United States District Court, S.D. Mississippi.
Decided March 27, 2013
[Copyrighted Material Omitted]
For Annie Chatman, Plaintiff: James Russell Segars, III, LEAD ATTORNEY, G. Joseph Diaz, Jr., THE DIAZ LAW FIRM, PLLC, Madison, MS.
For Pfizer, Inc., Wyeth, LLC, Defendants: Walter T. Johnson, LEAD ATTORNEY, WATKINS & EAGER, Jackson, MS; Leigh Davis Vernon, WATKINS & EAGER, PLLC, Jackson, MS.
For Schwarz Pharma, Inc., Defendant: John Simeon Hooks, LEAD ATTORNEY, ADAMS AND REESE, Ridgeland, MS.
For Pliva, Inc., Barr Pharmaceuticals, Inc., Defendants: Ronald Giles Peresich, Jr., LEAD ATTORNEY, Page, Mannino, Peresich & McDermott, PLLC, Biloxi, MS; Matthew V. Brammer - PHV, Tiffany Reece Clark - PHV, PRO HAC VICE, ULMER & BERNE, LLP - Cincinnati, Cincinnati, OH.
For Ranbaxy Pharmaceuticals, Inc., Defendant: Taylor B. McNeel, LEAD ATTORNEY, BRUNINI, GRANTHAM, GROWER & HEWES, PLLC-Biloxi, Biloxi, MS; Gregory S. Thomas - PHV, PRO HAC VICE, LECLAIRRYAN, Newark, NJ; John E. Wade, Jr., BRUNINI, GRANTHAM, GROWER & HEWES, Jackson, MS.
For Teva Pharmaceuticals USA, Inc., Defendant: George Ellis Abdo, III, LEAD ATTORNEY, DANIEL, COKER, HORTON & BELL, Jackson, MS; Christopher Land - PHV, Richard A. Oetheimer - PHV, PRO HAC VICE, GOODWIN PROCTER, LLP - Boston, Boston, MA.
David Bramlette, UNITED STATES DISTRICT JUDGE.
MEMORANDUM OPINION AND ORDER
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) [docket no. 70] and the Brand Defendants have moved for summary judgment pursuant to Rule 56 [docket no. 72]. Having carefully considered the Motions, the Plaintiff's opposition thereto, applicable statutory and case law, and being otherwise fully advised in the premises, the Court finds that Generic Defendants' Motion to Dismiss is granted and Brand Defendants' Motion for Summary Judgment is granted in part and denied in part.
I. SUMMARY OF THE ARGUMENTS
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,
Inc. v. Mensing, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011), that federal law pre-empts failure-to-warn claims against a generic drug manufacturer, and therefore they cannot be liable for Chatman's failure-to-warn claim. But they seek to extend the application of this holding by arguing that all Chatman's claims, regardless of whether they are characterized as strict liability or gross negligence claims, are in essence claims for their failure to warn of the dangers of taking their drug. As the Generic Defendants explain in their briefs, the majority of courts, applying different states' tort laws, have adopted this basic view.
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.
A. Generic Defendants' Motion for Judgment on the Pleadings
1. Standard of review for a Rule 12(c) motion
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 A. 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. " 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 (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.
2. The Parties dispute the impact of Mensing
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.
Mensing, 131 S.Ct. at 2572. The cases were consolidated on appeal to the Supreme Court, which was asked to determine " whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, [the plaintiffs' failure-to-warn claims]." Id. The answer to this question turned on whether the generic manufacturers could unilaterally alter metoclopramide's labeling,  i.e., the warning given to the plaintiffs, through the various mechanisms provided by the FDA rules and regulations. The Supreme Court held that it is impossible under the FDA's regulatory scheme for a generic manufacturer to unilaterally alter its drug's labeling because the regulations require a generic drug to have the same composition and labeling as that of its brand-name counterpart. Id. at 2575-78. Since Reglan's labeling was deemed insufficient by the plaintiffs, see id. at 2574, the Supreme Court concluded that it was impossible for the metoclopramide manufacturers to ...