The U.S. Supreme Court has taken up a series of cases that addresses the issue of whether federal agency approval of medical devices and drugs shields manufacturers of those products from liability under state laws. In a case decided Feb. 20, the Court held that federal law preempts state liability claims if certain medical devices received U.S. Food and Drug Administration (FDA) approval. The Court also considered if that same protection should be extended to drug manufacturers.

In Riegel v Medtronic Inc., the Court held that the 1976 Medical Device Amendments (MDA) contained express preemption language. Congress intended to create a federal oversight responsibility and, therefore, intended to limit the rights of those injured by medical devices. Allowing state law liability claims would create a conflict between federal and state law requirements, according to the Court. The preemption language, the Court held, "bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA."

FDA's premarket approval process is its most rigorous medical device review and is applied only to certain medical devices — in this case, a balloon catheter used in angioplasty. "These devices may enter the market only if the FDA reviews their design, labeling, and manufacturing specifications and determines that those specifications provide a reasonable assurance of safety and effectiveness. Manufacturers may not make changes to such devices that would affect safety or effectiveness unless they first seek and obtain permission from the FDA," according to the opinion.

In a Feb. 21 article, BNA (subscription required) quotes the attorney arguing on behalf of the plaintiff as saying that this decision curtails patients' ability to receive compensation when they are harmed by medical devices that fail. Justice Ruth Bader Ginsburg, the lone dissenter in the case, argued Congress had no intent to curtail the public's right to compensation when injured because "a legislative design to preempt state common-law tort actions" does not exist in MDA and because FDA did not provide any federal compensation remedy.

According to a Feb. 26 BNA article, the Court denied review Feb. 25 of another medical device liability suit from Texas involving a heart valve that was voluntarily recalled after a supplemental FDA premarket approval process concluded the valve needed an infection-resistant coating. The Court was asked to overturn a Texas appeals court ruling that the state claim was preempted by the MDA language.

The same day, the Court heard arguments in a similar case from Michigan involving drug manufacturers. According to another Feb. 26 BNA article, in Warner-Lambert Co. v Kent, a lawyer representing pharmaceutical companies argued that Michigan's tort-reform law, which allows liability suits against drug makers in cases where the company has misled FDA during or after the approval process, is preempted by federal law. The basis for the argument is the same conflict between state and federal requirements as found in Riegel.

The drug makers were supported in their arguments, according to the article, by the Solicitor General's office of the U.S. Justice Department. In an amicus curiae brief, the Bush administration argued that FDA and the drug makers have a relationship that is "inherently federal." What is unique about the administration's position, according to a Feb. 26 New York Times article, is that FDA has historically argued these liability lawsuits protected patients; under the Bush administration, the lawsuits are generally regarded as conflicting with FDA's ability to do its job and with FDA's discretion about whether it was misled.

The New York Times reported in its March 4 edition that the Court voted 4-4 on the case March 3. Chief Justice John Roberts recused himself because he owns stock in the drug maker Pfizer Inc., the parent company of Warner-Lambert. The tie vote means that the suit against Warner-Lambert may proceed in Michigan courts.

According to the Times article, the Court agreed to hear yet another drug liability case in the October term, Levine v. Wyeth, that could extend preemption even further if products have received FDA approval.

There are at least three implications from this line of cases. First, the Court seems to be moving toward extending preemption over state tort law to a broader category of products under FDA's jurisdiction. Since Riegel was decided by an 8-1 vote, it seems clear that the Court is interpreting the MDA language to be clearly preemptive. This gives manufacturers liability protection via FDA approval and removes citizens' ability to receive compensation for injuries from faulty products — at least under the most rigorous FDA reviews.

Second, this is also an instance in which the law fails the public. The Court is ignoring FDA's inability to regulate these products effectively. Two recent studies point out how severely limited the FDA is in carrying out its mission after years of staffing losses and budget cuts. One is a 2006 report from the Institute of Medicine. The other report is from FDA's own Subcommittee on Science and Technology, which was asked to assess "whether science and technology at the FDA can support current and future regulatory needs." The reports are scathing indictments of governmental failure.

Third, both Congress and the executive branch have an obligation to make sure the FDA can regulate effectively these products if indeed the responsibility is "inherently federal." In addition, it is incumbent upon both branches to ensure that patients harmed by ineffective or dangerous drugs and faulty medical devices have a way to hold manufacturers responsible. If the Court finds that federal law removes liability suits as one incentive to industry to produce safe products, the other branches must restore protections to American citizens.