IN RE: REGLAN/METOCLOPRAMIDE LITIGATION, APPEAL OF: MORTON GROVE PHARMACEUTICALS INC., AND WOCKHARDT USA, LLC, 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. 001997.
BEFORE: STEVENS, P.J., BOWES, and PLATT, [*] JJ.
Morton Grove Pharmaceuticals, Inc. and Wockhardt USA, LLC (collectively "Morton Grove") appeal from the trial court's November 18, 2011 order overruling their preliminary objections that were premised upon a position that certain of the counts in question were pre-empted under federal law. This appeal is one of four related appeals arising from mass tort litigation involving Plaintiffs, persons whom were allegedly injured after ingesting metoclopramide. Common to each appeal are the issues of whether all claims against generic manufacturers are failure-to-warn claims indistinguishable from those held pre-empted by the United States Supreme Court's decision in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), and whether the trial court thereby erred in not dismissing them. We have previously rejected the blanket pre-emption of all state-tort claims. We have ruled that pre-emption applies only to failure-to-warn claims against generic manufacturers that arose prior to the enactment of the Federal Drug Administration Amendments Act of 2007 ("FDAAA") and that are premised solely on the content of generic drug labels that conform to the label of the brand-name drug.
In the instant appeal, Morton Grove contends that it remains a generic manufacturer entitled to claim the benefit of Mensing pre-emption despite the Federal Drug Administration's ("FDA") designation of it as the reference listed drug ("RLD") holder for liquid syrup metoclopramide. Morton Grove premises jurisdiction to entertain this interlocutory appeal on the collateral order doctrine. We accept jurisdiction on that basis. After thorough review, we affirm.
The relevant facts are as follows. Morton Grove originally obtained permission to manufacture and sell liquid syrup metoclopramide by submitting an Abbreviated New Drug Application ("ANDA") to the FDA to obtain the right to sell a generic form of liquid metoclopramide. That document demonstrated that the syrup was equivalent in "active ingredients, safety, and efficacy" to the RLD. 21 U.S.C. § 355(j)(2)(A). Thereafter, the RLD holder discontinued marketing its drug, and the FDA withdrew approval. Under applicable regulations, the FDA was empowered to fill the void left by the withdrawn RLD by designating one of the generic manufacturers to serve as a substitute. The FDA designated Morton Grove as the RLD for liquid syrup metoclopramide. According to Morton Grove, despite its status as the RLD, it is merely a generic drug manufacturer which had no power to unilaterally alter its own labeling. See Mensing, supra.
Morton Grove filed preliminary objections to the master complaint, disputing that it had any special duties or responsibilities with regard to the label as a result of its designation by the FDA as the RLD holder. The trial court overruled the preliminary objections without prejudice to raising the same issue in a motion for summary judgment. Morton Grove's motion for reconsideration was denied, but the court granted its motion 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. § 702(b)). Morton Grove then filed both a timely petition for permission to appeal, which this Court denied by order of March 12, 2012. Morton also filed 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.
Morton Grove presents one issue for our consideration:
Does the FDA's unilateral designation of Morton Grove's ANDA product as a RLD impose additional duties or obligations different from those of any ANDA [, i.e., generic] holder, and enable plaintiffs to assert unique state-law claims against Morton Grove solely on the basis of the RLD designation?
Morton Grove's brief at 3-4.
We refer to our related opinions at Nos. 81 and 82 EDA 2012, which contain the legal basis for our exercise of collateral order jurisdiction. In addition, we held therein that Mensing does not confer upon generic drug manufacturers blanket pre-emption of all state-law tort claims. Our resolution of issues involving Morton Grove's status will determine whether it can avail itself of Mensing pre-emption at all.
In reviewing the trial court's order overruling preliminary objections, 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 issue, as framed by Morton Grove, is one involving interpretation of federal law. It maintains that despite its status as the RLD holder for liquid syrup metoclopramide, it remained a generic manufacturer of an ANDA-approved product, and that it had no ability to use the Changes Being Effected ("CBE") process to modify its warnings label. Thus, it claims, under the Mensing rationale, that it cannot be liable under state tort law for failure to change its label.
Plaintiffs counter that the successor RLD is the same as the name-brand manufacturer for purposes of FDA regulations. They argue that the FDA's designation of Morton Grove as a successor RLD places that entity in the "shoes of the pioneer manufacturer, " with the authority and the duty to update warnings on the drug's label. Appellees' brief at 34. To hold otherwise, Plaintiffs contend, would result ...