The Supreme Court in Riegel v. Medtronic, Inc. recently denied a man an award for damages when his balloon catheter ruptured during heart surgery due to over-inflation. The man sued the manufacturer of the catheter, alleging that the device violated New York state law and that the defective product caused him to suffer from severe and permanent injuries. After hearing the facts, the Supreme Court found that the federal Medical Device Act prevented the man from seeking remedies based on his state common law claims of strict liability, breach of implied warranty and negligence.
The Medical Device Act bars a State from establishing any requirements that are 1) different from or in addition to any federal requirements which 2) relate to the safety and effectiveness of a medical device. The purpose of the Act is to provide federal oversight to the introduction of new medical devices. The Act categorizes devices into three categories, with more federal oversight regulating the most complex of the devices. Class I, which include items such as bandages or examination gloves, is subject to the lowest level of oversight. Examples of devices that fall within Class II are powered wheelchairs or surgical drapes. Class III devices, which include replacement heart valves and pacemaker pulse generators, are those that are purported to be used for sustaining human life, that significantly prevent impairment of human health, or that present a potential unreasonable risk of illness and injury. Class III devices are subject to the most federal oversight. According to the Act, medical equipment manufacturers cannot market or make changes to Class III devices without FDA approval.
In determining whether to grant pre-market approval, the FDA applies a balancing test that weighs the probable health benefit against the probable risk of injury or illness. Thus, a device that has the potential to cause injury could still be approved if the FDA determines that its benefits significantly outweigh that risk.
In the case at hand, doctors inserted the Evergreen Balloon Catheter into the patient’s coronary artery in attempt to dilate it. Despite the manufacturer’s warnings not to use the device in patients with a heavily calcified coronary artery and to refrain from over-inflating it past its rated burst pressure, doctors did both of those actions. As a result, the patient suffered a heart block, was placed on life support, and underwent an emergency coronary bypass surgery. In response, the man brought a suit against Medtronic, claiming that its catheter was designed, labeled, and manufactured in violation of NY state law. The Supreme Court found that the Medtronics catheter in question complied with Class III pre-market approval requirements of the FDA. As a result, the Court held that the man was pre-empted from bringing any state law claims because in doing so, it would impose additional requirements expressly prohibited by the Medical Devices Act.
While this case imposes some limitation on an individual’s ability to recover from damages sustained in medical injury case, the Court left open several issues. First, the case only applies to medical devices and doesn’t include approved drugs. Additionally, the Court only addresses the impacts of the Medical Device Act on Class III devices. Finally, the case only applies to devices that have met the federal requirements. Devices that are not in compliance with regulations are still subject to claims of strict liability.
If you or someone close to you has been injured by a malfunctioning medical device, you may still be able to recover. The laws on medical malpractice and product liability are complex, but we are here to help. If you have been injured in the state of California due to a malfunctioning device, please call us at The Law Offices of Greenberg & Rudman LLP at 1-800-ALAWPRO (1-800-252-9776) for a free consultation regarding your rights.
The Law Offices of Greenberg & Rudman LLP are an experienced and respected Southern California law firm dedicated to protecting the rights of people injured through the negligence of others. With an extensive 
