A Texas family has filed suit against the European drug company Lundbeck Pharmaceuticals for the injuries their son sustained after taking Onfi, an anti-seizure medication. The parents of the 11-year-old allege that the drug caused their son to develop Stevens Johnson Syndrome, a rare and extreme disorder of the skin and mucous membranes.
After developing SJS, the boy incurred serious skin and hair loss, as well as the loss of his fingernails. His parents, Madeline and Rogelio Escareno, said in the lawsuit that Onfi has caused their son to be permanently disfigured and traumatized, and are demanding that Lundbeck pay them compensation for the boy’s injuries.
Onfi (Clobazam) is an anti-seizure medication which falls into the category of drugs called benzodiazepines. Onfi is often prescribed with other medications to help prevent seizures associated with a severe form of epilepsy called Lennox-Gaustaut syndrome. The drug was approved by the FDA in October 2011, for treatment of patients aged 2 years and older. Since being approved, the medication has been prescribed to more than 30,000 patients in the United States. Sadly it has been linked to at least 20 reported cases of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis worldwide.
While the Escarenos’ son did not suffer from Lennox-Gaustaut syndrome, which the drug was specifically formulated to treat, he was prescribed Onfi for the off-label use to treat his epilepsy. However, shortly after beginning this treatment, the boy began developing severe skin lesions, causing skin to detach from various parts of his body including inside and outside of his mouth, throat, and genital areas. According the lawsuit, the condition eventually manifested into SJS’s deadlier and latent cousin, Toxic Epidermal Necrolysis.
Though badly injured, the boy was able to survive the disease after undergoing nearly a month of treatment at Fort Worth’s Cook Children’s Medical Center in March 2013. The proof of his injuries is still clear-the Escarenos say that their son is both physically and psychologically scarred. According to the Escarenos’ lawsuit, there were no warnings or indications printed on the drug’s label of the possibility of SJS or TEN developing from its use. The family said that had they known about those side effects, that they would never have put their son on the medication. In the lawsuit, it was confirmed that no warnings of SJS or TEN were available by March 2013, and that warnings were announced by the FDA in December 2013. In the lawsuit, the family accuses Lundbeck of knowing these warnings, and intentionally withholding the information to protect their profit margins.
Additionally, the family also alleged Lundbeck of illegally promoting Onfi for uses not approved by the FDA. Because the company had marketed the drug to treat a much broader range of epilepsy conditions, the Escarenos say that is why their son was prescribed the drug for off-label use. Doctors are permitted to prescribe medications for any reason deemed medically relevant, however it is illegal for drug companies to promote drugs for off-label uses.
Stevens-Johnson syndrome is considered to be a medical emergency resulting from a reaction to a medication or an infection. According to Mayo Clinic, Stevens-Johnson syndrome begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters. Then the top layer of the affected skin dies and sheds. Recovery after Stevens-Johnson syndrome can take weeks to months, depending on how severe the condition is.
Common symptoms of SJS include, but are not limited to:
• Facial swelling • Tongue swelling • Hives • Skin pain • A red or purple skin rash that spreads within hours to days • Blisters on skin and the mucous membranes of mouth, nose, eyes and genitals • Shedding of skin • Fever, chills, headaches, muscle aches, joint pains
Despite the rigorous approval process required by the Food and Drug Administration (FDA), we are still plagued by dangerous medications and drugs. In some cases, drug companies will go so far as to conceal dangers to speed up government approval and aggressively lobby for reform in the FDA’s procedures. Although drug companies are legally required to test products before even seeking FDA approval, sometimes that testing is done hastily and improperly. Drug companies are also obligated to warn about possible side effects, disclose all material information and discourage misuse on labels. Sometimes, as was the case with Lundbeck, this vital information is not disclosed to consumers, inevitably resulting in patients becoming ill, injured, or dying.
At the law offices of Altman & Altman, LLP, our firm handles various types of dangerous drug and injury claims brought against large pharmaceutical companies. Often times, it is not until years after a drug is introduced on the market that its devastating side-effects are felt by consumers. Our nation-wide defective drug practice aims to assist those individuals and families that have been adversely affected by such dangerous medications.
If you suspect that you or a loved one has become ill because of a defective medication or drug, you may be entitled to compensation. These types of cases are particularly complex and it is in your best interest to contact an attorney who has the knowledge and experience to help settle such cases. At Altman & Altman, our team of seasoned Massachusetts Products Liability Attorneys has helped victims and families across the Commonwealth recover millions of dollars in personal injury settlements and verdicts. We pride ourselves on delivering legal representation of the highest quality as well as being available around the clock to assist any and all of our clients’ needs.
With offices conveniently located in both Cambridge and downtown Boston, our attorneys have the ability to speak with clients face-to-face about their products liability case. In addition, we can and will arrange to travel to your home, office or other location to meet with you to discuss your case. We are available 24 hours a day, seven days a week, and all initial consultations are confidential and completely free of charge.
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