New York sues over device maker's lack of disclosure

Defibrillator design flaw information was critical, a lawsuit brought by the New York attorney general claims. Some say the move interferes with the FDA's role.

By Kevin B. O'Reilly, AMNews staff. Dec. 12, 2005.

New York Attorney General Eliot Spitzer last month filed a civil lawsuit against heart-device maker Guidant Corp. alleging that the company defrauded physicians and patients by failing to inform them of a crucial design change in one of its implantable cardiac defibrillators.

Spitzer's suit asks the court to make Guidant pay back any profit it made from the Ventak Prizm 2 DR Model 1861 defibrillator in question. It is yet another shot across the bow at a company and an industry Spitzer believes has not been transparent enough to the public.

"The real question is whether or not Guidant withheld information from doctors and the FDA," said Robert Sorrentino, MD, a cardiac electrophysiologist at the Medical College of Georgia in Augusta.

Marc Violette, a spokesman for Spitzer's office, said they believe physicians and patients were harmed by not having pertinent information.

"Guidant deprived those physicians of the ability to make a reasoned and fully informed decision about whether to approach their patients with this information and to consult with them about what action to take," he said.

This is not Spitzer's first attempt to force more disclosure to physicians and patients. In June 2004, Spitzer similarly argued that drugmaker GlaxoSmithKline had concealed pertinent information from physicians about its antidepressant drug Paxil by not publishing clinical trial data that questioned the safety and efficacy of its use by children and adolescents. The drugmaker settled the case by making the studies publicly available and paying $2.5 million.