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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