Product News and Recalls

Lance v. Wyeth decision calls in to question “Learned Intermediary” doctrine

Over 40 years ago, the Pennsylvania Supreme Court adopted a legal standard known as the learned intermediary doctrine. Under this standard, a drug manufacturer has a duty to warn doctors–but not patients–about risks associated with prescription medication. The theory is that the doctor, who knows the individual characteristics of her patients, makes an individualized risk/benefit analysis with the patient. In a lot of cases, this makes sense. Back when doctors had time to individually counsel patients, the necessary information about the risks and benefits of a drug would be considered with each prescription.

But the healthcare landscape has changed in the last 40 years. Drugs are marketed directly to consumers. Pfizer spent more than $1.4 billion marketing Lipitor directly to consumers, according to the AARP. Pharmaceutical companies created the “Low-T” campaign, encouraging patients to go to their doctors and ask about low testosterone. Thousands of pharmaceuticals sales agents “detail” busy doctors by showing them favorable studies about their drugs, and generally pressing favorable information and company-funded results.

Meanwhile, the managed care setting, doctors are not able to make money counseling patients; the insurance system is set up to reimburse them for prescribing drugs and running tests.

In Lance v. Wyeth, the Pennsylvania Supreme Court hinted that it might entertain revisiting the learned intermediary doctrine, given these changes in the industry. In the opinion, the Court devoted a section to this legal standard, and noted that “some of the underpinnings of the principle have come into question in light of changed practices in the prescription drug industry. These include the emergence of direct-to-consumer advertising and the evolution of the health-care delivery system encompassing new forms of managed care.”

The Court did not elaborate on when or how it would reconsider this doctrine, noting that the issue was not before it in the Lance case. Based on this language, however, it appears that the Court would be willing to hear arguments about whether the learned intermediary doctrine  should apply in every drug case; few exceptions have been available in the last 40 years. Although the doctrine makes sense in circumstances in which a patient relied on his doctor, it would not be appropriate to bar an otherwise meritorious claim if the patient exercised her own independent judgment (perhaps through internet research), or if the doctor is unavailable to testify to  prove, on a plaintiff’s behalf, that a different warning on a drug would have changed his prescribing practices.

The hint in the Lance case that the doctrine might not be applied where it doesn’t make sense to do so is good news for patients harmed by drug makers who rush to take in profits at the expense of patient safety. Lopez McHugh and other plaintiff firms will be keeping an eye out for the appropriate case to show that the learned intermediary doctrine should not apply in cases involving direct-to-consumer advertising.