Drug & Device News

In the case of Caltagirone v. Cephalon, Philadelphia Court of Common Pleas Judge Denis P. Cohen has granted the plaintiff the right to subpoena documents concerning pharmaceuticals manufacturer Cephalon from the U.S. Attorney's Office for the Eastern Dirstrict of Pennsylvania. The civil suit is being brought by a man who claims his son's methadone overdose can be traced back to an addiction he developed from using Cephalon's fentanyl-laced lollipops, marketed under the name Actiq. Although these lollipops were approved for use only by cancer patients who had been prescribed them for pain relief by oncologists specially trained in dealing with Schedule II opioids, the plaintiff contends that Cephalon sales representatives marketed Actiq to doctors for a number of other uses, including the relief of migraine headaches. Among these, according to the claim, was the plaintiff's decedent's doctor, who prescribed Actiq to him for treatment of migraines in 2005. The plaintiff's decedent became addicted, states the claim, and after consuming nearly 6,000 lollipops between 2005 and 2011, he began taking methadone to combat the addiction. The son died of a methadone overdose in May 2014.

To prepare his case against Teva Pharmaceuticals, which acquired Cephalon in 2011, the plaintiff wants documents held by the U.S. Attorney related to a case that resulted in a 2008 guilty plea by Cephalon for its off-label promotion of Actiq and other drugs. In a Sept. 29, 2008, U.S. Department of Justice (DOJ) release announcing that settlement, the DOJ explained: “Cephalon undertook its off-label promotional practices via a variety of techniques, such as training its sales force to disregard restrictions of the FDA-approved label, and to promote the drugs for off-label uses. For example, the Actiq label stated that the drug was for 'opioid tolerant cancer patients with breakthrough cancer pain, to be prescribed by oncologist or pain specialists familiar with opioids.' Using the mantra 'pain is pain,' Cephalon instructed the Actiq sales representatives to focus on physicians other than oncologists, including general practitioners, and to promote this drug for many uses other than breakthrough cancer pain.”