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Ortho-McNeil-Janssen Pharmaceuticals v. State of Arkansas

The State of Arkansas sued the pharmaceutical company Janssen under the state’s Medicaid fraud and unfair trade practices laws. The claims were based on Janssen’s marketing of the antipsychotic drug Risperdal without adequate warnings about risks posed by the drug, including weight gain and diabetes. An Arkansas trial court ruled for the state and imposed penalties on Janssen exceeding $1 billion. Janssen appealed to the Arkansas Supreme Court, raising a variety of statutory and constitutional objections to the judgment, including the argument that the state’s claims are impliedly preempted by FDA regulation of prescription drugs.

In support of the state, Public Citizen filed an amicus curiae brief demonstrating that the Supreme Court’s decision in Buckman v. Plaintiffs’ Legal Committee, which held claims of “fraud on the FDA” to be preempted by federal law, does not apply to the claims asserted by Arkansas in this case. Without addressing preemption, the court ruled for Janssen, holding that the conduct at issue did not fall within the scope of the state Medicaid law.