Doctors and Medical Device Companies Square Off on Questions of Liability
As medical devices grow increasingly sophisticated, disputes have begun to arise between doctors and medical device manufacturers over who bears the responsibility when a patient is injured by a device. In some instances, manufacturers try to hold doctors liable for using a device improperly, and in others doctors try to hold manufacturers liable if the device did not function correctly. Disputes such as these bring two different theories of liability together in unforeseen ways: medical malpractice and products liability. How these disputes are resolved could have an important impact on how courts assess liability in future malpractice cases.
American Medical News, a publication of the American Medical Association, reported last month on an orthopedic surgeon in Kentucky who implanted a pain pump in a patient’s shoulder to administer painkillers after reconstructive surgery. The patient later returned, complaining of shoulder pain. An examination revealed that the patient had developed chondrolysis, a condition that causes significant deterioration of joint cartilage. It can be caused by certain types of anesthetic if they are continuously administered into or near the joint. The pain pump had evidently caused the chondrolysis because of the type of anesthetic administered.
The patient sued the pump manufacturer, alleging that the company failed to warn the doctor of the risks of complications from this particular use of the pain pump. The manufacturer brought the doctor in as a third-party defendant and alleged that the doctor used the pain pump “off-label,” meaning in a way not intended by the manufacturer or approved by the Food and Drug Administration (FDA). The case is still in progress in Kenton County, Kentucky.
Doctors have a duty to their patients to provide diligent care. Because of their special training, they occupy a particular position of trust under the law and have unique responsibilities. They must rely, however, on a wide range of products and equipment in order to provide state-of-the-art care, which means they must rely on various warranties and assurances from third-party companies. These include pharmaceutical companies and medical device manufacturers. Doctors can only provide care to the best of their ability with the knowledge available to them. They are responsible for learning how to use medical devices such as pain pumps, but in the event that something goes wrong, the question becomes whether or not they used a device correctly or if the device was somehow defective.
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The U.S. Food and Drug Administration (FDA) announced a series of initiatives in late September that it hopes will further ensure the safety of the food supply. The proposed measures, known as the Retail Food Safety Action Plan, would apply to food service establishments such as stores, restaurants, and schools. The Plan will focus on food safety rules at the state and local levels. It establishes a set of “model rules” to help managers in food service establishments handle food safety procedures, and standards for training personnel on food safety issues. The Plan follows a series of recent stories in the news about food contamination such as the recent cantaloupe recall.
The Consumer Product Safety Commission has approved new 
Jack D. Lebowitz
Vadim A. Mzhen



