Criminal investigators at the U.S. Food and Drug Administration have joined the agency’s probe into how Guidant Corporation handled problems with its heart devices, according to Thursday’s New York Times.
The FDA has been looking more closely at Guidant’s products, and recently completed an inspection of the company’s St. Paul, Minnesota Cardiac Rhythm Management facility. That inspection led to a Class I recall of some of Guidant’s best-selling pacemakers.
One aspect of interest to the FDA is whether Guidant properly reported device failures and manufacturing changes. Executives of Guidant maintain that they properly reported all issues to the FDA.
FDA spokeswoman, Julie Zawisza, told the Times that the agency does not confirm or deny ongoing investigations, and a spokesman for Guidant, Steven Tragash, told the newspaper that he was not aware that the company had been contacted. He added that the company was aware that some former employees had been contacted by the FDA.
Once the FDA completes its investigation, it can choose to forward its findings to the Justice Department, which can take a number of actions, including bringing civil or criminal charges against the company.
The FDA investigation is not Guidant’s only problem. Both the New York Times and the Wall Street Journal reported on Tuesday that Guidant had paid doctors to implant its medical devices. The Times said that Guidant had paid physicians $1,000 for implanting an improved electrical component, called a lead, into three patients.
Guidant stated that they ran programs like the electrical lead evaluation so they could improve future models. However, according to the Times, critics of the industry have long charged that some companies use research studies to mask what are really marketing efforts.
The Times editorial page also weighed in on the issue of physician ties to medical device makers, stating that “many surgeons have ties to manufacturers, ties that are often not revealed to their patients or to hospitals.” The editorial went on to say that while doctors maintain they need close relationships with manufacturers so they can help perfect medical devices, there are several ongoing investigations to determine if these consulting arrangements are in fact “unethical and unlawful payoffs for using the devices."
