PAUL E. HASSETT,
DONALD DAFOE, M.D., JAMES F. BURKE, JR., M.D., GEORGE FRANCOS, M.D., RAKESH GULATI, M.D., JEFFERSON UNIVERSITY PHYSICIANS, JEFFERSON RENAL ASSOCIATES, THOMAS JEFFERSON UNIVERSITY HOSPITAL, WYETH INC., WYETH PHARMACEUTICALS INC., SCHWARZ PHARMA, INC., SCHWARZ PHARMA, INC. D/B/A SCHWARZ PHARMA, USA, SCHWARZ PHARMA, USA, PLIVA INC., TEVA PHARMACEUTICALS INDUSTRIES, LTD, TEVA PHARMACEUTICALS INDUSTRIES, LTD D/B/A TEVA PHARMACEUTICAL USA, INC., TEVA PHARMACEUTICAL USA, INC., APPEAL OF: PLIVA, INC., AND TEVA PHARMACEUTICALS USA, INC., Appellants
Appeal from the Order Entered November 18, 2011 In the Court of Common Pleas of Philadelphia County Civil Division at No(s): August Term, 2008 No. 01551
BEFORE: STEVENS, P.J., BOWES, and PLATT, [*] JJ.
PLIVA, Inc. and Teva Pharmaceutical USA, Inc., ("Generic Defendants") appeal from November 18, 2011 order overruling their preliminary objections in the nature of a demurrer to a master complaint filed by Paul E. Hassett, who was allegedly injured after ingesting metoclopramide. The Generic Defendants assert that all of Mr. Hassett's claims against generic manufacturers of metoclopramide, regardless of the legal theory advanced and without consideration of the state law applicable, 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. 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 and 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 brand-name label.
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 the 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.
Mr. Hassett and the other 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 claims 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 Reference Listed Drug ("RLD") holders, and those pertaining to generic drug manufacturers, many of which 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 already approved RLD. In addition, the legislation also 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 warnings to doctors via Dear Doctor letters. 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 preempted by federal law.
In reliance upon Mensing, Generic Defendants filed preliminary objections to Mr. Hassett's 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.
The court denied Generic Defendants' 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)). Generic Defendants then filed both a timely petition for permission to appeal, which this Court denied by order of March 12, 2012, and an appeal as of right. Mr. Hassett 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 Mr. Hassett has 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.
Prior to reaching the pre-emption issue, we must first address Mr. Hassett's contention that this Court lacks jurisdiction to entertain this interlocutory appeal. He maintains that the collateral order doctrine supplies the only possible basis for jurisdiction, but that the order appealed from does not meet the three-pronged test for its application.
A collateral order is defined as "an order separable from and collateral to the main cause of action where the right involved is too important to be denied review and the question presented is such that if review is postponed until final judgment in the case, the claim will be irreparably lost." Pa.R.A.P. 313(b). Our High Court has delineated three requirements that must be satisfied in order for the doctrine to apply. The order must be "separable from and collateral to the main cause of action;" it must involve a right that "is too important to be denied review;" and, "if review is postponed until final judgment, the claim will be irreparably lost." Vaccone v. Syken, 899 A.2d 1103, 1106 (Pa. 2006). The doctrine is to be narrowly interpreted as it is an exception to the rule of finality. Id.; see also Rae v. Pennsylvania Funeral Directors Association, 977 A.2d 1121, 1126 (Pa. 2009).
Mr. Hassett argues that Generic Defendants cannot satisfy any of the three prongs. He contends that pre-emption requires an examination of underlying state-law duties, and a determination as to whether those duties conflict with federal law. Such analysis, according to Mr. Hassett, necessarily involves the merits of the underlying claims. Further, Mr. Hassett maintains that it does not involve a right "too important to be denied review." Gunn v. Automobile Ins. Co., 971 A.2d 505 (Pa.Super. 2009). He urges us to follow federal precedent to the effect that an order that a state claim is not pre-empted is not the equivalent of an immunity from suit and hence, not immediately appealable as a collateral order. See Martin v. Halliburton, 618 F.3d 476 (5th Cir. 2010), and cases cited therein. Finally, Mr. Hassett attempts to distinguish pre-emption from immunity from suit and asserts that the right is not irreparably lost if appellate review is postponed.
Generic Defendants rely upon our Supreme Court's decision in Pridgen v. Parker Hannifin Corp., 905 A.2d 422 (Pa. 2006), as the basis for collateral order jurisdiction. In resolving the issue of whether an order denying summary judgment premised on the General Aviation Revitalization Act's eighteen year statute of repose was appealable as a collateral order, the Court adopted and applied the United States Supreme Court's legal/factual approach to collateral orders espoused in Johnson v. Jones, 515 U.S. 304 (1995). In that case, the district court denied the police officers' motion for summary judgment premised on qualified immunity, finding sufficient evidence in the record that the officers watched and allowed others to beat the plaintiff to support liability. The officers appealed the order denying summary judgment as a collateral order. The Johnson Court concluded that the order was not appealable as the legal issue, qualified immunity, was not separate from the fact-related legal issues underlying the merits of the plaintiff's claims.
In Pridgen, plaintiffs maintained that the airplane crash was caused by a failure of engine and fuel system components that were replaced and overhauled within eighteen years of the date of the accident. Defendants countered that they did not manufacture or supply any of the allegedly defective replacement parts within eighteen years of the accident, an assertion that plaintiffs did not dispute. The rolling provision of the statute of repose provided that the eighteen-year period commenced to run when component parts were installed. Defendants framed the issue on appeal as a legal one: whether an original manufacturer was liable under GARA's rolling provision for the alleged failure of airplane replacement parts that it did not physically manufacture. Thus, the focus was on the terms of the statute, not on determinations of fact or the scope of liability. Our High Court, acknowledging that it "has adopted a practical analysis recognizing that some potential interrelationship between merits issues and the question sought to be raised in the interlocutory appeal is tolerable[, ]"concluded that this legal issue was separable from the merits of the underlying case. Pridgen, at 433 (citations omitted). Additionally, in furtherance of the policy of cost control, the Court found the federal interest underpinning GARA to be sufficiently important to allow appellate courts to weigh in on the issue. Finally, the Court viewed the substantial cost that manufacturers would incur in defending complex litigation at trial "a sufficient loss" to support the third element of the collateral order test.
The issue before us is whether all claims asserted by Mr. Hassett and the other plaintiffs against generic drug manufacturers are failure to warn claims pre-empted by Mensing. Thus, our analysis focuses largely on the scope of Mensing and the nature of the allegations contained in the Third Amended Long Form Master Complaint. We need not examine the merits of the underlying claims or resolve factual disputes. Hence, we find the preemption issue as phrased sufficiently separable from the merits of the underlying claims to satisfy the first prong of the collateral order doctrine.
With regard to the second prong, implicated herein is the role of state tort law in the federally regulated realm of generic drugs. The public policies surrounding comity and the Hatch-Waxman Amendments, designed to promote access to low-cost alternatives to name-brand drugs, are characteristic of rights "too important to be denied review." Finally, cognizant of the substantial cost that Generic Defendants would incur in defending more than two thousand lawsuits, we find sufficient loss to satisfy the third prong of the test.
Having concluded that we have jurisdiction to entertain the within appeal pursuant to the collateral order doctrine, we turn to the pre-emption issue. In reviewing the overruling of preliminary objections in the nature of a demurrer, we apply the same standard as the trial court. See De Lage Landen Services, Inc. v. Urban Partnership, LLC, 903 A.2d 586, 589 (Pa.Super. 2006). "All material facts set forth in the complaint as well as all inferences reasonably deducible therefrom are admitted as true for the purpose of this review. The question presented by the demurrer is whether, on the facts averred, the law says with certainty that no recovery is possible." Soto v. Nabisco, Inc., 32 A.3d 787, 790 (Pa.Super. 2011). Any doubt is resolved by refusing to sustain the demurrer. Insurance Adjustment Bureau, Inc. v. Allstate Ins. Co., 905 A.2d 462, 468 (Pa. 2006); Butler v. Charles Powers Estate, 29 A.3d 35 (Pa.Super. 2011) (reversed on other grounds by Butler v. Charles Powers Estate ex rel Warren, 65 A.3d 885 (Pa. 2013)). The trial court applied the proper legal standard and concluded that it was not certain that recovery was impossible. Our review is plenary, and we reverse only if the trial court has committed an error of law or an abuse of discretion. Id.
We recognize a presumption against federal pre-emption of state law. Dooner v. DiDonato, 971 A.2d 1187 (Pa. 2009) (citing Altria Group, Inc. v. Good, 555 U.S. 70 (2008)). In Kiak v. Crown Equipment Corp., 989 A.2d 385, 390 (Pa.Super. 2010), this Court attributed that presumption to the "dual jurisdiction" which "results from reasons of comity and mutual respect between the two judicial systems that form the framework of our democracy." Fetterman v. Green, 689 A.2d 289, 292 (Pa.Super. 1997); see also Cipollone v. ...