Man sues doctor, pharmacist after drug burns him from the inside out
PARKER, Colo. (KDVR) — A 22-year old Parker man spent three weeks in a local burn unit after he was prescribed a drug for a mental health condition he does not have.
The FOX31 Problem Solvers have agreed to only use Scott's first name.
His lawsuit in Douglas County District Court states he acquired Stevens Johnson Syndrome after being over-prescribed Lamictal, also known by the generic name Lamotrigine.
SJS is a condition that causes serious skin rashes, blisters and sores on mucous membranes like one's eyes.
It's a known side effect of overdosing on Lamictal, an anti-seizure medication sometimes prescribed off-label to treat bipolar depression.
"It was a 10 out of 10," is how Scott described the burning sensation he felt after developing SJS.
See photos of the injury:
His lawsuit comes three years after the then-19-year-old college sophomore woke up in a hospital bed, blind and voiceless.
Doctors had stitched his eyes shut and placed a breathing tube in his throat after a skin rash covering most of his body left him feeling like he had survived an inferno.
"I had two surgeries on my eyes in order to save them from not going blind," said Scott. "Inside of my mouth, I had burns and cuts, and so I couldn't even eat food."
Scott had gone to Aspen Creek Family Medicine in Parker in January 2016 for his yearly physical and mentioned feeling a little depressed.
FOX31 investigative reporter Rob Low asked Scott, "As you look back, do you think you had bipolar disorder?"
"No, no, I have never had mental health issues before this," Scott replied.
His physician, Dr. Michael Paul Elder, gave Scott a questionnaire for bipolar disorder. Answering yes to at least seven of 13 questions is supposed to indicate more follow-up, but even the one-page form says it is "For screening purposes only and not to be used as a diagnostic tool."
Scott only scored a six, but Dr. Elder miscounted, giving him a seven, and immediately prescribed Lamictal.
Lamictal is prescribed with what's known as a black box warning in its labeling instructions that mention "serious skin disorders leading to death" and "the incidence of skin disorders was increased when this drug was administered at doses higher than recommended."
Scott said he was not told about the black box warning when he was prescribed the drug.
"There was so many things wrong in this case that it's frightening," said Scott's attorney, Hollynd Hoskins.
In her lawsuit, Hoskins alleged her client was prescribed twice the recommended dosage on the first day, and by the second week, his dosage had been increased to four times the recommended amount.
"Not only was the diagnosis false -- he did not have bipolar -- not only did he diagnosis it with a screening tool, he prescribed Lamictal, a serious drug, at four times the recommended dose." said Hoskins.
Scott came back to Aspen Creek Family Medicine for a follow-up eight days after starting Lamictal. He mentioned having shaky hands, but the family nurse who treated him, Diedre Marchetti, didn't consider it a red flag.
"It's potentially a side effect of Lamictal. It's also a non-uncommon symptom of anxiety," Marchetti told Hoskins in her deposition.
Scott's lawsuit also names a Walgreen's pharmacist named Anisa Bartells for not mentioning the black box warning that comes with a prescription of Lamictal. The following exchange comes from her deposition with Hoskins:
Anisa Bartells: "A black box warning contains important prescribing information about a drug."
Hollynd Hoskins: "And is a black box warning something you would use as a pharmacist?"
Anisa Bartells: "No."
Dr. Elder admitted in his deposition that he never discussed the black box warning with Scott and he expressed no concerns about overdosing his patient.
A portion of the deposition is quoted below:
Hollynd Hoskins: "Is [Scott] the only patient where you used your judgment to deviate from the FDA guidelines and instructions in dosing and titrating Lamictal?"
Dr. Michael Elder: "No."
Hollynd Hoskins: "So there are other patients where you have deviated from the FDA's instructions and guidelines prescribing Lamictal?"
Dr. Michael Elder: "Yes."
When asked during his deposition why he would overdose his patient given the obvious risk, Dr. Elder responded, "Well, the severity of his depression. I felt like his depression was more on the severe side, and that was a concern for me to treat him and to escalate his dosage regimen in order to bring his depression under better control quickly."
Hoskins said there is no evidence Scott actually had bipolar depression.
"This doctor was not qualified to make that diagnosis," said Hoskins. "He used a vague, 10-minute questionnaire and that led to a false diagnosis. He used the wrong dosage and that led to a very life-threatening, serious rash in Scott."
"I had rashes and bubbles on the bottom of my feet. I had to walk on top of the rashes and bubbles. You could feel them pop and burst, and just the pain -- it was like standing on needles," Scott said. The 22-year old can now finally walk without pain. In May, he graduated from the University of Colorado Boulder.
However, Scott will have vision issues the rest of his life and has been told he may develop Glaucoma.
"Hard to believe that all the little checkpoints where someone could have caught what was going wrong... that they didn't," Scott said.
At the time of the depositions, Dr. Elder still hadn't reported Scott's adverse reaction to the FDA even though it's required under law.
The lawsuit against Dr. Elder, Marchetti and Bartells is set to go to trial in October. Attorneys for all three defendants declined to comment.