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H. (T.) v. NOVARTIS PHARMACEUTICALS CORPORATION

Amicus Curiae Brief of Chamber of Commerce of the United States of America

33 Cited authorities

  1. Wyeth v. Levine

    555 U.S. 555 (2009)   Cited 1,429 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 744 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. Small v. Fritz Cos., Inc.

    30 Cal.4th 167 (Cal. 2003)   Cited 629 times   5 Legal Analyses
    Holding that complaint for negligent misrepresentation in a holder action must be "pled with the same specificity required in a holder's action for fraud."

  4. Schrock v. Wyeth, Inc.

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

  5. Germain v. Teva Pharmaceuticals

    756 F.3d 917 (6th Cir. 2014)   Cited 144 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

  6. Brown v. Superior Court

    44 Cal.3d 1049 (Cal. 1988)   Cited 279 times   4 Legal Analyses
    Holding manufacturers immune from strict liability for pharmaceutical design defects

  7. Sindell v. Abbott Laboratories

    26 Cal.3d 588 (Cal. 1980)   Cited 320 times   2 Legal Analyses
    Holding DES manufacturers liable under California law in proportion to their market shares

  8. Conte v. Wyeth, Inc.

    168 Cal.App.4th 89 (Cal. Ct. App. 2008)   Cited 131 times   15 Legal Analyses
    Holding that, under California law, the brand-name manufacturer owes a duty of care to patients who ingest the generic drug

  9. Webb v. Special Electric Co., Inc.

    63 Cal.4th 167 (Cal. 2016)   Cited 99 times   5 Legal Analyses
    Recognizing the three strict products liability theories

  10. Smith v. Wyeth Inc.

    657 F.3d 420 (6th Cir. 2011)   Cited 87 times   6 Legal Analyses
    Holding that the plaintiffs' state-law failure to warn claims were preempted by Mensing because “[t]he Supreme Court held unequivocally ... that federal law preempts state laws that impose on generic-drug manufacturers the duty to change a drug's label, thus barring the plaintiffs' state-law tort claims”

  11. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,241 times   334 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 6-5-530 - Liability for damages

    Ala. Code § 6-5-530   Cited 15 times

    (a) In any civil action for personal injury, death, or property damage caused by a product, regardless of the type of claims alleged or the theory of liability asserted, the plaintiff must prove, among other elements, that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based, and not a similar or equivalent product. Designers, manufacturers, sellers, or lessors of products not identified as having

  13. 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"

  14. Section 314.80 - Postmarketing reporting of adverse drug experiences

    21 C.F.R. § 314.80   Cited 113 times   7 Legal Analyses
    Requiring report of “serious and unexpected” adverse event within 15 days

  15. Section 314.81 - Other postmarketing reports

    21 C.F.R. § 314.81   Cited 45 times   26 Legal Analyses
    Requiring transmittal of the advertisement with Form FDA-2253

  16. Section 314.97 - Supplements and other changes to an approved ANDA

    21 C.F.R. § 314.97   Cited 24 times   4 Legal Analyses
    Applying §§ 314.70 and 314.71 to approved abbreviated applications

  17. Section 314.98 - Postmarketing reports

    21 C.F.R. § 314.98   Cited 16 times   1 Legal Analyses
    Imposing a duty on generic manufacturers to report adverse drug experiences to the FDA

  18. Section 314.71 - Procedures for submission of a supplement to an approved application

    21 C.F.R. § 314.71   Cited 12 times   2 Legal Analyses

    (a) Only the applicant may submit a supplement to an application. (b) All procedures and actions that apply to an application under § 314.50 also apply to supplements, except that the information required in the supplement is limited to that needed to support the change. A supplement is required to contain an archival copy and a review copy that include an application form and appropriate technical sections, samples, and labeling; except that a supplement for a change other than a change in labeling

  19. Section 314.72 - Change in ownership of an application

    21 C.F.R. § 314.72   Cited 1 times

    (a) An applicant may transfer ownership of its application. At the time of transfer the new and former owners are required to submit information to the Food and Drug Administration as follows: (1) The former owner shall submit a letter or other document that states that all rights to the application have been transferred to the new owner. (2) The new owner shall submit an application form signed by the new owner and a letter or other document containing the following: (i) The new owner's commitment

  20. Rule 8.208 - Certificate of Interested Entities or Persons

    Cal. R. 8.208   Cited 17 times

    (a)Purpose and intent The California Code of Judicial Ethics states the circumstances under which an appellate justice must disqualify himself or herself from a proceeding. The purpose of this rule is to provide justices of the Courts of Appeal with additional information to help them determine whether to disqualify themselves from a proceeding. (b)Application This rule applies in appeals in civil cases other than family, juvenile, guardianship, and conservatorship cases. (Subd (b) adopted effective