ROBERT C. CHAMBERS, Chief Judge.
Pending before the Court is Defendants' motion (ECF No. 50) to dismiss Plaintiffs' Second Amended Complaint ("SAC"). The parties presented oral argument regarding the motion to dismiss on January 16, 2013, in Huntington. For the reasons stated below, the Court
The drug at the center of this litigation — Plavix (clopidogrel bisulfate) — is a prescription anticoagulant, or blood thinner. The Food & Drug Administration ("FDA") initially approved Plavix for use
The Employer Teamsters-Local Nos. 175/505 Health and Welfare Trust Fund and International Brotherhood of Teamsters Voluntary Employee Benefits Trust ("Plaintiffs") commenced this action against Defendants Bristol Myers Squibb Company ("BMS"), Sanofi-Aventis U.S., L.L.C., and Sanofi-Aventis U.S., Inc.
Plaintiffs properly filed their First Amended Complaint ("FAC") on April 6, 2012, adding a claim for breach of implied warranty of merchantability in addition to unjust enrichment. ECF No. 13. Defendants moved for dismissal of the FAC, and that motion became ripe for disposition on July 9, 2012. The Court scheduled oral argument concerning the motion to dismiss for October 12, 2012, but then canceled oral argument because Plaintiffs indicated that they wanted to amend their pleadings.
Plaintiffs timely moved on October 18, 2012, for leave to file a second amended complaint due to recent legal developments, namely, a recently unsealed complaint filed in the Southern District of Illinois. See U.S. v. Bristol Myers Squibb, No. 11-cv-246-DRH-SCW (S.D.Ill.). The Court granted such leave, and Plaintiffs filed the SAC on October 24, 2012. ECF No. 48. As with the FAC, the SAC alleges unjust enrichment and breach of implied warranty of merchantability. The SAC differs from the FAC in many regards, however, such as: the attachment of multiple exhibits, whereas the FAC had none; the inclusion of more substantive details; reference to the recently unsealed complaint; and a re-wording of the breach of implied warranty claim.
Plaintiffs allege that Defendants misrepresented Plavix as being more effective than aspirin for certain indicated usages, namely treating patients who recently experienced myocardial infarction ("MI") or stroke. Specifically, Plaintiffs claim that Defendants mischaracterized scientific studies as supporting these efficacy claims, when in fact such studies do not actually show Plavix's superiority. Plaintiffs allege that the marketing campaign surrounding Plavix influenced doctors' decisions in prescribing the drug. While each Plavix pill costs approximately $4.00, an equivalent dose of aspirin costs approximately $0.04. Given this price difference and Plavix's lack of superiority over aspirin, Plaintiffs — as third party payors ("TPPs") — allege that they suffered damages by reimbursing Plavix prescriptions on behalf of their insureds. Plaintiffs allege that the monetary benefit retained by Defendants constitutes unjust enrichment. Plaintiffs further claim that Defendants have breached the implied warranty of merchantability. Specifically, Plaintiffs allege that "Plavix was not fit for its ordinary and intended pharmacological purpose of being a superior alternative to aspirin for certain indicated usages" and that "Defendants
Defendants have moved for dismissal of the SAC. ECF Nos. 50, 51. They argue that there are significant independent intervening events between the Plavix marketing and the prescription reimbursements, and that proximate causation is therefore lacking. Additionally, Defendants argue that Plaintiffs have not suffered any economic injury from paying for Plavix prescriptions because premiums cover the Plavix reimbursement costs, and insurance funds take into account the risk of wrongful prescriptions when setting premiums. Lastly, Defendants argue that Plaintiffs' claims sound in fraud and must therefore meet the pleading standard of Federal Rule of Civil Procedure 9(b), which such claims fail to do.
Defendants' motion to dismiss the SAC became ripe for disposition on December 3, 2012.
In Section I, the Court discusses generally the requirements of Rule 12(b)(6). Next, in Section II, the Court examines whether Plaintiffs plausibly state a claim for relief based on the elements of each claim, apart from any causation requirement; specifically, Section II discusses how Plaintiffs characterize Plavix's ordinary purpose, and Plaintiffs' pleading of unjust enrichment. Lastly, in Section III, the Court analyzes Plaintiffs' pleading of causation.
In Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007), the United States Supreme Court disavowed the "no set of facts" language found in Conley v. Gibson, 355 U.S. 41, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957), which was long used to evaluate complaints subject to 12(b)(6) motions. 550 U.S. at 563, 127 S.Ct. 1955. In its place, courts must now look for "plausibility" in the complaint. This standard requires a plaintiff to set forth the "grounds" for an "entitle[ment] to relief" that is more than mere "labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Id. at 555, 127 S.Ct. 1955 (internal quotation marks and citations omitted). Accepting the factual allegations in the complaint as true (even when doubtful), the allegations "must be enough to raise a right to relief above the speculative level...." Id. (citations omitted). If the allegations in the complaint, assuming their truth, do "not raise a claim of entitlement to relief, this basic deficiency should ... be exposed at the point of minimum expenditure of time and money by the parties and the court." Id. at 558, 127 S.Ct. 1955 (internal quotation marks and citations omitted).
In Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009), the Supreme Court explained the requirements of Rule 8 and the "plausibility standard" in more detail. In Iqbal, the Supreme Court reiterated that Rule 8 does not demand "detailed factual allegations[.]"
Plaintiffs allege that Defendants are liable for breach of implied warranty of merchantability and unjust enrichment because Plavix was not as effective as claimed. Specifically, Plaintiffs raise the following allegations:
SAC.
As mentioned earlier, Plaintiffs' SAC re-words the claim for breach of implied warranty of merchantability as it appeared in the FAC. In the SAC, Plaintiffs allege that "Plavix was not fit for its ordinary and intended pharmacological purpose of being a superior alternative to aspirin for certain indicated usages" and that "Defendants therefore breached the warranty implied by law that Plavix was fit for the ordinary purposes for which it was to be used." ¶ 58-59 (emphasis added). In comparison, the FAC alleged that "at the time of the purchases Plavix did not have the quality that a buyer would reasonably expect" and "at the time of these purchases, Defendants knew that Plavix was not of the quality to safely and effectively treat
West Virginia statutory law details the requirements of the implied warranty of merchantability:
W. Va.Code § 46-2-314 (emphasis added). This statute is based on the Uniform Commercial Code. See U.C.C. § 2-314. The implied warranty is created by operation of law, and is not premised on a seller's promises or representations beyond identifying the ordinary purpose of the product.
Plavix's ordinary purpose is to act as an anticoagulant. The FDA approved Plavix for its blood-thinning properties in treating patients who experienced a recent heart attack, stroke, PAD, or ACS. There is no indication that the FDA approval was related to Plavix's efficacy compared to aspirin and other alternatives. Also, this Court has reviewed the Plavix labeling information, and has found nothing on that label suggesting that Plavix's ordinary purpose was to act as a superior alternative to aspirin or Aggrenox.
Plaintiffs do not allege that Plavix was not fit for its ordinary purpose of being an anticoagulant. Rather, Plaintiffs allege that Plavix was not better than alternatives such as aspirin and Aggrenox. Under the U.C.C., claims about a product's superiority over another product are not part of the implied warranty of merchantability. RICHARD A. LORD, 18 WILLISTON ON CONTRACTS § 52:76 (4th ed. 2012) (footnotes omitted) ("As a general principle ... the implied warranty of merchantability requires only that the goods be fit for their ordinary purpose, not that they be perfect or in perfect condition, or be outstanding or superior, or of the best or highest quality."); see also Sessa v. Riegle, 427 F.Supp. 760, 769 (E.D.Pa.1977), aff'd, 568 F.2d 770 (3d Cir.1978) ("The standard established [by U.C.C. § 2-314] does not require that
Iqbal and Twombly require that a cause of action be supported by factual allegations sufficient to make the claim plausible. The factual allegations in the SAC concern affirmative conduct by Defendants amounting to an express warranty
Next the Court turns to Plaintiffs' unjust enrichment claim. The elements of an unjust enrichment claim are: "(1) a benefit conferred upon the [defendant], (2) an appreciation or knowledge by the defendant of such benefit, and (3) the acceptance or retention by the defendant of the benefit under such circumstances as to make it inequitable for the defendant to retain the benefit without payment of its value." Veolia Es Special Servs., Inc. v. Techsol Chem. Co., No. 3:07-cv-0153, 2007 WL 4255280, at *9 (S.D.W.Va. Nov. 30, 2007) (citing 26 WILLISTON ON CONTRACTS § 68:5 (4th ed.)). West Virginia specifically requires that the benefits were "received and retained under such circumstance that it would be inequitable and unconscionable to permit the party receiving them to avoid payment therefor." See Realmark Devs., Inc. v. Ranson, 208 W.Va. 717, 542 S.E.2d 880, 884-85 (2000) (citing Copley v. Mingo Cnty. Bd. of Educ., 195 W.Va. 480, 466 S.E.2d 139 (1995)).
The Court notes that at least one state allows unjust enrichment claims to be dismissed when the underlying tort claim has also been dismissed. See, e.g., In re Yasmin & Yaz (Drospirenone) Mktg., Sales Practices & Prods. Liab. Litig., No. 3:09-MD-02100-DRH, 2010 WL 3119499, at *9 (S.D.Ill. Aug. 5, 2010) (citing Allegheny Gen. Hosp. v. Philip Morris, Inc., 228 F.3d 429 (3d Cir.2000)) (dismissing unjust enrichment claim, under Pennsylvania law, when fraud or misrepresentation claim had been dismissed). West Virginia law has no such requirement, and so the Court's dismissal of the breach of implied warranty claim would not alone provide a sufficient basis for dismissing the unjust enrichment claim.
The Court nonetheless dismisses Plaintiffs' unjust enrichment claim because, as with their claim for breach of implied warranty of merchantability, Plaintiffs have not pled unjust enrichment with sufficient plausibility to pass muster under Iqbal and Twombly. The SAC alleges that Defendants misrepresented Plavix's efficacy, Defendants
In summary, the Court dismisses both of Plaintiffs' causes of action for failure to state a plausible claim.
Even if Plaintiffs had sufficiently alleged that Plavix failed to fulfill its ordinary purpose and that Defendants' retention of payments for Plavix — a drug which fulfilled its ordinary purpose as an anticoagulant — constituted unjust enrichment, both claims would still be dismissed for failure to sufficiently plead proximate causation.
Defendants claim that the causation between the alleged marketing activities and the reimbursement of Plavix prescriptions is riddled with too many intervening events for the Court to impose liability on Defendants. In support of their motion to dismiss, Defendants point to Pennsylvania Employees Benefit Trust Fund v. AstraZeneca Pharmaceuticals LP, No. 6:09-cv-5003-Orl-22DAB, 2009 WL 2231686 (M.D.Fla. July 20, 2009). In that case, a health and welfare trust fund sued AstraZeneca for breach of express warranty and unjust enrichment, based on AstraZeneca's alleged misleading and false marketing of the drug Seroquel. The district court held that reliance was a required element of the express warranty claim, and would have dismissed on those grounds alone. See id. at *4 ("[T]he third party recipient of an express warranty must be aware of the specific terms of the warranty in order to sustain a claim for breach of that warranty. Thus, Plaintiff cannot simply rely on the prescription pads of physicians or claims for reimbursement from pharmacies as a means by which express warranties were conveyed.").
That district court separately concluded, however, that the complaint also failed to allege proximate causation, as distinct from reliance. In doing so, that court relied on its own earlier discussion of proximate cause in Ironworkers Local Union No. 68 v. AstraZeneca Pharmaceuticals LP, 585 F.Supp.2d 1339 (M.D.Fla.2008), aff'd on other grounds, 634 F.3d 1352 (11th Cir.2011). Specifically, the district court stated that "[t]hough this Court's opinion in Ironworkers examined the issue of proximate cause primarily in the context of Plaintiffs' federal RICO claims, the reasoning underlying that opinion applies with equal force to the state claims presented in this case." Pa. Emps. Benefit Trust Fund, 2009 WL 2231686, at *5 (footnote omitted). The court then noted that "physicians use their independent medical judgment to decide whether Seroquel is the best treatment for a given patient," and "[this] independent judgment can be influenced by a number of things, only one of which may be representation by a manufacturer as to a particular drug's relative safety and efficacy." Id., 2009 WL 2231686, at *5 (quoting Ironworkers, 585 F.Supp.2d at 1344). The court then dismissed for lack of proximate causation.
The district court decision in Ironworkers, affirmed on other grounds by the
Another district court has applied the Holmes "direct relation" proximate causation standard, this time to misleading marketing claims against Bayer for its advertising of the contraceptive drug YAZ. In re Yasmin, 2010 WL 3119499 (S.D.Ill. Aug. 5, 2010). That district court, relying on Holmes, dismissed the plaintiffs' civil RICO claims, and additionally dismissed the plaintiffs' common law negligence and misrepresentation claims. Id., 2010 WL 3119499, at *7-9 (noting that "the proximate cause analysis for Plaintiffs' common law actions mirrors the direct proximate cause analysis applicable in civil RICO actions").
The Third Circuit Court of Appeals examined causation, and found it lacking, in In re Schering Plough Corp. Intron/Temodar
These situations are distinguishable from that presented in In re Neurontin Marketing & Sales Practices Litigation, where the District Court of Massachusetts entered judgment in favor of Plaintiffs Kaiser Foundation Health Plan and Kaiser Foundation Hospitals on their claim against Pfizer under California's Unfair Competition Law, in relation to Pfizer's marketing of the drug Neurontin. No. 04-CV-10739-PBS, 2011 WL 3852254 (D.Mass. Aug. 31, 2011). In support of this judgment, the court noted that defendants had made misrepresentations about Neurontin directly to and concealed information directly from Kaiser's Drug Information Service ("DIS"), which is responsible for researching drugs and forwarding drug information to the committees that ultimately decide what drugs to approve for prescription by doctors. Id. at *56.
The courts in the above cases all engaged in necessary line-drawing to limit the permissible scope of recovery when an alleged injury involves a potentially complex chain of causation with many intervening events. The Supreme Court of Appeals of West Virginia engaged in similar line drawing in White v. Wyeth, 227 W.Va. 131, 705 S.E.2d 828 (2010), where individuals who purchased and used certain hormone replacement therapy drugs sought damages from drug manufacturer Wyeth and an advertising agency. The plaintiffs alleged that the defendants engaged in unfair and deceptive advertising and marketing practices, in violation of the West Virginia Consumer Credit and Protection Act ("WVCCPA"). In the course of answering a certified question about the pleading of reliance under the WVCCPA, the court examined the nature of the acts alleged. Specifically, "when consumers allege that a purchase was made because of an express or affirmative misrepresentation, the causal connection between the deceptive conduct and the loss would necessarily include proof of reliance on those overt representations." Id. at 837 (citations omitted). In contrast, "[w]here concealment,
In the end, however, the court found that the statutory consumer action at issue, West Virginia Code Section 46A-6-106(a), and the WVCCPA generally, did not apply to private causes of action related to prescription drugs. Id. at 837-38. This is because doctors, rather than consumers, select which drugs to prescribe to an individual, and consumers are thereby protected by the doctor's medical judgment. Id. (citations omitted). White examines a cause of action under the WVCCPA, which has its own statutory purposes, as distinct from the causes of action in the instant case. Therefore, although Plaintiffs' allegations characterize Defendants' wrongful conduct as the types of affirmative acts which would require reliance under White, this Court hesitates to find that Plaintiffs must prove reliance in the present case.
In summary, Holmes and the other cases above suggest that the proximate causation analysis is about carefully drawing a line so as to distinguish the direct consequences in a close causal chain from more attenuated effects influenced by too many intervening causes. Based on the foregoing, this Court is persuaded that the proximate causation analysis for both of Plaintiffs' claims should be similar to that utilized in claims for consumer fraud and RICO, as well as other state law claims, as outlined above. Although the cases discussed involve various causes of action, they all use the same guiding principles in assessing proximate causation, and this Court is guided by those same principles in the instant case. The Court finds that Plaintiffs' claims do not satisfy the "direct relation" test found in Holmes and affirmed by the district court in Ironworkers, and also finds that the policies announced in Holmes weigh in favor of dismissal here. Between Defendants' alleged misleading marketing and Plaintiffs' prescription reimbursements lies a vast array of intervening events, including the "independent medical judgment" of doctors. Ironworkers, 585 F.Supp.2d at 1344. Without any specific allegations as to who received these misrepresentations, how the misrepresentations influenced doctors, and why certain patients received Plavix instead of alternative medications, this Court is left without sufficient allegations from which to properly infer that proximate causation is satisfied. Therefore, both of Plaintiffs' claims should be dismissed for lack of causation.
Because the Court has found other grounds which provide sufficient justification for dismissing both of Plaintiffs' claims, the Court need not reach the issue of whether Plaintiffs' claims sound in fraud and, if so, whether Plaintiffs' claims satisfy the higher pleading standard mandated under Federal Rule of Civil Procedure
For the reasons stated above, the Court
The Court
Though a claim for breach of implied warranty of fitness for a particular purpose may also theoretically be possible, Plaintiffs have not presented this claim either. See W. Va.Code, § 46-2-315.
Holmes, 503 U.S. at 269-70, 112 S.Ct. 1311 (citations omitted). The Supreme Court mentions that these policies underlie Clayton Act causation, and "apply with equal force" to RICO claims. Id. at 269, 112 S.Ct. 1311. This Court likewise finds these policies to be persuasive in the causation analysis generally.