By Anne C. Vitale
A recent $2.2 million settlement shows that pharmacists cannot expect to be shielded from malpractice liability simply because they accurately fill a doctor's prescription.
In this St. Louis City case, the widow of an 80-year-old man claimed that his doctor prescribed toxic levels of Methotrexate, a rheumatoid arthritis medication. She contended that the pharmacist should have caught the doctor's mistake.
According to Paul J. Passanante, the widow's lawyer, the pharmacist initially argued that any negligence should be attributed solely to the doctor, since pharmacists are not involved in diagnosing patients and cannot substitute their own judgment.
But Passanante said the law clearly favors the patient on this issue.
"A pharmacist's duty may extend beyond merely accurately filling a prescription," he said. "And a pharmacist may be required to do more to protect patients from risks which the pharmacist can reasonably foresee."
A report on the settlement among the parties, whose identities are confidential, appears on Page 5.
Toxicity
The 80-year-old man was legally blind and suffered from a variety of other ailments, including hypertension, prostate problems, renal compromise and congestive heart failure. He also wore a pacemaker.
On May 10, 1999, he sought medical treatment from his physician for nodule lesions on his forearm, elbow, ears and hand. He also complained of fever and sweating, especially at night, and swelling of his hands, ankle and knee.
The doctor diagnosed rheumatoid arthritis and prescribed Methotrexate — 2.5 mg to be taken twice a day. The man had his prescription filled at a regional pharmacy chain and began taking the drug as prescribed.
After a few days, he began to experience inflammation in his mouth and difficulty swallowing — symptoms of Methotrexate toxicity. He reported these symptoms to his doctor, but the doctor and pharmacy refilled the prescription on May 20.
Four days later, the man went to the emergency room at Forest Park Hospital in St. Louis with complaints of irritation, inflammation and ulcers in his mouth, difficulty swallowing and rectal bleeding. Diagnostic tests also revealed hyponatremia, low sodium in his blood, and pancytopenia, a reduction in all cellular elements of the blood.
The man was diagnosed with Methotrexate toxicity and treated with Leucovorin, an antidote used to reverse the adverse effects of Methotrexate. His symptoms improved, but during the hospitalization he suffered two episodes of aspiration and died on June 10.
Malpractice
The man's widow sued the doctor and the pharmacy for malpractice. Passanante said that one of her experts, Dr. M. Eric Gershwin — who specializes in internal medicine and rheumatology — testified that Methotrexate is an immuno-suppressive drug that, if taken on a daily basis without medical monitoring, can be fatal. Dr. Gershwin testified that Methotrexate can be used to treat rheumatoid arthritis if it is given in the appropriate doses and the patient is monitored for signs and symptoms of toxicity.
However, Passanante said that Dr. Gershwin testified that the man's symptoms did not meet the criteria for a diagnosis of rheumatoid arthritis — as established by the American Rheumatism Association and the American College of Rheumatology. Therefore, the widow contended that her husband did not suffer from rheumatoid arthritis and it was inappropriate for his doctor to prescribe such a dangerous drug.
According to Passanante, Dr. Gershwin testified that if the doctor suspected rheumatoid arthritis, he should have referred him to a rheumatologist. He further testified that no competent doctor would prescribe Methotrexate to be taken on a daily basis because of the drug's cumulative effect on the body's ability to produce white blood cells. When properly prescribed, he said it is given intermittently, allowing the body to "recover" between dosages.
In addition, Passanante said that a toxicologist testified that the doctor's Methotrexate prescription exceeded the maximum recommended dosage, causing the decedent to ingest highly toxic amounts of the drug on a daily basis, ultimately resulting in his death. Because of the immuno-suppressive action of the drug, he testified that daily administration results in a synergistic toxicity. Therefore, he testified that it is much safer for a patient to receive 35 mg per week in a single weekly dosage than to receive 5 mg per day for 7 days.
Pharmacist
The widow claimed — and her experts testified — that the pharmacy was negligent in filling the prescriptions as ordered by the doctor.
In defense, the pharmacy retained experts who testified that the prescription was properly filled because the amount of the drug prescribed did not exceed the maximum dosage recommended on a weekly basis.
Passanante said the defendants also contended that the decedent's two episodes of aspiration were not related to the Methotrexate toxicity. They claimed that his symptoms had been reversed and were improving before he suffered the aspirations and died.
Furthermore, he said the doctor and pharmacy contended that there were two caps on non-economic damages applicable to the case since there were two defendants involved in one occurrence. Therefore, they claimed that $1,194,000 was the maximum recovery available.
But Passanante maintained that the doctor ordered and the pharmacy filled a second prescription for Methotrexate — before the first prescription would have even been consumed, if taken as directed. Therefore, he contended that there were four caps applicable to the widow's claims.
Following a pre-trial conference with Judge Jimmie Edwards the week before trial was scheduled to begin, the parties agreed to a $2.2 million settlement.
Precedent
"Many attorneys believe that in order to establish pharmacy negligence, the pharmacy must mis-fill the prescription," Passanante said. But he noted that the law had changed within the last five years to broaden liability for pharmacists.
In the 1999 case of Horner v. Spalitto, the Missouri Court of Appeals' Western District reversed contrary precedent and ruled that a pharmacist who correctly filled a customer's prescription as written by his doctor could be sued for negligence after the customer died of a drug overdose.
The Horner decision paved the way for Passanante's argument that the pharmacy, which merely filled the prescription as ordered by the physician, was nevertheless negligent.
"A reasonably competent pharmacist should know that a daily dosage of Methotrexate is a poison," he said.
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May 31, 2004
