43 Cited authorities

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"
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
Riegel v. Medtronic, Inc.
552 U.S. 312 (2008) Cited 1,031 times 62 Legal Analyses
Holding that a State’s “‘requirements’” “includ[e] [the state’s] common-law duties”
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
English v. General Electric Co.
496 U.S. 72 (1990) Cited 1,315 times 8 Legal Analyses
Holding that a tort arising from whistleblower retaliation at a nuclear facility was insufficiently related to radiological safety aspects in the facility's operation
Geier v. Am. Honda Motor Co.
529 U.S. 861 (2000) Cited 787 times 16 Legal Analyses
Holding the absence of an express pre-emption clause “does not bar the ordinary working of conflict pre-emption principles”
Bates v. Dow Agrosciences LLC
544 U.S. 431 (2005) Cited 549 times 11 Legal Analyses
Holding that a preemption clause barring state laws "in addition to or different" from a federal Act does not interfere with an "equivalent" state provision
Sprietsma v. Mercury Marine
537 U.S. 51 (2002) Cited 332 times 7 Legal Analyses
Holding that the Coast Guard's decision not to regulate propeller guards did not impliedly pre-empt petitioner's tort claims
Bausch v. Stryker Corp.
630 F.3d 546 (7th Cir. 2010) Cited 631 times 7 Legal Analyses
Holding that tort law claims based on manufacturing defects were not impliedly preempted
Phoenix Canada Oil Co. v. Texaco Petroleum
488 U.S. 908 (1988) Cited 210 times
Holding that one shower per week did not violate constitutional rights
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"
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"
Section 314.50 - Content and format of an NDA
21 C.F.R. § 314.50 Cited 148 times 16 Legal Analyses
Recognizing the proprietary nature of DSD and SP specifications by requiring that each ANDA applicant provide its own distinct specifications
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”

Dolin v. Smithkline Beecham Corporation, et al

43 Cited authorities

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"

Holding that the FDA's drug labeling judgments pursuant to the FDCA did not obstacle preempt state law products liability claims

Holding that a State’s “‘requirements’” “includ[e] [the state’s] common-law duties”

Holding that federal drug and medical device laws pre-empted a state tort-law claim based on failure to properly communicate with the FDA

Holding that a tort arising from whistleblower retaliation at a nuclear facility was insufficiently related to radiological safety aspects in the facility's operation

Holding the absence of an express pre-emption clause “does not bar the ordinary working of conflict pre-emption principles”

Holding that a preemption clause barring state laws "in addition to or different" from a federal Act does not interfere with an "equivalent" state provision

Holding that the Coast Guard's decision not to regulate propeller guards did not impliedly pre-empt petitioner's tort claims

Holding that tort law claims based on manufacturing defects were not impliedly preempted

Holding that one shower per week did not violate constitutional rights

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"

Defining "major changes" as those "requiring supplement submission and approval prior to distribution of the product"

Recognizing the proprietary nature of DSD and SP specifications by requiring that each ANDA applicant provide its own distinct specifications

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”