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State of Oklahoma v. Johnson & Johnson

Dr. Danesh Mazloomdoost Testifies on Opioid Tolerance Leading to $572.1M Judgment Against J&J

The Expert: Dr. Danesh Mazlomdoost, an anesthesiologist and pain medicine specialist in Lexington Kentucky, testifies as to the effect of opioids on patients and the knowledge of those effects in the larger healthcare community.

By Dr. Gary F. Gansar, MD, FACS
Senior Physician Medical Director, AMFS

Dr. Danesh Mazloomdoost, a board-certified anesthesiologist and pain medicine specialist from Lexington, Kentucky, testifies in a 2019 bench trial in which the state claimed that Johnson & Johnson fomented the opioid crisis and created a public nuisance with its deceptive marketing and distribution of pain medicines.

The expert testifies with clarity and authority, first explaining that pain levels naturally vary over time depending upon activity, positioning, etc. The exposure of opioids will reduce the pain shortly after administration, but this exposure also increases the patient’s sensitivity to pain by lowering the pain threshold. When the pain naturally fluctuates, it is then interpreted by the patient as being worse pain, due to the lower pain threshold, a condition known as hyperalgesia. So as the patient notes that the pain medication is becoming less effective due to the development of tolerance, he also is becoming more sensitive to pain as a direct result of the administration of the opioid. The timing of this phenomenon is not yet known, but even one single injection of fentanyl will increase the pain sensitivity as well as the recruitment of adjacent sensory nerves in the region, essentially encouraging the use of the opioid more frequently and at higher doses. Over time, this causes chronic opioid users to complain of pain just from touching their skin.

The way that the opioids are prescribed is contributing to a worsening of this situation. For instance, patients are told that they should take the opioids as needed within a certain time frame. It is not possible to distinguish between the natural fluctuations of pain and the worsening of the pain peak. The patient just perceives that the pain seems to be getting worse, and takes pain medicine before allowing the natural fluctuation to return the discomfort to a lower level. This reinforces to the patient that the medication is what is alleviating the pain instead of the natural fluctuation in pain level. It also encourages the patient to take more medication more frequently than he needs to.

Mazloomdoost, a nationally recognized expert on this topic, says that the mechanism of action and resultant chronic consequences are not well understood by doctors across the nation that he is asked to address about it. This has led to an overprescribing of opioid medication by doctors. Drawing upon his experience as an anesthetist, the doctor gives an example. He testifies that he gives fentanyl during an operation in a dose high enough to allow his patient to be cut open. If an outpatient has been on a fentanyl patch for pain for a year, the tolerance and hypersensitivity that results will have that patient taking twice the operative anesthetic dose—every hour.

Further, Mazloomdoost clarifies why fentanyl is seen as short acting and requiring frequent repeat doses, a perception that can be very dangerous. Once administered, fentanyl saturates into the fat of the body. The brain being mostly fatty tissue is saturated first, then the rest of the body’s fat becomes saturated as repeat doses are given. The fentanyl is being stored, then later released by the body’s fat, which can not only be dangerous, but it can also lead to a rapid tolerance and addiction to the medication.

The expert accuses the pharmaceutical giant of failing to properly inform the prescribing doctors of these mechanisms and dangers. Instead, he says, by stating that this is a short-acting medication that needs to be constantly readministered, the company is contributing to its misuse and eventual abuse. This misinformation started by the drug company was rapidly spread by physicians across the country from one to another. He feels that nothing less than a cultural shift in the understanding of pain and its treatment will be required to curtail the misinformation disseminated.

The testimony was effective. The judge granted awarded $572.1 million.


About the Author Dr. Gary F. Gansar, MD, FACS

Gary Gansar, MD, is residency-trained in general surgery. He served as Chief of Surgery and Staff at Elmwood Medical Center and on the Medical Executive Committee at Touro Infirmary and Mercy Hospital in New Orleans, LA. Dr. Gansar was Board Certified in general surgery while in active practice. He joined AMFS in 2015 as a Physician Medical Director.

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