Balancing the Risk in Medical Products

The New York Times recently reported a dramatic increase in complaints regarding artificial hips, widely used in hip replacements. The culprit is the metal-on-metal hip implant, used in an estimated one-third of hip replacements. Serious injuries result from the deterioration of the artificial hip, which often causes fragments to break off while in the body.  The Food and Drug Administration (F.D.A.), the agency receiving the complaints, is responsible for allowing the device to enter the market, in compliance with the agency’s testing requirements and rules for the device.  According to the article, the agency’s rules allow all- metal hip replacements to be sold without testing in patients or tracking performance. However, on May 6th, 2011 the F.D.A. sent postmarket surveillance study orders to manufacturers, requiring producers to study failing devices and the harm to patients. The question is whether this will be enough.

One of the debates in tort reform is whether there should be agency preemption of lawsuits. Proponents argue that government agencies are charged with studying the products, and promulgating rules, regulations and requirements. Therefore, where manufacturers meet those standards, there should be no space for liability to consumers for product failure.  Additional arguments suggest that the money saved from court administration should instead facilitate improving agency research and function. However, dangerous product failures, such as the all-metal hip implant, highlight many counter-arguments. One such counter-argument is that agencies simply are not equipped to handle the knowledge, research, and development required to provide comprehensive standards and monitoring for the variety of products on the market. For example, the F.D.A. oversees food, prescription drugs, medical devices, tobacco, cosmetics, and veterinary medicine. Another argument claims that lawsuits provide valuable knowledge to manufacturers and agencies, through the relevant discovery, facts, and evidence involved in a case. Furthermore, a lawsuit provides a means for recovery to injured consumers. Additional considerations must also include the consequences of lawsuits on the access, price, and availability, of products, as well as the line drawn as to whether a product is risky enough to enough people to warrant these consequences. Certainly, there are advantages and disadvantages to both sides of the preemption argument. Ultimately, at present, tort law has not embraced agency preemption.

Medical devices add another wrinkle to the process. Surgeons and other medical professionals are involved in offering, recommending and installing all-metal hip replacements. The implications on medical malpractice and the learned intermediary doctrine1, implicate surgeons’ judgment when it comes to products that are available and have passed standards, yet are the subject of complaints. Some surgeons have stopped using all-metal hips altogether, as there are other models available that combine plastic with metal. However, some all-metal models have not been the source of complaints. Ultimately, these questions come down to whose cost-benefit analysis consumers will rely on, and who we will hold accountable if these decisions prove to be unsatisfying.

1The learned intermediary doctrine provides that a manufacturer can be shielded from liability for failure to warn where the manufacturer adequately warned a learned intermediary, such as a prescribing physician, who is responsible for warning the patient.

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