Whistle-Blower Law in Off-Label Marketing

At the MA law firm of Altman & Altman, LLP, our dedicated Whistle-blower Off-Label Marketing Lawyers understand the difficulties faced by individuals bringing forward off-label lawsuits. Our pharmaceutical whistle-blower attorneys will help you navigate these difficult waters and will hold all disclosures in the strictest of confidence. If you wish to bring forward information regarding off-label marketing fraud, please Contact our Team of Off-label Marketing Whistle-blower Lawyers. Our team is available to speak with you around the clock, including nights and weekends.

While the pharmaceutical industry remains a $400 billion industry boasting high profits even in times of economic uncertainty, recently pharmaceutical companies have faced a wide array of market challenges. In recent years, pharmaceutical companies have seen a dramatic decline in innovation, patent expiration on many of the most profitable drugs, and even fierce competition from generic drug manufacturers. These challenges have let the pharmaceutical companies to pour their money into advertising, with most pharmaceutical companies spending twice as much on marketing existing drugs than on research for new medications. As part of this renewed drive for profits, many companies often market existing drugs for off-label uses. Off-label uses are uses other than those that the drug was approved by the Food and Drug Administration (FDA) for. While it’s not illegal for doctors to use their discretion to prescribe drugs for off-label purposes, it is illegal for the drug companies to market a drug for an unapproved purpose. Further, the larger problem faced by off-label prescriptions occurs when pharmacies seek reimbursement for prescriptions through Medicaid of Medicare for uses that haven’t been approved for reimbursement. Many of these practices occur often, but the FDA doesn’t have adequate resources in order to investigate all of the companies potentially involved. Due to the lack of resources, the courts have allowed whistleblowers to bring claims against these drug companies on behalf of the government under the False Claims Act. In these cases, the whistleblower is not only protected from retaliatory conduct by the company, but also could share in the money recovered by the government from the drug company.

The False Claims Act (FCA) explicitly prohibits retaliation against an employee because that employee engaged in a protected activity. Protected activity, as defied by the statute, includes lawful acts done by the employee in order to stop the company from further violating the FCA. This means that an employee can’t be fired, demoted, suspended, or in any way harassed by the company for his attempt to stop the company from violating the FCA. The courts have not only enforced this part of the act, but in 2009 Congress expanded the act to include not just employees or agents of the company will receive protection, but entities such as independent contractors will share the same protections. Further, employees are even protected if an investigation occurs and no violation of the FCA is found, so long as the employee was reasonable in bringing the claim.

In bringing a claim against a company for retaliation, the elements the whistleblower must prove are simple. First, the employee must be engaged in an activity protected under the FCA, second that the defendant knew the employee was engaged in the protected activity, and finally that the employee was retaliated against because of the protected activity. This simply means that in order to receive whistleblower protection, the employee must show that he exposed the company’s violation of the FCA and was retaliated against because his employer knew he was the one to expose the violation.

When a whistleblower helps to bring a claim against a pharmaceutical company, he is not only protected by the law from retaliation but he also has the opportunity to share in the government’s recovery. Penalties for a violation of the FCA are often harsh for pharmaceutical companies, as they could face a fine of $10,000, plus three times the amount of damages that the government sustained from their fraudulent actions. In addition to these fines, the company could face punitive damages, which are assessed to a defendant in order to punish conduct that the public finds to be morally reprehensible. If the whistleblower brings the suit against the company on behalf of the government, the whistleblower collects between 25-30% of the damages in addition to attorney’s fees and costs. While this certainly means that whistleblowing could become a profitable enterprise for a number of employees, the FCA walks a fine line between encouraging employees to speak out when something illegal is happening at their company and exposing their company to frivolous litigation.

Whistle-Blower Off-Label Marketing Lawyers at Altman & Altman, LLP

If you wish to come forward with information regarding off-label marketing practices, please contact the team of whistle-blower attorneys at Altman & Altman, LLP to schedule a free-of-charge initial consultation. Our off-label marketing attorneys are available to speak with you around the clock - 24 hours a day, 7 days a week.

Our experienced Whistleblower lawyers will support you throughout the process in order to make you as comfortable as possible when bringing forth this type of claim. Contact our office today to speak with an attorney regarding your off-label marketing whistle-blower case.

Sources and Additional Resources

Stephanie Greene, False Claims Act Liability for Off-Label Promotion of Pharmaceutical Products, 110 Penn St. L. Rev. 41 (2005).

Claire Sylvia, The False Claims Act Prohibits Retaliation Against an Employee, Contractor, or Agent Because the Person Engaged in Activity Protected Under the Act, PRACTITIONER INSIGHTS (West).

Graham County Soil & Water Conservation Dist. v. United States ex rel. Wilson, 545 U.S. 409, 416, 125 S. Ct. 2444, 2449, 162 L. Ed. 2d 390 (2005).