Abbott, A Clinical Trial And A Doctor’s Allegiance

Abbott, A Clinical Trial And A Doctor’s Allegiance

November 14th, 2011 // 1:32 pm @

drugmakers that are battling claims a med caused someone harm is to use a doctor as a shield. In legal parlance, this is known as the learned intermediary doctrine, which, basically, states that a drugmaker has fulfilled its responsibility for providing all necessary information to a doctor, who then interacts with a patient.

But Abbott Laboratories attempted to add a new twist to this defense in a case in which a woman claims she developed lymphoma after being treated with its Humira medication for rheumatoid arthritis. How so? The doctor treating Gayathri Murthy was no ordinary doc: he was also a principal investigator for a Humira trial. In other words, this was not your run-of-the-mill doc who would normally be expected to show indifference toward the drug chosen to treat a patient. Compensation was involved.

Moreover, he showed her a promotional video created by Abbott to encourage people to enroll in the clinical trial. And by creating such a video about Humira for a trial, Abbott directly promoted the med to Murthy, which meant the drugmaker “circumvented the doctor-patient relationship,” according to a ruling issued earlier this week by US District Court Judge Keith Ellison in Houston. As a result, Abbott lost its effort to have the lawsuit dismissed (read the ruling here).

Here is the quick background: Murthy was diagnosed with rheumatoid arthritis in late 2004 and was infused with Humira from around February 2005 through January 2006 by her rheumatologist, Jovan Popovich, according to her lawsuit. However, he also convinced her to enroll in the clinical trial, dubbed HERO. The med was provided free of charge, of course. She was subsequently diagnosed with Stage III, large B-cell lymphoma for which she underwent chemo.

But Murthy contends that Abbott did not properly warn about the extent to which Humira may cause lymphoma. She asked Popovich, who is described as “Abbott’s agent, “about the risk of other side effects from the medication. His response was simply, “have you seen the side effects of aspirin?” And she charges that the video did “little if anything to alert the patient to the very real risk of life-threatening Humira-induced cancer,” according to the lawsuit (read it here).

Moreover, she maintains that side effect info on the informed consent form was “incomplete and misleading,” and that Abbott did not properly warn patients directly about the risks of cancer tied to Humira until required to do so by the FDA in 2009. “If Ms. Murthy had been fully informed, i.e., ‘warned,’ about the dangers of Humira-induced lymphoma, she would not have agreed to participate in Abbott’s HERO study or otherwise to infuse or inject Humira into her body.”

She also scored one other point with the judge, who ruled that she can also press her claim for a breach of contract, a reference to her hope that Abbott will be forced to pay for the medical treatment as a result of the cancer (here is the consent form signed by Murthy).

Of course, Abbott and its lawyers get points for trying to argue that Popovich was a learned intermediary; they are entitled to make any argument they want. But it did not take much for the judge to dismiss their reasoning. A doctor who is conducting a clinical trial is akin to a hired hand and no longer acting only with the best interests of the patient in mind. Warnings about side effects aside, Abbott must know that hiding behind a doctor who is also being compensated is like trying to have it both ways. We have asked Abbott for a comment and will update you accordingly.

[UPDATE: We have now received this reply from an Abbott spokeswoman: “Humira has more than 14 years of safety and efficacy data. The therapeutic risks associated with Humira are well known and documented in the prescribing label. We believe the case is without merit and will defend accordingly.” There was, however, no response concerning the use of the learned intermediary defense.]

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