“Contraceptive Injuries.” Drug company ABC Drugs came out with a new birth control
pill guaranteed to prevent pregnancy for one year after the consumption of one pill. The
FDA approved warnings of the drug’s side effects including nausea and headache to be
provided with the pill. After it was initially put on the market, the company became
aware of some risks of dizziness from taking the drug. The company, however, did not
warn of that risk because the company was concerned that individuals might not buy
the pill, and federal law did not specifically require a warning regarding dizziness.
Belinda thought the pill was a great idea and obtained a prescription for it at a date after
the company became aware of the issues involving dizziness. She took one and felt fine
for a few days. Then, however, she began feeling dizzy. Her dizziness caused her to fall
breaking her leg on some steps. She later discovered that the birth control pill likely
made her dizzy. Belinda decided to sue under a state law claim for failure to warn,
however, she waited a number of years before bringing her action. The drug company
claimed that it had no duty to list dizziness as a risk because its warning complied with
all FDA requirements. The drug company also claimed that the time in which it could
be sued had expired both because Belinda waited too long after she was injured and
also too long from the date of product purchase. 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.