Cardiologist Testifies In Favor Of Medical Device Safety Bill

Congress hearings into a bill that would provide injured patients the right to file a product liability lawsuit against the maker of a malfunctioning device, are continuing.

Dr. William Maisel, who is a cardiologist at Boston's Beth Israel Deaconess Medical Center and a director of the Medical Device Safety Institute, testified before Congress for a second time in four months, in support of the Medical Device Safety Act of 2009. Dr. Maisel also chairs the Food and Drug Administration's Circulatory Advisory Committee. He testified that although the FDA does an "exceptional job" of monitoring medical device safety, it cannot be expected to monitor the safety of devices that it has already approved. According to Dr. Maisel, it's simply not possible for the agency to monitor every single product that it approves. Medical devices are extremely complicated, and while the agency may find sufficient data to approve of a device before distribution in the market, the devices may reveal flaws that only make their presence felt after months and years of wear and tear. These flaws could result in serious injuries, or even death.

In May, Dr. Maisel testified before a House panel in support of the Medical Device Safety Act of 2009. The bill aims to overthrow the immunity that medical device companies enjoy from lawsuits. In Riegel vs. Medtronic, the Supreme Court decided in 2008, that because the device in dispute had been approved by the FDA, the company was immune to product liability lawsuits filed by patients who were injured after using the product. That interpretation has effectively meant that thousands of patients, who have been implanted with devices, have no recourse to civil justice in the event of injuries caused by a malfunctioning medical device.

Medtronic Inc., the company that was at the center of dispute leading to the Supreme Court ruling, has enjoyed immunity from lawsuits that would otherwise have been filed because of defects in pacemakers and Implantable Cardiac Defibrillators (ICDs). Across the country, including California, hundreds of patients have been injured from malfunctioning cardiac devices. In many cases, the device has emitted an electrical shock that was strong enough for the person to suffer serious pain, or even death. Removing the implanted devices requires extremely complicated and specialized surgery, that comes with the risk of failure. Several patients have died in the process of having the defibrillators removed. Other patients, who continue to live with the defibrillator, live in the fear that the electric jolt and the searing pain, will return. These patients have been effectively robbed of the right to hold Medtronic accountable, and to seek justice for their injuries.

California product liability lawyers and patient safety advocates have expressed their strong support for the Medical Device Safety Act of 2009. Even the New England Journal of Medicine has voiced its support for a patient's rights to sue a company in case of medical injuries. Earlier this year, the Supreme Court held that patients, who have been injured through use of defective pharmaceutical drugs, can hold the drug maker accountable. We hope that patients injured by medical devices will soon have the same right.