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DOJ investigates hundreds of drugs in whistleblower cases

Pharma Compliance Alert, November 5, 2008

The Department of Justice (DOJ) is currently deciding whether to intervene in more than 150 whistleblower lawsuits against pharmaceutical companies, according to Jamie Yavelberg, assistant director of the DOJ’s civil division fraud section of the Commercial Litigation Branch.

Yavelberg, speaking at the Pharmaceutical Regulatory and Compliance Congress in Washington, D.C., said the DOJ is currently investigating more than 600 drugs and more than 600 pharmaceutical companies. Many of the cases involve multiple drugs or multiple companies. The cases involve off-label promotion, kickbacks, and average wholesale pricing.

In the past five years, the number of suits filed against pharmaceutical companies has exploded, Yavelberg said. The government receives an average of 43 new cases each year. In addition, states are becoming more proactive and more aggressive and whistleblowers are bringing new types of cases.

In turn, Yavelberg said, courts are pressuring the DOJ to decide sooner whether to intervene in cases under seal. The DOJ is very selective about which cases it pursues, turning down more cases than it pursues.

She urged pharmaceutical companies to work with the government because it’s the right thing to do. “If you have a problem, fix it,” Yavelberg said.

Cooperating gives the pharmaceutical company a voice in the investigation and puts the company in a better position to make a persuasive cases about what happened and what it did in response.

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