ARTICLES FROM IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Limitations of Comment k[index]

Courts have been reluctant to extend Comment k and the "learned intermediary" doctrine to medical devices. As we discussed in a previous article in this series, the courts expect that physicians are experts in pharmacology, but do not expect them to be clinical engineers.[3] While the courts do not generally require that warnings be given to the patient, they do not allow the manufacturer to assume that the physician using the device is either competent or knowledgeable. This complicates warnings and puts physicians and device manufacturers in conflict when there is a question of misuse of the equipment. Plaintiffs, of course, love the spectacle of the physician claiming that the device manufacturer should have made the device idiot-proof and the device manufacturer claiming that nothing could be safe in the hands of such an idiot as the defendant physician.

In addition to the fundamental problem of being treated like lawnmower manufacturers, medical device manufacturers must also deal with the differing standards of liability that coexist in the various states. While most states have adopted 402(A) and Comment k, each adopts it within the context of its other laws. These laws affect the standards of proof, the presentation of evidence, and the rules for determining if a warning is properly presented. The net effect is there may not be a single label and set of product information materials that is appropriate for every state.

Business associations have been trying to get Congress to pass a federal products liability law for the past decade. This law, based on the Model Uniform Products Liability Act, would establish uniform standards in all the states. However, there is little chance that this law will pass. It is opposed by the national and state trial (plaintiffs) lawyers associations and various consumer rights organizations.

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