Teva Pharmaceuticals, an Israeli-based drug maker, is at the mercy of the U.S. Department of Justice after allegations of False Claims Act violations surfaced late last year. The company is highly-respected for its Multiple Sclerosis and Parkinson’s Disease drugs, but has unfortunately been met with a subpoena for records pertaining to these widely popular medicines. Specifically, Teva’s MS drug Copaxone and its Parkinson’s drug Azilect were allegedly marketed improperly in violation of FDA standards, which could result in significant penalties against Teva Pharmaceuticals.
Details of Teva Probe
Earlier this year, the U.S. Department of Justice issued a subpoena against Teva relating to the sales, marketing, and promotion strategies for Copaxone and Azilect. The discovery request occurred amid allegations filed by an unidentified qui tam plaintiff pursuant to a sealed complaint filed in federal district court. Under the FCA, a whistleblower case begins when a plaintiff with original knowledge of possible fraud files a sealed complaint with the help of an attorney. The DOJ must investigate the case to determine if it holds merit and, if so, whether the U.S. government should intervene.
In a report issued last month by Teva Pharmaceuticals, they revealed that they may face possible liability ranging from $5,500 to $11,000 per violation. These statements are required by the Securities and Exchange Commission for any publicly-traded company. In an effort to evade questioning during the discovery process, Teva released only a brief statement asserting it is complying with the requirements of the subpoena.
Connection Between the False Claims Act and Improper Marketing
At first blush, it may not be obvious how the FCA applies to improper labeling and marketing, as it seems to be more of a consumer protection issue. However, the FCA prohibits any applications for Medicare or Medicaid reimbursement arising as a result of improper pressure on doctors, by pharmacological companies, to get patients to try a drug. The FCA seeks to ensure that all patients opt to try a certain drug at their own will and based upon comprehensive medical information and the advice of their doctor’s impartial medical judgment. Patients who are encouraged to try drugs due to a doctor’s potential kickback or a pharmacy company’s improper marketing are not receiving fair and balanced information about their course of treatment.
A pharmaceutical company may only market a drug for its intended purpose, which is set in coordination and based on the approval of the FDA after rigorous testing and clinical trials. If a company attempts to promote or market a drug outside of its approval, any patient who is prescribed the drug for an unapproved reason is presumed to have not received adequate information about the drug or is presumed to have been prescribed based on improper influence. In turn, if the patient is under a Medicare or Medicaid prescription drug plan, the subsequent request for reimbursement for the wrongfully-prescribed drug is considered a violation of the False Claims Act and is punishable by fines and penalties.
As the investigation against Teva continues, the documents remained sealed and the facts surrounding the case are not readily available. However, the DOJ has made clear that Teva may have engaged in unlawful marketing practices like those described above. We encourage you to stay tuned to our blog for more information forthcoming about this all-too-common scenario.
Check Your Prescriptions for Approval
Are you taking prescription drugs that may not be necessary or effective in your course of treatment? It is not too difficult to check the labels of your prescription medications for their approval rating from the FDA. If you find that your prescription was given to you for a condition other than those approved by the FDA, your doctor, pharmacy, or drug maker could be engaging in unlawful conduct similar to that of Teva Pharmaceuticals. For more information about a whistleblower lawsuit, contact Berger Montague today.