LITTLE ROCK, Ark. (Legal Newsline) - The Arkansas Supreme Court has affirmed the dismissal of a lawsuit against AstraZeneca Pharmaceuticals, deciding that nine plaintiffs haven't suffered any harm because of the company's marketing of Nexium.
Associate Justice Elana Cunningham Wills and the Court agreed with the decision by Searcy County Circuit Judge Michael Maggio, who said the plaintiffs' complaint was well-researched but provided "little or no proof" that AstraZeneca had committed an actionable tort.
The plaintiffs alleged that AstraZeneca marketed Nexium as superior to Prilosec, a similar heartburn drug produced by the company that had its patent expire in 2001.
Nexium's labeling had been approved by the Food and Drug Administration.
"The information included in the labeling of a new drug reflects a determination by the FDA that the information is not 'false or misleading,'" Wills wrote Nov. 5.
"By approving information to be included in the drug labeling, the FDA has determined that the information complies with its rules and regulations. Therefore, if the FDA labeling supports the statements made in the advertising for an FDA-approved drug, the statements are not actionable under the (Arkansas Deceptive Trade Practices Act)."
Attorneys James Beck and Mark Herrmann, on their blog Drug and Device Law, said the only worthwhile recovery in the suit would have been for attorneys fees.
Beck and Herrmann said the case was significant because Arkansas' became the first state supreme court decision to "affirm the dismissal of a consumer fraud action against an FDA-regulated defendant based upon a safe harbor provision relating to government-regulated conduct."
The safe harbor provision of state consumer protection law bars companies from being sued for conduct approved by a federal or state regulatory agency. Beck and Herrmann say the concept also shows up in the laws of Connecticut, Florida, Indiana, Maine, Masssachusetts, Montana, Nebraska, New Mexico, Ohio, Rhode Island, South Carolina, South Dakota, Utah, Washington, and Wyoming.
From Legal Newsline: Reach John O'Brien by e-mail at firstname.lastname@example.org.