(CN) - Cephalon and Teva Pharmaceuticals need not face racketeering claims over their off-label promotion of the addictive painkiller Fentora, a federal judge ruled.
The Indiana/Kentucky/Ohio Regional Council of Carpenters Welfare Fund brought the complaint
in December, hoping to represent a class that allegedly paid higher prescription costs on behalf of its members for Fentora, a powerful opioid with the active ingredient fentanyl, a narcotic about 100 times more potent than morphine.
Though the Food and Drug Administration approved the painkiller only for cancer patients tolerant to "around-the-clock opioid therapy," the fund said Teva Pharmaceuticals USA Inc. and its subsidiary Cephalon Inc. promoted it for off-label uses.
Only about 7 percent of prescriptions for Fentora were written for on-label uses through the first three years that it was sold, according to the complaint.
Indeed, the fund pointed out that, long before Fentora entered the market, Cephalon had to pay the U.S. Department of Justice $425 million for its illegal marketing of another fentanyl-based drug called Actiq.
Once Actiq lost its patent protection in 2006, Cephalon allegedly bought rights to Fentora from Cima Labs to target the same off-label market, aided by promotion companies and doctors.
Based on "reports of serious and life-threatening adverse events in both properly-prescribed and misprescribed patients," however, Cephalon's efforts to expand Fentora's indication to treat all opioid-tolerant patients failed before an FDA advisory committee, according to the complaint.
The FDA even chided Cephalon for misleading online advertisements that failed to communicate the risks associated with the use of the drug, the complaint states.
Senior U.S. District Judge Harvey Bartle III in Philadelphia dismissed the complaint on May 21.
"Importantly, while Cephalon's actions may well constitute improper off-label promotion under the FDCA and its regulations, we reiterate that it does not follow that the promotion is fraudulent," Bartle wrote, abbreviating the Food, Drug and Cosmetics Act. "Fentora's 'black box' warning label, available to potential prescribing physicians, clearly identifies the dangers of abuse and respiratory depression that form the basis of the fund's concerns, and there is no allegation that the defendants concealed this information.
"Without more, the fund's complaint fails adequately to allege any misrepresentation or omission sufficient to plead a 'scheme to defraud' for mail or wire fraud," the judge added.
Evidence of Cephalon's allegedly fraudulent online seminar and publications about Fentora also failed to sway the court.
"We stress that it is not illegal for physicians, exercising their independent medical judgment, to prescribe Fentora for off-label use, that is, to patients outside of the breakthrough cancer pain context," Bartle wrote. "Under the circumstances, it is simply insufficient to allege off-label promotion by the defendants without describing the 'who, what, when, where and how' of any scheme to defraud as that term is defined by federal law, or without providing the necessary precision or substantiation that would otherwise excuse a failure to plead the date, place, or time of the alleged fraud."