Articles on Law, Science, and Engineering

"Voluntary" Mandatory Reporting[index]

I believe that manufacturers and user facilities should consider volunteering more information than is mandated by the FDA. This is especially important for user facilities because their FDA-mandated reporting duties are so limited. (The special problems of manufacturers will be discussed in a future article after the new rules for manufacturer reporting have been promulgated.) Failing to comply with the FDA-mandated reporting requirements can result in FDA sanctions, JCAHO accreditation problems, and state licensing actions. More importantly, it can undermine the user facility's internal incident reporting system and exacerbate tort (malpractice) liability against the user facility.

As discussed previously, risk management systems are most effective when they are designed to detect problems before they result in patient injuries. Unfortunately, this is the antithesis of the FDA reporting requirements. A user facility that reports only the statutory minimum to the FDA will face the problem that this minimum will tend to become the standard for the institution's own reporting system. This is a natural result of the general reluctance of personnel to file incident reports and the habit of lawyers to recommend that one should do no more than the law requires. Thus denied important information about product risks, the institution will not be able to effectively anticipate and prevent patient injuries.

The risk of increased legal liability is two fold. The first has already happened, in that the chronic failure to recognize and report human factors problems has made them seem inevitable. The result is that the user facility is more likely to be found negligent for improperly using the device, rather than the failure being seen as one of device design. The second risk is a natural consequence of the combination of the failure to report common problems and a new series of legal decisions that limited the legal liability of medical device manufacturers.

Several federal courts have recently ruled that FDA regulation provides medical device manufacturers with some protection from products liability litigation. Simply put, manufacturers may not be held liable for an FDA-approved device design, manufacturing process, or label. They still may be held liable for injuries due to a broken or malfunctioning device. In the case that established this protection, the patient allegedly suffered an adverse reaction to a collagen injection. (Collagen is treated as a medical device by the FDA.) In her lawsuit she claimed the design was defective and that she should have been warned of the danger of the adverse reaction.

The court found that the FDA had balanced the risks and costs of the device design when it approved the device for marketing. Further, the FDA's approval of the label established as a matter of law that it provided adequate information to the physician-user of the device. (To the extent that this protection depends on the FDA carefully examining the device at issue, it will be limited to devices that have been through the premarket approval process. It also presumes that the manufacturer did not withhold material information from the FDA.) The effect of this limitation on products liability will be to encourage lawyers to sue device user facilities. In particular, the preemption will be strongest for human factors-related problems. As long as the FDA approves the device and its instruction manual, it will be the user facility's problem if the device is difficult to use and thus increases user errors. The only remedy for this bind is for user facilities to systematically report all problems with the device to the FDA and to pressure the FDA to require modifications in the device. If the FDA is put on notice of the problem and it acts against the manufacturer, it may remove the products liability protection by effectively limiting the FDA approval of the device.

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