Learned Intermediary Rule: Problem-Solution Analysis

Topics: Pharmacology, Physician, Medicine Pages: 6 (1023 words) Published: October 3, 2014

Week 5 Problem-Solution Analysis Paper
MGT 623

The learned intermediary rule, first introduced in 1966, states that a pharmaceutical manufacturer shall give adequate warnings regarding a drug’s potential risks to the physician prescribing the drug. It is then the duty of the physician to provide the patient with enough information about the drug’s potential risks when administered to the in order for the patient to make an informed choice as to whether they want to proceed with the treatment. There are six premises underlying the Learned Intermediary Doctrine. (1) Doctors have the requisite experience and training, and they, not the patients or the drug companies, ultimately make the decision to prescribe or not to prescribe a drug. (2) In traditional doctor-patient relationships, patients rely heavily upon the doctor’s advice and counsel concerning their health, not upon the advice of drug manufactures. (3) Courts hesitate to intervene into the doctor-patient relationship, and constrain a doctor’s independent judgment about what should or should not be prescribed to patients. (4) Drug manufacturers do not have a relationship or other effective means to communicate with the consumers because drugs are prescribed through doctors, and distributed by pharmacies. (5) Even if drug manufacturers warned consumers, the complexity of the risks and warnings would be difficult to translate into understandable risk-conveying language for the untrained consumer. (6) If manufacturers directly warn uniformed consumers, they may deter patients from taking the prescribed medicines or following their doctor’s advice. (Foreman, 2001, Web of Manipulation, page 104) The belief is that the healthcare professional is knowledgeable enough to make an educated decision as to whether or not there are significant risks with administering the drug to the patient. The healthcare professional is to assess the pros and cons of prescribing the drug based on the known risks. (Learned Intermediary Rule Also Protects Clinical Trials.2007.www.sedgwicklaw.com) The learned intermediary rule became law under the context of the long-held belief that the doctor typically knows what's best, as well as the long-held tradition in America of the doctor providing medications compounded by local pharmacists to their patients, which more often than not were provided through house calls. This rule became law as a result of the Supreme Court case: "Logan V. Greenwich Hospital Association". When prescription drugs are directly marketed or advertised to customers, the majority believes that the learned intermediary rule does not and should not apply, and the manufacturer must be held responsible for educating the patients of the drugs risks. This has become increasingly more prevalent with the advent of the internet and the use of Web marketing/advertising. The learned intermediary rule was incorporated prior to the internet age and is believed to be outdated and obsolete in many instances. In the past pharmaceutical manufacturers never advertised their products to patients, but only to physicians. The majority believes that when marketing efforts that seek to influence the patient directly in regards to their choice in selecting a particular drug are made by a manufacturer, and they make claims to the appropriateness of the product for use, then the manufacturer should provide the proper warnings to the patient in regards to the dangers and side effects that may be experienced. (Halbert/Ingulli, 2012, Page 273) The dissent’s view is that the intermediary rule does indeed apply because of the criteria and stipulations that are involved. The drug in this case is not an over-the-counter drug, and must be prescribed by a physician. This in and of itself, would make it pertinent that a physician be involved as an intermediary between the patient and the pharmaceutical company, although the pharmaceutical company has marketed directly to the patient. In...

References: Halbert, T., & Ingulli, E. (2012). Law & ethics in the business environment (7th ed.). Mason, OH: South-Western.
Learned Intermediary Rule Also Protects Clinical Trials, Spring 2007, Retrieved from www.Sedgwicklaw.com
April L. Foreman, Web of Manipulation: The Learned Intermediary Doctrine and Direct-to-Consumer Advertising on the World Wide Web, 35 J. Marshall L. Rev. 97 (2001)
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