Wimberly et al v. Abbott Laboratories, Inc.

Motion to Dismiss for Failure to State a Claim

E.D.N.Y.April 28, 2017

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW YORK MARGARET WIMBERLY and FREDDIA WIMBERLY-HAGANS, as Proposed Co- Administrators of the Estate of KATIE WIMBERLY, Deceased, Plaintiffs, v. ABBOTT LABORATORIES, INC. Defendant. Civil Action No. 16-CV-04167 (LDW)(ARL) ECF Case NOTICE OF DEFENDANT ABBOTT LABORATORIES, INC.’S RULE 12(b)(6) MOTION TO DISMISS THE AMENDED COMPLAINT PLEASE TAKE NOTICE, that upon the accompanying Memorandum of Law in Support of Defendant Abbott Laboratories, Inc’s Rule 12(b)(6) Motion to Dismiss the Amended Complaint, dated February 3, 2017, Defendant Abbott Laboratories, Inc. by its undersigned attorneys, will move this Court at 944 Federal Plaza Central Islip, New York 11722, on a date to be determined by the Court, for an order pursuant to Federal Rule of Civil Procedure Rule 12(b) to dismiss Plaintiff’s Amended Complaint and such other and further relief as the Court deems just and proper. Pursuant to the Court’s order, dated January 4, 2017, opposing papers, if any must be served on or before March 20, 2017. Case 2:16-cv-04167-LDW-ARL Document 23 Filed 04/28/17 Page 1 of 3 PageID #: 95 2 Dated: February 3, 2017 /s/ Eric P. Stephens JONES DAY Eric P. Stephens 250 Vesey Street New York, NY 10281 Tel: (212) 326-3939 Fax: (212) 755-7306 epstephens@jonesday.com Melissa B. Hirst 77 West Wacker Chicago, Illinois 60601-1692 Tel: (312) 782-3939 Fax: (312) 782-8585 mbhirst@jonesday.com Attorneys for Abbott Laboratories Inc. Case 2:16-cv-04167-LDW-ARL Document 23 Filed 04/28/17 Page 2 of 3 PageID #: 96 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW YORK MARGARET WIMBERLY and FREDDIA WIMBERLY-HAGANS, as Proposed Co- Administrators of the Estate of KATIE WIMBERLY, Deceased, Plaintiffs, v. ABBOTT LABORATORIES, INC. Defendant. Civil Action No. 16-CV-04167 (LDW)(ARL) ECF Case DECLARATION OF SERVICE I, Eric P. Stephens, counsel for Abbott Laboratories Inc., do hereby declare under the penalty of perjury under the laws of the United States of America that on the 3rd day of February, 2017, I served the foregoing upon Plaintiffs’ counsel via electronic mail at jdell@D2TrialLaw.com and ksinnott@D2TrialLaw.com. /s/ Eric P. Stephens Attorney for Abbott Laboratories Inc. Case 2:16-cv-04167-LDW-ARL Document 23 Filed 04/28/17 Page 3 of 3 PageID #: 97 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW YORK MARGARET WIMBERLY and FREDDIA WIMBERLY-HAGANS, as Proposed Co- Administrators of the Estate of KATIE WIMBERLY, Deceased, Plaintiffs, v. ABBOTT LABORATORIES, INC. Defendant. Civil Action No. 16-CV-04167 (LDW)(ARL) ECF Case MEMORANDUM OF LAW IN SUPPORT OF DEFENDANT ABBOTT LABORATORIES, INC.’S RULE 12(b)(6) MOTION TO DISMISS THE AMENDED COMPLAINT Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 1 of 16 PageID #: 98 TABLE OF CONTENTS Page -i- I. Background ........................................................................................................................ 1 II. Argument ........................................................................................................................... 3 A. Legal Standard ....................................................................................................... 3 B. Plaintiffs Fail To Allege The Existence Of An Express Warranty ........................ 4 C. Plaintiffs Fail To Allege The Existence Of A Defect In The Meter ...................... 5 1. Because they fail to allege the existence of any defect, Plaintiffs do not state a strict liability claim ................................................................... 5 2. Because they fail to allege the presence of any breach of a duty by Abbott, Plaintiffs do not state a negligence claim ..................................... 8 3. Because they fail to allege the existence of any defect, Plaintiffs do not state a breach of warranty claim .......................................................... 9 D. Plaintiffs Fail To Allege Any Link Between An Alleged Defect In The Meter And Ms. Wimberly’s Injury ...................................................................... 10 E. If Requested, Leave To Amend Should Be Denied ............................................. 11 III. Conclusion ....................................................................................................................... 12 Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 2 of 16 PageID #: 99 TABLE OF AUTHORITIES Page -ii- Cases Am. Guar. & Liab. Ins. Co. v. Cirrus Design Corp., No. 09-CV-8357, 2010 WL 5480775 (S.D.N.Y. Dec. 30, 2010) ..................................................................................................... 7, 10 Ashcroft v. Iqbal, 556 U.S. 662 (2009) ....................................................................................... 3, 4 Barrett v. Black & Decker (U.S.) Inc., No. 06 Civ. 1970, 2008 WL 5170200 (S.D.N.Y. Dec. 9, 2008).............................................................................................................. 7 Bell Atlantic Corporation v. Twombly, 550 U.S. 544 (2007) ............................................... 3, 4, 11 Bertini v. Smith & Nephew, Inc., No. 13 Civ. 0079, 2013 WL 6332684 (E.D.N.Y. July 15, 2013) ............................................................................................................ 7 Cavanaugh v. Ford Motor Co., No. 13-CV-4584, 2014 WL 2048571 (E.D.N.Y. May 19, 2014) .................................................................................................. passim Denny v. Ford Motor Co., 662 N.E.2d 730 (N.Y. 1995) ............................................................ 8, 9 Gaudette v. Saint-Gobain Performance Plastics Corp., No. 1:11-CV-932, 2014 WL 1311530 (N.D.N.Y. Mar. 28, 2014) ....................................................................................................... 8, 9 Goldin v. Smith & Nephew, Inc., No. 12 Civ. 9217, 2013 WL 1759575 (S.D.N.Y. Apr. 24, 2013) .................................................................................................. 5, 9, 10 Morrison v. Hoffman-La Roche, Inc., 14-CV-4476, 2016 WL 5678546 (E.D.N.Y. Sept. 29, 2016) ................................................................................................. 7, 8, 11 Pinello v. Andreas Stihl AG & Co. KG, No. 8:08-CV-00452, 2011 WL 1302223 (N.D.N.Y. Mar. 31, 2011) ..................................................................................................... 4, 10 Reed v. Pfizer, Inc., 839 F. Supp. 2d 571 (E.D.N.Y. 2012) ........................................................ 4, 9 Savage v. Beiersdorf Inc., No. 13-CV-0696, 2013 WL 5532756 (E.D.N.Y. Sept. 30, 2013) ....... 9 Simon v. Smith & Nephew, Inc., 990 F. Supp. 2d 395 (S.D.N.Y. 2013)................................... 8, 10 Valente v. Textron, Inc., 931 F. Supp. 2d 409 (E.D.N.Y. 2013) ..................................................... 8 Voss v. Black & Decker Mfg. Co., 450 N.E.2d 204 (N.Y. 1983).................................................... 5 Statutes N.Y. U.C.C. § 2-313 ....................................................................................................................... 5 N.Y. U.C.C. § 2-725 ....................................................................................................................... 4 Rules Fed. R. Civ. P. 12 ........................................................................................................................ 1, 3 Fed. R. Civ. P. 8 .......................................................................................................................... 1, 3 Other Authorities N.Y. Pattern Jury Instr.-Civil 2:120 ................................................................................................ 6 N.Y. Pattern Jury Instr.-Civil 2:125 ................................................................................................ 9 Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 3 of 16 PageID #: 100 For the second time, Plaintiffs have filed a complaint that says virtually nothing about their claims. Their story appears to be that their elderly mother, Katie Wimberly, used a FreeStyle Lite Blood Glucose Meter (for reasons unknown), experienced a single low blood glucose reading, and fell and fractured her shoulder at some unknown point after that low blood glucose reading. Ms. Wimberly then passed away years later (of apparently unrelated causes), and her daughters filed this lawsuit. This scenario does not come close to stating a claim against Abbott Laboratories Inc., under a theory of negligence, strict liability, or breach of warranty. Put simply, there is no allegation that Abbott’s product malfunctioned in any way. Diabetics experience high blood glucose readings and low blood glucose readings over the course of a day. The Meter does no more than tell a user what those blood glucose readings are. The Meter does not provide insulin. The Meter does not tell a user how much insulin to take. The Meter does not cause a user’s blood glucose levels to increase or decrease. The Amended Complaint ignores all of this. It fails to state a claim because it does not plausibly allege the existence of an express warranty, the presence of any defect in the Meter, or how any defect in the Meter caused Ms. Wimberly’s injury. All of these failings require dismissal of the Amended Complaint in its entirety. See Fed. R. Civ. P. 8; Fed. R. Civ. P. 12(b)(6). And, because Plaintiffs have repeatedly refused to correct the deficiencies in their complaint, this dismissal should be with prejudice. I. BACKGROUND The Amended Complaint includes three unlabeled causes of action and, at various points, purports to bring claims on theories of strict liability, negligence, and breach of warranty. (ECF No. 18, “Am. Comp.” ¶¶ 16-53.) The various theories are jumbled together among the three causes of action. (See id.) Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 4 of 16 PageID #: 101 2 Katie Wimberly allegedly used a FreeStyle Lite blood glucose meter, Model # DCGS 170-N2617, to monitor her blood glucose level on May 23, 2013. (Id. ¶¶ 9-15.) The Amended Complaint is silent as to why Ms. Wimberly used the Meter, when her daughters purchased it, what the Meter was supposed to do, and how it failed to perform as expected. (See generally id.) After failing to include these basic facts, it is hardly surprising that the Amended Complaint is equally mysterious about the Meter’s alleged defects. Instead, the Amended Complaint presumes that the Meter was defective, but fails to allege any facts supporting the existence of such a defect and fails to explain how that defect caused Ms. Wimberly’s injuries. (See generally id.) The Amended Complaint includes page after page of rote legal conclusions, such as that Abbott “warranted that said product was safe to use in every respect, and had been designed, created, assembled, and manufactured safely and warranted that it was good, safe, and proper to use.” (Am. Compl. ¶ 22; see also id. ¶¶ 21-53.) These unadorned legal conclusions-such as Plaintiffs’ statement that Ms. Wimberly “used said product of Defendant in the manner intended and/or foreseeably intended, when the product caused injury to the Plaintiff Decedent, thereby causing severe and catastrophic personal injuries to Plaintiff Decedent” (id. ¶ 20)-provide no detail or facts to tell Abbott what this case is about. At most, these statements are boilerplate recitation of some of the legal elements of strict liability, negligence, or warranty claims. See, e.g., id. ¶ 30 (alleging “upon information and belief” that the Meter was “defective”). The Amended Complaint nowhere states how the Meter allegedly failed. The sole allegation is that Katie Wimberly used the Meter “on May 23, 2013” and “while or after” using the meter, “Plaintiff suffered pain and discomfort, including but not limited to, lowered blood glucose levels leading to a fall on May 23, 2013, which caused a fracture to Plaintiffs right Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 5 of 16 PageID #: 102 3 shoulder.” (Id. ¶ 15.) Fundamental questions about the event remain unanswered: Why did Ms. Wimberly use the Meter? What happened on May 23, 2013? When did she use the Meter? When did she fall? How did she use the Meter? How was the Meter defective? How was her alleged injury connected to the Meter? A reader of the Amended Complaint can only guess. II. ARGUMENT Plaintiffs do not allege any facts suggesting: (i) that Abbott made an express warranty with respect to the Meter; (ii) that the Meter malfunctioned or was somehow defective; or (iii) that Ms. Wimberly was injured by a defect in the Meter. The Amended Complaint fails to provide the most basic information about Plaintiffs’ claims, and, as a result, Abbott lacks sufficient notice of the claims brought against it. The Amended Complaint must be dismissed under Rule 12(b)(6). A. Legal Standard Federal Rule of Civil Procedure 8(a)(2) requires a complaint to contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” Rule 12(b)(6), in turn, provides that a party may move to dismiss a complaint on the basis that it fails “to state a claim upon which relief can be granted.” Fed. R. Civ. P. 12(b)(6). In Bell Atlantic Corporation v. Twombly, the Supreme Court explained that Rule 8 “requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do[.]” 550 U.S. 544, 555 (2007). When evaluating a complaint for the purposes of ruling on a Rule 12(b)(6) motion, a court must disregard “[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements[.]” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citing Twombly, 550 U.S. at 555). Instead, a reviewing court will only assume the truth of “well-pleaded factual allegations”-not legal conclusions. Id. at 678- 79. Thus, to survive a Rule 12(b)(6) motion, a complaint must contain “sufficient factual matter, Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 6 of 16 PageID #: 103 4 accepted as true, to ‘state a claim for relief that is plausible on its face.’” Id. at 663 (quoting Twombly, 550 U.S. at 570); see also Twombly, 550 U.S. at 555 (“[f]actual allegations must be enough to raise a right to relief above the speculative level”). Here, the only well-pleaded facts that this Court could deem true are that Ms. Wimberly used the Meter on one particular date and suffered a fall that day. This does not come close to stating a claim on any of the theories variously alleged by Plaintiffs against Abbott. The Amended Complaint fails to meet the standards of Rule 8, Twombly, and Iqbal, and must be dismissed. B. Plaintiffs Fail To Allege The Existence Of An Express Warranty. The Amended Complaint purports to bring claims for breach of an express warranty.1 (See, e.g., Am. Compl. ¶¶ 15, 21, 28.) It fails, however, to allege the required elements of such a claim. An express warranty claim requires (a) proof that an express warranty existed; (b) was breached; and (c) that plaintiff relied on the warranty to her detriment. See Cavanaugh v. Ford Motor Co., No. 13-CV-4584, 2014 WL 2048571, at *4 (E.D.N.Y. May 19, 2014) (citing Reed v. Pfizer, Inc., 839 F. Supp. 2d 571, 578 (E.D.N.Y. 2012)). The element of breach includes a requirement that the product at issue be defective. Id. A plaintiff must set forth the terms of the warranty upon which she relied. See Pinello v. Andreas Stihl AG & Co. KG, No. 8:08-CV-00452, 2011 WL 1302223, at *17 (N.D.N.Y. Mar. 31, 2011) (collecting cases applying New York law). If she fails to do so, her claim will be dismissed. See id.; Cavanaugh, 2014 WL 2048571, at *4 (dismissing plaintiff’s breach of warranty claim because they did not allege the terms of the alleged warranty or that the truck was 1 Plaintiffs’ breach of express warranty claim is likely barred, since a breach of warranty claim accrues on the date of tender of delivery and the statute of limitation runs four years after that date. See N.Y. U.C.C. § 2-725(1). Because the Amended Complaint lacks even such basic facts as when Plaintiffs purchased the Meter, however, this cannot be fully evaluated at this time. Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 7 of 16 PageID #: 104 5 defective); Goldin v. Smith & Nephew, Inc., No. 12 Civ. 9217, 2013 WL 1759575, at *6 (S.D.N.Y. Apr. 24, 2013) (same). An express warranty is an “affirmation of fact or promise by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain[.]” N.Y. U.C.C. § 2-313(1)(a). Plaintiffs include no such affirmations or promises here. Instead, they allege generally that the Meter was “a fundamental part of staying on top of diabetes” (Am. Compl. ¶ 21) and that Abbott sold products “to help people stay strong and healthy in all stages of life.” (Id. ¶ 9.) Plaintiffs nowhere explain why these general statements about health or well-being should be construed as making specific promises to Ms. Wimberly-nor, more critically, do they say how Abbott allegedly breached these statements through the manufacture and sale of the Meter. Both of these defects are fatal to Plaintiffs’ express warranty claim. C. Plaintiffs Fail To Allege The Existence Of A Defect In The Meter. All of Plaintiffs’ claims-strict liability, negligence, and breach of warranty-turn on the existence of a defect or a breach of the duty of care. Because the Amended Complaint does not allege any facts supporting the existence of any such defect, it must be dismissed. 1. Because they fail to allege the existence of any defect, Plaintiffs do not state a strict liability claim. The Amended Complaint does not state a strict liability claim. First, although it mentions § 402A of the Restatement (Second) of Torts, § 402A is not recognized by New York courts as providing a separate cause of action. Rather, the doctrine of strict liability is governed by New York common law, and the key inquiry is slightly different than the Restatement’s “unreasonably dangerous” standard. See, e.g., Voss v. Black & Decker Mfg. Co., 450 N.E.2d 204, 208 (N.Y. 1983) (noting that under New York law, the standard for strict liability is whether a product is “not reasonably safe”); see also N.Y. Pattern Jury Instr.- Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 8 of 16 PageID #: 105 6 Civil 2:120 (discussing the same standard for strict liability and applying it to jury instructions). Thus, to the extent Plaintiffs intend to bring a § 402A-based strict liability claim, it must be dismissed as a matter of law. Second, New York generally recognizes three types of defect that can give rise to a strict liability claim: defects in manufacturing, design, and warnings. See N.Y. Pattern Jury Instr.- Civil 2:120 (strict liability jury instruction, collecting cases). Each theory of strict liability requires Plaintiffs to plead the existence of a slightly different type of defect. See, e.g., id. For example, the New York Pattern Jury Instructions-Civil notes that a manufacturing defect might be described as “a defect in the vehicle’s manufacture in that the brakes failed to work,” while a design defect might be that “the cutting machine was dangerous without a hand guard,” and a warning defect could be that “safety warnings were inadequate in that they failed to warn of the risk of rollover accidents resulting from the vehicle’s higher center of gravity.” Id. Yet no such concrete, fact-specific defect is ever alleged in the Amended Complaint. Instead, the Amended Complaint remains agnostic on the existence of any possible defect-under any of Plaintiffs’ three theories of strict liability-and simply repeats legal conclusions about a defect. (See generally Am. Compl.) This is not enough. A complaint that does not specify the defective component, describe any deviations from the manufacturing process, or explain why the product at issue is defective as compared to other of the same type of products made by the manufacturer fails to state a claim for strict liability based on a manufacturing defect. See, e.g., Cavanaugh, 2014 WL 2048571, at *1, *3 (dismissing a complaint that failed to identify the defective component of a bucket truck, to supply any facts regarding the manufacturing process, or to allege that the bucket truck was defective as compared to other bucket trucks manufactured by defendants); Am. Guar. & Liab. Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 9 of 16 PageID #: 106 7 Ins. Co. v. Cirrus Design Corp., No. 09-CV-8357, 2010 WL 5480775, at *3 (S.D.N.Y. Dec. 30, 2010) (dismissing manufacturing defect claim because “Plaintiffs . . . not only fail [ ] to specify the defective component but . . . also failed to adequately allege any deviations from the manufacturing process, improper workmanship, or defective materials”); Barrett v. Black & Decker (U.S.) Inc., No. 06 Civ. 1970, 2008 WL 5170200, at *11 (S.D.N.Y. Dec. 9, 2008) (“Plaintiff fails to plead which part of the [product] was defective, or in what way some particular defect caused plaintiff's injury.”). Similarly, a complaint that does not “plead facts identifying how the device is defectively designed or the existence of a feasible alternative design” must be dismissed. Bertini v. Smith & Nephew, Inc., No. 13 Civ. 0079, 2013 WL 6332684, at *3 (E.D.N.Y. July 15, 2013); Cavanaugh, 2014 WL 2048571, at *2-*3 (dismissing a design defect strict liability claim where the “Complaint does not identify how the Bucket Truck was defectively designed, nor does the Complaint make any mention of a feasible alternative design” and, instead, “merely states legal conclusions, such as that the ‘said product was defective and that said defect was a substantial factor in causing the injury’”). And, of course, where plaintiffs “have not adequately specified the danger that was not warned against, they cannot state a plausible claim for failure to warn.” Cavanaugh, 2014 WL 2048571, at *2, *4 (dismissing plaintiffs’ strict liability warnings claim); Morrison v. Hoffman- La Roche, Inc., 14-CV-4476, 2016 WL 5678546, at *8 (E.D.N.Y. Sept. 29, 2016) (dismissing a warnings claim that was “silent about the content of [the product]’s warnings and does not allege that the [product] label specifically failed to warn of these injury risks”); see also id. at *7 (“Various federal district and appellate courts have dismissed failure to warn claims when the Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 10 of 16 PageID #: 107 8 plaintiff does not plead facts specifically indicating how the provided warnings were inadequate.”) (collecting cases from the 2nd, 9th, and 11th Circuits). Plaintiffs’ failure to allege any of these types of defects dooms their strict liability claims. Finally, Plaintiffs try to save their strict liability claims by mentioning that Abbott had “recalls on other Blood Glucose Meters.” (Am. Compl. ¶ 14.) Even if a particular recall were identified, described in detail, and somehow connected to the Meter at issue, it would still be insufficient to allege the existence of a design defect. See Simon v. Smith & Nephew, Inc., 990 F. Supp. 2d 395, 404-05 (S.D.N.Y. 2013) (holding that the existence of a recall on one product “does not support [plaintiff’s] claim of a design defect with respect to [another product]” and that “[t]he bare fact of the voluntary recall does not suffice to prove a design defect”) (internal quotations omitted). For all these reasons, Plaintiffs fail to state a claim for strict liability, on any theory. See Morrison, 2016 WL 5678546, at *5 (dismissing a complaint because “[m]erely alleging that [a product] is defective in its design and manufacture because ‘it is not reasonably fit, suitable or safe for its intended purpose and/or its foreseeable risks exceed the benefits associated with its design and manufacturing’ lacks the specificity required to meet the Twombly/Iqbal plausibility standards”). 2. Because they fail to allege the presence of any breach of a duty by Abbott, Plaintiffs do not state a negligence claim. “New York courts generally consider strict products liability and negligence claims to be ‘functionally synonymous.’” Gaudette v. Saint-Gobain Performance Plastics Corp., No. 1:11- CV-932, 2014 WL 1311530, at *10 (N.D.N.Y. Mar. 28, 2014); see also Denny v. Ford Motor Co., 662 N.E.2d 730, 735 (N.Y. 1995) (same); Valente v. Textron, Inc., 931 F. Supp. 2d 409, 437 n.24 (E.D.N.Y. 2013) (“New York courts have treated the differences between negligence and Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 11 of 16 PageID #: 108 9 strict liability as inconsequential”), aff'd, 559 Fed. App’x 11 (2d Cir. Mar. 10, 2014); cf. N.Y. Pattern Jury Instr.-Civil 2:125 (addressing only negligent manufacture and cross-referencing section 2:120 of the pattern jury instructions on strict liability claims for design and failure-to- warn defects). For this reason, the same standards used to analyze defect under strict liability are also used to analyze breach in a claim of negligence. See Savage v. Beiersdorf Inc., No. 13-CV- 0696, 2013 WL 5532756, at *5 (E.D.N.Y. Sept. 30, 2013) (“[F]ailure to warn claims are identical under strict liability and negligence theories of recovery.”); Gaudette, 2014 WL 1311530, at *11 (“In order to prove a design defect claim, the same prima facie case is required under both negligence and strict liability theories.”); see also Denny, 662 N.E.2d at 735 (noting that the risk/utility balancing test used on the “defect” element of strict liability is a “negligence- inspired” approach). Thus, Plaintiffs’ negligence claims fail because the Amended Complaint fails to allege any facts showing the existence of a defect or breach of any duty by Abbott. See Cavanaugh, 2014 WL 2048571, at *5 (so holding and dismissing plaintiffs’ negligence claim for “failure to state a plausible claim”); Goldin, 2013 WL 1759575, at *3-*5, *6 (dismissing plaintiff’s negligence claims for failing to plead any facts supporting the existence of a defect in warnings, manufacture, or design). 3. Because they fail to allege the existence of any defect, Plaintiffs do not state a breach of warranty claim. As discussed above, to succeed on a claim for breach of an express warranty, Plaintiffs must allege that the Meter was defective. See Reed, 839 F. Supp. 2d at 578 (dismissing an express warranty claim because “[t]he allegations [we]re not sufficient to draw a reasonable inference that (1) [the product] was defective or (2) what defendants promised was different than what they provided”). An implied warranty claim, too, requires that plaintiffs allege “(1) that the Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 12 of 16 PageID #: 109 10 product was defectively designed or manufactured; (2) that the defect existed when the manufacturer delivered it to the purchaser or user; and (3) that the defect is the proximate cause of the accident.” Pinello, 2011 WL 1302223, at *17 (citation omitted). Because, as discussed above, Plaintiffs nowhere plead the existence of a defect with respect to the Meter, the Amended Complaint also fails to state a claim for breach of an express or an implied warranty. D. Plaintiffs Fail To Allege Any Link Between An Alleged Defect In The Meter And Ms. Wimberly’s Injury. Each of Plaintiffs’ theories of liability requires them to allege that Ms. Wimberly’s injuries were the direct and proximate result of a defect or a breach of duty by Abbott. See Am. Guar. & Liab. Ins., 2010 WL 5480775, at *3 (to state a claim for strict liability based on manufacturing defect, plaintiff must allege that “the defect was the cause of plaintiff's injury”); Simon, 990 F. Supp. 2d at 403 (quoting Colon v. BIC USA, Inc., 199 F. Supp. 2d 53, 83 (S.D.N.Y. 2001)) (to state a claim for strict liability based on design defect, plaintiff must allege that the “defective design was a substantial factor in causing plaintiff’s injury”); Cavanaugh, 2014 WL 2048571, at *4 (to state a claim for strict liability for failure to warn, a plaintiff must allege “that failure to [properly warn] was the proximate cause of harm”); Pinello, 2011 WL 1302223, at *17 (implied warranty requires proximate cause); Goldin, 2013 WL 1759575, at *6 (breach of express warranty requires a plaintiff to show that she relied on an express warranty that was breached to her detriment). Yet Plaintiffs fail to allege any facts to show that Ms. Wimberly’s injury was caused by the Meter. The Amended Complaint does not connect any alleged problem with the Meter with Ms. Wimberly’s injury. It provides no detail regarding what happened on May 23, 2013-or any time before or after-that would enable Abbott to understand how she was using the Meter, how Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 13 of 16 PageID #: 110 11 she was allegedly hurt, and what role the Meter is alleged to have played. This detail is absolutely critical, given the type of device she was using. The Meter Ms. Wimberly was using does no more than monitor a user’s blood glucose levels. It does not provide the user with insulin-to lower her blood glucose level-nor does it tell her how many carbohydrates she should eat to raise her blood glucose level. The Meter simply provides information about the current state of a user’s blood glucose. Absent some description of how Ms. Wimberly used the Meter, when she used it, and how and when she was injured, the Amended Complaint does not provide facts that raise Plaintiffs’ “right to relief above the speculative level.” Twombly, 550 U.S. at 555. E. If Requested, Leave To Amend Should Be Denied. As described at length above, the Amended Complaint is extremely thin. It must be noted that this is Plaintiffs’ second complaint. Their initial pleading in state court was completely unintelligible; on its face, the injury suffered by the decedent, the nature of the defect, the relationship of Plaintiffs to the decedent-indeed, whether the decedent was even alive-were all unknowable. After Abbott pointed out these numerous defects-as well as the fact that Plaintiffs’ case turned on the existence of a recall that never occurred-Plaintiffs were given leave to file an amended complaint. The Amended Complaint removed the reference to a recall that never existed and explained who the Plaintiffs were, but otherwise failed to improve upon the original pleading. Leave to amend may be denied where plaintiffs are supporting an undue delay, where there is evidence of a dilatory motive or bad faith, or where there are repeated failures to cure deficiencies by amendments previously allowed. See Morrison, 2016 WL 5678546, at *12. Here, the original complaint was filed in May 2016. Since that time, Abbott has had to ask Plaintiffs to specify what their damages are, correct Plaintiffs regarding the lack of any recall Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 14 of 16 PageID #: 111 12 relating to the FreeStyle Lite meter at issue here, and write two letters (and now a motion) requesting that Plaintiffs provide the basic facts about their claims. After Abbott’s first letter to the Court pointing out the obvious deficiencies, Plaintiffs actually opposed Abbott’s relief, yet immediately told Abbott that they would be filing an amended complaint when the parties met for a pre-motion hearing. Plaintiffs have repeatedly delayed this case and persistently refused to provide any factual underpinning for their claims over the past nine months without any justification. They should not be given another opportunity to amend their deficient complaint. III. CONCLUSION For all the foregoing reasons, Defendant Abbott Laboratories Inc. hereby moves to dismiss Plaintiffs’ Amended Complaint in its entirety under Federal Rule of Civil Procedure 12(b)(6). Dated: February 3, 2017 /s/ Eric P. Stephens JONES DAY Eric P. Stephens 250 Vesey Street New York, NY 10281 Tel: (212) 326-3939 Fax: (212) 755-7306 epstephens@jonesday.com Melissa B. Hirst 77 West Wacker Chicago, Illinois 60601-1692 Tel: (312) 782-3939 Fax: (312) 782-8585 mbhirst@jonesday.com Attorneys for Abbott Laboratories Inc. Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 15 of 16 PageID #: 112 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW YORK MARGARET WIMBERLY and FREDDIA WIMBERLY-HAGANS, as Proposed Co- Administrators of the Estate of KATIE WIMBERLY, Deceased, Plaintiffs, v. ABBOTT LABORATORIES, INC. Defendant. Civil Action No. 16-CV-04167 (LDW)(ARL) ECF Case DECLARATION OF SERVICE I, Eric P. Stephens, counsel for Abbott Laboratories Inc., do hereby declare under the penalty of perjury under the laws of the United States of America that on the 3rd day of February, 2017, I served the foregoing upon Plaintiffs’ counsel via electronic mail at jdell@D2TrialLaw.com and ksinnott@D2TrialLaw.com. /s/ Eric P. Stephens Attorney for Abbott Laboratories Inc. Case 2:16-cv-04167-LDW-ARL Document 23-1 Filed 04/28/17 Page 16 of 16 PageID #: 113 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW YORK MARGARET WIMBERLY and FREDDIA WIMBERLY-HAGANS, as Proposed Co- Administrators of the Estate of KATIE WIMBERLY, Deceased, Plaintiffs, v. ABBOTT LABORATORIES, INC. Defendant. Civil Action No. 16-CV-04167 (LDW)(ARL) ECF Case REPLY MEMORANDUM OF LAW IN FURTHER SUPPORT OF DEFENDANT ABBOTT LABORATORIES, INC.’S RULE 12(b)(6) MOTION TO DISMISS THE AMENDED COMPLAINT Case 2:16-cv-04167-LDW-ARL Document 23-2 Filed 04/28/17 Page 1 of 12 PageID #: 114 TABLE OF CONTENTS Page -i- I. Argument ........................................................................................................................... 1 A. Plaintiffs Misstate the Legal Standard ................................................................... 1 B. Plaintiffs Fail To Allege Facts Supporting A Plausible Product Defect ................ 2 C. Plaintiffs Fail To Allege Facts Supporting A Plausible Causal Link Between an Alleged Defect and Katie Wimberly’s Fall ........................................ 4 D. Plaintiffs’ Request for Leave to Amend Should Be Denied .................................. 5 II. Conclusion ......................................................................................................................... 8 Case 2:16-cv-04167-LDW-ARL Document 23-2 Filed 04/28/17 Page 2 of 12 PageID #: 115 TABLE OF AUTHORITIES Page -ii- Cases Arista Records LLC v. Doe 3, 604 F.3d 110 (2d Cir. 2010) ................................................... 1, 2, 4 Ashcroft v. Iqbal, 556 U.S. 662 (2009) ........................................................................................... 1 AT & T Corp. v Syniverse Tech., Inc., 12-CV-1812 NRB, 2014 WL 4412392 (S.D.N.Y. Sept. 8, 2014) .............................................................................. 2 Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) ........................................................................... 1 Cole v Fischer, 07-CV-11096 (BSJ), 2009 WL 1514691 (S.D.N.Y. May 29, 2009)..................... 5 Fillmore E. BS Fin. Subsidiary LLC v. Capmark Bank, 552 Fed. Appx. 13 (2d Cir. 2014) .......... 2 Jones v. N.Y. State Div’n of Military & Naval Affairs, 166 F.3d 45 (2d Cir. 1999) ....................... 6 Kalnit v. Eichler, 99 F. Supp. 2d 327 (S.D.N.Y. 2000) .................................................................. 5 Nakahata v. N.Y.-Presbyterian Healthcare Sys., Inc., 723 F.3d 192 (2d Cir. 2013) ...................... 3 Ricciuti v. N.Y.C. Transit Auth’y, 941 F.2d 119 (2d Cir.1991)....................................................... 6 Sodhi v Mercedes Benz Fin. Servs., USA, LLC, 957 F. Supp. 2d 252 (E.D.N.Y. 2013) ................ 6 Stoner v. Walsh, 772 F. Supp. 790 (S.D.N.Y. 1991) ...................................................................... 4 Rules Fed. R. Civ. P. 11 ............................................................................................................................ 3 Case 2:16-cv-04167-LDW-ARL Document 23-2 Filed 04/28/17 Page 3 of 12 PageID #: 116 Plaintiffs concede that they have not stated a claim for breach of express warranty and point to no allegations to show the existence of a manufacturing, design, or warning defect in the Meter-let alone one that would have caused Katie Wimberly’s fall. Instead, Plaintiffs mis-cite their Amended Complaint and urge the Court to allow them to file another inadequate amended complaint. The Court should decline Plaintiffs’ invitation and dismiss this case with prejudice. I. ARGUMENT A. Plaintiffs Misstate the Legal Standard. All parties agree that Rule 8 requires a complaint to include a “short and plain statement of the claim showing that the pleader is entitled to relief,” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007), including “sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting id.); see Plaintiffs’ Opposition (“Pl. Opp.”) at 2, 5; Abbott Memorandum in Support of its Motion to Dismiss (“Abbott MTD”) at 3-4 (both citing the above passages). No heightened pleading standard applies to this case, and-contrary to Plaintiffs’ suggestion-Abbott never argued for one. See id. It is Plaintiffs-not Abbott-who apply an incorrect definition of notice pleading. Plaintiffs quote their allegation that they “seek[] damages to redress Defendant’s design, manufacture and failure to warn of the defective product known as FreeStyle Lite Blood Glucose Monitoring System” and argue that this sentence alone satisfies Rule 8. Pl. Opp. at 3. This is absurd. See Twombly, 550 U.S. at 555; Iqbal, 556 U.S. at 678. And-again, contrary to Plaintiffs’ suggestion-the Second Circuit does not apply a different version of Rule 8 than the Supreme Court does. See, e.g., Arista Records LLC v. Doe 3, 604 F.3d 110 (2d Cir. 2010) (noting that the Twombly court found that dismissal was appropriate because the “complaint’s factual allegations described only actions that were parallel, and were doctrinally consistent with Case 2:16-cv-04167-LDW-ARL Document 23-2 Filed 04/28/17 Page 4 of 12 PageID #: 117 2 lawful conduct, [so] the conclusory allegation on information and belief that the observed conduct was the product of an unlawful agreement was insufficient to make the claim plausible”). As Arista and subsequent Second Circuit decisions make clear, where (as here) a complaint’s allegations “are not ‘based on factual information that makes the inference of culpability plausible,’” the claims must be dismissed. See, e.g., Fillmore E. BS Fin. Subsidiary LLC v. Capmark Bank, 552 Fed. Appx. 13, 18 (2d Cir. 2014) (quoting Arista, 604 F.3d at 120). Every one of Plaintiffs’ claims fails to allege such factual information and should be dismissed.1 B. Plaintiffs Fail To Allege Facts Supporting A Plausible Product Defect. The Amended Complaint lacks a single factual allegation describing how the Meter malfunctioned or was defective. See Abbott MTD at 1-3, 5-10. Instead, Plaintiffs make only generalized and conclusory allegations about the Meter and an alleged incorrect blood glucose reading. E.g., Am. Comp. ¶ 10 (“This Defective Product caused injury and damages to Plaintiffs”), ¶ 13 (the Meter “contains a defect that is present at the time of manufacture”); see also Pl. Opp. at 2 (the Meter “malfunctioned … by way of giving an incorrect reading of her glucose levels.”). “Such allegations are essentially a recitation of the legal standard and are plainly insufficient to state a claim.” Fillmore, 552 Fed. Appx. at 15 (affirming the dismissal of a similarly deficient complaint). After reading the Amended Complaint, the most basic question in this case remains unanswered: How was the Meter defective? Since the Amended Complaint contains no allegations to answer this question, in their Opposition, Plaintiffs make up facts and law to oppose Abbott’s arguments. Both tactics fail. 1 Plaintiffs’ Opposition fails to respond to Abbott’s argument that the complaint does not allege either the existence of an express warranty or breach of the same. Abbott MTD at 4-5. Accordingly, the Court should grant that portion of Abbott’s Motion. See AT & T Corp. v Syniverse Tech., Inc., 12-CV-1812 NRB, 2014 WL 4412392, at *7 (S.D.N.Y. Sept. 8, 2014) (holding that “silence concedes the point” and collecting cases). Case 2:16-cv-04167-LDW-ARL Document 23-2 Filed 04/28/17 Page 5 of 12 PageID #: 118 3 First, Plaintiffs’ Opposition states-without support-that the Meter was the subject of a recall. Pl. Opp. at 2 (“Despite Defendant[‘s] recall of said product …”). But the Amended Complaint says just the opposite. Am. Comp. ¶ 14 (“Defendant has failed to recall the product …”). Of course, the Court must consider the allegations of the Amended Complaint-not Plaintiffs’ unsupported statements-in deciding this Motion. Nakahata v. N.Y.-Presbyterian Healthcare Sys., Inc., 723 F.3d 192, 202 (2d Cir. 2013) (“We do not consider matters outside the pleadings in deciding a motion to dismiss for failure to state a claim.”). But the fact that Plaintiffs revive this allegation in their Opposition is a huge step backwards. The Meter was not recalled. See Abbott MTD at 11-12. Plaintiffs’ original complaint included this allegation, and Abbott told Plaintiffs’ counsel (and the Court) via letter on August 3, 2016 and in person at the conference on October 4, 2016 that the Meter was not recalled. See Dkt. 6 at 2. The FDA’s publicly-accessible database confirms this. See Exhibit 1 to the Declaration of Eric P. Stephens in Further Support of Defendant’s Motion to Dismiss, dated April 28, 2017 and submitted simultaneously herewith (showing that a search of recalls for FreeStyle Lite returns only a recall of certain test strips, not the Meter). Second, Plaintiffs speculate: “There is potentially a plethora of evidence to be ascertained that supports Plaintiff’s Amended Verified Complaint.” Pl. Opp. at 6 (emphasis added). As a factual matter, Abbott’s own investigation proves this statement false. As a legal matter, Plaintiffs get the standard exactly wrong. Plaintiffs (and their counsel) must have a good faith, factual basis for their claims before they file them-or risk sanctions. Fed. R. Civ. P. 11(b)(3). Plaintiffs previously stated that they would provide Abbott with Katie Wimberly’s medical records and information to support their claim, but have never done so. Instead, they are now proposing to file a third complaint containing contradictory and inaccurate information. See Case 2:16-cv-04167-LDW-ARL Document 23-2 Filed 04/28/17 Page 6 of 12 PageID #: 119 4 discussion, infra, at I.D. If Plaintiffs do not have evidence to support their claims, this suit must be dismissed-not allowed to proceed forward at significant expense to Abbott. After all, “[t]he purpose of discovery is to find out additional facts about a well-pleaded claim, not to find out whether such a claim exists.” Stoner v. Walsh, 772 F. Supp. 790, 800 (S.D.N.Y. 1991). Because all of Plaintiffs’ claims rely on the presence of a defect in the Meter, and because the Amended Complaint fails to allege any such defect, the Amended Complaint must be dismissed. See also Abbott MTD at 5-10. C. Plaintiffs Fail To Allege Facts Supporting A Plausible Causal Link Between an Alleged Defect and Katie Wimberly’s Fall. Plaintiffs’ Opposition, like the Amended Complaint, fails to link any defect in the Meter to Katie Wimberly’s fall. The Opposition focuses on the allegation that the Meter “gave an incorrect reading of [her] glucose levels, allowing them to drop, unbeknownst to her, to a degree which caused Decedent to fall and fracture her right shoulder.” Pl. Opp. at 5 (quoting Am. Compl. ¶ 43). This misses the point. Plaintiffs must allege that a defect in the meter caused her injury. The Meter is only a monitor; it cannot provide insulin to lower blood glucose levels or carbohydrates to raise them. Absent allegations that show (1) what Ms. Wimberly’s blood glucose actually was; (2) what allegedly erroneous blood glucose reading she received from the Meter; (3) how she responded to the reading; and (4) how long after the reading (and any steps taken to manage her diabetes) the fall occurred, Abbott has no idea whether a blood glucose reading had any connection with her fall. In short, the Amended Complaint provides no basis for “the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Arista, 604 F.3d at 120 (citing Iqbal). Case 2:16-cv-04167-LDW-ARL Document 23-2 Filed 04/28/17 Page 7 of 12 PageID #: 120 5 D. Plaintiffs’ Request for Leave to Amend Should Be Denied. Katie Wimberly allegedly fell and injured herself on May 23, 2013, nearly four years ago. Plaintiffs have had two previous attempts to describe the events of that day and explain (with the help of counsel) why they believe Abbott is responsible for that injury. They have failed to do this in any factual, logical manner. Instead, all of Plaintiffs’ complaints have relied on conclusions and legal boilerplate. Plaintiffs’ first complaint did not identify Katie Wimberly’s injury or her relationship to Plaintiffs, relied on a recall that never occurred, and alleged that Ms. Wimberly was both alive and dead. After Abbott pointed out these defects, Plaintiffs filed a second complaint. The Amended Complaint admits that there was no recall, but assumes that there was an unspecified defect in the Meter that “allowed” Katie Wimberly’s blood glucose to drop and concludes that her fall was caused by that defect. See Am. Compl. ¶ 43. As discussed at length above, the Amended Complaint does not pass muster under Rule 12(b)(6). See discussion, supra, at I.A-C. Abbott has expended significant resources in defending itself against the inchoate claims raised in the first two complaints, and Plaintiffs’ pleading has not improved. Abbott should not be forced to defend itself in a case that Plaintiffs cannot be bothered to plead in compliance with Rule 8. See Cole v Fischer, 07-CV-11096 (BSJ), 2009 WL 1514691, at *1 (S.D.N.Y. May 29, 2009) (denying leave to amend following unexcused eight-month delay and full briefing of defendants’ motion to dismiss where the amendment “would cause undue prejudice to Defendants, compelling them to undertake the additional and considerable expense of filing a second motion to dismiss”); Kalnit v. Eichler, 99 F. Supp. 2d 327, 344 (S.D.N.Y. 2000) (dismissing complaint without leave to amend where, as here, the court “twice considered plaintiff's allegations … and twice found them to be insufficient”). Case 2:16-cv-04167-LDW-ARL Document 23-2 Filed 04/28/17 Page 8 of 12 PageID #: 121 6 This is particularly true here, where Plaintiffs’ proposed Second Amended Complaint is even more deficient than the complaint that is the subject of this Motion. Leave to amend should be denied where amendment would be futile. See Abbott MTD at 11-12; Ricciuti v. N.Y.C. Transit Auth’y, 941 F.2d 119, 123 (2d Cir.1991) (“Where a party opposes a motion to amend a complaint based on futility, the proposed pleadings may be reviewed for adequacy.”); Jones v. N.Y. State Div’n of Military & Naval Affairs, 166 F.3d 45, 55 (2d Cir. 1999) (An amendment is futile where the “complaint would be subject to immediate dismissal.”); Sodhi v Mercedes Benz Fin. Servs., USA, LLC, 957 F. Supp. 2d 252, 255 (E.D.N.Y. 2013) (“A proposed amendment would be futile when it would not survive a 12(b)(6) motion to dismiss.”). Here, Plaintiffs’ proposed amendment would be futile. First, the Second Amended Complaint fails under Rule 12(b)(6) for the same reasons as the current complaint. The proposed complaint provides no additional facts supporting: (1) the existence or breach of any warranty (Pl. Opp., Ex. A ¶¶ 21-22); (2) the existence of a manufacturing, design, or warning defect in the Meter (Id. ¶¶ 13, 41); or (3) a link between such a defect and Katie Wimberly’s fall (Id. ¶ 2). And the proposed complaint recycles the same boilerplate and legal conclusions from the current complaint. E.g., id. ¶ 26 (Ms. Wimberly “while using the product in accordance with its intended use was caused to suffer and sustain severe bodily injuries.”). Second, the Second Amended Complaint adds two failings not present in the current complaint, making it even more susceptible to dismissal under Rule 12(b)(6). As discussed above, the proposed complaint mistakenly revives a previously withdrawn (and recognizably false) allegation that the Meter was recalled. See discussion, supra, at I.B. In addition, the proposed complaint confusingly alleges that Katie Wimberly had both too-high blood glucose Case 2:16-cv-04167-LDW-ARL Document 23-2 Filed 04/28/17 Page 9 of 12 PageID #: 122 7 levels and too-low blood glucose levels, leading to a fall. E.g., Pl. Opp., Ex. A ¶¶ 13, 24, 30, 44, 51. While a plaintiff may plead causes of action in the alternative, the facts are not so mutable. Either Ms. Wimberly’s blood glucose was too high (in which case she may have taken insulin to lower it) or it was too low (in which case she might have eaten carbohydrates to raise it). Both things cannot be true at the same time. And without knowing which of the two possibilities occurred-as well as what reading her Meter reported, what she did in response, and when the allegedly erroneous reading occurred-Abbott has no hope of understanding how the Meter could be connected to Katie Wimberly’s fall. See discussion, supra, at I.B. The addition of these conflicting and contradictory allegations make the proposed Second Amended Complaint even less plausible than the current complaint under Twombly and Iqbal- and insufficient under Federal Rule of Civil Procedure 12(b)(6). Plaintiffs’ request for leave to amend should be denied as futile. Case 2:16-cv-04167-LDW-ARL Document 23-2 Filed 04/28/17 Page 10 of 12 PageID #: 123 8 II. CONCLUSION For all the foregoing reasons and the reasons set forth in Abbott’s moving papers, Defendant Abbott Laboratories Inc.’s motion to dismiss Plaintiffs’ Amended Complaint in its entirety and with prejudice under Federal Rule of Civil Procedure 12(b)(6) should be granted and Plaintiffs’ request for leave to amend should be denied. Dated: April 28, 2017 /s/ Eric P. Stephens JONES DAY Eric P. Stephens 250 Vesey Street New York, NY 10281 Tel: (212) 326-3939 Fax: (212) 755-7306 epstephens@jonesday.com Melissa B. Hirst 77 West Wacker Chicago, Illinois 60601-1692 Tel: (312) 782-3939 Fax: (312) 782-8585 mbhirst@jonesday.com Attorneys for Abbott Laboratories Inc. Case 2:16-cv-04167-LDW-ARL Document 23-2 Filed 04/28/17 Page 11 of 12 PageID #: 124 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW YORK MARGARET WIMBERLY and FREDDIA WIMBERLY-HAGANS, as Proposed Co- Administrators of the Estate of KATIE WIMBERLY, Deceased, Plaintiffs, v. ABBOTT LABORATORIES, INC. Defendant. Civil Action No. 16-CV-04167 (LDW)(ARL) ECF Case DECLARATION OF SERVICE I, Eric P. Stephens, counsel for Abbott Laboratories Inc., do hereby declare under the penalty of perjury under the laws of the United States of America that on the 28th day of April, 2017, I served the foregoing upon Plaintiffs’ counsel via electronic mail at jdell@D2TrialLaw.com, ksinnott@D2TrialLaw.com, and MOMalley@D2TrialLaw.com. /s/ Eric P. Stephens Attorney for Abbott Laboratories Inc. Case 2:16-cv-04167-LDW-ARL Document 23-2 Filed 04/28/17 Page 12 of 12 PageID #: 125 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW YORK MARGARET WIMBERLY and FREDDIA WIMBERLY-HAGANS, as Proposed Co- Administrators of the Estate of KATIE WIMBERLY, Deceased, Plaintiffs, v. ABBOTT LABORATORIES, INC. Defendant. Civil Action No. 16-CV-04167 (LDW)(ARL) ECF Case DECLARATION OF ERIC P. STEPHENS IN FURTHER SUPPORT OF DEFENDANT ABBOTT LABORATORIES, INC.’S RULE 12(b)(6) MOTION TO DISMISS THE AMENDED COMPLAINT I, Eric P. Stephens, pursuant to 28 U.S.C. § 1746, declare, under penalty of perjury, as follows: 1. I am an associate at the law firm of Jones Day, counsel to Defendant Abbott Laboratories Inc. I am a member in good standing of the Bar of the State of New York. 2. I submit this Declaration in Further Support of Defendant Abbott Laboratories, Inc.’s Rule 12(b)(6) Motion to Dismiss the Amended Complaint, dated February 3, 2017, to transmit to the Court true and correct copies of documents relevant to that motion and listed below. Case 2:16-cv-04167-LDW-ARL Document 23-3 Filed 04/28/17 Page 1 of 3 PageID #: 126 2 3. Exhibit 1 attached hereto, is a print out of the United States Food and Drug Administration Medical Device Recall Database for all “Freestyle Lite” products in 2013, as reflected in that database on April 27, 2017. I declare under penalty of perjury that the foregoing is true and correct. Executed on this 28th day of April, 2017. New York, NY /s/ Eric P. Stephens Eric P. Stephens Case 2:16-cv-04167-LDW-ARL Document 23-3 Filed 04/28/17 Page 2 of 3 PageID #: 127 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW YORK MARGARET WIMBERLY and FREDDIA WIMBERLY-HAGANS, as Proposed Co- Administrators of the Estate of KATIE WIMBERLY, Deceased, Plaintiffs, v. ABBOTT LABORATORIES, INC. Defendant. Civil Action No. 16-CV-04167 (LDW)(ARL) ECF Case DECLARATION OF SERVICE I, Eric P. Stephens, counsel for Abbott Laboratories Inc., do hereby declare under the penalty of perjury under the laws of the United States of America that on the 28th day of April, 2017, I served the foregoing upon Plaintiffs’ counsel via electronic mail at jdell@D2TrialLaw.com, ksinnott@D2TrialLaw.com, and MOMalley@D2TrialLaw.com. /s/ Eric P. Stephens Attorney for Abbott Laboratories Inc. Case 2:16-cv-04167-LDW-ARL Document 23-3 Filed 04/28/17 Page 3 of 3 PageID #: 128 EXHIBIT 1 Case 2:16-cv-04167-LDW-ARL Document 23-4 Filed 04/28/17 Page 1 of 7 PageID #: 129 1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain 2. http://www.addthis.com/bookmark.php 3. http://www.fda.gov/default.htm 4. http://www.fda.gov/MedicalDevices/default.htm 5. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm 6. /scripts/cdrh/cfdocs/search/default.cfm?FAQ=true 7. ../cfRes/res.cfm?start_search=1&event_id=&productdescriptiontxt=freestyle% 20lite&productcode=&IVDProducts=&rootCauseText=&recallstatus=¢ erclassificationtypetext=&recallnumber=&postdatefrom=1%2F1%2F2013&postdateto=12%2F31% 2F2013&productshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=&knumber=&sortcolumn=pda 8. ../cfRes/res.cfm?start_search=1&event_id=&productdescriptiontxt=freestyle% 20lite&productcode=&IVDProducts=&rootCauseText=&recallstatus=¢ erclassificationtypetext=&recallnumber=&postdatefrom=1%2F1%2F2013&postdateto=12%2F31% 2F2013&productshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=&knumber=&sortcolumn=pdd 9. ../cfRes/res.cfm?start_search=1&event_id=&productdescriptiontxt=freestyle% 20lite&productcode=&IVDProducts=&rootCauseText=&recallstatus=¢ erclassificationtypetext=&recallnumber=&postdatefrom=1%2F1%2F2013&postdateto=12%2F31% 2F2013&productshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=&knumber=&sortcolumn=cca 10. ../cfRes/res.cfm?start_search=1&event_id=&productdescriptiontxt=freestyle% 20lite&productcode=&IVDProducts=&rootCauseText=&recallstatus=¢ erclassificationtypetext=&recallnumber=&postdatefrom=1%2F1%2F2013&postdateto=12%2F31% 2F2013&productshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=&knumber=&sortcolumn=ccd 11. ../cfRes/res.cfm?start_search=1&event_id=&productdescriptiontxt=freestyle% 20lite&productcode=&IVDProducts=&rootCauseText=&recallstatus=¢ erclassificationtypetext=&recallnumber=&postdatefrom=1%2F1%2F2013&postdateto=12%2F31% 2F2013&productshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=&knumber=&sortcolumn=cda 12. ../cfRes/res.cfm?start_search=1&event_id=&productdescriptiontxt=freestyle% 20lite&productcode=&IVDProducts=&rootCauseText=&recallstatus=¢ erclassificationtypetext=&recallnumber=&postdatefrom=1%2F1%2F2013&postdateto=12%2F31% 2F2013&productshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=&knumber=&sortcolumn=cdd 13. ../cfRes/res.cfm?start_search=1&event_id=&productdescriptiontxt=freestyle% 20lite&productcode=&IVDProducts=&rootCauseText=&recallstatus=¢ erclassificationtypetext=&recallnumber=&postdatefrom=1%2F1%2F2013&postdateto=12%2F31% 2F2013&productshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=&knumber=&sortcolumn=lna 14. ../cfRes/res.cfm?start_search=1&event_id=&productdescriptiontxt=freestyle% 20lite&productcode=&IVDProducts=&rootCauseText=&recallstatus=¢ erclassificationtypetext=&recallnumber=&postdatefrom=1%2F1%2F2013&postdateto=12%2F31% 2F2013&productshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=&knumber=&sortcolumn=lnd 15. ./res.cfm?id=123985 Page Last Updated: 04/26/2017 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский ةيبرعلا | | Kreyòl Ayisyen | Français | Polski 1 result found Product: freestyle lite Date Classified from: 1/1/2013 Date Classified to: 12/31/2013 Results per Page 10  New Search Export To Excel | Help6 Product Description 7 8 Recall Class 9 10 Recall Date 11 12 Recalling Firm 13 14 FreeStyle Lite Blood Glucose Test Strips; For In Vitro Diagnostic Testing. 50 Count; 100 Count Pro...15 1 Dec-17-2013 Abbott Diabetes Care,Inc. Links on this page: Medical Device Recalls FDA Home3 Medical Devices4 Databases5 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfmMedical Device Recalls 4/27/2017 Case 2:16-cv-04167-LDW-ARL Document 23-4 Filed 04/28/17 Page 2 of 7 PageID #: 130 | Português | Italiano | Deutsch | 日本語 یسراف | | English Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Nondiscrimination Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive Links on this page: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfmMedical Device Recalls 4/27/2017 Case 2:16-cv-04167-LDW-ARL Document 23-4 Filed 04/28/17 Page 3 of 7 PageID #: 131 6 510(k) 7 |DeNovo8| Registration & Listing9 | Adverse Events10 |Recalls11|PMA12|HDE13|Classification14|Standards15 CFR Title 2116|Radiation-Emitting Products17|X-Ray Assembler18|Medsun Reports19|CLIA20|TPLC21 New Search Back to Search Results Class 1 Device Recall FreeStyle Lite Blood Glucose Test Strips 22 Date Initiated by Firm November 18, 2013 Date Posting Updated December 17, 2013 Recall Status1 Terminated 3 on August 03, 2015 Recall Number Z-0486-2014 Recall Event ID 6688623 510(K)Number K09260224 Product Classification System, test, blood glucose, over the counter25 - Product Code NBW26 Product FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 70819 9; - 50 count UPC 6 99073 70822 9 - 50 count UPC 6 99073 71026 0 - 50 count UPC 6 99073 70827 4 - 100 count Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood. Code Information Part number: 71026-70; , Lot number: 1281732; Exp. date: 2014/05;, Lot number: 1283603; Exp. date: 2014/06; Part number: 70827-71:, Lot number: 1363015, Exp. Date: 2014/11;, Lot number: 1363109, Exp. Date 2014/11: , Lot number: 1365921, Exp. Date 2014/12; Part number 70827-72:, Lot number: 1366006 Exp. Date : 2014/12;, Lot number 1366111, Exp. Date: 2014/12;, Lot number 1366337; Exp. Date: 2014/12;, Lot number: 1366515, Exp Date: 2014/12; Part number 70822-71;, Lot number 1283345: Exp. Date: 2014/05;, Lot number 1365920; Exp. Date: 2014/12;, Lot number 1365934; Exp. Date: 2014/12; Part number: 70822-72:, Lot number: 1350414: Exp Date: 2014/07;, Lot number 1363321; Class 1 Device Recall FreeStyle Lite Blood Glucose Test Strips FDA Home3 Medical Devices4 Databases5 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123985Class 1 Device Recall ... 4/27/2017 Case 2:16-cv-04167-LDW-ARL Document 23-4 Filed 04/28/17 Page 4 of 7 PageID #: 132 1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain 2. http://www.addthis.com/bookmark.php 3. http://www.fda.gov/default.htm 4. http://www.fda.gov/MedicalDevices/default.htm 5. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm Exp. Date 2014/11: Part number: 70819-70:, Lot Number: 1365056: Exp. Date 2014/11;, Lot number: 1366347: Exp. Date: 2014/12;, Lot number: 1367917; Exp. Date 2014/12, Lot number: 1374907; Exp. Date 2015/03. Recalling Firm/ Manufacturer Abbott Diabetes Care, Inc. 1360 S Loop Rd Alameda CA 94502-7000 For Additional Information Contact Kelly Duffy 510-239-2775 Manufacturer Reason for Recall Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood glucose meter built into the OmniPod system. Erroneously low results that are not recognized may pose significant risks to your health. FDA Determined Cause 2 Other Action Abbott Diabetes Care sent an Urgent Product Recall letter in November 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers who were affected were instructed to take the following steps: Call Abbott Diabetes Care Customers Service immediately at 1-888-736-9869 for replacement of the affected product. While waiting for replacement strips to arrive, use an alternate method to measure their blood glucose. If only test strips available to customers were from affected lots, customers should not stop testing their blood glucose. Customers were instructed to dispose of the test strips in accordance with their local and state disposal regulations. Customers with questions were instructed to call Abbott Diabetes Care Customers Service at 1-888-736-9869. For questions regarding this recall call 510-239-2775. Abbott issued a press release at the request of CDRH on november 27, 2013. Quantity in Commerce 141,219 cartons for human use - total Distribution Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark, Egypt, Finland, France, Germany, Jamaica, Ireland, Israel, United Kingdom, Luxembourg, Netherlands, Norway, Sweden, Switzerland, UAE, and Canada. **Center Recommended Depth - Consumers/User** Total Product Life Cycle TPLC Device Report27 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls28. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.5529. 510(K) Database 510(K)s with Product Code = NBW and Original Applicant = ABBOTT DIABETES CARE INC.30 Links on this page: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123985Class 1 Device Recall ... 4/27/2017 Case 2:16-cv-04167-LDW-ARL Document 23-4 Filed 04/28/17 Page 5 of 7 PageID #: 133 6. /scripts/cdrh/devicesatfda/index.cfm 7. /scripts/cdrh/cfdocs/cfPMN/pmn.cfm 8. /scripts/cdrh/cfdocs/cfpmn/denovo.cfm 9. /scripts/cdrh/cfdocs/cfRL/rl.cfm 10. /scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm 11. /scripts/cdrh/cfdocs/cfRES/res.cfm 12. /scripts/cdrh/cfdocs/cfPMA/pma.cfm 13. /scripts/cdrh/cfdocs/cfHDE/hde.cfm 14. /scripts/cdrh/cfdocs/cfPCD/classification.cfm 15. /scripts/cdrh/cfdocs/cfStandards/search.cfm 16. /scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm 17. /scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm 18. /scripts/cdrh/cfdocs/cfAssem/assembler.cfm 19. /scripts/cdrh/cfdocs/Medsun/searchReportText.cfm 20. /scripts/cdrh/cfdocs/cfClia/Search.cfm 21. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm 22. http://www.fda.gov/safety/recalls/enforcementreports/default.htm 23. /scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=66886 24. /scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K092602 25. /scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=NBW 26. /scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=NBW 27. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=NBW 28. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm329946.htm 29. /scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=7.55 30. /scripts/cdrh/cfdocs/cfPMN/pmn.cfm? start_search=1&productcode=NBW&knumber=&applicant=ABBOTT%20DIABETES% 20CARE%20INC%2E Page Last Updated: 04/26/2017 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский ةيبرعلا | | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 یسراف | | English Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Nondiscrimination Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123985Class 1 Device Recall ... 4/27/2017 Case 2:16-cv-04167-LDW-ARL Document 23-4 Filed 04/28/17 Page 6 of 7 PageID #: 134 Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive Links on this page: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=123985Class 1 Device Recall ... 4/27/2017 Case 2:16-cv-04167-LDW-ARL Document 23-4 Filed 04/28/17 Page 7 of 7 PageID #: 135