Articles on Law, Science, and Engineering

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

The Tort System Must Fail at Medical Device Regulation[index]

The tort system's greatest weakness is that the jury only sees the injured plaintiff and the defendant. Whether the court is trying one individual's case, or a class action lawsuit with 10,000 plaintiffs, the jury only sees the risks and benefits to the injured person, measured against the financial gain or other gain of the defendant. The third-party beneficiaries of the defendant's conduct are invisible to the jury.

In a lawsuit against a medical device manufacturer, the jury is asked if the defendant should pay money to the plaintiff to compensate the plaintiff for the injuries allegedly caused by the medical device. What is missing from the jury's view are all the people who benefited from the device. The people who will pay the largest part of any tort award are also missing: the patients who will need the device in the future. Can the jury really fairly decide how much it is worth to these future users to improve the safety of the device? Can this be measured at all if the jury awards would remove the device from the market, making it unavailable to those who might need it in the future?

Tort scholars call these polycentric problems - problems that have no optimal solution. They are not unique to medical device law. A famous teaching case involves the decision whether to make power poles strong enough to remain standing when hit by a car.[3] This protects pedestrians, but increases the chance of injury to the driver who hits the pole. The problem arises because the jury tends to side with whomever is injured in the case before it, thus raising the cost of accidents without sending a signal on how to reduce them.

Tort actions against medical device manufacturers are usually polycentric because juries can never escape their institutional bias toward the injured plaintiffs before them, at the expense of the rights of the invisible potential users of the devices. The only rational way to balance the risks and benefits of medical devices is to defer to an expert agency. This is the system Congress established when it passed the MDA.

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