Intended for healthcare professionals

Feature Off-label Marketing

Pfizer versus Kaiser: insurers want their day in court

BMJ 2013; 346 doi: (Published 12 June 2013) Cite this as: BMJ 2013;346:f3738
  1. Ed Silverman, editor
  1. 1Pharmalot, Millburn, NJ, USA
  1. pharmalot{at}

Drug companies have paid out billions in fines for illegal marketing, but a recent court ruling may now give insurance firms encouragement to seek their pound of flesh as well, Ed Silverman investigates

In a move that is certain to put the pharmaceutical industry on the defensive, a federal appeals court panel recently issued a pair of rulings against Pfizer that could encourage insurers and health plans to file a surge of lawsuits—if they can prove they paid unnecessarily for illegally marketed medicines.

In the first instance, the US First Circuit Court of Appeals upheld a lower court ruling that the world’s largest drug maker should pay $142m (£91m; €107m) to the Kaiser Foundation Health Plan, which claimed damages for covering the epilepsy drug gabapentin (Neurontin) for off-label uses, including bipolar disorder, migraines, and neuropathic pain.

In the other ruling, the appeals court overturned a different lower court ruling and allowed Aetna, one of the largest US insurers, and a health plan run by Harden Manufacturing to revive their lawsuits, which claimed that Pfizer engaged in racketeering and induced physicians to prescribe gabapentin for the same unapproved uses.

“A reasonable jury could have concluded, based on the evidence, that [Pfizer’s] scheme relied upon the expectation that fraudulent off-label marketing to doctors would induce them to act in a foreseeable fashion—ie, to write off-label prescriptions for Neurontin that would be paid for by Aetna,” wrote the three judge panel, which included former US Supreme Court Justice David Souter.

The Kaiser decision, in particular, is important because, until now, drug makers have regularly succeeded in convincing courts that it is impossible to prove that every physician who prescribed a drug had been influenced to do so by marketing messages. In fact, four other federal appeals courts have not awarded damages to third …

View Full Text

Log in

Log in through your institution


* For online subscription