Texas parents Madeline and Rogelio Escareno are suing the European drug giant Lundbeck Pharmaceuticals for the injuries their son suffered from ingesting Onfi, alleging that their 11-year-old son developed the extreme allergic reaction Stevens Johnson Syndrome because of taking the epilepsy medication.

As a result of developing Stevens Johnson Syndrome, the boy was left with serious skin loss, hair loss, and even the loss of  his fingernails. The Escanaros state in their Onfi lawsuit that their son has been left permanently disfigured and traumatized by these events, and demand Lundbeck pays them compensation.

Onfi (clobazam) was approved in October 2011 for the treatment of patients two-years-old or older with a specific and severe epilepsy condition called Lennox-Gastaut Syndrome (LGS). Since its release, approximately 31,000 patients have been prescribed Onfi in the United States, and  it has been reportedly been connected to at least 20 cases of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis worldwide. Six of these cases were in the United States, with at least four involving children.

Even though he did not suffer from LGS, the Escarenos’ son was prescribed Onfi for the off-label use to treat his epilepsy. Soon after starting the medication, the Escaranos’ son developed severe skin lesions, and his skin started to detach from his body in large chunks, including from the inside and outside of his mouth, throat, and genital areas. Reports indicate that after he developed Stevens Johnson Syndrome, it had developed into its deadlier and latent cousin, Toxic Epidermal Necrolysis.

Luckily, the Escaranos’ son survived, but had to undergo treatment for a month in Cook Children’s Medical Center, in Fort Worth, Texas in March 2013. While he indeed survived his ordeal, he has been permanently scarred physically and psychologically from the experience. The Escarenos explain in their Onfi lawsuit there were no warnings or indications of SJS or TEN on the drug’s label, and if they had known about it, they never would have put their son on the medication.

It is important to note that while the minor plaintiff was injured, there were no warnings of SJS or TEN available, but the warnings did come later that year.  Sometime later in 2013, the FDA announced that Onfi had the potential to cause severe skin reactions in some patients. The Escaranos allege that Lundbeck had known about this previously, but deliberately kept this information concealed to protect their profit margins.

Additionally, the family also accuses Lundbeck of illegally promoting Onfi for uses which were not approved by the FDA. Their son was prescribed this medication despite not having LGS, because the company had marketed the drug to treat a much broader range of epilepsy conditions. While doctors are allowed to prescribe drugs for any reason they deem medically relevant, it is illegal for drug companies to promote drugs for off-label uses.

Stevens Johnson Syndrome is a severe allergic skin reaction, which is onset by one or more medications. Its latent form, Toxic Epidermal Necrolysis, is most often times fatal, and showcases the final stages of Stevens Johnson Syndrome where up to 90 percent of the body is covered in purple or reddish skin lesions.  Typically, Stevens Johnson Syndrome covers the body 10 percent to 30 percent in lesions, and can potentially cause blindness and permanent scarring.  Due to the nature of the skin lesions, patients with this condition are treated the same way a burn victim would be treated.

The Escarenos are suing Lundbeck Pharmaceuticals for negligence, false advertising, concealing information, and misrepresenting a product.