Bristol-Myers Squibb ($BMY) and Otsuka won't have to fight claims that they promoted Abilify for off-label uses or used kickbacks to persuade doctors to prescribe the antipsychotic drug. A U.S. judge tossed out those allegations, leveled by a couple of whistleblowers in 2011, for lack of specific evidence.
But the two former Bristol-Myers sales reps did back up accusations that the company fired them to retaliate against their whistleblowing, Judge William Bertelsman said in his ruling.
It's the latest set of whistleblower claims tossed because the plaintiffs didn't present specific information about specific medical claims to federal healthcare programs such as Medicare and Medicaid. Other False Claims Act rulings have assumed that off-label marketing and kickbacks led to false healthcare claims.
Although the former reps did offer up evidence that the companies promoted Abilify to pediatric psychiatrists before the drug was approved for kids, for instance, they didn't follow the prescription chain after that, according to the judge's ruling. The reps didn't prove that the doctors wrote off-label scripts, that patients filled those scripts, or that claims for payment were filed with Medicare or Medicaid. Without that evidence, their off-label accusations had to go.
Bertelsman made a similar decision about the kickback allegations in the lawsuit. The two reps, Joseph Ibanez and Jennifer Edwards, delivered enough backup to show that the companies paid doctors to speak about Abilify, handed out samples, offered free meals, and used other incentives to persuade physicians to prescribe the drug. But all of that information didn't show that the companies violated anti-kickback laws, because the reps didn't prove that the doctors who received these things "wrote even one prescription to a federal-health-care program recipient on which an entity submitted a claim for reimbursement to the government," the ruling states.
But Bristol-Myers will have to face accusations that the two reps were terminated because they complained about the company's promotional practices. Ibanez and Edwards showed that they reported their concerns to higher-ups and that their performance was criticized after that. Plus, the two were terminated without an opportunity to defend themselves, the judge said. That's enough to suggest that Bristol-Myers may have fired them in retaliation, Bertelsman wrote.
In 2007, Bristol-Myers paid $515 million to settle Justice Department allegations that it promoted Abilify for off-label uses and used kickbacks to boost scripts. Otsuka made a similar deal with the feds in 2008, paying more than $4 million to settle an off-label Abilify probe.
- read the judge's ruling (PDF)
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