Doctors often prescribe drugs for off-label uses—and, if those drugs prove effective, doctors are more likely than not to
share news of their success with their colleagues. But doing so can raise problems, as the current legal predicament of Alabama
neurologist David R. Longmire dramatically illustrates.
Like many physicians treating epilepsy patients, Longmire first used the anticonvulsant Neurontin as a supplemental therapy
to control seizures, for which it has FDA approval. In doing so, though, he observed an unexpected result: The patients he
treated experienced a reduction in their accompanying pain. The idea that Neurontin could be used not simply to achieve better
seizure control but also to reduce pain intrigued Longmire, who'd written several articles on the evaluation of certain forms
of neuropathic pain.
After he began talking about his findings to colleagues, he received an invitation from Parke-Davis, the division of pharmaceutical
maker Warner-Lambert responsible for the drug. The drug maker wanted him to participate in a meeting with other physicians
who'd observed similar results. That meeting was the beginning of a series of efforts—by Longmire and others, who were paid
by the drugmaker—to inform physicians about Neurontin's pain-relieving and other off-label effects.
Now, more than a decade later, those same efforts have placed Longmire at the center of several contentious lawsuits. In May,
healthplans and other plaintiffs claimed, in two separate suits, that Longmire participated with Warner Lambert (now owned
by Pfizer) in a wrongful scheme to promote Neurontin for pain control and other non-FDA-approved uses. According to the complaint,
which echoes charges first outlined by the government in its 2004 criminal and civil prosecution of Warner-Lambert, the scheme
to market Neurontin for off-label uses caused doctors to prescribe it more often than they otherwise would have, thereby costing
plaintiffs millions of dollars in improper reimbursements. They're suing to recover these costs and impose punitive damages.
The twin suits prompted Longmire to file one of his own. In May, he sued Warner-Lambert (along with Pfizer), for embroiling
him in its fraudulent scheme. The suit sought damages both for the harm done to his reputation and the costs of defending
himself in the other two cases. This summer, Warner-Lambert/Pfizer successfully filed a motion to dismiss the Longmire suit.
We looked through this thicket of actions and counteractions to see how a doctor who claims he acted in good faith went from
sharing his off-label experiences with colleagues to his own legal hell.
A criminal case spawns a gaggle of civil suits
To understand Longmire's current legal mess, you need to go back several years, to the government's criminal indictment of
Warner-Lambert. In that indictment, prosecutors charged the drugmaker with doing an end run around a key provision of the
Federal Food, Drug, and Cosmetic Act. This provision says, in effect, that once the FDA approves a prescription drug for certain
intended uses, the drug's maker can't market or promote it for other or "off-label" uses.
The prohibition doesn't extend to doctors, however. They can—and often do—talk to colleagues about their success with a particular drug's off-label use. Among other things, prosecutors
charged Warner-Lambert with taking advantage of this fact, recruiting physician consultants to do something the company itself
couldn't do: promote Neurontin for non-FDA-approved uses, including neuropathic pain control. Longmire was among the physicians
who participated in these promotions, said prosecutors, although they stopped short of naming him as a defendant in their
suit.
After the dust settled, Warner-Lambert pled guilty to two counts of violating the law and agreed to pay more than $430 million
in fines and a settlement. Of this amount, $152 million went toward the settlement of claims at both the state and federal
level, arising from Medicaid payments for Neurontin.
With the government's criminal and civil case resolved, private insurers across the country began taking aim at the drugmaker.
Echoing many of the allegations set out in the government's case, they claimed in federal suit after federal suit that the
pharmaceutical company's marketing practices had cost them money. (Now consolidated into two civil lawsuits, these cases are
currently pending in federal district court in Boston.)