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 — Posted Dec. 12, 2005

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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.

But some legal observers say that Spitzer's creative, aggressive approach to patient protection preempts the Food and Drug Administration's regulatory role.

Ted Frank, director of the liability project at the American Enterprise Institute in Washington, D.C., said states shouldn't get involved and federal law should not be preempted.

In cases where a device has received the FDA's premarket approval, as Guidant's Ventak Prizm did, Frank said the act of balancing a device's risks versus its benefits should properly be left in the federal agency's hands.

"The danger here is why Eliot Spitzer?" Frank said. "Why not the fellows in Kansas and Connecticut or Nevada? Before you know it, you have 50 regulatory bodies trying to do the same thing. There's no guarantee they're not going to want contradictory things, and there's a great danger of overwarning."

New York's case against Guidant

Guidant started selling the Ventak Prizm 2 DR Model 1861 defibrillator in 2000. In February 2002 the company uncovered a design flaw that caused an electric short and prevented the device from sending a lifesaving shock when needed, the Spitzer complaint alleges. After making changes to the device in April 2002, Guidant continued to sell the devices manufactured prior to the design change without directly informing physicians of a problem, according to the lawsuit. The pre-April 2002 device caused at least two deaths, Guidant said last June.

The company reported problems related to the device to the FDA's adverse events database as required by law, but in his lawsuit Spitzer argues that New York law required Guidant to reveal to physicians that it changed the Ventak Prizm's design.

"Concealing information, or providing misleading information, that is material to a decision regarding which [defibrillator] to purchase constitutes deceptive conduct that is directed at both the physician who prescribes a device and the patient who relies on that physician's professional judgment," the complaint states.

A Guidant spokesman declined to comment on the pending litigation. In July, Guidant appointed University of Miami electrophysiology professor Robert J. Myerburg, MD, to head an independent panel to recommend guidelines to better track device-related adverse events and improve communication with doctors and patients.

The Spitzer suit is the latest in a string of bad news to hit Guidant. The company recalled more than 100,000 defibrillators and pacemakers this year, is under investigation by 34 other state attorneys general and has been hit with nearly 100 recall-related lawsuits, according to a Securities and Exchange Commission filing last month. The FDA began looking into Guidant's handling of the Ventak Prizm 2 in May, but it's unclear when the investigation will conclude.

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Case at a glance

The People of the State of New York v. Guidant Corp.

Venue: New York County Court
At issue: Whether the State of New York can force a medical device company to pay back profits on a defibrillator physicians purchased before the company made changes to the product, changes the company allegedly made without informing physicians or patients.
Potential impact: The suit, if successful, could encourage drug- and device-makers to go above and beyond FDA requirements when disclosing potential problems to physicians and patients. Some legal observers say that could preempt the FDA's role and increase the regulatory burden with little benefit to patients.

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