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

question 64

Multiple Choice

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.

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