A landmark episode, brought to light by two Minneapolis cardiologists, changed the way the medical device industry deals with the safety of heart implants. Now these very same doctors, some five years later, have raised a fundamental question about medical safety and the law: who should be held accountable when a company sells a flawed product that can injure or kill patients? They ask: Is it the company or the people who run it? The lawsuit that arose from the doctors’ revelations involves heart defibrillators once made by the Guidant Corporation (now part of Boston Scientific.)
Guidant continued to sell the devices, even after it discovered that some might short-circuit and fail. The defibrillators, intended to protect people from erratic, potentially fatal heart rhythms, have been associated with at least six deaths, including that of a 21-year-old patient of the two cardiologists. The doctors don’t believe enough has been done to protect the public when corporations knowingly put defective medical devices on the market.
Short of executives facing prosecution, drug companies see the financial settlements reached by the Justice Department as a price of doing business, according to industry critics. In the corporate world, the likelihood that an executive would face criminal prosecution depends on the industry and the shifting interests of prosecutors. In recent years, the Justice Department has placed a particular emphasis on charging individuals in bribery, antitrust and other financial cases. While officials of medical products companies have sometimes been prosecuted, one of the few recent criminal cases involving corporate officers of a major medical manufacturer was in 2007, when federal prosecutors in Virginia brought misdemeanor charges against three top executives of the drug company Purdue Pharma, which makes the prescription narcotic OxyContin.
The problems involving Guidant’s heart devices came to light in 2005 when The New York Times published an article based on interviews with Dr. Hauser and Dr. Maron. It was soon disclosed that Guidant had known that two of its defibrillator models could fail catastrophically by short-circuiting just when they were charging up to send out a life-saving jolt. While the company fixed the flaw in newer devices, Guidant never alerted doctors or regulators about the problem. Patients continued for a time to get the potentially flawed older defibrillators because the company did not pull the implants from hospital shelves.
The case highlighted problems with the way makers of medical devices disclosed defects, and it resulted in both greater regulatory oversight of the industry and increased self-regulation. Prosecutors charged that Guidant had knowingly sold the potentially flawed defibrillators, but that issue was not addressed in the company’s plea agreement this month. The two misdemeanor charges in that agreement relate to the completeness and accuracy of the company’s filings with the FDA.
Source: New York Times
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