What is off label promotion and marketing?

Off-label promotion, also referred to as off label marketing, is the unlawful practice of a company marketing its pharmaceuticals or medical devices for uses that the Federal Drug Administration has not approved.

Pharmaceutical fraud whistleblowers have played an important role in protecting patients who might be harmed as a result of off-label marketing by filing qui tam lawsuits that expose those practices by pharma and medical device companies. Those companies have paid billions of dollars to settle off-label marketing cases, and whistleblowers have been rewarded for their assistance with a share of those recoveries, which in many instances has meant millions of dollars.

Federal law requires drug companies and medical device companies to seek FDA approval of their products for specific uses by specific patient groups and in the case of pharmaceuticals, at specific dosages. This information is included in the informational materials for each drug and medical device. To get the FDA’s approval, the companies must provide data proving that their product is safe and effective for those specific uses.


What is the off-label promotion of medical devices?

Off-label marketing of medical devices may involve the promotion and marketing of experimental devices that have not yet been approved or approved medical devices for uses that have not been authorized.

Prohibitions against off-label marketing of pharmaceuticals and medical devices protect the public. Pharma companies often use sales strategies to convince doctors to prescribe their prescription drugs even when those off-label uses could cause dangerous side effects and harm patients. This is also true of medical device companies.

Doctors are allowed to prescribe drugs and medical devices for “off-label” therapeutic uses based on what they think is best for each individual patient. However, the law prohibits drug companies and medical device companies from promoting their own products for uses beyond those approved by the FDA. Off-label uses of drugs and medical devices can in some instances hurt patients’ health and endanger their lives.

Off-label marketing strategies can involve a variety of misconduct. Pharma companies and medical device companies sometimes make false or misleading statements to doctors and patients about off-label uses of their products. They also might offer improper inducements or kickbacks to doctors to encourage those uses and thereby increase their sales.

Companies also might pay physicians to give lectures that promote off-label uses or pay them to be authors of articles that promote off-label uses when the articles actually were written by ghost writers hired by the pharma or device company.


How do whistleblowers report off-label marketing?

If a pharma company is promoting off-label uses of its drugs and Medicare, Medicaid or other federal healthcare programs are billed for those drugs, the pharma company could be liable for fraud under the False Claims Act. Similarly, medical device companies that engage in off-label marketing and cause Medicare or Medicaid or other federal healthcare programs to be billed for their products also could be liable for false claims.

Whistleblowers with information about off label marketing pharmaceuticals and medical devices can blow the whistle by filing a qui tam lawsuit under the False Claims Act and be rewarded, if the case is successful. Qui tam lawsuits are a way for whistleblowers to sue an entity defrauding the government and recover funds on the government’s behalf.

Many whistleblowers in off-label marketing cases have been sales representatives or account representatives whose companies are engaging in those improper practices. But a whistleblower can be anyone who knows about companies marketing their products for off-label uses and can provide the government with detailed information.

After a qui tam lawsuit is filed, the government investigates the allegations to determine whether it wants to join, or intervene in, the case. If the government declines to intervene, whistleblowers may pursue qui tam cases on their own and receive a larger share of the recovery as a reward. Whistleblowers are rewarded with 15% to 30% of the recovery, depending on a number of factors.

The False Claims Act also provides for redress for whistleblowers who are suffer employment retaliation.


What are examples of off-label marketing?

Many of the world’s largest pharma companies have paid hundreds of millions and even billions of dollars to settle whistleblower cases involving off-label marketing.

Phillips & Cohen represented the leading whistleblowers in two record-setting settlements of off-label marketing charges against two pharma companies, GlaxoSmithKline and Pfizer.

GlaxoSmithKline paid $3 billion to settle four qui tam lawsuits and criminal charges involving off-label marketing. Phillips & Cohen represented a former Glaxo senior marketing development manager and a former regional vice president in a qui tam case that alleged Glaxo engaged in nationwide marketing schemes to push sales of Advair, Wellbutrin, Imitrex and other popular prescription drugs for off-label uses. The lawsuit also alleged that Glaxo used improper financial inducements to market its drugs and misrepresented the safety and efficacy of those drugs.

Pfizer paid $2.3 billion to settle off-label marketing charges – most of it due to a qui tam case by a former Pfizer sales rep represented by Phillips & Cohen. His lawsuit alleged that Pfizer promoted one of its drugs, Bextra, for uses and in doses that far exceeded what the FDA had approved and that some of those off-label uses endangered patients’ lives.

Other Phillips & Cohen cases involving off-label marketing by a pharma company include one against Cephalon. Phillips & Cohen’s client, a former sales manager, was the first person to report Cephalon’s off-label marketing practices to the government. Cephalon paid $425 million to settle criminal charges and several qui tam lawsuits, including the one filed by Phillips & Cohen, which alleged the company had ordered employees to use certain unlawful sales strategies to convince doctors to prescribe Cephalon’s Actiq, Gabitril and Provigil drugs for off-label uses.


What are examples of off label promotion for medical devices?

Medical device manufacturer Biocompatibles Inc. paid $36 million to settle a whistleblower case and related criminal charges that alleged the company marketed a FDA-approved embolization device for off-label uses as a drug-delivery device for chemotherapy to treat patients with liver cancer.

Medtronic paid $2.8 million to resolve a whistleblower complaint brought by a former Medtronic sales rep that alleged the company promoted the use of its SubQ stimulation to reduce chronic pain, even though the safety and efficacy of the medical procedure had not been established as required by the FDA. Medtronic promoted this procedure, the qui tam lawsuit alleged, by selling SubQ devices to pain management physicians at steep discounts and promising them they could make $10,000 profit on each patient. To get Medicare reimbursement for the off label promotion medical device use, Medtronic allegedly instructed hospitals to use a billing code assigned to the FDA-approved use.


Phillips & Cohen protects off-label marketing whistleblower       

If you are aware of off-label marketing by a pharma company or medical device company, contact Phillips & Cohen for a free, confidential review of your matter with experienced whistleblower attorneys.


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