Elan Reaches $203M Settlement with DOJ over Zonegran Marketing
Elan Pharmaceuticals Inc. has agreed to pay $203 million to resolve a federal probe into illegal marketing of the epilepsy drug Zonegran.
The U.S. Department of Justice (DOJ) announced the Zonegran settlement on Wednesday, which will address both criminal and civil liability charges. Eisai Inc., a Japanese company that purchased Zonegran from Elan, has also agreed to pay $11 million to settle a civil lawsuit over its own alleged off-label marketing of Zonegran.
In addition to paying the fines, Elan has agreed to plead guilty to charges that it misbranded Zonegran as a treatment for mania, bipolar disorder, migraine headaches, eating disorders and as a weight loss drug. It also was charged for marketing the drug to treat epilepsy in children under the age of 16. The DOJ also accused Elan of paying illegal kickbacks to doctors in order to get them to prescribe Zonegran for off-label uses.
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Under the settlement, Elan has agreed to enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services (OIG-HHS). The agreement will require the company to report regularly to OIG-HSS to show that it has instituted procedures to prevent similar crimes in the future.
Zonegran (zonisamide) is approved by the FDA only for treatment of seizures in adults. It was first marketed in the U.S. by Elan in 2000, until Eisai Inc. bought the rights to market the drug in 2004.
In February 2009, the FDA warned that Zonegran side effects may cause a chemical imbalance in the blood known as metabolic acidosis, which can damage the kidneys and bones and could retard growth in children.
The settlement comes as a result of a whistleblower lawsuit brought by Dr. Lee Chartock, a doctor from Massachusetts. Under the qui tam provision of the False Claims Act, 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. 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 claim.
Elan will pay a criminal fine of $97,050,266 for a misdemeanor violation of the Food Drug and Cosmetic Act. The company will also forfeit $3.6 million in assets. The company will pay another $102,890,517 for the civil lawsuit brought under the False Claims Act. $10 million of that money will go to Chartock. Eisai’s $11 million is also to resolve civil liability; $1 million of which will also go to Chartock.
sDecember 13, 2022 at 3:25 pm
I have been getting this medicine for the last 2 years
AlyssaMay 16, 2022 at 11:53 pm
I have been on this medication for 3 months now it's a recall on it. I just got in the mail today may 16 2022
LoriMay 16, 2022 at 8:11 pm
I have been on zonisamide for 3 years an just got a recall letter today I have had many side effects an many health issues since an doctors did not know what was causing them well now we know ! Mabe I should have a law suit !!
JonnaMay 16, 2022 at 12:38 pm
I've been taking this medication since 2018 and I'm still currently on it. I was acidosis at one point and they didn't understand why, also developed stomach problems. I'm having a normal bleeding and bruising and the doctors don't know why also and I believe it's due to this medication.
StepheriaMay 6, 2022 at 12:17 am
I have been on this medication for at least 8 years or more. During the 2/3 year of being on the medication, my husband and I got pregnant. I lost my baby within 8/10 weeks of confirmed pregnancy. I have not been able to get pregnant since. Prior to medication, I carried, delivered and have two healthy children. This has been traumatic for me causing me to withdraw and even become incontinent or[Show More]I have been on this medication for at least 8 years or more. During the 2/3 year of being on the medication, my husband and I got pregnant. I lost my baby within 8/10 weeks of confirmed pregnancy. I have not been able to get pregnant since. Prior to medication, I carried, delivered and have two healthy children. This has been traumatic for me causing me to withdraw and even become incontinent or aware I was leaking bodily fluid until I was standing.
KaylaAugust 27, 2020 at 6:28 pm
Is being on zonisamide while pregnant the reason my daughter has to go see a growth specialist?
theodisJuly 9, 2020 at 11:21 pm
This medication should be taken off the market. This medicine had my son almost wheelchair confined.
RoseannaSeptember 27, 2018 at 4:33 am
I have been on Zonisamide since 2011. After my neurologist found out that I had seizures on both sides of my brain. Now I have developed Lupus one of the rarest side effects. If I had known about it. I wouldn’t have taken it at all. Cause of how many people have had it where I live. Many people have had it nobody knows why. It’s just made it easier for me to get o.
AnthonySeptember 21, 2017 at 5:31 pm
I've been on 500 mg Zonegran for at least 10years . The Side effects outweighs the positive effects of this medication. I'm weaning down now and will be pill free 9/25/2017. Can't wait , but the medication is not good whatsoever......I made my Dr... reevaluate my partial seizures because I've not had any aura in at least 5 years. So i have been on it for years for nothing.
KathyDecember 16, 2014 at 10:40 pm
I've been on Zonisamide for 4 years I think as treatment for migraines. I developed kidney stones in both kidneys and problems after lithotripsy. No one said it was a drug NOT for migraines. No one told me it could cause kidney stones. It's been 5 months since my first kidney stone attack. I would rather have a dozen kids. The pain is horrible! I never would have taken this drug if I knew it ca[Show More]I've been on Zonisamide for 4 years I think as treatment for migraines. I developed kidney stones in both kidneys and problems after lithotripsy. No one said it was a drug NOT for migraines. No one told me it could cause kidney stones. It's been 5 months since my first kidney stone attack. I would rather have a dozen kids. The pain is horrible! I never would have taken this drug if I knew it caused stones.
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