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Dolin v. Smithkline Beecham Corporation, et al

MEMORANDUM other 79 , Motion to Dismiss for Failure to State a Claim 81

39 Cited authorities

  1. Wyeth v. Levine

    555 U.S. 555 (2009)   Cited 1,435 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 749 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. Mut. Pharm. Co. v. Bartlett

    570 U.S. 472 (2013)   Cited 416 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"

  4. Board of Education v. A, C S, Inc.

    131 Ill. 2d 428 (Ill. 1989)   Cited 404 times
    Holding that under Illinois law the economic loss doctrine does not bar recovery on an asbestos-in-building claim when the asbestos has contaminated the buildings thus damaging other property

  5. Kirk v. Michael Reese Hospital & Medical Center

    117 Ill. 2d 507 (Ill. 1987)   Cited 344 times   2 Legal Analyses
    Holding that neither doctors nor hospital owed a duty to the plaintiff to control the patient's conduct, in part because there had been no allegations that the hospital or doctors were aware of any dangerous propensities of the patient

  6. Mikolajczyk v. Ford Motor Co.

    231 Ill. 2d 516 (Ill. 2008)   Cited 177 times   1 Legal Analyses
    Holding that a product defect must have "existed at the time the product left the defendant's control" for strict liability to apply

  7. Conte v. Wyeth, Inc.

    168 Cal.App.4th 89 (Cal. Ct. App. 2008)   Cited 132 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

  8. Pelfresne v. Village of Williams Bay

    917 F.2d 1017 (7th Cir. 1990)   Cited 212 times
    Finding a litigant forgoes a point by not "supporting it with pertinent authority, or by [not] showing why it is sound despite a lack of supporting authority"

  9. Salerno v. Innovative Surveillance Tech

    402 Ill. App. 3d 490 (Ill. App. Ct. 2010)   Cited 78 times
    Holding that the plaintiff must provide expert testimony to establish that the manufacturer deviated from the standard of care "[b]ecause products liability actions involve specialized knowledge or expertise outside of a layman's knowledge"

  10. Foster v. American Home Prod. Corp.

    29 F.3d 165 (4th Cir. 1994)   Cited 113 times   8 Legal Analyses
    Holding that "a plaintiff seeking to recover for an injury by a product [must] demonstrate that the defendant manufactured the product at issue" under Maryland law

  11. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,252 times   341 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 1,169 times   165 Legal Analyses
    Defining “new drug”

  13. Section 351 - Adulterated drugs and devices

    21 U.S.C. § 351   Cited 341 times   32 Legal Analyses
    Referencing the U.S. Pharmacopeia's strength, quality, and purity standards

  14. Section 225 ILCS 85/25 - [Section Scheduled to be repealed 1/1/2028]

    225 ILCS 85/25   Cited 6 times

    No person shall compound, or sell or offer for sale, or cause to be compounded, sold or offered for sale any medicine or preparation under or by a name recognized in the United States Pharmacopoeia National Formulary, for internal or external use, which differs from the standard of strength, quality or purity as determined by the test laid down in the United States Pharmacopoeia National Formulary official at the time of such compounding, sale or offering for sale. Nor shall any person compound,

  15. Section 410 ILCS 620/1

    410 ILCS 620/1   Cited 4 times   1 Legal Analyses

    This Act shall be known and may be cited as the Illinois Food, Drug and Cosmetic Act. 410 ILCS 620/1 Laws 1967, p. 959.

  16. Section 410 ILCS 620/3.14 - Dispensing or causing to be dispensed a different drug in place of the drug or brand of drug ordered or prescribed without the express permission of the person ordering or prescribing

    410 ILCS 620/3.14

    Except as set forth in Section 26 of the Pharmacy Practice Act, this Section does not prohibit the interchange of different brands of the same generically equivalent drug product, when the drug products are not required to bear the legend "Caution: Federal law prohibits dispensing without prescription", provided that the same dosage form is dispensed and there is no greater than 1% variance in the stated amount of each active ingredient of the drug products. A generic drug determined to be therapeutically

  17. Section 225 ILCS 120/10 - [Section Scheduled to be repealed 1/1/2028] Purpose

    225 ILCS 120/10

    The purpose of this Act is to implement the Federal Prescription Drug Marketing Act of 1987 (PDMA), U.S. Pub. L. 100-293, 102 Stat. 95, codified at U.S.C. Sec. 321 et seq.; and particularly PDMA requirements that no person or entity may engage in the wholesale distribution of human prescription drugs in any state unless the person or entity is licensed by that state in accordance with federally prescribed minimum standards, terms, and conditions as set forth in guidelines issued by United States

  18. Section 314.80 - Postmarketing reporting of adverse drug experiences

    21 C.F.R. § 314.80   Cited 114 times   7 Legal Analyses
    Requiring report of “serious and unexpected” adverse event within 15 days

  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 320.1 - Definitions

    21 C.F.R. § 320.1   Cited 54 times   3 Legal Analyses

    The definitions contained in § 314.3 of this chapter apply to those terms when used in this part. 21 C.F.R. §320.1 81 FR 69658, Oct. 6, 2016 81 FR 69658, 12/5/2016

  21. Section 201.100 - Prescription drugs for human use

    21 C.F.R. § 201.100   Cited 47 times   9 Legal Analyses
    Exempting certain approved and new drugs from the FDCA's labeling requirements for adequate directions for use

  22. Section 202.1 - Prescription-drug advertisements

    21 C.F.R. § 202.1   Cited 42 times   29 Legal Analyses
    Defining labeling to include virtually any type of audio, visual or printed matter descriptive of a drug and supplied by a manufacturer

  23. Section 314.108 - New drug product exclusivity

    21 C.F.R. § 314.108   Cited 28 times   33 Legal Analyses

    (a)Definitions. The definitions in § 314.3 and the following definitions of terms apply to this section: Approved under section 505(b) means an NDA submitted under section 505(b) and approved on or after October 10, 1962, or an application that was "deemed approved" under section 107(c)(2) of Public Law 87-781 . Bioavailability study means a study to determine the bioavailability or the pharmacokinetics of a drug. Clinical investigation means any experiment other than a bioavailability study in which