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Mitchell v. Boehringer Ingelheim Pharmaceuticals, Inc.

United States District Court, W.D. Tennessee, Eastern Division

November 21, 2017




         Plaintiff Melissa Mitchell filed this product liability action under the Tennessee Product Liability Act (“TPLA”), Tenn. Code Ann. § 29-28-101 et seq., against Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals, Inc. (“BIPI”), alleging that she developed diabetic ketoacidosis (“DKA”) after she began taking Jardiance, a prescription medication approved by the Food and Drug Administration (“FDA”) as safe and effective for the treatment of type 2 diabetes. Defendant BIPI holds the New Drug Application (“NDA”) for Jardiance and co-markets the product with Eli Lilly and Company.[1] Jurisdiction is predicated on diversity of citizenship, 28 U.S.C. § 1332. Defendant BIPI has filed a motion to dismiss Plaintiff's second amended complaint. (ECF No. 62.) Plaintiff has filed a response to the motion (ECF No. 64), and Defendant has filed a reply to the response. (ECF No. 65.) For the reasons set forth below, Defendant's motion is PARTIALLY GRANTED and PARTIALLY DENIED.

         A motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) tests the legal sufficiency of the complaint. RMI Titanium Co. v. Westinghouse Elec. Corp., 78 F.3d 1125, 1134 (6th Cir. 1996). Under Federal Rule of Civil Procedure 8(a)(2), a pleading must contain a “short and plain statement of the claim showing that the pleader is entitled to relief.” The Supreme Court clarified the pleading standard in Bell Atlantic Corporation v. Twombly, 550 U.S. 555 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009). Under Twombly, to survive a motion to dismiss, a complaint need not contain “detailed factual allegations, ” but it must contain more than “labels and conclusions” or “a formulaic recitation of the elements of a cause of action ...” 550 U.S. at 570. A complaint does not “suffice if it tenders ‘naked assertions' devoid of ‘further factual enhancement.'” Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 557). “[A] complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.'” Id. (quoting Twombly, 550 U.S. at 570). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. (citing Twombly, 550 U.S. at 556).

         The plausibility standard “does not impose a probability requirement at the pleading stage; it simply calls for enough facts ‘to raise a reasonable expectation that discovery will reveal evidence of illegal [conduct].'” Twombly, 550 U.S. at 556. In deciding whether the plaintiff has set forth a plausible claim, the Court must accept the factual allegations in the complaint as true. Id.; see also Erickson v. Pardus, 551 U.S. 89 (2007). This presumption, however, is not applicable to legal conclusions. Iqbal, 556 U.S. at 678. Therefore, “[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Id. (citing Twombly, 550 U.S. at 555).

         “A court considering a 12(b)(6) motion may consider materials in addition to the complaint if such are public records.” Rodney v. LaHood, 359 F. App'x 634, 637 (6th Cir. 2010). FDA documents may properly be considered on a motion to dismiss. See, e.g., Spier v. Coloplast Corp., 121 F.Supp.3d 809, 811 n. 2 (E.D. Tenn. 2015) (taking judicial notice of “various publicly available” FDA documents).

         Plaintiff's second amended complaint (ECF No. 56) alleges that Jardiance (empagliflozin) was approved by the FDA on August 1, 2014, as safe and effective for the treatment of type 2 diabetes. (SAC ¶ 15, ECF No. 56.) It is the third member of the newest class of medications used to treat type 2 diabetes known as sodium-glucose co-transporter 2 (“SGLT2”) inhibitors. (Id.) The second amended complaint further alleges that Plaintiff began taking Jardiance to treat her diabetes in or about February 2015 and used Jardiance consistently until June 2, 2015. (Id. ¶¶ 26, 33.)

         “On May 15, 2015, the FDA issued a safety alert covering the SGLT-2 inhibitor class, warning about the risk of DKA.” (Id. ¶ 35.) The data on which the May 15, 2015, safety alert was premised “was collected from March 2013 to June 6, 2014, nearly two months prior to Jardiance's approval” and came from the FDA Adverse Event Reporting System (“FAERS”), “a publicly available database.” (Id. ¶¶ 36-37.) “As part of its continued evaluation, on December 4, 2015[, ] the FDA issued a new safety communication disclosing they had found 73 adverse events reported between March 2013 and May 2015 that required hospitalization due to ketoacidosis related to SGLT-2 inhibitors.” (Id. ¶ 38.)

         Plaintiff contends that Defendant BIPI “did not warn about the risks of DKA” at the time “JARDIANCE was approved” (id. ¶ 53) and did not “amend the label or utilize the [FDA's Changes Being Effected (‘CBE')] process” to warn about the risks of DKA before Plaintiff used the medication (id. ¶ 68(c)). She alleges that she was injured as a result of taking the drug without being warned of the possible risks. In addition to developing DKA, Plaintiff alleges that she experienced “other related health complications.” (Id. ¶¶ 90, 114.)

         According to Plaintiff, Jardiance's warnings were defective and/or unreasonably dangerous with regard to the increased risk of exposure to DKA because there were no warnings for DKA at any time prior to Plaintiff's alleged injury on June 2, 2015, and no DKA warning at any time prior to the December 4, 2015, label change. (Id. ¶¶ 54-56.)

         Defendant contends that Plaintiff's failure-to-warn theory is premised solely on adverse events that occurred before Defendant received FDA approval for Jardiance. Defendant argues that any state law duty under the TPLA to provide a different warning at the time of Jardiance's FDA approval is preempted because, pursuant to federal regulations and Supreme Court precedent, the FDA assessed the warning at the time of approval, deemed Jardiance to be safe and effective when accompanied by that warning, and required Jardiance to be accompanied by the warning approved by the FDA at the commencement of marketing Jardiance. Accordingly, Defendant argues that both Plaintiff's strict liability and negligence claims, predicated on a failure-to-warn theory, are preempted by federal law. Defendant also argues that, even if Plaintiff's failure-to-warn theory is not preempted, she has not plausibly alleged how the Jardiance label was defective or unreasonably dangerous or how the alleged defect in the Jardiance label caused her injuries.

         As this Court has previously noted,

[t]he TPLA governs products liability actions in Tennessee and defines “product liability action[s]” as “all actions brought for or on account of personal injury, death or property damage caused by or resulting from the manufacture, construction, design, formula, preparation, assembly, testing, service, warning, instruction, marketing, packing, or labeling of any product.” The TPLA also encompasses several different theories of products liability: “strict liability in tort; negligence; breach of warranty, express or implied; breach of or failure to discharge a duty to warn or instruct, whether negligent or innocent; misrepresentation, concealment, or nondisclosure, whether negligent or innocent; or under any other substantive legal theory in tort or contract whatsoever.”

Strayhorn v. Wyeth Pharm., Inc., 887 F.Supp.2d 799, 813 (W.D. Tenn. 2012) (internal footnotes omitted). To maintain a claim under the TPLA, regardless of the theory of recovery, “the plaintiff must show that: (1) the product was defective and/or unreasonably dangerous, (2) the defect existed at the time the product left the manufacturer's control, and (3) the plaintiff's injury was proximately caused by the defective product.” Sigler v. Am. Honda Motor Co., 532 F.3d 469, 483 (6th Cir. 2008). See also Tenn. Code Ann. § 29-28-105(a) (providing that, under the TPLA, a plaintiff may recover for injuries caused by a product that was “in a defective condition or unreasonably dangerous at the time [the product] left the control of the manufacturer or seller”).

         Under Tennessee law, “[m]anufacturers of prescription drugs . . . have a duty to market and distribute their products in a way that minimizes the risk or danger . . . [and] may discharge their duty by distributing the drugs with proper directions and adequate warnings;” adequate warnings are defined as those that “contain a full and complete disclosure of the potential adverse reactions to the drug.” Pittman v. Upjohn Co., 890 S.W.2d 425, 428-29 (Tenn. 1994). “To plead a ‘failure to warn' claim, Plaintiff must allege facts for the Court to infer that the Device was ‘unreasonably dangerous' within the meaning of T.C.A. § 29-28-102(8).” Maness v. Boston Sci., 751 F.Supp.2d 962, 970 (E.D. Tenn. 2010) (footnote omitted).

         As noted by Defendant, the FDA has the sole authority to approve prescription drugs for sale in the United States, and the Federal Food, Drug, and Cosmetic Act requires drug manufacturers to gain FDA approval before marketing or selling a new drug in interstate commerce. 21 U.S.C. § 355(a). To receive approval, the drug must “meet[] the statutory standards for safety and effectiveness, manufacturing and controls, and labeling, ” as determined by the FDA. 21 C.F.R. § 314.105(c) (“[The] FDA is required to exercise its scientific judgment to determine the kind and quantity of data and information an applicant is required to provide for a particular drug to meet the statutory standards.”) The NDA or sNDA[2] must include “the labeling proposed to be used” for the drug, 21 U.S.C. § 355(b)(1)(F), 21 C.F.R. § 314.50(c)(2)(i), and “a discussion of why the [drug's] benefits exceed the risks under the conditions stated in the labeling.” 21 C.F.R. § 314.50(d)(5)(viii). The NDA or sNDA must also include “[t]he proposed text of the labeling . . . with annotations to the information in the [application] that support the inclusion of each statement . . . .” Id. § 314.50(c)(2)(i). To approve an NDA or sNDA, the FDA must determine, “based on a fair evaluation of all material facts, ” that the proposed label is not “false or misleading in any particular, ” 21 U.S.C. § 355(d)(7), or otherwise “does not comply with the requirements for labels and labeling.” 21 C.F.R. § 314.125(b)(6)-(8). Once the FDA has approved an NDA or sNDA, the manufacturer must use the FDA-approved label. 21 U.S.C. §§ 331(c), 333(a), 352(a), (c).

         After the FDA approves a drug, there are two ways a manufacturer can change the drug's label. “First, the default rule is that a manufacturer must secure FDA approval for a proposed change prior to distributing the product with the changed label.” In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34, 37 (1st Cir. 2015) (citation omitted). Second, a drug manufacturer can, without prior FDA approval, make certain types of changes to the drug's label by sending a “supplement submission” to the FDA pursuant to the CBE process.[3] 21 C.F.R. § 314.70(c)(6)(iii).

         To use the CBE process, the drug manufacturer must satisfy two requirements. First, the label change must reflect “newly acquired information.” Id. “Newly acquired information” is defined as “data, analyses, or other information not previously submitted to the Agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.” 21 C.F.R. § 314.3(b). Second, the label change must be for the purpose of accomplishing at least one of five objectives, including “[t]o 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 . . . .” 21 C.F.R. § 314.70(c)(6)(iii)(A).

         In the present case, any claim that Plaintiff has made against Defendant based on the alleged inadequacy of the initial FDA approved label fails as a matter of law because Defendant was required to use that label when it first marketed Jardiance and could not have changed the label after FDA approval based on alleged pre-launch data that was known to the FDA at the time of the approval. See In re Celexa, 779 F.3d at 43 (affirming dismissal of complaint because defendants could not have independently changed drug label at time of FDA approval). See alsoUtts v. Bristol-Myers Squibb Co., 26 F.Supp.3d 66 (S.D.N.Y. 2016) (holding that failure-to-warn claims were preempted when claims were premised on adequacy of the label as approved by FDA when drug was first marketed and when plaintiffs did not plead “newly acquired information” that would have allowed the manufacturer to independently change drug label to add or improve warnings pursuant to CBE process); In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices & Prods. Liab. Litig., 185 F.Supp.3d 761, ...

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