Mosley v. Wyeth Inc.
Decision Date | 28 June 2010 |
Docket Number | Civil Action No. 09-0284-KD-C. |
Citation | 719 F.Supp.2d 1340 |
Parties | Odessa MOSLEY, et al., Plaintiffs, v. WYETH, INC., et al., Defendants. |
Court | U.S. District Court — Southern District of Alabama |
OPINION TEXT STARTS HERE
COPYRIGHT MATERIAL OMITTED.
Thomas Edward Dutton, Pittman, Hooks, Dutton & Hollis, P.C., Birmingham, AL, Alexandra Vanassa Boone, Javier Gonzalez, William Burton Curtis, Miller, Curtis & Weisbrod, Dallas, TX, Daniel J. McGlynn, Terrence Joseph Donahue, McGlynn Glisson & Mouton, Baton Rouge, LA, for Plaintiffs.
Jeffrey R. Pilkington, Davis Graham & Stubbs LLP, Denver, CO, Philip H. Butler, Bradley Arant Boult Cummings LLP, Montgomery, AL, Frederick George Helmsing, Jr., McDowell Knight Roedder & Sledge, L.L.C., Edward G. Bowron, Burr & Forman, LLP, Mobile, AL, Andrew J. Calica, Henniger S. Bullock, Mayer Brown LLP, New York, NY, Joseph P. Thomas, Columbus, OH, Thomas Gene McIntosh, Cincinnati, OH, Kathleen T. Cobb Kaufman, Mobile, AL, Linda A. Maichl, Cincinnati, OH, Rex Allen Littrell, Jon W. Oebker, Tucker Ellis & West LLP, Richard A. Dean, Hugh M. Stanley, Cleveland, OH, for Defendants.
This matter is before the Court on Wyeth, Inc. (“Wyeth”) and Schwarz Pharma, Inc. (“Schwarz,” and, together with Wyeth, the “Reglan manufacturers”)' motion for summary judgment (Docs. 73, 74, & 75), reply brief (Doc. 84), and notices of supplemental authority (Docs. 88, 93, 94, 111, & 128), and the plaintiffs' response in opposition (Doc. 83) and notice of supplemental authority (Doc. 98). For the reasons set forth herein, the Reglan manufacturers' motion for summary judgment is GRANTED.
Summary judgment should be granted only if “there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(c). 1 The party seeking summary judgment bears “the initial burden to show the district court, by reference to materials on file, that there are no genuine issues of material fact that should be decided at trial.” Clark v. Coats & Clark, Inc., 929 F.2d 604, 608 (11th Cir.1991). The party seeking summary judgment also always bears the “initial responsibility of informing the district court of the basis for its motion, and identifying those portions of ‘the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any,’ which it believes demonstrate the absence of a genuine issue of material fact.” Id. (quoting Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986)). If the nonmoving party fails to make “a sufficient showing on an essential element of her case with respect to which she has the burden of proof,” the moving party is entitled to summary judgment. Celotex, 477 U.S. at 323, 106 S.Ct. 2548. However, Tipton v. Bergrohr GMBH-Siegen, 965 F.2d 994, 998-999 (11th Cir.1992), cert. den., 507 U.S. 911, 113 S.Ct. 1259, 122 L.Ed.2d 657 (1993) (internal citations and quotations omitted). The mere existence of a factual dispute will not automatically necessitate denial; rather, only factual disputes that are material preclude entry of summary judgment. Lofton v. Secretary of Dept. of Children & Family Serv., 358 F.3d 804, 809 (11th Cir.2004), cert. den., 543 U.S. 1081, 125 S.Ct. 869, 160 L.Ed.2d 825 (2005).
Metoclopramide is a prescription drug approved by the FDA to treat gastroesophageal reflux disease and diabetic gastroparesis. (Doc. 1, ¶ 3.72; Doc. 74, p. 8; Doc. 83, p. 6). Metoclopramide is available in both brand-name (“Reglan”) and generic formulations. (Doc. 74-1, ¶ 6; Doc. 83, p. 6).
At different times during the time period relevant to the Mosleys' complaint, Defendants Wyeth and Schwarz manufactured and distributed Reglan and were each at a relevant point in time the reference-listed drug (“RLD”) holder for metoclopramide. (Doc. 74, p. 9; Doc. 83, pp. 6 & 9).
Defendant Actavis-Elizabeth, LLC, a wholly owned subsidiary of Defendant Actavis, Inc. (together with Actavis-Elizabeth, LLC, “Actavis”) and the successor to Purepac Pharmaceutical Inc., is a manufacturer and distributor of generic metoclopramide. (Doc. 1, at ¶¶ 1.05, 3.05, & 3.59). Defendant Pliva USA, Inc. (“Pliva”) is also a manufacturer and distributor of generic metoclopramide. ( See id. at ¶¶ 3.04 & 3.59).
Sometime in 2005, Odessa Mosley's treating physician prescribed Reglan at a dosage of 10 mg to treat her reflux, nausea and vomiting. (Doc. 1, ¶ 3.08). After Mrs. Mosley ingested metoclopramide tablets as prescribed on a long-term basis, she began exhibiting abnormal body movements “which have since been linked to her use of Reglan/metoclopramide” ( id. at ¶¶ 3.11-3.13, & 3.15) and ultimately developed a movement disorder called tardive dyskinesia as a result of taking metoclopramide ( id. at ¶¶ 3.16).
On February 26, 2009, the federal Food and Drug Administration (“FDA”) issued a safety alert and ordered manufacturers of metoclopramide to add a “Black Box Warning” to their labels. (Doc. 83, p. 10). The warning indicates that the prevalence of tardive dyskinesia among patients using metoclopramide beyond twelve weeks may be as high as 20%, 100 times greater than previous warnings had indicated. ( Id.).
Plaintiffs Odessa and Ulysses Mosley (together, “the Mosleys”) initiated this lawsuit by filing a complaint on May 21, 2009, alleging claims against all defendants of negligence, strict liability, breach of warranty, misrepresentation and fraud, and gross negligence. (Doc. 1, ¶¶ 4.01-5.03). 3
On September 4, 2009, the Mosleys served a Notice of Product Identification stating that “based on the available information consisting of the pharmacy records from Target Pharmacy and Walgreen's pharmacy,” Mrs. Mosley's prescription records “reflect the following manufacturers of ... metoclopramide she ingested[:] Pliva, Inc [, and] Purepac (now Actavis).” (Doc. 74-3).
The Reglan manufacturers timely filed the instant motion for summary judgment (Doc. 73) as to “all claims against Wyeth and Schwarz” on the basis that “[t]he undisputed fact that Mrs. Mosley did not purchase or ingest any metoclopramide what were manufactured or sold by Wyeth or Schwarz is dispositive of Plaintiffs' claims under Alabama law.” (Doc. 74, p. 24).
According to the plaintiffs, they (Doc. 83, p. 17).
However, the Mosleys contend in opposition to the Reglan manufacturers' motion for summary judgment that the Reglan manufacturers, “as the producer of Reglan, the Reference Listed Drug for [the] generic metoclopramide” that Mrs. Mosley ingested ( Id., pp. 6-7), were
responsible for authoring and disseminating misrepresentations regarding the risk of tardive dyskinesia with long-term use of metoclopramide for which they had no scientific support. Both defendants were aware of the increased risk associated with prolonged use of metoclopramide, and chose to withhold this information from the FDA and health care providers....
( Id., p. 19). The Mosleys insist that “[i]n the regulatory framework for drugs approved by the FDA,” a New Drug Application (“NDA”) holder is “primarily responsible for the labeling and warnings given to prescribing physicians and patients,” and that (Doc. 83, pp. 8, 11-12). The plaintiffs further contend that “[a]s the RLD holder, Wyeth and Schwarz voluntarily assumed heightened duties and responsibilities imposed by the Code of Federal Regulation ...,” citing specific regulations in support of their claims. ( Id.).
The Mosleys also explain that their
claims against Wyeth and Schwarz do not relate to the composition or manufacture of the metoclopramide [Mrs. Mosley] ingested, but rather focus [ ] on the inaccurate and insufficient information promulgated by [the Reglan manufacturers] and by which the drug was prescribed. This false information created a sense of security and safety regarding metoclopramide which caused or contributed to the misuse of the drug by Plaintiff's prescribing doctor, and led directly to the severe damages suffered by Plaintiff.
* * *
The argument is not that Defendants' product caused Plaintiff harm, 4 but rather that their dissemination of false and misleading information, which they knew would be relied upon by the generic manufacturers in generating their own labels, was the direct and proximate cause of Plaintiff's injuries.
( Id., p. 7-8).
B. Legal Conclusions
Jurisdiction obtains pursuant to 28 U.S.C. § 1332 (Docs. 1, 18, 19, 27 & 103), and this Court is bound to apply Alabama substantive law. See Erie R. Co. v. Tompkins, 304 U.S. 64, 58 S.Ct. 817, 82 L.Ed. 1188 (1938).
In situations “ ‘involving negligent misrepresentations relied upon by third parties, or parties who were not in privity of contract with the person making the misrepresentation,’ ” Alabama's “Supreme Court has instructed that liability for...
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