Legal case asks who to blame for medical device failure

Apr 22 2010

The New York Times: A legal case now pending asks a question increasingly faced by the medical world -- "who should be held accountable when a company sells a flawed product that can injure or kill patients? Is it the company or the people who run it?" Five years ago, two cardiologists discovered that a company had been knowingly selling faulty heart defibrillators that short-circuited and failed, ending several times in the unnecessary death of patients. The case is expected to bring the largest fine ever paid by a medical device maker, but the doctors said "they did not believe simply exacting money from a company was deterrent enough to prevent other company officials from making bad decisions."

According to the Times, "In recent years, the Justice Department has won hundreds of millions of dollars in fines from drug and device makers, including a string of cases in which the companies have pleaded guilty to violating federal laws. But corporate executives rarely face criminal charges in such actions, even though they can be held liable under federal law for regulatory violations that occur on their watch — whether or not prosecutors can prove the executives participated in the wrongdoing or even knew about it."

It is still rare for executives to face criminal prosecution for corporate failings, but that might be changing, like in cases against the makers of OxyContin, charged for allowing the drug to be marketed and promoted illegally. In the case of the defibrillators, the doctors hope it changes the way medical device makers are held accountable. "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" (Meier, 4/20).