Novartis Settles Marketing Lawsuit Over Trileptal, Other Drugs
Novartis Pharmaceuticals Corporation has agreed to plea guilty to charges of off-label marketing and bribing doctors to prescribe the anti-epileptic drug Trileptal, as well as other drugs, and has agreed to pay nearly half a billion dollars to settle a whistleblower lawsuit and federal charges.
The Department of Justice (DOJ) announced the Trileptal settlement (pdf) on September 30. The DOJ claimed that Novartis created marketing materials that promoted Trileptal for the treatment of neuropathic pain and bipolar disease; neither of which is an approved use by FDA. While doctors can prescribe drugs to treat any ailment they feel is appropriate, it is illegal for drug companies to promote drugs for uses not federally approved.
In addition to the marketing charges, the DOJ claims that the drug maker violated the False Claims Act by paying illegal kickbacks to health care professionals to induce them to prescribe Trileptal, Zelnorm, Sandostatin, Exforge and Tekturna for off-label uses. The DOJ claims that Novartis used speaker programs, advisory boards, entertainment, travel and meals as bribes. Novartis earned hundreds of millions of dollars from the illegal activities, according to the DOJ.
As part of the settlement, Novartis agreed to pay a forfeiture of funds and a criminal fine totaling $185 million. It also agreed to settle four civil whistleblower lawsuits for $237.5 million. The whistleblower suits were brought by former employees, including Jim Austin, Daryl Copeland, Steve McKee and Jeremy Garrity, who will receive $25.6 million of the civil lawsuit settlement.
Whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers from the offenders under the qui tam provision of the False Claims Act. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the case. The DOJ intervened in all four cases.
Trileptal (Oxcarbazepine) is an anticonvulsant drug approved by FDA to treat seizures, but it is frequently used to treat bipolar disorder and neuropathic pain as well. In April 2005 the label was updated to add warnings that the drug had been linked to rare and sometimes fatal skin disorders known as Stevens-Johnson Syndrome (SJS), which is referred to as Toxic Epidermal Necrolysis Syndrome (TENS) in severe cases.
SJS is known to occur as a side effect of several medications, causing the skin to burn, producing blisters, severe rashes and the skin may begin to separate from the body. It can also cause eye damage that could lead to blindness. When the skin lesions affect more than 30% of the body, the condition is referred to as TENS. Treatment in a hospital Intensive Care Unit (ICU) or Burn Unit is often required, and the conditions can be fatal in many cases.
In 2008, the FDA added suicide warnings to Trileptal and 10 other anti-epileptic drugs after findings from clinical trials suggested that patients taking the drugs were nearly twice as likely to experience suicidal behavior or thoughts when compared to those taking a placebo.
9 comments
My elderly mother has been taking Trileptal for the treatment of Bipolar for 10 years. I just found out that Trileptal was falsely advertising this medication for Bipolar which is her diagnosis. My mother does not have epileptic seizures.. My mother has not had any warnings from her psychiatric doctor, psychiatric nurses or anyone who has treated her along with continuously prescribing this medication. This action of misleading the public for monetary gains rather than concern for human life is incomprehensible.
My son was unresponsive and we took him to the emergency room where they tested his urine. They found benzodiazepine in his system and we thought our nurse had given him xanax. But after reading and doing some research, I found some websites that say trileptal is a benzo and others that say it is not; however, Trileptal is used to treat beno addictions and it leads me to question if maybe it comes up as a benzo in a drug test. We are also wondering if maybe his sodium levels were down and may have caused him to go into electrolyte shock? Trileptal is my son’s perscribed medication.
I was placed on this med by my psychiatrist for bipolar. Rather than getting better….I got worse. I become more suicidal and not less suicidal. I nearly killed myself on this med.
I was pregnant and given trileptral in a clinic in New Bern and I was treated with it for Bipolar. I dont have seizures. I upset. my baby born with problems, and I was ill.I am a diabetic instead asd well.
I need more information on this I was on this just over 7 years ago and while on it I was pregnant with my son.
My daughter had her first siezure at five months was diagnosed with epilepsy at 13 months. Trileptal has been a miracle and saved my childs life
I sure wish I had read this information before I started taking this medication.. I ran to my Dr. a few days ago because I thought I was going blind on top of other bad things… My question is Why are doctors still prescribing ths crap?
I have taken the trileptal.
I was prescribed this med for bi polar disorder and after taking it for a week, I had fallen three times and the last time I fell, I messed up my legs really bad. The med caused severe weakness in my muscles and my balance was so off. it was hard to walk by myself without help. It also increased my anxiety and depression. That was only a week that I took it. Why are the doctors still prescribing this stuff ?!?