On
May 15, 2018, the United States intervened in five “whistleblower” lawsuits that
have been consolidated in United States District Court in Los Angeles and accuse
Insys Therapeutics, Inc. of paying illegal kickbacks and defrauding federal
health programs in connection with the marketing of Subsys, an opioid
painkiller manufactured and sold by the Arizona-based company. The
civil claims asserted against Insys are allegations only, and there has been no
determination of liability.
The five cases brought pursuant to the False Claims Act were ordered unsealed
late last week, as was the government’s complaint in intervention. The United
States has separately pursued a number of criminal cases against Insys
employees and Subsys prescribers.
The cases allege illegal marketing tactics related to Subsys, a sublingual
spray form of fentanyl, an opioid painkiller. In 2012, Subsys
was approved by the Food and Drug Administration for the treatment of
persistent breakthrough pain in adult cancer patients who are already
receiving, and tolerant to, around-the-clock opioid therapy.
The government’s complaint alleges that Insys paid kickbacks to induce
physicians and nurse practitioners to prescribe Subsys for their patients. Many
of these kickbacks allegedly took the form of sham speaker fees to physicians,
jobs for the prescribers’ relatives and friends, and lavish meals and
entertainment.
The United States also alleges that Insys improperly encouraged physicians to
prescribe Subsys for patients who did not have cancer, and that Insys employees
lied to insurers about patients’ diagnoses in order to obtain reimbursement for
Subsys prescriptions that had been written for Medicare and TRICARE
beneficiaries.
The qui tam provisions of the False Claims Act allow whistleblowers to file
lawsuits on behalf of the United States when they believe that a party has
submitted false claims for government funds, and to receive a share of any
recovery. Now that the United States has intervened, the civil cases will be considered far more serious by the civil defendants. When the United States declines to intervene, the cases are easier to resolve and typically settle for much less.
Attorney Commentary: This case is an example of why providers who obtain speaker fees, meals, entertainment or other items of value need to consider whether their prescribing habits have changed or whether they have been influenced in any way by the payments. In the past, physicians and providers assumed that large pharmaceutical companies were compliant with the law and researched these issues. This is no longer the case as we can see from this case. The facts alleged are somewhat extreme but any provider accepting speaker fees should ensure that any future prescriptions are medically necessary and should consider patient disclosure as well. If in doubt, seek a legal opinion.
Posted by Tracy Green
