By David Yucht, J.D.
The FDA’s "changes being effected" regulation permits drug manufacturers to change a label without advanced approval if the change is designed to enhance a warning based on "newly acquired information" about a" causal association" between the drug and a risk of harm. Failure to warn claims are preempted only when the FDA would have rejected a proposed label change.
A state appellate panel in California reversed a trial court ruling that failure to warn claims against the manufacturer of Risperdal were preempted by federal law. However, based on New York law, which applies the "learned intermediary" doctrine, the appellate court upheld the dismissal of these claims as to a New York resident, finding that there was no evidence that his treating physician would have changed her prescribing behavior had she been given a different warning (Risperdal and Invega Product Liability Cases, May 8, 2020, Dhanidina, H.).
Risperidone, sold under the registered trademark Risperdal, is an anti psychotic medication that was first approved by the Food and Drug Administration (FDA) in 1993 for treating psychosis in adults. Risperi done elevates blood levels of prolactin, a hormone produced by the pituitary gland. Elevated levels of prolactin are associated with gynecomastia, a condition characterized by the enlargement of male breast tissue. Three adolescent patients were prescribed risperidone after it was approved by the FDAto treat behavioral symptoms in children with autism. They alleged that risperidone caused them to develop gynecomastia. They sued risperidone’s manufacturers and distributors for failure to adequately warn of that risk. One of the manufacturers, Janssen Pharmaceuticals, Inc., moved for summary judgment on federal preemption grounds as to all three patients. Janssen also moved for summary judgment against one of the individuals, claiming he could not raise a triable issue of fact under New York law, which requires a patient to show that the treating physician would have changed his or her prescribing behavior had he or she had an adequate warning. The trial court granted both motions. The patients appealed.
Learned intermediary. Finding that there was no evidence that the New York patient’s treating physician would have changed her prescribing behavior had she been given a different warning, the appellate court affirmed summary judgment as to the New York patient based on the learned intermediary doctrine. Under New York law, a pharmaceutical manufacturer has a duty to warn of all potential dangers in its prescription drugs that "in the exercise of reasonable care it should have known to exist." However, this duty to warn applies to the prescribing medical professional, not the individual patient. The basis for this rule is that the physician acts as a "learned intermediary" between the manufacturer and the patient. The patient here, who was a New York resident, was diagnosed with autism and ADHD as a child. He exhibited aggressive behavior, including screaming, tantrums, and physical aggression. His psychiatrist prescribed risperidone for approximately 14 months. At the time she prescribed risperidone to this patient, her custom was to mention gynecomastia in "passing," but she did not "delve into" it the way she would have with other side effects. When presented with the studies that showed a higher rate of gynecomastia among pediatric patients, the psychiatrist did not indicate whether her decision to prescribe risperidone would have changed. Rather, she stated that, while she would include the higher rate in her risk-benefit analysis, risperidone may have still been the best choice for this patient.
Preemption. However, the appellate court reversed the summary judgment decisions that were based on preemption grounds, finding that the manufacturer did not meet its burden to establish its preemption defense. An FDA regulation called the "changes being effected" (CBE) regulation permits drug manufacturers to change a label without advanced approval if the change is designed to add or strengthen a warning when there is "newly acquired information" about the "evidence of a causal association" between the drug and a risk of harm. The FDA reviews CBE submissions and can reject label changes even after the manufacturer has made them. State-law failure to warn claims concerning prescription drugs are preempted only when there is clear evidence that the FDA would have rejected a proposed label change. Here, the manufacturer failed to provide the FDA with additional information with respect to elevated prolactin levels during different time periods. Specifically, children who had elevated prolactin after taking risperidone for eight to 12 weeks were 2.8 times more likely to develop prolactin-related side effects, including gynecomastia. As the risperidone label made no mention of the likelihood of developing side effects related to elevated prolactin levels for different time periods, this information demonstrated a risk of greater frequency than reported on the label. Accordingly, the manufacturer did not meet its burden to show by clear evidence that it fully informed the FDA and that the FDA, in turn, rejected a proposed label change.
The case Nos. are B284315, B284002, B284317.
Attorneys: Martin N. Buchanan (Law Office of Martin N. Buchanan) for Janssen Pharmaceuticals, Inc. and Janssen Research and Development, LLC. Rodney M. Hudson (Drinker Biddle & Reath LLP) for Johnson & Johnson and McKesson Corp.
Companies: Janssen Pharmaceuticals, Inc.; Janssen Research and Development, LLC; Johnson & Johnson; McKesson Corp.
MainStory: TopStory PreemptionNews CausationNews WarningsNews DrugsNews CaliforniaNews
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