Eckhardt v. Qualitest Pharmaceuticals Inc.

858 F. Supp. 2d 792, 2012 WL 1511817, 2012 U.S. Dist. LEXIS 62202
CourtDistrict Court, S.D. Texas
DecidedApril 30, 2012
DocketCivil Action No. M-11-235
StatusPublished
Cited by9 cases

This text of 858 F. Supp. 2d 792 (Eckhardt v. Qualitest Pharmaceuticals Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. Texas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Eckhardt v. Qualitest Pharmaceuticals Inc., 858 F. Supp. 2d 792, 2012 WL 1511817, 2012 U.S. Dist. LEXIS 62202 (S.D. Tex. 2012).

Opinion

ORDER

MICAELA ALVAREZ, District Judge.

Pending before the Court is the self-styled “Motion to Dismiss by Defendants Qualitest Pharmaceuticals, Inc. and Vintage Pharmaceuticals, LLC” and supporting memorandum.1 Defendants Qualitest Pharmaceuticals, Inc. and Vintage Pharmaceuticals, LLC, the generic manufacturer defendants (“Generics”), argue that in light of PLIVA, Inc. v. Mensing,2 Plaintiffs’ second amended complaint should be dismissed under Federal Rules of Civil Procedure 8, 9 and 12.3 After considering the motion, memorandum, response and relevant authorities, the Court finds that the motion should be GRANTED.

I. Background4

Plaintiffs filed their first complaint on April 13, 2011.5 On June 29, 2011, they filed an amended complaint.6 Plaintiffs filed their second amended complaint on August 26, 2011.7 The second amended complaint alleges Roy Eckhardt (“Eckhardt”) developed a neurological disorder known as tardive dyskinesia in early 2008.8 Plaintiffs allege that Eckhardt’s condition was caused by Reglan/metoclopramide, which his doctor began prescribing in 2007 [795]*795to treat Eckhardt’s gastrointestinal problems.9 Plaintiffs sued both brand-name and generic manufacturers of Reglan/metoclopramide.10 The thirty-three page complaint advances several theories of recovery ranging from negligence to fraud.11 Generics’ motion to dismiss argues that all of Plaintiffs’ claims against Generics should be dismissed for failure to state a claim upon which relief may be granted.

II. Dismissal Standards

“The ultimate question in a Rule 12(b)(6) motion is whether the complaint states a valid claim when all well-pleaded facts are assumed true and are viewed in the light most favorable to the plaintiff.”12 “A pleading that states a claim for relief must contain: ... (2) a short and plain statement of the claim showing that the pleader is entitled to relief....” 13 “To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ ”14 “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” 15 “[T]he tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions. Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.”16

To the extent that Plaintiffs allege fraud or misrepresentation, those claims are subject to the heightened pleading standards of Rule 9(b).17 Rule 9(b) “requires that [a plaintiff] ‘state with particularity the circumstances constituting the fraud.’ ‘Put simply, Rule 9(b) requires the who, what, when, where, and how to be laid out.’ ”18

III. Analysis

The Court will begin its analysis by reviewing a recent Supreme Court decision that dealt with preemption of certain claims against generic manufactures of metoclopramide, then the Court will explore the interaction of Mensing and Texas products liability law, and finally the Court will evaluate whether Plaintiffs have stated any claims that are not preempted.

A. PLIVA, Inc. v. Mensing

As a threshold matter, the Court will address the elephant in the room, PLIVA Inc. v. Mensing.19 The Supreme Court handed down this opinion on June 23, 2011,20 which was six days before Plaintiffs [796]*796filed their first amended complaint and two months before Plaintiffs filed their second amended complaint.

Mensing is strikingly similar to the case now before the Court. Mensing was a consolidation of lawsuits in which Gladys Mensing and Julie Demahy sued generic manufacturers of metoclopramide.21

Each alleged, as relevant here, that long-term metoclopramide use caused her tardive dyskinesia and that the Manufacturers were liable under state tort law (specifically, that of Minnesota and Louisiana) for failing to provide adequate warning labels. They claimed that ‘despite mounting evidence that long term metoclopramide use carries a risk of tardive dyskinesia far greater than that indicated on the label,’ none of the [generic manufacturers] had changed their labels to adequately warn of that danger.22

The defendant generic manufacturers responded by arguing “that federal law preempted the state tort claims.”23

The Supreme Court began its preemption analysis by identifying and comparing the state tort duties with the applicable federal drug labeling requirements,24 and highlighted various differences between the approval and labeling requirements of brand-name and generic drugs.25 The opinion contrasted the complicated FDA approval process for new drugs with the approval process under the Hatch-Wax-man Amendments for “ ‘generic drugs’ [which] can gain FDA approval simply by showing equivalence to a reference listed drug that has already been approved by the FDA.”26 The Supreme Court defined a “generic drug” as a “drug designed to be a copy of a reference listed drug (typically a brand-name drug), and thus identical in active ingredients, safety, and efficacy.”27 Similarly, the majority contrasted the labeling duties of brand-name and generic drug manufacturers in seeking drug approval. “A brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label. A manufacturer seeking generic drug approval, on the other hand, is responsible for ensuring that its warning label is the same as the brand name’s.”28

The Supreme Court then turned to the issue of whether generic manufacturers were permitted to change their labels “after initial FDA approval.”29 The majority analyzed this issue under the principles of conflict preemption stating, “[w]here state and federal law ‘directly conflict,’ state law must give way”30 and “[w]e have held that state and federal law conflict where it is ‘impossible for a private party to comply with both state and federal requirements.’”31 It is important to note that Mensing turned on the issue of conflict preemption-not express preemption. When the Supreme Court conducted a conflict preemption analysis in Mensing, it determined:

We find impossibility here. It was not lawful under federal law for the [generic manufacturers] to do what state [797]*797law required of them.

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Cite This Page — Counsel Stack

Bluebook (online)
858 F. Supp. 2d 792, 2012 WL 1511817, 2012 U.S. Dist. LEXIS 62202, Counsel Stack Legal Research, https://law.counselstack.com/opinion/eckhardt-v-qualitest-pharmaceuticals-inc-txsd-2012.