“A Long 10 Years for Risperdal Payout,” Says Whistleblower’s Attorney

New Brunswick, NJWhile the payout to Johnson & Johnson Risperdal whistleblowers is one of the biggest awards ever, attorney Gary Farmer - whose client was one of the Risperdal whistleblowers - says it is not much more than a slap on the wrist for the giant drug company.

Janssen Pharmaceuticals, a pharmaceutical company of J&J, will pay the federal government more than $2 billion to settle charges that it illegally marketed the blockbuster antipsychotic drug Risperdal. The whistleblower seal was just lifted on November 4, which allows Farmer to discuss the case and reveal his client.

Victoria Starr, a former Janssen sales representative and whistleblower involved in the settlement, contacted 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.”

This practice made Starr so uncomfortable that she left the company. She approached Farmer when she was working as a pharmacology consultant for a nursing home: ironically in that capacity she was a target of Risperdal sale reps’ marketing activities.

“Victoria knew too well the dangerous side effects of the drug, so in early 2004, she came forward and we filed a complaint on her behalf,” Farmer explains. “Doctors were reporting their Risperdal patients’ extreme weight gain to her but Victoria was given materials by Janssen that downplayed the issue. When marketing to nursing homes, Janssen emphasized the reduction in labor costs by keeping patients in a chemical straightjacket - they would sleep all night.”

(Farmer also represented whistleblowers in the Eli Lilly debacle - its Zyprexa drug is eerily similar to Risperdal. “Their Zyprexa scheme was called ‘5-6-7’: Give the patient 5mg of the drug at 6 p.m. and they will sleep until 7 a.m.,” he says.)

Farmer and his firm learned from the government that other Janssen employees had filed complaints so the five whistleblowers agreed to work together and share the proceeds. Starr’s complaint was the first case filed.

Risperdal Whistleblower

The government needs to have the tools available to uncover fraud. Of great concern to a potential whistleblower is getting fired or blackballed within the industry if word gets out. Ten years is a long wait…

“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. “I don’t think any of the Risperdal whistleblowers imagined it would be a 10-year process but sometimes the government is a cruise ship rather than a sports car. And our government is often ill-equipped to uncover fraud and false claims so we increasingly rely on citizens to come forward.”

Choosing to blow the whistle is a tough decision, and retaliation is a big issue. For instance, if employees at sales meetings complain, they can experience subtle forms of retaliation such as getting their territory increased. If you cannot cover your territory, you don’t get bonuses and they squeeze you out to avoid severance and retirement benefits. Farmer says today’s marketing schemes involve emphasizing sales over medical issues. A majority of the whistleblowers in the Eli Lilly case had pharmacology degrees; they had worked in this field since the 70’s and knew about drug interaction and dangerous side effects. Now drug companies hire good-looking business majors who don’t care about the science, safety be damned. It’s all about the money. “Sure we have a for-profit country and capitalism is wonderful but there has to be a balance,” he says.

Trends with the False Claims Act

The False Claims Act is a valuable tool to ensure that taxpayers do not get ripped off. Thanks to whistleblowers, it has made a comeback over the past 10 years or so.

“Companies will do unscrupulous things in the quest for profit,” says Farmer. “A serious problem arises when they put sales before safety so we want to encourage citizens to come forward. This Act provides whistleblowers with the greatest protection from retaliation and the government allocates between 15-25 percent of the settlement amount to whistleblowers.”

There has been a trend amongst corporate defendants who have been sued under the False Claims Act to argue two issues:

1. The first amendment should trump these off-label claims. In other words, free speech should allow drug companies to market their drug for something other than the FDA approved it for. Unfortunately, profit incentive can compel people to put a drug on the market without regard for patient safety, so we need the FDA as watchdog. “We all know that free speech has its limits, but the notion of free speech allowing companies like J&J to make the FDA redundant is ludicrous,” says Farmer.

2. When you file a complaint, there is a rule under civil procedure regarding how you allege fraud - it is very specific.

Drug companies argue that unless the whistleblower comes forward with an allegation and has proof of a fraudulent claim, it must be dismissed. Farmer explains that drug companies want the whistleblower to come forward with a claim form submitted on behalf of a patient to a government payer (such as Medicare) to satisfy the fraud rule. This means that in order for a whistleblower to bring this case, they must violate HIPAA laws and also violate the patient’s right of privacy. No whistleblower should have a patient’s file.

“Say you are an honest sales rep for a drug company and you are asked to market a drug off label - it has not been approved for certain issues such as Risperdal and dementia. You are concerned and come forward. But the Defendant can get the case dismissed if you don’t get the patient records,” adds Farmer.

So how could this happen?

“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.”

The $2.2 billion Risperdal settlement was a drop in the bucket for Johnson & Johnson. J&J is worth some $251 billion.

Farmer continues. “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. I believe the government should cut that cord, but until they do so, we need whistleblowers.”

While Johnson & Johnson didn’t admit liability or wrongdoing to civil charges, it said the settlement would help it move forward and suggested the regulatory environment is gray. “We remain committed to working with the U.S. Food and Drug Administration and others to ensure greater clarity around the guidance for pharmaceutical industry practices and standards,” said Michael Ullmann, Vice President and General Counsel for J&J. Risperdal continues to be reimbursed by Medicare and Medicaid.

Just a few weeks ago, Farmer was contacted by a woman whose 17-year-old son has developed breasts from taking Risperdal. Janssen also knew about these risks. Some young men are facing mastectomies.

Farmer encourages anyone with proof that a pharmaceutical or medical device company has engaged in some form of fraudulent activity against the federal government to come forward.