Learned Intermediary – Who Makes the Decision?

In this inaugural blog, we pose the question — “Do you want to cede your right to make informed decisions about your own health to a doctor who might be getting paid by the company whose drug he is prescribing to you?”

I spent 7 years, 1 month and 22 days as an Army lawyer.  Worked on My Lai, military justice, and constitutional law.  My colleague Captain Fred Shepherd served as defense counsel for numerous young Marines.   Now we spend most of our professional time trying to wrest justice out of Big Pharma.  We choose the people we represent, and we represent good people with legitimate legal claims.   They entrust their stories to us, and we tell them to judges and to juries.

In the days and weeks and months to come, we will use this blog-space to speak out on issues important, not only to our clients, but also to society as a whole.   The topic today is one of extraordinary importance.

Elnora Jones didn’t really appreciate the fact that her doctor was being paid money by Abbott Labs to prescribe Humira to her.  A modest sum to “screen” her, but more if she took the drug, and even more if she stayed on it.   Abbott had the gall to call this patient bounty program “HERO.”     Another of our clients in Houston also received her Humira injections via the “HERO” program.   Neither of these women were told that Humira could cause lymphoma.   Both contracted this life-threatening cancer.

Abbott now says that it is not liable to either of these patients or their families because — even if they were not told the drug could cause cancer – their Abbott-paid doctors functioned as “learned intermediaries” and they knew about this risk.

The federal judge in Elnora Jones’ case asked the Tennessee Supreme Court whether it would recognize an exception to the “learned intermediary” doctrine in circumstances such as those presented here, where the doctor was being paid by the drug company to prescribe this medication.    The Tennessee Supreme Court declined to answer the question; so the federal judge will have to make his own Erie “prediction” about that.  So, too, will the judge in the Houston case, slated for trial on 12/2/13.

Our Firm agrees with the West Va. Supreme Court  that the “Learned Intermediary” doctrine Is “anachronistic, outmoded, and unpersuasive” in the modern day world of pharmaceutical marketing, and, at the very minimum, that courts should recognize “exceptions” to this doctrine where, as here, the drug company was crossing the palms of the prescribing physicians with cold, hard cash.    What will the courts and jurors say?  Stay tuned.