The Physician's Liability for Drugs and Medical Devices

Most medical treatment uses some form of drug therapy. Consequently, most medical malpractice actions have a drug liability aspect. A physician has a duty to exercise the skill and care generally shown by competent physicians with similar training in diagnosing a condition and prescribing drugs or medical devices. If not, the physician can be held liable for professional negligence or medical malpractice.

Drug Package Inserts and Learned Intermediary Rule

The package inserts that accompany a drug contain the manufacturer's disclosures to the physician about the risks of the drug and the directions for its use. The physician is considered a "learned intermediary" between the patient and the manufacturer. Under the learned intermediary rule, warnings to physicians usually relieve the manufacturer of any duty to directly warn the patient. It is up to the physician to decide whether the drug is appropriate for the patient and to provide the patient with warnings and advice about its use. The physician will not be held liable if it is shown that the package insert failed to adequately warn about the drug and that such failure was the immediate cause of the patient's injury.

Drug Selection and Use of Medical Device

The physician has a duty to use reasonable care and skill in selecting an appropriate drug and dosage. The same duty applies when the physician prescribes a medical device. Courts have held that a physician has a duty not to prescribe a higher dosage of a dangerous drug than is necessary to manage the patient's condition.

Adverse Reactions

There is always a possibility of an adverse reaction or harmful side effect with the use of drugs and medical devices. The physician will be held liable for adverse reactions under certain circumstances. In deciding liability, the courts considers: whether there was a duty to test the patient for hypersensitivity; whether the physician failed to warn about possible adverse reactions; whether the physician failed to follow the manufacturer's directions and warnings; and whether the physician continued to give the drug after an adverse reaction or side effect had occurred.