By Levy M. Burns, J.D.
Acknowledging that courts are divided on whether a judge or a jury should make "clear evidence" determinations under the U.S. Supreme Court’s Wyeth v. Levine standard, an Illinois appellate court answered a certified question that the issue should be resolved by the jury because it is essentially a fact-finding inquiry.
On a certified question from an Illinois trial court, which had denied a motion for summary judgment brought by a pharmaceutical manufacturer in an action concerning an anti-diabetes medication, the Illinois Appellate Court determined that, under Wyeth v. Levine, 555 U.S. 555 (2009), the jury, not the judge, should be the fact-finder when determining, on the issue of federal law preemption of state law failure to warn claims, whether there was "clear evidence" that the Food and Drug Administration (FDA) would not have permitted a prescription drug manufacturer to have included the plaintiff’s requested warning in the drug’s labeling. The court found that given the clear factual questions requiring resolution, a jury was the appropriate arbiter of fact (Rinder v. Merck Sharp & Dohme Corp., January 23, 2019, Smith, F.).
Merck Sharp & Dohme Corp. (Merck), the manufacturer of the anti-diabetes drug Januvia®, was sued for failure to warn by the survivors of four individuals who developed pancreatic cancer after using the drug over a period of five years. The survivors contended that Merck knew that Januvia carried an increased risk of pancreatic cancer, yet failed to warn of the risk in the drug’s labeling. Merck moved for summary judgment, arguing that federal law would preempt any such failure to warn claims because, according to the federal statutes and regulations that controlled pharmaceutical drug labeling, the FDA would not have permitted the manufacturer to include the warnings in the drug's labeling. Federal judicial precedent, pursuant to Wyeth, had established that federal preemption was appropriate when "clear evidence" was presented that the FDA would have prevented such warnings.
Merck presented extensive evidence as part of its summary judgment motion to satisfy the clear evidence standard articulated in Wyeth, under which state law failure to warn claims would be preempted. However, Merck’s motion was denied by the Illinois trial court, which ruled that such questions of fact were to be determined by jury. When issuing its denial ruling, the trial court certified the question for the state appellate court to clarify the point. The appellate court affirmed the trial court’s finding that a jury should make the "clear evidence" determination."Clear evidence" findings. The appellate court noted that courts in many jurisdictions were split in their rulings on this issue. The court acknowledged that although the clear evidence inquiry established under Wyeth presented a mixed question of law and fact, this dispute essentially concerned the state of scientific and medical knowledge linking the use of a drug to pancreatic cancer, and what inferences should be drawn from that knowledge about how the FDA would have responded had the manufacturer attempted to change its product’s label.
The appellate court concluded that although the FDA's regulations provided the legal standards of causation and proof through which the factual dispute between the survivors and Merck must be analyzed, the substantive issue was a factual one. Absent "smoking gun" evidence of the FDA's position on the issue being presented by the manufacturer, a factual dispute remained, which required final determination by a jury.
The cases are Nos. 1-17-1969 and 1-17-1970.
Attorneys: Stephanie A. Scharf (Scharf Banks Marmor, LLC) for Merck Sharp & Dohme Corp. Kenneth Brennan (TorHoerman Law, LLC) for Danitta Rinder.
Companies: Merck Sharp & Dohme Corp.
MainStory: TopStory CourtDecisions CausationNews EvidentiaryNews PreemptionNews WarningsNews DrugsNews IllinoisNews
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