DANNY C. REEVES, District Judge.
This matter is pending for consideration of the joint Motion to Dismiss filed by Defendants Brenn Distribution, Inc.; Brenn Manufacturing, Inc.; Covidien, Inc.; Generics Bidco I, LLC; Generics Bidco II, LLC; Generics International (US Parent), Inc.; Generics International (US), Inc.; Mallinckrodt Holdings, LLC; Mallinckrodt, Inc.; Mylan Pharmaceuticals, Inc.; Mylan, Inc.; Propst Distribution, Inc.; Qualitest Pharmaceuticals, Inc.; Teva Biopharmaceuticals USA, Inc.; Teva Pharmaceuticals USA, Inc.; Vintage Pharmaceuticals, Inc.; Vintage Pharmaceuticals, LLC; Watson Pharmaceuticals (New Jersey), Inc.; and Watson Pharmaceuticals, Inc. (collectively, "the Generic Defendants").
This multidistrict litigation ("MDL") arises from injuries the plaintiffs or their decedents allegedly suffered as a result of ingesting propoxyphene, a prescription pain medication sold under the brand names Darvon and Darvocet as well as in generic form. Shortly before the MDL proceedings were transferred to this Court, the United States Supreme Court issued its decision in Mensing, holding that federal law, which requires warning labels on generic drugs to match those of the corresponding brand-name drugs, preempted the plaintiffs' state-law failure-to-warn claims against generic drug manufacturers. See 131 S Ct. at 2572. Because state law placed a duty "on all drug manufacturers to adequately and safely label their products," while federal law "prevented [generic] [m]anufacturers from independently changing their drugs' safety labels," id. at 2577, it was impossible for generic manufacturers to comply with both state and federal law. Id. at 2578. In other words, generic manufacturers' state-law duty to strengthen the drug labels directly conflicted with their "ongoing federal duty of sameness." Id. at 2575; see id. at 2578. Thus, under the doctrine of impossibility preemption, the Supremacy Clause mandated that state law must "give way." Id. at 2577.
The plaintiffs in this MDL were permitted to amend their complaints following publication of the Mensing decision. [See Record No. 198] In their amended complaints, the plaintiffs generally allege the following claims against the Generic Defendants: design defect (strict liability), defect due to inadequate warning (strict liability), negligent design, negligence, negligent failure to warn, fraudulent nondisclosure, negligent misrepresentation, fraudulent misrepresentation, statutory negligence, breach of express warranty, and breach of implied warranty.
The plaintiffs maintain that Mensing is inapplicable to their amended claims, primarily because they "are not contending that the Generic Defendants should have added new, unapproved warnings about propoxyphene's risks," but rather "that the Generic Defendants knew their product was unreasonably dangerous and should have voluntarily withdrawn it from the market."
According to the plaintiffs, their "wrongful marketing" claims include design defect, negligent design, negligence, and breach of implied warranty. [Id. at 15] They point to two Sixth Circuit decisions, Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010), and Tobin v. Astra Pharmaceutical Products, Inc., 993 F.2d 528 (6th Cir. 1993), that supposedly constitute "controlling precedent" requiring the Court to find against preemption. [Record No. 568, p. 16] In Wimbush and Tobin, the Sixth Circuit concluded that state-law tort claims were not preempted by the Food, Drug and Cosmetic Act ("FDCA"). See 619 F.3d at 646; 993 F.2d at 537. Both cases were decided prior to Mensing, however. More importantly, neither involved a generic manufacturer.
The question in Wimbush and Tobin was whether initial approval of a drug by the federal Food and Drug Administration ("FDA") resulted in preemption of state-law tort claims based on the brand-name manufacturer's alleged wrongdoing "in the process leading up to . . . approval." Wimbush, 619 F.3d at 643; see id. at 642 ("As the district court framed it, the issue is whether a state-court finding that a manufacturer was negligent in bringing the drug to market conflicts or is inconsistent with the FDA's subsequent approval of that drug for the market."); Tobin, 993 F.2d at 537 (rejecting defendants' contention that allowing state products liability claims amounted to "a mockery of the scientific analysis employed by the FDA and the Advisory Committee which conclusively found that [the drug] was efficacious" (internal quotation marks omitted)). Here, by contrast, the conflict between state and federal law arises out of the sameness requirement imposed on generic manufacturers by the FDCA after the drug is approved. As the Mensing Court recognized, this distinction is significant.
131 S. Ct. at 2582; see id. at 2581 & n.8 (distinguishing Wyeth, 555 U.S. 555). In short, the Court agrees with the Generic Defendants that Wimbush and Tobin, "which involve different legal theories, implicate a different regulatory scheme, and were decided prior to Mensing, are inapposite." [Record No. 1038, p. 10]
This leaves the plaintiffs' contention that there is no conflict between state and federal law (and thus, no preemption) because the Generic Defendants were always free to simply remove propoxyphene products from the market. [See Record No. 568, pp. 15-24.] The Mensing plaintiffs made the same argument, without success, in their petition for rehearing. See Respondents' Petition for Rehearing, Pliva, Inc. v. Mensing, 131 S.Ct. 2567 (July 18, 2011) (No. 09-993), 2011 U.S. S. Ct. Briefs LEXIS 878, at *3-6. And on remand, the Eighth Circuit interpreted Mensing to encompass such claims, vacating the portion of its earlier opinion that embraced the failure-to-withdraw theory and denying the plaintiff's motion to file a supplemental brief on that issue, among others. See Mensing v. Wyeth, Inc., 658 F.3d 867 (8th Cir. 2011), and 588 F.3d 603, 611 (8th Cir. 2009) ("The generic defendants were not compelled to market metoclopramide. If they realized their label was insufficient but did not believe they could even propose a label change, they could have simply stopped selling the product."); Appellant Gladys Mensing's Motion for Leave to File a Supplemental Brief at 4-5, Mensing, 658 F.3d 867 (Sept. 8, 2011) (No. 08-3850). The Sixth Circuit was likewise unpersuaded by the post-Mensing failure-to-withdraw argument. See Smith v. Wyeth, Inc., 657 F.3d 420, 423 (6th Cir. 2011); Appellants' Supplemental Letter Brief Regarding Pliva, Inc. v. Mensing at 5-6, Smith, 657 F.3d 420 (Aug. 15, 2011) (Nos. 09-5460, 09-5466, 09-5509); see also Gross v. Pfizer, Inc., No. 10-cv-00110-AW, 2011 U.S. Dist. LEXIS 134895, at *8-9 (D. Md. Nov. 22, 2011) (noting rejection of failure-to-withdraw argument in Mensing and Smith).
While the plaintiffs attempt to get around Mensing by asserting "failure to withdraw" rather than failure to warn, they have not demonstrated that their so-called wrongful marketing claims escape preemption.
The plaintiffs assert that Mensing does not preclude warning claims premised on the Generic Defendants' alleged failure to timely change the labeling on their propoxyphene products after July 2009, when the FDA ordered Xanodyne to strengthen the label. [See Record No. 568, pp. 31-33.] At least two courts have found, since Mensing, that generic manufacturers may be liable for failure to warn if the FDA had already approved a label change — i.e., if it would not have been impossible for the generic manufacturer to comply with both state and federal law. See Lyman v. Pfizer, Inc., No. 2:09-cv-262, 2012 U.S. Dist. LEXIS 13185, at *16-19 (D. Vt. Feb. 3, 2012); Fisher v. Pelstring, No. 4:09-cv-00252-TLW, 2011 U.S. Dist. LEXIS 116162, at *12 (D.S.C. Sept. 30, 2011). Both cases, however, involved metoclopramide (the drug at issue in Mensing), which the generic manufacturer acknowledged did not bear a strengthened warning approved by the FDA in 2004. See Fisher, 2011 U.S. Dist. LEXIS 116162, at *12 ("[The] possible deviation in PLIVA's label for generic metoclopramide, which both parties indicate exists, is sufficient to conclude the plaintiffs' claims are not entirely preempted." (emphasis added)).
There is no such consensus in this case. Instead, the sole indication that a failure to update occurred is the following vague allegation:
[See Record No. 287, p. 43 ¶ 205; see also id., p. 19 ¶ 96, p. 51 ¶ 241, p. 57 ¶ 258 (same).]
Regardless of any preemption issues, the plaintiffs are still subject to basic pleading requirements. Thus, their complaints "must contain sufficient factual matter, accepted as true, to `state a claim to relief that is plausible on its face.'" Ashcroft v. Iqbal, 129 S.Ct. 1937, 1949 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)). 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). It requires "more than a sheer possibility that a defendant has acted unlawfully." Id.
Under this standard, the plaintiffs' conclusory allegations, which consist of "pure conjecture" that generic propoxyphene labels were not timely updated, fail. In re Fosamax (Alendronate Sodium) Prods. Liab. Litig. (No. II), No. 08-008 (GEB-LHG), 2011 U.S. Dist. LEXIS 135006, at *38 (D.N.J. Nov. 21, 2011) ("That a failure to timely update [drug] labeling `could have occurred' is nothing `more than a sheer possibility' and is not `sufficient to state a claim for relief.'" (quoting Iqbal, 129 S. Ct. at 1949)). Here, the complaints do not: (1) identify which of the Generic Defendant(s) allegedly failed to make the label changes; (2) elaborate on the allegation of untimeliness (e.g., length of delay or why it was unreasonable); or (3) explain how any alleged failure to update injured the plaintiffs. The plaintiffs thus have offered "nothing `more than a sheer possibility'" that one or more of the Generic Defendants may have failed to timely update the labeling on propoxyphene products after July 2009 and that the plaintiffs were injured as a result. Id. (quoting Iqbal, 129 S. Ct. at 1949). Preemption issues aside, these claims cannot withstand the Generic Defendants' motion to dismiss.
Finally, the plaintiffs assert that Defendants Mylan Pharmaceuticals, Inc.; Mylan, Inc. (collectively "Mylan"); and Watson Pharmaceuticals, Inc. are not protected by Mensing because they were the reference listed drug ("RLD") holders for certain propoxyphene products. [See Record No. 568, pp. 35-37.] The Generic Defendants do not dispute that Mylan and Watson were RLD holders. However, they point to FDA publications indicating that the FDA, not the RLD holder, controls label changes if the new drug application ("NDA") holder has removed its product from the market for reasons other than safety or effectiveness. See, e.g., Determination That Brethine (Terbutaline Sulfate) Injection Was Not Withdrawn from Sale for Reasons of Safety or Effectiveness, 72 Fed. Reg. 39,629 (July 12, 2007) ("If the FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise [Abbreviated New Drug Application] applicants to submit such labeling."). Further, they cite a recent federal case in which the same argument was rejected. See Moore v. Mylan, Inc., No. 1:11-CV-03037-MHS, 2012 U.S. Dist. LEXIS 6897, at *20-25 (N.D. Ga. Jan. 5, 2012). The plaintiffs, meanwhile, provide no authority to support their contention that when a generic drug manufacturer becomes an RLD holder, it is thereby empowered to independently change the drug's warning label. Thus, the Court is unpersuaded that Mylan and Watson are subject to liability based on their status as RLD holders.
All remaining claims relate to the sufficiency of the warnings on propoxyphene products and, therefore, are preempted in accordance with Mensing. As the plaintiffs admit, their fraud, misrepresentation, and consumer-protection claims challenge label content. [See Record No. 568, p. 39 n.20 ("Plaintiffs have alleged that these claims relate to misrepresentations on the products['] labeling . . . ."); see Record No. 287, p. 62 ¶ 272 (describing representations allegedly made by the Generic Defendants "in their instructional materials and labeling"); see also id., p. 67 ¶ 287 (same).] Because the Generic Defendants were required to conform their labeling to that of the brand-name drugs, they could not have corrected any alleged misrepresentation without running afoul of federal law. Cf. Mensing, 131 S. Ct. at 2577-78. Likewise, any express warranty contained in the labeling was beyond the Generic Defendants' control.
The plaintiffs' claim of statutory negligence is also preempted. Although they state in their response that this claim "assert[s] only traditional state common law causes of action" [Record No. 568, p. 41], as described in the complaint, it is premised on the Generic Defendants' alleged "violat[ion of] federal standards for the sale of prescription drugs set forth in the [FDCA]." [Record No. 287, p. 69 ¶ 300; see id., p. 70 ¶ 301 (same)] The count includes a laundry list of federal regulations, mostly relating to labeling or "misbranding," allegedly violated by the Generic Defendants. [See id., pp. 70-71 ¶¶ 301(a)-(i).] Such claims are precluded by Mensing insofar as they challenge the content of generic drug labels.
To the extent the plaintiffs allege that the Generic Defendants failed to comply with the FDCA or FDA regulations, their claim is preempted pursuant to Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001). In Buckman, the Supreme Court held that because the exclusive power to enforce the FDCA rests with the FDA, state-law claims "based on failure to properly communicate with the FDA" were preempted. Mensing, 131 S. Ct. at 2578 (citing Buckman, 531 U.S. 341). Because there is no private right to enforce the FDCA, see Buckman, 531 U.S. at 349 n.4, the plaintiffs' statutory negligence claim, which is based solely on alleged FDCA violations, must fail. Finally, the plaintiffs acknowledge that if their underlying tort claims are preempted, their derivative claims — e.g., wrongful death, survivorship, unjust enrichment, and loss of consortium — likewise cannot survive the Generic Defendants' motions to dismiss. [See Record No. 568, p. 42.]
The Court rejects the plaintiffs' contention that they should be allowed discovery and another chance to amend their complaints. "Plaintiffs [are] not entitled to an advisory opinion from the 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) (alteration in original) (internal quotation marks omitted). Under Iqbal, plaintiffs are not 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., 650 F.3d 1046, 1051 (6th Cir. 2011) (citing Iqbal, 129 S. Ct. at 1954). Rather, in such cases, dismissal with prejudice is proper. See id. at 1053.
Furthermore, the Court should deny leave to amend a pleading if amendment would be futile. Winget, 537 F.3d at 573. Counsel for the plaintiffs acknowledged at oral argument that if the Court found their claims to be preempted, there would be no reason to amend the complaints. Likewise, insofar as certain plaintiffs individually opposed the Generic Defendants' motions to dismiss on the ground that they had not had an opportunity to amend their complaints to conform to the "master complaint" (i.e., the Alix Amended Complaint), the futility of such an amendment renders their request moot. [See Record No. 574.]
In accordance with this memorandum opinion, it is hereby
Additionally, the motions to dismiss filed by Defendants Covidien, Inc. and Mallinckrodt, Inc. [MDL Record No. 674] and Defendants Mylan, Inc. and Mylan Pharmaceuticals, Inc. [MDL Record No. 684] in Civil Action No. 2: 11-352, which are based on the same arguments addressed herein, are likewise
In light of the Court's resolution of the Generic Defendants' joint motions to dismiss, the supplemental Motions to Dismiss filed by Defendants Covidien, Inc.; Mallinckrodt, Inc.; and/or Mallinckrodt Holdings, LLC [MDL Record Nos. 459, 469, 474, 542, 544, 546, 555, 557, and 559]; Teva Pharmaceuticals USA, Inc. [MDL Record Nos. 462, 561, 562, 563, 564, 565, and 566]; Teva Biopharmaceuticals USA, Inc. [MDL Record No. 567]; and Mylan, Inc. and/or Mylan Pharmaceuticals, Inc. [MDL Record Nos. 503, 517, and 520] are
Finally, because the plaintiffs' proposed First Supplemental and Amended Complaints in Civil Action Nos. 2: 11-307, 2: 11-311, and 2: 11-312 seek to assert claims against defendants dismissed from this action under the rationale set forth above and in other opinions issued this date, their motions to file First Supplemental Amended Complaints [MDL Record Nos. 1111, 1113, and 1114] are