Originally Published MX March/April 2003

GOVERNMENTAL & LEGAL AFFAIRS

Other potential arenas of legal action in medical product liability exist besides those discussed in the article. The following areas, while not severely risky, bear watching—especially by companies directly involved in them.

Clinical Trials. Both the company conducting trials and the clinical research organization are exposed to risk. Patient-safety concerns with respect to clinical trials involve informed consent, improper volunteer recruitment, and conflicts of interest among clinical investigators and business partners.

Cochlear Implants. Some plaintiffs allege that the design of a prominent implant admits infections that cause meningitis. A national plaintiff law firm has launched a Web site devoted to lawsuits against the product (http://www.lieffcabraser.com/cochlear.htm).