The United States Court of Appeals for the Eleventh Circuit (“Federal Appellate Court”) held in its published opinion dated December 22, 2020, “This tragic case began when Karen Hubbard suffered a catastrophic stroke. The stroke left her paralyzed and her cognitive functions severely impaired. Her oral contraceptive, Beyaz–a drug known to increase the risk of blood clots that can cause strokes–may have been to blame. We must decide whether Karen Hubbard and her husband Michael Hubbard have adduced sufficient evidence to survive summary judgment on their claims against the manufacturers of Beyaz, Bayer Pharma AG and Bayer HealthCare Pharmaceuticals Inc. (together, “Bayer”), for failing to provide an adequate warning of the risk of stroke. We hold they have not. Georgia’s learned intermediary doctrine controls this diversity jurisdiction case.”
Georgia’s Learned Intermediary Doctrine
Georgia’s learned intermediary doctrine imposes on prescription drug manufacturers a duty to adequately warn physicians, rather than patients, of the risks their products pose. But a plaintiff claiming a manufacturer’s warning was inadequate bears the burden of establishing that an improved warning would have caused her doctor not to prescribe her the drug in question.
Georgia law assigns the burden of proving proximate causation to the plaintiff where a prescription drug warning is presumptively inadequate: “If the warning is inadequate, or merely presumed to be, the plaintiff must demonstrate that the deficient warning proximately caused the alleged injury to prevail.”
The Federal Appellate Court stated in the present case, “The Hubbards have not met this burden. The prescribing physician testified unambiguously that even with the benefit of the most up-to-date risk information about Beyaz, he considers his decision to prescribe Beyaz to Karen Hubbard to be sound and appropriate. Under our binding precedent interpreting Georgia law, the Hubbards, therefore, cannot recover. Though the Hubbards have suffered greatly, the law plainly entitles Bayer to summary judgment. We affirm the judgment of the district court.”
Karen Hubbard began taking Bayer’s combination oral contraceptive (“COC”) in approximately 2001. She took Yasmin from 2001 until May 2006, when she began taking YAZ. Though her prescribing physician, Dr. Lawrence Rowley, didn’t know for sure why she changed her prescription, he thought the change would have been made because YAZ contains a lower dose of estrogen, and his office “always prefer[s] to use the lower-dose pills.” Karen Hubbard remained on YAZ until December 2011, when she began taking Beyaz. Though Dr. Rowley again did not know for sure what explained the change, he thought it was likely due to the folate that Bayer added to Beyaz. Karen Hubbard had been taking Beyaz for a little less than a year when she suffered a stroke in October 2012.
The Hubbards argued that the warnings available to Dr. Rowley in December 2011 were inadequate, including because they lacked the information made available in the 2012 update to the Beyaz label. The Hubbards further claimed that Dr. Rowley’s testimony on his December 2011 knowledge of the increased venous thromboembolism (VTE) risks associated with Beyaz was “equivocal” and that Bayer’s new warning “changed the way he counseled patients.” Without unequivocal testimony from Dr. Rowley that he would have prescribed Beyaz to Karen Hubbard after reading an appropriate warning, the Hubbards argued, summary judgment was not warranted.
The Federal Appellate Court stated, “”If the warning is inadequate, or merely presumed to be, the plaintiff must demonstrate that the deficient warning proximately caused the alleged injury.” Id. at 816. To establish proximate cause, the plaintiff must prove a causal link between the inadequate warning and the prescription decision. Thus, “in cases where a learned intermediary has actual knowledge of the substance of the alleged warning and would have taken the same course of action even with the information the plaintiff contends should have been provided, courts typically conclude that the causal link is broken and the plaintiff cannot recover.””
The Federal Appellate Court held: “even when viewed in the light most favorable to the Hubbards, the evidence does not raise a genuine issue of material fact and that Bayer is entitled to final summary judgment as a matter of law. Dr. Rowley “provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings,” as well as the information found in Bayer’s updated 2012 Beyaz label, he would still have prescribed Beyaz to Karen Hubbard. See Dietz, 598 F.3d at 816. Moreover, Dr. Rowley’s testimony indicates that he already knew in December 2011 what he considered to be substantially the same risk information later included in the 2012 Beyaz label. The causal chain is therefore broken, and the Hubbards cannot establish proximate cause. Most importantly, Dr. Rowley unambiguously testified that he views his December 2011 decision to prescribe Beyaz to Karen Hubbard as an appropriate one, even now that he knows exactly what was included in the 2012 label … All told, Dr. Rowley testified clearly that the information found in the 2012 label update would not have changed his decision to prescribe Beyaz to Karen Hubbard; and, indeed, that he already knew of the relevant risks at the time of the prescription. Under controlling case law, this precludes the Hubbards from establishing proximate cause.”
Source Hubbard v. Bayer HealthCare Pharmaceuticals Inc., USCA11 Case: 19-13087.
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