According to the Wall Street Journal â€¦
â€œJudge Wilson said he was granting Merck's motion to dismiss Ms. Ledbetter's case, citing an FDA policy rule issued in February 2006. That rule says the agency's approval process trumps state law in how manufacturers of health-care products must warn consumers about their potential risks.â€
A victory for Merck, sure â€“ but more importantly, a victory for FDA authority -- and for sanity.
As Dan Troy has written:
â€œJudgments concerning the need for and formulation of statements in drug labeling and advertising are squarely within FDAâ€™s statutory authority and expertise, and they deserve deference from courts and juries applying state tort law. The agency carefully considers the scientific evidence relating to a proposed warning, as well as the public health consequences of including or omitting particular language from drug labeling or advertising. FDA should not have to act to safeguard its control over the label each time a plaintiff brings a state law action challenging the absence of a particular warning in drug labeling. Where FDA repeatedly has reviewed particular drug labeling and advertising content, state courts and juries should not second-guess the agencyâ€™s scientific determinations.â€
â€œFDAâ€™s legal authority over drug labeling and advertising is broad, and its expertise is unmatched. The agencyâ€™s decisions on the content of these communications deserve substantial deference from courts applying state tort law in product liability cases that challenge the adequacy of drug warnings.â€
It should also be noted that the FDA has consistently stood behind the concept of preemption through both Republican and Democratic administrations.