Failure to monitor INR leads to severe bleeding, disability
A MAN WITH A HISTORY OF DEEP VEIN THROMBOSIS was taking warfarin 10 mg every even day and 7.5 mg every odd day. His physician changed the warfarin dosage while the patient was taking ciprofloxacin, then resumed the original regimen once the patient finished taking the antibiotic.
No new prescriptions were written to confirm the change nor, the patient claimed, was a proper explanation of the new regimen provided. His international normalized ratio (INR) wasn’t checked after the dosage change.
After 2 weeks on the new warfarin dosage, the patient went to the emergency department (ED) complaining of groin pain and a change in urine color. Urinalysis found red blood cells too numerous to count. Although the patient told the ED staff he was taking warfarin, they didn’t check his INR. He was given a diagnosis of urinary tract infection (UTI) and discharged.
Three days later, the patient returned to the ED because of increased bleeding from his Foley catheter. Once again his INR wasn’t checked and he was discharged with a UTI diagnosis and a prescription for antibiotics. Two days afterwards, he was taken back to the hospital bleeding from all orifices. His INR was 75.
The patient spent a month in the hospital, most of it in the intensive care unit, followed by 3 months in a rehabilitation facility before returning home. He remained confined to a hospital bed.
PLAINTIFF’S CLAIM The physician and hospital were negligent for failing to instruct the patient regarding the change in warfarin dosage and neglecting to check his INR.
THE DEFENSE No information about the defense is available.
VERDICT $700,000 Maryland settlement.
COMMENT The management of anticoagulation has numerous pitfalls for the unwary. Careful monitoring can save lives—and lawsuits.
Rash and hives not taken seriously enough
A HISTORY OF 3 SEIZURES in a 7-year-old boy prompted a neurologist to prescribe valproic acid. The neurologist later added lamotrigine because of the child’s behavior problems. After taking both medications for 2 weeks, the child developed a rash, at which point the neurologist discontinued the lamotrigine and started diphenhydramine.
The following day, the child was brought to the ED with an itchy rash and hives on his torso and extremities. An allergic reaction was diagnosed and the child was discharged with instructions to take diphenhydramine along with acetaminophen and ibuprofen as needed. When informed of the ED visit, the neurologist requested a follow-up appointment in 4 weeks.
Two days later, the child was back in the ED because the rash had progressed to include redness and swelling of the face. Once again, he was discharged with a diagnosis of allergic reaction and instructions to take diphenhydramine and acetaminophen.
Two days afterward, the child was taken to a different ED, from which he was airlifted to a tertiary care center and admitted to the intensive care unit for treatment of Stevens-Johnson syndrome. The condition advanced to toxic epidermal necrolysis with sloughing of skin and the lining of the gastrointestinal tract. Several weeks later, the child died.
PLAINTIFF’S CLAIM The neurologist was negligent in prescribing lamotrigine for the behavior problem instead of referring the boy to a child psychologist. The lamotrigine dosage was excessive; the neurologist didn’t respond properly to the report of a rash.
The pharmacist was negligent in failing to contact the neurologist to discuss the excessive dosage. Discharging the child from the ED with a life-threatening drug reaction was unreasonable.
THE DEFENSE The defendants denied that they were negligent or caused the child’s death. They were prepared to present the histories of the parents, whose backgrounds included drug abuse, and state investigations regarding the care of the child.
VERDICT $1.55 million Washington settlement.
COMMENT When prescribing a drug with a potentially serious adverse effect, it’s always prudent to document patient education and follow-up thoroughly. Even though hindsight is 20/20, an “allergic reaction” in a patient on lamotrigine should raise red flags.