A federal district judge in Washington, DC has granted a pharmaceutical company’s motion for summary judgment in a lawsuit brought by a patient alleging the failure to warn of certain risks associated with the company’s drug. In Patteson, et al v. AstraZeneca, L.P., et al, the plaintiff allegedly suffered debilitating complications from prolonged use of the company’s anti-psychotic medication Seroquel. She filed suit against the company and her treating physician. The court granted AstraZeneca’s motion for summary judgment on the grounds that the company’s duty to warn of risks applied to the doctor, not the patient.
The plaintiff, Kay Patteson, sought treatment from Dr. John Maloney, also a defendant in the lawsuit, in May 2006, according to the court’s ruling. She complained of “anxiety, depression, chronic insomnia, and serious alcohol abuse and dependence.” After other drugs did not alleviate her insomnia, Dr. Maloney prescribed the anti-psychotic drug Seroquel for off-label insomnia treatment. Patteson’s symptoms improved at first, but then began to worsen in April 2007. She began to suffer “progressive weakness in her lower extremities and difficulty walking.” Several physicians could not determine the cause of her condition, although Dr. Maloney reduced her Seroquel dosage during this time. Most doctors attributed her symptoms to the large number of stressors in her life.
Patteson consulted a new doctor in January 2008, who suggested the Seroquel might be responsible for her symptoms. A neurologist diagnosed her in February with tardive dyskinesia, a condition associated with long-term use of anti-psychotic drugs, “characterized by repetitive, involuntary, purposeless movements.” In September 2010, Patteson and her husband filed suit against Dr. Maloney and AstraZeneca in DC Superior Court, asserting nine causes of action based on negligent failure to warn of the risk of tardive dyskinesia. AstraZeneca removed the case to the U.S. District Court, and both defendants filed their own motions for summary judgment.
AstraZeneca and Dr. Maloney each claimed that the suit was barred by the statute of limitations. AstraZeneca further argued that the “learned intermediary” doctrine barred Patteson’s suit. The court found that the “continuing-treatment” rule, which tolls the statute of limitations “until the doctor ceases to treat the patient in the specific matter,” trumped Dr. Maloney’s claim and denied his motion. The court granted AstraZeneca’s motion.
The “learned intermediary” doctrine, as described by the court, provides that a drug manufacturer that provides warnings of potential risks to a prescribing physician is not responsible for warning each of the physician’s patients who receive the drug. The duty to warn shifts to the physician. If a court finds that the manufacturer’s warnings to a doctor were not adequate, a plaintiff must still prove that the insufficient warning was a “producing cause” of the injuries in order to prevail on a claim. The court held that the drug labels provided to Dr. Maloney contained adequate warnings of the risks associated with Seroquel, and that Dr. Maloney was aware of the risks of tardive dyskinesia, even if he believed the risks were low. The court also rejected the plaintiffs’ claim that AstraZeneca had “overpromoted” Seroquel
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Memorandum Opinion (PDF), Patteson, et al v. AstraZeneca, L.P., et al, U.S. District Court for the District of Columbia, July 9, 2012
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