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Bell v. Boehringer Ingelheim Pharmaceuticals, Inc.

United States District Court, W.D. Pennsylvania

May 31, 2018

WILLIAM L. BELL, JR, Plaintiff,


          Joy Flowers Conti Chief United States District Judge

         I. Introduction

         Plaintiff William L. Bell, Jr. ("Bell") alleges that he developed an acute kidney injury as a direct result of taking the prescription drug Jardiance. The court dismissed the original complaint in its entirety based upon the lack of actual facts pled about how each defendant acted negligently or fraudulently in Jardiance's design or warnings or how each defendant's alleged breaches of the standard of care caused Bell's injuries. (February 15, 2018 Opinion, ECF No. 20). The court gave Bell leave to file an amended complaint, but cautioned him to plead how the design or warnings were faulty and to assure that the complaint contained sufficient factual allegations to render the claims "plausible" against each defendant, because the court was unlikely to permit further amendment. Id.

         Bell filed an amended complaint. (ECF No. 22). Defendants Boehringer Ingelheim Pharmaceuticals, Inc. ("BrPI")[1] and Eli Lilly & Company ("Lilly") renewed their motions to dismiss the amended complaint in its entirety. (ECF Nos. 24, 26). Both defendants contend that Bell again failed to plead sufficient facts to support any cognizable claims. Lilly filed a separate motion, arguing that because BIPI is the sole applicant holder of the Jardiance New Drug Application ("NDA") filed with the Food and Drug Administration ("FDA") Lilly never had authority to change Jardiance's labeling or design. The motions are fully briefed and ripe for disposition.

         II. Documents considered

         A court may properly look at public records without converting a motion to dismiss into one for summary judgment. Johnson v. Talton, No. CV 17-01446, 2018 WL 1427086, at *1 (W.D. Pa. Mar. 22, 2018) (citing Southern Cross Overseas Agencies, Inc. v. Wah Kwong Shipping Group Ltd., 181 F.3d 410, 426 (3d Cir. 1999), and Pension Benefit Guar. Corp. v. White Consol. Indus., 998 F.2d 1192, 1196 (3d Cir. 1993)). A plaintiff with a legally deficient claim cannot survive a motion to dismiss simply by failing to attach a dispositive document on which he relied. Pension Ben. Guar. Corp., 998 F.2d at 1196.

         The court will take judicial notice of the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book"). The Orange Book is a "publically available list of drugs which have been approved [by the FDA] for safety and effectiveness." Warren v. Boehringer Ingleheim Pharm. Inc., No. 116CV01326SEBDML, 2017 WL 3970666, at *16 (S.D. Ind. Sept. 8, 2017) (citing Abbott Labs. v. Zenith Labs., Inc., 934 F.Supp. 925, 927 (N.D. 111. 1995), and Morris v. Wyeth, Inc., No. 9-854, 2012 WL 601455 (W.D. La. Feb. 23, 2012)). The Orange Book lists BIPI as the sole "applicant holder" for Jardiance. Id.; avail, at product.cfm?Appl Type=N&Appl No=204629, last visited on May 22, 2018.

         Numerous courts have concluded that FDA warning letters are publicly available evidence of agency actions, of which the court may take judicial notice. Bowling v. Johnson & Johnson, No. 17-CV-3982, 2018 WL 1587598, at *4 (S.D.N.Y. Mar. 28, 2018) (collecting decisions); accord Alfred v. Frito-LayN. Am., Inc., No. 17-CV-1345, 2018 WL 1185227, at *2 (S.D. Cal. Mar. 7, 2018) ("FDA warning letters available on the FDA's website are also appropriate subjects of judicial notice") (citation omitted); Fed.R.Evid. 201. In Salvio v. Amgen, Inc., 810 F.Supp.2d 745, 750-51 (W.D. Pa. 2011), the court took judicial notice of the medication's package warning label in granting a motion to dismiss design and failure to warn claims. The court will consider FDA warning letters and label changes regarding SGLT2 inhibitors such as Jardiance. See, e.g., Bowling, 2018 WL 1587598, at *4 (and decisions cited therein).

         The court will consider the FDA's NDA Approval letter (ECF No. 25-1), which is referenced in the amended complaint (ECF No. 22 ¶¶ 21-22) and integrally related to the claims in this case. The court will consider the information available at the FDA website,, last visited on May 22, 2018, to which both parties have cited. (ECF No. 22 n. 3, 4; ECF No. 25 at 8 n.4). These documents will be considered for their existence, but not for the truth of the facts recited therein. Southern Cross Overseas Agencies, 181 F.3d at 426.

         III. Factual Background

         Despite the court's conclusion in the February 15, 2018 memorandum opinion that the allegations in Bell's original complaint were conclusory and substantially identical to those held to be insufficient in several other cases, the amended complaint makes only a few factual revisions. (Compare ECF Nos. 1, 22). The court will incorporate its recitation of the factual background in the February 15, 2018 memorandum opinion and set forth the additional facts to be considered from the amended complaint and documents from the FDA website.

As set forth in the complaint, in July 2014, defendants submitted an NDA to the FDA for Jardiance. Complaint ¶ 20 (ECF No. 1). In August 2014, the FDA approved Jardiance for the treatment of Type II diabetes. Id. ¶ 21. Jardiance is the tradename for the drug empagliflozin, which is a member of the gliflozin class of sodium-glucose cotransporter 2 ("SGLT2") inhibitors. Id. ¶ 22. SGLT2 inhibitors are designed to inhibit renal glucose reabsorption with the goal of lowering blood glucose. Id. ¶24. Excess glucose is not metabolized. Instead, it is excreted through the kidneys. Id. ¶ 24. Jardiance is indicated for only improved glycemic control in type 2 adult diabetics, but defendants market it for off label purposes, including weight loss, reduced blood pressure and improved glycemic control in type 1 diabetes. Id. ¶ 25. Since the release of Jardiance, the FDA has received a significant number of reports of diabetic ketoacidosis. Id. ¶ 26. Bell alleges that defendants knew about the significant risk of diabetic ketoacidosis but did not adequately warn consumers or the medical community about the severity of such risks. Id. ¶ 30.
On June 13, 2015, Bell began taking Jardiance per his doctor's instructions, primarily to treat diabetes. Id. ¶ 32. Bell relied on defendants' claims that Jardiance was safe and effective for the treatment of diabetes. Id. ¶ 35. On August 31, 2015, Bell suffered acute renal failure. Id. ¶ 37.

         (February 15, 2018 memorandum opinion, ECF No. 20).

         In response to the court's comment that Bell did not plead the roles of each defendant, he now pleads that BIPI and Lilly agreed to jointly develop and commercialize diabetes compounds and "worked in conjunction to research, develop, test and market Jardiance." (ECF No. 22 ¶ 19). In response to the court's comment that Bell failed to identify alternative, safer designs, he now pleads that other products were available, including metformin, Diabinese, Amaryl and Glucotrol. (ECF No. 22 ¶ 41). The amended complaint does not contain any facts about why these products are safer or why the design of Jardiance was negligent.

         Bell added some details about his own condition. He developed type-2 diabetes in 2005. (ECF No. 22 ¶ 34). He began taking 25 milligrams of Jardiance daily on June 13, 2015, as prescribed by his physicians at Joslin Diabetes Center. (ECF No. 22 ¶ 34). At the time he was prescribed Jardiance, he had normal kidney function. (ECF No. 22 ¶ 34). He suffered an acute kidney injury on August 31, 2015. (ECF No. 22 ¶ 38). Bell avers that despite ...

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