Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Warren v. Boehringer Ingleheim Pharmaceuticals Inc.

United States District Court, S.D. Indiana, Indianapolis Division

September 8, 2017



          SARAH EVANS BARKER, United States District Court Judge

         Spouses Tanya and Larry Warren (“Tanya, ” “Larry, ” together, “the Warrens”) brought this products-liability action based on diversity jurisdiction against the manufacturers of Jardiance, a drug for treating diabetes: Boehringer Ingelheim Pharmaceuticals, Inc., and its parent company Boehringer Ingelheim International GmbH (“Boehringer”), and Lilly USA, L.L.C., and its parent company Eli Lilly and Company (“Lilly”) (together, “the Manufacturers”).

         Before the Court are two motions to dismiss for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6). The Manufacturers jointly seek dismissal of all the Warrens' claims as insufficiently pleaded under Federal Rules of Civil Procedure 8 and 9, and of one claim as pre-empted by federal law (“the Manufacturers' motion”). Lilly separately seeks dismissal of two of the Warrens' claims as pre-empted by federal law for a reason peculiar to it (“Lilly's motion”).

         The Manufacturers' motion is granted in part and denied in part. Lilly's separate dismissal motion is granted in its entirety.

         Factual and Procedural History

         Taken as true, the Warrens' factual allegations reveal the following: The Warrens are Louisiana citizens who live in the town of Olla, Louisiana. Pls.' Am. Compl. ¶¶ 9-10. Tanya suffers from type 2 diabetes mellitus, id. at ¶ 21, for which her endocrinologist prescribed Jardiance, at a dosage of 10 milligrams taken by mouth once daily, beginning on or about February 4, 2015. Id. at ¶¶ 45-46.

         Jardiance is indicated “for the improvement of glycemic control in adults with type 2 diabetes.” Id. at ¶ 26. It belongs to a class of drugs called sodium glucose cotransporter 2 (SGLT2) inhibitors, id. at ¶ 22, the effect of which is to “inhibit renal glucose reabsorption through the SGLT2 receptor in the proximal renal tubules, causing glucose to be excreted through the urinary tract . . . .” Id. at ¶ 23. SGLT2 inhibitors “are designed to target primarily the SGLT2 receptor, but have varying selectivity for this receptor, and block other sodium-glucose cotransporter receptors, including SGLT1.” Id. at ¶ 24.

         After Jardiance's release to market, [1] the United States Food and Drug Administration (FDA) received reports that some of its users experienced diabetic ketoacidosis. Id. at ¶ 30. Ketoacidosis is a “life-threatening” condition, id. at ¶ 5, that “may lead to complications such as cerebral edema, pulmonary edema, cerebrovascular accident, myocardial infarction, nonspecific myocardial injury, severe dehydration, and coma.” Id. at ¶ 36. Jardiance may also make ketoacidosis more difficult to detect “because in many cases Jardiance will keep blood sugar below 250 mg/dl, a threshold often used when diagnosing diabetic ketoacidosis.” Id. at ¶ 37. In December 2015, the FDA requested that the Manufacturers of Jardiance and the manufacturers of other SGLT2 inhibitors warn their users about the risks of ketoacidosis. Id. at ¶ 32. The Manufacturers apparently declined the FDA's request. See Id. at ¶¶ 39-41, 131(a), (b).

         Tanya began taking Jardiance as directed by her endocrinologist. Id. at ¶ 45. On May 28, 2015, less than four months after it was prescribed for her, Tanya was hospitalized for ketoacidosis. Id. at ¶ 47. The Warrens note that Jardiance and other SGLT2 inhibitors may also cause kidney and bone problems in their users, e.g., Id. at ¶ 23, 31, 34-35, 38-39, 43, 135, but Tanya does not claim to have suffered such conditions. However, as a result of ketoacidosis, Tanya, and derivatively Larry, experienced “pain and suffering, emotional distress, loss of enjoyment of life, and economic loss[.]” Id. at ¶ 48.

         The Warrens brought the instant action in this Court on May 27, 2016. Dkt. 1. In response to our order, Dkt. 4, the Warrens filed an amended complaint properly setting out their diversity jurisdiction allegations on June 9, 2016. Dkt. 5. The amended complaint alleges eleven claims against all the Manufacturers, whom the Warrens hold jointly responsible for all aspects of Jardiance's design and marketing. Pls.' Am. Compl. ¶ 27.

         The Warrens seek to hold the Manufacturers liable as follows: Counts (I) defective design; (II) failure to warn; (III) negligence; (IV) negligent misrepresentation; (V) breach of implied warranty of merchantability; (VI) breach of express warranty; (VII) fraudulent misrepresentation; (VIII) fraudulent concealment; (IX) deceptive acts under Indiana's Deceptive Consumer Sales Act, Ind. Code ch. 24-5-0.5; (X) Terry's loss of consortium; and (XI) punitive damages. The Manufacturers moved to dismiss the amended complaint on September 20, 2016. Dkt. 20. Lilly separately moved to dismiss two of the claims that same day. Dkt. 22. Each motion has been fully briefed and is now ripe for decision. Dkt. 21, 23, 26-28, 30.

         Legal Standard

         “A pleading that states a claim to relief must contain . . . a short and plain statement of the claim showing that the pleader is entitled to relief . . . .” Fed.R.Civ.P. 8(a); Adams v. City of Indianapolis, 742 F.3d 720, 728 (7th Cir. 2014). A motion to dismiss for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6) “test[s] the legal sufficiency of a complaint.” Triad Assocs., Inc. v. Chi. Hous. Auth., 892 F.2d 583, 586 (7th Cir. 1989), abrogated on other grounds by Bd. of Cty. Comm'rs v. Umbehr, 518 U.S. 668 (1996). To survive dismissal,

a complaint must “state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). 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.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). . . . We draw all reasonable inferences and facts in favor of the nonmovant, but need not accept as true any legal assertions. Vesely v. Armslist LLC, 762 F.3d 661, 664-65 (7th Cir. 2014).

Wagner v. Teva Pharms. USA, Inc., 840 F.3d 355, 357-58 (7th Cir. 2016). This Court has previously noted that, “[a]lthough Twombly and Iqbal represent a new gloss on the standards governing the sufficiency of pleadings, they do not overturn the fundamental principle of liberality embodied in Rule 8.” DuRocher v. Riddell, Inc., 97 F.Supp.3d 1006, 1013 (S.D. Ind. 2015) (Barker, J.).

         Where, as here, the deadline for amending a complaint as of right has passed, Fed.R.Civ.P. 15(a)(1)(B), further amendment requires leave of court or the defendants' consent. Id. at (a)(2). “Although leave to file a second amended complaint should be granted liberally, a district court may deny leave for several reasons including . . . futility of amendment.” Dubicz v. Commonwealth Edison Co., 377 F.3d 787, 792 (7th Cir. 2004) (quotations omitted); see Fed. R. Civ. P. 15(a)(2) (“The court should freely give leave when justice so requires.”).

         Analysis and Decision

         We turn first to resolve a choice of law issue. Thereafter, we address whether the Warrens' complaint satisfies Rule 8, Fed. R. Civ. P., by advancing plausible claims to relief. Assuming the allegedly pre-empted claims satisfy Rule 8, we finally will take up the pre-emption defenses raised jointly by the Manufacturers and separately by Lilly.

         I. Choice of Law

         A federal court sitting in diversity applies the whole law of the state in which it sits, that is, its substantive law including its choice-of-law rules. Klaxon Co. v. Stentor Elec. Mfg. Co., 313 U.S. 487, 496 (1941); Auto-Owners Ins. Co. v. Websolv Computing, Inc., 580 F.3d 543, 547 (7th Cir. 2009). A federal court's task is to apply the law “as we believe the highest court of the state would apply it.” Pisciotta v. Old Nat'l Bancorp, 499 F.3d 629, 634 (7th Cir. 2007).

         The Manufacturers contend that Indiana courts would apply Louisiana law in resolving this case. The Warrens tacitly concede that point by failing to contest it, by defending the sufficiency of their complaint under Louisiana law, and by conceding that Louisiana law bars several of their claims. See Pls.' Resp. Br., pp. 4-9, 9 n. 3. Because a court “do[es] not worry about conflict of laws unless the parties disagree on which state's law applies[, ]” Wood v. Mid-Valley, Inc., 942 F.2d 425, 427 (7th Cir. 1991) (distinguishing subject-matter jurisdiction and federal comity), we shall apply Louisiana law to this case without further discussion.

         Accordingly, the Manufacturers' motion is GRANTED as to the Warrens' Count (IX) deceptive acts brought under Indiana's Deceptive Consumer Sales Act, Ind. Code ch. 24-5-0.5. Because amendment would be futile, Count (IX) is DISMISSED WITH PREJUDICE.

         II. The Warrens' Claims Under Louisiana Law

         In Louisiana, “the exclusive theories of liability for manufacturers for damage caused by their products” are established by the Louisiana Products Liability Act (LPLA). La. Stat. Ann. § 9:2800.52 (emphasis added); Reynolds v. Bordelon, 2014-2371 (La. 6/30/15); 172 So.3d 607, 612. A plaintiff may not recover for damage caused by a manufacturer's product “on the basis of any theory not set forth” in the LPLA. La. Stat. Ann. § 9:2800.52; Ashley v. Gen. Motors Corp., 27, 851 (La.App. 2 Cir. 1/24/96); 666 So.2d 1320, 1321-22.

         The Warrens concede that “the LPLA's exclusivity provision bars . . . claims beyond [its] scope . . . .” Pls.' Resp. Br., p. 9 n.3. This concession is well taken. It reaches Counts (III) negligence, Stahl v. Novartis Pharms. Corp., 283 F.3d 254, 261 (5th Cir. 2002); (IV) negligent misrepresentation, Donald v. AstraZeneca Pharms., L.P., No. 16-17753, 2017 WL 1079186 (E.D. La. Mar. 22, 2017); (V) breach of implied warranty of merchantability, Jefferson v. Lead Indus. Ass'n, Inc., 106 F.3d 1245, 1251 (5th Cir. 1997); (VII) fraudulent misrepresentation, id.; and (VIII) fraudulent concealment, Grenier v. Medical Engineering Corp., 99 F.Supp.2d 759, 763 (W.D. La. 2000). Count (XI) punitive damages is generally unavailable under Louisiana law unless expressly authorized by statute, Int'l Harvester Credit Corp. v. Seale, 518 So.2d 1039, 1041 (La. 1988), and the LPLA contains no such authorization. See La. Stat. Ann. §§ 2800.51 through .60; see also, e.g., Bladen v. C.B. Fleet Holding Co., 487 F.Supp.2d 759, 770 (W.D. La. 2007).

         The Manufacturers' motion is therefore GRANTED as to each of these claims. With the dismissal of the fraud claims, the Manufacturers' Rule 9, Fed. R. Civ. P., arguments are moot. See Fed. R. Civ. P. 9(b) (fraud pleaded with particularity); Dkt. 20 (moving to dismiss under Rule 9(b)). Because amendment would be futile, Counts (III), (IV), (V), (VII), (VIII), and (XI) are DISMISSED WITH PREJUDICE.

         The Manufacturers argue further that “the Court should dismiss all of [the Warrens'] substantive claims, because [the Warrens] have not brought any of these claims pursuant to the LPLA.” Defs.' Br. Supp., p. 8 (emphasis added). With this, we disagree. “[A] plaintiff need not plead legal theories in her complaint[, ]” King v. Kramer, 763 F.3d 635, 642 (7th Cir. 2014), and “specifying an incorrect theory is not a fatal error.” Rabe v. United Air Lines, Inc., 636 F.3d 866, 872 (7th Cir. 2011).

         The question remaining, then, is whether the Warrens have pleaded sufficient facts to raise a facially plausible claim to relief under the LPLA. Wagner, 840 F.3d at 358. The Warrens argue that their four remaining claims are sufficiently pleaded under the LPLA to survive dismissal: Counts (I) defective design, (II) failure to warn, (VI) breach of express warranty, and Terry's derivative claim for Count (X) loss of consortium. We discuss these claims below.

         Under the LPLA, the manufacturer of a product is liable for damage proximately caused “by a characteristic of the product that renders the product unreasonably dangerous” arising from “a reasonably anticipated use of the product” by the plaintiff or another. La. Stat. Ann. § 9:2800.54(A); Reynolds, 172 So.3d at 612. Thus, a plaintiff under the LPLA must prove four elements:

(1) that the defendant is a manufacturer of the product; (2) that the [plaintiff's] damage was proximately caused by a characteristic of the product; (3) that this characteristic made the product “unreasonably dangerous”; and (4) that the [plaintiff's] damage arose from a reasonably anticipated use of the product by the product by the [plaintiff] or someone else.

Stahl, 283 F.3d at 261.

         A product may be found unreasonably dangerous in only four respects: in construction or composition;[2] in design; in failing to provide an adequate warning; and in failing to conform to an express warranty of the manufacturer. La. Stat. Ann. § 9:2800.54(B)(1) through (4); Reynolds, 172 So.3d at 612-13. As relevant here, the characteristic allegedly making the product unreasonably dangerous “must exist at the time product left the control of its manufacturer.” La. Stat. Ann. § 9:2800.54(C); Reynolds, 172 So.3d at 613.

         The Warrens allege that the Manufacturers manufactured Jardiance, Pls.' Am. Compl. ¶ 27, and that the Manufacturers “expected and intended Jardiance to reach, and it did in fact reach, [Tanya] without any substantial change in the condition of the product from when it was initially manufactured . . . .” Id. at ¶ 68.The Warrens allege further that Jardiance is prescribed for the treatment of adult type 2 diabetes, id. at ¶ 26, that Tanya has type 2 diabetes, id. at ¶ 29, and that Tanya was prescribed Jardiance by her endocrinologist and took it as directed. Id. at ¶ 45. Finally, the Warrens allege that, as a result, Tanya suffered ketoacidosis and its “severe and life threatening side effects . . . .” Id. at ¶ 21. These averments plausibly allege that the Manufacturers are manufacturers of the product, that any unreasonable danger existed at the time the product left the Manufacturers' control, and that Tanya's damage arose from a reasonably anticipated use of the product by her.

         We examine next each ground of unreasonable danger asserted and its causal relationship to the Warrens' injuries.

         A. Count (I): Defective Design

         The Warrens plead first that Jardiance is unreasonably dangerous in design. Under the LPLA,

A product is unreasonably dangerous in design if, at the time the product has left its manufacturer's control:
(1) There existed an alternative design for the product that was capable of preventing the claimant's damage; and
(2) The likelihood that the product's design would cause the claimant's damage and the gravity of that damage outweighed the burden on the manufacturer of adopting such alternative design and the adverse effect, if any, of ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.