The preemption doctrine, a legal theory developed by the American courts, finds its source mainly in the U.S. Constitution.1 Basically, it leads to the recognition of the supremacy of federal law over state law. Under the doctrine, any state law that conflicts with a federal law is void.

This doctrine takes on a whole new dimension in the area of pharmaceuticals due to the broad spectrum of federallyregulated activities and the vast quantity of state-based suits.

The Supreme Court of the United States recently applied the preemption doctrine in a lawsuit that a patient brought against the manufacturer of a class III medical device – an angioplasty catheter.2 The suit, founded on state common law, was dismissed because a pre-market approval system had been implemented under federal law and due to the presence of a clause ensuring the paramountcy of federal over state law.3

But what of health products – like prescription drugs – for which federal legislation does not claim paramountcy over state law? This is the question that the Supreme Court of the United States will hopefully answer in the next few months. In the matter of Wyeth v. Levine4 currently in deliberation, the Supreme Court will be determining whether Food & Drug Administration standards governing information that should appear on prescription drug monographs – standards that result from a complex and complete normative set of federal jurisdiction – supersede state standards that impose additional or different risk disclosure requirements and render them inapplicable. If they do, this could result in the dismissal of all suits and actions based on such causes of action. While there are standards that apply to class III medical devices, federal legislation contains no specific provision regarding the paramountcy, over state law, of federal rules applicable to the prescription-drug approval mechanism. The manufacturer is therefore requesting that the action be dismissed on the grounds that there is an implied preemption doctrine.

Commentary: The Canadian counterpart of the preemption doctrine is the doctrine of federal paramountcy, which holds that a provincial law of general application, like the Consumer Protection Act or the Civil Code of Québec, does not apply if its effects are incompatible with federal legislation and regulations on research, development, commercialisation, marketing, advertising, packaging and drug sale activities that are governed by the Food and Drugs Act and it regulations. However, many actions in the pharmaceutical industry are based on provincial legislation, and seek to guarantee, among other things, a level of quality, safety and information.

Various actions currently pending before the Canadian courts might soon shed new light on the issue.

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On March 4, 2009, the U.S. Supreme Court handed down a 6-3 decision in Wyeth v. Levine5. Penned by Justice Stevens, this ruling from the highest court in the United States dismissed Wyeth’s argument that the “preemption doctrine” is implied in the sale of prescription drugs. Wyeth was therefore ordered to pay Ms. Levine US$6.7 million. Look for our detailed commentary on this decision in our upcoming Bulletin.