11th Circuit Sides with Bayer in Blood Clot Warning Case

On Tuesday, a panel of Eleventh Circuit judges held that a plaintiff in a products liability case involving the contraceptive Beyaz — which is “known to increase the risk of blood clots that can cause strokes” — did not adduce sufficient evidence to survive summary judgment.  The court held in favor of Bayer.

The plaintiff in this case suffered a catastrophic stroke, which left her paralyzed and her cognitive functions severely impaired., the opinion explained.  They sued Bayer alleging its product was the cause.  Under Georgia’s learned intermediary, the court found, prescription drug manufacturers have a duty to adequately warn physicians, rather than patients, of the risk their products can cause.  The plaintiff’s burden here was to establish that an improved warning would have caused her doctor not to prescribe her the drug in question; the panel held the plaintiff failed to meet this burden.

The plaintiff argued that in December 2011, the label of Beyaz lacked information of risks that were provided in the updated 2012 labels and thus, in December 2011, the warnings available were inadequate.  Furthermore, the plaintiff claimed her doctor’s testimony on his December 2011 knowledge of the increased blood clot risks associated with Beyaz was “equivocal,” and that Bayer’s new warning “changed the way he counseled patients.”

The district court agreed with Bayer that the testimony of the plaintiff’s doctor established “that no different warning would have changed the prescribing decision and avoided the injury.”  In affirming the district court’s decision to rule in favor of Bayer, the panel of circuit judges relied heavily on the plaintiff’s doctor’s, unambiguous testimony regarding his decision to prescribe Beyaz to the plaintiff in December 2011.  Specifically, “[m]ost importantly, (the doctor) unambiguously testified that he views his December 2011 decision to prescribe Beyaz to (the plaintiff) as an appropriate one, even now that he knows exactly what was included in the 2012 label.”  At the doctor’s deposition he was asked “Do you believe today that your decision to prescribe Beyaz for (the plaintiff) was appropriate?” He responded, “Yes.” 

The panel went on stating if the above testimony was not enough, the doctor’s response to the 2012 Beyaz label update further indicated that if he had knowledge of that information in December 2011, it would not have changed his decision to prescribe Beyaz to the plaintiff.  Additionally, the panel asserted the plaintiff failed to present sufficient evidence to show that the updated 2012 labels of Beyaz changed her doctor’s counseling of patients.

The plaintiff was represented by Parks Chesin & Walbert, Cory Watson, Sherrod & Bernard, and Farris Riley & Pitt.  Bayer was represented by Bartlit Beck and Weinberg Wheeler Hudgins Gunn & Dial.