Liability And Medicine In The 21st Century

Today’s New York Times had an article by Barry Meier  that discusses the case of a 33 year old man who died following the attempted removal of a lead from his heart. The lead went from his implantable defibrillator into a heart blood vessel and then to his heart muscle. The article is in the Business Section of the Times because of the implications of this particular device extraction.


Basic defibrillator terminology and function


A defibrillator is an electronic device that is designed to deliver small electrical shocks to a person’s heart when the heart is not beating properly. An implantable defibrillator consists of a generator and leads. The generator is both the sensing device that determines if a shock is needed and the shock generating device. The generator is implanted under a person’s skin and superficial muscles. Leads are very thin electrical cables that come from the generator and go into the heart through blood vessels. Leads sense the beating of the heart and deliver the information to the generator. If necessary, the generator sends the shock back to the heart by way of the leads. It’s a feedback system. Any part of the system, leads or generator, can malfunction or become defective in some way.


The story


The manufacturer of this particular device had full FDA approval for its use. However, after it was in use, the product underwent an upgrade and the newer leads were thinner than the originally approved leads. The newer leads, unlike the original leads, had not undergone testing in humans before going on the market. Unfortunately, the newer leads had a high rate of breakage and had to be recalled after more than 235,000 people had them implanted. Doctors and their patients had to decide, on a case by case basis, whether or not to remove the leads or leave them in place when they malfunctioned.


A 2008 court ruling stated that Class III devices, which receive the closest FDA scrutiny, are protected from lawsuits against the manufacture even if the device is faulty. This leaves patients and families without legal recourse should the device fail and cause injury or death. There is now a suit before the Supreme Court that is weighing whether or not to extend this protection to drug manufacturers.


I’m not writing about this because I have a solutions or even a clear opinion. Clearly the FDA did not approve the second type of lead. Clearly this man’s widow and small children are in distress. Was this an FDA oversight or was it a manufacturer’s breakdown in the clinical research process? At what point should manufacturer liability end? Would closer scrutiny and oversight of device and drug manufacture stifle research? If a patient is fully informed (in the proper language, at the proper time, etc) of the risks of a procedure and still decides to have the procedure, should the doctor and the manufacturer be liable? Should it be only the doctor? Only the manufacturer? Neither?


These are only a few of the questions in this case and in the others that were thrown out of court and in the others that are to follow.


I welcome comments and discussion on this. Perhaps there is an answer.


Mary Lou Bernardo, PhD, MSN


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