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Lawsuits Say GSK Failed to Warn of Lamictal Side Effects
By Amanda Antell
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All 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. Â
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.
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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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All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.
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18 thoughts onLawsuits Say GSK Failed to Warn of Lamictal Side Effects
I was started on a high dose of Lamictal in 2011, followed by huge hives on my scalp, I had no idea that the drug was causing this at the time, the practitioner kept me on it for 3 years basically fired me without any justifiable reason and I suffered with the condition accompanied by endless other severe health related issues I had no prior history of, thyroid adenoma, hospitalization for pneumonia and cellulitis requiring IV antibiotics numerous times, pneumonia, the prescribing psyD has ignored all requests for records release for my continued care, To date since 2014. Is there a spectrum of Steven-Johnson syndrome? I have read that if any rash above the neck is experienced the drug is supposed to be d/c ‘ed? The condition was excruciating for 3 years and severe, without detailed records to diagnose it, I still remain sick, There could be no other explanation for my difficulties other than starting a 400 mg dose of Lamictal, Not necessarily seeking anything but the records necessary to regain my health, there could be no other explanation as to why a practitioner would ignore years of requests for 17! Inpatient admissions to a trauma informed care facility, I suffered with the scalp condition the entire time, isn’t it illegal not to release medical records?
Is there a lawsuit going on for memory losd caused by lamictal?
I have severe memory loss and I am a registered nurse. I am quitting my job because I have difficulty remembering patients names and even completing simple tasks.
Is there a lawsuit on lamictal for memory loss?
I am seeking for an attorney to take the case about my daughter being on Lamictal for 12 years and the increase in dosage by one doctor and the other doctor stating it was not needed because of case history and Landau Kefflner. The increase in dosage caused her teeth to decay at a rapid rate. I just need an attorney to represent us. So far I have been rejected because they are not handling that type of case at the moment.
Here at Top Class Actions, we report on class action lawsuits and settlements around the country to bring awareness to you, our viewers. We do not actually file any lawsuits as we are not attorneys, and therefore cannot offer legal advice.
We offer a submission form on our website for you to fill out if you are seeking class action legal help. Attorneys will then review your submission to determine if you have a case. If they feel you qualify, they will contact you directly. You can submit your information here: https://topclassactions.com/start-a-class-action/. You may want to consult your own attorney, and should you choose to go that route, we recommend checking out http://www.consumeradvocates.org/find-an-attorney. Once there, you will be able to search a broad database of specialized attorneys in your area that you may consult.
We wish you the best of luck in your pursuit of justice!
Horrible rash covering head scalp to toe was hospitalized and suffer till this day, I was given several boxes of samples to start off slow and go into full dose for hard core bipolar. I have scars from all of the welts and pictures to prove. Please help me be part of mass torte
Started Lamictal September 24th 2015 and on November 7th I started seeing double (Binocular Diplopia). By December 2015 the diplopia became permanent and I started experiencing severe head pain, eye pain, jaw pain, nausea, vomiting and constant vertigo. My teeth also started to chip off in chunks. I’ve been seen by a team of Neurologists, Ophthalmologists, Rheumatologists and Internal Medicine. They initially treated me with 60mg day of PREDNISONE for suspected GIANT CELL ARTERITIS (GCA). From late December on, my vision has severely worsened to the point that I am now legally blind and the other symptoms have also worsened and are now permanent. After having numerous tests [ MRA, (2) MRI, MRV, CT Scan, EEG Optic Nerves, Spinal Tap and a BiLateral Temporal Biopsy.] Many of these were performed in a research hospital and all came back negative for Giant Cell Arteritis. During my stay in the hospital, I was given an IV dose of 1000mg PREDNISONE for 3 days to try and keep me from going totally blind. After leaving the hospital I decided to start looking into my initial problem, diplopia and I happened to come across its link to LAMICTAL. Is there anyone out there who has seen or heard of these type of problems that I’m experiencing?
Lamictal. ..Really bad headaches, very sensitive to light, bad suicidal thoughts and attempts when stopped. Been on for almost 5 years now. My teeth were perfect with nothing wrong. Limicatal is rotting out my teeth with 11 cavities and 9 crowns needed. Who can afford that?! Eventually, I will have no teeth left and don’t have any other options. I wished I would have never started, now I have to be on it for the rest of my life. Who else knows what else it is rotting in my body.
Hello my name is James and my wife is Angela and we were both on Lamictal from 2005-06/07 Angie was put on it for seizure disorder and I am a combat veteran with PTSD and was put on it as a mood stabilizer. Both my wife and I HAD near perfect teeth with no dental issues however, about 14 months into Lamictal treatment we started losing teeth at an alarming rate so we stopped taking it but it was far to late in the game we both now have NO TEETH none and never even a mention or an apology to this day all these years later WE STILL HAVE NO TEETH and cannot afford dentures to add insult to injury. So, if you can find someone who handles such cases we would be eternally grateful
Hello , I was on Lamotrigine is it possible for me to be part of this class action ?
4 years on lamictal severe agoraphobia bad headaches sensitive to light naseau stiff neck confusion dizzy social disorder can’t even leave to get mail have no life!
Re a very severe case of Stevens Johnston and TENs from Lamactil given by a psychiatrist re Bipolar in Australia
Considering potential for liability of manufacturer
Any ideas?
Regards
David Campbell SC