A Texas family is suing Lundbeck Pharmaceuticals for the injuries their son allegedly suffered after taking their antiepileptic drug, Onfi.

Plaintiffs Madeline and Rogelio E. are filing legal action against the defendant for failing to protect their son from an extreme Onfi side effect, Stevens Johnson Syndrome (SJS).

Their son had allegedly developed SJS soon after taking Onfi in early 2013; the medication label failed to mention the possibility of Stevens Johnson Syndrome, their Onfi lawsuit alleges. Madeline and Rogelio state that their son has been permanently altered and psychologically traumatized, and their Onfi lawsuit demands that Lundbeck compensate them for their son’s emotional and physical damages.

As many patients know, Onfi (Clobazam) is a popular anti-seizure medication that is a part of the benzodiazepines drug family. This drug was approved by the FDA in October 2011 to treat patients with a severe form of epilepsy called Lennox-Gaustaut syndrome.

Onfi has proven to be wildly popular in the epilepsy patient community, as it has been prescribed to over 30,000 people in the United States. However, this drug is one of the most commonly associated with Stevens Johnson Syndrome, with at least 20 confirmed cases worldwide.

Despite how frequent the Onfi SJS complaints are, Lundbeck has yet to make progress on revising Onfi’s label to include stronger or more explicit warnings of Stevens Johnson Syndrome.

While the minor plaintiff did not suffer from Lennox-Gaustaut syndrome, the physicians still prescribed the medication off-label because it had shown positive treatment responses with other epileptic conditions.

It is important to note that while a pharmaceutical company cannot legally advertise a drug or product for unapproved purposes, a doctor con prescribe them for other purposes. This proved to be a near fatal mistake, as skin lesions soon appeared all over the patient’s body.

These lesions caused the boy’s skin to detach from different areas of his body including the inside and outside of his mouth, throat, and genital areas. Reportedly, the condition got so bad that it had eventually evolved into the more severe cousin of SJS, Toxic Epidermal Necrolysis (TEN).

Overview of Onfi Stevens Johnson Syndrome

Stevens Johnson Syndrome is an extremely rare allergic skin reaction that is specifically caused by one or medications, and can have fatal consequences.

SJS is famously characterized by the red or purple skin lesions that can take up to 30 percent of skin surface area; TEN is identified with more extreme skin damage, which can consume up to 90 percent of the patient’s skin. The lesions from both of these conditions cause the skin to detach and melt off the body, which exposes the patient’s muscle tissue to possible infection.

The nature of these injuries often cause the patients to be treated in their hospital’s burn unit, and sometimes the patients need skin grafts.

Despite the worsening condition, the minor plaintiff was able to survive this ordeal. After receiving a month of hospital treatment, he was officially discharged in March 2013. To this day, the boy still has prominent physical scarring and is still wary of the possibility of recurrence.

This boy’s ordeal has led his parents to take legal action against the pharmaceutical company for illegal marketing practices and product liability allegations. The plaintiff couple insist that they never would have allowed their son to take Onfi if they had known about the possibility of Stevens Johnson Syndrome.

It is important to note that SJS warnings were not available until March 2013, which was the same time the minor plaintiff was released from the hospital. These warnings were later confirmed by the FDA in December 2013, which further fueled the plaintiff family’s reasons to take legal recourse.

In their lawsuit, they accuse the company of deliberately concealing this information to protect the market value of Onfi, and for advertising Onfi to treat more conditions than it was approved to do so.

As harrowing as this condition was on the minor plaintiff, he is lucky compared to many patients who encounter Stevens Johnson Syndrome. Children are especially vulnerable to the severity of this condition, with its extreme side effects and quick progression.

Despite how serious SJS and TEN are, most pharmaceutical companies do not mention them as possible side effects on their medication labels because they are extremely rare conditions. This does not dismiss the severity of these conditions, nor does it allow pharmaceutical companies to escape accountability in the case a patient is injured.