In Mark Blackburn v. Shire US Inc, et al, Case No. 20-12258 (11th Cir. November 29, 2021), the Eleventh Circuit reversed the District Court’s grant of summary judgment in favor of the defendant drug manufacturer on plaintiff’s failure to warn claim and sent the case to the Alabama Supreme Court for review on a couple of questions of Alabama state law.
Plaintiff is a Professional Golfers’ Association instructor who has Crohn’s disease and he brought a failure to warn claim against Shire U.S. Inc. over its anti-inflammatory drug LIALDA claiming that the pharmaceutical company had a duty to warn of potential side effects and required monitoring in stronger language. Plaintiff Blackburn was prescribed LIALDA, an anti-inflammatory drug specifically aimed at the gut. LIALDA is not FDA-approved to treat Crohn’s, but it is approved to treat ulcerative colitis, Crohn’s “sister” disease. Blackburn was subsequently diagnosed with advanced-stage kidney disease.
Blackburn did not claim that Shire, LIALDA’s manufacturer failed to warn of the risk of kidney disease as both he and his doctor knew that the drug might impair his kidney function. Instead, Blackburn contends that Shire should have more explicitly warned his doctor about how regularly to monitor his kidney function after prescribing LIALDA. He contends that, if LIALDA’s warning label had been better, his physician would have discovered the effect on his kidneys sooner and prevented his injury. The District Court disregarded his physician’s testimony about whether he would have read and incorporated a different label into his practices as “unsubstantiated speculation” and “self-interested” testimony.
The Eleventh Circuit disagreed and found that a genuine dispute of material fact precluded it from affirming the summary judgment based on the district court’s reasoning about the doctor. But, before it could decide whether to affirm or reverse, the Eleventh Circuit decided that it needed to determine whether Blackburn’s theory of liability is consistent with Alabama law and identified two unsettled, dispositive questions of Alabama law, which it certified to the state’s highest court. Those questions were: (1) May a pharmaceutical company’s duty to warn include a duty to provide instructions about how to mitigate warned-of risks? And (2) May a plaintiff establish that an improper warning caused his injuries by showing that his doctor would have adopted a different course of testing or mitigation, even though he would have prescribed the same drug?
We will continue to keep an eye on this one.