Emley v. Wal-Mart Stores, Inc.
| Decision Date | 27 June 2019 |
| Docket Number | Cause No. 1:17-cv-2350-WTL-TAB |
| Parties | DONNA EMLEY, et al., Plaintiffs, v. WAL-MART STORES, INC., et al., Defendants. |
| Court | U.S. District Court — Southern District of Indiana |
This cause is before the Court on the following motions: Defendant L. Perrigo Company's ("Perrigo") Motion for Summary Judgment on the Basis of Preemption (Dkt. No. 85) and related motions for oral argument (Dkt. Nos. 87 and 101); Defendant Wal-Mart Stores, Inc.'s ("Wal-Mart") Motion for Summary Judgment on the Basis of Preemption (Dkt. No. 88); Defendant Wal-Mart's [Second] Motion for Summary Judgment (Dkt. No. 120); Defendant Perrigo's [Second] Motion for Summary Judgment (Dkt. No. 122); and Defendant L.N.K. International, Inc.'s ("L.N.K.") Motion for Summary Judgment (Dkt. No. 124). Because the Court does not find that oral argument would be helpful, the motions for oral argument are DENIED. Each of the remaining motions is ripe for review and the Court, being duly advised, rules as follows.
Federal Rule of Civil Procedure 56(a) provides that summary judgment is appropriate "if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." In ruling on a motion for summary judgment, the properly supported facts asserted by the non-moving party must be believed, and all reasonable inferences must be drawn in the non-movant's favor. Zerante v. DeLuca, 555 F.3d 582, 584 (7th Cir. 2009) (). However, a party who bears the burden of proof on a particular issue may not rest on his pleadings, but must show what evidence he has that there is a genuine issue of material fact that requires trial. Johnson v. Cambridge Indus., Inc., 325 F.3d 892, 901 (7th Cir. 2003). The non-moving party bears the burden of specifically identifying the relevant evidence of record, and "the court is not required to scour the record in search of evidence to defeat a motion for summary judgment." Ritchie v. Glidden Co., 242 F.3d 713, 723 (7th Cir. 2001).
The relevant background facts of record, viewed in the light most favorable to the Plaintiffs, as the non-moving parties, are as follow. Additional facts are included throughout the Entry as relevant.
On June 11, 2015, and again on June 12, 2015, Donna Emley took two pills from a bottle of Equate-brand acetaminophen because she was experiencing general muscle aches and cold symptoms. Dennis1 had purchased a twin-back of Equate acetaminophen (the "Perrigo Product") in November 2013 from a Wal-Mart near the Plaintiffs' home in Fort Wayne, Indiana.2 Hechose acetaminophen because Donna was undergoing treatment for colorectal cancer at the time and she had been advised by her oncologist to take acetaminophen for relief from headaches and other symptoms.
On June 13, 2015, the Plaintiffs travelled to Kentucky for a planned vacation, during which they were to act as caretakers of a small farm. In the late afternoon or evening after arriving at the farm, Donna noticed a mild rash. The rash worsened overnight, and her eyes became itchy and watery. Early the next morning, the Plaintiffs drove to a nearby Wal-Mart store in Tennessee to purchase medication to help alleviate Donna's symptoms. Donna believed that she was suffering an allergic reaction, perhaps to something she had been exposed to on the farm, and that Benadryl would help. Donna waited in the car while Dennis went into the store, where he purchased Equate brand Severe Allergy and Sinus Headache medication (the "L.N.K. Product"), which contains acetaminophen. Donna took one dose of the L.N.K. Product immediately, and then took another dose approximately four hours later, per the package instructions.
When her symptoms did not improve after her second dose of the L.N.K. Product, Donna went to the Gilbert Grave Urgent Care Center in Bowling Green, Kentucky on the afternoon of June 14, 2015. The physician she saw there sent her to the Bowling Green Medical Center, where she was admitted and remained hospitalized until June 19, 2015. She continued to receive acetaminophen during her treatment there.
On June 19, 2015, Donna was transferred to the Vanderbilt University Medical Center, where she was diagnosed with Toxic Epidermal Necrolysis ("TEN"). At that time, she was no longer given acetaminophen. Donna remained hospitalized from June 19, 2015, until July 16, 2015, for treatment of TEN and related symptoms.
The Plaintiffs allege, and for purposes of this ruling the Court assumes, that the acetaminophen contained in the Perrigo Product and the L.N.K. Product caused Donna to develop TEN. The Plaintiffs further allege that the Products were defective because their label did not contain the following warning regarding the risk that acetaminophen can cause severe skin reactions (hereinafter referred to as "the Warning"):
Each Defendant moves for summary judgment on the ground that the Plaintiffs' claims are preempted by federal law. Specifically, the Defendants argue that the claims are preempted because it would have been impossible for them to comply with both the state-law duties upon which those claims are based and the duties imposed on them by federal law. In other words, they argue that the Plaintiffs' claims against them are barred under the doctrine of impossibility preemption.
The Defendants' preemption defense is based upon the fact that the Food and Drug Administration ("FDA") regulates the content of warning labels on drugs pursuant to the FederalFood, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq. and related regulations. The Supreme Court has instructed that determinations regarding preemption "must be guided by two cornerstones of our pre-emption jurisprudence":
First, the purpose of Congress is the ultimate touchstone in every pre-emption case. Second, in all pre-emption cases, and particularly in those in which Congress has legislated in a field which the States have traditionally occupied, we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.
Wyeth v. Levine, 555 U.S. 555, 565 (2009) ().
In Wyeth, the Supreme Court considered preemption as it applied to state-law failure-to-warn claims against the manufacturer of a drug being sold pursuant to an approved New Drug Application ("NDA"). Although "[t]he FDA's premarket approval of a new drug application includes the approval of the exact text in the proposed label," and "[g]enerally speaking, a manufacturer may only change a drug label after the FDA approves a supplemental application," the Court noted that the applicable regulations provided for a "changes being effected" ("CBE") process which permitted a manufacturer "to make certain changes to its label before receiving the agency's approval." Wyeth, 555 U.S. at 568. This includes changes made to "add or strengthen a contraindication, warning, precaution, or adverse reaction" or to "add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product." 21 C.F.R. §§ 314.70(c)(6)(iii)(A), (C). Thus, the Court found that the manufacturer could have used the CBE process to add the warning in question to its label without prior approval from the FDA. And while "the FDA retains authority to reject labeling changes made pursuant to the CBE regulation in its review of the manufacturer's supplementalapplication, just as it retains such authority in reviewing all supplemental applications," the Court held that "absent clear evidence that the FDA would not have approved a change to [the drug's] label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements." Wyeth, 555 U.S. at 571. Accordingly, impossibility preemption did not operate to bar the plaintiff's claims based on the NDA manufacturer's failure to include a particular warning on the drug's label.
The Supreme Court reached the opposite conclusion in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), which involved a drug being sold pursuant to an approved Abbreviated New Drug Application ("ANDA"). The ANDA process is a separate regulatory scheme that applies to generic versions of drugs that already have been approved by the FDA under the NDA process. The Supreme Court determined that the CBE process was not available to ANDA manufacturers; rather, the applicable regulations require that a generic drug being sold pursuant to an approved ANDA have the same label as the equivalent brand-name drug being sold pursuant to an NDA. PLIVA, 564 U.S. at 618 (). Because there was no mechanism for an ANDA manufacturer to change its label independently of the NDA manufacturer without violating federal law, "it was impossible for the [ANDA] Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same," id., and the plaintiffs' claims were preempted. The Court recognized that it made "little sense" from the plaintiffs' perspective that the question of whether a plaintiff could pursue a failure-to-warn claim depended upon whether the plaintiff was injured by a brand-name or generic drug, but noted that "'it is not this Court's task to decide whether the...
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