CASES AGAINST PHARMACEUTICAL COMPANIES
The United States Government and the States, under Medicaid, buy more prescription drugs than any other customer of the big and small pharmaceutical companies. The temptation to cheat is apparently overwhelming, as pharmaceutical companies have paid billions in settlements which, without whistleblowers, would have never been recovered by the taxpayers.
Our cases have resulted in the return of hundreds of millions of dollars from drug companies to the taxpayers. Types of cases include:
The Food and Drug Administration, or “FDA,” requires pharmaceutical companies to undergo a rigorous process before it decides that prescription drugs as being safe and effective for use in humans. In the end, the will approve a drug for particular uses. Although doctors are free to prescribe drugs for purposes for which they have not been approved (known as “off-label” uses), the theory is that the doctors do so because they have learned about the off-label use from appropriate sources, such as studies or word of mouth at medical conferences. It is illegal for pharmaceutical manufacturers to market drugs for off-label uses, and it is illegal for Medicaid programs to reimburse for off-label prescriptions unless the use is well-documented as being safe and effective. Nonetheless, many drug companies send out cadres of marketing representatives to convince doctors to use drugs for unapproved purposes, often coupled with gifts and cash payments to the physicians. False Claims Act cases involving illegal off-label marketing by large pharmaceutical corporations have resulted in return of billions to the Treasury and large awards to relators. Click here to learn more about our cases against Novartis, one of the world’s largest pharmaceutical corporations.
Ideally, physicians only give their patients prescription drugs after making a reasoned medical decision based on their education, training, and knowledge of the costs and benefits of those drugs. In reality, however, many physicians prescribe drugs simply to maintain their favored positions with large pharmaceutical companies. Perhaps you’ve noticed various items in your own doctor’s office that display pharmaceutical company logos. These companies employ scores of sales representatives to tout the benefits of their drugs, and most of them spend more money on marketing than they do on research and development. While pens, notepads, and the like are generally tolerated as allowable marketing practices, substantial items and services begin to raise eyebrows. Such “gifts” from pharmaceutical companies can range from fancy steak dinners to extravagant vacations to cold, hard cash. Any type of remuneration meant to induce an increase in prescriptions is called a “kickback.” Unsurprisingly, this quid pro quo is highly illegal and violates the Federal Antikickback Statute. It can also form the basis of a qui tam suit under the False Claims Act.
The Government recently started tracking payments made to healthcare providers. Is your physician on the list? Click here [https://openpaymentsdata.cms.gov/] to access the database and find out.
The United States is supposed to receive the lowest price of any pharmaceutical purchaser. (It is, after all, the largest purchaser.) The Medicaid Rebate Statue requires each pharmaceutical manufacturer who wants its drugs to be eligible for Medicaid reimbursement to file a Rebate Agreement which includes “Best Price” information. These prices are used to calculate a rebate that the manufacturer then has to pay to the state Medicaid programs. The net effect is that the government is supposed to get the lowest price.
Such cases have resulted in massive recoveries for the United States. Hallmarks of this kind of fraud are exorbitant deals between the pharmaceutical companies and “special” customers, such as HMO formularies, chain drug stores, and the like, including those who repackage prescription drugs as house brands. We have experience with AWP/AMP/WAC cases and other pricing issues.
FDA NEW DRUG APPLICATION MISCONDUCT
Pharmaceutical companies and others whose conduct is regulated by the FDA sometimes provide misleading information to the agency in order to get a drug approved under false pretenses. Under certain circumstances, this can rise to such a level that the resulting prescription payments violate the False Claims Act. These cases are sometimes referred to as “fraud on the FDA.”
Pharmaceutical manufacturers are required to adhere to strict quality-assurance requirements. It’s not a violation of the False Claims Act not to do this, but we think it is a violation to knowingly or recklessly put drugs into the marketplace which were manufactured in violation of CgMP requirements.
If you believe that you have information about a fraudulent scheme in the pharmaceutical industry, contact us to schedule a prompt consultation.