APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF OKLAHOMA (D.C. No. 5:08-CV-00453-M)
Terrence J. Donahue, McGlynn Glisson & Mouton, Baton Rouge, Louisiana, for the Plaintiffs-Appellants.
Jeffrey Francis Peck, Ulmer & Berne LLP, Cincinnati, Ohio (Linda E. Maichl and Joseph P. Thomas with him on the brief) for Defendant-Appellee Pliva, Inc..
Kannon K. Schanmugam, Williams & Connolly LLP, Washington, D.C. (James M. McDonald, Williams & Connolly LLP, Washington, D.C.; Henninger S. Bullock and Andrew J. Calica, Mayer Brown, LLP, New York, New York, with him on the brief) for Defendant-Appellee Wyeth, Inc. and Schwarz Pharma, Inc..
Richard H. Nakamura Jr., Morris Polich & Purdy, LLP, Los Angeles, California (Tammara Tukloff, Morris Polich & Purdy LLP, San Diego, California; J.R. Baker and Kim A. Tran, Hiltgen & Brewer, P.C., Oklahoma City, Oklahoma, with him on the brief) for Defendant-Appellee Qualitest Pharmaceuticals, Inc..
Before LUCERO, HARTZ, and HOLMES, Circuit Judges.
LUCERO, Circuit Judge.
Susan and Steven Schrock filed suit against brand-name and generic manufacturers of the drug metoclopramide, alleging that Susan Schrock's use of generic metoclopramide caused her to develop tardive dyskinesia, a neurological disorder characterized by involuntary body movements. The district court dismissed all claims in favor of the manufacturers in a series of orders. On appeal, the Schrocks challenge the dismissal of their claims against PLIVA USA, Inc. ("PLIVA"), Qualitest Pharmaceuticals, Inc. ("Qualitest"), Schwarz Pharma, Inc. ("Schwarz"), and Wyeth, Inc. ("Wyeth").
Following oral argument, we abated this appeal pending the Supreme Court's decision in Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S.Ct. 2466 (2013). In light of the Court's opinion in Bartlett, we are compelled to conclude that the Schrocks' breach-of-warranty claims against PLIVA and Qualitest, the generic drug manufacturers, are preempted by federal law. We also agree with the district court that the Schrocks' non-warranty claims against the generic manufacturers are barred by Oklahoma's two- year statute of limitations. Okla. Stat. tit. 12 § 95.
With respect to the Schrocks' claims against Schwarz and Wyeth, name-brand manufacturers of metoclopramide, we are in accord with the district court's determination that Oklahoma tort law would not provide a remedy. Given prior Oklahoma precedent and the clear consensus of courts in other jurisdictions, we predict that Oklahoma would not impose a duty on brand-name drug manufacturers to consumers of a generic manufacturer's products.
Finally, we reject the argument that the Schrocks' notice of appeal was untimely as to certain orders they seek to appeal. Exercising jurisdiction under 28 U.S.C. § 1291, we affirm.
Under the 1962 amendments to the Federal Food, Drug, and Cosmetic Act ("FDCA"), Pub. L. 87-781, 76 Stat. 780 (1962) (codified at 21 U.S.C. §§ 301 et seq.), a manufacturer seeking federal approval to market a new drug "must prove that it is safe and effective and that the proposed label is accurate and adequate." PLIVA, Inc. v. Mensing, 131 S.Ct. 2567, 2574 (2011) (citing 21 U.S.C. § 355(b)(1), (d)). Initially, the same rules applied to all drug manufacturers. See Mensing, 131 S.Ct. at 2574. However, Congress later passed the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. 98-417, 98 Stat. 1585 (codified as amended in scattered sections of 21 and 35 U.S.C.), known as the Hatch-Waxman Amendments, that created special rules for generic drug manufacturers. See Mensing, 131 S.Ct. at 2574.
These Amendments were intended "to provide a swifter route for approval of generic drugs." Bartlett, 133 S.Ct. at 2471. "Under Hatch-Waxman, a generic drug may be approved without the same level of clinical testing required for approval for a new brand-name drug, provided that the generic drug is identical to the already-approved brand-name drug in several key respects." Id. To be approved for sale, a generic drug must be "identical [to its branded equivalent] in active ingredients, safety, and efficacy, " as well as in "the safety and efficacy labeling." Mensing, 131 S.Ct. at 2574 & n.2 (quotation and alteration omitted).
After a generic or brand-name drug is approved, "the manufacturer is prohibited from making any major changes to the 'qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.'" Bartlett, 133 S.Ct. at 2471 (quoting 21 C.F.R. § 314.70(b)(2)(i)). Generic manufacturers "are also prohibited from making any unilateral changes to a drug's label, " thus "approval for a generic drug may be withdrawn if the generic drug's label is no longer consistent with that for the brand name drug." Id. (quotation and alteration omitted) (citing 21 C.F.R. §§ 314.94(a)(8)(iii), 314.150(b)(10)).
Metoclopramide was first approved by the Food and Drug Administration ("FDA") under the brand name Reglan. Generic manufacturers began production of metoclopramide in 1985, the same year the FDA-mandated label for all versions of metoclopramide was modified to warn that "tardive dyskinesia . . . may develop in patients treated with metoclopramide." Mensing, 131 S.Ct. at 2572. The labeling also added that "therapy longer than 12 weeks has not been evaluated and cannot be recommended." Id. (alteration omitted).
Over time, evidence began to suggest that long-term use of metoclopramide can cause tardive dyskinesia. Id. In 2004, brand-name manufacturers of the drug requested a label change, which the FDA approved, to add that "therapy should not exceed 12 weeks in duration." Id. (alteration omitted). In 2009, the FDA ordered a "black box warning"—the strongest warning issued by the agency—to be placed on the label of metoclopramide stating, "[t]reatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible . . . . Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases." Id.
Susan Schrock was prescribed brand-name metoclopramide (Reglan) on three occasions between March 2000 and March 2005. Each time, however, she purchased generic metoclopramide instead. On either May 2 or 3, 2005, Susan Schrock visited Dr. Michael Tribbey, a neurologist, complaining of "neck drawing and arm weakness" that began six to eight weeks prior. Dr. Tribbey diagnosed her with "a form of dystonia, " a neurological movement disorder, that was "quite possib[ly] related to metoclopramide, " and recommended that she stop taking it. Susan Schrock discontinued the drug, and researched side effects of metoclopramide online. Following a hiatus during which her symptoms abated, she reported a worsening of her uncontrollable neck twisting in October 2006. In July of 2007, she was formally diagnosed with tardive dyskinesia.
On April 30, 2008, the Schrocks sued Schwarz and Wyeth, former manufacturers of Reglan, and PLIVA, a manufacturer of generic metoclopramide, along with others not at issue in this appeal. Claims of negligence, strict products liability, breach of warranties, misrepresentation, and fraud were advanced in the federal court proceedings. After the district court concluded that Schwarz and Wyeth did not owe a duty to the Schrocks because Susan Schrock used only generic versions of metoclopramide, it granted summary judgment in favor of those companies on March 11, 2007. Schwarz and Wyeth sought certification of the district court's order under Fed.R.Civ.P. 54(b). The district court entered a judgment in their favor on April 20, 2009, but did not explicitly certify the order as final under Rule 54(b).
On April 14, 2010, the district court granted the Schrocks' motion for leave to file an amended complaint adding claims against Qualitest, which pharmacy records showed had manufactured some of the generic metoclopramide that Susan Schrock used. Qualitest promptly moved to dismiss, arguing the suit was barred by the statute of limitations. PLIVA filed a motion for summary judgment on the same basis. On July 20, 2010, the district court granted summary judgment in favor of PLIVA, and dismissed all but the breach-of-warranty claims against Qualitest. On December 8, 2011, the district court dismissed the breach-of-warranty claims pursuant to a Rule 12(b)(6) motion by Qualitest, concluding the claims were preempted. On the same date, the court entered final judgments in favor of PLIVA and Qualitest.
On January 5, 2012, the Schrocks filed a motion to alter or amend the December 8, 2011 judgment in favor of Qualitest. The district court denied the motion on February 24, 2012. On March 23, 2012, the Schrocks filed a notice of appeal designating the grants of summary judgment in favor of Wyeth, Schwarz, and PLIVA, and the grants of Qualitest's motions to dismiss as the orders being appealed.
We first determine whether the Schrocks' notice of appeal was timely. Schwarz and Wyeth argue that the district court's April 20, 2009 judgment in their favor was a final judgment, thus the Schrocks' March 23, 2012 notice of appeal is untimely under Fed. R. App. P. 4(a)(1)(A). After the district court granted Schwarz and Wyeth's motion for summary judgment, those companies filed a motion under Fed.R.Civ.P. 54(b). In granting this motion, the district court entered a judgment stating: "[i]n light of the Court's Order granting said defendants summary judgment and ...