The Justice Department has been playing target practice with off-label marketing cases lately: Setting 'em up and knocking 'em down. Now, it's Johnson & Johnson in the feds' sights. The government has decided to join two whistleblower suits against J&J, alleging that the company illegally promoted the heart drug Natrecor for uses not approved the FDA.
As the Associated Press notes, J&J got approval to market Natrecor for patients with severe congestive heart failure in 2001. But the lawsuits allege the company started urging doctors to use the drug for less severe CHF. As you know, doctors can choose to prescribe drugs for unapproved uses, but companies aren't allowed to push their products off-label.
The Justice Department says it plans to fight for reimbursement of the money Medicare spent on unapproved uses. If state attorneys general decide to opt into the suits as well, they might seek Medicaid paybacks.
You'll recall that some of the biggest in Big Pharma have settled off-label marketing claims recently. Pfizer took a $2.3 billion charge for Bextra claims, and GlaxoSmithKline announced a $400 million charge on marketing and promotion claims related to several products. Eli Lilly, meanwhile, paid $1.4 billion in settlement of Zyprexa marketing claims.