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Drugmaker prevails over comp insurers in off-label opioid case

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The U.S. District Court of Appeals for the 3rd Circuit has dismissed workers compensation insurers' claims that a pharmaceutical company marketed its powerful opioids for off-label uses.

Travelers Indemnity Co., Travelers Casualty & Surety Co., Standard Fire Insurance Co., and St. Paul Fire and Marine Insurance Co. Inc., brought claims against Frazer, Pennsylvania-based Cephalon Inc., a subsidiary of Teva Pharmaceutical Industries Ltd., for intentional misrepresentation, negligent misrepresentation, violations of state consumer protection laws, and unjust enrichment, court records show.

The insurers alleged that the pharmaceutical company marketed Actiq and Fentora to doctors for non-cancer pain, according to records. However, the opioids are only approved by the U.S. Food and Drug Administration to “manage breakthrough pain in cancer patients who were already receiving and were tolerant to opioid pain medications.”

Together with their claimants, the insurers said more than $18 million was spent on Actiq and Fentora since 2004, according to records.

Cephalon's marketing went “beyond mere off-label promotion” to include “untruthful, factually inaccurate, incomplete and/or otherwise misleading promotion,” the insurers argued, according to records. They also identified five doctors who prescribed Fentora and received payments or benefits from the pharmaceutical company.

But, the insurers didn't “identify any specific fraudulent statements, omissions, or misrepresentations that were made to doctors who prescribed Actiq and Fentora,” records show.

The U.S. District Court for the Eastern District of Pennsylvania, Philadelphia in July 2014 found that the insurers did not show “the contents of these statements and materials” nor did they “specify when, where, or to whom any sales pitch was made,” according to records.

The court dismissed the claims for lack of standing and for failure to state a claim, as they didn't “set out their fraud claims with sufficient specificity,” records show.

On appeal, a three-judge panel for the U.S. District Court of Appeals for the 3rd Circuit on Monday affirmed the district court's decision.

“Because Plaintiffs have not alleged the particular facts surrounding the alleged fraud … their claims sounding in fraud cannot stand,” the ruling states.