In the landmark decision Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that failure-to-warn claims against generic drug manufacturers are preempted by regulations under the Federal Food, Drug, and Cosmetic Act (FDCA) prohibiting generic manufacturers from making unilateral changes to a drug’s labeling. Two years later, in Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013), the Supreme Court extended Pliva to design defect claims based on product mislabeling. However, this past November, FDA proposed a rule change which, if adopted, will effectively eliminate the preemption defense for generic drug manufacturers, rendering Pliva and Bartlett moot.
You walk into the office on Monday morning to find a copy of a complaint and some other documents on your chair. On top is a yellow post-it note from a partner, asking you to see her about working on a new case. What can you do to set yourself up for success on this new matter?
Every new matter needs a plan of attack, and that plan of attack has to begin as soon as you receive the assignment. To give yourself the best chance of success in satisfying your partner and getting the best result for your client, you should always develop and follow a plan that looks at the end game, even while the game is just beginning.