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H. (T.) v. NOVARTIS PHARMACEUTICALS CORPORATION

Amicus Curiae Brief of Product Liability Advisory Council, Inc.

75 Cited authorities

  1. Buckman Co. v. Plaintiffs' Legal Committee

    531 U.S. 341 (2001)   Cited 1,184 times   80 Legal Analyses
    Holding that federal drug and medical device laws pre-empted a state tort-law claim based on failure to properly communicate with the FDA

  2. 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

  3. People v. Chun

    45 Cal.4th 1172 (Cal. 2009)   Cited 1,028 times
    Holding that Cal. Penal Code § 246 cannot be a predicate offense to support second-degree felony-murder conviction

  4. 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

  5. People v. Elliott

    53 Cal.4th 535 (Cal. 2012)   Cited 462 times
    In People v. Elliott (2012) 53 Cal.4th 535 (Elliott), the Supreme Court further explained the relevancy inquiry: " '[T]o be admissible, evidence of the culpability of a third party offered by a defendant to demonstrate that a reasonable doubt exists concerning his or her guilt... must link the third person either directly or circumstantially to the actual perpetration of the crime.

  6. Demahy v. Schwarz Pharma, Inc.

    702 F.3d 177 (5th Cir. 2012)   Cited 419 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"

  7. Rutherford v. Owens-Illinois, Inc.

    16 Cal.4th 953 (Cal. 1997)   Cited 597 times   12 Legal Analyses
    Holding "plaintiffs may prove causation in asbestos-related cancer cases by demonstrating that the plaintiff's [or decedent's] exposure to defendant's asbestos-containing product in reasonable medical probability was a substantial factor in contributing to the aggregate dose of asbestos the plaintiff or decedent inhaled or ingested, and hence to the risk of developing asbestos-related cancer"

  8. Erlich v. Menezes

    21 Cal.4th 543 (Cal. 1999)   Cited 464 times   1 Legal Analyses
    Holding that a defendant may not be liable for negligent breach of contract

  9. Moore v. Regents of University of California

    51 Cal.3d 120 (Cal. 1990)   Cited 608 times   1 Legal Analyses
    Holding that in obtaining a patient's consent to a procedure, "a physician must disclose personal interests unrelated to the patient's health, whether research or economic, that may affect the physician's professional judgment"

  10. 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

  11. 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

  12. 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

  13. Section 314.94 - Content and format of an ANDA

    21 C.F.R. § 314.94   Cited 224 times   37 Legal Analyses
    Explaining that products stemming from Drug Efficacy Study Implementation approvals are subject to today's ANDA regulations

  14. Section 1910.1200 - Hazard communication

    29 C.F.R. § 1910.1200   Cited 188 times   68 Legal Analyses
    Requiring employers to develop written programs describing their compliance and make them available to the agency on request

  15. 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”

  16. Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

    21 C.F.R. § 201 app A to Part 201   Cited 27 times   7 Legal Analyses

    I. Section 201.66 Standard Labeling Format A. Overall 1. The "Drug Facts" labeling is set off in a box or similar enclosure by the use of a barline with all black type printed on a white, color contrasting background. B. Typeface and size 1. "Drug Facts" is set in 14 point Helvetica Bold Italic, left justified. 2. "Drug Facts (continued)" is set in 8 point Helvetica Bold Italic for the words "Drug Facts" and 8 point Helvetica Regular for the word "(continued)" and is left justified. 3. The headings

  17. Section 29.1303 - Flight and navigation instruments

    14 C.F.R. § 29.1303

    The following are required flight and navigational instruments: (a) An airspeed indicator. For Category A rotorcraft with VNE less than a speed at which unmistakable pilot cues provide overspeed warning, a maximum allowable airspeed indicator must be provided. If maximum allowable airspeed varies with weight, altitude, temperature, or r.p.m., the indicator must show that variation. (b) A sensitive altimeter. (c) A magnetic direction indicator. (d) A clock displaying hours, minutes, and seconds with