In Hubbard v. Bayer Healthcare Pharmaceuticals Inc., No. 19-13087 (11th Cir. December 22, 2020), the Eleventh Circuit Eleventh Circuit rejected a suit on behalf of a 41-year-old who suffered a stroke while taking birth control pills, citing Georgia’s learned intermediary doctrine.
Here, 41-year-old plaintiff Karen Hubbard suffered a catastrophic stroke in 2012 caused by a blood clot to her brain — a venous sinus thrombosis, a type of venous thromboembolism (VTE). She had been taking Beyaz, a birth control pill manufactured by Bayer. While she first received a prescription for Beyaz on December 27, 2011, Karen had been taking similar Bayer birth control products since 2001. The pills are associated with an increased risk of blood clots. The Beyaz warning label in place at the time of Karen?s Beyaz prescription warned of a risk of VTEs and summarized studies.
The Eleventh Circuit affirmed summary judgment in favor of Bayer. Georgia?s learned intermediary doctrine controlled this diversity jurisdiction case. That doctrine imposes on prescription drug manufacturers a duty to adequately warn physicians, rather than patients, of the risks their products pose. 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. 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 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.”