Case Notes

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.

Teva argued unsuccessfully that the subpoena should not issue because it was unduly burdensome and too broad, as the 2008 settlement pertained not only to promotion of Actiq, but also two other drugs. The drug company also pointed out that the activity admitted to in the 2008 settlement occurred between January 2001 and October 2001 — years before the plaintiff's decedent was ever prescribed Actiq.

Plaintiffs' attorney Richarch Hollawell, of Console & Hollawell, says the information the plaintiff is seeking could be central to his case. “There was a qui tam, a whistleblower case [as part of the government's case] where somebody from the company stepped forward, and they gave statements about the practices of the company,” he said. “The guilty plea references a lot of marketing material and that's the information we're seeking.” Hollawell says that he hopes the prosecutors will be cooperative with his client, not unduly asserting privilege or work-products protections, as Judge Cohen's Jan. 9 order specifically notes that documents protected by these things need not be turned over to the Caltagirone plaintiff.

Prosecutors Must Provide Documents to Civil Claimant in Off-Label Promotion Suit

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 that 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 son's doctor, who prescribed Actiq to the son for treatment of migraines in 2005. The plaintiff's son 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 plaintiff's 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.

Teva argued unsuccessfully that the subpoena should not issue because it was unduly burdensome and too broad, as the 2008 settlement pertained not only to promotion of Actiq, but also two other drugs. The drug company also pointed out that the activity admitted to in the 2008 settlement occurred between January 2001 and October 2001 — years before the plaintiff's decedent was ever prescribed Actiq.

Plaintiffs' attorney Richarch Hollawell, of Console & Hollawell, says the information the plaintiff is seeking could be central to his case. “There was a qui tam, a whistleblower case [as part of the government's case] where somebody from the company stepped forward, and they gave statements about the practices of the company,” he said. “The guilty plea references a lot of marketing material and that's the information we're seeking.” Hollawell says that he hopes the prosecutors will be cooperative with his client, not unduly asserting privilege or work-products protections, as Judge Cohen's Jan. 9 order specifically notes that documents protected by these things need not be turned over to the Caltagirone plaintiff.