Pepacola, the worlds most famous and popular brand of soda, has just launched a new product, a carbonated soft drink that enables the consumer to taste colors. Pepacola designs a brand-new container made out of a new material composed primarily of discarded shoe bottoms to be used with their new color tasting product. Pepacola contracts with Manny's Manufacturing and Manny's utilizes Pepacola's design to manufacture the new containers. Manny's entire staff quits and Manny's is forced to hire new, inexperienced staff to operate their manufacturing machines. A new employee mistakenly enters the number 3 into a manufacturing machine instead of the number 33 and the Pepacola containers they produce look just like the original design but are slightly thinner and therefore more prone to break if dropped. Pepacola discovers that if the soft drink is consumed with pepperoni pizza, some people pass out. Fearing that releasing this information to the public would hurt sales, Pepacola decides to keep their findings secret. Adam Ant loves Pepacola's new product and drinks three to four of them every day. Adam Ant also loves pizza and, while eating at his favorite pizzeria, he opens and drinks his favorite color tasting drink and passes out, hitting his head on a table. His bottle of color tasting soft drink breaks and a waitress slips and falls on the spilled soft drink and breaks her neck.

On April 7, 2000, Diana Levine-a professional musician who played bass, guitar, and piano-went to her local clinic for treatment of a migraine headache. As on previ- ous visits, she received an intramuscular injection of Demerol for her headache and Phenergan for her nausea. Still suffering, she returned later that day and a physician assistant gave her a second dose by what is called the IV-push method. Something went wrong. Phenergan entered Levine's artery, came in contact with arterial blood, and led to gangrene. Levine's doctors were forced to amputate first her right hand, and then her entire forearm. After settling claims against the health care center and clinician, Levine sued Wyeth, the company that made Phenergan. Her claims: Wyeth should have instructed clinicians to use the IV-drip method instead of the higher risk IV-push method. Wyeth defended its Phenergan packaging labels, claiming they must be ade- quate because the FDA-the federal agency charged with enforcing the Food, Drug, and Cosmetic laws-approved them. The Vermont courts rejected that claim, letting stand a $7.400,000 jury award in Levine's favor. Wyeth appealed to the Supreme Court. Wyeth v. Levine United States Supreme Court, 2009 129 S.Ct. 1187 Justice STEVENS delivered the Opinion of the Court ... Directly injecting the drug Phenergan into a patient's vein creates a significant risk of catastrophic consequences. ... The warnings on Phenergan's label had been deemed sufficient by the federal Food and Drug Administration (FDA) when it approved Wyeth's new drug application in 1955 and when it later approved changes in the drug's labeling. The question we must decide is whether the FDA's approvals provide Wyeth with a complete defense to Levine's tort claims. We con- clude that they do not ... .The evidence presented during the 5-day jury trial showed that the risk of intra-arterial injection ... can be almost entirely eliminated through the use of IV-drip, rather than IV-push, administration. ... [Further evidence showed that in 1998, the agency instructed that Phenergan's final printed label "must be identi- cal" to the FDA-approved package insert.] The question presented by the petition is whether the FDA's drug labeling judgments "preempt state law product liability claims [which are] premised on the theory that different labeling judgments were necessary to make drugs rea- sonably safe for use."... Our answer to that question must be guided by two cornerstones of our pre- emption jurisprudence. First, "the purpose of Congress is the ultimate touchstone in every pre-emption case."... Second, "[ijn all pre-emption cases, and particularly in those in which Congress has 'legislated ... in a field which the States have tradi tionally occupied,' ... we 'start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.' "... In order to identify the "purpose of Congress" [in adopting the Food, Drug, and Cosmetic Act], it is appropriate to briefly review the history of federal regu- lation of drugs and drug labeling. In 1906, Congress enacted its first significant public health law, the Federal Food and Drugs Act. ... The Act, which prohibited the manufacture or interstate shipment of adulterated or misbranded drugs, sup- plemented the protection for consumers already provided by state regulation and common-law liability. In the 1930s, Congress became increasingly concerned about unsafe drugs and fraudulent marketing, and it enacted the Federal Food, Drug, and Cosmetic Act (FDCA). ... The Act's most substantial innovation was its provision for premarket approval of new drugs ... . As it enlarged the FDA's powers to "protect the public health" and "assure the safety, effectiveness, and reliability of drugs," Congress took care to preserve state law. In 2007, after Levine's injury and lawsuit, Congress again amended the FDCA. ... For the first time, it granted the FDA statutory authority to require a manufac turer to change its drug label based on safety information that becomes available after a drug's initial approval. ... [The law also made] it clear that manufacturers remain responsible for updating their labels. Wyeth first argues that Levine's state-law claims are pre-empted because it is impossible for it to comply with both the state-law duties underlying those claims and its federal labeling duties. The FDA's premarket approval of a new drug application includes the approval of the exact text in the proposed label. ... There is, however, an FDA regulation that permits a manufacturer to make certain changes to its label before receiving the agency's approval. Among other things, this "changes being effected" (CBE) regulation provides that if a manufacturer is changing a label to "add or strengthen a contraindication, warning, precaution, or adverse reaction" or to "add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product," it may make the labeling change upon filing its supplemental application with the FDA; it need not wait for FDA approval ... . Wyeth suggests that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. Yet through many amendments to the FDCA andWyeth suggests that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. Yet through many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warn- ings remain adequate as long as the drug is on the market