Jury to decide if FDA would have blocked Merck from revising Januvia label over cancer risk: Appeals panel

By Jonathan Bilyk | Dec 27, 2018

A pharmaceutical company facing lawsuits over whether its diabetes drug may have caused pancreatic cancer will need to let a jury decide whether federal regulators would have prevented the drugmaker from revising the medication’s warning label to specifically mention a risk of developing that cancer.

On Dec. 26, a three-justice panel of the Illinois First District Appellate Court upheld the findings of a Cook County judge, saying there were too many unanswered questions in the case to say for certain whether the U.S. Food and Drug Administration would have barred Merck Sharp & Dhome Corp. from adding the cancer risk warning to its drug, Januvia.

So, the justices rejected Merck’s attempt to have a judge decide the question.

“… We believe the nature of the fact-finding called for … goes far beyond the kind of preliminary fact-finding that a judge performs in resolving personal jurisdiction and choice-of-law disputes,” the justices wrote. “It requires much more extensive and substantive fact-finding appropriately decided after a full trial, and thus the jury should be the appropriate fact-finder.”

The case centered on a question that arose out of lawsuits brought by named plaintiffs Danitta Rinder, Gay Brinkley, Alan Paprocki and Sally Donzelli, who accused Merck of negligence for failing to revise Januvia’s warning label to specifically reference the threat of developing pancreatic cancer from taking the drug. They asserted because of this, their relatives contracted pancreatic cancer and later died.

The plaintiffs allege Merck knew Januvia, a drug approved by the FDA as an “incretin-based therapy” to treat type-2 diabetes, also “caused or increased the risk of developing pancreatic cancer, and it failed to warn of this risk in the drug’s labeling,” according to the appellate decision.

Incretins are “gastrointestinal hormones that cause an increase in the amount of insulin released from cells in the body after eating,” the decision stated.

According to the decision, the plaintiffs’ relatives took Januvia at some point during the years 2007-2012.

After the lawsuits were filed in 2013, Merck filed a motion for summary judgment, asking the court to quickly end the cases in its favor. In that motion, Merck asserted the warning labels are governed strictly by the FDA, and it would have been prevented from adding the cancer warning to the labels even if it desired to do so.

Merck never attempted to revise the warning labels. But the company pointed to evidence indicating the FDA has investigated “the pancreatic safety of incretin-based medications” since at least 2009, “and it made an affirmative scientific decision that the evidence did not warrant a change in labeling.”

Merck also claimed a 2013 communication from the FDA, in which regulators noted it was investigating “potential pancreatic toxicity associated with the incretin mimetics,” but “has not concluded these drugs may cause or contribute to the development of pancreatic cancer.”

Because of these statements, Merck said, there was “clear evidence” the FDA would have rejected any attempt to revise Januvia’s label to reflect pancreatic cancer risk.

The plaintiffs, however, asserted Merck had misinterpreted the document, noting the FDA was continuing to investigate the potential pancreatic cancer risk, and that the document “was to be updated if ‘data become (sic) available that provide sufficient evidence that a drug is not associated with the safety concern…’”

The 2013 communication has not been updated, the plaintiffs noted.

Plaintiffs argued “the mere fact that the FDA considers its investigation ongoing, when combined with the existing scientific data, indicates there exists ‘some basis to believe there is a causal relationship’ between the use of Januvia and pancreatic cancer, which satisfies the standard for adding it as an ‘adverse reaction’ to Januvia’s label.’”

Cook County Circuit Judge Daniel T. Gillespie sided with plaintiffs on the question, saying there was too much uncertainty remaining on the question to conclude the FDA would have prevented Merck from revising the label. So, the judge said, he did not believe federal law would preempt the lawsuits from advancing to trial on state law negligence claims.

The judge, however, advanced a certified question to the First District Appellate Court, asking justices to decide whether the issue should be decided by a judge, as desired by Merck, or a jury, as sought by plaintiffs.

On appeal, the justices also sided with the plaintiffs on the question.

They agreed the case presented too many uncertainties, especially since Merck had never attempted to secure FDA approval to revise the label.

They said this meant further proceedings were warranted to decide if the lawsuits should be preempted under the so-called “clear evidence” standard created under the U.S. Supreme Court’s decision in Wyeth v. Levine.

And the justices further rejected Merck’s arguments that the question belongs before a judge, and not a jury.

While justices noted Merck presented ample evidence indicating a majority of such Wyeth inquiries are handled by judges, they said this does not mean all such inquiries should bypass the jury.

“Here, Merck is not pointing to an actual FDA action or decision to be reviewed (i.e., an actual rejection by the FDA of an attempt to add the warning at issue to the label by the manufacturer),” the justices wrote. “Instead, the decision-maker is being asked to extrapolate from other evidence whether it is clear what the FDA’s action or decision would have been if Merck had attempted to change Januvia’s label … to add the warning that the plaintiffs allege was necessary.

“… The substance of the FDA’s decision is what matters, not the FDA’s compliance with the law in reaching that decision. Thus, we perceive these inquiries to be different and believe that the Wyeth inquiry presents a question for the jury in this case,” the justices found.

The decision was authored by Justice James Fitzgerald Smith, with justices Nathaniel Howse Jr. and Cynthia Y. Cobbs concurring.

The decision was issued as an unpublished order under Supreme Court Rule 23, which limits its use as precedent.

According to Cook County court records, the plaintiffs are represented by attorneys with the firms of Torhoerman Law LLC, of Chicago, and Tomasik Kotin Kasserman LLC, of Chicago.

Merck is represented by the firm of Scharf Banks Marmor LLC, of Chicago.

 

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Circuit Court of Cook County Illinois First District Appellate Court Merck & Company, Inc. Scharf Banks Marmor LLC Tomasik Kotin Kasserman , LLC

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