Articles on Law, Science, and Engineering

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

Standards for Medical Device Safety[index]

Medical devices have significant risks associated with their use. Some of these risks are due to the patient's underlying ill health - the surgery necessary for a hip replacement poses substantial risk to a frail elderly person. Some risks arise from the nature of the procedure - the eye is so exquisitely sensitive that some patients will have an adverse reaction to an intraocular lens (IOL) irrespective of the device that is used. Finally, and most importantly, there are always trade-offs between functionality and safety - a patient who cannot breath on his/her own and must depend on a mechanical ventilator will be much safer in an intensive care unit than in home care, but economic and psychological considerations make home care more desirable.

Medical device regulation is predicated on a balancing of risks. The MDA does not demand risk-free devices, only devices whose benefits substantially outweigh their risks. This is especially true for the Class III medical devices at issue in most of the cases before the courts. While most Class III devices pose a risk to the patient, this risk is less than the risks posed by the serious diseases these devices are used to treat. If a standard were adopted that medical devices must be risk free, then Class III medical devices will disappear from the market.

This is the core issue underpinning the preemption of tort claims by the MDA -- the FDA, and not a jury, should decide how much risk is acceptable in a medical device. This balancing of cost and risk takes into account the key factor ignored by the plaintiff's lawyers: the benefit of medical devices to persons who are not injured by them:

"Public health is a valid federal purpose, and Congress can reasonably weigh possible loss to the idiosyncratic few against benefits to the public generally . . . The legislative history shows that this was precisely the Congressional intent. Concededly . . . the principle emphasis [was] . . . on the protection of the individual user. But [the legislative history] also shows the intent to "encourage . . . research and development" and "permit new and improved devices to be marketed without delay." . . . Perfection is impossible and a few individuals may be denied full protection at the cost of benefiting the rest."

Whether a tiny plastic valve that allows a hydrocephalic child to develop normally, or an intraocular lens that allows an elderly person to escape the blindness of cataracts, the vast majority of medical devices benefit their users.

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