Robinson ex rel. T.R. v. Eli Lilly & Co.

TIMOTHY ROBINSON, on Behalf of T.R., a minor child, Plaintiff, v. ELI LILLY AND COMPANY, Defendant.

CIVIL ACTION NO. 5:17-CV-338-KKC

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF KENTUCKY CENTRAL DIVISION AT LEXINGTON

August 23, 2018

OPINION AND ORDER*** *** ***

This matter is before the Court pursuant to Defendant Eli Lilly's Motion to Dismiss for Failure to State a Claim (DE 10). For the following reasons, the motion is GRANTED IN PART and DENIED IN PART. The Court dismisses Robinson's claims¹ alleging design defects, manufacturing defects, breach of warranties, fraudulent concealment, and negligent misrepresentation. Robinson's failure to warn claims, arising in both strict liability and negligence, may proceed.

I. INTRODUCTION

In late 2000, during her first trimester of pregnancy, Gina Robinson took Prozac as prescribed by a physician. (DE 1-2 at 6). She later gave birth to T.R., who was born with cardiac birth defects, which required corrective surgery at the age of nine.

T.R.'s father, Timothy Robinson claims that at the time of Gina Robinson's pregnancy, the manufacturer and distributor of Prozac, Eli Lilly and Company, knew through animalstudies, post-marketing reports and other sources, that Prozac was associated with a significant risk of cardiac defects in babies whose mothers ingested Prozac during pregnancy. Id. at 8. Robinson claims that despite this knowledge, Eli Lilly aggressively and actively promoted Prozac "as being a safe alternative for pregnant women," and never informed doctors of the serious risks. Id. at 10. Robinson's complaint asserts multiple claims against Eli Lilly, including strict liability for failure to warn, negligence, breach of warranties, fraudulent concealment and negligent misrepresentation. Eli Lilly has moved to dismiss the complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). (DE 10). Specifically, Eli Lilly argues that each of Robinson's claims are either preempted, fail to meet the pleading requirements, or are not viable claims under Kentucky law. The Court considers the arguments below.

II. ANALYSIS

A. Rule 12(b)(6)

In determining whether a plaintiff's complaint can withstand a motion to dismiss, the Court will assume the veracity of well-pleaded factual allegations and then determine whether they plausibly give rise to an entitlement to relief. Ashcroft v. Iqbal, 556 U.S. 662, 679, 129 S.Ct. 1937 (2009). A complaint should be dismissed pursuant to Rule 12(b)(6) if there is no law to support the claims, if the alleged facts are insufficient to state a claim, or if an insurmountable bar to relief exists on the face of the complaint. See Browning v. Pennerton, 633 F.Supp.2d 415, 429 (E.D. Ky. Jun. 22, 2009) (citing Rauch v. Day & Night Mfg. Corp., 576 F.2d 697 (6^th Cir. 1978).

To survive a motion to dismiss, the complaint "must contain either direct or inferential allegations" establishing each material element required for recovery under some actionable legal theory." Moore v. Zydus Pharmaceuticals (USA), Inc., 277 F.Supp.3d 873, 877 (E.D. Ky. 2017) (quoting Bishop v. Lucent Technologies, Inc., 520 F.3d 516, 519 (6^th Cir. 2008)). "Evenunder Rule 12(b)(6), a complaint containing a statement of facts that merely creates a suspicion of a legally cognizable right of action is insufficient." Bishop, 520 F.3d at 519.

1. Strict Liability in Tort - Failure to Warn

Robinson's first cause of action is styled as a failure to warn claim sounding in strict liability. (DE 1-2 at 20). To plead a failure to warn claim in a prescription drug case, the plaintiff must "allege facts for the Court to infer that (1) the manufacturer failed to provide her prescribing physician with adequate warnings about risks of which it knew or should have known and (2) the inadequate warnings proximately caused her injuries." Estate of DeMoss v. Eli Lilly and Co., 234 F.Supp.3d 873, 880 (W.D. Ky. 2017). This test reflects that in 2004, Kentucky adopted the learned intermediary rule, an exception to the general rule that a drug manufacturer's duty to warn of any risks inherent in the product runs to the ultimate consumer. See Larkin v. Pfizer, Inc., 153 S.W.3d 758, 770 (Ky. 2004). But "even though the manufacturer's duty to warn runs only to the learned intermediary, that warning must still be adequate." Id. at 764.

At this stage, Robinson has sufficiently alleged that the warnings provided by Eli Lilly were inadequate, and that they caused the relevant injury. In his complaint, Robinson adequately set out the specific means by which Eli Lilly knew or should have known of Prozac's alleged connection to cardiac birth defects. (DE 1-2 at 7) (citing animal studies, post-marketing reports, and other sources, including scholarly articles). Robinson alleges Eli Lilly failed to warn physicians or consumers of the risk of cardiac birth defects through labeling or any other means. See, e.g., (DE 1-2 at 6-9). Robinson further claims that if Ms. Robinson's prescribing physicians or health care providers had known of this risk, she would have never started—or subsequently discontinued—her use of Prozac, and T.R. would not have suffered injury. (DE 1-2 at 12). At this stage of the litigation, the Court finds thatRobinson has stated a claim upon which relief may be granted. Therefore, Eli Lilly's motion to dismiss will be denied as to Robinson's first cause of action.

2. Negligence

Robinson also alleges that Eli Lilly was negligent in manufacturing, researching and designing Prozac. To prevail on a negligence claim under Kentucky law, a plaintiff must establish that:(1) the defendant owed a duty of care to the plaintiff; (2) the defendant breached its duty; and (3) there was consequent injury to the plaintiff. See Mullins v. Commonwealth Life Ins. Co., 839 S.W.2d 245, 247 (Ky. 1992).

In his complaint, Robinson states that Eli Lilly was, among other things, negligent in manufacturing, researching, and designing Prozac; and that Eli Lilly failed to adequately test and warn of the risks and dangers of Prozac both before and after its sale. (DE 1-2 at 21). To the extent Robinson's negligence claim is based on a design defect, the claim is preempted by federal law as discussed in a subsequent section of this Opinion. To the extent Robinson alleges a negligent manufacturing claim, the claim must be dismissed. Robinson makes no factual allegations as to how Eli Lilly might have breached the duty of care in manufacturing Prozac or deviated from Prozac's intended design. See Greene v. B.F. Goodrich Avionics Systems, Inc., 409 F.3d 784, 788 (6^th Cir. 2005) ("Under Kentucky law, a manufacturing defect exists in a product when it leaves the hands of the manufacturer in a defective condition because it was not manufactured or assembled in accordance with its specifications").

As previously discussed, Robinson has sufficiently claimed that Lilly failed to warn of potential risks regarding the usage of Prozac during pregnancy. This does not, however, prevent Robinson from asserting his strict liability claim. See generally Estate of DeMoss, 234 F.Supp.3d at 881 (W.D. Ky. 2017) ("Under Kentucky law, a plaintiff can advance both astrict-liability claim and a negligence claim against the manufacturer of a product for injury suffered by that product") (internal citation omitted).

3. Breach of Warranty

The third and fourth causes of action are breach of warranty claims: express and implied. (DE 1-2 at 22). Neither claim survives the motion to dismiss.

To begin, the Court questions whether an express warranty claim can be premised on an omission, such as Eli Lilly's failure to warn of a particular risk. See Strayhorn v. Wyeth Pharmaceuticals, Inc., 737 F.3d 378, 395 (6^th Cir. 2013) (finding no merit to express-warranty claims under Tennessee law where plaintiff attacked adequacy of drug label, rather than a false affirmation); see also House v. Bristol-Myers Squibb Company, No. 3:15-CGV-00894-JHM, 2017 WL 55876 (W.D. Ky. Jan. 4, 2017) (finding plaintiff could not base express warranty on an omission, such as failure of prescribing information to contain adequate information, under Kentucky law).

Regardless, claims for breach of warranty under Kentucky law may proceed only where there is privity between the parties. See Waterfill v. National Molding Corp., 215 Fed.Appx. 402, 405 (6^th Cir. 2007); see also Naiser v. Unilever U.S., Inc., 975 F.Supp.2d 727, 738 (W.D. Ky. 2013). Contractual privity must be uninterrupted and direct from the seller to "his buyer." See Compex Intern. Co., Ltd. V. Taylor, 209 S.W.3d 462, 465 (2006) (citing KRS 355.2-318). Here, Robinson doesn't allege any kind of contractual privity between Lily and the consumer. As such, the claim for implied breach of warranty is dismissed. See Munn v. Pr Hosp. Products Group, Inc., 750 F.Supp.244, 248 (W.D. Ky. 1990) (dismissing an implied warranty claim because the doctor, and not the patient, purchased surgically implanted nails).

Robinson argues an exception to privity exists for his express warranty claim. (DE 14 at 8). A line of cases in the United States District Court for the Western District of Kentuckyhas recognized that Kentucky law allows an exception to the privity requirement when a manufacturer makes express warranties directly to the intended consumer of the product. See e.g., Bosch v. Bayer Healthcare Pharm., Inc., 13 F.Supp.3d 730, 746-49 (W.D. Ky. 2014); see also Huff v. Howmedica Osteonics, No. 5:14-CV-00134-TBR, 2014 WL 4918807 (W.D. Ky. Sept. 30, 2014). But unlike in Bosch and Huff, the complaint in this case does not specify the warranties allegedly made by Eli Lilly. See e.g., Bosch, 13 F.Supp.3d at 746-49 (noting that the complaint identified the types and sources of communication, when plaintiff received the communications, and the specific assertions contained within); see also Huff, No. 5:14-CV-00134-TBR, 2014 WL 4918807 (noting that the Defendant did not dispute making express warranties to Plaintiff through the media about the...