What is the most likely result regarding the company's position that it had no duty to warn of the risk of dizziness because it complied with FDA requirements?
A) That the Federal Food, Drug, and Cosmetic Act (FDCA) establishes both a floor and a ceiling for drug regulation and that no additional warning requirements regarding dizziness could be imposed.
B) That absent clear evidence that the FDA would not have approved a change in the warning to include dizziness, a state law cause of action based on failure to warn would be allowed.
C) That no warning regarding dizziness could be required in addition to FDA approved warnings because dizziness is not a serious condition causing a "black box" type of warning involving risk of serious injury death.
D) That a state law cause of action would be allowed to go forward only upon the submission of clear evidence that a regulatory agency of the state had requested that the warning label be revised to warn of dizziness.
E) That while the plaintiff could go forward with a federal claim in relation to the lack of a warning regarding dizziness, a state law cause of action would be barred because of the company's compliance with FDA regulations.

Question

Quizplus · Accepted Answer

In Wyeth v. Levine the Supreme Court allowed the plaintiff to proceed with a state law claim that a drug manufacturer should have provided warnings in addition to those required by the FDA recognizing that the plaintiff's common-law claims "do not stand as an obstacle to the accomplishment of Congress' purposes in the FDCA."

What Is the Most Likely Result Regarding the Company's Position