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House v. Bristol-Myers Squibb Co.

United States District Court, W.D. Kentucky, Louisville Division

December 29, 2016

ANNA HOUSE PLAINTIFF
v.
BRISTOL-MYERS SQUIBB COMPANY, ASTRAZENECA PLC, ASTRAZENECA LP, ASTRAZENECA PHARMACEUTICALS LP, and ASTRAZENECA AB DEFENDANTS

          MEMORANDUM OPINION & ORDER

          Joseph H. McKinley, Jr., Chief Judge.

         This matter is before the Court on a motion to dismiss pursuant to Fed.R.Civ.P. 12(b)(6) by Defendants Bristol-Myers Squibb Company and AstraZeneca Pharmaceuticals LP[1][DN 15]. Fully briefed, this matter is ripe for decision. For the reasons set forth below, the motion to dismiss is GRANTED.

         I. Background

         This case is a personal injury action concerning Invokana, Invokamet, and Farxiga, which are prescription medications approved by the Food and Drug Administration (“FDA”) for the treatment of type 2 diabetes. Plaintiff Anna House, a Kentucky resident, alleges that she developed diabetic ketoacidosis and kidney failure as a result of using these medications. (See Compl. [DN 1] ¶¶ 4, 8.) House asserts twelve claims against Defendants Bristol-Myers Squibb Company, a Delaware corporation; AstraZeneca PLC, a United Kingdom corporation; AstraZeneca LP, a Delaware corporation; AstraZeneca Pharmaceuticals LP, a Delaware corporation; and AstraZeneca AB, a Swedish corporation (collectively, the “Farxiga Defendants”) based on her alleged use of and injuries caused by Farxiga. (Id ¶¶ 6, 12-16.) House alleges that the Farxiga Defendants designed, developed, manufactured, marketed, distributed, and sold Farxiga into the stream of commerce. (Id ¶ 34.)

         In January 2014, Farxiga was approved by the FDA as a sodium-glucose cotransporter 2 (“SGLT2”) inhibitor for the treatment of type 2 diabetes. (Id ¶ 34.) SGLT2 inhibitors, including Invokana, Invokamet, and Farxiga, are designed to help diabetics reduce excess blood sugar. (Id ¶ 29.) They work by blocking reabsorption of glucose in the kidneys, and, instead, they increase glucose secretion through urination. (Id ¶ 30.) The FDA has since received a significant number of reports of diabetic ketoacidosis and severe kidney damage from Invokana, Invokamet, and Farxiga users. (Id ¶ 36.) On May 15, 2015, the FDA issued a safety announcement regarding a risk of ketoacidosis associated with the SGLT2 inhibitor class of diabetes medications. (Id ¶ 61.) House alleges that, despite the reported adverse events, the Farxiga Defendants failed and refused to conduct proper safety studies, failed to properly assess and publicize alarming safety signals, suppressed information revealing serious and life-threatening risks, willfully and wantonly failed to provide adequate instructions, and made willful misrepresentations regarding the nature and safety of their respective medications. (Id ¶ 62.)

         House began taking Farxiga on or about June 2014 (id ¶ 48) and subsequently suffered diabetic ketoacidosis (id ¶ 53.) Plaintiff filed her Complaint on December 22, 2015 [DN 1]. She asserts claims for strict liability design defect (Count I); strict liability failure to warn (Count II); gross negligence (Count III); negligence (Count IV); breach of express warranty (Count V); breach of implied warranty (Count VI); fraudulent misrepresentation (Count VII); negligent misrepresentation (Count VIII); negligent design (Count IX); fraudulent concealment (Count X); fraud (Count XI); and violation of the Kentucky Consumer Protection Act (Count XII). Plaintiff asserts each of these twelve claims against the Farxiga Defendants based on their alleged role in the design, manufacture, marketing, and sale of Farxiga. (See Compl. [DN 1] ¶ 1.) Plaintiff also filed identical claims against Janssen Pharmaceuticals, Inc. (“Janssen”), Johnson & Johnson, and Mitsubishi Tanabe Pharma Corporation (“Mitsubishi”), based on her alleged use of and injuries caused by Invokana and Invokamet. After all properly-served Defendants moved to dismiss the claims against them, the claims against Janssen, Johnson & Johnson, and Mitsubishi were transferred to the District of New Jersey pursuant to an order by the United States Judicial Panel on Multidistrict Litigation. (See In re: Invokana (Canagliflozin) Products Liability Litigation, MDL No. 2750 (Dec. 7, 2016) [DN 43].) Thus, the only remaining claims before this Court are those asserted against the Farxiga Defendants.

         II. Discussion

         A. Standard of Review

         Upon a motion to dismiss for failure to state a claim pursuant to Federal Rule of Civil Procedure 12(b)(6), a court “must construe the complaint in the light most favorable to plaintiff[], ” League of United Latin Am. Citizens v. Bredesen, 500 F.3d 523, 527 (6th Cir. 2007), “accept all well-pled factual allegations as true, ” id., and determine whether the “complaint states a plausible claim for relief, ” Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009). Under this standard, the plaintiff must provide the grounds for his or her entitlement to relief, which “requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007).

         A plaintiff satisfies this standard only when he or she “pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678. A complaint falls short if it pleads facts “‘merely consistent with' a defendant's liability, ” id. at 678 (quoting Twombly, 550 U.S. at 557), or if the alleged facts do not “permit the court to infer more than the mere possibility of misconduct, ” id. at 679. Instead, the allegations must “‘show[] that the pleader is entitled to relief.'” Id. at 679 (quoting Fed.R.Civ.P. 8(a)(2)).

         When a plaintiff pleads claims which sound in fraud, those claims are subject to the heightened pleading standard of Federal Rule of Civil Procedure 9(b), which provides that “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” Fed.R.Civ.P. 9(b). “At a minimum, the Sixth Circuit requires the allegations to contain the ‘time, place, and content of the alleged misrepresentation on which he or she relied; the fraudulent scheme; the fraudulent intent of the defendants; and the injury resulting from the fraud.'” Our Lady of Bellefonte Hosp., Inc. v. Tri-State Physicians Network, Inc., 2007 WL 2903231, at *6 (E.D. Ky. Sept. 27, 2007) (quoting Coffey v. Foamex L.P., 2 F.3d 157, 161-62 (6th Cir. 1993)). “Generalized and conclusory allegations that the Defendant['s] conduct was fraudulent do not satisfy Rule 9(b).” Bovee v. Coopers & Lybrand C.P.A., 272 F.3d 356, 361 (6th Cir. 2001).

         B. Analysis

         1. Strict Liability Claims (Counts I & II)

         House has asserted two strict liability claims based on the theory that Farxiga was defective, both in their design (Count I) and because the Defendants failed to warn of the risk of injury caused by the medications (Count II).

         a. Strict Liability Design Defect Claim

         Under Kentucky law, to prevail in a strict products liability action, a plaintiff must establish: “(1) that there is a product, which is (2) in a defective condition unreasonably dangerous to the user or consumer or his property, and (3) which reaches the user or consumer without substantial change in the condition in which it is sold; (4) that the product is sold by one who is engaged in the business of selling such a product which (5) results in physical harm to the ultimate user or consumer or his property.” Bosch v. Bayer Healthcare Pharms., Inc., 13 F.Supp.3d 730, 742 (W.D. Ky. 2014) (citations omitted). A plaintiff also must establish that there was “an alternative, safer design that is practicable under the circumstances.” Id.

         Defendants first argue that, because of comment k to section 402A of the Restatement (Second) of Torts, they are not subject to design defect liability, and therefore the Court should dismiss Count I of House's Complaint. Kentucky follows the Restatement (Second) of Torts, including comment k to section 402A. Prather v. Abbott Labs., 960 F.Supp.2d 700, 706 (W.D. Ky. 2013) (citing McMichael v. Am. Red Cross, 532 S.W.2d 7, 9-11 (Ky. 1975)). Comment k “provides an exception to the general rule of strict liability for ‘apparently useful and desirable product[s], attended with a known but apparently reasonable risk.'” Id. (quoting Restatement (Second) of Torts § 402A cmt. k). Where comment k applies, a prescription drug manufacturer “is not subject to strict liability for design defects. Instead, the manufacturer's liability is limited to manufacturing defects, for those cases in which the [drug] given had been improperly prepared, and warning defects, where a manufacturer's failure to market a drug . . . without adequate warnings of its dangers renders the product defective.” Snawder v. Cohen, 749 F.Supp. 1473, 1476 (W.D. Ky. 1990); see Foister v. Purdue Pharma, L.P., 295 F.Supp.2d 693, 705 (E.D. Ky. 2003).

         In Kentucky, the scope of comment k is determined on a case-by-case basis. Prather, 960 F.Supp.2d at 707; see Weiss v. Fujisawa Pharm. Co., No. CIV.A. 5:05-527-JMH, 2006 WL 3533072, at *1, *3-4 (E.D. Ky. Dec. 7, 2006). However, as the analysis under comment k is highly fact dependent, see Weiss, 2006 WL 3533072, at *4, and the cases relied on by Defendants were addressing comment k in the context of motions for summary judgment, the ...


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