Levine v. WYETH INC.

684 F. Supp. 2d 1338, 2010 U.S. Dist. LEXIS 56559, 2010 WL 456773
CourtDistrict Court, M.D. Florida
DecidedFebruary 10, 2010
Docket6:09-cv-00854
StatusPublished
Cited by9 cases

This text of 684 F. Supp. 2d 1338 (Levine v. WYETH INC.) is published on Counsel Stack Legal Research, covering District Court, M.D. Florida primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Levine v. WYETH INC., 684 F. Supp. 2d 1338, 2010 U.S. Dist. LEXIS 56559, 2010 WL 456773 (M.D. Fla. 2010).

Opinion

ORDER

VIRGINIA M. HERNANDEZ COVINGTON, District Judge.

This cause comes before the Court pursuant to a Motion for Summary Judgment (Doc. #44), filed by Defendants Wyeth, Wyeth Pharmaceuticals Inc., and Schwarz Pharma, Inc. (collectively “Defendants”). On January 13, 2010, the Honorable Anthony E. Porcelli, United States Magistrate Judge, issued a Report and Recommendation (Doc. # 76), recommending that the motion be granted in favor of Defendants.

As of this date, there are no objections to the report and recommendation, and the time for the parties to file such objections has elapsed.

After conducting a careful and complete review of the findings and recommendations, a district judge may accept, reject or modify the magistrate judge’s report and recommendation. 28 U.S.C. § 636(b)(1); Williams v. Wainwright, 681 F.2d 732, 732 (11th Cir.1982), cert. denied, 459 U.S. 1112, 103 S.Ct. 744, 74 L.Ed.2d 964 (1983). In the absence of specific objections, there is no requirement that a district judge review factual findings de novo, Garvey v. Vaughn, 993 F.2d 776, 779 n. 9 (11th Cir.1993), and the court may accept, reject or modify, in whole or in part, the findings and recommendations. 28 U.S.C. § 636(b)(1)(C). The district judge reviews legal conclusions de novo, even in the absence of an objection. See Cooper-Houston v. S. Ry. Co., 37 F.3d 603, 604 (11th Cir.1994); Castro Bobadilla v. Reno, 826 F.Supp. 1428, 1431-32 (S.D.Fla.1993), aff'd, 28 F.3d 116 (11th Cir.1994).

Upon consideration of the Report and Recommendation of the Magistrate Judge and upon this Court’s independent examination of the file, it is determined that the Magistrate Judge’s Report and Recommendation should be adopted.

Accordingly, it is

ORDERED, ADJUDGED, and DECREED:

(1) Judge Porcelli’s Report and Recommendation (Doc. # 76) is ADOPTED, CONFIRMED, and *1341 APPROVED in all respects and is made a part of this Order for all purposes, including appellate review.
(2) Defendants’ Motion for Summary-Judgment (Doc. # 44) is GRANTED.
(3) The Clerk is directed to enter judgment in favor of Defendants Wyeth, Wyeth Pharmaceuticals Inc., and Schwarz Pharma, Inc. and against Plaintiff as to all claims alleged against these Defendants.

REPORT AND RECOMMENDATION

ANTHONY E. PORCELLI, United States Magistrate Judge.

Before the Court is a Motion for Summary Judgment (Dkt. No. 44) filed by Defendants Wyeth, Wyeth Pharmaceuticals Inc., and Schwarz Pharma, Inc. (collectively “Defendants”). For the reasons given below, the Court RECOMMENDS that Summary Judgment be GRANTED in favor of Defendants. 1

I. Factual Background

Plaintiff Jason Levine (“Plaintiff’) suffers from tardive dyskinesia, a drug-induced neurological movement disorder. (Dkt. No. 59 pp. 2.) Plaintiff alleges that he developed this condition as a result of ingesting generic metoclopramide, which is used primarily for the treatment of gastrointestinal problems. (Id. pp. 1-2.) Defendants are pharmaceutical corporations that have engaged in, at times relevant to this lawsuit, the manufacture of name brand metoclopramide, sold under the proprietary name Reglan. (Dkt. No. 44 Exs. A-B.) Plaintiff alleges that Defendants acted as the Reference Listed Drug (“RLD”) Holder for Reglan, which was the Reference Listed Drug for generic metoclopramide. Plaintiff concedes he never ingested Reglan or any other metoclopramide made by the Defendants. (Id. Ex. C.) However, Plaintiff argues that despite mounting evidence that long term metoclopramide use carried a risk of tardive dyskinesia far greater than indicated on the label, Defendants failed to take any steps to change the label warnings. Plaintiff cites to multiple studies which suggested that the prevalence and severity of metoclopramide-induced tardive dyskinesia were underestimated, and occurred approximately 100 times more often than previously reported when metoclopramide was used beyond a twelve week period. (See Dkt. No. 59 Exs. A-D.) According to Plaintiff, Defendants either negligently or intentionally distributed false and misleading information regarding the risks of using metoclopramide. (Id. pp. 4.) And although Plaintiff never ingested Reglan or generic metoclopramide made by Defendants, he claims that his physician(s) may have relied on information provided by Defendants (such as information found in labels, promotional materials, package inserts, etc.) when they prescribed him generic metoclopramide. (Id. pp. 6.)

Plaintiffs causes of action are set forth generally against each of the named defendants in this action. Accordingly the Court considers each cause of action as they pertain to the instant Motion and Defendants. With respect to Count I alleging negligence, Plaintiff asserts that *1342 Defendants owed a duty to the general public to exercise reasonable care in the marketing of metoclopramide and breached that duty because they failed to warn that, as designed, metoclopramide was capable of causing serious personal injuries such as those suffered by Plaintiff. (Dkt. No. 1 ¶ 98.) Additionally, Plaintiff alleges, inter alia, that Defendants represented to physicians that Reglan was safe and effective for use, that Defendants failed to provide adequate training or information to medical care providers for appropriate use of Reglan, and that Defendants failed to warn the public that Reglan should not be prescribed for more than twelve weeks. (Id. ¶¶ 99(a)-(j).)

As to Count II, Plaintiff alleges Defendants are strictly liable under a products liability theory for placing into the stream of commerce a defective and unreasonably dangerous product. (Id. ¶ 103.) Although Plaintiff concedes that he did not ingest Defendants’ drug, Plaintiff argues in his Opposition that the package insert/labeling information formed part of an overall product. (Dkt. No. 59 pp. 17-18.) Plaintiff asserts that Defendants are the equivalent of a component part manufacturer because they provided the information in the insert/label which was allegedly defective. (Id.) Additionally, Plaintiff alleges under Count III that Defendants breached their express and implied warranties of merchantability because the metoclopramide was unfit for its intended purposes. (See Dkt. No. 1 ¶¶ 106-08.)

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Bluebook (online)
684 F. Supp. 2d 1338, 2010 U.S. Dist. LEXIS 56559, 2010 WL 456773, Counsel Stack Legal Research, https://law.counselstack.com/opinion/levine-v-wyeth-inc-flmd-2010.