Neeley v. Wolters Kluwer Health, Inc., No. 4:11-CV-325 JAR

CourtUnited States District Courts. 8th Circuit. United States District Court (Eastern District of Missouri)
Writing for the CourtJOHN A. ROSS
PartiesDENISE NEELEY and HAROLD NEELEY, Plaintiffs, v. WOLTERS KLUWER HEALTH, INC., et al., Defendants.
Decision Date29 July 2013
Docket NumberNo. 4:11-CV-325 JAR

WOLTERS KLUWER HEALTH, INC., et al., Defendants.

No. 4:11-CV-325 JAR


Dated: July 29, 2013


This matter is before the court on Defendants Wolters Kluwer Health, Inc. and Wolters Kluwer United States, Inc.'s Motion to Dismiss (ECF No. 144), Barr Laboratories, Inc.; Barr Pharmaceuticals, LLC; and Watson Laboratories, Inc.'s Motion to Dismiss (ECF No. 146), Barr Laboratories, Inc.; Barr Pharmaceuticals, LLC; Watson Laboratories, Inc.; Wolters Kluwer Health, Inc.; and Wolters Kluwer United States, Inc.'s Motion to Dismiss Based On Insufficient Allegations (ECF No. 148), Defendant Watson Pharma, Inc.'s Notice of Joinder in Barr Laboratories, Inc.; Barr Pharmaceuticals, LLC; Watson Laboratories, Inc.; Wolters Kluwer Health, Inc.; and Wolters Kluwer United States, Inc.'s Motion to Dismiss Based On Insufficient Allegations (ECF No. 167), and Defendant Wyeth LLC, Wyeth Pharmaceuticals Inc., and Schwartz Pharma, Inc. n/k/a UCB, Inc.'s Motion for Summary Judgment (ECF No. 174). These matters are fully briefed and ready for disposition.

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In November 2006, Plaintiff Denise Neeley's (referred to herein as "Plaintiff" or "Ms. Neeley") physician prescribed her Reglan three times per day to treat gastroesophageal reflux disease (GERD). (Second Amended Complaint and Demand for Jury Trial ("Compl." or "Complaint"), ECF No. 122, ¶71). Reglan is sold as a generic drug as metoclopramide ("MCP"). Plaintiff admits that she ingested only the generic MCP. (ECF No. 164; Compl., ¶75) From approximately November 2006 through February 2008, Plaintiff ingested 10 mg of MCP approximately three times per day. (Compl., ¶72). Plaintiff also had been prescribed Reglan/MCP off and on for over a thirty-year period beginning in approximately 1987. On April 12, 2010, Plaintiff was diagnosed with tardive dyskinesia. (Compl., ¶¶79, 80).

On July 25, 2012, Plaintiffs Denise and Harold Neeley filed their Second Amended Complaint. Wyeth, LLC, Wyeth Pharmaceuticals, Inc., and Schwarz Pharma, Inc., n/k/a/ UCB, Inc., are referred to herein as the "Brand Defendants." (Compl., ¶37).1 Barr Laboratories, Inc.; Barr Pharmaceuticals, LLC; and Watson Laboratories, Inc., and Watson Pharma, Inc. are referred to herein as the "Generic Defendants." (Compl., ¶38). Wolters Kluwer Health, Inc.; and Wolters Kluwer United States, Inc. are referred to herein as the "PEM Defendants." (Compl., ¶39).


I. Motions to Dismiss

A. Standard of Review

In ruling on a motion to dismiss, the Court must view the allegations in the Complaint liberally in the light most favorable to Plaintiff. Eckert v. Titan Tire Corp., 514 F.3d 801,

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806 (8th Cir. 2008)(citing Luney v. SGS Auto Servs., 432 F.3d 866, 867 (8th Cir. 2005)). Additionally, the Court "must accept the allegations contained in the complaint as true and draw all reasonable inferences in favor of the nonmoving party." Coons v. Mineta, 410 F.3d 1036, 1039 (8th Cir. 2005) (citation omitted). To survive a motion to dismiss, a complaint must contain "enough facts to state a claim to relief that is plausible on its face." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007) (abrogating the "no set of facts" standard for Fed. R. Civ. P. 12(b)(6) found in Conley v. Gibson, 355 U.S. 41, 45-46 (1957)). While a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff's obligation to provide the grounds of his entitlement to relief "requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Twombly, 550 U.S. at 555; Huang v. Gateway Hotel Holdings, 520 F. Supp. 2d 1137, 1140 (E.D. Mo. 2007).

B. Generic Defendants

1. Hatch-Waxman Amendments and FDA Regulations

The labeling of prescription drugs is governed by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §301, et seq. "A manufacturer seeking federal approval to market a new drug must prove that it is safe and effective and that the proposed label is accurate and adequate." PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2574, 180 L. Ed. 2d 580 (2011). In 1984, Congress amended the FDCA to allow generic drug manufacturers "to gain FDA approval simply by showing that its drug is equivalent to an already-approved brand-name drug, and that the safety and efficacy labeling proposed for its drug is the same as that approved for the brand-name drug." Id. These amendments, commonly referred to as the Hatch-Waxman Amendments,

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allowed generic manufacturers to develop generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand-name drug. Id.

"To obtain approval for a generic drug, the manufacturer generally must show the generic drug is 'bioequivalent' to the brand name drug and has the same active ingredients, route of administration, dosage and strength." Bell v. Pfizer, Inc., 716 F.3d 1087, 1094 (8th Cir. 2013)(citing 21 U.S.C. §355(j)(2)(A)). A generic drug application must also 'show that the [safety and efficacy] labeling proposed ... is the same as the labeling approved for the [brand-name] drug.'" Mensing, 131 S. Ct. at 2574 (quoting § 355(j)(2)(A)(v))(alterations in Mensing). "[G]eneric drug manufacturers have an ongoing federal duty of 'sameness.'" Mensing, 131 S. Ct. at 2575. FDA regulations "allow changes to generic drug labels only when a generic drug manufacturer changes its label to match an updated brand-name label or to follow the FDA's instructions." Mensing, 131 S. Ct. at 2575-76 (deferring to the FDA's interpretation of its CBE [changes-being effected process] and generic labeling regulations).

"The federal labeling regulations also apply to letters providing 'additional warnings to prescribing physicians and other healthcare professionals' (Dear Doctor letters), which must be 'consistent with and not contrary to [the drug's] approved ... labeling.'" Mensing, 131 S.Ct. at 2576 (quoting 21 C.F.R. §201.100(d)(1))(alterations in Mensing). "A Dear Doctor letter that contained substantial new warning information would not be consistent with the drug's approved labeling." Mensing, 131 S. Ct. at 2576. Likewise, "if generic drug manufacturers, but not the brand-name manufacturer, sent such letters, that would inaccurately imply a therapeutic difference between the brand and generic drugs and thus could be impermissibly 'misleading.'" Mensing, 131 S. Ct. at 2576.

2. Conflict of Laws

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The parties seem to agree that Kentucky law applies to their state law claims and, therefore, no conflict of law analysis is required. See, e.g., ECF No. 102, pp. 5, 142 ; ECF No. 147, p. 33 (both applying Kentucky law).

3. Discussion

Plaintiffs allege claims against Generic Defendants for negligence, negligent misrepresentation and negligent supply of information for the guidance of others (Count II), breach of warranty (Counts IV), misrepresentation and fraud (Count V), strict product liability (Count VIII), violation of the Missouri Merchandising Practices Act ("MMPA") and/or Kentucky Consumer Protection Act ("KCPA") (Count IX), joint and several liability, enterprise liability, market share liability, concert of action liability (Count X), loss of consortium (Count XII), punitive damages (Count XIII), and Plaintiff's damages (Count XIV). Plaintiffs' claims against Generic Defendants arise primarily from their failure to update their warnings to comport with the brand name defendants' warnings. Specifically, Plaintiffs allege that "[b]y failing to update their drug information, including their labels, package inserts, drug databases and PEMs, distributed to doctors and patients alike, Defendants inaccurately warned of true risks of Reglan/MCP and misrepresented the safety of the drug for long-term usage." (Compl., ¶123). Plaintiffs contend that "Generic Defendants failed to update and/or revise their labels for their Reglan/MCP products with the 1985, 2004, and/or 2009 FDA-mandated label revisions, thereby failing to adequately warn of the true risks of the use of Reglan/MCP and misleading physicians, patients and the

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healthcare community to believe long term use of Reglan/MCP (longer than twelve weeks) was safe." (Compl., ¶284).

Generic Defendants first contend that the case should be dismissed because the Court does not have jurisdiction over them. (ECF No. 147, p. 2). In addition, Generic Defendants contend that Plaintiffs' lawsuit should be dismissed because it is preempted by federal law. (Id.).

a. Personal Jurisdiction over Generic Defendants

Generic Defendants contend that this Court lacks either specific or general jurisdiction. None of the Generic Defendants have their principal place of business in Missouri, nor are they incorporated in Missouri. (ECF No. 147, p. 6). Generic Defendants assert that Plaintiffs are Kentucky residents and the events allegedly causing them injury have no connection to this forum. (ECF No. 147, p. 9). Further, they contend that Plaintiffs' causes of action do not arise out of any contacts Generic Defendants had with Missouri. (Id.).

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