. Today, biomaterials include various ceramics, synthetic polymers, substances derived from biological processes and composites.

A series of high-profile lawsuits in the 1990s resulted in some biomaterials suppliers avoiding sales to medical device manufacturers. This created fears that a public health crisis would ensue and adversely affect innovation. In response, Congress passed the BAAA in August 1998. Although traditional common law doctrines protected biomaterials suppliers in product liability suits prior to the passage of the BAAA, Congress determined that the biomaterials field warranted special procedural protections because of its role in improving public health and its economic importance.

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