Pliva, Inc. v. Dement
| Decision Date | 20 November 2015 |
| Docket Number | A15A1159,Nos. A15A1157,A15A1158,A15A1162,A15A1161,A15A1404.,A15A1160,A15A1163,A15A1349,A15A1164,A15A1165,s. A15A1157 |
| Citation | 780 S.E.2d 735 |
| Parties | PLIVA, INC. v. DEMENT. Gold Standard, Inc. v. Dement. Wolters Kluwer Health, Inc. v. Dement. Teva Pharmaceuticals USA, Inc. v. Dement. Dement v. PLIVA, Inc. et al. Dement v. Alaven Pharmaceutical, LLC et al. PLIVA, Inc. v. Tanner. Tanner v. Wyeth LLC et al. Tanner v. PLIVA, Inc. et al. Wolters Kluwer Health, Inc. v. Tanner. Generics Bidco I, LLC v. Dement. |
| Court | Georgia Court of Appeals |
James L. Hollis, Atlanta, Geremy W. Gregory, for Pliva, Inc.
Robert C. Buck, Atlanta, for Dement and Tanner.
J. Allen Maines, Caroline J. Tanner, Steven A. Moulds, Atlanta, for Gold Standard, Inc.
Stephen L. Cotter, Myrece R. Johnson, Lynn M. Roberson, Atlanta, for Wolters Kluwer Health, Inc.
Michael J. Goldman, Atlanta, for Teva Pharmaceuticals USA, Inc.
Stephen M. Brooks, Lucas A. Westby, Atlanta, for Alaven Pharmaceutical, LLC and Wyeth, LLC.
Paul E. Weathington, David C. Hanson, Atlanta, for Generics Bidco I, LLC.
These cases, which we have consolidated for the purposes of deciding the appeals, concern claims related to the prescription drug metoclopramide (brand name "Reglan"). Angela Dement and Dorothy Tanner allegedly developed a neurological condition, tardive dyskinesia, after taking generic versions of the drug; Dement used the drug from February 2008 to June 2009, and Tanner used it from August 2004 to December 2004.
Each of the plaintiffs filed an action against multiple defendants, including three companies that manufactured a generic version of the drug (PLIVA, Inc., Generics Bidco I, LLC, and Teva Pharmaceuticals USA, Inc., hereinafter collectively referred to as the "generic drug manufacturers"), four companies that manufactured the name brand version of the drug (Alaven Pharmaceutical, LLC, Wyeth LLC, Wyeth Pharmaceuticals, Inc., and Schwarz Pharma, Inc., hereinafter collectively referred to as the "name brand drug manufacturers"), and two companies that authored patient education materials pertaining to the drug (Wolters Kluwer Health, Inc. and Gold Standard, Inc.).
In the complaints, the plaintiffs asserted claims against the defendants in connection with allegedly inadequate warnings based on, inter alia, negligence, misrepresentation, and breach of warranty. The plaintiffs sought damages for injuries resulting from alleged violations of federal law and breaches of common law duties; the plaintiffs' allegations included the following: the generic drug manufacturers failed to include in their package labeling warnings that the drug should not be taken for more than 12 weeks, failed to timely update the labeling to include such warnings, and failed to communicate warning label change information to the healthcare community; the name brand drug manufacturers distributed the drug without disclosing warnings or accurate information about the risks of long-term use; and the authors of patient education materials provided misleading drug information to the plaintiffs' pharmacies (for patient use). Various defendants filed motions to dismiss, for summary judgment, and for judgment on the pleadings, which, as detailed below, the trial court granted in part and denied in part. These appeals are from the trial court's rulings on those motions.1
Case No. A15A1161. DEMENT v. PLIVA et al.
1. The generic drug manufacturers moved to dismiss the plaintiffs' claims against them, asserting that all of the claims were barred by the principle of federal preemption, as stated by the United States Supreme Court in PLIVA v. Mensing.2 The trial court agreed in part, and granted the motions to dismiss (as preempted by federal law) those claims that were based on a "failure to warn arising under Georgia law," failure to withdraw or suspend sales, and failure to communicate warning label change information to the healthcare community. (The court denied the motions to dismiss as to the claims for "failure to update" the labels.3 ) Dement appeals the ruling to the extent the motions to dismiss were granted, contending that Mensing is distinguishable and does not require dismissal.
In Mensing, the plaintiffs brought actions asserting against generic drug manufacturers state-law tort claims based on the defendants' alleged failure to provide adequate warning labels for the generic drug metoclopramide.5 Under state laws applicable to the actions brought in Mensing, all drug manufacturers had a duty to adequately warn consumers and safely label their products.6 It was undisputed in Mensing that, accepting the plaintiffs' allegations as true, state law required generic drug manufacturers to use a "different, safer" label than the brand-name manufacturers' label.7 But, the Court pointed out, federal regulations require that the labels on generic drugs match the label on the brand-name counterparts, thus preventing generic drug manufacturers from independently changing their drugs' safety labels.8 "[F]ederal law would permit the [generic drug manufacturers] to comply with the state labeling requirements if, and only if, the FDA and the brand-name manufacturer changed the brand-name label to do so."9 Thus, the Mensing Court held, the state-law claims were barred because it was impossible for generic drug manufacturers to comply with both state-law duties to adequately warn consumers and safely label their products and federal requirements that generic drug labels be the same as federally-approved labels for the brand-name drug (the federal "sameness" requirement).10
The generic drug manufacturers, as defendants, bear the burden of establishing a preemption defense.11
(a) Contrary to the assertion of the generic drug manufacturers in their motions to dismiss, the Mensing Court did not "[find] unequivocally that claims against generic drug companies are preempted under the Supremacy Clause of the United States Constitution."12 The Mensing decision is not so broad. As the Supreme Court explained in Mutual Pharmaceutical Co. v. Bartlett,13 under Mensing, state-law failure to warn claims were preempted by federal law because "it was impossible for the [generic drug manufacturers] to comply with both their state-law duty to change the label and their federal law duty to keep the label the same" as the federally-approved label.14 Thus, under Mensing, the impossibility preemption applies to those claims involving a generic drug manufacturer's failure to unilaterally alter its labeling to comply with state-law warning duties; Mensing does not provide generic drug manufacturers with blanket immunity against all state-law warning claims.
Dement asserted claims other than those regarding the generic drug manufacturers' federal "sameness" duties. She alleged that the generic drug defendants also had duties under Georgia law, including the following duties: "the manufacturer of a product which, to its actual or constructive knowledge, involves danger to users, has a duty to give warning of such danger";15 and "[a] manufacturer's failure to warn of the dangers in using a product may constitute a defect in the product for purposes of strict liability."16 Dement alleged that the generic drug manufacturers violated those duties, inter alia, by failing to provide adequate warnings (which, she added, the generic drug manufacturers could have provided after the name-brand manufacturers changed their label, without violating federal "sameness" rules). Thus, the impossibility principle was not implicated as to Dement's claims, and preemption, as set out in Mensing, does not apply. Accordingly, the trial court erred by dismissing the claims as preempted. Notably, although Georgia's appellate courts have not decided whether state-law failure to warn claims such as those asserted by Dement are precluded under Mensing, several courts in other jurisdictions have (as we do here) declined to dismiss state-law failure to warn claims asserted against generic drug manufacturers.17
(b) Similarly, Mensing does not require dismissal of Dement's claims based on the generic drug manufacturers' failure to suspend or withdraw sales of a misbranded drug. In her complaint as amended, Dement included allegations that the generic drug manufacturers had: placed misleading labels on their drug; failed to update the drug's labels with the mandated 2004 label revisions; failed to disclose all known risks regarding the drug; made misleading warranties regarding the drug's safety; concealed the drug's defects; allowed the drug to leave their control when it was defective or unreasonably dangerous; and, despite having knowledge that the drug was unsafe, continued to...
To continue reading
Request your trial
-
Fox v. Norfolk S. Corp.
...on a finding that the Federal Railroad Safety Act preempted plaintiff's state law negligence claims); PLIVA, Inc. v. Dement , 335 Ga. App. 398, 401-402 (1) (a), 780 S.E.2d 735 (2015) cert. granted, Case No. S16C0685 (September 6, 2016) (appeal withdrawn February 10, 2017) (reversing trial c......
-
Akerman v. GlaxoSmithKline, LLC (In re Zofran (Ondansetron) Prods. Liab. Litig.)
...authority directly on point, there is a decision on point from the intermediate Georgia Court of Appeals. See PLIVA, Inc. v. Dement , 335 Ga.App. 398, 780 S.E.2d 735 (2015), cert. granted (Ga. Sept. 6, 2016) (No. S16C0685).In Dement , plaintiffs alleged that they had developed a neurologica......
- Matabarahona v. State
-
Product Liability
...at *21.117. Id.118. Id.; 21 C.F.R. § 807.81(a)(3) (2017).119. Kaku, 2017 U.S. Dist. LEXIS 45118, at *21. 120. Id.121. 335 Ga. App. 398, 780 S.E.2d 735 (2015).122. Id. at 398-99, 780 S.E.2d at 737-38.123. Id. at 401, 780 S.E.2d at 739.124. Id.125. Id. at 401-02, 780 S.E.2d at 739-40.126. Id.......