NELSON S. ROMÁN, District Judge.
Plaintiff Angela Rose Sullivan brings this action against Defendant Aventis, Inc. alleging claims for design defect, manufacturing defect, failure to warn, breach of implied warranty, breach of express warranty, negligence, fraud, negligent misrepresentation, negligence per se, and unjust enrichment. Defendant moves to dismiss pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. For the following reasons, Defendant's motion is GRANTED in part and DENIED in part.
This is a pharmaceutical products liability action based on Plaintiff's mother's use of a fertility drug called Clomid. Clomid was approved by the Food and Drug Administration ("FDA") on February 1, 1967, and is one of the oldest fertility treatments available. (Second Am. Compl. ¶ 9, ECF No. 38.) Clomid was designed, manufactured, and marketed by Defendant, Defendant's affiliates, Defendant's predecessors-in-interest, and/or Defendant's affiliates' predecessors-in-interest.
To survive a motion to dismiss, a complaint must supply "factual allegations sufficient `to raise a right to relief above the speculative level.'" ATSI Commc'ns, Inc. v. Shaar Fund, Ltd., 493 F.3d 87, 98 (2d Cir. 2007) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)). In other words, the complaint must allege "enough facts to state a claim to relief that is plausible on its face." Starr v. Sony BMG Music Entm't, 592 F.3d 314, 321 (2d Cir. 2010) (quoting Twombly, 550 U.S. at 570). "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." Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). In applying this standard, a court should accept as true all well-pleaded factual allegations, but should not credit "mere conclusory statements" or "[t]hreadbare recitals of the elements of a cause of action." Id.
The thrust of Defendant's motion is that Plaintiff's claims, though artfully pleaded, are substantively indistinguishable from claims for wrongful life, which is not a recognized cause of action under New York law. Defendant also asserts that Plaintiff's design defect claim is preempted by federal law and barred by comment k to the Restatement (Second) of Torts § 402A. Finally, Defendant argues that the following claims are inadequately pleaded or legally barred: design defect, manufacturing defect, failure to warn, breach of implied warranty, breach of express warranty, fraud, negligent misrepresentation, and unjust enrichment.
In Becker v. Schwartz, the New York Court of Appeals rejected wrongful life as a cause of action under New York law. 46 N.Y.2d 401, 410-12 (1978). In the lead case, the plaintiff was the mother of a child born with Down syndrome. Id. at 405. The mother asserted that her physicians negligently failed to inform her of the increased risk of Down syndrome in children born to women of her age, or of the availability of an amniocentesis test to determine whether the fetus would be born with the condition. Id. at 405-06. In Park v. Chessin, a companion case decided pursuant to the same opinion, the plaintiff mother gave birth to a child who, afflicted with polycystic kidney disease, died five hours later. Id. at 406-07. Her physicians thereafter erroneously told her that polycystic kidney disease was not hereditary and that her chances of having another child with the disease were "practically nil." Id. at 407. Relying on that advice, the mother conceived another child who was born with the same condition and survived only two years and six months. Id.
The New York Court held that the parents in these cases could not recover on behalf of their children for two reasons.
Prenatal torts, in contrast to wrongful life claims, are recognized causes of action under New York law. Thus, where "a pregnant woman is injured through negligence and the child subsequently born suffers deformity or other injury as a result, recovery therefor may be allowed to the child, provided the causal relation between the negligence and the damage to the child be established by competent medical evidence." Woods v. Lancet, 303 N.Y. 349, 351 (1951); Int'l Union, United Auto., Aerospace & Agr. Implement Workers of Am., UAW v. Johnson Controls, Inc., 499 U.S. 187, 213 (1991) ("[E]very State currently allows children born alive to recover in tort for prenatal injuries caused by third parties. . . ."). New York courts have distinguished prenatal torts from wrongful life on the basis of whether the relevant counterfactual is "nonexistence" or a healthy child. For example, in Sheppard-Mobley ex rel. Mobley v. King, the defendant physicians allegedly erroneously advised an expecting mother that her fetus would die or suffer "terrible" birth defects if carried to term because of the presence of fibroids in the mother's uterus. 4 N.Y.3d 627, 634-35 (2005). The physicians administered methotrexate to the mother in an attempt to terminate the pregnancy, but the treatment was unsuccessful and the child was born with severe birth defects allegedly caused by the methotrexate. Id. The New York Court recognized the infant plaintiff's claim as a prenatal tort, and distinguished it from Becker on the basis that, but for the defendants' negligence, "[the mother] would not have undergone methotrexate treatments and she would have given birth to a healthy child." Id. at 638; see also Hughson v. St. Francis Hosp. of Port Jervis, 459 N.Y.S.2d 814, 815 (App. Div. 1983) ("Unlike the infants in Becker and its companion case of Park v. Chessin, who would assertedly have chosen never to have been born at all rather than to have been born with Down's Syndrome or polycystic kidney disease, the infant at bar would presumably have been born normal and healthy but for the appellants' wrongful act.").
Some authorities distinguish wrongful life claims from prenatal torts on the basis of whether the defendant's negligence caused the birth defect, and Plaintiff urges the Court to apply that distinction here. See Morgan v. Christman, No. CIV. A. 882311O, 1990 WL 137405, at *3 (D. Kan. July 20, 1990). For example, the District of Kansas in Morgan, construing Kansas law, reasoned that in a traditional wrongful life claim, the physician's negligence does not "actually" cause the child's impairment.
The thrust of Plaintiff's design defect theory is that Clomid could feasibly have been designed such that it would have helped Plaintiff's mother conceive with a substantially smaller risk of harm to Plaintiff. The relevant counterfactual, then, is that if Clomid had not been defectively designed, Plaintiff would have been born healthy notwithstanding her mother's use of Clomid. This calls for comparing Plaintiff to a healthy child—a task that courts routinely entertain—and the Court need not confront the injury problem or the obstacle of "calculation of damages dependent upon a comparison between the Hobson's choice of life in an impaired state and nonexistence," Becker, 46 N.Y.2d at 411-12.
Plaintiff's failure to warn theory is a closer question, but at this stage of the proceedings, the Court will not dismiss it. The relevant counterfactual is that, if Plaintiff's mother had been adequately informed of Clomid's risks, she would not have taken Clomid. But that does not necessarily mean that she would not have conceived naturally. Clomid allegedly functions by "induc[ing] ovulation for the purpose of pregnancy." (Second Am. Compl. ¶ 8.) Plaintiff does not allege that her mother was infertile or that she was able to conceive only through the use of Clomid. Instead, she alleges that her mother "took the fertility drug, Clomid [sic] with the intent that it help her conceive [and] conceived shortly thereafter." (Id. ¶¶ 10-11.) Construing the allegations in the light most favorable to the Plaintiff, there is a plausible counterfactual that Plaintiff would have been born without the use of Clomid (and therefore, without her complained-of impairments).
Plaintiff's design defect claim is not preempted. Because federal law is "the supreme Law of the Land," U.S. Const. art. VI, cl. 2, "Congress has the power to preempt state law," Arizona v. United States, 132 S.Ct. 2492, 2500 (2012). In interpreting the presence and scope of preemption, a court starts with the "assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." Wyeth v. Levine, 555 U.S. 555, 565 (2009). But in every preemption case, "the purpose of Congress is the ultimate touchstone." Id. (internal quotation marks omitted).
"The Supreme Court has recognized three typical settings in which courts will find that Congress intended to preempt state law." In re Methyl Tertiary Butyl Ether (MTBE) Prods. Liab. Litig., 725 F.3d 65, 96-97 (2d Cir. 2013), cert. denied sub nom. Exxon Mobil Corp. v. City of New York, N.Y., 134 S.Ct. 1877 (2014). "First, when Congress expressly provides that a federal statute overrides state law, courts will find state law preempted if, applying standard tools of statutory construction, the challenged state law falls within the scope of congressional intent to preempt." Segedie v. Hain Celestial Grp., Inc., No. 14-CV-5029 NSR, 2015 WL 2168374, at *2 (S.D.N.Y. May 7, 2015) (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 484 (1996)). Second, when Congress legislates so comprehensively in one area as to "occupy the field," courts may infer from the federal legislation that Congress intended to preempt state law in that entire subject area. Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372 (2000). "Third, when neither of the first two categories applies but state law directly conflicts with the structure and purpose of a federal statute, [courts] may conclude that Congress intended to preempt the state law." MTBE, 725 F.3d at 96-97. Courts may find a conflict with preemptive effect only in two circumstances: first, when "compliance with both federal and state regulations is a physical impossibility," and second, when the state law "stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Arizona, 132 S. Ct. at 2501 (internal quotation marks omitted); see also MTBE, 725 F.3d at 97.
Defendant asserts that Plaintiff's design defect claim is preempted under Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013) (5-4), which concerned the applicability of impossibility preemption.
The Court begins by identifying Defendant's duties under New York law. See id. at 2473. Under New York law, "[i]n order to establish a prima facie case in strict products liability for design defects, the plaintiff must show that the manufacturer breached its duty to market safe products when it marketed a product designed so that it was not reasonably safe and that the defective design was a substantial factor in causing plaintiff's injury." Voss v. Black & Decker Mfg. Co., 59 N.Y.2d 102, 107 (1983). New York, like New Hampshire, follows a "risk-utility" approach to determining whether a product is not reasonably safe, which calls for consideration of several factors:
Id. at 109. "The purpose of risk/utility analysis is to determine whether the risk of injury might have been reduced or avoided if the manufacturer had used a feasible alternative design." McCarthy v. Olin Corp., 119 F.3d 148, 155 (2d Cir. 1997); Bolm v. Triumph Corp., 422 N.Y.S.2d 969, 975 (App. Div. 1979) ("The reasonableness of choosing among various alternatives and adopting the safest one feasible is not only relevant in a design defect action, it is at the very heart of the case."). Brand-name drug manufacturers can thus avoid liability under New York law by choosing a safer design for a drug.
There is yet another way for brand-name drug manufacturers to avoid liability—they can strengthen a drug's warning label. Although New York has not adopted the "consumer expectations" test in evaluating design defect claims, see Tomasino v. Am. Tobacco Co., 807 N.Y.S.2d 603, 606 (App. Div. 2005) ("The plaintiff's design defect causes of action as against the manufacturer appellants, therefore, were not, as they suggest, `subject to dismissal based solely on the conclusion that, as a matter of law, after 1969 when warnings were required to be included on cigarettes, cigarettes were in the condition contemplated by consumers at the time of purchase.'"), one of the factors of the "risk-utility" analysis under New York law is "the degree of awareness of the potential danger of the product which reasonably can be attributed to the plaintiff." Voss, 59 N.Y.2d at 109. This factor is directly impacted by the strength of the drug's warnings. See, e.g., Jackson v. Bomag GmbH, 638 N.Y.S.2d 819, 822-23 (App. Div. 1996) (holding that recovery for design defect was precluded by the plaintiff's awareness of a brochure advertising an optional safety feature that would have prevented the harm for the plaintiff's specialized use of the machine); cf. Donuk v. Sears, Roebuck & Co., 859 N.Y.S.2d 701, 702 (App. Div. 2008) (holding that recovery for design defect for a snow thrower was precluded by warning labels cautioning the plaintiff against reaching into the machine's chute while the engine was running, which demonstrated that the plaintiff's own negligence was the sole proximate cause of the harm). Moreover, for drugs that are unavoidably unsafe,
The next step is to determine whether this state-law duty makes compliance with any federal law impossible. "Impossibility pre-emption is a demanding defense," Levine, 555 U.S. at 573, and it is not established here. Federal law, as the Bartlett Court pointed out and as Defendant argues, restricts a manufacturer from altering the design of a drug post-FDA approval. Bartlett, 133 S. Ct. at 2471 ("Once a drug—whether generic or brand-name—is approved, the manufacturer is prohibited from making any major changes to the `qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.'" (citing 21 C.F.R. § 314.70(b)(2)(i))). But counsel has cited no federal law that restricts a brand-name drug manufacturer from designing a reasonably safe product prior to FDA approval.
For all of the above reasons, the design defect claims asserted here are not barred by impossibility preemption under Bartlett. The Western District of Wisconsin has reached roughly the same conclusion for similar reasons. See Estate of Cassel v. Alza Corp., No. 12-CV-771-WMC, 2014 WL 856023, at *5 (W.D. Wis. Mar. 5, 2014). The Court acknowledges that the Western District of New York has applied Bartlett preemption to claims involving a brand-name drug. See Amos v. Biogen Idec Inc., 28 F.Supp.3d 164, 169 (W.D.N.Y. 2014). But in that case, the plaintiffs conceded that their design defect claims were preempted and withdrew them; apparently no party argued that the Bartlett Court's reasoning does not logically extend to brand-name drugs. Id. And to the extent that the Eastern District of Missouri has reached a conclusion inconsistent with this Court's decision, that case was construing Missouri law and is nonbinding. Thompson v. Allergan USA, Inc., 993 F.Supp.2d 1007, 1014 (E.D. Mo. 2014).
New York's interpretation of comment k to the Restatement (Second) of Torts § 402A does not bar the design defect claim. The New York Court of Appeals in Martin described the "comment k" defense as follows: "Although a prescription drug is by its nature an inherently unsafe product and would in the usual case impute strict liability to its manufacturer, a defense is provided against such liability when the drug is `properly prepared, and accompanied by proper directions and warning.'" 83 N.Y.2d at 8 (quoting Wolfgruber v. Upjohn Co., 423 N.Y.S.2d 95 (App. Div. 1979), aff'd, 52 N.Y.2d 768 (1980)). The "comment k defense is unavailable for products negligently manufactured, negligently distributed or unaccompanied by proper warnings." Id. Here, Plaintiff has adequately pleaded a failure to warn claim. See Part II.C, infra. Accordingly, the design defect claim is not barred by comment k at this stage.
Plaintiff has adequately alleged a design defect claim. To state a claim for design defect a plaintiff must show that: "(1) the product as designed posed a substantial likelihood of harm;
(2) it was feasible to design the product in a safer manner; and (3) the defective design was a substantial factor in causing the plaintiff's injury." Goldin v. Smith & Nephew, Inc., No. 12 CIV. 9217 JPO, 2013 WL 1759575, at *4 (S.D.N.Y. Apr. 24, 2013). Plaintiff alleges that her mother took Clomid and that due to an extended half-life, the medicine remained in her mother's system during the period of Plaintiff's organogenesis, causing Plaintiff's birth defects. The Second Amended Complaint further identifies scientific authorities purportedly opining that Clomid can remain in the mother's system during gestation and can cause birth defects when exposed to a fetus. Plaintiff alleges that "safer alternative designs" existed that were "economically and technologically feasible" that would have "prevented and/or significantly reduced the risk of the Plaintiff's injuries without impairing the reasonably anticipated or intended function of the product." It is plausible to infer that Plaintiff is referring to designs in which the drug does not remain in the mother's system during organogenesis. The above allegations are sufficient to place Defendant on notice of the nature of the Plaintiff's claims. Defendant argues that the Iqbal-Twombly standard demands more detail concerning how the design should have been altered and why it was feasible. Imposing such a standard would "require the plaintiff to possess technical or scientific knowledge about the inner workings of the product, which would contravene the notice pleading requirement of Federal Rule of Civil Procedure 8, even under the Iqbal-Twombly standard." Williamson, 2013 WL 3833081, at *4. The cases cited by Defendant are largely distinguishable because Plaintiff here has pleaded greater detail than the plaintiffs in those cases. Cf., e.g., DiBartolo, 914 F. Supp. 2d at 622-23; Lewis v. Abbott Labs., No. 08 CIV. 7480SCRGAY, 2009 WL 2231701, at *4 (S.D.N.Y. July 24, 2009); Reed v. Pfizer, Inc., 839 F.Supp.2d 571, 578 (E.D.N.Y. 2012). Plausibility requires "enough fact[s] to raise a reasonable expectation that discovery will reveal evidence" of the alleged misconduct. Twombly, 550 U.S. at 556. That standard is met here.
Plaintiff's manufacturing defect claim fares differently. Plaintiff's entire theory of the case is that Clomid causes birth defects, not the particular dose of Clomid that Plaintiff's mother took. All factual allegations point to the inference that Clomid was defective, if at all, by design. (E.g., Second Am. Compl. ¶ 24 ("Defendant knew or should have known about these adverse side effects as early as 1962 [i.e., thirty years before Plaintiff's mother took the drug]."); id. ¶ 40 ("Merrell submitted a proposed draft of an amended package insert . . . [including] a warning that Clomid and/or its metabolites may remain in the body during early pregnancy in every woman who conceives during a treatment cycle." (emphasis added)); id. ¶ 46 ("Clomid impairs the biosynthesis of cholesterol by inhibiting the function of enzymes. . . .").) The lone suggestion of a manufacturing defect—paragraph 78 of the Second Amended Complaint—is formulaic and conclusory. And even in that paragraph, Plaintiff simply alleges that "Clomid contained manufacturing defects," i.e., Clomid generally. Nowhere does Plaintiff allege that the dose(s) administered to Plaintiff's mother deviated from other doses in any way. Although a plaintiff is permitted to plead in the alternative, Fed. R. Civ. P. 8(d)(2)-(3), those alternative claims must find support in factual allegations. Here, the pleadings allege no facts to raise a reasonable expectation that discovery will reveal a manufacturing defect in the doses of Clomid administered to Plaintiff's mother. Accordingly, Plaintiff's manufacturing defect claim must be dismissed.
Defendant's arguments as to the adequacy of Plaintiff's failure to warn allegations are unavailing. Defendant's citation to the learned intermediary doctrine as a basis for dismissal must fail because Plaintiff does, in fact, allege that Defendant failed to warn Plaintiff's prescribing physician of the purported dangers of Clomid. Defendant's proximate cause argument is unconvincing. See Raney v. Owens-Ill., Inc., 897 F.2d 94, 95-96 (2d Cir. 1990) (proximate cause may be inferred from alleged circumstances). Accordingly, Plaintiff's failure to warn claim survives to the extent it is premised on Defendant's failure to warn Plaintiff's mother's physician.
Defendant's argument as to Plaintiff's claim for breach of implied warranty is largely premised on dismissal of her claims for design defect and manufacturing defect. As the Court has found that Plaintiff's design defect claim survives, these arguments are moot. Accordingly, the Court will not dismiss the claim for breach of implied warranty.
Defendant's claim that Plaintiff failed to "state how the express warranty was made" is simply untrue. (See Second Am. Compl. ¶ 58.) Defendant also argues that Plaintiff failed to allege that she complied with New York's litigation-notice requirement, N.Y. U.C.C. § 2-607(3)(a), which requires express warranty claimants to notify the defendant of the alleged breach within a reasonable time after having discovered it. "[R]equiring notice is designed to defeat commercial bad faith, not to deprive a good faith consumer of his remedy." Id. § 2-607 cmt. 4. "[T]he sufficiency and timeliness of the notice is generally a question for the jury." Tomasino v. Estee Lauder Cos. Inc., 44 F.Supp.3d 251, 260 (E.D.N.Y. 2014). Moreover, "what constitutes a reasonable time for taking an action depends on the nature, purpose and circumstances of such action." Id. (internal quotation marks omitted). "New York cases applying N.Y. U.C.C. § 2-607(3) suggest that a plaintiff's pleadings may constitute reasonable notice in certain cases." Id. at 261 n.6. Plaintiff alleges that Defendant actively concealed the breach and that she did not know and could not have known of the alleged breach. (See Second Am. Compl. ¶¶ 63-66.) These allegations are sufficient, for now, to preserve the claim.
Plaintiff's fraud claim must be dismissed because it is not pleaded with "particularity." Fed. R. Civ. P. 9(b). A fraud claimant must: "(1) detail the statements (or omissions) that the plaintiff contends are fraudulent, (2) identify the speaker, (3) state where and when the statements (or omissions) were made, and (4) explain why the statements (or omissions) are fraudulent." Harsco Corp. v. Segui, 91 F.3d 337, 347 (2d Cir. 1996). A plaintiff must allege "the who, what, when, where, and how" of the alleged fraud. See also PNCEF, LLC v. Oz Gen. Contr. Co., No. CV-11-724(SJF)(ARL), 2012 WL 4344538, at *8 (E.D.N.Y. Aug. 2, 2012).
Plaintiff's opposition identifies two fraudulent statements: (1) that Defendant "widely advertised and promoted Clomid as safe and effective medication for us [sic] to induce ovulation for the purpose of pregnancy" and (2) that Defendant "represented in its package inserts and other product labeling that `no causative evidence of a deleterious effect of Clomid therapy on the human fetus has been seen.'" Plaintiff's allegations with respect to the "advertise[ments] and promot[ions]" are wholly insufficient. Plaintiff does not allege which advertisements her mother saw, when she saw them, when they ran, the advertising medium (e.g., television, print, billboard), or what words were used. Plaintiff's allegations with respect to the representations on package inserts and "other product labeling" do allege the specific words used. But the Second Amended Complaint does not specifically allege that Plaintiff's mother read these representations (let alone when she viewed the "package inserts and other product labeling"), nor does the Second Amended Complaint specifically allege that Plaintiff's mother relied on the package insert or label (if she in fact read them) in deciding to take Clomid. DDR Const. Servs., Inc. v. Siemens Indus., Inc., 770 F.Supp.2d 627, 657-58 (S.D.N.Y. 2011) (a plaintiff must allege, inter alia, that "plaintiff believed and justifiably relied upon the statement and was induced by it to engage in a certain course of conduct"). Plaintiff identifies no authority that states that a court may infer reliance in these circumstances. Accordingly, this claim must be dismissed.
Defendant's sole proffered basis for dismissing the negligent misrepresentation claim is that Plaintiff was not in privity, or any relationship approaching privity, with Defendant, and that she has not alleged that she was a "known party" to Defendant or that Defendant undertook conduct linking it to her. See DiBartolo, 914 F. Supp. 2d at 624 (explaining that absent privity, a negligent misrepresentation claimant must allege "(1) an awareness by the maker of the statement that it is to be used for a particular purpose; (2) reliance by a known party on the statement in furtherance of that purpose; and (3) some conduct by the maker of the statement linking it to the relying party and evincing its understanding of that reliance"). This argument is logically incomplete on its face. Defendant does not explain why Plaintiff, rather than Plaintiff's mother, is the relevant person under these standards. Accordingly, the Court will not dismiss the claim on this basis.
The New York Court of Appeals recently clarified New York law on the availability of an unjust enrichment cause of action:
Corsello v. Verizon N.Y., Inc., 18 N.Y.3d 777, 790 (2012). The New York Court affirmed the trial court's dismissal of an unjust enrichment claim reasoning that because the plaintiffs had alleged actionable wrongs, "To the extent that these claims succeed, the unjust enrichment claim is duplicative; if plaintiffs' other claims are defective, an unjust enrichment claim cannot remedy the defects." Id at 791. Plaintiff has alleged actionable wrongs, and the unjust enrichment claim is based on identical facts. The unjust enrichment claim is dismissed.
For the foregoing reasons, Defendant's motion to dismiss is GRANTED in part and DENIED in part, and Plaintiff's claims of manufacturing defect, fraud, and unjust enrichment are DISMISSED. Defendant shall have twenty-one days from the date of this Order to file responsive pleadings. An initial case management and scheduling conference pursuant to Fed. R. Civ. P. 16 is scheduled for September 30, 2015 at 11:00 a.m., at the United States Courthouse, 300 Quarropas Street, Courtroom 218, White Plains, New York 10601. The parties shall confer in accordance with Fed. R. Civ. P. 26(f) at least 21 days prior to the conference and attempt in good faith to agree upon a proposed discovery plan that will ensure trial readiness within six months of the conference date. The patties shall also complete a Civil Case Discovery Plan and Scheduling Order and bring it to the conference. The Court respectfully directs the Clerk to terminate the motion at ECF No. 41 and to amend the caption of this case in accordance with the first page of this Opinion.
SO ORDERED.
1990 WL 137405, at *2 n.1. It is worth pointing out, though, that under the plaintiff's theory in Morgan, at least one of the children would not have existed at all but for the defendant's negligence.