Rinder v. Merck Sharp & Dohme Corp.

• Decision Date: 23 January 2019
• Docket Number: No. 1-17-1969 & 1-17-1970 (cons.),1-17-1969 & 1-17-1970 (cons.)
• Citation: 429 Ill.Dec. 143,123 N.E.3d 1202,2019 IL App (1st) 171969
• Parties: Danitta RINDER, Individually and as Special Administrator of the Estate of Gregg Rinder, Gay Lynne Brinkley, Individually and as Executor of the Estate of Myra Jo Brinkley, and Alan C. Paprocki, Individually and as Executor of the Estate of Carolyn J. Paprocki, Plaintiffs-Appellees, v. MERCK SHARP & DOHME CORP., Defendant-Appellant. Sally Donzelli, Individually and as Special Administrator of the Estate of George Donzelli, Plaintiff-Appellee, v. Merck Sharp & Dhome Corp., Defendant-Appellant.
• Court: United States Appellate Court of Illinois

2019 IL App (1st) 171969
123 N.E.3d 1202
429 Ill.Dec. 143

Danitta RINDER, Individually and as Special Administrator of the Estate of Gregg Rinder, Gay Lynne Brinkley, Individually and as Executor of the Estate of Myra Jo Brinkley, and Alan C. Paprocki, Individually and as Executor of the Estate of Carolyn J. Paprocki, Plaintiffs-Appellees,
v.
MERCK SHARP & DOHME CORP., Defendant-Appellant.

Sally Donzelli, Individually and as Special Administrator of the Estate of George Donzelli, Plaintiff-Appellee,
v.
Merck Sharp & Dhome Corp., Defendant-Appellant.

No. 1-17-1969 & 1-17-1970 (cons.)

Appellate Court of Illinois, First District, THIRD DIVISION.

Opinion filed January 23, 2019

Stephanie A. Scharf and George D. Sax, of Scharf Banks Marmor LLC, of Chicago, and Ana C. Reyes and Paul E. Boehm, of Williams & Connolly LLP, of Washington, D.C., for appellant.

Kenneth J. Brennan, of TorHoerman Law LLC, of Edwardsville, for appellees.

PRESIDING JUSTICE FITZGERALD SMITH delivered the judgment of the court, with opinion.

429 Ill.Dec. 146

123 N.E.3d 1205

¶ 1 This consolidated appeal involves two pharmaceutical product liability lawsuits concerning the drug Januvia, which is manufactured and marketed by the defendant, Merck Sharp & Dhome Corp. (Merck). The two lawsuits involve four plaintiffs, who allege their family members died of pancreatic cancer caused by their use of Januvia. The plaintiffs allege that, as of the time their family members were taking Januvia, Merck knew that use of Januvia caused or increased the risk of developing pancreatic cancer and it failed to warn of this risk in the drug's labeling. The four plaintiffs' decedents used Januvia at various times between 2007 and 2012. It is undisputed that Januvia's labeling did not contain any mention of pancreatic cancer.

¶ 2 Januvia was approved by the United States Food and Drug Administration (FDA) in 2006 as a drug to treat type 2 diabetes, a disease that results in chronically elevated blood-sugar levels. If left untreated, type 2 diabetes can lead to various significant health complications. Januvia is one of two classes of drugs sometimes referred to as "incretin-based therapies." Incretins are gastrointestinal hormones that cause an increase in the amount of insulin released from cells in the body after eating. Incretin-based therapies essentially prolong the effect of an incretin hormone that stimulates the production of insulin and in turn lowers blood sugar.

¶ 3 Merck filed a motion for summary judgment, arguing that the plaintiffs' failure-to-warn claims were preempted by federal law. Specifically, Merck argued that federal law made it impossible for Merck to satisfy its duties under state tort law (i.e. , by providing the warnings on Januvia's label that the plaintiffs alleged were necessary) because, according to the federal statutes and regulations that controlled the labeling of pharmaceutical drugs, the FDA would have rejected any attempt by Merck to add that warning to Januvia's label. This appeal addresses the specific question of whether Merck's affirmative defense presents a question to be resolved by the judge or by a jury. The trial court ruled that the question presented a factual inquiry that a jury should decide, and it denied Merck's motion for summary judgment. In doing so, however, it certified to this court the following question of law pursuant to Illinois Supreme Court Rule 308 (eff. July 1, 2017):

" ‘Under Wyeth v. Levine , 555 U.S. 555 [129 S.Ct. 1187, 173 L.Ed.2d 51] (2009), federal law preempts state-law failure to warn claims related to use of a prescription drug if there is ‘ "clear evidence" ’ that the FDA would not permit the manufacturer to include the plaintiff's requested warning in the drug's labeling. Is the question whether the defendant has presented the necessary ‘ "clear evidence" ’ one for resolution by the court or jury?’ "

For the reasons set forth below, our answer to the certified question is that the issue should be resolved by the jury.

¶ 4 BACKGROUND

¶ 5 To provide the necessary context for the parties' arguments, we first set forth an explanation of the federal statutory and regulatory framework that governs the labeling of prescription drugs. We must then briefly discuss the "clear evidence" test that the Supreme Court set forth in Wyeth , 555 U.S. at 571, 129 S.Ct. 1187, which addressed when a state law failure-to-warn claim is preempted by those federal

123 N.E.3d 1206

429 Ill.Dec. 147

drug-labeling regulations. Against this background, we will address the nature of the dispute raised by Merck's motion for summary judgment about whether "clear evidence" exists that the FDA would not have permitted it to add a pancreatic cancer warning to Januvia's labeling. This will then allow us to proceed with our analysis of the certified question, whether the issue presented in the "clear evidence" test is to be decided by the judge or jury.

¶ 6 Federal Drug Labeling Statutes and Regulations

¶ 7 The Federal Food, Drug, and Cosmetic Act governs the marketing and sale of prescription drugs in the United States. 21 U.S.C. § 301 et seq. (2012). It prohibits any drug from being introduced into interstate commerce unless the FDA approves an application in which the manufacturer shows that the drug is safe and effective. Id. § 355. The application must also include "the labeling proposed to be used for such drug." Id. § 355(b)(1)(F); 21 C.F.R. § 314.50(c)(2)(i) (2012).

¶ 8 All prescription drug labeling must include certain information, including among other things a "warnings and precautions" section and an "adverse reactions" section. 21 C.F.R. § 201.57(a)(10)-(11) (2012). The "warnings and precautions" section must "describe clinically significant adverse reactions," including "any that are potentially fatal" or "are serious even if infrequent." Id. § 201.57(c)(6)(i). The "adverse reactions" section is broader than the warnings and precautions section and describes the overall adverse reaction profile of the drug. Id. § 201.57(c)(7). An adverse reaction is defined as "an undesirable effect, reasonably associated with use of a drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence." Id. It includes "only those adverse events for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event." Id.

¶ 9 The Supreme Court has explained that it is a "central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times." Wyeth , 555 U.S. at 570-71, 129 S.Ct. 1187. The drug's manufacturer "is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market." Id. at 571, 129 S.Ct. 1187 ; see also 21 U.S.C. § 355(o)(4)(I) (2012).

¶ 10 Fulfilling this latter responsibility may involve revising the drug's label following its initial approval, and the FDA regulations provide drug manufacturers with two options for doing so. The first and more common option, which is not the one generally involved in cases applying the Wyeth inquiry, requires the manufacturer to submit an application and obtain the FDA's approval for the label change prior to making changes.¹ 21 C.F.R. § 314.70(b)(2)(v)(A), (b)(3) (2012).

¶ 11 The second option, which is the one generally involved in cases applying the

429 Ill.Dec. 148

123 N.E.3d 1207

Wyeth "clear evidence" inquiry, is known as the "changes being effected" or "CBE" regulation. The CBE regulation provides for several situations in which a manufacturer is allowed to change a drug's label without obtaining prior approval from the FDA. Id. § 314.70(c)(6)(iii) ; Wyeth , 555 U.S. at 568, 129 S.Ct. 1187. One of those situations is a label change "to reflect newly acquired information"² to "add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling under [ 21 C.F.R.] § 201.57(c)." 21 C.F.R. § 314.70(c)(6)(iii)(A) (2012). The standard for inclusion set forth in 21 C.F.R. § 201.57(c) provides in part that "labeling must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established." Id. § 201.57(c)(6)(i). In its notice of the final rule concerning 21 C.F.R. § 314, the FDA explained this standard further:

"If new safety information meets the requirements of § 201.57(c)(6), it is appropriate for inclusion in the labeling of a drug or biologic and a sponsor must update its labeling ‘as soon as’ such information becomes available. That section states that causation need not have been ‘definitely established’ for a warning to be required to appear in labeling, but rather that there need only be ‘reasonable’ evidence of a causal association with the drug, a standard that could be met by a wide range of evidence. A CBE submission may be made when the

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