Whistleblower Attorneys in Salt Lake City

Proficiently Handling Pharmaceutical & Medical Device Fraud

Pharmaceuticals make up a massive portion of health care expenditures every year in the United States. Because the profit margins to pharmaceutical companies are so high, schemes abound to promote the overuse of expensive drugs in every sector of our health care system. Some of the largest false claims recoveries in recent years have involved pharmaceutical and medical device fraud.

Off-Label Marketing

The most common source of false claims whistleblowing and successful whistleblower cases against pharmaceutical companies involves what is called, “off-label marketing”. Under the jurisdiction of the Food and Drug Administration (FDA), pharmaceuticals, biologicals (drugs derived from biological sources), and devices are approved for human use following extensive testing. FDA approval includes indications (diagnoses and symptoms) for their use, dosages, and other matters that are part of the regulatory approval (the labeling process). In off-label marketing, the drug company promotes use of the drug for other diseases or conditions (or even in higher or lower doses) than those approved by the FDA.

To learn more, call us today at (801) 845-9866 and speak with one of our knowledgeable whistleblower attorneys in Salt Lake City.

While physicians are, generally speaking, permitted to prescribe a drug “off label” and under certain circumstances, a payor will pay for an off-label use, drug companies are prohibited from marketing the drug for off-label uses. That is because promoting off label uses constitutes misbranding of the drug.

Many pharmaceutical companies engage in off-label marketing. Some forms are obvious, and others are not so obvious. Often, successful whistleblowers are sales representatives, regional sales managers, and others in a position to receive corporate training, email, and even compensation involving off-label marketing volumes, tactics, or strategy.

Indications that off-label marketing may be going on include:

• Compensating sales representatives and regional managers for volumes of sales that include off-label uses of the drug
• Pushing prescribing physicians or clinics to switch patients from a competitor’s drug when the competitor’s drug is actually for a different approved indication
• Sponsoring “medical seminars” with paid physicians who talk about potential off-label uses
• Pushing research studies (often funded by the drug company itself) that directly or indirectly state that a drug may have off-label uses
• Providing material and information verbally or by email or otherwise promoting the use of a drug at dosages significantly below or above the FDA approved level while claiming that the drug is likely to be effective at the same or the increased dosage
• Creating bogus or compromised research studies, professional panels, or “patient groups” where the professional information and participants are all paid, directly or indirectly, by the pharmaceutical company. These groups then convince others to prescribe the drug for off-label purposes.

Pharmaceutical Kickback Schemes

Another form of pharmaceutical fraud is a covert kickback. Kickbacks can be paid in many ways. Anti-kickback laws prohibit providing another with anything of value if one purpose is to encourage writing prescriptions for a particular drug company’s product.

These kickbacks can include:

• Systems of paying speakers and their travel expenses to conferences for high-volume prescribers
• “Research grants” with little or no actual research required and given to those who are high users of the drug company’s products
• “Medical directorship” or “consultant” payments to high users
• “Per-unit” rebate programs

Whistleblowers have successfully brought false claims cases for these and many other schemes.

In addition to drug companies, medical device manufacturers engage in the same sorts of activities. Medical devices, pacemakers, implants of all types, spinal fusion products, and many others have been the subject of these off-label marketing and kickback schemes.

These fraud schemes are not carried out by one or two people. Many in the company and the physicians’ offices or clinics often know of these systems. Rather than being a co-conspirator in concealing this activity, becoming a whistleblower can extract you from the morass.

If you are aware of these schemes, contact the experienced Salt Lake City whistleblower attorneys at Eisenberg, Cutt, Kendell & Olson Attorneys at Law and call (801) 845-9866.