Medical Implants in the New Biomedical Frontier

More than a million tissue transplants and medical device implants were performed in 2005, according to available estimates. It is reported that the organ and tissue transplantation market in the U.S. was valued at more than $11 billion in 2005. Today, the multi-billion-dollar biomedical industry continues to expand well beyond its more humble origins of blood, organ and tissue banking. These developing biotechnologies have forced courts to address novel issues and concerns regarding a new generation of biosurgical implants outside the parameters of settled judicial and statutory frameworks dealing with medical implants. The widespread usage of such new implants has also called into question the settled case law that hospitals and physicians may not be held strictly liable for the implantation of defective medical device products. See, eg ADDENDUM * TORT LAW: IV: Passing the Essence Test: Health Care Providers Escape Strict Liability for Medical Devices), 50 S.C. L. Rev. 463 (1999). New types of implants, such as cryopreserved heart valves, may be manufactured from human tissue, but they bear little resemblance to the tissue banking practices sought to be protected under the state blood shield statutes enacted over a quarter of century ago.