Yet Another Pharma Company Pays Huge Fine for Misleading Marketing

On my post of May 8, 2012, I reported that, after a rash of huge United States Justice Department fines against various large drug companies for deceptive marketing of drugs used in bipolar disorder and other psychiatric conditions, two states picked up the gauntlet. The states of South Carolina and Arkansas fined Ortho-McNeil-Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson, for overstating the effectiveness and minimizing the risks of their antipsychotic medication Risperdal.

The company responsible for this deceptive advertising was one that had somehow escaped the scrutiny of the federal government.

Until now.

There is this from the US Department of Justice. This same company was fined 2.2 billion dollars for misleading and deceptive advertising for this medication. (My posts about this sort of thing are getting just plain routine, and a bit tiresome):

 "WASHINGTON - Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider.  The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion....

In a criminal information filed today in the Eastern District of Pennsylvania, the government charged that, from March 3, 2002, through Dec. 31, 2003, Janssen Pharmaceuticals Inc., a J&J subsidiary, introduced the antipsychotic drug Risperdal into interstate commerce for an unapproved use, rendering the product misbranded.  For most of this time period, Risperdal was approved only to treat schizophrenia.  The information alleges that Janssen’s sales representatives promoted Risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion.  The information alleges that the company created written sales aids for use by Janssen’s ElderCare sales force that emphasized symptoms and minimized any mention of the FDA-approved use, treatment of schizophrenia.  The company also provided incentives for off-label promotion and intended use by basing sales representatives’ bonuses on total sales of Risperdal in their sales areas, not just sales for FDA-approved uses.  

In a plea agreement resolving these charges, Janssen admitted that it promoted Risperdal to health care providers for treatment of psychotic symptoms and associated behavioral disturbances exhibited by elderly, non-schizophrenic dementia patients.  Under the terms of the plea agreement, Janssen will pay a total of $400 million, including a criminal fine of $334 million and forfeiture of $66 million.  Janssen’s guilty plea will not be final until accepted by the U.S. District Court...

In a related civil complaint filed today in the Eastern District of Pennsylvania, the United States alleges that Janssen marketed Risperdal to control the behaviors and conduct of the nation’s most vulnerable patients: elderly nursing home residents, children and individuals with mental disabilities.  The government alleges that J&J and Janssen caused false claims to be submitted to federal health care programs by promoting Risperdal for off-label uses that federal health care programs did not cover, making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal...

The complaint also alleges that Janssen knew that patients taking Risperdal had an increased risk of developing diabetes, but nonetheless promoted Risperdal as “uncompromised by safety concerns (does not cause diabetes).”  When Janssen received the initial results of studies indicating that Risperdal posed the same diabetes risk as other antipsychotics, the complaint alleges that the company retained outside consultants to re-analyze the study results and ultimately published articles stating that Risperdal was actually associated with a lower risk of developing diabetes."

So far, these huge fines have not seemed to have done a whole lot in discouraging this practice. The companies more than recoup the costs.

States Pick up Where Feds Left Off in Fining Drug Companies for Deceptive Advertising

After the Feds did their job, the states are now getting into the action.  Pharmaceutical companies are now starting to be fined in state courts for fraudulent promotion of their psychiatric medications.

Anyone who is still wondering why there has been an explosive increase over the last two decades in the use of two classes of psychiatric medications  - so-called “atypical” antipsychotic medication and anti-convulsants - for the treatment of a variety of diagnoses for which they are not indicated need look no further than to my previous posts about U.S. Department of Justice fines levied against pharmaceutical companies for said fraudulent promotion. (2/17/10, 3/22,10, 3/27/10, 4/28/10, 4/30/10, 10/1/10, 12/20/10).  

This blog has also focused on how, with an enthusiastic assist from pharmaceutical companies, the definitions of the psychiatric disorders for which the drugs actually are indicated have been expanded to the point where they are in danger of becoming FUBAR’S (F***’d up beyond all recognition).

To summarize what the US Department of Justice previously found:

May, 04. American pharmaceutical manufacturer Warner-Lambert agreed to plead guilty and pay more than $430 million to resolve criminal charges and civil liabilities in connection with its Parke-Davis division’s illegal and fraudulent promotion of Neurontin.  One of these uses was for bipolar disorder.  Studies later indicated the drug was ineffective for bipolar disorder.

January, 2009. Eli Lilly pays a settlement to the DOJ of $1.4 billion for concealing side effects and off-label marketing of Zyprexa just as their biggest seller, Prozac was about to go off patent in 2001.

September, 2009. Pfizer agrees to a settlement for $2.3 billion for off label marketing of several drugs including the atypical anti-psychotic Geodon

April 2010 - AstraZeneca fined $520 million – off label marketing of Seroquel.

April 2010 - Ortho-McNeil-Janssen Pharmaceuticals Inc., fined $81 - off label marketing of Topamax.

September 2010 - Novartis Pharmaceuticals Corporation fined $422.5 million off label marketing of Trileptal.

December 2010 – Elan Pharmaceuticals fined $203 million – off label marketing of Zonegran.

Now the states of South Carolina and Arkansas have fined Ortho-McNeil-Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson, for overstating the effectiveness and minimizing the risks of their antipsychotic medication Risperdal.

The following summaries of what happened are paraphrased without permission from the American Psychiatric Association’s Psychiatric News.  These legal actions were also widely reported by the press throughout the country.

First was South Carolina, from January of 2012:

A South Carolina judge upheld a $327 million civil penalty against Johnson & Johnson for overstating the safety and effectiveness of Risperdal.  A  jury had decided that they violated consumer protection laws by sending doctors a misleading letter in 2003 about this. The jurors also determined that the warning-label information was deceptive.  They found that the company had falsely claimed that Risperdal was better than competing drugs in a letter was sent to some 700,000 doctors nationwide,. The Food and Drug Administration (FDA) issued the company a warning letter about false and misleading claims that minimized risks such as diabetes and overstated the drug’s benefits. South Carolina’s law allows a judge to decide whether the company can be fined as much as $5,000 for each letter sent to South Carolina doctors.

Arkansas got involved just recently:

Johnson & Johnson "lied to patients and doctors" in its claims about Risperdal, said Arkansas Attorney General Dustin McDaniel, after a jury found the company guilty.  This is the latest case regarding fraudulent claims about the company's second-generation antipsychotic). The jury determined that the company downplayed and hid risks associated with the drug, which has been linked to increased risk of stroke and death in elderly dementia patients and to seizures, weight gain, and diabetes. After the jury's decision, Arkansas Circuit Court Judge Tim Fox, issued a penalty of $1.19 billion for the nearly 240,000 violations of the state's Medicaid fraud law. The New York Times reported that he also fined the company $11 million for violations of the state's deceptive practices act. 

Like the title to one of my previous posts, the hits just keep on coming.  Unfortunately, the companies are treating these fines as a cost of doing business and are still making huge profits on these medications.  They know quite well that the damage has already been done.

With Rispiridal, it’s kind of a shame, since in my clinical experience its side effect profile in some ways actually does compare somewhat favorably with two of its main competitors -  for patients who are actually psychotic, of course.

The Second PhARMA Company Fined by DOJ in Just One Week

In my post of March 27, 2010, A Perfect Trifecta, I mentioned that a lot of psychiatrists seemed to be using an anti-epileptic drug called Topamax in patients whom they had diagnosed - often incorrectly - as having bipolar disorder.

It turns out that my observation was no accident. For the second time in just one week, the U.S. Department of Justice fined a pharmaceutical company for off-label marketing of drugs for psychiatric indications. Two Johnson & Johnson subsidiaries, pharmaceutical manufacturers Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc., have agreed to pay $81 million to wrap up a probe of their Topamax promotions.

Just like with AstraZeneca, the companies did not admit guilt, and just like with AstraZeneca, the fine was a paltry sum compared to the money they made from the drug being misused. The drug has NO psychiatric indication at all.

According to settlement document posted on the Justice Department website, during the period from January 1, 2001 through December 31, 2003, the companies promoted the use of the drug for a variety of psychiatric conditions, including but not limited to bipolar disorder and drug and alcohol dependency.

According to the Justice Department press release, Ortho-McNeil paid doctors to come with sales reps on detailing calls and suggest unapproved uses for the drug. Doctors also were allegedly hired to speak at meetings and dinners about off-label Topamax use.

Five drug companies so far have been proven to have a vested interest in expanding the diagnosis of bipolar disorder for their own profit.