Public Health Law Map - Beta 5 - Medical and Public Health Law Site

arrier method that is only 70% effective is probably not adequate to her needs. For
the patient who could not accept induced abortion in any form, the safety of the fetus
in the event of conception may be paramount. It would be unwise to insert an IUD in
a patient who would not allow its removal if she became pregnant with the device in
place. The medical care practitioner might be liable for an injury to the patient even
if she refused to follow his or her advice when the pregnancy occurred.
2. Legally Mandated Warnings for Oral Contraceptives
Oral contraceptives are unusual in that Congress mandates that each patient receive a
package insert with the pills to supplement the information provided by medical care
practitioners when obtaining informed consent to the use of these pills. Medical care
practitioners cannot rely on the patient’s reading this package insert. Effective
informed consent requires that the patient receive the information—not merely that
the information be available. Since the patient will not receive the package insert
until after the decision to take the pills has occurred, it is arguable that even a patient
who reads the insert has already committed to the treatment.
Congress established a warning requirement for these pills because it believed that
“the safe and effective use of oral contraceptive drug products requires that patients
be fully informed of the benefits and the risks involved in their use.” Although this
law is aimed at persons dispensing and manufacturing oral contraceptives, it provides
a useful benchmark for medical care practitioners counseling patients. The federal
law requires patients to be given the following information with a prescription for
oral contraceptives:
Package Insert for Oral Contraceptives
The name of the drug.
A summary including a statement concerning the effectiveness of oral
contraceptives in preventing pregnancy, the contraindications to the drug’s
use, and a statement of the risks and benefits associated with the drug’s use.
A statement comparing the effectiveness of oral contraceptives to other
methods of contraception.
A boxed warning concerning the increased risks associated with cigarette
smoking and oral contraceptive use.
A discussion of the contraindications to use, including information that the
patient should provide to the prescriber before taking the drug.
A statement of medical conditions that are not contraindications to use but
deserve special consideration in connection with oral contraceptive use and
about which the patient should inform the prescriber.
A warning regarding the most serious side effects of oral contraceptives.
A statement of other serious adverse reactions and potential safety hazards
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