DAVID BRAMLETTE, District Judge.
Plaintiff Annie Chatman brings suit in this Court pursuant to 28 U.S.C. § 1332 against Defendants Pfizer, Inc., Wyeth LLC, and Schwarz Pharma, Inc. N/K/A UCB, Inc., manufacturers of the brand-name drug Reglan (collectively, Brand Defendants), and Defendants Pliva, Inc., Barr Laboratories, Inc., and Teva Pharmaceuticals USA, Inc., manufacturers of Reglan's generic equivalent, metoclopramide (collectively, Generic Defendants). The First Amended Complaint [docket no. 55] alleges that, after taking metoclopramide, Chatman developed tardive dyskinesia, an irreversible neurological disorder characterized by repetitive and involuntary bodily movements, and states various state law claims against the Defendants. The Generic Defendants have moved for judgment on the pleadings pursuant to Rule 12(c)
Any difficulty these Motions present is not with the relevant facts, which are few and, for the present purposes, undisputed. Rather, the difficulty these Motions present is in resolving the question of whether either group of Defendants can be liable for causing Chatman's neurological disorder.
In 2007, Chatman's physician prescribed either Reglan or its generic equivalent metoclopramide to treat her gastroesophageal reflux disease (GERD). Two years after taking the generic drug, Chatman was diagnosed with tardive dyskinesia. Am. Compl. ¶ 23, docket no. 55; Pl.'s Pharm. Records, docket no. 72-3; Pl.'s Stipulation of Schwarz Prod. Id., docket no. 72-5; Pl.'s Stipulation of Wyeth Prod. Id., docket no. 72-6. The Generic Defendants argue that they cannot be liable for Chatman's injuries because all her causes of action are pre-empted by federal law. To reach this conclusion, they first contend, correctly, that the Supreme Court held in PLIVA,
Following on the heels of this argument are the Brand Defendants, who concede that federal law would not pre-empt a failure-to-warn claim against them, see Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009), but argue that the facts only support a failure-to-warn claim against the Generic Defendants because Chatman has admitted that she took the generic drug. They too cite case after case which holds that a brand-name drug manufacturer cannot be liable for the harms caused by its failure to warn of the dangers of taking a drug that it did not manufacture. They further contend that no alternative common-law theory of liability exists under which they could be liable for harms caused by a product that they did not make. In the end, the message of both groups of Defendants is the same: it may be unfortunate for Chatman, but the FDA has dealt her a losing hand. Mensing, 131 S.Ct. at 2581.
The Generic Defendants' Rule 12(c) motion is evaluated under the familiar 12(b)(6) standard. Jebaco, Inc. v. Harrah's Operating Co., 587 F.3d 314, 318 (5th Cir.2009). In considering a motion under Rule 12(b)(6), the "court accepts `all well-pleaded facts as true, viewing them in the light most favorable to the plaintiff.'" Martin K. Eby Constr. Co. v. Dallas Area Rapid Transit, 369 F.3d 464, 467 (5th Cir. 2004) (quoting Jones v. Greninger, 188 F.3d 322, 324 (5th Cir.1999)). However, "the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions. Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice." Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)).
To overcome a Rule 12(b)(6) motion, a plaintiff must plead "enough facts to state a claim to relief that is plausible on its face." Twombly, 550 U.S. at 570, 127 S.Ct. 1955. "Factual allegations must be enough to raise a right to relief above the speculative level, on the assumption that all the allegations in the complaint are true (even if doubtful in fact)." Id. at 555, 127 S.Ct. 1955 (citations and footnote omitted). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 556 U.S. at 678, 129 S.Ct. 1937.
While the Generic Defendants overstate their position with the assertion "Mensing mandates dismissal of the lawsuit," the Supreme Court's holding in that case is the obvious starting point. In Mensing, two plaintiffs separately brought suits in the Eighth and Fifth Circuits, alleging, like Chatman, that they developed tardive dyskinesia after taking metoclopramide.
In the present case, Chatman has pleaded the following claims against the Generic Defendants: negligence (Count I); strict liability (Count II); breach of warranties (Count III); misrepresentation, suppression of the evidence, and fraud (Count IV); and gross negligence (Count V). Even Chatman agrees that to the extent that these claims against the Generic Defendants fall within Mensing's holding, her claims are also pre-empted. Pl.'s Resp. Br. at 7. The debate between the Parties is (1) whether Mensing forecloses her failure-to-warn claim, even though she has alleged that the Generic Defendants did not communicate to her the FDA-approved 2003 and 2004 labeling changes, and (2) whether Mensing forecloses all of her remaining causes of action against the Generic Defendants because they are, at base, failure-to-warn claims. The Court will address each of these issues in turn.
As to Chatman's first so-called attempt to "plead around Mensing," Chatman asserts in her brief that the 2002 labeling for metoclopramide in the Physicians' Desk Reference (PDR) — the reference book on which the prescribing doctor may have relied — did not account for Reglan's FDA-approved 2003 and 2004 labeling changes, which respectively warned of the dangers the drug posed to geriatric consumers and the dangers of long-term use. Chatman argues that the Generic Defendants
The Fifth Circuit recently repudiated Chatman's failure-to-update argument in an published opinion. See Morris v. PLIVA, Inc., 713 F.3d 774, 776 (5th Cir.2013). Interpreting Mensing, the Fifth Circuit explained that not only does the Hatch-Waxman Act's "same as" requirement apply to the content of the labeling, but it also applies to how the labeling is communicated. Id. In other words, a generic manufacturer can only communicate the same information communicated by the brand-name manufacturer. Id. In her Amended Complaint, Chatman alleges that both the Brand Defendants and the Generic Defendants failed to update their labeling to match the stronger 2003 and 2004 FDA-approved labeling. Am. Compl. ¶ 113(m). Because she alleges that the Brand Defendants did not "take the lead" in communicating the stronger 2003 and 2004 warnings, see id., she may not maintain her failure-to-update argument against the Generic Defendants.
The more hotly disputed issue is whether Chatman's other claims against the Generic Defendants can be either reduced to a failure-to-warn claim or should be dismissed on other grounds. Specifically, the Generic Defendants argue that Mensing, Mississippi law, and Chatman's own pleadings work against the survival of each of her state-law claims. As the Generic Defendants recognize, the national consensus is that Chatman's other claims are poorly camouflaged failure-to-warn claims, and therefore most courts have rebuffed plaintiffs' attempts to recover under alternative state-law theories of liability including negligence and fraud. Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 187 (5th Cir. 2012) (per curiam) (citing cases). If Chatman's remaining claims are disguised failure-to-warn claims, then they are unquestionably subject to Mensing's preemption analysis.
The Mississippi Product Liability Act (MPLA), Miss.Code Ann. § 11-1-63, is the exclusive remedy for Chatman's strict liability claims against the Generic Defendants. Lawson v. Honeywell Int'l, Inc., 75 So.3d 1024, 1027 (Miss.2011). This statute has a failure-to-warn, defective-design, and breach-of-express-warranty component. Miss.Code Ann. § 11-1-63(a)(i) 2-(i)(4). The Court has already addressed Chatman's failure-to-warn claim above and therefore focuses on her two remaining products liability theories. The Generic Defendants argue that Chatman has failed to properly plead these alternative theories, but if the Court disagrees, they alternatively argue that these claims are also foreclosed by Mensing.
Having carefully considered Chatman's Count II, which is something of an amalgamation of each of Mississippi's strict liability theories, the Court concludes that Chatman has not successfully pleaded a design-defect claim. To start, for this theory to be successful, Chatman must not only identify the defect in the design but also allege that a viable alternative design exists. See Miss.Code Ann. § 11-1-63(f)(ii). Regardless of how liberally her Amended Complaint is construed, Chatman has done neither and, for this reason alone, she has not properly pleaded a true design-defect claim. Instead, what Chatman clearly and consistently alleges is that the drug's "defect" is in the information which did and did not accompany the drug, including warnings about the drug's extended use, the dangers posed to geriatric patients, and the possibility of developing tardive dyskensia. These allegations can only relate to the drug's labeling and thus are allegations that make up a failure-to-warn claim. The same is true of Chatman's breach-of-express-warranty claim, which is likewise premised entirely on the "factual representations" regarding the drug's use (in other words, the labeling). See Miss.Code Ann. § 11-1-63(a)(i) 4. There can be no doubt that Chatman's statutory claims are based on the inadequacy of the warning she was given, and therefore these claims are subject to Mensing and thus fall within the analysis above.
As for Chatman's other claims, there is some question as to whether those claims are still viable under Mississippi law. Some district courts have said that the MPLA "subsumes" other common-law claims of negligence against a product manufacturer or seller. Lashley, 877 F.Supp.2d at 471. Other district courts have stated that common-law negligence claims "can be brought alongside strict liability claims," but a determination as to the MPLA claims is dispositive of any coexisting common-law claims of product defect. McSwain v. Sunrise Med., Inc., 689 F.Supp.2d 835, 846 (S.D.Miss.2010) (explaining how Mississippi law is equivocal on this point); see also Murray v. Gen. Motors, LLC, 2011 WL 3684517, at *3 (S.D.Miss. Aug. 22, 2011) ("[A] plaintiff's
In fact, the Fifth Circuit has recognized the inherent overlap between strict liability claims and other common-law claims of negligence in the context of harms caused by prescription-drug use. In Swayze v. McNeil Laboratories, Inc., 807 F.2d 464 (5th Cir.1987), the plaintiffs brought suit against a drug manufacturer, alleging that their seven-year-old son lost his arm, and ultimately his life, because the drug manufacturer failed to warn of the dangers of intravenously administering the anesthetic fentanyl. Id. at 467. After considering the plaintiffs' claims, the court determined that the plaintiffs' strict liability and negligence claims were subject to the same fate because the reasonableness of the defendant's conduct depended on the adequacy of the warning.
The present circumstances, at least with regard to the Generic Defendants, are similar, if not identical, to those in Swayze. Lashley, 877 F.Supp.2d at 471. Chatman's injuries allegedly stem from her long-term use of metoclopramide, and her common-law theories of liability are premised on the inadequacy of the information provided to her through the Reglan-metoclopramide labeling. In Counts I and V, she alleges that the Defendants were negligent or grossly negligent in developing and monitoring their labeling. Am. Compl. ¶ 113. In Count III, she alleges that Defendants impliedly warranted through their labeling (the package inserts) that their drug was not unreasonably dangerous and was fit for its intended use. Id. ¶ 121. Even in Count IV, her fraud count, she alleges that the Defendants
Despite her good-faith attempt to "plead around Mensing," the only conclusion that the Court can reach is that Chatman uses each claim to attack the adequacy of the labeling and each falls within Mensing's sphere. To be clear, even if the Generic Defendants knew that their labeling contained false information and knew that their labeling was causing serious harm to consumers, i.e., if they intentionally committed some form of fraud under Mississippi law in connection with their labeling, Mensing instructs that the Supremacy Clause prevents Mississippi from imposing liability on them for harms caused in connection with their labeling because federal law renders them powerless to alter their drug's labeling under any circumstances. Mensing, 131 S.Ct. at 2577-78. Accordingly, Chatman's negligence, gross negligence, misrepresentation, suppression of the evidence, and fraud claims against the Generic Defendants must be dismissed with prejudice because those claims are pre-empted by the FDA's regulatory scheme.
As for the Brand Defendants, a different standard of review applies to their Motion for Summary Judgment. Summary judgment is apposite "if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R.Civ.P. 56(a). "A fact is `material' if its resolution in favor of one party might affect the outcome of the lawsuit under governing law. An issue is `genuine' if the evidence is sufficient for a reasonable jury to return a verdict for the nonmoving party." Ginsberg 1985 Real Estate P'ship v. Cadle Co., 39 F.3d 528, 531 (5th Cir.1994) (citations omitted). The party moving for summary judgment bears the initial responsibility of apprising the district court of the basis for its motion and the parts of the record which indicate the absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).
"Once the moving party presents the district court with a properly supported summary judgment motion, the burden shifts to the non-moving party to show that summary judgment is inappropriate." Morris v. Covan World Wide Moving, Inc., 144 F.3d 377, 380 (5th Cir.1998). "The evidence of the non-movant is to be believed, and all justifiable inferences are to be drawn in his favor." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). But the nonmovant must "do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). Moreover, "[t]he mere existence of a scintilla of evidence is insufficient to defeat a properly supported motion for summary judgment." Anderson, 477 U.S. at 252, 106 S.Ct. 2505. Summary judgment must be rendered when the nonmovant "fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Celotex Corp., 477 U.S. at 322, 106 S.Ct. 2548.
In her Amended Complaint, Chatman alleges the same claims against the Brand Defendants that she alleges against the Generic Defendants. Federal law does not preclude recovery from the Brand Defendants, and therefore they could be liable
Chatman, like many other plaintiffs who have found themselves in a similar predicament after Mensing, attempts to impose some liability on the Brand Defendants by virtue of the their connection to the Reglan-metoclopramide labeling. See Pl.'s Resp. Br. at 2. The theory Chatman advances has come to be known as "innovator" liability. See Allen Rostron, Prescription for Fairness: A New Approach to Tort Liability of Brand-Name and Generic Drug Manufacturers, 60 Duke L.J. 1123, 1176 (2011). The basic idea behind the theory is that the brand-name drug companies are responsible for creating and monitoring the content of both the brand-name and generic drug's labeling and therefore they can be liable for the harms caused by the labeling under common-law theories of liability, typically misrepresentation theories. The hope is that by attributing the harm to the labeling, a plaintiff may hold the brand-name manufacturer liable, particularly since the Supreme Court recently held that federal law protects generic manufacturers from any liability. This theory is not new, and as the Brand Defendants point out in a page-long footnote of string citations in their brief, see B. Defs.' Br. at 17-18 n. 10, it has been rejected by the overwhelming majority of district courts, including three courts applying Mississippi law. See, Gardley-Starks, 917 F.Supp.2d at 603-05, 2013 WL 139900, at *5; Lashley, 877 F.Supp.2d at 473; In re Darvocet, 856 F.Supp.2d 904, 909-910 (E.D.Ky.2012).
While the theory's near universal rejection by other district courts raises questions as to its viability, Erie requires this Court to carefully apply Mississippi law. E.g., Capital City Ins. Co. v. Hurst, 632 F.3d 898, 902 (5th Cir.2011). And Mississippi law-regardless of whether other jurisdictions would agree with its rationale —
In Honeywell, Pamela Lynn Lawson was involved in an automobile accident and alleged that her injuries were caused by her seatbelt buckle malfunctioning. Honeywell Intern., Inc., 75 So.3d at 1026. She brought suit against the seatbelt buckle designer, Honeywell International, Inc., in state court under theories of strict liability (MPLA claim), negligence, and negligence per se.
As to the first question, the Mississippi Supreme Court agreed with the trial court that Honeywell did not fall within the scope of the MPLA because Honeywell did not "produce" the seatbelt buckle. Id. at 1028-29. It reasoned that the MPLA only applies to manufacturers or sellers, and after consulting Black's Law Dictionary, concluded that because Honeywell did not "produce" the seatbelt buckle it was not a manufacturer. In its view, Honeywell was a "mere designer", id. at 1030, and mere designers are not subject to the MPLA. Id. at 1029. As to the second issue, however, the supreme court disagreed with the trial court that the MPLA was Lawson's exclusive remedy against Honeywell. It explained that the MPLA is only applicable to manufacturers and sellers, and because Honeywell was a "nonmanufacturing designer," the trial court erred by ruling that the MPLA precluded other common-law claims. Id. at 1030. Accordingly, the Mississippi Supreme Court remanded the case to the trial court so that Lawson's case could proceed to trial against Honeywell on her remaining claims. Id. at 1025.
Chatman agues that the Brand Defendants are in a similar position to a nonmanufacturing designer and thus may be liable for the dissemination of false and misleading information that they knew she would rely upon and that proximately caused her injuries. Pl.'s Resp. Br. at 11. The Brand Defendants' response to this assertion is two-fold. First, they claim to
The Brand Defendants are manufacturers of Reglan. Chatman clearly states in her brief that she is suing the Brand Defendants not because they made Reglan or designed metoclopramide, but because they are responsible for the warning that she was given. Pl.'s Resp. Br. at 2, 15. This allegation is substantiated by the scattered factual allegations and legal theories throughout her Amended Complaint. In order to prevail on Chatman's product liability claims, the Brand Defendants have made exceedingly clear that they were not the manufacturer of the drug Chatman ingested. They have been granted summary judgment on Chatman's products liability claims for this reason alone. Now they seek summary judgment on the ground that they are manufacturers. In addition to the case law, commonsense and fairness dictates that they cannot have it both ways. For the purposes of Chatman's misrepresentation claims, the Brand Defendants are not manufacturers.
Second, the Brand Defendants argue that Honeywell does not impose upon them a "new" duty under Mississippi law to protect a consumer from harms caused by a product manufactured by another. See B. Defs.' Reply Br. at 5. This assertion may be true, but Chatman's common-law claims are not necessarily foreclosed for this reason. Honeywell, at minimum, establishes that (1) the MPLA only applies to manufacturers and sellers and (2) common-law claims against a nonmanufacturer or non-seller, even when they arise from the same set of facts that support a products liability claim against another defendant, are not subject to or "subsumed by" the MPLA. See Honeywell Intern., Inc., 75 So.3d at 1030 (distinguishing Jowers by stating that manufacturers and nonmanufacturers must be treated differently); see also, Hankins v. Ford Motor Co., 2011 WL 6180410, at *6 n. 4 (S.D.Miss. Dec. 13, 2011). Based on these two premises, what Honeywell means to Chatman is simply that she may maintain her misrepresentation claims against the Brand Defendants even though they did not manufacture the product that contributed to her injury.
Accordingly, Chatman's claims cannot be dismissed simply as products liability claims, as the Brand Defendants urge.
Appearing to recognize that Honeywell might support this conclusion, the Brand Defendants go on to assert that finding that they owed a duty to Chatman in these circumstances would abandon settled principles of Mississippi law and "saddle" Mississippi with an aberrant tort rule. While the absence of an analogous case imposing liability appears to underpin their assertion, more fundamentally, they imply that because they had no relationship with Chatman, they had no duty to her. See B. Defs.' Br. at 15. Even if this fact was undisputed,
To elaborate briefly, the Brand Defendants could have a duty to Chatman without having a relationship with her if she is alleging that the warning given to her contained false information. Clark, 660 So.2d at 974. In an affirmative misrepresentation case, even though a defendant does not have a relationship with the plaintiff, it is still possible for the defendant to be liable for causing the plaintiff's physical injury if the plaintiff reasonably relies on false information provided by the defendant.
To this point, it is appropriate for the Court to address the "mountain of
Moreover, if foreseeability had been the Foster Court's "principal determinant,"
Turning back to the present case, as explained above, under Mississippi law the existence of a duty depends upon the nature of the parties' relationship only if Chatman is alleging that she was harmed not because of what the Brand Defendants did communicate to her, i.e., misfeasance, but because of what the Brand Defendants failed to communicate to her, i.e., nonfeasance. See Jowers, 2009 WL 995613, at *6. Absent a special or fiduciary relationship with Chatman, the Brand Defendants would not have a duty to prevent Chatman's injury — even if her injury was foreseeable — as long as the warning given to Chatman was not false and that it contributed to her injury.
Both Parties did an excellent job briefing what appears to be a difficult area of Mississippi law, but neither Party cited cases or raised facts that this Court deems dispositive to Chatman's misrepresentation claims. The Court suspects that Chatman is alleging that the problem with the warnings that were given to her were that they were not sufficient to protect her from injury. This allegation would be a misrepresentation claim by omission.
In light of the foregoing,
Miss. Code Ann. § 11-1-63(c)(ii) (emphasis added).