Wolters Kluwer Health, Inc. v. Dorothy Tanner

CourtCourt of Appeals of Georgia
DecidedNovember 20, 2015
DocketA15A1349
StatusPublished

This text of Wolters Kluwer Health, Inc. v. Dorothy Tanner (Wolters Kluwer Health, Inc. v. Dorothy Tanner) is published on Counsel Stack Legal Research, covering Court of Appeals of Georgia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Wolters Kluwer Health, Inc. v. Dorothy Tanner, (Ga. Ct. App. 2015).

Opinion

FIRST DIVISION DOYLE, C. J., PHIPPS, P. J., and BOGGS, J.

NOTICE: Motions for reconsideration must be physically received in our clerk’s office within ten days of the date of decision to be deemed timely filed. http://www.gaappeals.us/rules

November 20, 2015

In the Court of Appeals of Georgia A15A1157. PLIVA, INC. v. DEMENT. A15A1158. GOLD STANDARD, INC. v. DEMENT. A15A1159. WOLTERS KLUWER HEALTH, INC. v. DEMENT. A15A1160. TEVA PHARMACEUTICALS USA, INC. v. DEMENT. A15A1161. DEMENT v. PLIVA, INC. et al. A15A1162. DEMENT v. ALAVEN PHARMACEUTICAL, LLC et al. A15A1163. PLIVA, INC. v. TANNER. A15A1164. TANNER v. WYETH LLC et al. A15A1165. TANNER v. PLIVA, INC. et al. A15A1349. WOLTERS KLUWER HEALTH, INC. v. TANNER. A15A1404. GENERICS BIDCO I, LLC v. DEMENT.

PHIPPS, Presiding Judge.

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

2 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

1 We granted the applications for interlocutory review in Case Nos. A15A1157 and A15A1158. We accepted the remaining appeals as permissible cross-appeals. See generally Executive Jet Sales v. Jet America, 242 Ga. 307 (248 SE2d 676) (1978). In Case Nos. A15A1161 and A15A1165, the plaintiffs appeal the grant of the generic drug manufacturers’ joint motion to dismiss their claims that were based on Georgia law. In Case Nos. A15A1157, A15A1160, A15A1163 and A15A1404, the generic drug manufacturers appeal the denial of their joint motion to dismiss the plaintiffs’ claims for failure to warn based on their alleged failure to update their labels. In Case Nos. A15A1162 and A15A1164, the plaintiffs appeal the grant of summary judgment to the name brand drug manufacturers. In Case Nos. A15A1159 and A15A1349, Wolters Kluwer Health, Inc. appeals the denial of its motion to dismiss as to each plaintiff. In Case No. A15A1158, Gold Standard, Inc. appeals the denial of its motion for judgment on the pleadings as to Dement.

3 A. GRANT OF GENERIC DRUG MANUFACTURERS’ MOTIONS TO

DISMISS

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.

It is well established that a motion to dismiss for failure to state a claim upon which relief may be granted should not be sustained unless (1) the allegations of the complaint disclose with certainty that the claimant would not be entitled to relief under any state of provable facts asserted

2 _ U. S. _ (131 SCt 2567, 180 LE2d 580) (2011). 3 This ruling is discussed in Division 3, infra.

4 in support thereof; and (2) the movant establishes that the claimant could not possibly introduce evidence within the framework of the complaint sufficient to warrant a grant of the relief sought. In deciding a motion to dismiss, all pleadings are to be construed most favorably to the party who filed them, and all doubts regarding such pleadings must be resolved in the filing party’s favor.

[A] plaintiff is not required to plead in the complaint facts sufficient to set out each element of a cause of action so long as it puts the opposing party on reasonable notice of the issues that must be defended against. If within the framework of the complaint, evidence may be introduced which will sustain a grant of relief to the plaintiff, the complaint is sufficient. We review the trial court’s ruling on a motion to dismiss for failure to state a claim upon which relief can be granted under the de novo standard of review.4

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

4 TechBios, Inc. v. Champagne, 301 Ga. App. 592-593 (688 SE2d 378) (2009) (footnote omitted). 5 Mensing, 131 SCt at 2572.

5 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

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