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Stevens Johnson Syndrome Lawsuit Allowed to Continue

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Los Angeles, CAA Stevens Johnson Syndrome (SJS) lawsuit filed against a software company has been allowed to continue, following a decision by the California Court of Appeal. The lawsuit alleges the plaintiff was not warned about the risk of SJS and suffered serious side effects after taking a generic version of Lamictal. The software company filed a motion to dismiss the lawsuit, but the California Court of Appeal denied the motion to dismiss.

Plaintiff Kathleen Hardin took lamotrigine, a generic version of an anticonvulsant medication. Hardin reportedly developed SJS and toxic epidermal necrolysis (TEN) after using the medication. Her permanent injuries include complete blindness and severe and painful scarring, according to court documents. After she developed SJS and TEN, Hardin learned that lamotrigine is linked to an increased risk of SJS and TEN, especially when taken along with another medication that Hardin was also taking.

Hardin filed a lawsuit alleging negligence and product liability against her physician, GlaxoSmithKline (the drugmaker), the pharmacy (Safeway, Inc.), and Wolters Kluwer Health, Inc, (WKH), which produced the drug pamphlet that was given to Hardin with the medication.

PDX is the company that provides the software used to distribute the drug pamphlet. PDX does not write the pamphlets, but does help in their distribution.

In its ruling, the court notes that at one time there were long (eight-section) and short (five-section) versions of the drug pamphlets that pharmacies could distribute. Safeway elected to use only the five-section version and requested PDX revise its software so Safeway could continue using only the five-section monograph, despite regulatory guidelines that had earlier resulted in PDX no longer offering the five-section version of its pamphlets.

The short version of the lamotrigine pamphlet did not include the “Black Box” warning under the drug’s heading, which contained information that “serious and sometimes fatal rashes have occurred rarely with the use of this medicine,” and instructions to seek a doctor immediately if symptoms of a rash developed. The “Black Box” warning also alerted patients that there could be serious side effects from the rash even if the medication is discontinued.

Hardin alleges in her lawsuit that if she had been given that information she would not have taken the medication.

PDX moved to dismiss Hardin’s claims, stating that it did not owe her any duty. A similar motion from WKH resulted in the claims against it being dismissed. The trial court and now the appeal court rejected the motion to dismiss. The trial court found that by allowing Safeway to produce only the five-section pamphlet, PDX was now no longer merely a distributor of information. The appeal court upheld the trial court’s refusal to dismiss. As a result, the lawsuit against PDX will continue.

The lawsuit is Hardin v. PDX, Inc., No. A137035, 2014 WL 2768863.


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Posted by

Hi Michelle Jenkins. My sister had SJS in August of 2015 and was like you treated at University hospital in London Ontario. She was in the ICU for almost a month and almost died. I would like to connect the two of you if you are open to the idea. She is struggling with recovery and feels no-one understands the horrible nightmare she endure. Can I please have your email address so we can connect. Thank you

Posted by

Hello,,i was diagnosed with SJS in 2006? (the date is a blur) started off with burning feet! then hands...i was taking over the counter pain meds for my back, in other words,,mixing trying to find relief!.I was admitted to the hospital and within a few hours all hell broke loose. My body was burning, red sores,,mouth. nose, burning in all extremities. I was put in isolation for two weeks.Finally discharged only to be re admitted a few days later for another two weeks. When released, i still had burning hands/rashes on my chest/stomach and hands.The burning pain was constant, even though the sores disappeared. Although ten years later, i am still left with buring parts of my body. My eyes feel scratchy at times, feels like a piece of dirt in my eye. I am always worried this will come back with a vengence?!. The past ten or so years have been painfull most of the time with the burning, its amazing how you can get use to pain!.Just wanted to write these few words down. Is there any legal action taken by anyone?

Posted by

My name is Mickie Randall , I was put on lamictal , I did ok for the low dose the first 2 weeks. The third week I was told to increase it by double the amount, I had a week of TIA's ( mini strokes. Then on May 8, 2010 I was put in the hospital for a stroke. I couldn't walk or talk. I thought I was in over night, but I was there til May 16, 2010. They stopped the lamictal at the hospital. I have since regained my speech, I walk with a cane because of imbalance issues left from the stroke. I'm on disability now.I was 48, I'm now 53

Posted by

Good afternoon,
This is Michelle Angela Jenkins, I am a 40 year old woman who was diagnosed with the extremely rare Stevens-Johnson Syndrome.
Medically noted “Stevens–Johnson syndrome”, a form of toxic epidermal necrolysis, is a life-threatening skin condition, in which cell death causes the epidermis to separate from the dermis. The syndrome is thought to be a hypersensitivity complex that affects the skin and the mucous membranes. The most well-known causes are certain medications, but it can also be due to infections, or more rarely, cancers.”
I was diagnosed with epilepsy at the age of 9 years old. As a Canadian citizen I have been very fortunate to be followed closely by a neurologist, GP and incredible support from family and friends. I am happy to report that I have been seizure free for over 11 years.
This past summer I had married a wonderful man in which we had decided to conceive. For the past 20 years plus I had been on and had a successful seizure free life style on the drug-Valproic acid. As per advised by doctors names who will not be mentioned I was advised to switch to the drug Lamotrgine.
On January 10, 2015 I was admitted to the University Hospital in London, Ontario, Canada with Stevens-Johnson syndrome. Thankfully I was discharged January 20, 2015.
Notwithstanding a limited medical background I knew the importance of documenting the progress of this life-threatening syndrome, with hopes of educating others as Steven Johnson Syndrome is so rare but so dangerous.
What I would like to offer to you is documented graphic photographs of Steven Johnson Syndrome. I have photographs from two days before being admitted to the hospital, the ten day duration in the hospital, to twenty days beyond discharge. This is a complete journey of my conditions getting worse up to its height followed by my recovery.
I was encouraged by GPs and neurologists to look into selling my pictures with the great hope to educate others in the medical field. I would welcome any discussion with interested parties.


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