§Why CasetextPricing

H. (T.) v. NOVARTIS PHARMACEUTICALS CORPORATION

Appellants’ Response to Amicus Curiae Brief

65 Cited authorities

  1. 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

  2. Pliva, Inc. v. Mensing

    564 U.S. 604 (2011)   Cited 746 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

  3. Merrill v. Navegar, Inc.

    26 Cal.4th 465 (Cal. 2001)   Cited 1,230 times   2 Legal Analyses
    Restating the same criteria for exceptions from the rule set forth in section 1714

  4. Demahy v. Schwarz Pharma, Inc.

    702 F.3d 177 (5th Cir. 2012)   Cited 420 times   3 Legal Analyses
    Holding that Louisiana law did not recognize "claims against Wyeth and Schwarz" "because they did not manufacture the medication [the plaintiff] actually consumed"

  5. Rowland v. Christian

    69 Cal.2d 108 (Cal. 1968)   Cited 1,246 times   20 Legal Analyses
    Holding that Section 1714 superceded prior common-law negligence rules

  6. Kesner v. Superior Court of Alameda Cnty.

    1 Cal.5th 1132 (Cal. 2016)   Cited 242 times   19 Legal Analyses
    Holding that employers and property owners owe members of a worker's household a duty to prevent take-home exposure to asbestos

  7. Schrock v. Wyeth, Inc.

    727 F.3d 1273 (10th Cir. 2013)   Cited 255 times   1 Legal Analyses
    Holding similar argument waived

  8. Cabral v. Ralphs Grocery Co.

    51 Cal.4th 764 (Cal. 2011)   Cited 244 times   4 Legal Analyses
    Rejecting claimed exception to duty of care for stopping alongside a freeway

  9. O'Neil v. Crane Co.

    53 Cal.4th 335 (Cal. 2012)   Cited 201 times   27 Legal Analyses
    Holding that product manufacturer is not liable under any theory for harm caused by a third party's products

  10. Greenman v. Yuba Power Products, Inc.

    59 Cal.2d 57 (Cal. 1963)   Cited 868 times   4 Legal Analyses
    Holding a manufacturer's liability should be imposed irrespective of fault

  11. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,245 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"

  12. Section 321 - Definitions; generally

    21 U.S.C. § 321   Cited 1,167 times   163 Legal Analyses
    Defining “new drug”

  13. Section 154 - Contents and term of patent; provisional rights

    35 U.S.C. § 154   Cited 760 times   257 Legal Analyses
    Granting twenty years for utility patents

  14. Section 355g - Utilizing real world evidence

    21 U.S.C. § 355g   Cited 14 times   12 Legal Analyses

    (a) In general The Secretary shall establish a program to evaluate the potential use of real world evidence- (1) to help to support the approval of a new indication for a drug approved under section 355(c) of this title; and (2) to help to support or satisfy postapproval study requirements. (b) Real world evidence defined In this section, the term "real world evidence" means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical

  15. Section 855 - Alternative fine

    21 U.S.C. § 855   Cited 3 times

    In lieu of a fine otherwise authorized by this part, a defendant who derives profits or other proceeds from an offense may be fined not more than twice the gross profits or other proceeds. 21 U.S.C. § 855 Pub. L. 91-513, title II, §415, as added Pub. L. 98-473, title II, §2302, Oct. 12, 1984, 98 Stat. 2193.

  16. 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"

  17. Section 10.30 - Citizen petition

    21 C.F.R. § 10.30   Cited 140 times   35 Legal Analyses
    Describing the requirements for filing a citizens' petition

  18. Section 314.105 - Approval of an NDA and an ANDA

    21 C.F.R. § 314.105   Cited 94 times   5 Legal Analyses
    Explaining that a "tentative" approval is the same as a final approval with a delayed effective date

  19. Section 201.80 - Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in Section 201.56(b)(1)

    21 C.F.R. § 201.80   Cited 85 times   5 Legal Analyses
    Requiring a manufacturer to revise its label “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug”

  20. Section 10.25 - Initiation of administrative proceedings

    21 C.F.R. § 10.25   Cited 77 times   3 Legal Analyses
    Including forms under 21 C.F.R. § 314.50 among the forms that constitute a "petition"

  21. Section 10.33 - Administrative reconsideration of action

    21 C.F.R. § 10.33   Cited 10 times   7 Legal Analyses

    (a) The Commissioner may at any time reconsider a matter, on the Commissioner's own initiative or on the petition of an interested person. (b) An interested person may request reconsideration of part or all of a decision of the Commissioner on a petition submitted under § 10.25 . Each request for reconsideration must be submitted in accordance with § 10.20 and in the following form no later than 30 days after the date of the decision involved. The Commissioner may, for good cause, permit a petition

  22. Rule 8.520 - Briefs by parties and amici curiae; judicial notice

    Cal. R. 8.520   Cited 3,160 times

    (a)Parties' briefs; time to file (1) Within 30 days after the Supreme Court files the order of review, the petitioner must serve and file in that court either an opening brief on the merits or the brief it filed in the Court of Appeal. (2) Within 30 days after the petitioner files its brief or the time to do so expires, the opposing party must serve and file either an answer brief on the merits or the brief it filed in the Court of Appeal. (3) The petitioner may file a reply brief on the merits or