Last week Johnson & Johnson, through its subsidiary Janssen Pharmaceuticals, agreed to pay over $2.2 billion in fines, representing the third-largest pharmaceutical settlement in United States history. Somewhat forgotten in the shuffle are the people who brought this suit to fruition in the first place, five “whistleblowers”. One of the five is Victoria Starr, a former Janssen sales representative who contacted her attorney, Gary Farmer, back in 2003.
“Victoria was being pressured by Janssen to market Risperdal off label to doctors,” says Farmer. “And she was encouraged to market Risperdal to the elderly for issues such as dementia, which was not approved by the FDA, and to children with mental-health problems.”
When doctors complained to Starr of Risperdal patients having issues with extreme weight gain, Janssen provided her with materials that downplayed the issue. “When marketing to nursing homes, Janssen emphasized the reduction of labor costs by keeping patients in a chemical straightjacket – they would sleep all night,” explains Farmer.
Starr felt uncomfortable with the off label marketing she was encouraged to engage in and eventually left Janssen to work as a pharmacology consultant at a nursing home. Ironically, in that position she constantly had to listen to pitches from sales representatives of her former employer, Janssen.
In early 2004 Starr decided it was time to come forward and Farmer filed a complaint under the False Claims Act on her behalf. At this time Farmer learned from the government that four other Janssen employees had filed complaints as well so the five whistleblowers agreed to work together and share the proceeds.
The False Claims Act is a federal law that imposes liability on persons and companies who defraud the government. The law includes a “qui tam” provision that allows individuals who are not affiliated with the government to file actions on behalf of the government. These individuals are referred to as “whistleblowers” and stand to receive a portion (usually 15-25) of any damages recovered.
The greatest concern for a whistleblower is the potential backlash from their former employer or the industry as a whole. ‘Victoria will never find a job in the pharmaceutical industry again so it is crucial that whistleblowers like her are adequately rewarded; there has to be enough financial incentive to completely change your life,” says Farmer.
In the last decade the False Claims Act has been a valuable tool for the government thanks to whistleblowers like Starr. Still, companies are crafting arguments to defeat suits based on the False Claims Act. For one, companies argue that their first amendment rights should protect off label claims. In other words, they argue that free speech should allow drug manufacturers to market their drug for uses not approved by the FDA. The validity of this argument is up for debate. “I think you have to look at every court and see if that judge is siding with corporations. Conservative judges are buying into this corporate argument. Now corporations say they have a right to free speech and they do it with impunity,” says Farmer.
Companies fighting suits under the False Claims Act are also putting forth a more practical argument; they say plaintiffs are failing to allege fraud with adequate specificity. Drug manufacturers argue that unless the whistleblower comes forward with an allegation and has proof of a fraudulent claim, it must be dismissed. For example, these companies maintain that a court should require that the whistleblower come forward with a claim form submitted on behalf of a patient to a government payer (like Medicare) to satisfy a claim for a fraud.
Even in this case with Johnson & Johnson, Farmer has doubts as to whether the fine will serve as an adequate deterrent. Says Farmer, “I would bet that accountants in these drug companies determine it is worth the risk to sell their products off label and will continue the fraud. Furthermore, claiming “we have done nothing wrong” allows them to maintain their Medicare eligibility. Drug companies cannot exist without that source of money.”
A $2.2 billion fine may sound like a large amount, but when you consider that Johnson & Johnson is worth more than $250 billion it’s easy to understand why the risk of legal action for off label marketing is worth it to the company. Farmer believes that today’s marketing schemes involve emphasizing sales over medical issues. The unfortunate reality is that patients ultimately end up as the real victims of off label marketing by drug manufacturers.
If you or a loved one was injured as a result of prescription Risperdal you may be entitled to compensation. For more information or a free case evaluation call the experienced attorneys at Dolman Law Group. 727-451-6900.