Medications and Drug Injuries
In manufacturing and selling pharmaceuticals, companies owe to consumers a duty to assure that their drugs, medications, and medical devices are reasonably safe when used as intended. Too often, a pharmaceutical company will create an unreasonably dangerous product by failing to properly research a drug’s possible risks before placing it in the stream of commerce. In such instances, without being warned in advance of using the drug, human beings serve as unwitting guinea pigs. A drug’s approval by the FDA is not a guarantee of its safety and will not shield a drug manufacturer from liability.
Before selling pharmaceuticals to the public, drug manufacturers are obligated first to understand the drug’s dangers and possible side effects and then assure that the public is informed of the risks. A pharmaceutical that can be reasonably safe if accompanied by thorough warnings will be unreasonably dangerous absent such warnings according to the law.
The means used to inform the public vary with the nature of the pharmaceutical. With non-prescription drugs, the manufacturer’s warning is conveyed to users by proper labeling and enclosures. Simple written warnings, however, without a physician’s intervention between manufacturer and consumer, will not render all pharmaceuticals safe. Rather, the use of certain medications require a doctor’s supervision.
Prescription drugs represent a class of pharmaceuticals, the use of which requires the supervision of a learned intermediary, such as a physician. With such drugs, the manufacturer has a duty to warn only the intermediary, not the consumer. In most cases, as long as the drug company properly informs the physician of the drug’s dangers, the company has fulfilled its duty to the public.
Before a physician prescribes a pharmaceutical to a patient, the physician is duty-bound to fully apprise the patient of the drug’s risks, so that the patient is capable of making an informed decision in determining whether or not to take the drug. If the doctor fails in his or her duty to relay the manufacturer’s warning to the patient, responsibility usually will lie with the physician, not the drug manufacturer.
Physicians know that when they prescribe drugs, their knowledge concerning the medication is generally far superior to the patient’s. Consequently, the physician understands that the patient ordinarily relies heavily on the doctor’s judgment. Once the doctor has been advised of a prescription drug’s hazards, the doctor and not the patient, is in a position to understand whether the drug is appropriate for a particular patient. Likewise, the physician should take precautions against over-prescription. Because the doctor is well aware that the patient normally relies heavily on the doctor’s judgment in prescribing such drugs, the doctor should readily accept responsibility for the patient’s safety with regard to the prescription drug.
In seeking legal redress against a drug manufacturer for injuries caused by pharmaceuticals, the usual theories of products liability (strict liability, negligence, breach of warranty) are applicable. If the physician’s conduct is to blame, a negligence suit in medical malpractice would be justified.
Drug manufacturers and drug-prescribing physicians hold positions of trust. Many people heavily rely on their expertise. The drug companies and physicians should thus expect that if their imprudence causes damage, they will be held responsible.