A recent opinion out of the Philadelphia Court of Common Pleas reinforces the notion that claims asserted by private plaintiffs based on alleged off-label promotion of FDA regulated medications are preempted by federal law. See Caltagirone v. Cephalon, Inc., 2017 WL 1135576 (Pa. C.P. March 23, 2017).
The case involved Actiq, an opioid medication that was approved by the FDA in 1998 to treat cancer pain. Actiq is a form of Fentanyl and is highly addictive. The decedent, Joseph Caltagirone, began treatment with Dr. Thomas Barone for migraine headaches in 2005 and was prescribed Actiq from 2005 through 2011. The prescription of Actiq for the pain of migraines was a known off-label use. Mr. Caltagirone was first admitted to a facility for detoxification in April, 2006, and was in an out of drug treatment programs during the next four years for addictions to multiple schedule II opiates and other illicit drugs. Mr. Caltagirone died on May 15, 2014 at age 39 of “drug addiction” and “methadone toxicity.” His father, as administer of his estate, filed a Wrongful Death and Survival Act action against Defendants Cephalon, Inc., which manufactures and sells Actiq, and Teva Pharmaceuticals USA, Inc., which purchased Cephalon in 2011, asserting claims for negligence, fraud, misrepresentation and violation of Pennsylvania’s Unfair Trade Practices and Consumer Protection Law (UTPCPL). Id. at *1.
Plaintiffs alleged that Mr. Caltagirone’s addiction, which ultimately caused his death, was proximately caused by Defendants’ scheme to fraudulently market Actiq to the medical community. Specifically, Plaintiffs allege that despite the dangers of addiction and death, as well as a specific mandate from the FDA at the time of the drug’s approval that Actiq should be marketed only for malignant cancer patients and should not be marketed for off-label uses, Defendants marketed and sold Actiq for treatment of pain associated with a wide range of conditions, including migraine headaches. Each of Plaintiffs’ claims was based on the theory that Defendants engaged in conduct that was “specifically forbidden by the FDA.” Id. at *2.
Defendants sought dismissal of the complaint by filing Preliminary Objections in the nature of a demurrer under Pennsylvania law. Defendants raised two primary contentions: (1) that Plaintiffs’ claims were impliedly preempted by the FDA and federal law, and (2) that all claims were barred as a matter of law by Pennsylvania’s learned intermediary rule. Id.
Plaintiffs’ pleadings acknowledged that prescribing medications for off-label uses is common in the medical community, but alleged that Defendants’ promotion of the drug for indications not formally approved by the FDA and the Food Drugs and Cosmetics Act (FDCA) was unlawful. Defendants argued that because Plaintiffs’ negligence, misrepresentation, fraud and UTPCPL claims all rested on Defendants’ alleged marketing and promotion of Actiq for uses not specifically approved by the FDA, these claims were preempted. Plaintiffs attempted to dodge preemption by arguing that implied preemption is limited to medical devices, and that the parallel state tort claims they were invoking precluded preemption. The court did not buy it: “The sole basis for these Plaintiffs to believe they have a claim is because the conduct of promoting the drug for migraine headaches violates the FDCA…There is no private right to enforce the FDCA.” Id. at *3.
With respect to the learned intermediary doctrine, the court noted that Plaintiffs were not challenging Defendants’ warning labels; therefore, it was unclear whether the doctrine even applied. However, the parties presented arguments on the rule, and the court found that the doctrine’s principles were, at minimum, relevant to the issue of proximate causation. To that end, the court was not persuaded by Plaintiffs’ contention that Dr. Barone, who prescribed Actiq to the decedent, could not be “learned” because he was provided with “misinformation” by the Defendants and others. Id. at *4. By contrast, the court found that Dr. Barone was “fully aware of the characteristics and properties of Fentanyl,” which were commonly known in the medical community, and, in fact, continued to prescribe Actiq for several years after he had actual knowledge that his patient became addicted to the drug in 2006. Id. at *5. It was Dr. Barone’s duty, as the “actual consumer” under the learned intermediary rule, to prescribe his patient a safe and effective medication for migraines based on his training and experience, the information available to him, and his knowledge of his patient. It did not make a difference that Dr. Barone may also have been exposed to off-label promotion. See id.
Caltagirone joins a list of cases that have held that allegations of illegal off-label promotion are preempted because they amount to unauthorized attempts to enforce the FDCA, the type of action barred by Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). See Goldsmith v. Allergan, Inc., 2011 WL 147714 (C.D. Cal. Jan. 13, 2011); McDaniel v. Upsher-Smith Pharmaceuticals, Inc., ___ F. Supp.3d ___, 2017 WL 657778 (W.D. Tenn. Jan. 26, 2017). Based on relativity straightforward facts, the court easily reached the conclusion that preemption barred Plaintiffs’ claims here, and was equally swift to reject Plaintiffs’ argument that the learned intermediary doctrine should not apply because the prescribing physician was allegedly rendered “un-learned” by way of exposure to Defendants’ off-label marketing. It is worth noting that FDA’s off-label promotion restrictions have ignited significant industry and legal debate, including around First Amendment speech issues, and were the subject of a public hearing convened by the FDA in November 2016. Query how the federal preemption analysis would be impacted should the FDA loosen these regulations or even authorize truthful off-label promotion altogether. We will continue to follow developments in this area.