According to an increasing number of judges, the FDA should stick to regulating drugs for efficacy and safety and let the courts decide the scope of their own authority.
A series of recent federal and state court opinions have rejected arguments that the FDA’s authority to approve prescription drugs and their labels “preempts” state law court claims, and have refused to dismiss claims that drug companies failed to warn patients of dangers from certain prescription drugs. Recent rulings against the manufacturers Wyeth Pharmaceuticals, Eli Lilly & Co. and Merck & Co. Inc suggest that courts believe they are in the strongest position to protect the public from fraudulent pharmaceutical practices.
On July 3, 2007, Judge Eldon Fallon, U.S. Circuit Judge for the Eastern District of Louisiana, denied Merck & Co. Inc.’s motion for summary judgment, which argued that failure-to-warn claims were preempted by FDA labeling rules. The suits were filed by plaintiffs who suffered heart attacks after taking Merck’s now infamous pain reliever Vioxx. This ruling follows on the heels of a New Jersey Superior Court ruling in late June which denied a motion to dismiss a product liability claim, also based on preemption grounds, against Wyeth for its cancer-inducing hormone replacement therapy (HRT) drug Prempro.
Over the past few years, the FDA has been arguing that state failure-to-warn cases are preempted by the FDA’s authority. The FDA included a lengthy “preamble” to its revised guidelines on the labeling of prescription drugs, outlining its arguments on why such claims are preempted. The doctrine of federal preemption comes from the Supremacy Clause of the U.S. Constitution which states, “[t]his Constitution, and laws of the United States…shall be the supreme law of the land; and the judges in every state shall be bound thereby.” Thus, the FDA argues that once it has approved a drug label, a state court claim that consumers were injured by a drug company’s failure to include a warning about a known risk in the drug’s label conflicts with the FDA’s approval of the label. When federal law and state law conflict, the Supremacy Clause says that federal law prevails. Thus, the FDA argues that the courts cannot provide any redress to injured consumers in such failure-to-warn cases.
In denying Merck’s motion for summary judgment, Judge Fallon concluded that the Food Drug and Cosmetic Act (FDCA) lacks any express statement that Congress intended to displace state law claims in the prescription drug context. He went on to say that there is a well-established presumption against implying preemption since historically states’ “police powers” permit them to protect the health and welfare of their citizens.
The court noted that implying preemption in these cases would abolish state law remedies and would render those who sustain injuries from defective prescription drugs without a legal remedy. This reasoning is consistent with yet another U.S. District Court Judge’s rejection of a motion to dismiss filed Eli Lilly & Co., in a fraudulent marketing claim against its atypical antipsychotic drug Zyprexa. In fact, Judge Fallon cites that opinion several times. (See our blog entry on that decision, Judge Allows Zyprexa Class Action to Go Forward, Says Courts are “in the Strongest Position” to Protect Public from Fraudulent Drug Marketing)
Judge Fallon also does an admirable job disposing of the FDA preamble language. He finds that concluding that the claims are preempted, based upon the FDA’s preamble “inserted at the eleventh hour and drafted by an agency without the express or implied authority to abolish such remedies is Draconian and unacceptable.”
To see a copy of the Judge’s order, go here.