Illicit Marketing of Drugs and Devices Extends Beyond Off-Label Promotion to False Marketing by Means of Biased Medical Research

For years, the Justice Department and qui tam whistleblowers have pursued cases in which drug or device manufacturers market their products for unapproved “off-label” uses after gaining FDA approval for limited “on-label” indications. Although doctors can prescribe drugs and devices for any indication they deem medically appropriate, whether on or off-label, it is illegal for manufacturers to promote their products for off-label uses. Also, government healthcare programs generally do not reimburse for experimental uses of drugs and devices that are not medically accepted as reasonable and necessary.

In the typical off-label case, the whistleblower and the government complain not only about off-label promotion, but also about kickbacks paid to clinicians to influence their script-writing decisions and/or money lavished upon medical researchers to bias their published reports in ways that downplay safety risks and overstate the efficacy of the manufacturer’s drug or device. Although qui tam or False Claims Act cases of this sort are generally lumped together under the rubric of “off-label marketing,” I believe the real heart of these cases is the use of drug or device maker money to illicitly influence the script writing decisions of clinical physicians, whether the drugs or devices in question are used on or off-label.

Generally, to violate the False Claim Act, a manufacturer must “cause” others (often doctors or pharmacists) to submit false or fraudulent claims to government healthcare programs.  A claim made against Medicare or Medicaid in many of these cases is false or fraudulent not so much because it involves an off-label use (a doctor can, after all, prescribe an off-label use if it is medically indicated), but because the medical decision to prescribe the drug or device has been influenced by kickbacks or false information provided to the clinician.

In other words, illicit or false marketing that is actionable in a case under the False Claim Act can take the form not only of off-label marketing, but also: (1) marketing that is illicit because of money paid to clinical physicians to influence their script-writing decisions—a garden variety kickback; and (2) marketing that is illicit because of money paid to medical researchers to  bias the published medical literature, thereby influencing the script-writing decisions of clinicians—a kickback once removed in the chain of causation.  

The second of these illicit marketing schemes has yet to be well-recognized as a False Claims Act violation, but should be. The causation test generally employed in False Claims Act cases is foreseeablility. If a drug or device maker can reasonably foresee that publication of biased or corrupted medical literature will cause submission of claims for its product to government healthcare programs, then the test of causation is satisfied. Claims caused by this sort of marketing are false or fraudulent not only because they have originated from kickbacks that create conflicts of interest for researchers, but also because biased or corrupted research studies can be considered false statements or false documents used to get claims paid within the meaning of the False Claims Act.

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WM. Paul Lawrence, II serves as of counsel to Waters & Kraus, LLP. His practice focuses on appellate, class action, and qui tam (whistleblower) litigation under the False Claims Act.