Clinical Drug Trials on Trial

Clinical drug trials are triggering an increasing number of lawsuits in the US, ranging from wrongful death claims to the right to continue receiving drugs, according to attorneys on both sides of the litigation. (See also Merck Sued Over Vioxx Animal Tests above). Not only has this become a fertile ground for litigation, but plaintiffs have expanded their targets to include almost anyone associated with a clinical trial: doctors, universities, research institutions, drug companies, clinical trial review boards -- even patent holders of certain medical devices. In the past, lawsuits in this area typically arose from some aspect of the trial going awry. In two recent cases involving Amgen, however, the plaintiffs attempted to force the company to continue to provide them with the drug after the trial was terminated. Last year, Amgen halted a trial for a drug to treat Parkinson's disease based on data suggesting brain damage. This posed the question: "Who has the right to stop a trial: the patient or the sponsor?" In both cases it was decided that it was the sponsor's right. In what situations does the patient's right prevail? In the context of providing informed consent, does the subject of the trial have the right to have the risks of taking experimental drugs fully explained or does enrollment in a trial demonstrate informed decision making? These questions were canvassed in a case now on appeal, Dagosto v Fred Hutchinson Cancer Research Centre, No. 02-2-06303-9SEA (King Co, Wash, Super Ct). The answers were unclear as the jury awarded one plaintiff's family $1 million, while it cleared the Fred Hutchinson Cancer Research Center of negligence in the deaths of the other four plaintiffs. It will be interesting to see how the appellate court finally disposes of this issue. For the Amgen decisions see: Abney v Amgen, No. 5:05-CV-254 (ED Ky) and Suthers v Amgen, No. 05-CV-4158 (SDNY), leave to appeal sought. For further information visit: http://makeashorterlink.com/?E13D25A8B Summary by: Abigail Browne