• Superior Court upholds order sustaining preliminary objections, dismissing Defendant pharmaceutical companies, in wrongful death action where the asserted state law violations were pre-empted by federal law
  • July 17, 2018
  • Law Firm: - Office
  • Background

    Mr. Caltagirone was prescribed ACTIQ (a very powerful form of fentanyl approved by the FDA for “breakthrough” cancer pain) for his migraine headaches from a period of 2005 to 2011. In 2014, Mr. Caltagirone died from “drug intoxication” and “methadone toxicity”. Plaintiff, Joseph A. Caltagirone, individually and as administrator of the estate of his deceased son, Joseph F. Caltagirone brought a wrongful death and survival action against Defendant pharmaceutical companies for “unlawfully and recklessly promot[ing], market[ing], and [selling] ATIQ for off-label uses not approved by the FDA. Plaintiff’s argument was that his son’s addiction was the proximate cause of the pharmaceutical companies’ marketing of ATIQ for non-FDA approved purposes. The Trial Court sustained the pharmaceutical companies’ preliminary objections, dismissing the action with prejudice, as Plaintiff’s claim were premised on violations/disregard of the FDCA and FDA regulation, and thus were pre-empted.


    The Superior Court agreed with the Trial Court’s reasoning that, except in limited circumstances not applicable to the present situation, there is no private right to enforce the law and regulations of the FDA. Accordingly, as Plaintiff’s claims were premised on violations of the FDA’s “off-label” restrictions, they were pre-empted, and the Trial Court properly sustained the pharmaceutical companies’ preliminary objections.

    Questions about this case can be directed to Brook Dirlam, at (412) 926-1438 or [email protected]