ARTICLES FROM IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE

Authors' Conclusions[index]

While King v. Collagen Corp. has profound implications for medical device liability, it does not eliminate tort law claims for a provably defective device. Had plaintiff been able to show that the Zyderm she was given was contaminated, or that the defendant's manufacturing process had not conformed to the FDA's requirements, she could have proceeded with her claim. What the case does do is eliminate the claims that are, at core, based on no more than the idea that if a patient is injured, the device must be defective.

On the other hand, state law adopting products liability as set forth in section 402(A) of the Restatements leaves victims of known and acceptable risks of a medical device to suffer his own damages alone, while those benefiting from the device joyously reap its benefits.

A critical element in the King opinion is that an award of compensatory or other damages caused by a section 402(A) product is a form of state regulation that conflicts with FDA regulation of Class III medical devices. However, if state law were restructured as no-fault compensation distributing consumer risks, the competition between federal and state law may no longer exist: if there is no way to escape the liability for an injury, then there is no reason to change the label or the manufacturing process.

It remains to be seen whether states will reformulate product liability laws to avoid the tension with federal regulatory law found by the King Court. Like federal tort law, no-fault liability is likely to be opposed by the national and state trial lawyers associations, although it might be embraced by various consumer rights organizations. While simplifying many claims, it would not end litigation. Thus the plaintiff in the simple case involving a known idiosyncratic reaction would be much better off, but a plaintiff claiming a more controversial injury, such as Ms. King, would still have to litigate whether Zyderm could cause her disease.

King v. Collagen Corp. also changes the dynamics of the regulatory process. Manufacturers usually seek to have their devices approved with the least amount of FDA scrutiny. We might posit that the researchers who developed Zyderm probably did not appreciate the 10 years that it took them to get the product through FDA approval. Yet, had Zyderm breezed through FDA approval without much specific intervention by the agency, the court might not have found the plaintiff's claims preempted. It is certainly questionable whether Class I or II devices would be entitled to protection under the holding in King.

There is now, therefore, a similarity between FDA scrutiny of a medical device and the examining procedures of the U.S. Patent & Trademark Office. The courts are often influenced by the outcome of a strong traversal of claim rejections, especially when both the examiner and the inventor fully air important issues which may now be before the court.

Similarly, a manufacturer seeking approval for a medical device may seek more scrutiny by the FDA to deflect the effects of unknown risks. The manufacturer may weight the benefits of Class III regulation (reduced liability) against the delay and costs of the heightened scrutiny entailed by Class III status. We may also be treated to the first cases in which a manufacturer demands that a device get closer attention than the FDA wants to give it. This may be especially important for devices that are used in home health care and other environments where the potential for legal liability are very high.

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