By Joshua Frumkin, Esq.
Patient’s prescribing physician testified that he did not change prescriptions for patients who were happy with their existing contraceptive medication in spite of an updated drug label.
In a case stemming from a patient’s stroke, which was alleged to have been caused by her use of a Bayer-manufactured contraceptive drug, the U.S. Court of Appeals for the Eleventh Circuit affirmed the district court's grant of summary judgment for Bayer Pharma AG and Bayer Health Care Pharmaceuticals Inc. (collectively, Bayer) on the patient’s failure to warn claim. The appellate panel found that the patient could not establish proximate causation between the contraceptive drug’s new label and her injury because her physician had not changed his prescribing practices after Bayer updated the drug’s label (Hubbard v. Bayer HealthCare Pharmaceuticals Inc., December 22, 2020, Marcus, S.).
The patient suffered a catastrophic stroke in October 2012. She had been taking the combination oral contraceptive (COC) Beyaz since 2011, but had been taking COCs manufactured by Bayer since 2001. Beyaz is known to increase the risk of blood clots (VTEs) that can cause strokes. The medical community has known since the 1960s that COCs such as Beyaz are associated with an increased risk of VTEs, although the magnitude of risk varies with the particular pill. Beyaz is a "fourth generation" pill, which means that it has a lower level of estrogen and a different variety of progestin than earlier contraceptives. The progestin in Beyaz is known as drospirenone (DRSP). The warning label in place at the time of the patient's first and final Beyaz prescription warned that COCs generally pose a risk of VTEs and summarized studies on the higher risks of VTEs with DRSP specifically. In April 2012, after the patient received her final prescription, Bayer updated the Beyaz label based on the conclusion of a Food and Drug Administration (FDA) review of the existing epidemiologic studies on the risk of blood clots in COCs containing DRSP.
In January 2014, the patient brought suit against Bayer for failing to provide an adequate warning of the risk of stroke. The patient alleged that she suffered a VTE that was directly caused by her use of Bayer's birth control pills and their generic equivalents. Bayer moved for summary judgment in August 2018. Bayer argued that the evidence demonstrated that the patient's prescribing physician had actual knowledge of the risk of VTE associated with DRSP-containing COCs at the time of prescription. The patient asserted that the warnings available before the April 2012 update were inadequate and that summary judgment was inappropriate absent unequivocal testimony from the physician that he would have prescribed Beyaz to the patient after reading an appropriate warning. The district court granted summary judgment to Bayer under the learned intermediary doctrine, reasoning that the patient had needed evidence that the new warning label would have changed her doctor's prescription to prevail. The patient timely appealed.
Learned intermediary doctrine. The appellate panel affirmed the district court's ruling based on the prescribing physician's testimony. Georgia law requires that a consumer show that the manufacturer had a duty to warn about a product's extant risks. However, for prescription drugs, the manufacturer's duty is to warn the patient's treating physician; the decision to utilize certain drugs over others involves a professional assessment that a doctor, as the "learned intermediary," is more capable of performing than a patient is. For summary judgment purposes, a consumer must demonstrate that the deficient warning proximately caused the alleged injury. In other words, if the prescribing physician would have prescribed the same drug even with the information that allegedly was missing from the earlier label, the patient cannot prove causation and cannot recover.
Here, the court determined that the patient's prescribing physician, after being presented with the most up-to-date label and evidence of the risks associated with Beyaz, had testified that he still would have prescribed the drug. In fact, he testified that he did not change the way he prescribed birth control pills to his patients after review of the updated label, and continues to prescribe Beyaz and similar COCs. Moreover, he testified that his standard practice is to continue a patient's existing prescription if the patient had taken the drug for an extended period without complications. As the patient had a long history of taking Bayer-manufactured COCs, including those containing DRSP, the doctor saw no reason to change her prescription. Furthermore, although the April 2012 label update contained new information about the risk of VTEs posed by Beyaz, the evidence indicated that the physician had already known about the risk that those DRSP-containing pills posed a higher risk than other COCs. The physician testified that the updated label did not change his judgment of the pills, as the threefold increased risk was considered "so small that it really just didn't justify" changing the patient's prescription. The 2012 FDA update instead drove the doctor to more clearly communicate the risks to his patients, but did not ultimately affect his prescribing policy.
The patient argued that the physician now prescribes different pills that do not contain DRSP to his patients, which evidenced that the label change had induced different behavior. The court disagreed. The court noted the doctor's policy to maintain patients on their preexisting prescription, even after the 2012 update. Additionally, the doctor testified that the shift in prescriptions was due to his patients requesting different drugs; the court held that this shift was informative as to patient preference, but did not illustrate a change in the physician's own medical judgments. Because of this testimony, the patient could not establish proximate causation and Bayer was entitled to summary judgment as a matter of law.
Label not inadequate. The court rejected the patient's argument that when a warning is found to be inadequate, Georgia law irrebuttably presumes that the label was the proximate cause of injury. The court found that state law assigns the burden of proving proximate causation to the patient, pursuant to Dietz v. Smithkline Beecham Corp., 598 F.3d 812 (11th Cir. 2010). In that case, the Eleventh Circuit held that a patient cannot meet the burden to prove proximate causation if a physician testifies that he or she would prescribe the same drug in light of the new information. The court explained that the Dietz court failed to mention any shifting burden or otherwise articulate a presumption of proximate cause, rebuttable or otherwise. As such, the court held that Dietz foreclosed that finding until and unless Georgia courts decide otherwise. The patient relied on an unpublished Eleventh Circuit opinion to argue otherwise, but the court dismissed it, as that case predated Dietz. Moreover, the court determined that Bayer had produced sufficient evidence to rebut the presumption proposed by the patient, rendering the issue moot.
The case is No. 19-13087.
Attorneys: David F. Walbert (Parks Chesin & Walbert, PC) for Karen Leigh Hubbard. Kaspar J. Stoffelmayr (Bartlit Beck, LLP) and Carol Patrick Michel (Weinberg Wheeler Hudgins Gunn & Dial, LLC) for Bayer Healthcare Pharmaceuticals Inc. and Bayer Pharma AG.
Companies: Bayer Healthcare Pharmaceuticals Inc.; Bayer Pharma AG
MainStory: TopStory WarningsNews DrugsNews DesignManufacturingNews CausationNews AlabamaNews FloridaNews GeorgiaNews
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