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Appeals court backs carrier in off-label drug use case

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A 3-judge appeals court panel in Boston has sided with health carriers in cases involving allegations that a major drug manufacturer used misleading marketing strategies to increase sales of a prescription drug.

The panel, at the 1st U.S. Circuit Court of Appeals, upheld a U.S. District Court jury verdict in favor of the Kaiser Foundation Health Plan Inc. and its sister plans. The jury in that case, Kaiser vs. Pfizer (Nos., 11-1904, 11-2096), which was filed in Boston, awarded the Kaiser plans $142 million in damages.

The court also agreed to let Aetna Inc. (NYSE:AET) move forward with efforts to sue Pfizer in another case, Aetna vs. Pfizer (No. 11-1595).

The court also sided with a group health plan sponsor in a third case, Harden Manufacturing vs. Pfizer (No. 11-1806).

The carriers and the employer plan sponsor are suing over coverage of Neurontin, a brand-name version of gabapentin.

Gabapentin mimics some of the effects of GABA, a chemical that nerve cells use to communicate with one another. Pfizer won federal Food and Drug Administration (FDA) approval for doctors to use Neurontin to treat conditions such as seizures and nerve-related pain.

Doctors also have tried using Neurontin for “off-label” purposes, to treat conditions such as bipolar disorder and other psychiatric disorders. Prescribing a drug for an off-label use is legal, but critics say some efforts to use Neurontin off-label have had poor results.

In 2004, the U.S. Justice Department won a $430 million settlement in a case in which officials accused Pfizer of actively promoting off-label use of Neurontin.

Health insurers and managed care companies are trying to get Pfizer to return the money they paid for off-label use of Neurontin.

Pfizer said in a statement that it continues to believes that there was no basis in law or fact for the original district court judgment and awards in the Kaiser case.

In the Aetna case and the employer plan sponsor case, “Pfizer believes that the district court’s dismissals were  correct and disagrees with the conclusions of the 1st Circuit,” the company said. “We  are exploring our appellate options in all three of these cases.  Pfizer believes that doctors and the FDA, and not courts, should make determinations about the efficacy of medicines and whether they should  be prescribed to individual patients.”

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