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Caltagirone v. Cephalon, Inc.

Superior Court of Pennsylvania

June 8, 2018


          Appeal from the Order Entered March 23, 2017 in the Court of Common Pleas of Philadelphia County Civil Division at No.: September Term, 2016 No. 02877

          BEFORE: LAZARUS, J., OTT, J., and PLATT, J. [*]


          PLATT, J.

         Appellant, Joseph A. Caltagirone, appeals individually and as administrator of the estate of his deceased son, Joseph F. Caltagirone, from the order sustaining preliminary objections of Appellees, Cephalon, Inc. and Teva Pharmaceuticals, USA, Inc., to his second amended complaint, and dismissing it with prejudice.[1] We conclude that the trial court properly determined that Appellant's wrongful death and survival claims, premised on asserted violations of the Federal Food, Drug, and Cosmetic Act (FDCA), [2] (and implementing regulations), are pre-empted by the federal system of regulation and enforcement by the United States Food and Drug Administration (FDA). Accordingly, we affirm.

         We derive the facts of this case from the trial court's opinion, (see Memorandum in Support of Order Dismissing Plaintiffs' Second Amended Complaint, 3/23/17, at 1-4), and our independent review of the record.

         The decedent, Joseph F. Caltagirone, suffered from migraine headaches. In 2005, he began treating with Thomas C. Barone, D.O., who prescribed ACTIQ, a form of fentanyl marketed and sold by co-Appellee Cephalon, Inc.

         ACTIQ is a very powerful opioid approved by the FDA in 1998 only for "breakthrough" cancer pain of opioid-tolerant patients.[3] It is packaged and sold as a berry-flavored "lollipop" on a stick.[4] ACTIQ carries a "Black Box" warning label, (the most serious type of FDA warning, named for the required distinctive black perimeter), advising of the risk of serious adverse health consequences from the use of ACTIQ, including respiratory depression, addiction, and death. The Black Box label warns against the use of ACTIQ for any condition other than cancer pain, including, specifically, migraine headaches.

         Appellant acknowledges that physicians may prescribe medications for purposes other than those approved by the FDA, (known as "off-label" uses). However, he maintains that Appellees unlawfully and recklessly promoted, marketed and sold ACTIQ for off-label uses not approved by the FDA, in violation of the FDCA, and the FDA's implementing regulations, to increase sales. (See Second Amended Complaint, 1/05/17, at 8 ¶ 30).

         Dr. Barone prescribed ACTIQ to Decedent for about six years, from 2005 to 2011, for the relief of pain from his migraine headaches. This period included at least two episodes of inpatient hospitalization for Mr. Caltagirone's detoxification and related treatment. In 2011, Dr. Barone stopped prescribing ACTIQ for Mr. Caltagirone and moved him to other opioids. About two and a half years later, on May 15, 2014, Mr. Caltagirone died. The autopsy stated the cause of Mr. Caltagirone's death was "drug intoxication" from "methadone toxicity."

         Appellant brought a wrongful death and survival action suit against Cephalon and Teva. In pertinent part, the complaint alleged:

16. Despite Actiq's very limited purpose, approval and instructions for use, during the period from 2000 through at least 2011, Defendants engaged in an unlawful, deceptive and reckless pattern and practice of marketing, promoting and selling Actiq, for inter alia, the treatment of pain of patients with a wide range of conditions for which Actiq was inappropriate, highly dangerous, contradicted and specifically forbidden by the FDA as further set forth herein.

(Second Amended Complaint, at 4-5, ¶ 16) (emphasis added).

         Appellant maintains that Appellees engaged in a deliberate comprehensive marketing campaign to boost sales of ACTIQ beyond pain relief for cancer patients by promoting off-label use, including for migraine headaches. He asserts this program set higher quotas for sales representatives than could be met solely by sales for cancer patients. It also allegedly encompassed promotional distribution of "free" coupons for ACTIQ, the preparation of pertinent marketing materials for promotion of other uses including for migraine headaches, and commissioning key opinion leaders to write articles, do studies, and make presentations at medical conferences on the use of ACTIQ for pain management by non-cancer patients.

         The overarching theme of the complaint is that even though Mr. Caltagirone died from methadone toxicity, an adverse reaction to the methadone he was taking as prescribed by Dr. Barone, his underlying addiction was proximately caused by Appellees' program of ...

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