If that headline does not grab your attention I don’t know what else will. Healthcare professionals rely on information provided by the drug manufacturer when prescribing medications. This header is what you will see today but not back in 1999. The relationship between a drug manufacturer, approvals provided by the Food and Drug Administration (FDA) and actual use by Doctors is what can happen with companies that are not compliant with FDA rules. Further, amidst the numerous reports recently on the high costs of prescription medication in America, and the potentially compounding effect exempting the Affordable Care Act from the Anti-Kickback Statute has on this issue, comes the news of a $2.2 Billion settlement to resolve a scandalous pharmaceutical industry kickbacks allegation. In 2003, Chicago Pharmacist Bernard Lisitza, filed a lawsuit against pharmaceutical giant Johnson and Johnson (J&J), and Omincare, Inc., under the qui tam provision of the False Claims Act. The False Claims Act also known as the Lincoln Law is an American federal law imposed on persons and companies who defraud government programs. The qui tam provision allows ordinary citizens, like Mr. Lisitza, to file actions on behalf of the government, also known as “whistleblowing”.

Mr. Lisitza, is a former employee of Omnicare, Inc., the largest long-term care pharmacy in America. He alleged that Omnicare accepted kickbacks from J&J from 1999 through 2004 in return for the purchase and promotion of J&J drugs, particularly the atypical antipsychotic drug Risperdal. Risperdal is a Food and Drug Administration (FDA) approved drug for the treatment of schizophrenia and the short-term treatment of acute mania and mixed episodes associated with Bipolar Mood Disorder I. The FDA serves to protect public health by assuring the safety and effectiveness of drugs before it is commercially marketed for its applications. So when Janssen Pharmaceuticals, Inc. (JPI), a subsidiary of J&J, started marketing Risperdal in 2002 for the treatment of agitation associated with dementia in the elderly, they were falsely branding the drug as safe and effective despite being unapproved for this use by the FDA. In simple terms, J&J marketed Risperdal for a use the FDA never approved. According to the FDA commissioner Margaret A. Hamberg, M.D., “When pharmaceutical companies ignore the FDA’s requirements, they not only risk endangering the public’s health but also damaging the trust that patients have in their doctors and their medications,” she added that, “The FDA relies on data from rigorous scientific research to define and approve the uses for which a drug has been shown to be safe and effective. “ Risperdal has since been linked to increased mortality in elderly patients with dementia-related psychosis, the very group JPI marketed the drug to.

The case against J&J alleges that huge sums were paid to Omnicare in kickbacks under “market share rebate” agreements. According to the pharmacy whistleblower resource website, PharmacyFruadSettlement.com J&J conditioned payment of the rebates upon Omnicare’s ability to convince physicians to prescribe Risperdal instead of other anti-psychotic drugs. Under FDA regulations, physicians are allowed to prescribe drugs to treat patients for conditions that the drug does not have FDA approval for, but the drug may not be commercially branded for such purpose by pharmaceutical companies without FDA approval. The allegation is that JPI and J&J misbranded their product by giving physicians false security that the drug was safe and effective for use in the elderly and children. According to the government, Johnson & Johnson’s kickbacks drove Omnicare’s sales of J&J drugs from $100 million in 1999 to $280 million in 2004. Mr. Lisitza was allegedly fired by Omnicare after he challenged the Risperdal kickbacks and other improper practices. On November 3, 2009, Omnicare paid $98 million to settle Lisitza’s allegations.

It has been an arduous and complex law suit, but on November 1, 2013, a settlement agreement was finalized between the US, Bernard Lisitza, and J&J and Janssen Pharmaceuticals, Inc. The settlement served to resolve the allegations of kickbacks to Omnicare, Inc., as part of a $2.2 Billion False Claims Act Settlement. However, in the eyes of the average American citizen, this settlement is as good as an admission of guilt by J&J and Omnicare that they lined their pockets at the risk of one of the most vulnerable populations – the elderly. It also further ratifies the perception that the high prices of prescription medication in the US are driven by corporate greed. In the end, no amount of money agreed in a settlement can undo any harm that may have come to the patients and their families who placed their trust in the integrity of the healthcare system.

Bottom Line:
Become an empowered patient. All approved uses of medications can be found at www.fda.gov. If you are ever unsure about the use of a medication get a second opinion.

Thanks for reading!
 Have a story to share? Feel free to send me a note at rbusch@mbaaudit.com.

Rebecca S. Busch, RN,
Healthcare Advocate
http://mbaaudit.com/presentations/PHPbook.php