The Case

The plaintiff’s attorney retained a physician expert to review Mrs B’s medical records. “I think you have a case,” the expert told the attorney. “Rhabdomyolysis is a well-documented side effect of statin therapy. Certain medications increase that risk, particularly the concurrent use of medications that inhibit CYP3A4. The primary care physician should have known this and chosen a different antibiotic.”

The attorney took the case and sued Dr F for negligently prescribing clarithromycin, resulting in Mrs B experiencing rhabdomyolysis and suffering permanent injury limiting her enjoyment of life.

Dr F met with his defense attorney and tried to explain how the situation had occurred. The defense attorney consulted with his medical expert who said that the condition was very rare and only affected about 1.5 of each 100,000 people taking statins. “Of course, the higher the dose, the higher the risk,” said the expert, “And the risk increases when certain drugs, including clarithromycin, are taken concurrently. But still, very rare.”

Settlement negotiations failed, and the case advanced to a trial in front of a jury. Mrs B testified about her dramatic change in lifestyle and how an exciting and active retirement was no longer possible. Her attorney introduced medical experts who faulted Dr F for his failure to recognize the danger of prescribing that particular antibiotic to a patient taking simvastatin.


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Dr F’s attorney pointed out the rarity of rhabdomyolysis and denied that the physician’s choice of antibiotic amounted to negligence.

After deliberating for several hours, the jury returned a verdict for Mrs B in the amount of $600,000.

Protecting Yourself

Although rare, rhabdomyolysis is a well-known side effect of statin treatment. Patients should be advised to report muscle symptoms if they are on statins.

The pharmacy that dispensed the clarithromycin in this case was also sued, but the pharmacy’s liability or lack thereof did not absolve Dr F. The physician should have reviewed the medications the patient was currently taking before prescribing, and then should have taken into account the fact that she was on simvastatin when making his choice of medication for her.

To protect yourself, warn your patients who are prescribed statins about being aware of muscle weakness and reporting it promptly. Always double check that any other medication that you prescribe to a patient on statins is not contraindicated, such as a strong CYP3A4 inhibitor. Take the time to double check that what you are prescribing is the best choice for your patient. And as always, document everything.   

Reference

Zocor® [package insert]. Whitehouse Station, NJ: Merck & Co. Inc; 2020.