MONTGOMERY, Ala. (Legal Newsline) - Pharmaceutical manufacturers can be liable for failing to give doctors proper instructions on how to use their drugs, the Alabama Supreme Court ruled, in answer to a question from a federal appeals court. The state’s high court rejected defense arguments the learned-intermediary rule limited manufacturers’ duty to warning doctors about the potential risks of a medication.
Mark Blackburn sued Shire U.S. after his gastroenterologist, Dr. Dino Ferrante, prescribed Lialda for colitis. He later developed nephritis that destroyed 20% of his kidney function. The drug’s label warned of the risk of renal damage and urged doctors to evaluate the patient’s kidney before prescribing the drug and “periodically while on therapy.” Dr. Ferrante testified he didn’t read the Lialda label before prescribing it to Blackburn but that he thought “periodically” meant “once a year.” He also said he would have prescribed the same drug for his condition anyway.
A federal district judge dismissed the case, ruling Blackburn couldn’t prove the label caused his injury and Dr. Ferrante’s testimony he would have tested more frequently if the label was different was “self-interested” speculation. The Eleventh Circuit Court of Appeals reversed the decision, saying the fact the doctor didn’t read the label meant only he was familiar with it already and the trial judge shouldn’t have dismissed Dr. Ferrante’s testimony about changing his testing regimen at the summary judgment stage.
The 11th Circuit said Shire still might prevail, however, if Alabama law supported its arguments Shire met its duty under the learned-intermediary doctrine by warning doctors of the risk of renal damage and that plaintiffs must prove a doctor wouldn’t have prescribed the drug if it had a different warning.
The Alabama Supreme Court rejected both arguments in a Sept. 30 opinion by Justice Brad Mendheim. The court said Shire’s claim Dr. Ferrante failed to follow its warning to test renal function “periodically” “has nothing to do with the aspect of a failure-to-warn claim have been tasked with explicating,” he wrote. “Likewise, whether there is a medical consensus about the frequency of monitoring that is necessary when taking a mesalamine drug is a fact question that is not properly before us.”
The court ruled that under Alabama law, a failure-to-warn claim can include instructions for use.
“It follows that a plaintiff may establish causation by showing that his or her physician would have adopted a different course of testing or mitigation, even though the physician would have prescribed the same drug,” the court ruled.
The court dismissed as a “red herring” Shire’s argument the learned-intermediary doctrine left decisions about how to administer a drug to physicians, and to rule otherwise would interfere with the practice of medicine. But Justice William Sellers dissented, saying a 1984 Alabama Supreme Court decision limited drug manufacturers’ obligation to informing doctors about “any potential dangers that arise from the drug’s use.”
“Physicians, not drug manufacturers, are in the best position to evaluate patients to determine, based on a particular patient's unique medical history, personal features, and individual characteristics, whether to prescribe medication in the first place and how each patient should be monitored thereafter,” he wrote. “Imposing the duty Mark Blackburn urges essentially forces prescription-drug manufacturers into the role of medical providers.”