VITALIANO, District Judge.
Plaintiffs Brenda and Ronald Reed, citizens of West Virginia, commenced this action on November 19, 2010 seeking damages resulting from Ms. Reed's ingestion of Lybrel, an oral contraceptive pill allegedly designed, developed, and sold by defendants Pfizer, Inc. ("Pfizer") and Wyeth LLC ("Wyeth"). On January 20, 2011, defendants filed a letter requesting a pre-motion conference and permission to file a motion to dismiss. In that letter, defendants argued that plaintiffs' complaint should be dismissed based on a failure to plead plausible claims. The Court held the requested pre-motion conference on February 8, 2011. At that conference, "plaintiffs acknowledged that the complaint allowed room for further factual details." (Plaintiffs' Opposition, at 1.) The Court provided plaintiffs 30 days to file an amended complaint, which plaintiffs did do on the thirtieth day.
Defendants now move to dismiss the amended complaint for failure to state a claim upon which relief can be granted, arguing that, like the original complaint, the amended complaint fails to state plausible claims. Plaintiffs oppose defendants' motion, but as an alternative, seek leave to amend their pleadings yet again.
For the reasons recounted below, the motion to dismiss is granted without prejudice, and with leave to amend.
In early 2009, Ms. Reed was prescribed Lybrel to alleviate heavy menstrual periods. (Plaintiffs' Amended Complaint ("Compl.") at ¶ 15.) Shortly thereafter, she began ingesting Lybrel, one dose per day. (Id. at ¶ 16.) The complaint concludes that, "[a]s a direct and proximate result of ingesting Lybrel, [Ms. Reed] developed deep vein thrombosis ("DVT"), pulmonary embolus, vein and tissue damage, severe pain in the left leg and right lung, difficulty breathing, and other serious injuries that required hospitalization, extensive testing, and other medical treatment." (Id. at ¶ 19.) Ms. Reed, it is further alleged, "has been incapacitated from her normal functioning" and "will require lifelong medical care and attention." (Id. at ¶ 20.)
Furthermore, plaintiffs allege, inter alia, (1) defendants knew or should have known that Lybrel was "negligently created, formulated, designed, manufactured, tested, and marketed, that the drug was not accompanied by adequate warnings; that medical professionals were prescribing the drug for non-approved uses; and that the drug was otherwise negligently and recklessly advertised, marketed, promoted, distributed, and sold," and (2) defendants "improperly obtained the approval of the FDA to market Lybrel by misrepresenting the risks of the drug to the FDA and/or by failing to inform the FDA of risks inherent in the use of the drug," and that such misrepresentations "deprived [Ms. Reed] of the opportunity to make an informed choice regarding the risks and benefits associated with" Lybrel. (Compl. at ¶¶ 10, 14, 23.)
Federal Rule of Civil Procedure 8(a)(2) requires "a short and plain statement of the claim showing that the pleader is entitled to relief." This rule does not compel a litigant to supply "detailed factual allegations" in support of his claims, Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555,
Moreover, under Rule 12(b)(6), a complaint must be dismissed if it does not "contain sufficient factual matter, accepted as true, to `state a claim to relief that is plausible on its face.'" Id. (quoting Twombly, 550 U.S. at 570, 127 S.Ct. 1955). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. Determining plausibility is "a context-specific task that requires the reviewing court to draw on its judicial experience and common sense." Id. at 1950.
That said, the factual allegations are paramount as "a complaint need not pin plaintiff's claim for relief to a precise legal theory" nor provide "an exposition of his legal argument." Skinner v. Switzer, ___ U.S. ___, 131 S.Ct. 1289, 1296, 179 L.Ed.2d 233 (2011). In analyzing well-pled facts, a court will draw all reasonable inferences in favor of plaintiff. See Gorman v. Consol. Edison Corp., 488 F.3d 586, 591-92 (2d Cir.2007). Of course, though a court must presume the truth of all factual allegations in the complaint for purposes of Rule 12(b)(6), the court is not bound to accept the truth of legal conclusions couched as factual allegations. Papasan v. Allain, 478 U.S. 265, 286, 106 S.Ct. 2932, 2944, 92 L.Ed.2d 209 (1986). Further, on a motion to dismiss, a court may only consider the pleading itself, documents that are referenced in the complaint, documents that the plaintiff relied on in bringing suit and that are either in the plaintiffs possession or that the plaintiff knew of when bringing suit, and matters of which judicial notice may be taken. See Chambers v. Time Warner, Inc., 282 F.3d 147, 153 (2d Cir.2002); Int'l Audiotext Network, Inc. v. Am. Tel. & Tel. Co., 62 F.3d 69, 72 (2d Cir.1995).
Finally, should a court find pleadings to be inadequate, Rule 15(a) provides that the district court should freely grant leave to amend those pleadings when justice so requires. But, a district court correctly denies leave to amend "when an amendment is offered in bad faith, would cause undue delay or prejudice, or would be futile." Leonelli v. Pennwalt Corp., 887 F.2d 1195, 1198 (2d Cir.1989) (citing Foman v. Davis, 371 U.S. 178, 182, 83 S.Ct. 227, 230, 9 L.Ed.2d 222 (1962)).
The theories of liability initially relevant to determining whether plaintiffs have stated a viable claim are (1) failure to warn, (2) manufacturing defect, (3) design defect, (4) breach of express warranty, and (5) breach of implied warranty.
To prevail on a failure to warn claim, a plaintiff must prove, "(1) a manufacturer has a duty to warn (2) against dangers resulting from foreseeable uses about which it knew or should have known, and (3) that failure to do so was the proximate cause of the harm." State Farm Fire & Cas. Co. v. Nutone, Inc., 426 Fed. Appx. 8, 10 (2d Cir.2011) (citing Liriano v. Hobart Corp., 92 N.Y.2d 232, 237, 677 N.Y.S.2d 764, 700 N.E.2d 303 (1998)); accord Morningstar, 253 S.E.2d at 682-83. As part of satisfying those elements, a plaintiff is "required to prove that the product did not contain adequate warnings." Mulhall v. Hannafin, 45 A.D.3d 55, 841 N.Y.S.2d 282 (1st Dep't 2007). Following logically, a failure to warn cause of action is appropriately dismissed if a plaintiff does not plead facts indicating how the provided warnings were inadequate. Bailey v. Janssen Pharmaceutica, Inc., 288 Fed.Appx. 597, 608-09 (11th Cir.2008) (affirming the dismissal of a failure to warn claim when the complaint "only assert[ed] that the warning was insufficient because it failed to warn of various dangers of the use of [the drug], without explaining either the information available to [the] physician at the time of the administration of the drug or how the contents of the label were inadequate"); Wendell v. Johnson & Johnson, No. C 09-04124, 2010 WL 271423, at *4 (N.D.Cal. Jan. 20 2010) (dismissing a failure to warn claim because the plaintiffs "fail[ed] to allege how [the] warnings about [the drug] were inadequate"); Mills v. Bristol-Myers Squibb Co., No. CV 11-968, 2011 WL 3566131, at *3 (D.Ariz. Aug. 12, 2011) (dismissing a failure to warn claim because (1) plaintiff did not "plead any facts about what the [drug] label said or how it was deficient;" and (2) "the warning did describe a risk of [the alleged injury]").
Plaintiffs describe Ms. Reed's injuries as "deep vein thrombosis ("DVT"), pulmonary embolus, vein and tissue damage, severe pain in the left leg and right lung, difficulty breathing, and other serious injuries that required hospitalization, extensive testing, and other medical treatment." (Compl. at ¶¶ 19.) In contrast with their thorough recitation of Ms. Reed's claimed injuries, plaintiffs plead nothing about the content of Lybrel's warnings. This is likely because, as defendants note by reference to the FDA's website, Lybrel's FDA-approved warning labels warn of the very injuries plaintiffs have pled.
Given all of this, the Reeds fall short of stating a failure to warn claim because the amended complaint does not allege facts identifying how the provided warnings were inadequate. Instead it first alleges (1) "the drug was not accompanied by adequate warnings;" and (2) the drug was promoted "without sufficient disclosure of its dangerous propensities." (Compl. ¶¶ 10, 14.) But assertions that warnings were not "adequate" or "sufficient" are nothing more than legal conclusions unsupported by factual content. The fact gap is never closed. The complaint runs on merely to allege (1) defendants "misrepresent[ed] the risks of the drug to the FDA and/or fail[ed] to inform the FDA of risks inherent in the use of the drug;" and (2) the "warnings and information given to the medical community and women consumers did not accurately reflect the symptoms, duration, scope, or severity of the potential side effects, health concerns, and risks associated with ingesting Lybrel." (Compl. ¶¶ 14, 40.) These additional allegations are simply not "enough to raise a right to relief above the speculative level" since they do not include "enough factual matter (taken as true) to suggest that a [misrepresentation] was made." Twombly, 127 S.Ct at 1965. Pointedly, these allegations do not include any factual content regarding what the misrepresentations were or how the provided warnings and information failed to "accurately reflect" reality; they do not provide a plausible basis to support an inference that Pfizer and Wyeth misrepresented anything.
To cut to the chase, the fact (taken here as true) that Ms. Reed suffered from certain conditions that were also identified risks of ingesting Lybrel is tragic, but cannot alone make plausible a claim that
Accordingly, the Court finds that plaintiffs have not plausibly pled a failure to warn claim in their amended complaint. Indeed, the facts before the Court are that defendants did warn of the relevant risks. Plausibility requires some factual assertions as to how or why the acknowledged warning was inadequate, that is, about what risk of harm, or in what way, the acknowledged warning failed to warn.
A manufacturing defect claim is premised on the relevant product being defective because it was not manufactured as designed. See Am. Guarantee & Liab. Ins. Co. v. Cirrus Design Corp., No. 09 Cv. 8357, 2010 WL 5480775, at *3 (S.D.N.Y. Dec. 30, 2010); Morningstar, 253 S.E.2d at 681. Consistent with that premise, a manufacturing defect claim is properly dismissed if a plaintiff has not alleged "that the particular [drug] administered to her had a defect as compared to" other samples of that drug. Lewis, 2009 WL 2231701, at *2.
Plaintiffs fail to plead any facts making such an allegation. Rather, they merely plead the legal conclusions that defendants were (1) "negligent" in "formulating" "fabricating," "manufacturing," and "packaging," Lybrel; (2) did so "in violation of applicable statutes, regulations, and appropriate standards of care;" and (3) "failed to perform sufficient and necessary testing that would have shown Lybrel's defective condition." (Compl. at ¶¶ 23, 29, 30.) By not pleading facts indicating how or why the Lybrel ingested by Ms. Reed differed from its design, plaintiffs have not enabled the Court "to draw the reasonable inference that the defendants are] liable for the misconduct alleged." Iqbal, 129 S.Ct. at 1949 (quoting Twombly, 127 S.Ct. 1955). The manufacturing defect claim does not survive pleading.
A design defect claim, on the other hand, is premised on a manufacturer's failure to properly design a product, which is then placed on the market despite posing inappropriate risks. Voss v. Black & Decker Mfg., 59 N.Y.2d 102, 107, 463 N.Y.S.2d 398, 450 N.E.2d 204 (N.Y.1983). Morningstar, 253 S.E.2d at 681. Again, eschewing the opportunity to plead facts identifying Lybrel's design defect, the Reeds merely plead the legal conclusion that the Lybrel was defective. (Compl. at ¶¶ 10, 13) ("Defendants knew ... the drug was negligently ... designed," and that
Plaintiffs' design defect claim also fails for an additional reason. Plaintiffs do not plead facts alleging the existence of a feasible alternative design that would make the product safer, as is required to establish a design defect, under either New York or West Virginia law. Voss, 59 N.Y.2d at 108, 463 N.Y.S.2d 398, 450 N.E.2d 204. Church v. Wesson, 182 W.Va. 37, 385 S.E.2d 393, 396 (1989). As a result of such a failure, the claim is subject to dismissal. Lewis, 2009 WL 2231701, at *4 (finding a plaintiff did not "meet her burden to allege evidence that [a drug] is not reasonably safe" because "plaintiff has not alleged that it was feasible for [the manufacturer] to design [the drug] in a safer manner"); Am. Guarantee & Liab. Ins. Co., No. 09 Cv. 8357, 2010 WL 5480775, at *3 (S.D.N.Y. Dec. 30 2010) (dismissing a design defect claim because plaintiff did not plead, inter alia, "a feasible alternative design"). The complaint, as a consequence, does not validly plead a design defect claim.
Any "affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain creates an express warranty that the goods shall conform to the affirmation or promise." N.Y.U.C.C. § 2-313(1)(a); W. Va.Code, § 46-2-313(1)(a). A successful claim of a breach of express warranty requires proof that an express warranty existed, was breached, and that plaintiff had relied on that warranty. Horowitz v. Stryker Corp., 613 F.Supp.2d 271, 285-86 (E.D.N.Y.2009); Horan v. Turnpike Ford, Inc., 189 W.Va. 621, 433 S.E.2d 559 (1993). Further, a successful breach of warranty claim requires that the product be defective. Plemmons v. Steelcase Inc., No. 04 Civ. 4023, 2007 WL 950137, at *5 (S.D.N.Y. March 29, 2007) (citing Tardella v. RJR Nabisco, Inc., 178 A.D.2d 737, 737, 576 N.Y.S.2d 965 (N.Y.App.Div. 3d Dep't 1991)).
Plaintiffs fail to state an express warranty claim for reasons similar to why they did not meet the standard for a failure to warn claim, a design defect claim,
Horowitz v. Stryker Corp., 613 F.Supp.2d 271, 285 (E.D.N.Y.2009) is instructive here. The Horowitz court dismissed an express warranty claim (relating to a failure of an artificial hip) because, inter alia, the plaintiff did "not even describe how [the allegedly breached] representation was made." 613 F.Supp.2d at 286. In holding so, the court distinguished Huber v. Howmedica Osteonics Corp., No. 07-2400, 2008 WL 5451072 (D.N.J. Dec. 31, 2008), a case in which a plaintiff was found to have properly stated a breach of express warranty claim regarding the same type of artificial hip at issue in Horowitz. The Huber plaintiff alleged "the existence of evidence showing that the .5% defect rate printed on the [artificial hip's] label is actually much higher and that the defect rate was a basis of the bargain." Horowitz, 613 F.Supp.2d at 286, n. 8 (discussing Huber). As in Horowitz, and unlike in Huber, the Reeds have not alleged factual content sufficient for the Court to reasonably infer defendants breached any representation of fact or promise. Plaintiffs have alleged nothing which makes plausible that Lybrel's various risks differ from what was warranted.
For largely the same reasons, the Court finds plaintiffs have also failed to plead a proper breach of implied warranty
Plaintiffs have already attempted, but failed, to overcome pleading inadequacies previously identified. At the same time, what has been previewed in the amended complaint suggests that, with guidance from this Memorandum and Order, that plaintiffs may yet be able to plausibly replead at least some of their claims. The Court, as a result, grants leave to amend one more time. In exercising its discretion to do so, the Court has considered the high value to be placed on merit resolution of cases and controversies. Plaintiffs are advised that, given the Court's specific identification of pleading shortcomings, failure to address them successfully in the next round will not likely be rewarded with a third opportunity to cure.
For the foregoing reasons, all claims against defendants are dismissed without prejudice and with leave to amend. The second amended complaint shall be filed within 30 days of the date this order is entered on the docket.
SO ORDERED.