Demahy v. Wyeth Inc.

• Decision Date: 27 October 2008
• Docket Number: Civil Action No. 08-3616.
• Parties: Julie DEMAHY v. WYETH INC., et al.
• Court: U.S. District Court — Eastern District of Louisiana

586 F.Supp.2d 642

Julie DEMAHY v. WYETH INC., et al.

Civil Action No. 08-3616.

United States District Court, E.D. Louisiana.

October 27, 2008.

Richard Alvin Tonry, II, Brian L. Glorioso, Kristine Kuhn Sims, Raymond Joseph Brinson, Tonry, Brinson & Glorioso, LLC, Slidell, LA, for Julie Demahy.

Elizabeth Haecker Ryan, Lemle & Kelleher, LLP, New Orleans, LA, Kristen L. Mayer, Richard A. Dean, Tucker Ellis & West LLP, Cleveland, OH, for Wyeth Inc., et al.

ORDER & REASONS

CARL J. BARBIER, District Judge.

Before the Court is Defendant Actavis Inc.'s ("Actavis") Motion to Dismiss (Rec. Doc.19) under Rule 12(b)(6) based on federal conflict preemption. The motion came before the Court for oral argument on September 17, 2008, and was taken under advisement. Having reviewed the motion, the memoranda of counsel, the parties' statements at oral argument, and the applicable law, the Court finds as follows.

FACTS & PROCEDURAL HISTORY

Plaintiff Julie Demahy ("Demahy"), a fifty-eight year old female, began taking metoclopramide, the generic version of the name brand drug Reglan, in 2002 and continued treatment until April 2006. Metoclopramide is prescribed for treatment of gastroesophagal reflux disease, commonly known as acid reflux. In October of 2007, Demahy was diagnosed by physicians at the University of Texas, Southwestern Medical Center with tardive dyskinesia, which the doctors believed had been caused by longterm use of metoclopramide. Tardive dyskinesia is a neurological disorder that causes involuntary movements of the face, torso, and extremities.

As a result of her injuries allegedly caused by her treatment with metoclopramide, Demahy filed suit against Wyeth Inc., Schwarz Pharma, Inc., and Actavis in the 22nd Judicial District Court for the Parish of St. Tammany. In her state court complaint, Demahy asserted personal injury claims under the Louisiana Products Liability Act ("LPLA")¹, specifically for failure to warn of the risks of neurological disorder after longterm use of metoclopramide. In addition, Demahy claims that Actavis breached its duty to provide updated information regarding the hazards of metoclopramide to the Food and Drug Administration ("FDA"), which would have resulted in more adequate warnings on the labels for the drug. Further, Demahy claims that Actavis intentionally concealed scientific research regarding the risks of metoclopramide with respect to neurological disorders in order to mislead the medical community and prevent FDA action.

The case was removed to this Court on June 6, 2008 (Rec.Doc.1). Defendants Wyeth, Inc. and Schwarz Pharma, Inc. have been dismissed from the suit without prejudice (Rec.Doc.15). Thus, only defendant Actavis remains. Actavis, formerly Purepak Pharmaceutical Company, is a generic manufacturer of metoclopramide, and according to Demahy's pharmacy records was the manufacturer of the metoclopramide she consumed. The parties do not dispute that Actavis's label and package insert for its generic metoclopramide was at all relevant times identical to the label and package insert for the name brand drug.

THE PARTIES' ARGUMENTS

Actavis argues that Demahy's products liability claims under the LPLA should be dismissed as a matter of federal conflict preemption. Specifically, Actavis asserts that under the relevant provisions of the Food, Drug, and Cosmetics Act ("FDCA"),² the label and package insert for its generic product need not and in fact could not have been altered from the label and package insert that was approved by the FDA for name brand metoclopramide. As such, Actavis argues that Demahy's LPLA failure-to-warn claims are preempted both as a matter of direct conflict preemption, since Actavis's failure-to-warn duties under the LPLA directly conflict with its duties to maintain identical labels under the FDCA, and as a matter of socalled "obstacle preemption," since compliance with failure-to-warn tort principles under the LPLA would frustrate the goals of the FDCA and the 1984 Hatch-Waxman Amendments to the FDCA.

The Hatch-Waxman Amendments provided differing approval standards for generic drug manufacturers from those applicable to name brand drug manufacturers. See 21 U.S.C. § 355(j) (2008). According to Actavis, the Hatch-Waxman Amendment codified FDA regulations in order to streamline generic drug approval and eliminate the need for generic manufacturers to replicate the time-consuming and costly drug safety research already performed by the name brand manufacturer. The truncated process by which a generic drug is approved is referred to in § 355(j) as an Abbreviated New Drug Application ("ANDA") as opposed to the more extensive New Drug Application ("NDA") required for name brand drugs. Under the ANDA process, Actavis asserts that generic drugs are not subject to the same initial and continuing testing and reporting requirements as name brand drugs. Additionally, according to Actavis, the FDA mandates that generic drug labels must always remain identical to the FDA-approved labels of the pioneer name brand drug. See § 355(j)(2)(A)(v). As such, Actavis argues that the FDA has specifically rejected the availability to generic drug manufacturers of the Changes Being Effected ("CBE") mechanism provided in 21 C.F.R. § 314.70, which allows namebrand drug manufacturers to make unilateral post-approval labeling changes, subject to FDA notice and approval. Accordingly, Actavis asserts that Demahy's LPLA claims are preempted because any state law duty to alter or increase generic drug label warnings over and above the labeling approved by the FDA conflicts with the requirements and goals of the FDCA and applicable regulations.

In opposition, Demahy claims that the § 355(j) ANDA labeling requirements apply only during the initial approval process for a generic drug. After a generic drug has been approved by the FDA via the ANDA process, however, Demahy asserts that the generic manufacturer has a continuing duty under the LPLA and the FDCA to include warnings regarding newly discovered risks "as soon as there is reasonable evidence of a causal association with a drug." 21 C.F.R. §§ 201.57(c)(6)(I) & 201.80(e).

Demahy argues further that while it is "questionable" whether generic manufacturers can utilize the CBE procedures under 21 C.F.R. § 314.70 to unilaterally add new safety information to their labels, Actavis still had some duty to at least notify the FDA of possible adverse side effects. Thus, because Actavis essentially did nothing, it should be liable under the LPLA for failure to warn of the adverse neurological side effects of metoclopramide that allegedly caused Demahy's tardive dyskinesia.

In response, Actavis reiterates that generic drug labels must always remain identical to those of the name brand drug. Also, Actavis argues that the regulations relied on by Demahy regarding the duty to update labels are inapplicable to generic drug manufacturers.

LAW & DISCUSSION

As set forth by the Supreme Court in Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007), the standard to be applied when deciding a Rule 12(b)(6) motion is not whether it is conceivable that some set of facts could be developed to support the allegations in the complaint, but rather whether the plaintiffs have stated enough facts in the complaint to allow a court to conclude that it is "plausible" that the plaintiffs are entitled to relief. The Court must accept as true all well-plead allegations and resolve all doubts in favor of the plaintiff. Tanglewood East Homeowners v. Charles-Thomas, Inc., 849 F.2d 1568, 1572 (5th Cir.1988).

As a preliminary matter, it should be noted that Demahy's claims are preempted to the extent they allege fraud-on-the-FDA under state law with regard to Actavis's alleged intentional concealment of medical research concerning the neurological effects of metoclopramide. See Buckman Co. v. Pl.'s Legal Comm., 531 U.S. 341, 348, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (holding that "state law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, federal law"). Therefore, any fraud-on-the-FDA claim by Demahy under Louisiana law is preempted and must be dismissed under Rule 12(b)(6) for failure to state a cause of action.

A. Federal Conflict Preemption

Actavis asserts that Demahy's LPLA failure-to-warn claims are barred as a matter of implied federal conflict preemption³ under the FDCA and applicable interpretive regulations and other position documents of the FDA.

The principles of implied conflict preemption proceed from the Supremacy Clause of the United States Constitution, and provide that federal law must prevail over state law when "it is impossible for a private party to comply with both state and federal requirements or where state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Freightliner Corp. v. Myrick, 514 U.S. 280, 287, 115 S.Ct. 1483, 131 L.Ed.2d 385 (1995) (internal quotations and citations omitted) (emphasis added). Conflict preemption is "fundamentally a question of congressional intent," as opposed to instances of express preemption in which Congress enacts a statute that expressly provides for preemption of state law. Geier v. Am. Honda Motor Co., 529 U.S. 861, 884, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000). As such, analysis of implied federal conflict preemption should proceed from a "presumption against pre-emption [sic]" when a case concerns whether state authority conflicts with the existence of federal authority. New York v. F.E.R.C., 535 U.S. 1, 17-18, 122 S.Ct. 1012, 152 L.Ed.2d 47 (2002). Thus when federal authority is at odds with state law, a court must "start with the assumption that the historic police powers of the States," such as health and safety regulation, "were not to be superseded ... unless that was the clear and manifest purpose of Congress." Hillsborough County, Fl. v. Automated Med....