In the article titled “Product Liability Suits Involving Drug or Device Manufacturers and Physicians: The Learned Intermediary Doctrine and the Physician’s Duty to Warn” (Missouri Medicine November/December 2014) attorney Jason Husgen cites a case of toxic epidermal necrolysis (TEN) in a patient who received Zithromax, an antibiotic and Daypro, a non steroidal anti-inflammatory drug. According to the Learned Intermediary Doctrine the drug company is not responsible for this untoward reaction. It is the physician whose failure to warn who is liable under this doctrine. This doctrine, especially as described in the example given in the article, is completely impractical.
I have been in practice fifty years and have treated tens of thousands of patients and have never seen one case of TEN or its related condition Stevens Johnson Syndrome. I think most doctors in clinical practice have had similar experiences. Am I supposed to tell every patient about every risk, no matter how rare, that is present in the warning section of the package insert? NSAIDS can be obtained over the counter. Who is liable and who pays when a serious drug reaction occurs in that situation?
A far better solution to this problem can be found in the National Vaccine Injury Compensation Program. When a vaccine related injury or occurs death occurs compensation is paid out of a fund which is government funded by a small excise tax. The trial lawyers, of course, do not like this arrangement because they are out of the loop. They are constantly challenging the program in every ingenious way that they can think of.
For rare serious reactions that occur with drugs either a set aside should be made by the drug companies to compensate injured patients or an excise tax as in the vaccine injury program should be applied. Physicians can and do tell patients about the serious side effects and possible allergic reactions of drugs used to treat patients with life threatening diseases but cannot warn patients about every rare untoward reaction.
The Learned Intermediary Doctrine shifts liability from the drug and device manufacturers where it rightfully belongs to the physician. The other beneficiaries of the doctrine are the trial lawyers both plaintiff and defense. Doctors are much more vulnerable to law suits than are wealthy drug companies and device manufacturers. The author describes the reasoning the courts used to arrive at the Learned Intermediary Doctrine, which I find unconvincing and a violation of common sense. The Courts should not apply this seriously flawed doctrine.