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.
BACKGROUND
In 1957, the federal Food and Drug Administration (“FDA”) approved a New
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.” [7d] 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,
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
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 plaintiffs injury.” Smith v. Wyeth,
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
The plaintiffs’ responses identify several individual cases in which, although the complaints did not identify Xanodyne as the supplier of the product that caused the injury, the plaintiffs have subsequently confirmed the ingestion of a Xanodyne
III. Misrepresentation Theories
The plaintiffs contend that, regardless of the viability of their product liability claims, they have asserted a valid, separate claim for misrepresentation. [MDL Record No. 914, pp. 23-31] They maintain that even if their product liability claims fail, Xanodyne can still be held liable under misrepresentation theories “sounding in negligence and fraud.” [Id., p. 23] According to this argument, the plaintiffs “do not seek to hold Xanodyne liable because its products caused them harm; rather, they seek to hold Xanodyne hable because its misrepresentations did.”
Xanodyne counters that “the overwhelming national consensus is that brand-name drug manufacturers, sellers, and distributors cannot be held liable for injuries caused by drugs manufactured, sold, or distributed by other companies.” [MDL Record No. 445, p. 48] It asserts that the misrepresentation claims “stem[ ] from the use of a product” and are therefore properly characterized as product liability claims. [MDL Record No. 1034, p. 7] Moreover, Xanodyne argues, even if the plaintiffs can successfully show that their claims are not based on product liability law, “they cannot escape another fundamental principle of tort law — legal duty.” [Id., p. 9]
A. Misrepresentation Claims Are Product Liability Claims.
Xanodyne cites several cases in which the court found that misrepresentations such as those asserted by the plaintiffs here “are[] in fact ‘product liability’ claims that do not survive unless the plaintiff actually took the defendant’s product.” [Id., p. 8 (citation omitted) ] Indeed, the courts in many states have expressly rejected the argument that misrepresentation claims are distinct from product liability or failure-to-warn claims. E.g., Burke v. Wyeth, Inc., No. G-09-82,
B. Xanodyne Has No Legal Duty Toward Consumers of Generic Products.
Even assuming that misrepresentation claims against Xanodyne can be seen as distinct and separate from product liability claims, these claims must be dismissed in cases where plaintiffs ingested propoxyphene products that Xanodyne did not sell, manufacture, or distribute. As acknowledged by the plaintiffs in their complaints, the existence of a duty of care on the part of a manufacturer is one of the elements that must be established to prevail on a claim for fraud or misrepresentation. [See, e.g., MDL Record No. 287 ¶¶336, 358, 377 (Alix Complaint)] Thus, to hold Xanodyne liable for misrepresentation in cases that do not allege the ingestion of a Xanodyne product, plaintiffs must establish that Xanodyne owed them (or their prescribing physician) a legal duty.
Plaintiffs assert that the Court should “hold brand manufacturers liable for the damages their representations foreseeably caused to users of generic drugs.” [MDL Record No. 914, p. 31] In support, plaintiffs rely on two cases, Conte v. Wyeth, Inc. and Kellogg v. Wyeth, from the California Court of Appeal and the District of Vermont, respectively.
[I]t is reasonably foreseeable that a physician will rely upon a brand name manufacturer’s representations — or the absence of representations — about the risk of side effects of its drug, when deciding to prescribe the drug for a patient, regardless of whether the pharmacist fills the prescription with a generic form of the drug.
Kellogg,
As the plaintiffs conceded at oral argument, Conte and Kellogg represent a minority position, with the overwhelming majority of courts instead adopting a rule that rejects “the contention that a name brand manufacturer’s statements regarding its drug can serve as the basis for liability for injuries caused by another manufacturer’s drug.” Foster v. Am. Home Prods. Corp.,
Nevertheless, the plaintiffs maintain that these decisions do not bar their claims. [MDL Record No. 914, pp. 33-71] They contend that there are no “definitive rulings” in the states at issue because none of the decisions cited by Xanodyne were issued by the relevant state’s highest court. [Id., pp. 30, 33 (arguing that “not one of the opinions on Xanodyne’s list is from the highest court of any state”)] Additionally, the plaintiffs assert that the cases contrary to Conte and Kellogg were wrongly decided, and they urge this Court to reach a different outcome. The Court finds this argument to be without merit.
A federal court sitting in diversity is bound to follow the law of the forum state. See Erie R.R. Co. v. Tompkins,
IV. Wagers v. Eli Lilly and Company
In addition to the consolidated motions in the MDL proceeding, Xanodyne has filed a motion to dismiss in the individual case of Wagers v. Eli Lilly and Company, et al. (Civil Action No. 2: 11-355). This case was removed by Eli Lilly on December 7, 2011, after which it was consolidated with the MDL proceeding. [MDL Record No. 662] The case was removed to this Court the basis of diversity of citizenship. Although both the plaintiff and Xanodyne are citizens of Kentucky, Lilly alleged in its notice of removal that Xanodyne had been fraudulently joined in order to defeat federal jurisdiction.
There is fraudulent joinder when there is “sufficient evidence that a plaintiff could not have established a cause of action against non-diverse defendants under state law.” Coyne ex rel. Ohio v. Am. Tobacco Co.,
Because the Court has subject matter jurisdiction, it has the authority to rule on Xanodyne’s motion to dismiss. Cf. Baker v. Home Depot, No. 6:06-cv-526,
V. Leave to Amend
The plaintiffs seek leave to amend their complaints, in the event that the Court concludes that the product identifications provided in these cases are insufficient. [Record No. 914, p. 22] However, the Court notes that plaintiffs generally are “not entitled to an advisory opinion from the district court informing them of the deficiencies of the complaint and then an opportunity to cure those deficiencies.” Winget v. JP Morgan Chase Bank, N.A., 537 F.3d 565, 573 (6th Cir.2008). Under Iqbal, plaintiffs should not be permitted to conduct discovery in order to fix factually deficient complaints, even where the necessary information is within the defendant’s exclusive possession. New Albany Tractor, Inc. v. Louisville Tractor, Inc.,
CONCLUSION
The plaintiffs who have been identified in the motions to dismiss have failed to set forth allegations that establish — or even allow the Court to properly infer — that they ingested a Xanodyne product. Moreover, the plaintiffs have not identified any rule of law that would allow them to recover from a defendant that did not sell, manufacture, or distribute the product that caused their injuries. Therefore, the plaintiffs’ claims against Xanodyne will be dismissed as failing to state a plausible claim on which relief can be granted. Because claims for wrongful death and loss of consortium are derivative of the other claims asserted against Xanodyne, any derivative claims in the plaintiffs’ complaints will also be dismissed. Accordingly, it is hereby
ORDERED as follows:
1. Xanodyne’s Consolidated Motions to Dismiss [MDL Record Nos. 444, 639, 666] are GRANTED.
2. Xanodyne’s Motion to Dismiss in Wagers v. Eli Lilly and Company, et at., [Civil Action No. 2: 11-355, Record No. 6] is GRANTED.
3. In accordance with this Memorandum Opinion and Order, the claims asserted against Defendant Xanodyne Pharmaceuticals, Inc. in the following cases are DISMISSED, with prejudice:
• Case No. 2: 11-175;
• Case No. 2: 11-182;
• Case No. 2: 11-184;
• Case No. 2: 11-185;
• Case No. 2: 11-186;
• Case No. 2: 11-190;
• Case No. 2: 11-191;
• Case No. 2: 11-195;
• Case No. 2: 11-196;
• Case No. 2: 11-197;
• Case No. 2: 11-200;
• Case No. 2: 11-204;
• Case No. 2: 11-208;
• Case No. 2: 11-210;
• Case No. 2: 11-213;
• Case No. 2: 11-295;
• Case No. 2: 11-296;
• Case No. 2: 11-297;
• Case No. 2: 11-298;
• Case No. 2: 11-299;
• Case No. 2: 11-300;
• Case No. 2: 11-301;
• Case No. 2: 11-307;
*915 • Case No. 2: 11-311;
• Case No. 2: 11-312;
• Case No. 2: 11-325;
• Case No. 2: 11-328;
• Case No. 2: 11-329;
• Case No. 2: 11-330;
• Case No. 2: 11-335;
• Case No. 2: 11-339;
• Case No. 2: 11-350;
• Case No. 2: 11-352;
• Case No. 2: 11-355; and
• Case No. 2: 11-380.
Notes
. This opinion provides a basic history of the MDL proceeding. Future opinions in this action will contain only a brief summary of
. See also, e.g., Barnes v. Kerr Corp.,
. The Dickerson Complaint phrases this somewhat differently, instead alleging, “Plaintiff cannot determine every Defendant” that manufactured the particular product that caused the harm. [MDL Record No. 310 ¶ 15 (emphasis added) ] While this could be interpreted to mean that the plaintiff in Dickerson is able to identify some but not all of the manufacturers, the lack of specificity in his earlier allegations defeats a finding that Xanodyne manufactured the product Dickerson ingested. [Id. ¶ 13 (alleging only the ingestion of "Darvocet (brand name), Darvon 65 mg (brand name), Propo-N/Apap 100-65 (generic) for pain management for nearly 38 years, dating back to September of 1970” and failing to name any defendant manufacturer or provide any specific dates of ingestion) ] Plaintiffs do not dispute that the Dickerson Complaint does not specifically identify Xanodyne as the “seller of the drugs that [Dickerson] ingested.” [MDL Record No. 914, p. 21]
. The Meeks Complaint alleges that the plaintiff ingested Darvocet, which is the brand-name product. However, the complaint lacks any factual allegations regarding the time frame in which the product was ingested, making it impossible to determine which company manufactured or sold the product. [Record No. 298 ¶¶ 8-9] The Daugherty Complaint, on the other hand, alleges the ingestion of Darvocet-N 100 (a brand-name product) and provides dates, but those dates do not support a plausible conclusion that Xanodyne manufactured the products ingested. [Record No. 312 ¶ 64 (alleging ingestion of products manufactured by Eli Lilly, Qualitest, Mylan, and TEVA, but not Xanodyne) ]
. The Court must also dismiss claims that require identification of a specific defendant's product to proceed, even if they are not characterized as product liability claims. For instance, in Mississippi, warranty claims are separate from the Mississippi Product Liability Act. Bennett v. Madakasira,
. Xanodyne points out that this assertion is in contrast to the language of the complaints themselves. [MDL Record No. 1034, p. 8] Indeed, the introductory allegations of the complaints seemingly characterize the actions as product liability cases. Almost all begin with the following language: “This lawsuit concerns personal injury related to Plaintiff’s ingestion of prescription medication containing the active ingredient propoxyphene.” [E.g., MDL Record No. 287 ¶ 1] Even the complaint in Eldredge, in which the only claims against Xanodyne are brought under theories of misrepresentation, contains this language. [MDL Record No. 300 ¶ 1]
. None of the cases subject to these motions implicate the law of either California or Vermont.
. See also Metz v. Wyeth LLC,
. Wagers has not opposed the removal or filed a motion to remand.
