How badly did Pfizer harm payers?

Lipitor brings in about $12 billion in global sales every year, according to the complaint. But damages in this lawsuit will depend on domestic sales, which are not listed in the document. According to IMS Health, Lipitor sales came to $8.4 billion in 2005, $7.75 billion in 2004, $6.8 billion in 2003, $6.1 billion in 2002, and $5.2 billion in 2001. According to the plaintiffs, a significant percentage of the prescriptions were written off-label. Presuming that the plaintiffs succeed in certifying a national class for the lawsuit, the stakes are very high.

"We believe the damage comes to several billion dollars," says Jay Eisenhofer, lead attorney for the plaintiffs. "If it is $1.5 billion or $3 billion I'm not sure. We believe it is something like $300 million to $500 million per year for four or five years, which is how we arrived at the $1.5 to $3 billion."

In fact, they do. Doctors can write any drug off-label, but insurance companies can simply refuse to cover it. In many cases, they don't even need to see the indication. For many drugs, they can tell from the dose alone. The case of a 26-year-old schoolteacher in New Jersey is typical. After recovering from a benign brain tumor in childhood, the teacher, who does not want her name used in print, suffers as an adult from chronic debilitating migraines. Her doctor prescribes Imitrex (sumatripan) on a daily basis, which is the most effective course of treatment.

However, Imitrex is only indicated for sporadic migraines on-label, so prescribing 30 doses per month—instead of 10—tips off the insurance company that the prescription is written off-label, and the payer can decline claims for all but 10 pills a month. The teacher, who earns $41,000 per year, can either pay $400 per month for the 20 doses that are not covered by her insurance, or she can suffer migraine headaches two out of three days.

The Lipitor case is slightly more complicated. Unless the patient is hospitalized for acute coronary syndrome, payers often require doctors to certify that cheaper therapies—like a 60-day trial on another drug—have failed before approving Lipitor. Claim forms often reprint the ATP III guidelines.

Why didn't third-party payers suing Pfizer just deny the claims?

Asked why the Welfare Fund couldn't have used step-therapies and restrictive formularies to protect themselves from off-label prescriptions, Eisenhofer acknowledges that they could have.

"And I guarantee you that Pfizer will argue that they should have," Eisenhofer says. "But that doesn't absolve Pfizer from their responsibility. Pfizer will point the finger and say that the health and Welfare Fund should be responsible."