Houston v. Bayer Healthcare Pharmaceuticals, Inc.Houston v. Bayer Healthcare Pharmaceuticals, Inc.
AMENDED MEMORANDUM OPINION
Before the court is the motion of defendant Bayer Healthcare Pharmaceuticals, Inc, to dismiss this action pursuant to Federal Rule of Civil Procedure 12(b)(6). For the reasons that follow, the motion will be granted as to plaintiff’s implied warranty claim, but denied as to all other claims.
Background
For purposes of this opinion, all facts alleged in the complaint are taken as true. Plaintiff is a 26-year-old woman seeking to recover damages for injuries she alleges were caused by Mirena, a birth control device manufactured by defendant. Mire-na is a physical device placed in the uterus for up to five years. Compl. ¶ 19. It regularly releases “levonorgestrel,” a prescription medication, directly into the uterus. Id. ¶¶ 13, 17. It is used for birth control, id. ¶ 17, and “for treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception,” id. ¶ 15.
According to plaintiff, the levonorgestrel released by Mirena has been linked to development of a condition called “pseudo-tumor cerebri,” also known as “idiopathic intracranial hypertension,” (hereinafter,
Plaintiff used the Mirena device, id. ¶ 70, and was subsequently diagnosed with PTC/IIH, id. ¶ 72. She brings this action seeking recovery for her injuries under nine state law causes of action. The court has diversity jurisdiction under 28 U.S.C. § 1332 because the amount in controversy exceeds $75,000, and because defendant is a citizen of New Jersey and plaintiff is a citizen of Alabama.
Defendant now moves the court, pursuant to Federal Rule of Civil Procedure 12(b)(6), for dismissal of this case for failure to state a claim.
Analysis
Under the standard provided by Bell Atl. Corp. v. Twombly,
A. “Global Deficiency”
Defendant first argues that the complaint contains so few facts as to deprive defendant of fair notice of what it is being sued for. See Def.’s Mem. at 3-4; Def.’s Reply at 2-4 (arguing complaint is “so globally deficient” that it must be dismissed in its entirety, without analysis of any individual cause of action). As an initial matter, the court disagrees that there exists an abstract sufficiency hurdle, contained in the Federal Rule, that is entirely separate from any substantive law. So long as a plaintiff lists some cause of action in his complaint, the question is whether he has alleged facts to support that cause of action, not simply whether he has alleged facts. Indeed, the second prong of the Iqbal test, in which the court determines whether the complaint states a plausible claim for relief, requires by logical necessity some discussion of the elements of the causes of actions alleged. See
The only case from this district cited by defendant in support of its “global deficiency” theory, Weldon v. Washington Nat. Ins. Co., 2:13-CV-02209-RDP,
Even were such a “global deficiency” principle to exist, the court takes with healthy skepticism defendant’s claim that it has no notice here as to why it is being sued. The opening sentence of the complaint spells out that plaintiff seeks redress for “personal injuries suffered as a proximate result of [p]laintiff being prescribed and properly using the defective and unreasonably dangerous product Mire-na....” Compl. at 1. Later, plaintiff explains simply that she “had the Mirena IUS inserted into her body,” Compl. ¶ 70; that she subsequently became ill and “was ultimately diagnosed with [PTC/IIH],” id. ¶ 73; and that there exists some evidence that the disease was caused by the Mirena, id. ¶ 74; see id. ¶¶ 46-60 (evidence of possible link between levonorgestrel and PTC/ IIH). Finally, the complaint names and spells out eight causes of action, Compl. ¶¶ 76-189, so that defendant knows exactly where it needs to focus its attention as the case moves to the discovery phase. The complaint thus contains the “short and plain statement of the claim,” Fed.R.Civ.P. 8(a)(2), and the “demand for the relief sought,” 8(a)(3), required by the Federal Rules.
B. Missing Elements
While the complaint has not earned any general dismissal for “global deficiency,” it must still contain factual allegations sufficient to satisfy the elements of each individual claim. The court finds that plaintiff has failed to state a claim for breach of implied warranty, but that her other claims all survive defendant’s motion to dismiss.
1. Breach of Implied Warranty
Defendant’s sole winning argument is that plaintiff fails to state a claim for Breach of Implied Warranty (plaintiffs Count IV). Implied warranties are covered by the Alabama Commercial Code. Under § 7-2-314(1), “a warranty that the goods shall be merchantable is implied in a contract for their sale if the seller is a merchant with respect to goods of that kind.” Under § 7-2-314(2)(c), “goods to
This question came before the Supreme Court of Alabama, on certification from the Eleventh Circuit, in Spain v. Brown & Williamson Tobacco Corp.,
The Supreme Court’s answer was lengthy and not totally clear. The Court began by citing its decision in Shell v. Union Oil Co.,
The implied warranty mandated by this section of the U.C.C. is one of commercial fitness and suitability, and a private right of action is afforded only where the user or consumer is injured by the breach of that warranty. That is to say, the U.C.C. does not impose upon the seller the broader obligation to warrant against health hazards inherent in the use of the product when the warranty of commercial fitness has been complied with. Those injured by the use of or contact with such a product, under these circumstances, must find their remedy outside the warranty remedies afforded by the U.C.C.
Id. at 572 (emphases in original).
This reasoning would seem to answer the question decisively: the commercial code creates only commercial warranties, not safety warranties. However, the Spain court next described a subsequent case, Allen v. Delchamps, Inc.,
Without clear explanation, the Spain court concluded from these cases that “a claim alleging breach of an implied war
The product at issue in this case, the Mirena device, has a clear function other than consumption. It is used “for treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception,” Compl. ¶ 15, and “for birth control,” id. ¶ 17. The Commercial Code implied warranty is therefore not breached unless the Mirena fails to achieve these functions, regardless of what other harms it causes. That does not mean, of course, that a birth control device manufacturer can produce a device with unlimited danger so long as the device actually prevents pregnancy. It simply means that these dangers must be addressed by claims under tort theories such as the AEMLD, rather than under the Commercial Code. Because the only Mirena defect that plaintiff alleges in this ease is that it increases the risk of PTC/ IIH, plaintiff has not stated a claim for breach of implied warranty, and the implied warranty count will be dismissed.
2. Negligent Design
The remainder of defendant’s criticisms are less successful. Defendant first argues that plaintiff fails to state a claim for negligent design (plaintiffs Count I). Def.’s Mem. at 5-6. As the parties agree, negligence has four elements: plaintiff must provide evidence “that defendant (1) breached (2) a duty, which (3) proximately caused (4) plaintiffs injury.” E.R. Squibb & Sons, Inc. v. Cox,
Defendant is correct that these statements are legal conclusions, and the court will not consider them for purposes of the motion to dismiss. But defendant fails to take into account the many other statements in the complaint that do allege factual details. With respect to the duty and breach elements, the complaint alleges, among other things, that Mirena had “for-seeable risks associated with [its] design or formulation [including] the development of PTC/TIH, and rapid or sudden weight gain,” Compl. ¶ 80; and that “[d]espite an increasing number of [reported health issues], Defendant has made no effort to warn physicians, the healthcare community, or patients of the risk of developing [PTC/IIH] with Mirena,” Compl. ¶ 90. With respect to the causation and injury
Plaintiff meets the test of plausibility. It is, of course, true that one man’s “plausibility” is another man’s “implausibility.” It is as slippery a word as the word “reasonable.” Frankly, a jury is as qualified to determine what is or is not “plausible.”
3. Strict Liability/AEMLD Design Defect
Defendant next argues that plaintiff fails to state a claim for strict liability under the Alabama Extended Manufacturer’s Liability Doctrine (“AEMLD”) (plaintiffs Count III). Under the AEMLD, a plaintiff can recover under strict liability if he can show that “he suffered injury or damages to himself or his property by one who sells a product in a defective condition unreasonably dangerous to the plaintiff as the ultimate user or consumer, if (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.” Yamaha Motor Co., Ltd. v. Thornton,
Defendant originally argued in its Rule 12(b)(6) motion that plaintiff “does not identify what aspect of the Mirena design is allegedly defective.” Def.’s Mem. at 6. This argument is easily disposed of. Plaintiff alleged that the crucial defect of the Mirena device is that it “releases levo-norgestrel, a synthetic progestogen, directly into the uterus,” Compl. ¶ 17, and that this increases the risk of developing PTC/ IIH, Compl. ¶ 26. This must have occurred to defendant shortly after it filed its motion, because defendant’s argument had changed considerably by the time it filed its reply brief. There, it argues that plaintiff has not alleged a design defect because a Mirena without levonorgestrel would be an entirely different product. Def.’s Reply at 4-6. According to defendant, “[a]n allegation that a defendant should have manufactured a different product does not state a plausible design-defect claim.” Id. at 5.
Plaintiff has had no opportunity to respond to this new argument, and the motion to dismiss should be denied as to the AEMLD claim for that reason alone. See United States v. Krasnow,
Despite the fact that plaintiffs claim is based specifically on a doctrine called the “Alabama Extended Manufacturer’s Liability Doctrine,” defendant relies exclusively for its argument on cases applying the design defect laws of New York, Texas, and Louisiana. See Def.’s Reply at 5. Regardless of the definitions provided by those cases, “[f]or purposes of
4. Breach of Express Warranty
Defendant next argues the plaintiff has failed to state a claim for breach of express warranty (plaintiffs Count V). The Alabama Commercial Code provides that an express warranty is created by “[a] ny 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,” § 7 — 2—313(l)(a), or by “[a] ny description of the goods which is made part of the basis of the bargain,” § 7-2-313(l)(b). Defendant argues that plaintiff has failed to allege that any such affirmation of fact, promise, or description was made about the Mirena device.
Plaintiff has alleged facts to support her express warranty claim, albeit by the skin of her teeth. As to the “affirmation of fact or promise” element, she has alleged that the “designing, manufacturing, marketing, formulating, testing, packaging, labeling, producing, creating, making, constructing, assembling, and distributing of Mirena were expressly warranted to be safe ... for [p]laintiff and members of the public generally.” Compl. ¶ 153. As to the “part of the basis of the bargain” element, she has alleged that she “relied on [defendant's representations regarding Mirena in its package insert ... in deciding to use ... Mirena.” Id. ¶ 71. As to the breach element, she has alleged that “Mirena does not conform to these express warranties and representations because Mirena is not safe or effective and may produce serious side effects, including the development of [PTC/IIH]...” Id. \ 154. Taken as true, these allegations “plausibly,” in the eyes of this court, state a claim for breach of express warranty.
5. Fraud-Based Claims
Finally, defendant argues that plaintiff has failed to state claims based on fraud under the heightened pleading requirement of Federal Rule of Civil Procedure 9(b). These include plaintiffs claims for negligent misrepresentation (plaintiffs Count VI), fraudulent misrepresentation (plaintiffs Count VII), and fraud by suppression and concealment (plaintiffs .Count VIII). Rule 9(b) requires that, “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” In the Eleventh Circuit, this means that “a plaintiff must allege: ‘(1) the precise statements, documents, or misrepresentations made; (2) the time, place, and person responsible for the statement; (3) the content and manner in which these statements misled the Plaintiffs; and (4) what the defendants gained by the alleged fraud.’ ” Am. Dental Ass’n v. Cigna Corp.,
The allegations in this particular complaint meet the 9(b) standard when viewed in the context of the state law under which they are brought. In Alabama, a drug manufacturer “may be held liable for fraud or misrepresentation (by misstatement or omission)” based on “information and warning deficiencies” on a drug’s labelling. Wyeth, Inc. v. Weeks, No. 1101397,
Plaintiff has stated a claim of this kind with the “particularity” required by Rule 9. As to the “precise statements” requirement and the “time, place, person” requirement, she has alleged that Mirena comes with a package label that warns about certain dangers. Compl. ¶¶ 20-22. As to the “content and manner in which the statements misled” requirement, she has alleged that defendant “owed a duty to provide accurate and complete information regarding Mirena” on this labeling, id. ¶ 158, and that it breached this duty by failing to warn about “the increased risk of developing PTC/IIH, and the increased risk of suffering severe consequences due to not removing Mirena once a patient experiences symptoms of papilledema and/or [PTC/IIH],” id. ¶ 160. As to the “what defendants gained” requirement, she has alleged that this breach of duty induced plaintiff to use the Mirena device. Id. ¶¶ 162, 164. Defendant’s motion to dismiss will therefore be denied as to plaintiffs fraud-based claims.
6. Failure to Warn
Defendant does not argue that plaintiffs final claim, the failure to warn claim, (plaintiffs Count II), is deficient. The motion to dismiss will therefore be denied as to this claim.
C. Amendment
In a short, single paragraph at the end of her brief, plaintiff concludes with
Conclusion
For all the foregoing reasons, defendant’s motion to dismiss will be granted as to plaintiffs breach of implied and express warranty claims, but denied as to all other claims. The court will contemporaneously issue an order consistent with this opinion.
ORDER
For the reasons stated in the accompanying memorandum opinion, plaintiff has stated a claim upon which relief can be granted on all counts other than her breach of implied warranty count. Defendant’s motion to dismiss is GRANTED as to that claim, but DENIED as to all other claims.
Defendant shall answer the complaint no later than April 11, 2014.
Notes
. The Alabama Supreme Court has granted reargument in Wyeth, but the disposition of the issues under debate in that reargument will not effect the outcome of this case. In Wyeth, the plaintiff named as defendant the brand-name manufacturer of the drug at issue, though he had in fact been injured by a generic version of the drug produced by a third-party manufacturer. The Court agreed with plaintiff that liability for the brand-name manufacturer was appropriate because, under FDA rules, the generic manufacturer was required to reproduce verbatim the warning labels of the brand-name manufacturer. Whether or not the Supreme Court revisits that holding will not affect the underlying premise that a failure to provide proper warnings on drug labeling creates liability for fraud/misrepresentation by omission.