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) 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.
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