Learned intermediary doctrine under fire in Assembly

By CMTA Staff

Capitol Update, May 23, 2008 Share this on FacebookTweet thisEmail this to a friend

This week, the full Assembly may be considering AB 2690 (Paul Krekorian, D-Burbank), which if passed, would lead to increased liability for pharmaceutical manufacturers and potentially decreased access to appropriate medication.

AB 2690 attempts to eliminate a well-established and common-sense legal defense called the "learned intermediary doctrine" which recognizes that the warnings which accompany medicines and medical devices are directed to physicians, who have face-to-face interaction with patients, and who are best suited to evaluate the risks and benefits of prescription medication. Imposing a new duty on pharmaceutical manufacturers to warn consumers will create practical difficulties.  Because manufacturers can’t know in advance who will be prescribed the drugs, adequately disseminating all the information on risks would be nearly impossible.

Proponents of AB 2690 state that the bill specifically targets pharmaceutical products directly marketed to consumers.  The claim is that the doctrine is already undermined because consumers were made aware of particular products directly from the manufacturers.  The facts do not support this, however.  Direct advertising serves merely to educate individuals about potential treatments and to stimulate a dialogue between the patient and their individual physician.  Direct advertising does not change the fact pharmaceuticals can not be obtained without an individual having this conversation and ultimately getting a prescription from a licensed physician who is best suited to weigh the individual’s particular circumstances versus the specific risks associated with any treatment.  

Passage of this bill will result in increased lawsuits for both prescription drug manufacturers and physicians with no additional benefit to the patient. Imposing unjustified liability drives up health care costs and can deter the development or continued production of helpful medicines.  

CMTA urges its members to contact their Assembly representatives today and urge them to vote no on AB 2690.

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