§Why CasetextPricing

Nelson v. Biogen Idec, Inc. et al

MOTION for Summary Judgment

49 Cited authorities

  1. Anderson v. Liberty Lobby, Inc.

    477 U.S. 242 (1986)   Cited 236,174 times   38 Legal Analyses
    Holding that summary judgment is not appropriate if "the dispute about a material fact is ‘genuine,’ that is, if the evidence is such that a reasonable jury could return a verdict for the nonmoving party"

  2. Celotex Corp. v. Catrett

    477 U.S. 317 (1986)   Cited 216,278 times   40 Legal Analyses
    Holding that a movant's summary judgment motion should be granted "against a [nonmovant] who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial"

  3. Wyeth v. Levine

    555 U.S. 555 (2009)   Cited 1,432 times   101 Legal Analyses
    Holding that the FDA's drug labeling judgments pursuant to the FDCA did not obstacle preempt state law products liability claims

  4. Pliva, Inc. v. Mensing

    564 U.S. 604 (2011)   Cited 745 times   143 Legal Analyses
    Holding that state tort law that required generic drug manufacturers to provide adequate warning labels was preempted where federal law required manufacturers to use the same labels as their brand-name counterparts

  5. Mut. Pharm. Co. v. Bartlett

    570 U.S. 472 (2013)   Cited 415 times   67 Legal Analyses
    Holding "state-law design-defect claims that turn on the adequacy of a drug's warnings are pre-empted by federal law under PLIVA"

  6. Kaucher v. County of Bucks

    455 F.3d 418 (3d Cir. 2006)   Cited 1,928 times
    Holding risk of contracting infection from inmate inherent to corrections officer's employment, even if contraction resulted from "unsanitary and dangerous conditions" at correctional facility

  7. Rowe v. Roche

    189 N.J. 615 (N.J. 2007)   Cited 188 times   1 Legal Analyses
    Holding that in the absence of an actual conflict, the law of the forum state applies to resolve the disputed issue

  8. Germain v. Teva Pharmaceuticals

    756 F.3d 917 (6th Cir. 2014)   Cited 145 times   7 Legal Analyses
    Holding that brand-name manufacturers cannot be held liable for damages caused by ingestion of generic drugs under negligent misrepresentation law of 22 states

  9. Robinson v. McNeil Consumer Healthcare

    615 F.3d 861 (7th Cir. 2010)   Cited 76 times   7 Legal Analyses
    Finding a plaintiff's claim for an injury that occurred before the FDA's rejection of a proposed label change, which was clear evidence that it would not have accepted the plaintiff's proposed warning, to be preempted

  10. Zaza v. Marquess & Nell, Inc.

    144 N.J. 34 (N.J. 1996)   Cited 115 times   1 Legal Analyses
    Affirming summary judgment in favor of component part manufacturer because manufacturer's "sole obligation was to produce a component part that was safe and satisfactory according to the specifications by [the purchaser]" where only the second-stage manufacturer hired by the purchaser possessed the ability and specialized knowledge necessary to integrate safety devices into the completed product

  11. Rule 56 - Summary Judgment

    Fed. R. Civ. P. 56   Cited 328,681 times   158 Legal Analyses
    Holding a party may move for summary judgment on any part of any claim or defense in the lawsuit

  12. Section 301 - Short title

    21 U.S.C. § 301   Cited 2,427 times   48 Legal Analyses

    This chapter may be cited as the Federal Food, Drug, and Cosmetic Act. 21 U.S.C. § 301 June 25, 1938, ch. 675, §1, 52 Stat. 1040. STATUTORY NOTES AND RELATED SUBSIDIARIES EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES Act June 23, 1939, ch. 242, §§1, 2, 53 Stat. 853, 854, provided that:"[SEC. 1] (a) The effective date of the following provisions of the Federal Food, Drug, and Cosmetic Act is hereby postponed until January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1) [343(e)(1) of this

  13. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,244 times   337 Legal Analyses
    Granting the court discretion to change the date on which an ANDA may be approved if "either party to the action failed to reasonably cooperate in expediting the action"

  14. Rule 407 - Subsequent Remedial Measures

    Fed. R. Evid. 407   Cited 1,399 times   13 Legal Analyses
    Allowing for the exclusion of evidence of subsequent remedial measures

  15. Section 2A:58C-2 - Liability of manufacturer or seller in product liability action

    N.J. Stat. § 2A:58C-2   Cited 282 times   4 Legal Analyses
    Establishing elements for prima facie cause of action under New Jersey Products Liability Act

  16. Section 2A:58C-4 - No liability if warning provided

    N.J. Stat. § 2A:58C-4   Cited 138 times   7 Legal Analyses
    Imposing continuing duty to warn on defendants in failure to warn cases

  17. Section 355-1 - Risk evaluation and mitigation strategies

    21 U.S.C. § 355-1   Cited 36 times   18 Legal Analyses
    Providing that the FDA will send a letter to health care providers on behalf of an ANDA holder if such letter is a necessary part of a risk evaluation and mitigation strategy

  18. Section 314.70 - Supplements and other changes to an approved NDA

    21 C.F.R. § 314.70   Cited 353 times   37 Legal Analyses
    Defining "major changes" as those "requiring supplement submission and approval prior to distribution of the product"

  19. Section 201.57 - Specific requirements on content and format of labeling for human prescription drug and biological products described in Section 201.56(b)(1)

    21 C.F.R. § 201.57   Cited 252 times   27 Legal Analyses
    Listing requirements for different subsections for indications, dosage, and clinical studies

  20. Section 314.3 - Definitions

    21 C.F.R. § 314.3   Cited 144 times   30 Legal Analyses
    Defining "reference listed drug"

  21. Section 314.520 - Approval with restrictions to assure safe use

    21 C.F.R. § 314.520   Cited 21 times   4 Legal Analyses

    (a) If FDA concludes that a drug product shown to be effective can be safely used only if distribution or use is restricted, FDA will require such postmarketing restrictions as are needed to assure safe use of the drug product, such as: (1) Distribution restricted to certain facilities or physicians with special training or experience; or (2) Distribution conditioned on the performance of specified medical procedures. (b) The limitations imposed will be commensurate with the specific safety concerns

  22. Section 601.42 - Approval with restrictions to assure safe use

    21 C.F.R. § 601.42   Cited 1 times

    (a) If FDA concludes that a biological product shown to be effective can be safely used only if distribution or use is restricted, FDA will require such postmarketing restrictions as are needed to assure safe use of the biological product, such as: (1) Distribution restricted to certain facilities or physicians with special training or experience; or (2) Distribution conditioned on the performance of specified medical procedures. (b) The limitations imposed will be commensurate with the specific