Pliva, Inc. v. Mensing
564 U.S. 604 (2011) Cited 749 times 143 Legal AnalysesHolding 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
Erie R. Co. v. Tompkins
304 U.S. 64 (1938) Cited 20,474 times 18 Legal AnalysesHolding that state law governs substantive issues and federal law governs procedural issues
Bates v. Dow Agrosciences LLC
544 U.S. 431 (2005) Cited 550 times 11 Legal AnalysesHolding that a preemption clause barring state laws "in addition to or different" from a federal Act does not interfere with an "equivalent" state provision
Sindell v. Abbott Laboratories
26 Cal.3d 588 (Cal. 1980) Cited 320 times 2 Legal AnalysesHolding DES manufacturers liable under California law in proportion to their market shares
United States v. Generix Drug Corp.
460 U.S. 453 (1983) Cited 73 timesConcluding that the term drug “is plainly intended throughout the Act to include entire drug products, complete with active and inactive ingredients” and must “include more than just active ingredients ... unless subsection (D) is to be superfluous”
Smith v. Eli Lilly & Co.
137 Ill. 2d 222 (Ill. 1990) Cited 108 times 3 Legal AnalysesRejecting market share liability, in part, because of the difficulty of establishing any defendant's share of the market and the burden on courts in applying the theory
Woodill v. Parke Davis Co.
79 Ill. 2d 26 (Ill. 1980) Cited 142 times 1 Legal AnalysesHolding the requirement that plaintiff plead and prove defendant knew or should have known of danger that caused injury, and failed to warn is "entirely consistent with the principles of strict liability."
Connelly v. Uniroyal, Inc.
75 Ill. 2d 393 (Ill. 1979) Cited 90 timesHolding that a trademark licensor could be found liable as an “apparent manufacturer” of a defective tire where the licensor was not in the distribution chain but owned 95 per cent of the shares of the actual manufacturer, and the actual manufacturer followed “detailed information as to the [manufacturing] methods, processes and formulas” provided by the licensor
Hebel v. Sherman Equipment
92 Ill. 2d 368 (Ill. 1982) Cited 58 times 1 Legal AnalysesHolding out evaluated from standpoint of the "purchasing public"
Stacel v. Teva Pharmaceuticals, USA
620 F. Supp. 2d 899 (N.D. Ill. 2009) Cited 18 times 2 Legal AnalysesFinding that generic manufacturers had access to, and were subject to, the CBE process
Section 314.94 - Content and format of an ANDA
21 C.F.R. § 314.94 Cited 224 times 37 Legal AnalysesExplaining that products stemming from Drug Efficacy Study Implementation approvals are subject to today's ANDA regulations