Blog | Tuesday, June 5, 2012

Reglan and tardive dyskinesia: medical malpractice or guilt by association?

There was phone message on my desk to call a lawyer. I had no idea what he was seeking, but knew that I couldn’t be a target since plaintiff attorneys do not personally contact their victims to make an introduction.

I had no idea if his inquiry even pertained to a medical malpractice issue. Perhaps, he was cold calling to convince me that his estate planning skills could enrich the next several generations of Whistleblowers. Maybe he was going to notify me about a huge inheritance. Could it be that he wanted a screening colonoscopy for himself ASAP, and threw out his lawyer title to assure he would get a prompt call back? I then drifted into a reverie where lawyers were lined up outside my office all waiting for me to perform colonoscopies on them.

I returned the call and he asked if I would help in the defense of an internist who is being sued for medical malpractice. Years ago, this physician prescribed Reglan, an anti-nausea medicine, to a patient who subsequently developed tardive dyskinesia, an irreversible neurologic disorder that has a well-known association with the drug. I recall learning about this association when I was in medical school during the late Pleistocene Era. Although this adverse reaction is old news, the FDA has recently mandated a ‘black box’ warning of this complication on the drug’s product information material. Individuals with tardive dyskinesia suffer from involuntary and continuous oral, facial and bodily movements. It’s an awful condition.

Readers should keep in mind that an associated reaction is not proof of causation. It is a much weaker connection, which is not always grasped by the public or the press. Association means there is no proof, only vague suspicion. Yet, as drug companies know, an association can sink a drug.

Reglan is primarily prescribed to treat nausea or to strengthen lazy stomachs that do not empty food properly into the small intestine. I have prescribed it very rarely, not from fear of side-effects, but because the drug is not very effective. In addition, even when the drug does work, it tends to lose its efficacy over time, a phenomenon that we physicians call tachyphylaxis.

I do not know the facts of this particular case. Before making a judgment if the community standard was breached, I would need to know specific clinical details:
--Was Reglan the best option for the patient’s clinical circumstance?
--What were the existing therapeutic alternatives?
--Was standard dosing utilized?
--Did the patient taking the drug as prescribed?
--How long was the patient on Reglan?
--Did the patient follow-up with the physician as instructed?
--Was the patient aware of the risks and benefits of the drug?
--Was the diagnosis of tardive dyskinesia in dispute?
--Could there be another cause of tardive dyskinesia besides Reglan?

We did not discuss any of the relevant clinical information. I declined to participate in the case. Primarily, I did not want to invest the time that this effort would require. Moreover, agreeing to serve as an expert would mean that I would have to be available for depositions and trial. These latter entertaining activities can burn up hours and days of a physician’s time. Patient appointments would have to be cleared, perhaps for days. In the event that a trial would be necessary, how do I know how many days of my office schedule to cancel? Trial lengths are unpredictable, and delays and recesses are part of the process.

I also would not relish the opportunity of being interrogated in a deposition by opposing counsel. In a depo, unlike trial, any question is fair game. The attorney might very well have become an expert on Reglan, being able to ask me about published articles that I am not familiar with, but that he can quote authoritatively.

If readers are wondering why I might not know about these publications, it is because specialists and primary care physicians have to read so broadly on their specialty, that we cannot have deep vertical knowledge of every medical topic. It is easy for a lay person, however, to develop command of a narrow niche. Capable pharmacy representatives illustrate this phenomenon well.

While I would like to think that I could keep my cool, the attorney has an edge in this duel. Not only might he have deep knowledge of a narrow medical issue, but he is a professional interrogator.

This is not a casual conversation. Questions in depositions are asked for specific reasons. While I won’t use the term ‘set up’, questions are asked early in the depo to get the witness on the record. Then, an hour later, or at trial, the attorney may try to ask how those answers can be reconciled with contradictory information you later provided. If you are not accustomed to navigating across a treacherous legal minefield, then it is clear who has the advantage here.

It is an easy task to make any witness uncomfortable. Any of us could do this. If we were questioning an honorable physician, politician, businessman or priest, we could change the subject matter and ask insinuating questions that no ordinary and decent individual would welcome.

I concluded the conversation by telling the attorney that I would be pleased to review the record and offer an informal opinion on the strengths and weaknesses of the case, but I would not do so under oath. For me, there’s a Black Box warning against diving into the medical malpractice arena.

This post by Michael Kirsch, MD, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.