Sarah Mirando  |  June 11, 2013

Category: Pharmaceuticals

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Lawsuits Say GSK Failed to Warn of Lamictal Side Effects

By Amanda Antell

 

glaxosmithklineAll over the United States, people are suing pharmaceutical giant GlaxoSmithKline LLC (GSK) for aggressively promoting their anticonvulsant drug Lamictal without fully disclosing its risk of side effects. In July 2012, GSK pled guilty to criminal negligent charges, and paid $3 billion to resolve allegations of fraud and failure to report product safety data for Lamictal. The settlement was the largest health care fraud settlement in U.S. history.  

Lamictal (Lamotrigine) is an anticonvulsant drug marketed in the United States and Europe to treat epilepsy and bipolar disorder, but it has been used for a variety of other off-label uses, such as schizophrenia.

Lamictal is a popular drug and has successfully helped many people with its mood stabilizing properties. Unfortunately, there have been reports of rare side effects such as Steven Johnson Syndrome (SJS) and even toxic epidermal necrolysis (TEN) that were supposedly caused by Lamictal or the use of the drug in combination with other prescriptions.

Though Lamictal SJS or TEN is rare, there have been enough cases to spark investigations and lawsuits.

GSK is no stranger to litigation. Last summer, the company was ordered to pay $3 billion to resolve criminal and civil allegations brought by plaintiffs who alleged the company unlawfully promoted some of its prescription drugs by failing to report safety data, and performed false price reporting practices.
 
The company pled guilty to a three-count criminal offense, including:

  • Two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce.
  • One count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA).


In terms of the plea agreement, GSK had to pay a total of $1 billion for the criminal charges, which included a criminal fine of $956,814,400, and forfeiture in the amount of $43,185,600. The criminal plea agreement also included certain charges or violations not formally listed.

GSK had to pay an additional $2 billion to resolve the civil allegations with the federal government under the False Claims Act, as well as the varying states. The civil settlement resolved claims relating to Paxil, Wellbutrin and Avandia, and also resolved price-fraud allegations

Currently, dozens of victims and their families are suing GSK for defective product allegations, including for allegedly mislabeling the safety warnings for Lamictal.

If you believe that you or a loved one has been the victim of Lamictal Stevens Johnson Syndrome, you have legal options. Please visit the Stevens Johnson (SJS) & Toxic Epidermal Necrolysis (TEN) Class Action Lawsuit Investigation. There, you can submit your claim for a free legal review and if it qualifies for legal action, a seasoned drug injury lawyer will contact you for a free, no-obligation consultation. You will be guided through the litigation process at no out-of-pocket expenses or hidden fees. The SJS attorneys working this investigation do not get paid until you do.

 

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Updated June 11th, 2013

 

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18 thoughts onLawsuits Say GSK Failed to Warn of Lamictal Side Effects

  1. TB says:

    I only took lamotrigine for a few weeks. My lips blew up (it looked like I had lip filler) and I got a red rash all over my face and body.

  2. Emily says:

    I took lamotrigine for years for bipolar. It caused me to drop down to 108 lbs
    (I’m 5’7”). I had sores in my mouth and my teeth are destroyed. I never realized it was the meds. Then I start reading all of these other people were taking lamotrigine and it destroyed their teeth like mine. Every dentist I go to talks about how clean my teeth are which is so contradictory to the fact that they’re all rotting away. I brush I floss I use mouthwash. I always have. It’s the medication! Does anyone know of a class action lawsuit against them for destroying teeth? Had I known that it was even a 1% chance possibility that it would damage my teeth there is no way in hell I would have taken it! My teeth are everything to me and now they are destroyed. I can’t afford Dental Implants or even dentures. A warning should be provided right up there with “it could kill you, but it can also destroy your teeth in just a few short years.” The possibility of losing your teeth is a serious side effect!

  3. Linda Malsbury says:

    I am late to the party, but researching bad reactions to Lamotrigine. I was on it for >5 years. Dr increased dosages to 200 mg / 2x day. (I never associated my dental issues with it!) My balance was increasingly impaired, causing 9 significant falls in 6 months (one requiring hospitalization for broken vertebrae). ENTs and neurologists were baffled. Finally, the psychiatrist took me off the med. I feel a need to speak up. This is dangerous!

  4. Brett Campbell says:

    Lamotrigine is destroying my teeth. Is there anyone filing lawsuits for that?

    1. Jake says:

      I had to get dentures by the age of 30 because of this drug.

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