Some of the largest Qui Tam or False Claims Act (“FCA”) whistleblower settlements over the past decade have involved claims that pharmaceutical and medical device companies have committed fraud. The whistle blower cases that have led to these settlements include allegations that pharmaceutical (“pharma”) and device companies paid kickbacks to doctors who agreed to write prescriptions for their drugs or use their medical devices and/or that the corporate defendants have promoted their drugs or devices for off-label uses.

Kickbacks to doctors take many forms, including the obvious inducements, such as a pharmaceutical or device company hosting lavish events at ritzy resorts and paying doctors to attend or treating groups of providers to tickets to coveted sporting events. But kickbacks to doctors or other providers can also be in the form of more subtle payments or inducements to support defendants’ off-label promotion, such as through funding clinical research or by lending the providers’ names to ghost-written “scientific” articles promoting the superiority or efficacy of a drug or device. Doctors who are willing to promote off-label uses may find themselves asked to join a company’s “Speakers Bureau,” allowing them to earn thousands of dollars in speaking fees a year. Or, doctors may be invited to attend all expense paid Advisory Board meetings to learn more about off-label uses of a drug or device.

As noted above, the False Claims Act (FCA) or Qui Tam settlements over the past decade have also focused attention on off-label promotion of drugs for unapproved uses. Off-label promotion can range from the marketing of drugs or devices for disease types or unapproved (by the Food and Drug Administration or FDA) patient populations (such as children). Off-label promotion can even be for appropriate uses but at doses that are higher than the approved dose. Also included within the category of off-label promotion are those situations where a pharmaceutical or medical device company makes unsupported claims that its drug or device is superior to that of its competitors.

Still other whistleblower settlements in the pharma and device category have resolved claims that pharmaceutical or medical device manufacturers have violated Food and Drug Administration regulations relating to Good Manufacturing Practices or that the FDA was misled about the safety or efficacy of a drug or device during the initial approval period or the period involving subsequent modifications. A manufacturer’s false statements or omissions about studies or adverse events or the failure to report serious adverse events can also form the basis of a FCA Qui Tam claim.

As noted in a recent article examining whistleblower cases there are almost endless variations on the facts that can constitute pharma or device fraud, including:

• Designing sales pitches that lead inevitably to off-label uses

• Selectively presenting clinical data to support unapproved uses in discussions with providers

• Presenting claims of superiority or efficacy that are not supported by head-to-head comparisons in clinical trials

• Encouraging physician speakers to focus on anecdotal evidence of successful off-label use

• Targeting doctors who are known to be high off-label providers for financial rewards

• Using speakers who are known to support off-label uses for CME (continuing medical education) presentations

• Promoting data from animal or clinical studies in humans that do not meet FDA scientific standards, to justify off-label uses

• Using sales representatives who are designated as “medical liaisons” to avoid the FDA ban on pharma company representatives engaging in off-label discussions

• Discussing with physicians the best way to gain insurance reimbursement for off-label prescriptions

• Imposing quotas for internal bonuses that can only be met if sales representatives engage in off-label marketing

• Recruiting doctors to conduct clinical trials (“seeding trials”) to encourage discussion among doctors of off-label uses

• Ghostwriting medical journal articles to promote off-label uses

• The use of free samples to doctors to encourage their off-label prescribing of drugs

• Identifying patients who are potential off-label users through the review of patient charts in doctors’ offices

• Making payments to nonprofit, consumer-focused disease management groups to support off-label uses

If you have a concern about the marketing practices of your company and want to discuss it confidentially with an experienced qui tam lawyer, please fill out the information on our “Contact Us” form on the left side of this page. Alternatively, please feel free to call us at 1-800-829-7037 or send us an email at inquiries@ashcraftandgerel.com. We will have somewhat contact you about your claim within twenty four hours.