Wyeth Levine Injury Summary

The issue is whether the Wyeth held responsible or not for the Levine injury?

Congress did not explicitly expect for the FDCA to preempt state common law tort claims, and as for prescription drugs, state tort law cases proposal an extra imperative layer of consumer assurance that matches, and does not hinder, FDA regulation.

The resolution of this issue relies on whether the Wyeth held responsible for the Levine injury. Levine claims that Wyeth drug’s labeling specified many warnings about IV push, but did not contraindicate the technique. And, Wyeth had deficiently warned of the risk that an inadequate IV push might begin injuries like those she endured.
Wyeth argued that Levine’s claims were preempted and it’s impossible to follow both federal and state requirements. The FDA had approved the drug Phenergan for IV-push and approved labeling, which warned of the risks of inappropriate injection. As there exists an FDA regulation that is CBE (Changes Being Effected), which permits Wyeth to make certain changes to its label that is intended to increase the safe use of the drug. It is the responsibility of the Wyeth to

Congress did not intend the FDCA to preempt state law’s inability to warn actions. Wyeth 's argument misinterprets the purpose of the congress on the FDCA. In Skidmore v. Swift & Co., 323 U.S. 134, “Congress has not authorized a federal agency to pre-empt state law directly, the weight this Court accords the agency 's explanation of state law 's impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness.” Therefore, based on these arguments Wyeth should be liable under a state law claim that the label was inadequate and could have altered the label to increase drug safety making use of CBR regulation. In addition, the court has the sight to elucidate federal preemption