Articles on Law, Science, and Engineering

Public Policy and the Preemption of State Tort Claims against Medical Device Manufacturers (cont'd)

How does the Tort System Improve Safety?[index]

Plaintiff's lawyers argue that juries, through state tort law actions, should decide whether the risks of a given device outweigh its benefits. Juries assign a monetary value to each risk posed by a device through awards of compensatory damages. Juries would also establish the acceptable bounds of business practices for the medical devices industry through awards of punitive damages. For example, a jury might decide that a device should be removed from the market after a small number of alleged injuries. The manufacturer, in consultation with the FDA, might choose to leave the device on the market because of its benefits. The jury might well award punitive damages against the company because it knowingly left a "dangerous" device on the market.

Manufacturers have three ways to respond to this regulation by jury: 1) spend more money on safety features to prevent accidents; 2) if there is no feasible way to make the product safer, pay increased insurance premiums to pay for the tort claims and for punitive damages for continuing to allow accidents to occur; or 3) remove the product from the market. In the case of a new device, these pressures will discourage the manufacturer from embarking on clinical trials if liability will attach to the device before the manufacturer has a chance to develop basic clinical information about the device.

Plaintiffs demonstrate a naOn the second point, at least, there should be no disagreement: cost matters. The American health care system can no longer ignore the cost of medical care. Medical devices account for only a few percent of the United States health care budget, but even that small percentage matters in a time of shrinking financial resources to pay for health care for the aged and the poor. Any regulatory system that significantly increases the cost of using medical devices will decrease their availability. If the risk of litigation is too high, insurance will not be available and the product will have to be removed from the market.

If availability of the device is reduced, or if it is removed from the market altogether, its benefits to the general public will be lost. The difficult policy decision is whether these benefits to the general public health outweigh the risks to individual health. As Congress recognized when it passed the MDA, it is impossible to achieve this subtle balancing of risks and benefits in the torts system, while also insuring the uniformity and predictability of the legal climate that is essential to the orderly development, testing, and marketing of innovative new medical devices.

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