International Law

Pfizer, Warner-Lambert Must Defend RICO Claims for Off-Label Marketing of Neurontin

This posting was written by Mark Engstrom, Editor of CCH RICO Business Disputes Guide.

Two consumers who suffered from bipolar disorder could proceed with RICO claims against Pfizer, Inc., and Warner-Lambert Co.?manufacturers of the prescription drug Neurontin?because the consumers were able to show that their treating physicians had prescribed Neurontin in reliance on allegedly fraudulent ?off-label? marketing statements by the manufacturers, the federal district court in Boston has ruled.

More specifically, medical information letters that the treating physicians had received from the manufacturers created a triable issue of fact on the issue of proximate cause.

Clinical Trials

The letters showed that the manufacturers had discussed a clinical trial that purportedly revealed favorable results when Neurontin was used for mood disorders. The manufacturers failed, however, to mention the negative results of three other trials that studied the use of Neurontin for the treatment of bipolar disorder. Moreover, Pfizer failed to produce (for a previous bellwether trial) reliable scientific evidence that Neurontin was effective in treating bipolar disorder.

According to the court, the consumers had to show that this conduct caused the treating physicians to prescribe Neurontin when the physicians would otherwise have used alternative treatments. Because a finder of fact could reasonably infer that a treating physician would not prescribe a drug if aware of ?overwhelmingly and uniformly negative evidence? about the drug?s efficacy, the manufacturers? motion for summary judgment against the two consumers was denied.

Failed Claims

The court determined that four other consumers could not proceed with RICO claims against the manufacturers because their treating physicians testified that they had prescribed Neurontin to their patients based on their independent medical judgment. Indeed, the treating physicians denied having received any unsolicited, off-label ?detailing? by the manufacturers? sales representatives.

Moreover, they stated that their knowledge about the efficacy of Neurontin for off-label indications was informed by their clinical experiences with the drug and by information they received from trusted colleagues.

Because no admissible, non-hearsay evidence showed that the treating physicians had received or read any misleading or fraudulent publications about Neurontin?s use for off-label indications, the manufacturers? motion for summary judgment against the four consumers was granted.

Third-Party Payors' Claims

Similarly, third-party payors (TPPs) could not proceed with their RICO claims, the court decided. Because the TPPs did not rely on the manufacturers? alleged misrepresentations directly, the TPPs were unable to show that their injuries were proximately caused by manufacturer misrepresentations regarding the efficacy of Neurontin.

The TPPs did not proffer any evidence regarding the number and identity of prescribing physicians that had purportedly relied on the alleged fraud. Because proximate cause could not be established, the TPPs? RICO claims did not withstand summary judgment.

The decision is Neurontin Marketing and Sales Practices Litigation, CCH RICO Business Disputes Guide ¶11,970.

Full post as published by Trade Regulation Talk on December 21, 2010 (boomark / email).