On February 18, 2010, CVK partner Gene Buckle moderated a national tele-seminar on Advancing the Learned Intermediary Doctrine, sponsored by the ALFA (American Law Firm International) Drug and Medical Device Practice Group, of which Gene is a member of its steering committee. www.alfainternational.com. The other members of the speakers’ panel included Marisa Trasatti, a principal in the Baltimore law firm of Semmes, Bowen & Semmes, and Cindy Khin, Chief Claims Officer of Insurance Operations for Medmarc Insurance Group, the leading national insurer of medical technology and life sciences companies, and a client of CVK.
The seminar focused on how a drug manufacturer through counsel can best develop the learned intermediary defense to a products strict liability or negligent failure to warn claim for injuries or death resulting from the risks associated with taking prescription medication or using a prescribed medical device. The essence of the doctrine is that if a medical doctor prescribes the medication or device to the patient, and if the manufacturer of that medication or device has provided adequate warnings of the risks associated with the “product” to the physician (usually in the form of product literature, patient leaflets, package inserts, training manuals, physician brochures, box labels, etc.), then the manufacturer has no duty to warn the patient (the ultimate consumer) of those risks and has no liability for the harm caused by such failure to warn the ultimate consumer.
The rational for this learned intermediary doctrine is that the doctor in treating the patient uses his/her own medical judgment and expertise in doing so, and thus the ultimate decision on how to treat the patient, and with what, rests with the doctor. Hence the manufacturer of medical devices and drugs has no duty to warn a patient of the risks associated with “products” under the supervision of a physician. The issue then turns to was the doctor adequately warned, which is a much easier matter for the product manufacturer to prove than attempting to prove that the manufacturer somehow adequately warned the individual patient.
View a listing of the 50 states as to case law dealing with the Learned Intermediary Doctrine. For additional information concerning defending drug and medical device companies in product liability claims, contact Gene Buckle at email@example.com.