HARRISBURG - The Superior Court of Pennsylvania affirmed an order from the Court of Common Pleas of Philadelphia County that dismissed a wrongful death and survival lawsuit filed against pharmaceuticals companies Cephalon, Inc. and Teva Pharmaceuticals USA Inc., according to an opinion filed June 8.
Plaintiff Joseph Caltagirone challenged the trial court’s decision sustaining Cephalon and Teva's preliminary objections to the claims in the lawsuit. and dismissing the complaint.
The Superior Court said it agreed with the lower court’s ruling that the plaintiff's wrongful death and survival claims filed in accordance with the Federal Food, Drug and Cosmetic Act (FDCA) are blocked by Food and Drug Administration (FDA) provisions.
Senior Judge William Platt | PA Courts
Caltagirone filed the lawsuit against Cephalon and Teva Pharmaceuticals after his son, who was prescribed ACTIQ, a fentanyl drug sold by Cephalon, died.
The plaintiff said his son was on the medication for roughly six years to treat migraines before he died as a result of drug intoxication and methadone toxicity.
In his lawsuit, Caltagrione accused the companies of recklessly promoting, marketing and selling ACTIQ for off-label uses not approved by the FDA, in violation of the FDCA, and the FDA’s implementing regulations, in hopes of boosting sales, according to the Superior Court opinion.
In this case, the opinion said the Black Box label on ACTIQ's packaging said the medicine should only be used for treating cancer symptoms, including migraines and headaches. However, Caltagirone claimed the defendants promoted the use of the medicine for other purposes.
The Superior Court rule that the defendants' alleged improper promotion of the drug was not a direct infringement of the FDCA or its related policies. and, since the plaintiff's accusations completely depend on regulations concerning the FDA’s “off-label” rules, ones that the Superior Court categorized as “pre-empted,” it agreed with the lower court's order.