Blackburn v. Shire U.S. Inc.

MARK BLACKBURN, Plaintiff-Appellant, v. SHIRE U.S. INC, SHIRE LLC, Defendants-Appellees, SHIRE DEVELOPMENT LLC, et al., Defendants.

No. 20-12258

United States Court of Appeals, Eleventh Circuit

November 29, 2021

Appeal from the United States District Court for the Northern District of Alabama D.C. Docket No. 2:16-cv-00963-MHH

Before Jill Pryor, Luck, and Brasher, Circuit Judges.

OPINION

BRASHER, Circuit Judge.

Under Alabama law, the manufacturer of an unreasonably dangerous product has a duty to warn users of the risks presented by the product. When the unreasonably dangerous product is a drug that requires a prescription, a drug manufacturer's duty to warn is usually discharged by warning the prescribing physician of the product's risks.

Mark Blackburn was diagnosed with advanced stage kidney disease after taking LIALDA, a drug manufactured by Shire Pharmaceuticals. Blackburn does not contend that Shire failed to warn of the risk of kidney disease; 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 monitored him differently after prescribing LIALDA, discovered the effect on his kidneys sooner, and prevented his injury.

In our view, Blackburn's theory of liability raises two unsettled questions of Alabama law. First, may a pharmaceutical company's duty to warn include a duty to provide instructions about how to mitigate warned-of risks? Second, 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?

Because of how we resolve the federal issues in this appeal, these state-law questions are dispositive. For our part, we believe these questions are important enough-and the resolution uncertain enough-for us to certify them to the Supreme Court of Alabama.

I. BACKGROUND

Blackburn is a professional golf instructor. His training facility is located at a golf club in Birmingham, Alabama, but he frequently travels throughout the world to counsel some of the world's best players and represent one of the game's premium brands. Blackburn suffers from Crohn's disease.

Prior to moving to Birmingham, he lived and worked at a golf course in Guntersville, Alabama. Dr. Craig Young was one of Blackburn's clients and his de facto primary care physician. Young ordered routine bloodwork for Blackburn, and his "labs looked good." About eighteen months later, Blackburn reported persistent gastrointestinal issues, and Young referred him to Dr. Dino Ferrante, a gastroenterologist in Huntsville, Alabama. Ferrante documented Blackburn's primary complaint as urgent diarrhea up to four times daily. Something Young said during his referral led Ferrante to conclude that he did not need to order initial blood-work before treating Blackburn. After several tests and procedures, Ferrante diagnosed Blackburn with Crohn's disease.

Ferrante prescribed LIALDA, and Blackburn began taking the medication on November 6, 2013. LIALDA is the brand name for Shire's mesalamine drug, which is an anti-inflammatory drug specifically aimed at the gut. LIALDA is not approved by the FDA to treat Crohn's, but it is approved to treat ulcerative colitis, Crohn's "sister" disease. The drug is taken orally in pill form unlike other, more invasive Crohn's treatments, and Ferrante considered it the best option for Blackburn due to his travel schedule.

Mesalamine drugs like LIALDA pose a risk of kidney disease. The LIALDA label warns that "[r]enal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients given products such as LIALDA that contain mesalamine or are converted to mesalamine." Kidney disease is identified by a digression in kidney function over time. LIALDA can cause inflammatory cells to deposit in the kidneys, scarring organ tissue and diminishing kidney function. If a patient experiences this side effect, continuing to take the drug can lead to irreversible damage. To identify potential dis-ease-and thereby prevent severe impairment-the label recommends "that patients have an evaluation of renal function prior to initiation of LIALDA therapy and periodically while on therapy."

Renal function is evaluated by measuring the amount of creatinine in a patient's blood. Using the creatinine level, a physician can estimate glomerular filtration rate, which is a marker of how well a patient's kidneys are functioning.

Ferrante set a follow-up appointment for two months after he prescribed LIALDA, but either he or Blackburn canceled it. Even if Blackburn had kept the appointment, it is unlikely Ferrante would have ordered blood work to evaluate kidney function. As a matter of practice, Ferrante periodically tests renal function after "about a year" of treatment. By the time Blackburn had been taking LIALDA for a year, he had moved to Birmingham and requested a referral to a different doctor. Ferrante provided the referral, but Blackburn never followed up. Ferrante's office continued to fill Blackburn's prescriptions for over a year without examining him. Consequently, Blackburn's renal function went unmonitored during that time.

In all, Blackburn took LIALDA for somewhere between 12 and 16 months. He stopped filling the prescriptions in January 2015. Soon after that, Blackburn took himself off the drug because he felt that it wasn't working. He found that changing his diet partially relieved his Crohn's symptoms.

Soon after he stopped taking LIALDA, Blackburn discovered that he was suffering from advanced stage kidney disease. In April 2015, Blackburn underwent a blood test that revealed an excessive amount of creatinine, resulting in a low estimated glomerular filtration rate. His primary care physician referred him to Dr. Agata Przekwas, a nephrologist. Przekwas diagnosed Blackburn with advanced chronic interstitial nephritis, a type of kidney disease that manifests as irreversible scarring and diminished kidney function. The severity of kidney disease is expressed in six stages, with stage six requiring a patient to undergo dialysis. Blackburn's kidney disease was initially diagnosed as stage four, reflecting the fact that his kidneys were functioning at approximately 20 percent their normal capacity. Blackburn is currently awaiting a kidney transplant.

Przekwas and Dr. Jonathan Winston, a nephrology expert retained by Blackburn, concluded that Blackburn's injuries were preventable. Winston estimated that Blackburn's kidney disease was detectable at least six months before it was diagnosed, and possibly as early as August 2014. If Blackburn had stopped taking LIALDA at that time, Winston opined that his kidney function "would be either normal or near normal." And Winston attributed Blackburn's injury to the LIALDA label. Because of the amorphous "periodic" instruction, Winston reasoned that a physician following the label's warning could fail to detect kidney disease before it "worsen[ed] to a clinically significant level."

Benjamin England, a regulatory expert retained by Blackburn, explained that Shire could have changed the label to include a stronger monitoring instruction. He concurred in Winston's assessment of the label's inadequacies and added that sufficient evidence, including a "a growing body of medical literature," supported a stronger monitoring instruction. England also identified reports of renal impairment that Shire received between the label's initial approval and Blackburn's injury. He concluded that sufficient evidence would have led to a label change, had Shire sought one.

Blackburn sued Shire in June 2016. Shire initially moved to dismiss for lack of personal jurisdiction and judgment on the pleadings. Blackburn sought leave to amend his complaint, and the district court ordered Shire to show cause why leave should not be granted. Shire responded that the amendments would be futile, but the district court granted Blackburn's motion anyway.

Blackburn originally asserted four claims under Alabama law: strict liability for failure to warn under the Alabama Extended Manufacturers Liability Doctrine, breach of express warranty, and two fraud claims. On Shire's second motion to dismiss, the district court dismissed with prejudice all but the failure-to-warn claim. Blackburn twice moved the district court to revive the dismissed counts. First, Blackburn moved the district court to alter its dismissal to reflect that the counts were dismissed without prejudice, effectively granting him a second opportunity to amend his complaint. The district court denied the motion, concluding that Blackburn had forgone "ample opportunit[ies] to state claims on which relief could be granted." Instead of moving to amend his complaint while Shire's motion to dismiss was pending, Blackburn had "sat idly by" and waited for the district court to tell him whether his allegations were sufficient. Blackburn then moved for reconsideration, but the district court denied that motion as well. It concluded that the amendments would be futile because the LIALDA label did not create an express warranty for safeness that would support Blackburn's breach of express warranty or fraud-based claims.

Blackburn's remaining failure-to-warn claim alleged that the LIALDA label contained an inadequate warning regarding its potential renal toxicity. Specifically, Blackburn argued that if the label had provided more detailed instructions for safe use, his...