Claris Law Legal Blogging Community

Editor: Robert Blanchard
Profession: Attorney at Law

Category: Ortho Evra Legal News

Under George Bush, the FDA decided to conspire with the drug makers to make sure no one could sue over their dangerous medications. Unable to change the law in the courts, or even in the Republican Congress, the FDA just unlaterally wrote a preface to its recent rule changes saying that once the FDA approves a drug, the subject is totally preempted by Federal law. This preface contradicted years of settled law and even the FDA's own prior pronouncements on the topic. A recent letter the FDA wrote to on Judge however may halp clarify their position.

As many of you may be aware, the Center for Constitutional Litigation has been assisting plaintiffs' counsel in litigating the FDA preemption issue in Perry v. Novartis, a case alleging that Novartis' failure to warn of the carcinogenic nature of Elidel, its topical treatment for dermatitis, led to the Perry's two-year-old son's lymphoma. After Novartis moved to dismiss on preemption grounds, Judge Stewart Dalzell in the Eastern District of Pennsylvania invited the FDA to submit an amicus brief on the preemption issue.

The FDA today submitted its letter brief and, in my view, it represents a significant retreat from the broad preemption position the agency took in the January regulatory preamble. The FDA expressly disclaims any intention to "occupy the field" and makes clear that failure-to-warn claims that do not directly conflict with FDA regulatory decisions remain viable. I will try to get the letter posted to the preemption library but, for the time being, here are some relevant excerpts that are of broad applicability:

"A manufacturer may not deviate from FDA-approved product labeling except in limited circumstances. If the manufacturer of a non-generic prescription drug wishes to add or strengthen a warning, the manufacturer may provide FDA with a supplemental submission regarding the proposed labeling change, providing a full explanation of the basis for the proposed change. . . . If FDA has not rejected the supplement within 30 days after its submission, the manufacturer may distribute the drug with the new proposed labeling. . . . Even after the drug has been distributed, FDA may choose to reject the proposed labeling change and may order the drug manufacturer to cease distributing drugs with the new label. . .

If a drug manufacturer has 'reasonable evidence of a causal association' between the use of a drug and a 'clinically significant hazard,' the manufacturer has an obligation to seek FDA approval for a labeling change, in order to add a warning of the new potential hazard." (p. 3, citations and footnotes omitted).

"A failure-to-warn claim is not preempted merely because it imposes liability for a manufacturer's failure to provide a warning that has not yet been required by the FDA. Federal regulations explicitly recognize that manufacturers can, and in some limited instances must, modify their labels to add new warnings of hazards associated with the drug, without awaiting prior FDA approval. . . . Where, in light of new scientific evidence or other changed circumstances a drug label no longer ensures safe and effective use, FDA encourages manufacturers to work quickly and collaboratively with the agency to make necessary labeling changes." (p. 10)

"To the extent, therefore, that the defendants argue that federal preemption bars any failure-to-warn claim premised on a drug manufacturer's failure to provide a warning not contained in the drug's approved labeling, the defendants are incorrect. FDA has not attempted to 'occupy the field' of prescription drug labeling, and state tort liability for failure to warn does not necessarily prevent FDA from carrying out its regulatory goals. Federal regulations explicitly provide for labeling changes to be made to warn of new hazards or cautions relating to a drug without prior FDA approval. Under this regulatory scheme, preemptive conflict does not exist in every instance in which state tort law seeks to impose liability for the failure to provide a warning not affirmatively mandated by FDA. That said, in some circumstances the imposition of state tort liability on a drug manufacturer for failure to warn would conflict with FDA's regulatory authority or interfere with the accomplishment of federal objectives. Because FDA has not occupied the field, such determinations require an analysis of the agency's actions and the actions that are alleged to give rise to liability. A court must ask whether the warning sought by plaintiff would have rendered the drug misbranded in the agency's judgment at the relevant time, or if any new warnings proposed to be added to the warning label would have been rejected by the agency as unsubstantiated." (p.11) ---