Medical Device Link.

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).

Mercury Dental Fillings. In six European countries, dentists cannot legally fill teeth with silver amalgam (mercury). Mercury fillings were almost outlawed in Canada recently. A smattering of litigation could result if the public ever becomes concerned about mercury's toxicity in this context. Perhaps more than 100 million people are potential plaintiffs who could file claims for alleged health problems attributable to long-term exposure to mercury in dental amalgams.

Ophthalmic Laser Surgical Equipment. Some laser eye-surgery procedures are performed in shopping malls. Patients often entertain high expectations for postoperative clarity of vision. Even if few outcomes are adverse, those patients whose sight was impaired may sue both doctors and the makers of laser eye-surgery equipment. The doctors' liability exposure may be limited by law, but not the equipment makers'.

Copyright ©2003 MX