Preemption has its strong points

by • May 1, 2009 • UncategorizedComments Off on Preemption has its strong points1936

© 2009 The Medical-Legal News


While consumer and states’-rights advocates had their day in the sun in Wyeth v. Levine, the pro-preemption side makes strong points as well.
In a statement, attorney Bert Rein of Washington, D.C.’s Wiley Rein, which was a part of Wyeth’s legal team, said in reaction to the ruling in the Kansas City Star on March 20, “The medical and scientific experts at the FDA are in the best position to weigh the benefits and risks of a medicine and to assess how those benefits and risks should be described in the product’s label.”
He thus argues that non-medical people, acting as jurors, should not be making decisions on drug administration standards.
In the Star posting, Rein noted: “Congress created federal public health agencies such as the Food and Drug Administration because it takes experts to consider the complexities and the risks and benefits of prescription drugs and medical devices.” He went on to say that “by permitting lay juries to second-guess the FDA’s decisions on what options doctors should have available in administering prescription drugs, the Supreme Court’s decision in Wyeth v. Levine creates uncertainty for patients and doctors by placing the experience of a single patient above the public health interests of everyone.”
He finished by noting that “elevating risk avoidance over utility is not always the best way to regulate.”
More of Rein’s argument can be read
Pro-preemption attorneys also argue that having mismatched standards imposed by juries, in potentially as many as 50 states, could be a nightmare for drug makers, with subsequent higher prices and less innovation for consumers.
In an article on, Steven Weisburd of Dechart in Austin noted that the Wyeth v. Levine ruling only applies to failure-to-warn cases (not negligent manufacture or design defect cases) and only applies where preemption is implied by a federal agency, such as the FDA, as opposed to being expressly stated by Congress.
He said, “The decision is disappointing from an industry perspective, but it is limited to this category of implied preemption in failure-to-warn claims.”
Supreme Court Justice Clarence Thomas, whose conservative federalism views caused him to concur in the judgment, echoed by saying, according to, that “‘congressional and agency musings’ about possible intent to preempt state suits are not adequate substitutes for explicit preemption provisions enacted into law.” 

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