United States: Amarin/Caronia: What Lies Ahead For Tort Preemption?

In a strange coincidence, the death of Frances Oldham Kelsey on August 7, 2015 coincided with the release of the decision in Amarin v. FDA, 1:15-CV-03588-PAE, Doc. 73 (SDNY Aug. 7, 2015). Ms. Kelsey is generally credited with the regulatory changes that require evidence of efficacy before a product can be marketed for a specific use. Those changes came about because of the promotion of thalidomide, a drug that physicians prescribed for nausea during pregnancy, which caused profound deformities in developing fetuses.

The Amarin court addressed a related issue—whether manufacturers could be prevented from disseminating information concerning indications, dosages, durations, or in combinations not in the Food and Drug Administration (FDA) approved label (i.e. off-label). The court concluded that more, not less, truthful information was needed, observing that off-label use is often recognized as the standard of care in medicine and has been recognized as such by the United States Supreme Court. Id. at 5-9. It is an unassailable truth that no one has ever died or been injured because they had too much truthful scientific or medical information. Health care is improved and lives are saved when doctors have unrestricted access to truthful information concerning the safety and effectiveness of FDA-regulated products for on-label use, and the health benefits are even greater when the information concerns off-label uses.

In Amarin, the court rejected the government's misreading of the landmark opinion in U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012), and significantly curtailed the FDA's power to bar a manufacturer from disseminating truthful, non-misleading scientific and medical information. Less obvious and potentially more significant for manufacturers, is the issue of tort duties that can arise when the FDA's oversight is limited.

The terms "promotion," "advertising" and "off-label" are not defined in the Food Drug and Cosmetic Act, and to no one's surprise, the FDA's regulation of speech concerning promotional activities and advertising related to off-label use has been a muddled mess. The lack of a clear set of rules has allowed the FDA unfettered discretion in defining the applicability of these terms in civil and criminal enforcement proceedings. The Amarin court details the current regime for disseminating truthful scientific information concerning new uses and the narrative reveal a regulatory scheme worthy of Monty Python and the Bridge of Death. For a detailed analysis and discussion of the due process, deference and First Amendment considerations underlying this issue see The First Amendment and the Emerging Tort of Off-Label Promotion, Washington Legal Foundation, No. 183, April 2013) and "Parallel" State Law Tort Claims or Does the FDA Really Favor Private Enforcement of the FDCA?  Federation of Defense and Corporate Counsel, July 2015.

In Amarin, the court observed the landmark significance of Caronia stating that the "Second Circuit's 2012 decision in Caronia addressed, for the first time, the interplay between the FDCA's misbranding provisions and the First Amendment. Amarin, supra at 18, emphasis added. The government may have been too clever in its strategy regarding Caronia. If it had read the opinion like the rest of the legal community, it might have recognized the folly in not appealing the Caronia decision. As the Amarin court observed: "Had the FDA believed that Caronia gravely undermined the drug approval process, it should have sought review of that decision." Id. at 67.

The court in Amarin flatly rejected the position the FDA has been touting for decades— that it was not prosecuting speech but conduct that is evidence of intent. The court ruled that "the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment." Id. at 45.

The court further rejected the government's attempt to rewrite the holding in Caronia:

Where the speech at issue consists of truthful and non-misleading speech promoting the off-label use of an FDA-approved drug, such speech, under Caronia, cannot be the act upon which an action for misbranding is based. Id. at 49.

The Caronia and Amarin cases hold far more than academic importance. These cases sit at the juncture of free speech and preemption. When the FDA cannot prevent a manufacturer from providing truthful scientific and medical information about its product, a manufacturer may have a state law duty to speak and its ability to defeat a claim on preemption grounds is threatened.

The FDA has never been comfortable balancing due process and First Amendment concerns with its desire to pursue enforcement. The result has been a regime under constant criticism as violating due process guarantees, producing regulatory determinations not worthy of court deference and trampling the First Amendment. Despite the uproar, FDA's threats of criminal sanctions, debarment and civil penalties overwhelmed industry, and the FDA reaped more than $12 billion in penalties. Nonetheless, the growing assault on the FDA's stranglehold continued, most notably with the landmark decision in Caronia, a watershed decision that most commentators, except the FDA and former government lawyers, predicted would change how the FDA regulates industry communications.

The Speech/Preemption Dilemma – What Is That Light At The End Of The Tunnel?

Before applauding the demise of FDA's stranglehold on the dissemination of truthful scientific information too loudly, manufacturers are well advised to recognize the freight train of tort claims approaching and heed the Amarin court's suggestion to "consult with the FDA before promoting off-label use." Id. at 53. An FDA stamp of approval on a company's marketing efforts may be a lifeline to preserve a preemption challenge. In what may turn out to be a frequently quoted statement, the court highlighted the duty owed by manufacturers stating:

Amarin bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use... remain truthful and non-misleading. Id. at 66.

If history is any guide, tort claimants may pose a more formidable threat to manufacturers than the FDA. Only time will tell whether they have won the battle only to lose the war under Allergan and Amarin.

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