For the past five years, the US Attorney in Brooklyn, New York, has been investigating Amgen for allegedly violating the False Claims Act. At issue are a host of allegations, most notably that Amgen violated HIPAA and offered kickbacks to doctors in order to boost sales of its various meds and steal market share from such rivals Johnson & Johnson.
Along the way, however, the biotech believed an agreement was reached in which the government would coordinate contact with current Amgen employees, but then argued the understanding was breached when the feds began attempting to conduct interviews and subpoena documents. And so last year, Amgen filed a protective order, but late last week, a judge upheld an earlier recommendation (see this) and ruled the feds can continue pursuing Amgen employees as they see fit (read the ruling here).
The decision is a blow to the biotech, which has been struggling to keep its practices from public view. You may recall that Amgen routinely requires employees to sign agreements that indicate any disputes will be resolved by binding arbitration, which means documents and testimony are kept confidential. However, the requirement has become an issue among some former sales reps who have sued Amgen and claim the proceedings actually hide misdeeds (read here).
In their view, arbitration has prevented the full extent of Amgen marketing actions from coming to light at a time when 15 state attorneys general are pursuing a lawsuit against Amgen for an alleged 'kickback scheme’ to boost sales. There were also subpoenas issued from Attorneys General from New York and New Jersey, who are probing violations of consumer fraud laws and state false claims acts concerning the Enbrel rheumatoid arthritis med. The reps also say Amgen violated HIPAA by encouraging reps to pull patient records from physician offices.
In one such instance, former rep Elena Ferrante claims Amgen sales managers encouraged reps to promote Enbrel off-label and encouraged docs to prescribe Enbrel to patients who may not have needed the drug (see this). Another former rep, Marc Engleman, says reps were directed to pull patient files from physician offices, orchestrate letter-writing campaigns to patients and insurers, and coordinate and attend patient outreach seminars as part of an off-label marketing effort (read here).
"Amgen's protective orders are artificial restraints on the government and the attorneys who are seeking information concerning Amgen's Medicare fraud, illegal kickbacks and manipulation of the AWP," or average wholesale price, Lydia Cotz, an attorney for Ferante, writes us. "We hope now, based on this order, the government can investigate those individuals directly and not have to rely on Amgen's attorneys who have withheld discovery and evidence throughout parallel Arbitration Proceedings that are intertwined with the False claims acts that are being investigated.
Meanwhile, another former sales rep, Kassie Westmoreland, has filed a lawsuit in federal court in Boston in which she charged Amgen provided free ‘overfills’ of its Aranesp anemia medication and encouraged doctors to bill Medicare and Medicaid for the extra amounts. During the run-up to the trial, which is expected to take place later this year, five former Amgen exec took 'the Fifth' during depositions (see this).
We await a reply from Amgen and will update you accordingly. UPDATE: An Amgen spokeswoman sends us this: "Amgen has declined to appeal the court’s dismissal of the Motion for a Protective Order. Amgen intends to continue to cooperate with Unites States Attorneys’ Office for the Eastern District of New York in this ongoing matter."