Week 5 Problem-Solution Analysis Paper
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 ...view middle of the document...
(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 The learned intermediary rule was incorporated prior to the internet age and is believed to be outdated and obsolete in many instances.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 addition, since surgery is required in order to administer this drug under the skin of the patient, the deep involvement of the physician as an intermediary would make it pertinent that this rule apply to the situation. (Halbert/Ingulli, 2012, Page 274)
From a consumer perspective, direct-to-consumer advertising helps to make patients...