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
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.
The generic drug manufacturers, as defendants, bear the burden of establishing a preemption defense.
(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."
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";
(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 sell the drug. Notably, Dement asserted in her trial brief in response to the motion to dismiss that the generic drug was misbranded because the generic drug manufacturers had failed to, inter alia, include information that they were required to include, namely the 2004 update; that Georgia law prohibits drug manufacturers from selling misbranded drugs;
Although Dement did not in her complaint use the terms "misbranded" or "failure to suspend or withdraw sales," a court deciding a motion to dismiss a complaint must resolve all doubts in favor of the party that filed the complaint.
(c) However, the trial court properly dismissed Dement's claims based on "failure
Construing the pleadings most favorably to Dement, we hold that the generic drug manufacturers failed to establish that Dement could not possibly introduce evidence within the framework of the complaint sufficient to warrant a grant of the relief sought as to her claims for failure to warn and failure to suspend or withdraw sales.
2. Tanner appeals the grant of the generic drug manufacturers' motion to dismiss, making substantively the same contentions Dement makes in Case No. A15A1161. Tanner's complaint set forth similar allegations. For the reasons set out in Division 1 above, the trial court erred by granting the generic drug manufacturers' motion to dismiss Tanner's failure to warn and failure to suspend or withdraw sales claims, but properly granted the motion as to the failure to communicate claim. The judgment is reversed as to the two former claims, and affirmed as to the latter claim.
3. In denying the generic drug manufacturers' motions to dismiss claims based on alleged failure to update labeling to include the 2004 warning that the drug should not be taken for more than 12 weeks, the trial court found that Dement's complaint had set forth sufficient allegations to state a claim for relief. PLIVA appeals the ruling. We affirm.
As stated above, Dement alleged that in 2004 the name brand drug manufacturers updated the labeling of their drug to include a warning that the drug should not be used for longer than 12 weeks. PLIVA concedes that federal law requires generic drug manufacturers to duplicate verbatim the brand-name drug's label, that PLIVA was obligated to update its packaging in 2004 to include the new warning when the name brand drug manufacturers did, and that PLIVA failed to do so.
Nonetheless, PLIVA moved to dismiss Dement's "failure to update" claim, arguing that it is an impermissible attempt to enforce the FDCA's "sameness" requirement, and that the federal duty of sameness is not enforceable by private litigants.
(a) First, Dement alleged in her complaint that PLIVA had a duty under Georgia common law to provide adequate warnings about its product, which PLIVA could have done by updating its labeling in 2004 (to conform to the FDA-approved and mandated revisions). Such an update was not rendered impossible by federal law.
(b) Second, Dement does not seek to enforce the FDCA or recover for a violation
The trial court did not err by refusing to dismiss Dement's failure to update claims.
4. To the extent Teva raises the same arguments here that PLIVA raised in Case No. A15A1157, its arguments are likewise without merit.
On a motion to dismiss for failure to state a claim, the court must accept the plaintiff's claims as true and determine whether the complaint states a cause of action.
5. PLIVA appeals the denial of its motion to dismiss Tanner's claim based on failure to update. The order appealed is substantively the same as the one PLIVA appeals in Case No. A15A1157,
6. Generics Bidco I, LLC appeals the trial court's denial of its motion to dismiss, asserting the same contentions PLIVA makes in Case No. A15A1157. Those contentions are without merit, for the reasons discussed in Division 3.
Generics Bidco I asserts additionally that Dement's claim that the generic drug manufacturers failed to timely update their labels must be dismissed as to Generics Bidco I because it did not exist as an entity until 2007, and when it entered the market its drug had updated labeling. However, that assertion goes beyond the framework of the complaint. Because it cannot be said with certainty that, within the framework of the complaint, no evidence could be introduced that would support Dement's claims for relief, the motion to dismiss was properly denied.
7. This court reviews the grant of summary judgment de novo, viewing the evidence in the light most favorable to the nonmovant.
In granting summary judgment to the name brand drug manufacturers, the trial court held that those defendants could not be held liable because the plaintiffs had not been exposed to their products. In her challenge to the ruling, Dement contends that the name brand drug manufacturers are strictly liable because they controlled the design and labeling of the generic drugs, or, alternatively, common law negligence claims are available; further, public policy supports such claims. There was no error.
Under Georgia law, Dement, proceeding under a theory of negligence or strict liability, must prove that the defendants manufactured or distributed the product that caused her harm, or that she was exposed to the defendants' product.
8. Tanner makes the same challenges as Dement to the grant of the name brand drug manufacturers' summary judgment motion. Tanner's challenge fails for the reasons set out in Division 7.
D. DENIAL OF PATIENT EDUCATION MATERIALS AUTHOR'S MOTION TO DISMISS
9. Wolters Kluwer Health, Inc., contends that the trial court erred by denying its amended motion to dismiss claims asserted against it. In its motion to dismiss, Wolters Kluwer Health asserted that it owed Dement no legal duty, that the First Amendment to the Constitution barred her claim, and that no privity existed between Dement and Wolters Kluwer Health. The court found the motion to be premature, stating that the motion required the court to consider matters outside the parties' pleadings, and
Our Supreme Court has recently reiterated that a motion to dismiss should not be granted unless the allegations of the complaint disclose with certainty that the claimant would not be entitled to relief under any state of provable facts asserted in support thereof.
Dement's complaint includes the following pertinent allegations: Wolters Kluwer Health authored patient education materials, which pharmacists then provided to their patients; the materials included information about prescription drugs, including the drug at issue here; the drug information was typically given to patients (stapled to their prescription package) when the prescription was picked up, as it was here; Wolters Kluwer Health undertook to provide accurate drug information in the materials it authored and made available to pharmacies for their customers; Wolters Kluwer Health had knowledge that those using the drug would rely upon the information in the materials; Dement read and relied upon misstatements about the drug in the materials; and, as a result of Wolters Kluwer Health's wrongful conduct, Dement was injured.
Inasmuch as Wolters Kluwer Health has not established that Dement cannot possibly introduce evidence within the allegations of the complaint entitling her to any of the relief sought,
10. Wolters Kluwer Health makes substantively the same contentions as to Tanner in this case that it made in Case No. A15A1159 as to Dement.
11. Gold Standard, Inc., contends that the trial court erred by denying its motion for judgment on the pleadings when Dement failed to state a claim upon which relief could be granted. Specifically, Gold Standard asserts that it owed Dement no duty of care, that there was no privity between Dement and Gold Standard, and that its right to distribute the information was protected by the First Amendment. There was no error.
Our review of the trial court's ruling is de novo.
Accepting Dement's well-pleaded facts as true,
Judgments affirmed in Case Nos. A15A1157, A15A1158, A15A1159, A15A1160, A15A1162, A15A1163, A15A1164, A15A1349 and A15A1404. Judgments in Case Nos. A15A1161 and A15A1165 affirmed in part and reversed in part.
DOYLE, C.J., and BOGGS, J., concur.
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.