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

What about Compensating Plaintiffs?[index]

Plaintiffs argue that Congress cannot mean to preempt tort claims because this would deny them compensation for injuries. Yet this is the point of preemption: if there were no potential injuries, there would be no need for preemption. All preemption implies a limitation of remedies for the larger benefit of the public. In the case of medical devices, there are several protections against dangerous products.

The FDA is the first line of defense against dangerous products. If the FDA detects that the manufacturer is not complying with the IDE, it can terminate the clinical trial. If the product is already on the market, the FDA can seize all of the inventory and prevent any additional shipments of the device. The FDA can also prosecute the company under the criminal laws and can impose substantial fines.

FDA protection is very important because, unlike tort law, it is prospective. The FDA can seize a potentially dangerous device in a very short period of time, removing it from the market until its safety and efficacy can be properly evaluated. A clinical trial under an IDE can be stopped in a few hours if serious problems are detected. Tort actions, in contrast, are only retrospective. The action may not be filed until years after the injury, and the case may not be resolved for a decade.

In cases that involve an IDE, the research must be approved by the Institutional Review Board (IRB) of the institution where the research is performed. The IRB must assure that the FDA research protocol is followed, that the patient's are selected in an appropriate manner, and that the patients are given the information mandated by the FDA.

Medical devices are prescribed and installed by physicians. Even in cases where the device is still in the investigation stage, there is a treating physician. This is because almost all medical device clinical trails are therapeutic research. In therapeutic research the experimental device is implanted to benefit patients as well as to explore its safety and efficacy. There is very little non-therapeutic research with medical devices, especially class III devices.

With both clinical trials under the IDE and devices that have already been approved for marketing, the physician prescribing the device should be aware of the patient's medical condition and whether the device is indicated for the patient's condition. This physician is responsible for assuring that informed consent is really given, that the device is installed without negligence, and that any complications that arise from the use of the device are promptly treated. If the physician does not care for the patient competently, he/she may be sued for professional liability.

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