Wrongful Death: Medication Complication resulting in Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

The Medical Malpractice and Wrongful Death Case Facts:

Beth S. was 15 years old when she and her mother made an appointment for Beth to see an adolescent psychiatrist in a small town in western Ohio. Beth had been seeing a psychologist for anxiety and depression for several months prior to making an appointment with a psychiatrist.

At their first appointment, the doctor diagnosed Beth with bipolar disorder. Beth and her mother were not persuaded that this diagnosis was correct, as it did not comport with their lay understanding of bipolar disorder. The doctor wanted to start Beth on medications right away, but Beth and her mother decided they would think about it for a little while.

Eventually, Beth’s mom called the doctor’s office and said they were willing to try medications for Beth. Seroquel (quetiapine) and Lamictal (lamotrigine) were then prescribed. Beth began taking the medications as directed. She then saw the doctor for a follow-up visit. At that time, the doctor changed the dosing schedule for Beth’s medications and wrote a new prescription for Lamictal, at 200mg per day. Beth picked up that prescription and followed the directions that had been communicated to her in the doctor’s office.

A couple days later, Beth developed a sore throat, fever, and nasal congestion. Within hours, Beth’s condition changed dramatically. The pain in her throat became much worse, and she developed a rash on her face, arms, and trunk. Beth’s mother took her to a local medical center, where she was evaluated and treated briefly, before being transferred to a nearby children’s hospital with a diagnosis of possible Stevens-Johnson Syndrome (“SJS”).

SJS is a rare, serious condition that causes a significant and sometimes life-threatening rash. It is associated with various medications, including Lamictal. When the rash progresses and affects at least 10-15% of the body’s surface area, it is called Toxic Epidermal Necrolysis (“TENS”). TENS is potentially lethal.

At the children’s hospital, Beth was admitted for treatment in the Pediatric Intensive Care Unit. This particular children’s hospital was the preferred destination because it also has a pediatric burn unit, and patients with SJS-TENS need treatment similar to the treatment received by burn victims.

Beth received appropriate care at the children’s hospital, but her condition continued to worsen. Nearly her entire body surface area was affected by the rash. Ultimately, Beth’s internal organs were affected, as was her ability to oxygenate. Beth died from complications of SJS-TENS.

Building Our Medical Negligence Case

The Eisen Law Firm’s initial investigation centered on obtaining and reviewing all of Beth’s medical records and the pertinent medical literature. The medical records included Beth’s psychology and psychiatry records, her pediatric and dermatology records, and her records from the medical center and children’s hospital.

Brian Eisen, lead attorney on this case at The Eisen Law Firm, obtained and reviewed nearly 50 primary journal articles on several subjects, including: (1) diagnosis and treatment of pediatric bipolar disorder; (2) use of Lamictal in pediatric bipolar disorder; (3) diagnosis and treatment of SJS-TENS; (4) off-label pediatric drug use; and (5) use of Lamictal for pediatric epilepsy treatment (Lamictal is approved for this condition). We do not use paralegals or nurses for medical literature research, and although Mr. Eisen reviews textbooks, he relies mostly on the actual, published studies from primary journal articles.

Mr. Eisen also consulted with several different experts in the fields of psychiatry (2), pediatric psychiatry (3), dermatology, pharmacy, pharmacology, SJS-TENS, and burn unit medicine (2).

The Medical Negligence Case Begins

After obtaining a suitable affidavit of merit, The Eisen Law Firm filed a lawsuit. The named defendants were the psychiatrist and his practice group. The litigation was extensive and time-consuming. Discovery included standard interrogatories and requests to produce records, as well as more unique requests, such as detailed audit trail and electronic medical records information. This additional discovery was necessary because the doctor insisted at his deposition that he had written in the medical records various things that would have substantiated his diagnosis of bipolar disorder, but those items were not included in the “complete” records initially provided to the estate. The doctor ultimately produced a second, “audit” version of the electronic records that purported to reflect additional notes made by the doctor.

During discovery, the doctor and several of his staff members testified that Beth and her mother were repeatedly warned of the risks associated with the medication Lamictal. They were supposedly told that FDA had never approved the use of this medication for adolescents with bipolar disorder, that the medication can cause non-lethal and lethal rashes, and that it was of paramount importance that Beth adhere strictly to a clearly-described regimen of slowly-escalating doses of Lamictal.

In contrast, Beth’s mother testified that the doctor never told her that the medication was not approved for adolescent bipolar disorder, and that he instructed them that Beth should accelerate the dose escalation to 200mg sooner than indicated in the medical records. This factual dispute was likely to be front and center in the jury trial of this matter.

The Medical Negligence Case Continues

The Eisen Law Firm’s case rested on four main arguments: (1) The doctor accelerated the dose escalation of the Lamictal, unnecessarily increasing the risk of an SJS-TENS reaction; (2) The doctor should not have prescribed Lamictal as a first-line medication for an adolescent patient, as the medication had never been approved by FDA or demonstrated to be safe and effective in the treatment of pediatric bipolar disorder; (3) The doctor failed adequately to warn Beth and her mother about the dangers associated with Lamictal; and (4) The doctor failed to diagnose properly Beth’s psychiatric condition.

The Eisen Law Firm retained of one of the world’s foremost authorities on the medication Lamictal. He took the position that the published studies – and even the unpublished data – do not support the conclusion that Lamictal is effective in treating bipolar disorder in patients of Beth’s age, especially for the treatment of bipolar “mixed state,” which was the specific diagnosis made by the psychiatrist.

The Eisen Law Firm retained the services of a forensic pediatric psychiatrist, who was prepared to testify that the doctor’s diagnosis of bipolar disorder was likely incorrect, and that his use of Lamictal under the circumstances was inappropriate.

The Eisen Law Firm also hired a burn unit and SJS-TENS expert who was prepared to testify that the Lamictal caused the injury, that the accelerated dose escalation worsened the situation, and that Beth likely would have survived had the doctor not escalated the dose, or had he opted for an available alternative medication.

Finally, The Eisen Law Firm hired a forensic accountant to offer an opinion about the economic loss created by Beth’s death.

The defense retained six expert witnesses: (1) a pediatric and adolescent psychiatrist, who has published extensively on medication management of pediatric bipolar disorder; (2) an expert in emergency medicine; (3) an expert in pharmacy and pharmaceutical sciences; (4) a family practice expert; (5) an intensive care and burn unit expert; and (6) an expert on electronic medical records and computer forensic analysis.

The defense contested every aspect of the case. It took the position that the diagnosis of bipolar disorder was correct, and that the selection and dosing of medication was appropriate. It also claimed that Beth failed to follow clear, verbal and written instructions relating to the dose escalation. Finally, it claimed that Beth’s reaction to the medication was idiosyncratic, extreme, and atypical and had nothing whatever to do with the dose escalation.

At the conclusion of the discovery phase of the litigation, The Eisen Law Firm drafted and filed a partial motion for summary judgment, seeking to limit the ability of the defense to pursue various of its defenses, including most significantly the defense that non-parties contributed to Beth’s injuries.

Our Medical Malpractice Case: Mediation and Settlement Phase

While the summary judgment motion was pending, the parties set up and participated in a private mediation, which ultimately resulted in a confidential settlement. This was a difficult case of disputed liability that The Eisen Law Firm was able to argue and settle successfully on behalf of our client.

The Eisen Law Firm spent over a year and a half working on this case , and we were committed to continue litigating the case and trying it if necessary. Lead attorney, Brian Eisen, has been handling medical negligence cases exclusively for 23 years. He is known for both his knowledge of medicine and his ability to successfully argue legal matters. While there was nothing he could do to bring Beth back, Beth’s mother and their family benefitted greatly from his zealous work as a patient advocate and his knowledge of both the medical and legal fields.