Lack of testing advice on Crohn’s drug label debated at 11th Circuit

(CN) — An 11th Circuit panel heard arguments Wednesday over whether a golf coach’s kidney disease was directly caused by a drug company’s failure to provide physicians instructions on how to safely use a medication.

Mark Blackburn began taking the drug Lialda to treat his Crohn’s disease in November 2013. In 2015, the coach for amateur and professional golf players on the PGA tour was diagnosed with stage four chronic kidney disease.

The drugmaker, Shire, included warnings of a risk of kidney damage on the Lialda label, making this case different from most “failure to warn” challenges. The crux of Blackburn’s lawsuit against the company is that Shire did not provide instructions regarding the frequency of testing needed while taking the medicine.

Blackburn says if Shire had included instructions in its written warning for prescribing physicians to perform renal assessments at specific intervals, his doctors would have done those tests and detected his kidney injury before it became severe. 

His lawyer Jonathan H. Waller told the three-judge panel Wednesday that this information would have made his physicians aware that they needed to alter his testing schedule. The argument bolsters testimony by Blackburn’s physicians, who contended that they would have followed the label instructions for safe use of the medicine, and Waller said U.S. District Judge Madeline Hughes Haikala ignored the doctors’ statements when granted summary judgment to Shire this past summer.

Haikala found no evidence Blackburn’s doctors would have heeded testing instructions had they been on the Lialda label. She said the lack of evidence severed the causation link between Shire’s failure to provide the information and Blackburn’s kidney damage. 

Shire's attorney Jeff Peck with Ulmer & Berne LLP told the 11th Circuit panel the doctors’ testimony was self-serving and speculative. 

“When someone is looking back retroactively and saying what they would have done, that is speculation,” Peck said, adding that it would be in the doctor’s best interest to go on the record. 

U.S. Circuit Judge Robert J. Luck, a Donald Trump nominee, interjected to note that “this is a speculative endeavor by nature.”

Peck concurred there is room for some speculation in cases like this, but argued the doctors had not exactly followed protocol in an effort to show there is no evidence that they would have followed additional instructions.

Waller told the panel the doctor who took over Blackburn's medical care had been a doctor for over a decade, and had spoken to his own longtime pattern of heeding medical labels and instructions. Peck pushed back.

“Our position is that the doctor is the decision maker,” Peck said, arguing it is not the drugmaker’s responsibility to tell doctors how to care for their patients. 

“The courts recognize that those other things that follow after a physician has decided to prescribe a drug, are in the practice of medicine," he added, arguing Shire had fulfilled its duty by warning of the risks of the drug before the physicians decided to prescribe it and noting Blackburn had missed an appointment in January 2014 — a point also made by Haikala in her summary judgment. 

Luck pointed out the missed appointment was not a testing appointment. Waller agreed, noting the purpose of the visit was "to see if he was having an adverse reaction, symptoms. It was not for the purpose of doing blood work.”

To Peck’s other point, Waller argued Blackburn’s doctor specifically testified there would have been a better outcome for his patient if Shire had included testing instructions. 

Fellow Trump appointee U.S. Circuit Judge Andrew Brasher and Barack Obama appointee U.S. Circuit Judge Jill Pryor rounded out the panel, which indicated it may certify a question to the Alabama Supreme Court. 

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