Skip to main content

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 a 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.


  1. Interesting take. You, a practicing physicians who like many other practicing physicians, does not have the time or willingness to assist in a case against a fellow physician. Much less an injured plaintiff.

    Yet most physicians rail against those physicians who testify for the plaintiff (regardless of the merit of the case) as "whores" because they get paid for their time.

    Seems problem identification is easy, but solutions that require your time aren't part of what you're prescribing for a cure. Oh well, we'll always have damage caps!

  2. Thanks for the comment. You are correct that I don't have the time or inclination to enter the legal arena. My full time job and life leave little idle time, and I'm not going to fill it with testifying, waiting in court, etc. In contrast, physician experts who testify for plaintiff attorneys often do this for a living. This is often a significant segment of their professional life. In other words, these 'experts' are not struggling to find the time to testify; they welcome opportunities to do so. I have offered solutions on prior blog posts, but it is hard to overcome the views of idealogues and those who are ocnsumed with self-interest.

  3. Aren't you consumed with self interest? In fact, your whole post is about your time and your self interest. And all your "reform" solutions are about helping you.

    So who exactly is consumed with self interest here?

  4. Three experiences crossed my mind as I read your post. By the way I am a retired attorney, and I would be happy to see you for a colonoscopy to help fulfill your dream, but I have my own doctor for that whose office is much closer.

    The first experience, or rather experiences, is seeing commercials on TV nearly every night for attorneys who promise "compensation" for people who suffer alleged side effects from various prescription medications. I am not as familiar as an M.D. or pharmacist with prescription drugs, but I recognize many of the side effects as those which the drug companies include in their literature as possible side effects. If the drug companies warn of the side effects in advance, then my attitude is that the patient and/or his physician and/or his pharmacist (the physician and pharmacist should anticipate that the patient will not be willing or able to read the fine print in the literature that comes with the drug) has assumed the risk and the drug company should be off the hook.

    The second experience is in the course of teaching American Government online, I reinforce that part of the textbook that says that the fact two things are correlated does not necessarily means that one causes the other.

    The third experience is ready Thomas Sowell's book Intellectuals and Society in which he repeatedly makes the point that the fact often the fact that businesses take certain actions, such as denying more loans to minority applicants or not allowing as many into college, conveys cultural differences between groups rather than causing them. His argument is that finding statistical difference should not be sufficient evidence to show intent.

    All this points in the same direction - correlation is a clue, but it is not proof.

  5. Michael, appreciate your humor and our mutual respect of Thomas Sowell. Agree that there is an epidemic of trying to connect stuff suggesting causality, when no true connection exists. To the anonymous commenter who again suggests that I am pursuing self-interest, read other blog posts here peruse the blog and you will soon see that my own profession and myself are often in the crosshairs.


Post a Comment

Popular posts from this blog

Why Most Doctors Choose Employment

Increasingly, physicians today are employed and most of them willingly so.  The advantages of this employment model, which I will highlight below, appeal to the current and emerging generations of physicians and medical professionals.  In addition, the alternatives to direct employment are scarce, although they do exist.  Private practice gastroenterology practices in Cleveland, for example, are increasingly rare sightings.  Another practice model is gaining ground rapidly on the medical landscape.   Private equity (PE) firms have   been purchasing medical practices who are in need of capital and management oversight.   PE can provide services efficiently as they may be serving multiple practices and have economies of scale.   While these physicians technically have authority over all medical decisions, the PE partners can exert behavioral influences on physicians which can be ethically problematic. For example, if the PE folks reduce non-medical overhead, this may very directly affe

Why This Doctor Gave Up Telemedicine

During the pandemic, I engaged in telemedicine with my patients out of necessity.  This platform was already destined to become part of the medical landscape even prior to the pandemic.  COVID-19 accelerated the process.  The appeal is obvious.  Patients can have medical visits from their own homes without driving to the office, parking, checking in, finding their way to the office, biding time in the waiting room and then driving out afterwards.  And patients could consult physicians from far distances, even across state lines.  Most of the time invested in traditional office visits occurs before and after the actual visits.  So much time wasted! Indeed, telemedicine has answered the prayers of time management enthusiasts. At first, I was also intoxicated treating patients via cyberspace, or telemedically, if I may invent a term.   I could comfortably sink into my own couch in sweatpants as I guided patients through the heartbreak of hemorrhoids and the distress of diarrhea.   Clear

Do Doctors Talk to Each Other?

 I will share with readers a recent occurrence between me and another doctor that was both rare and refreshing.  I was serving as the gastrointestinal consultant on one of the doctor’s patients.  I performed a scope examination of the stomach and obtained some routine biopsy specimens.  The pathology results were abnormal, but benign.  No urgent action was needed, but a full airing of the significance of the results would require a conversation between me and the patient in an office visit.  I notified the patient that there was no medical threat at all and we would unpack it all during his next visit. The referring physician wondered about this delay, which perhaps is a different style from other gastroenterologists (GI’s) who he works with.   (My guess is that other GI’s may opt to handle the issue with the patient on the phone or via the portal. I think, however, that there’s too much complexity to fully address this issue in this manner.) So, here’s what the referring doctor did.