Learned Intermediary Doctrine

Maryland Law on Drug Companies Duty to Warn

The learned intermediary doctrine, which has been adopted by almost every jurisdiction in some form, provides that manufacturers of prescription drugs and medical devices discharge their obligation to the end user of the product by providing warnings to the prescribing doctor. t is well-settled that a drug manufacturer has an obligation to inform physicians of material hazards associated with the use of prescription drugs.  Butt drug companies have no direct duty to warn the ultimate users of a drug.

In other words, drug companies have no obligation to directly warn patients about the risks associated with their drugs or medical devices. The rationale for this is that prescription drugs are often complex and prescribing doctors can take into account the propensities of the drug, as well as the susceptibilities of his patient and properly weigh the risk against the benefits.

Maryland law also recognizes the “learned intermediary” doctrine, which provides that manufacturers need only warn the prescribing physician and not the patient directly. Ames v. Apothecon, 431 F. Supp. 2d 566 (D.Md. 2006). Drug companies selling drugs or medical devices have no duty to directly warn patients. But they still have an obligation to make doctors aware – usually via the package insert – of the risks associated with their drugs or medical devices. It is up to the doctor to make the right call as to whether the drug or device is appropriate for a particular patient.

Pharmacy Patients

Under Maryland law, a pharmacist has a duty to accurately fill a prescription for drugs and verify prescriptions that may be fatal to the patient.  Maryland also recognizes the learned intermediary doctrine which provides that a manufacturer has the duty to warn a doctor, but has no duty to warn the patient of prescription drug interactions or side effects.

The Fourth Circuit, applying Maryland law, has held that a pharmacist has no duty to warn a customer when filling a doctor’s prescription, noting that:

If the law is going to [allow a doctor to be] second-guessed by the pharmacist…only danger could result. A pharmacist…[advising] a patient not to take a drug prescribed by a physician might easily cause death or serious injury, and we think the practice of medicine by pharmacists … is not a field in which we should even encourage them to engage, much less require it….”

Hofherr v. Dart Industries, Inc., 853 F.2d 259, 263-64 (4th Cir. 1988).

Getting a Lawyer

Our Maryland products liability lawyer review both individual and class action lawsuits in the Baltimore-Washington throughout the country, often dealing with drug and device companies failure to properly warn doctors about the risks associated with certain drugs or medical devices and we are also malpractice lawyers with a track record of success.

If you want to discuss your case with one of our products liability lawyers or get information on a particular class action lawsuit pending, call us at 800-553-8082 or click here for a free Internet consultation.

• Average Product Defect Verdicts (data on product defect verdicts by type of product)
• Sample Product Defect Complaint (utility pole explosion case)
• Riegel v. Medtronics (2008 Supreme Court opinion in medical device case)
• Wyeth v. Levine (Supreme Court drug injury case to be decided in 2009)