IN RE: REGLAN/METOCLOPRAMIDE LITIGATION, APPEAL OF: TEVA PHARMACEUTICALS USA, INC., PLIVA ET AL., Appellants
Appeal from the Order Entered November 18, 2011 In the Court of Common Pleas of Philadelphia County Civil Division at No(s): January Term, 2010 No. 01997
BEFORE: STEVENS, P.J., BOWES, and PLATT, [*] JJ.
PLIVA, Inc. and Teva Pharmaceutical USA, Inc., ("Generic Defendants") appeal from the November 18, 2011 order overruling their preliminary objections in the nature of a demurrer to a master complaint filed by Plaintiffs, who are persons allegedly injured after ingesting metoclopramide. The Generic Defendants assert that all of Plaintiffs' claims against generic manufacturers of metoclopramide, regardless of the legal theory advanced and without consideration of the applicable state law, are failure-to-warn claims. They continue that all causes of action are indistinguishable from those held pre-empted by the United States Supreme Court in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), and that the trial court erred in not dismissing them. In addition, Generic Defendant Hospira Inc. ("Hospira") presents a discrete pre-emption issue on appeal: that any claim prior to 2009 premised on its failure to update its label to conform to that of the Reference Listed Drug holder ("RLD"), referred to as a Mensing carve-out claim,  is also pre-empted because the RLD did not update its warning until 2009. After careful review, we reverse in part and affirm in part.
Generic Defendants premise jurisdiction to entertain this interlocutory appeal on the collateral order doctrine. We accept jurisdiction on that basis. For the reasons that follow, we reject Generic Defendants' characterization of all claims herein as Mensing failure-to-warn claims as well as their proposed blanket application of impossibility pre-emption without any regard for the applicable state law. Since all of the Mensing claims pre-dated the Food and Drug Administration Amendments Act of 2007 (hereinafter the "FDAAA" or the "Act"), 121 Stat 823, the Court expressed "no view on the impact of" that legislation. Mensing, supra at 2574 n.1. Thus, we decline to find post-Act claims pre-empted unless there is a thoughtful and careful examination of the federal law and state law applicable to ascertain whether state law compels what is impossible under federal law. However, we do find pre-empted under Mensing those failure-to-warn claims arising prior to the 2007 Act that are premised solely on the content of generic drug labels that conform to the name-brand label. Since pre-Act failure-to-warn carve-out claims against Hospira fall within the ambit of this holding, they are preempted.
The within appeal is one of four related appeals arising from mass tort litigation in Philadelphia County involving the name-brand drug Reglan and its generic bioequivalent, metoclopramide. The Food and Drug Administration ("FDA") approved metoclopramide under the brand name Reglan in 1980, and five years later, generic manufacturers started producing the drug. The drug stimulates digestive function by speeding up the movement of food through the system, and it is prescribed to treat chronic digestive problems such as diabetic gastroparesis and gastroesophageal reflux. In the years following FDA approval, long-term use of metoclopramide was linked to tardive dyskinesia, a severe and usually permanent neurological disorder characterized by involuntary and uncontrollable movements of the head, neck, face, arms, and trunk including facial grimacing and tongue thrusting. Third Amended Master Long Form Complaint at ¶82. Studies showed that as many as twenty-nine percent of those people who took the drug for several years developed tardive dyskinesia. Changes to the label were made in 1985, 2004, and 2009, to strengthen warnings of the dangers associated with use of the drug for more than twelve weeks.
Plaintiffs in this mass tort litigation commenced civil actions against both the name-brand manufacturers and generic manufacturers seeking damages for personal injuries and deaths due to their ingestion of either the name brand metoclopramide, Reglan, or its generic bioequivalent. While such claims were pending, the United States Supreme Court granted certiorari in two cases: Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009) (under Minnesota law) and Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010) (under Louisiana law), to determine whether state failure-to-warn cause of action based upon inadequate drug labeling could be maintained against generic drug manufacturers. The precise question was "whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state-law claims." Mensing, 131 S.Ct. at 2572.
The Mensing Court thoroughly discussed the differences in the federal regulations governing name-brand drug manufacturers, i.e., the RLD holders, and those regulations pertaining to generic drug manufacturers. Many of the latter regulations originated with the passage of the 1984 Hatch-Waxman Amendments. That legislation streamlined the process whereby generic drug manufacturers could receive FDA approval to market their drugs. Rather than requiring generic manufacturers to file a New Drug Application ("NDA") with the FDA, and to conduct extensive clinical trials to prove that their drugs were safe and effective, the Amendments permitted generic manufacturers to submit Abbreviated New Drug Applications ("ANDA") demonstrating that the generic drug contained the same active ingredient, in the same dosage, with the same therapeutic effect as the previously approved RLD. In addition, the legislation mandated that the generic drug's labeling be identical to the RLD's labeling. 21 U.S.C. § 355(j)(2)(A)(v). While an RLD could change the warning on its label by utilizing a process known as "Changes Being Effected" ("CBE"), 21 C.F.R. § 314.70(c)(6)(iii)(C), that procedure was not available to generic manufacturers. Rather, a generic manufacturer could only change its label to conform to an updated RLD label or in response to an FDA directive.
The FDAAA, 121 Stat. 823, was enacted on September 27, 2007. The Mensing Court noted that its holding "express[ed] no view on the impact of the 2007 Act." Mensing at 2574 n.1. The Court concluded that federal law applicable at the time the relevant events occurred in Mensing and Demahy precluded generic drug manufacturers from unilaterally changing their labels to strengthen a warning, which was the duty imposed in state failure-to-warn cases. It rejected the plaintiffs' assertions that generic manufacturers could use the CBE procedure to change their labels or issue Dear Doctor letters conveying additional warnings. The fact that generic manufacturers could take steps to urge the FDA to change the warnings on the drug's label did not mandate a different result. The Mensing Court reasoned that "when a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes." Mensing, at 2581-82. State law yielded to federal law. Thus, Minnesota and Louisiana tort-law claims based on generic drug manufacturers' failure to provide adequate warning labels for generic metoclopramide were pre- empted by federal law. In both cases, the generic labels were the same as the label of the name-brand manufacturer.
In reliance upon Mensing, Generic Defendants filed preliminary objections to Plaintiffs' Third Amended Long Form Master Complaint seeking dismissal of all claims against generic manufacturers of metoclopramide on pre-emption grounds. The trial court overruled the preliminary objections and held that Generic Defendants failed to sustain their heavy burden of proving with certainty that no legal recovery was possible. The court recognized the rebuttable presumption that under Pennsylvania's choice of law rules, the law of the domiciles of the various Plaintiffs would apply, and that blanket pre-emption was premature absent a state-by-state analysis.
Generic Defendant Hospira filed additional preliminary objections arguing that as to it, the Mensing carve-out claims based on a generic manufacturer's failure to update its label to conform with the updated label of the brand-name manufacturer also were pre-empted. The facts peculiar to the issue raised by Hospira are as follows. Hospira is a generic manufacturer of metoclopramide in an injectable form, which is administered in hospitals and clinics generally for acute conditions. Hospira's brief at 14. It is undisputed that Baxter Healthcare ("Baxter") remains the RLD holder for injectable Reglan since it filed an NDA in 2002, and that, under federal regulations, Hospira was required to conform its label to that of the RLD holder. There is also apparently no dispute that Baxter did not include a warning of the increased risks associated with use of metoclopramide beyond twelve weeks until the FDA mandated changes to all metoclopramide labeling in 2009. Thus, Hospira maintained that it was impossible for it to update its label to conform to an updated RLD label because the RLD did not update its label until the FDA forced it to in 2009.
The court denied Generic Defendants' and Hospira's motion for reconsideration, but granted their motions to certify the order as one involving "a controlling question of law as to which there is a substantial ground for difference of opinion" and for which "an immediate appeal . . . may materially advance the ultimate determination of the matter." Order, 12/16/11, at 1 (quoting 42 Pa.C.S.A. §702(b)). Hospira and Generic Defendants then filed both a timely petition for permission to appeal, which this Court denied by order of March 12, 2012, and a direct appeal under Pa.R.A.P. 313. Plaintiffs moved to quash the appeal. By order of April 11, 2012, this Court denied the motion without prejudice to reassert the issue before this panel, which Plaintiffs have done.
Generic Defendants raise one issue for our review:
Did the trial court err in refusing to dismiss Plaintiffs' claims against the Generic Defendants as preempted by federal law in light of the United States Supreme Court's holding in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011)?
Appellants' brief at 2.
Hospira's additional issue on appeal is:
Whether plaintiffs' argument that Mensing does not preempt claims against a generic manufacturer who failed to adopt or effectively communicate a warning that was added to the labeling for brand-name Reglan® Tablets applies to Hospira, which manufactured and sold only the injectable form of generic metoclopramide and therefore was required by federal law to follow and copy the labeling of its reference listed drug – Baxter Healthcare's ("Baxter") brand-name Reglan® Injection – which did not include the alleged warning.
Hospira's brief at 7 (emphasis in original).
Prior to reaching the pre-emption issue, we must first address Plaintiffs' contention that this Court lacks jurisdiction to entertain this interlocutory appeal. They maintain that the collateral order doctrine supplies the only possible basis for jurisdiction, but that the ...