Trial design, exclusion criteria, vulnerable groups seen causing trial suits.(Litigation)

PHILADELPHIA -- Emerging theories aside, there are three primary areas currently fueling clinical trials litigation--design of clinical trials, exclusionary criteria used to recruit subjects and the handling of vulnerable populations, defense attorneys told a Center for Business Intelligence (CBI) meeting here Dec. 4-5.

These issues touch sponsors, IRBs, CROs and investigators in varying ways, and each of these entities bears varying responsibility depending upon the particular circumstances and nature of the suit, said Frederick Rom, partner with Womble Carlyle Sandridge & Rice PLLC, in Research Triangle Park, NC.

Rom discussed several emerging legal theories that are "coming out of nowhere." They are broad, catchall concepts that, while not yet been established in the courts, are gaining some traction. One is the concept of fiduciary responsibility, which says the defendant "has a special relationship with the plaintiff and has an affirmative duty, an obligation, to act in their best interests," Rom said.

"There is a disconnect in the public's perception of clinical trials, in that they are seen as valuable to human health, but they are being handled improperly," Rom said. "People are very quick to bring lawsuits when they feel their expectations have not been met."

In this climate, he said, "plaintiffs' attorneys are seeing blood in the water."

Physicians clearly have this responsibility to their patients, but now the concept is beginning to be applied to investigators, IRBs and CROs. Whether sponsors could get caught in this net is as yet unclear, but in all cases, the concept would lay open the clinical trials community to liability on several fronts. "This argument hasn't found a receptive court yet, but it's out there and the lawyers are working on it," Rom said.

In trial design, several established legal tactics are finding new life in the current climate, Rom said. These include negligence, fraud, product liability and lack of informed consent. An area related to informed consent, misrepresentation, is becoming a "favorite theme," particularly in the recruitment of trial subjects. "Plaintiffs use this to take a swing in their closing arguments because they can really go after the sponsor's motivations," he said.