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.
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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.
READER COMMENTS
Laurie West
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raymond kennedy
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Mickie Randall
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Michelle Jenkins
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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.