June 21, 2006

Everyone involved with clinical trials, including sponsors, sites and investigators, faces a complex landscape of criminal and civil legal risks, according to experts speaking at a recent industry conference.

Recent legal claims filed over clinical trials include fraud, failure to obtain informed consent, battery, negligence, breach of fiduciary duty, unjust enrichment, breach of contract, and breach of the right to be treated with dignity as a research subject, John Isidor of Schulman Associates Institutional Review Board said June 19 at the Drug Information Association annual conference in Philadelphia.

While the dignity claim might sound frivolous, he said, it resulted in an out-of-court settlement totaling several million dollars in a case brought by patients who had undergone amniocentesis as part of a clinical study. The payout occurred even though none of the women suffered any physical harm, Isidor said.

In another case, the court held that the informed consent document was a legal contract and that the investigator was serving as the sponsoring pharmaceutical company's agent, a view that many people in the industry would consider questionable, Isidor said. The result was that the judge ordered the company to provide the plaintiff with a drug for chronic fatigue syndrome free of charge for a year -- even though the plaintiff was, in fact, receiving a placebo.

Courts do reject some plaintiffs' arguments, Isidor said, citing two recent cases in which patients sued to force Amgen to restart a trial of its artificial GDNF treatment for Parkinson's disease. The court rejected the plaintiffs' claims of breach of contract, since the sponsor had the stated right to unilaterally shut down the trial.

The federal government pays close attention to the way trials are run, as well. Ann Begley of the law firm Kirkpatrick & Lockhart Nicholson said the FDA and the Office for Human Research Protections (OHRP) use their enforcement powers to protect clinical trial participants and ensure data integrity, although the OHRP's authority extends mainly to federally funded studies or to sites that have subjected themselves voluntarily to its rules. (http://www.fdanews.com/did/5_121/)