Off-Label Marketing Case Involving Calgene Survives Despite Defendants’ Motion to Dismiss

Earlier this month, a False Claims Act case against drug maker Calgene was unsealed, revealing allegations of off-label marketing with regard to its controversial cancer drug Thalomid. The case, in which the government opted not to intervene, has been subject to several months’ worth of procedural wrangling by both parties. However, federal District Court judge George King ultimately refused Calgene’s attempts to have the case dismissed for failing to properly state a claim of fraud – issuing a 16-page order essentially reprimanding the company for its paltry attempts at avoiding liability.

Background of Case Against Calgene

The False Claims Act case against Calgene centers on a controversial drug known as Thalomid. In the 1960s, this drug was marketed to combat morning sickness – a common side effect associated with the early stages of pregnancy. However, the drug quickly became linked to serious birth defects and prompted landmark litigation. The result of the 1960s Thalomid case was expanded oversight and involvement by the Food and Drug Administration, an agency tasked with protecting consumers from dangerous and risky drugs.

Fast forward to present day, and Thalomid is now marketed as a drug effective in the fight against cancer. However, the underlying facts of the whistleblower lawsuit against Calgene, which was filed by a former sales employee, reveal that the company may be skirting around FDA regulations and fraudulently marketing its product for unapproved use.

The federal government will not reimburse Medicare and Medicaid claims for prescription drug coverage if the drug is being prescribed in a manner not congruent with the FDA’s approval, in response to marketing by a drug manufacturer. In other words, if a doctor prescribes a drug to a patient to treat a condition not considered by the FDA during clinical trials and testing, after being persuaded to do so by the drug’s manufacturer, that prescription cannot be reimbursed.

According to the complaint, Calgene was engaging in this exact practice, which is known as off-label marketing. More specifically, the relator alleges that for a period spanning at least ten years, the company was marketing the drug in a manner “tantamount to human experimentation.” The company allegedly routinely marketed its drugs to physicians as safe and effective for the treatment of several forms of cancer; however, it downplayed and ignored the risks of serious, life-threatening blood clots.

Calgene won FDA approval in 1998 to sell Thalomid for the treatment of a skin disorder similar to leprosy. From there, it gained approval to market its product for the treatment of multiple myeloma. Despite these limited approvals, Thalomid was marketed to oncologists for the treatment of a wide spectrum of cancers, and sales associates were allegedly required to cite studies on the drug that were not supported by scientific evidence.

Contact a Reputable Whistleblower Lawyer Today  

If you are aware of similar misconduct relating to the off-label marketing of drugs to physicians treating Medicare or Medicaid patients, you may be eligible to file a whistleblower lawsuit under the federal False Claims Act. Successful False Claims Act plaintiffs may be able to receive up to 30 percent of the ultimate recovery. For more information, contact us today.

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By | 2018-03-27T10:13:13+00:00 July 30th, 2014|Healthcare Fraud|