Blackburn v. Shire U.S., Inc.

380 So.3d 354

Mark BLACKBURN

v.SHIRE U.S., INC., and Shire, LLC

1210140

Supreme Court of Alabama.

September 30, 2022

Rehearing Denied January 13, 2023

Keith Jackson of Riley & Jackson, P.C., Birmingham; and Jonathan H. Waller of Waller Law Office, PC, Birmingham, for appellant.

Thomas E. Walker of White Arnold & Dowd, P.C., Birmingham; and Jeffrey F. Peck and Kevin M. Bandy of Ulmer & Berne LLP, Cincinnati, Ohio, for appellees.

Ryan J. Duplechin of Beasley, Allen, Crow, Methvin, Portis & Miles, P.C., Montgomery; and R. Edwin Lamberth of Gilmore Law Firm, Mobile, for amicus curiae Alabama Association for Justice, in support of the appellant; and Navan Ward, President, American Association for Justice, Washington, D.C., for amicus curiae American Association for Justice, in support of the appellant.

Frederick G. Helmsing, Jr., of McDowell Knight Roedder & Sledge, L.L.C., Mobile, for amicus curiae Alabama Defense Lawyers Association and DRI, in support of the appellees.

Gerald Swann, Jr., of Ball, Ball, Matthews & Novak, PA, Montgomery; and Craig A. Alexander of Rumberger Kirk, Birmingham, "of counsel" for Alabama Defense Lawyers Association; and Archibald T. Reeves IV of McDowell, Knight, Roedder & Sledge, LLC, Mobile, "of counsel" for ORI.

MENDHEIM, Justice.

Pursuant to Rule 18, Ala. R. App. P., the United States Court of Appeals for the Eleventh Circuit has certified to this Court the following questions:

"1. Consistent with the learned intermediary doctrine, may a pharmaceutical company’s duty to warn include a duty to provide instructions about how to mitigate warned-of risks?

"2. May a plaintiff establish that a failure to warn 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?"

Blackburn v. Shire US Inc., 18 F.4th 1310, 1322 (11th Cir. 2021) ("Blackburn II"). This Court accepted and now answers those questions.

I. Facts

Dr. Dino Ferrante, a gastroenterologist, prescribed LIALDA, which is manufactured by Shire U.S., Inc., and Shire, LLC (referred to collectively as "Shire"), to help patient Mark Blackburn with his Crohn’s disease. "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." Blackburn II, 18 F.4th at 1314. Thus, Dr. Ferrante prescribed LIALDA for an "off-label" purpose, but one that is common. After taking LIALDA for between 12 to 16 months, Blackburn discovered that he had developed kidney disease, specifically advanced chronic interstitial nephritis, which had resulted in irreversible scarring and had diminished his kidney function to 20% of normal capacity. As a result, Blackburn is awaiting a kidney transplant.

In November 2013, when Blackburn began taking LIALDA, the "Warnings and Precautions" portion of its label included the following:

"5.1 Renal Impairment

"Renal 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.

"It is recommended that patients have an evaluation of renal function prior to initiation of LIALDA therapy and periodically while on therapy. Exercise caution when using LIALDA in patients with renal dysfunction or a history of renal disease."

(Bold typeface in original; emphasis added.) The recommendation to "have an evaluation of renal function prior to initiation of LIALDA therapy and periodically while on therapy" was included in LIALDA’s first label when it was approved for distribution in 2007, and it is that portion of the label which is the basis of Blackburn’s failure-to-warn claim. See Shire’s brief, p. 7.

In June 2016, Blackburn sued Shire in the United States District Court for the Northern District of Alabama, alleging strict liability for failure to warn under the Alabama Extended Manufacturer’s Liability Doctrine ("the AEMLD"), breach of express warranty, and fraud. The breach-of-warranty and fraud claims were dismissed, and Shire sought summary judgment on the failure-to-wam claim.

"Mr. Blackburn does not contend that Shire failed to warn of possible kidney injury when using LIALDA. Instead, Mr. Blackburn alleges that the recommended ‘periodic’ evaluation ‘constitutes a defective and unsafe instruction for safe use of LIALDA.’ [Quoting Blackburn’s complaint.] He contends that the term ‘periodic’ as generally used in drug labels refers to either semi-annual or annual testing and that Shire’s warning should have ‘provide[d] for blood testing of renal function at intervals necessary to reasonably protect patients from LIALDA’s potential renal toxicity.’ [Quoting Blackburn’s complaint.]

"Mr. Blackburn contends that the language regarding testing for renal function in Shire’s warning should resemble language used by other manufacturers of mesalamine-based drugs. PENTASA, like LIALDA, is a 5-aminosalicylic acid (’5-ASA’) or mesalamine-based drug. In the United Kingdom, PENTASA is marketed with the warning that patients ‘should have renal function monitored, with serum creatinine levels measured prior to treatment start, every 3 months for the first year, then [every 6 months] for the next 4 years and annually thereafter.’ Similarly, OCTASA, another 5-ASA drug, is marketed in the United Kingdom with the following instruction:

" ‘It is recommended that all patients have an evaluation of their renal function prior to initiation of Octasa therapy and repeatedly whilst on therapy. As a guideline, follow-up tests are recommended 14 days after commencement of treatment and then every 4 weeks for the following 12 weeks. Short monitoring intervals early after the start of Octasa therapy will discover rare acute renal reactions. In the absence of an acute renal reaction monitoring intervals can be extended to every 3 months and then annually after 5 years.’

"Mr. Blackburn asserts that an appropriate label for LIALDA, a mesalamine-based drug, should include instructions recommending ‘evaluation of renal function by a simple serum (blood) test of creatinine levels on a monthly basis for the first three months after initiation of therapy and then on a quarterly basis for at least one year.’ [Quoting Blackburn’s complaint.] Mr. Blackburn contends that Shire’s failure to include this testing regimen in the LIALDA package warning in the fall of 2013 proximately caused his kidney injury."

Blackburn v. Shire U.S., Inc., No. 2:16-cv-00963-MHH, 2020 WL 2840089, June 1, 2020 (N.D. Ala. 2020) ("Blackburn I") (not published in Federal Supplement) (citations to the record omitted).

"[Dr. Agata] Przekwas[, a nephrologist,] and Dr. Jonathan Winston, a nephrology expert retained by Blackburn, concluded that Blackburn’s injuries were preventable. Winston estimated thatBlackburn’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 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 II, 18 F.4th at 1315.

Dr. Ferrante testified that, to him, testing renal function "periodically" meant "once a year," though he "acknowledged that ‘periodically’ can mean other time periods as well and that there is no specific definition of ‘periodically’ in the medical profession." Blackburn I. He also stated that if the LIALDA label had contained language similar to the labels for PENTASA and OCTASA, mentioned in the initial quote from Blackburn I above, he " ‘would have followed those protocols.’ " Id.

The federal district court granted Shire’s summary-judgment motion, holding that there was an "absence of admissible evidence of a causal link between Shire's instructions for renal evaluations when prescribing LIALDA and Mr. Blackburn’s injury." Blackburn I. Blackburn appealed. The Eleventh Circuit Court of Appeals disagreed with the federal district court’s application of the facts on summary judgment. It concluded that Dr. Ferrante’s testimony that he did not read the LIALDA label should not have been interpreted as meaning that the label’s contents did not matter to him but, rather, that "the existing label’s warning was so well known to the physician that he did not read it before each new prescription." Blackburn II, 18 F.4th at 1319. Furthermore, the Eleventh Circuit Court of Appeals rejected the federal district court’s conclusion that Dr. Ferrante’s testimony that he would have altered his testing regimen for Blackburn if the LIALDA label had been different was "unsubstantiated speculation" and "self-interested" because such a conclusion "goes to credibility, not the usefulness of the testimony at summary judgment." Id. at 1320.

Even though the Eleventh Circuit Court of Appeals rejected the federal district court’s basis for entering a summary judgment in favor of Shire, it acknowledged that Shire had presented an alternative basis for...