PHILADELPHIA (CN) - Three insurance companies demand $17.5 million from Cephalon and Teva Pharmaceuticals, claiming they pushed the powerful painkiller Actiq for off-label uses though the FDA approved it only for treating "breakthrough pain" in cancer patients.
Travelers Indemnity Co., St. Paul Fire and Marine Insurance Co., and Standard Fire Insurance sued Cephalon, and Teva Pharmaceuticals in Federal Court. Teva bought Cephalon in October 2011, and Cephalon is now its wholly owned subsidiary, according to the complaint.
The insurers say Cephalon and Teva have been pushing Actiq for off-label uses since at least October 2000.
Doctors are allowed to prescribe drugs for off-label uses, but drug companies are not allowed to promote the drugs for that.
Actiq is "a powerful and highly addictive painkiller, approved by the U.S. Food and Drug Administration ('FDA') for the limited purpose of managing 'breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain' - i.e., a narrow class of cancer patients with pain that cannot be managed using other narcotic-based drugs," the insurers say in the complaint.
"Despite these very specific limitations, during the period beginning as early as October 2000 and continuing through the present ... defendants engaged in a continuing pattern and practice of marketing, promoting and selling Actiq for, inter alia, the treatment of pain in a wide range of patients for whom Actiq is medically unnecessary, contraindicated, ineffective and/or otherwise inappropriate.
"During the relevant period, defendants also made certain material misrepresentations to the medical community and the general public regarding the safety, efficacy and appropriateness of Actiq, which caused, and continue to cause, issuance of prescriptions for Actiq to a multitude of non-cancer patients throughout the United States for whom the Actiq is medically unnecessary, contraindicated, ineffective and/or otherwise inappropriate and who would be better served by receiving other drugs," the complaint states.
The insurers say these patients include workers injured on the job whose prescriptions were covered by worker's compensation insurance.
They claim Cephalon and Teva caused the insurers and their customers to pay thousands of extra dollars to fill Actiq prescriptions for non-cancer injuries.
"But for defendants' deceptive and improper marketing and sales scheme, the injured workers who received Actiq paid for by Travelers and its customers would have received medically appropriate, less dangerous, and less costly drugs to treat the various conditions associated with their injuries, and Travelers and its customers would have not incurred additional and unnecessary expenses related thereto," the complaint states.
Fentanyl, Actiq's primary ingredient, is twice as powerful as morphine and is a Schedule II controlled substance, the complaint states.
"Schedule II controlled substances are inherently dangerous because they have a high potential for abuse that may lead to psychological or physical dependence. For the same reason, Schedule II controlled substances also have an associated risk of fatal overdose," the complaint states.
The insurers claim Cephalon and Teva trained their sales reps to "aggressively promote" Actiq to doctors who did not treat cancer patients, for conditions such as migraines, herniated discs, and burns.
"To avoid detection, defendants trained their sales representatives to conduct their deceptive and improper promotion of Actiq most often in private sales pitches or 'details' to physicians or other healthcare providers," the complaint states.
The insurers claim the drug companies also instructed their sales reps to tell doctors to give patients higher dosages than the FDA-recommended amounts, so the patients couldn't complain the drug didn't work.
The insurers claim Cephalon and Teva made more than $1 billion from their aggressive marketing strategy. at the expensive of public safety.
"Actiq has been associated with numerous deaths, some of which have resulted from overdoses or other misuses of the drug. Defendants have also reported numerous additional serious but non-fatal incidents related to Actiq," the complaint states.
The insurers claim that they paid for Actiq prescriptions because of the drug companies' misleading claims that the drug was safe for non-cancer injuries.
"In sum, Travelers and its customers paid no less than $17.5 million in connection with such claims for Actiq and additional and unnecessary expenses arising out of use of Actiq prescriptions," the complaint states.
The plaintiffs seek $17.5 million in damages, disgorgement of all profits from off-label sales of Actiq, and civil penalties.
They are represented by Katherine Scanlon with Seiger, Gfeller & Laurie, of West Hartford, Conn.
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