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West Virginia High Court Vacates $4.47M Judgment; FDA Warning Letters Not Matter Of Law

CHARLESTON, W.Va. -- (Mealey's) The West Virginia Supreme Court of Appeals on Nov. 18 reversed a $4,475,000 consumer law judgment against Johnson & Johnson concerning the marketing of Risperdal and Duragesic after agreeing with the defendant that the judge in a bench trial improperly relied on Food and Drug Administration warning letters as a matter of law (State of West Virginia, ex rel. Darrell V. McGraw, Jr. v. Johnson & Johnson, et al., No. 35500, W.Va. Sup. App.).

Risperdal is an atypical antipsychotic drug.  Duragesic is a brand of the narcotic pain drug fentanyl that is administered through a skin patch.

In 2003, West Virginia Attorney General Darrell V. McGraw Jr. sued Johnson & Johnson and subsidiary Janssen Pharmaceutical Products L.P. in the Brooke County Circuit Court, alleging that they violated the state Consumer Credit and Protection Act by communicating false and misleading information to health care providers about the drugs.  McGraw alleged that the defendants misrepresented Risperdal's risk of hyperglycemia and diabetes and the need to monitor patients' blood glucose.

McGraw also alleged that the defendants misrepresented the abuse potential of Duragesic and downplayed its side effects.

In 2008, Judge Martin J. Gaughan granted McGraw's cross-motion for summary judgment and, based on FDA warning letters to the defendants about their representations about the drugs, found that as a matter of law the defendants made false and misleading statements in violation of state law.  The judge then conducted a bench trial on whether the false and misleading statements were made repeatedly and willfully under the Consumer Protection Act and how many violations occurred.

The judge found 4,450 violations and assessed a penalty of $5,000 for each phone call and $500 for each mailed promotional item.  The defendants appealed.

The Supreme Court of Appeals ruled that "the FDA's belief, as expressed in the warning letters and subsequent corrective letters, that Janssen violated the FDCA [federal Food, Drug and Cosmetic Act] is not sufficient to establish, as a matter of law, that the Appellants' communications to healthcare providers were actually false and misleading in violation of the Consumer Protection Act."

"Whether Janssen's statements and omission in the Risperdal DHCP [Dear Health Care Professional] letter and the Duragesic file card are actually false and misleading under the FDCA, and thus constitute 'unfair or deceptive acts or practices' under the Consumer Protection Act, is a question of fact to be decided by a finder of fact," the court continued.  "The State, therefore, must present evidence that Janssen's specific statements and omissions do, in fact, violate the relevant laws, and the Appellants are entitled to present evidence to the contrary."

The high court vacated the trial court's final order and remanded the case for further proceedings.

[Editor's Note:  Full coverage will be in the Dec. 12 issue of Mealey's Emerging Drugs & Devices.  In the meantime, the opinion is available at or by calling the Customer Support Department at 1-800-833-9844.  Document #28-101202-002Z.  For all of your legal news needs, please visit]

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For more information, call editor Tom Moylan at 215-988-7739, or e-mail him at