By Brian J. McCormick, Jr., Esq.
During my career I have successfully prosecuted four of the largest whistleblower settlements in U.S. history. Below, I offer some insight on challenges these cases pose. Before cases make their way to court, how do fraudulent practices grow into billions of dollars lost? Problems develop when pharmaceutical companies encourage sales teams to market prescription drugs for uses that the Food and Drug Administration has not approved the drugs for.
"Off-label" marketing tactics used by salespersons lead physicians to believe they can prescribe the respective drugs for non-approved conditions. Physicians may then prescribe the drug for a condition that was marketed to them. The patient may qualify for public benefit programs like Medicare or Medicaid, and submit their prescription receipts for reimbursement. Then, the drug company receives money for the prescription, and the government covers the cost of a medication that should not have been prescribed for this patient's particular condition.
Pharmaceutical companies using these tactics earn profits at the expense of the government. Myself and other attorneys who litigate whistleblowing cases help parties who suffered to regain what was lost. The government's expenses in whistleblowing cases may be vast. Unnecessary prescriptions may be written for:
- Workers' compensation
- Veterans' benefits
- Bureau of Prisons
- And more
Off-label marketing is not the only tactic pharmaceutical companies use to increase sales. Kick-backs may be used to convince a physician to prescribe the drug. (Under these circumstances, a case may also be brought against the doctor for accepting the kick-back.) Overcharging of prescription drugs is another method. Contracts between pharmaceutical companies and hospitals are not always monitored closely, and pricing variations could go unnoticed. Another way drug companies increase profits is to cut routine tests. The drug company may be contractually obligated to perform a series of tests, but they may only complete some of the tests in order to save money.
After successfully litigating historic whistleblower settlements - cases that separately settled for billions of dollars each - I am intimately familiar with how liability is recognized by courts and jurors. Proving liability in these cases requires evidence. Some types of evidence include:
- Unreasonably high sales goals for pharmaceutical representatives
- Sales presentations and sales aids marketing off-label drug use
- Other internal marketing plans focused on off-label drug use
- Statements from staff who created pharmaceutical sales plans
- Salespersons ordered to use copies of medical journal articles citing off-label drug test results
- Statements from doctors and nurses who experienced off-label marketing from a sales representative
- Medical staff that witnessed a doctor accepting a kick-back
Drug salespersons encouraged to market drugs for off-label use may feel like they have no choice but to follow their superior's instructions. Compromising their employment may be out of the question. But salespersons do have options - if they do not feel confident in reporting the fraud internally and do not want to switch employers, they can contact the government.
The rules and regulations surrounding prescription drug sales are not simple. No matter what avenue the salesperson decides to take, he or she should consult with a lawyer first. Whistleblower protection laws are in place to allow employees to report or testify about employer's actions that may be illegal. Contact our firm to learn more.