Esposito v. Eli Lilly & Co. (In re Darvocet, Darvon & Propoxyphene Prods. Liab. Litig.)

Decision Date05 March 2012
Docket NumberCivil Action No.2:11–339–DCR.,Civil Action No. 2:11–330–DCR.,Civil Action No. 2:11–184–DCR.,Civil Action No. 2:11–182–DCR.,Civil Action No. 2:11–213–DCR.,Civil Action No. 2:11–335–DCR.,Civil Action No. 2:11–210–DCR.,Civil Action No. 2:11–298–DCR.,Civil Action No. 2:11–307–DCR.,Civil Action No. 2:11–352–DCR.,Civil Action No. 2:11–329–DCR.,Civil Action No. 2:11–297–DCR.,Civil Action No. 2:11–208–DCR.,MDL No. 2226.,Civil Action No. 2:11–195–DCR.,Civil Action No. 2:11–191–DCR.,Civil Action No. 2:11–190–DCR.,Civil Action No. 2:11–350–DCR.,Civil Action No. 2:11–355–DCR.,Civil Action No. 2:11–311–DCR.,Civil Action No. 2:11–301–DCR.,Civil Action No. 2:11–197–DCR.,Civil Action No. 2:11–325–DCR.,Civil Action No. 2:11–204–DCR.,Civil Action No. 2:11–295–DCR.,Civil Action No. 2:11–186–DCR.,Civil Action No. 2:11–196–DCR.,Civil Action No. 2:11–300–DCR.,Civil Action No. 2:11–312–DCR.,Master File No. 2:11–md–2226–DCR.,Civil Action No. 2:11–296–DCR.,Civil Action No. 2:11–175–DCR.,Civil Action No. 2:11–299–DCR.,Civil Action No. 2:11–200–DCR.,Civil Action No. 2:11–380–DCR.,Civil Action No. 2:11–328–DCR.,Civil Action No. 2:11–185–DCR.
Citation856 F.Supp.2d 904
PartiesIn re DARVOCET, DARVON AND PROPOXYPHENE PRODUCTS Liability Litigation. Esposito v. Eli Lilly and Company, et al., Alix v. Eli Lilly and Company, et al., Gilbert v. Eli Lilly and Company, et al., Hunsucker v. Eli Lilly and Company, et al., West v. Eli Lilly and Company, et al., Eldredge v. Eli Lilly and Company, et al., Kellehar v. Eli Lilly and Company, et al., Hallaway v. Eli Lilly and Company, et al., Lowe v. Eli Lilly and Company, et al., Coney v. Eli Lilly and Company, et al., Rogers v. Xanodyne Pharm. Inc., et al., Daugherty v. Eli Lilly and Company, et al., Meeks v. Eli Lilly and Company, et al., Simpson v. Qualitest Pharm., Inc., et al., Lynch v. Eli Lilly and Company, et al., Dickerson v. Eli Lilly and Company, et al., Labit v. Eli Lilly and Company, et al., Balben v. Eli Lilly and Company, et al., Forrest v. Eli Lilly and Company, et al., Noel v. Eli Lilly and Company, et al., Green v. Eli Lilly and Company, et al., Wheeler v. Eli Lilly and Company, et al., Knight v. Xanodyne Pharm., Inc., et al., Del Favero v. Xanodyne Pharm., Inc., et al., Blackwell v. Xanodyne Pharm., Inc., et al., Sandel v. Eli Lilly and Company, et al., Shumaker v. Eli Lilly and Company, et al., Felts v. Eli Lilly and Company, et al., Smith v. Eli Lilly and Company, et al., Lewis–Crossno v. Eli Lilly and Co., et al., Hect v. Eli Lilly and Company, et al., Adams v. Eli Lilly and Company, et al., Miller v. Eli Lilly and Company, et al., Wagers v. Eli Lilly and Company, et al., Brown v. Eli Lilly and Company, et al.
CourtU.S. District Court — Eastern District of Kentucky

OPINION TEXT STARTS HERE

MEMORANDUM OPINION AND ORDER REGARDING XANODYNE PHARMACEUTICALS, INC.'S MOTIONS TO DISMISS

DANNY C. REEVES, District Judge.

Xanodyne Pharmaceuticals, Inc. (“Xanodyne”) has filed three consolidated motions to dismiss in this multidistrict litigation. [MDL Record Nos. 444, 639, 666] It has also filed a motion to dismiss in an individual case, Wagers v. Eli Lilly and Company, et al., on the same grounds. [Civil Action No. 2: 11–355, Record No. 6] Xanodyne contends that the claims asserted against it by the plaintiffs in these cases should be dismissed pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. The basic thrust of the argument in support of these motions is that Xanodyne cannot be held liable to plaintiffs who have failed to establish that they ingested a product that it sold, manufactured, or distributed. Plaintiffs attempt to prevent dismissal by characterizing their misrepresentation claims as separate theories of recovery for which identification of the defendant's specific product is not required. For the reasons explained below, Xanodyne's motions will be granted.

BACKGROUND1

In 1957, the federal Food and Drug Administration (“FDA”) approved a New Drug Application (“NDA”) for Darvon, a propoxyphene-containing drug used to treat mild to moderate pain. Darvon was developed by Eli Lilly and Company (“Lilly”). The FDA approved Lilly's NDA for Darvocet, a drug which contained propoxyphene and acetaminophen, in 1973. Lilly retained all the rights to these propoxyphene-containing drugs until February 2002, when it sold its NDA to NeoSan. Xanodyne, in turn, purchased the rights from NeoSan on July 25, 2005.

In 2009, the FDA Advisory Committee voted to suspend the marketing of propoxyphene–containing drugs. The FDA ordered Xanodyne to conduct clinical trials to assess the dangers of cardiotoxicity from propoxyphene. The study confirmed that propoxyphene can cause “significant changes to the electrical activity of the heart.” News Release, U.S. Food & Drug Admin., Xanodyne Agrees to Withdraw Propoxyphene from the U.S. Market (Nov. 19, 2010). As a result, Xanodyne agreed to stop marketing propoxyphene products in the United States, and generic manufacturers of the drug were asked to do the same.

This multidistrict litigation (“MDL”) arises from injuries allegedly suffered as a result of ingesting propoxyphene products. Plaintiffs have brought various claims against Xanodyne, including: (1) strict liability theories of product liability; (2) negligence theories of product liability; (3) breach of express and implied warranty; (4) fraudulent nondisclosure; (5) negligent misrepresentation; and (6) fraudulent misrepresentation. Xanodyne filed its consolidated motions to dismiss on November 30, 2011, December 16, 2011, and December 20, 2011, respectively. [MDL Record Nos. 444, 639, 666] On February 27, 2012, the parties presented oral arguments on the issues raised in these motions.

ANALYSIS

Xanodyne seeks dismissal of the claims against it in all cases in which the plaintiffs “ingested formulations of [propoxyphene] manufactured, sold, and distributed by entities other than Xanodyne.” [MDL Record No. 445, p. 11] It argues that it is “black-letter law that a plaintiff cannot state a claim for injuries allegedly due to a purportedly defective product against a defendant that did not manufacture or distribute the product the plaintiff actually ingested.” [ Id.] Thus, Xanodyne asserts, the complaints do not satisfy the pleading requirements of Federal Rule of Civil Procedure 8(a), because they fail to sufficiently allege that Xanodyne sold or manufactured the product ingested and thus “contain merely ‘formulaic recitation[s] of the elements' of their causes of action.” [ Id., p. 22 (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)) ] Moreover, Xanodyne maintains that the complaints fail to state claims upon which relief may be granted because, regardless of the theory on which the claim is asserted, the claims asserted by plaintiffs are product liability claims. As such, identification of a specific defendant's product is required for a plaintiff to proceed against that defendant. [ Id., pp. 22–23] Finally, Xanodyne contends that it is entitled to dismissal of any derivative claims asserted against it, “because the derivative claims cannot survive without the substantive claims.” [ Id., p. 49]

I. Standard for Motion to Dismiss

Rule 8 of the Federal Rules of Civil Procedure provides that, to state a claim for relief, a pleading must contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(1). When evaluating a motion to dismiss under Rule 12(b)(6), the Court must determine whether the complaint alleges “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, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009) (quoting Twombly, 550 U.S. at 555, 127 S.Ct. 1955). The plausibility standard is met “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. (citing Twombly, 550 U.S. at 556, 127 S.Ct. 1955). It requires “more than a sheer possibility that a defendant has acted unlawfully.” Id. Thus, although the complaint need not contain “detailed factual allegations” to survive a motion to dismiss, “a plaintiff's obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Twombly, 550 U.S. at 555, 127 S.Ct. 1955 (internal quotation marks and alteration omitted).

II. Product Identification

In every state implicated by Xanodyne's motions, it is well-settled law that a “threshold requirement of any products-liability claim is that the plaintiff assert that the defendant's product caused the plaintiff's injury.” Smith v. Wyeth, 657 F.3d 420, 423 (6th Cir.2011).2 There is no theory of product liability under which a defendant can be held liable for an injury caused by a product that it did not sell, manufacture, or otherwise supply to the plaintiff. Therefore, in the context of product liability claims, a plaintiff must state sufficient allegations to allow at least the reasonable inference that the product that caused the injury was made, sold, or distributed by the defendant in question. See Iqbal, 129 S.Ct. at 1949. In this case, then, Xanodyne is entitled to dismissal of product liability claims asserted by plaintiffs who have either alleged the ingestion of another company's product or who have simply alleged that they do not know which defendant sold or manufactured the product ingested.

Not one of the plaintiffs in these cases has properly identified Xanodyne as the entity that marketed, sold, or manufactured the product he or she ingested. Instead, most actually allege that the plaintiff ingested a “generic form of Darvocet.” [ E.g., MDL Record No. 291 ¶ 8 (Balben Complaint) ] Several plaintiffs indicate that the product might have been sold by Xanodyne, but they plead themselves out of a claim by asserting that they ingested “Darvon, Darvocet and/or Propoxyphene.” [ E.g., MDL Record No. 302 ¶ 8 ( Hunsucker Complaint) ] Such allegations are insufficient to show that the plaintiff is entitled to relief because the “and/or” language permits the Court to infer the possibility that the plaintiff ingested only generic propoxyphene, and “it is this possibility that is fatal” to these complaints. Patterson v. Novartis Pharm. Corp., 451 Fed.Appx. 495, 497–98 (6th Cir.2011). Other plaintiffs allege the ingestion of Darvon or Darvocet, the brand name for propoxyphene, but then admit that they...

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