MONTGOMERY, Ala. (Legal Newsline) - The Alabama Supreme Court has reversed a lower court's judgment in favor of Publix Super Markets over a change in the dosage of a woman's prescription.
On Aug. 7, 2003, Dr. Robert Sorrell performed a total knee arthroplasty on plaintiff Alice Nail. Following her surgery, Nail suffered from a pulmonary thromboembolism, a blockage of the main artery of the lung. As a result, Sorrell prescribed Coumadin, an anticoagulant medication. Dr. M. Scott Touger was Nail's physician following the surgery, and he continued to prescribe Coumadin for Nail.
From August 2003 to July 2006, Touger prescribed 1-milligram tablets to be taken five times a day. Instead of indicating a specific dosage, the prescriptions said "use as directed" or "UAD." Nail refilled the prescriptions 15 times at a Publix store in Homewood, Ala.
On July 10, 2006, Nail called Touger's office to get another refill for her Coumadin. A nurse in Touger's office called the Publix pharmacy and gave an employee a prescription for 5-milligram tablets of Coumadin to be "used as directed."
Publix has a computer system that tracks its customers' prescriptions. The store also had a policy to counsel all of its customers about their prescriptions.
Nail picked up her prescription from Publix and signed a form indicating she declined counseling for the prescription. However, Nail says she was not told by the pharmacist that her prescription had been changed from 1-milligram to 5-milligram tablets.
Nail took the 5-milligram tablets with the same frequency as she took the 1-milligram tablets, i.e., five times a day. So, instead of 5 milligrams daily, she was taking 25 milligrams.
On July 19, 2006, Nail went to the emergency room at Brookwood Medical Center complaining of chest pain, back pain, coughing and bruising on her stomach.
Nail was later admitted to the hospital, where she was diagnosed with Coumadin toxicity and an epidural hematoma of the cervical spinal cord. She underwent surgery to remove the hematoma.
On May 6, 2008, Nail sued Publix and Touger in Jefferson Circuit Court, alleging that both Publix and Touger had violated the Alabama Medical Liability Act.
On June 9, 2010, Publix filed a summary judgment motion. In support of its motion, Publix included a copy of a "Prescription Insurance Claim and Counseling Log." The document showed that Nail had signed the log indicating that on July 10, 2006 she was "offered" counseling and received her medication.
Nail responded to Publix's summary judgment motion and attached an affidavit from Roger Lander, a pharmacist. She also attached her own affidavit in which she stated that when she picked up her prescription, she was told to sign a sheet. She again stated that no one at the Publix pharmacy offered to counsel her about the Coumadin and that no one informed her that the prescription had changed.
The trial court held a hearing on the summary judgment motion, and on Aug. 19 the court entered an order in favor of Publix on all claims. On Aug. 23, 2010, the trial court made the order final. Nail appealed to the state Supreme Court.
Justice Michael F. Bolin authored the Court's 19-page majority opinion.
In it, he said the evidence submitted by both parties in support of and in opposition to the motion for summary judgment presented a question of fact as to whether Nail was counseled about the change in her prescription strength.
However, at issue is whether the learned-intermediary doctrine applies to Nail's claims against Publix, barring the pharmacy from liability, the Court said.
The principle behind the doctrine is that prescribing physicians act as learned intermediaries between a manufacturer and the consumer/patient and, therefore, the physician stands in the best position to evaluate a patient's needs and assess the risks and benefits of a particular course of treatment.
"In the present case, Nail argues that Publix had a duty to tell her that her dosage had changed. Nail is not arguing that the pharmacist at Publix should have told her the risks or side effects of Coumadin," it wrote. "Under the learned-intermediary doctrine, the pharmacist does not have a duty to warn customers of the hazardous side effects either orally or by way of the manufacturer's package insert."
The plaintiff, the Court said, is simply arguing that the pharmacist should have told her that there was a significant change in her dosage of a very dangerous drug, not that Publix should have warned her against any possible harm in taking that specific dosage amount.
"Notifying a customer that there has been a change in prescription strength does not infringe upon the physician-patient relationship," it wrote. "Accordingly, we cannot say that the learned-intermediary doctrine bars Nail's claim against Publix."
The Court remanded the case.
From Legal Newsline: Reach Jessica Karmasek by e-mail at email@example.com.