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Question:  What is the "Learned Intermediary Doctrine" and to what extent does it protect prescription drug and medical device manufacturers from liability?

Answer:  In most states, pharmaceutical and medical device companies benefit from the “Learned Intermediary Doctrine.”¹ According to the Doctrine, once a life sciences manufacturer provides a medical professional, such as a physician, with product warnings about a prescription product, the manufacturer has discharged its duty to warn of possible hazards associated with the use of the product. In turn, it becomes the duty of the medical professional to warn the patient. The Doctrine does not alter the manufacturer’s duty to provide adequate warnings. It merely substitutes the medical professional for the patient as the required recipient of the warnings. Most importantly, the Doctrine shields the manufacturer from liability should a patient later seek to assert a failure to warn claim against the manufacturer. The plaintiff’s claim against the manufacturer will fail, as the manufacturer will have met its duty under the law by warning the medical professional.

The Doctrine, however, is a creature of state law, and as such its application varies by state. Exceptions to the Doctrine have been carved out, and it is crucial for manufacturers to be aware of them and curtail their reliance on the Doctrine accordingly.

The Direct-to-Consumer Advertising Exception

The Doctrine was crafted at a time when manufacturers of prescription drugs and medical devices advertised exclusively to physicians and the healthcare industry, and social media was nonexistent.² In the last 15 years or so, manufacturers have increasingly engaged in “direct to consumer” advertising campaigns through print, radio, television, and the Internet.³ This shift has raised questions about the enduring application of the Doctrine when consumers are receiving information about prescription drugs or medical devices directly from manufacturers, instead of solely from medical professionals. Many have argued for an exception to the Doctrine where a manufacturer engages in direct-to-consumer advertising, and plaintiffs have increasingly asked courts to find the manufacturer liable for its inadequate warnings when the manufacturer has directed communication about the drug or device to consumers. Despite this heightened debate, only one state—New Jersey—has explicitly recognized a direct-to-consumer advertising exception to the Doctrine.⁴

Exceptions where “Individualized Medical Judgment” is Absent

One rationale behind the creation of the Doctrine relates to the nature of the relationship between medical professionals and patients. Manufacturers should be required to warn medical professionals, as opposed to patients, because medical professionals are best able to assess product warnings and their applicability given medical professionals' expertise and their knowledge of each particular patient’s needs. In other words, the warnings accompanying a prescription drug or medical device are directed to the medical professional, rather than the patient, because it will be the prescribing medical professional who will use independent medical judgment to weigh the manufacturer’s warnings and the personal medical history of the patient to determine whether to prescribe a particular drug or device. Thus, it is questionable whether the Doctrine applies when the medical professional makes no such individualized medical judgment. There have been two specific situations in which the courts have ruled that the Doctrine does not apply for this reason. The Doctrine was found not to apply when (1) medical professionals provided mass immunizations (vaccines); and (2) when they prescribed certain birth control products. In both instances, courts found there was an erosion of the doctor-patient relationship under the circumstances.

Conclusion

Although life sciences manufacturers can generally rely on the protection of the Doctrine in a failure to warn claim, the Doctrine’s protections are far from absolute. Manufacturers should be wary when engaging in direct-to-consumer advertising and take heed that most scholars predict that New Jersey may not be the last state to carve out a direct-to-consumer advertising exception to the Doctrine. Manufacturers also need to assess whether it is foreseeable that their drug or device will be dispensed en masse or in another context in which the traditional consideration and judgment of the medical professional may be absent.