Two months ago, a federal court reinstated a whistleblower lawsuit against Amgen, and cited one of its own recent rulings for doing so. In that earlier case, the US Court of Appeals for the First Circuit had decided that a drug or device maker remains liable under the False Claims Act, even when a pharmacy or hospital was unaware that a kickback was made to a doctor to induce the sale of a product for which reimbursement was sought from Medicare and Medicaid.

The ruling was called a game changer by lawyers who anticipated that drug and device makers would likely find themselves fending off lawsuits that might, otherwise, have been dismissed (read here). Until then, courts had ruled the False Claims Act could not have been violated if a pharmacy does not know that a prescription was only written because a drugmaker gave a kickback to a doctor. But whistleblowers have argued that a violation occurs once reimbursement is sought from Medicaid or Medicare (here is the appeals court ruling).

Amgen became the first example of a drug maker that suffered a reversal as a result of the recent ruling. And so now the drug maker is asking the US Supreme Court to review the case on the grounds that conflicting legal tests have been used in various circuit courts to interpret the False Claims Act and anti-kickback violations. Whether the Supreme Court will agree to a review remains to be seen, of course, but this will be closely watched for the same reasons that appeals court generated interest (here is petition filed by Amgen and an accompanying appendix with the Supreme Court).

At issue are allegations that Amgen provided free ‘overfills’ of its Aranesp anemia medication and encouraged doctors to bill Medicare and Medicaid for the extra amounts. The lawsuit, which was filed five years ago by Kassie Westmoreland, a former Amgen employee, also charges the biotech offered kickbacks to doctors in the form of fictitious consulting arrangements and weekend getaways in order to steal market share from Johnson & Johnson, which sells the rival Procrit treatment (read the lawsuit here).

Although the feds declined to intervene three years ago, the US Department of Justice had filed an amicus brief with the appeals court supporting Westmoreland. We should note that 17 states and the District of Columbia did join the lawsuit, although the Georgia case was recently dismissed. This particular lawsuit, by the way, generated some headline noise earlier this year when a handful of former Amgen execs ‘took the Fifth’ in depositions (back story).

court pic thx to rob crawley on flickr