Elsevier

Dental Abstracts

Volume 62, Issue 2, March–April 2017, Pages 66-67
Dental Abstracts

The Front Office
Learned intermediary doctrine

https://doi.org/10.1016/j.denabs.2016.12.010Get rights and content

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Background

In Watts v Medicis Pharmaceutical Corp, the plaintiff was given a prescription for Solodyn (minocycline) and some product information that cautioned against using the drug for more than 12 weeks. She used it for 20 weeks, and 2 years later, she received the same prescription and used the drug for another 20 weeks. She then became ill and was diagnosed with drug-induced lupus and hepatitis. Although the hepatitis resolved, the lupus became a life-long problem. The patient sued the drug

Learned Intermediary Doctrine

In cases where product liability is claimed, generally the basis is a finding that the product contains informational defects relating to the instructions for use or that the warnings with the product were inadequate, making the product defective and unreasonably dangerous. The plaintiff in such cases must prove the manufacturer had a duty to warn the agent’s end user of the danger and injury occurred as a result of that lack of sufficient warning. However, in health care, the manufacturer or

Fraud Charges

The plaintiff was required to prove that there was some type of false promise or misinterpretation associated with the sale or advertisement of the product and that injury resulted from this omission or misinformation. The court found that pharmaceuticals (and medical devices) are objects and goods, so they meet the requirements of the law, which deals with “merchandise.” The information packets the patient received contained a statement that Solodyn’s safety for use exceeding 12 weeks “has not

Dental Practice Implications

Dentists prescribe some medications and some devices and should know all of the potential side effects or negative sequelae associated with them. The information that most dentists have on these items usually comes from sales reps or hired speakers from the manufacturer. Patients can’t purchase the products directly from the manufacturers, so dentists become their learned intermediaries. Most dentists don’t take the time to read all about every drug they prescribe or all the devices and

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Jerrold L: Learned intermediary. Am J Orthod Dentofacial Orthop 140:386-388, 2016

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