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Hyoung v. Yoo

Dr. Mark Needham Details Standard of Care on Drug Side Effect Information, Helps Clear Doctor in Med Mal Trial

The Expert: Dr. Mark Needham, a family medicine specialist who testified as to the appropriateness of the medication at issue and the standard of care as to the detail a patient should give on a medication’s potential side effects.

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

Dr. Mark Needham, a family medicine specialist from southern California, testifies for the defense in medical malpractice case examining the development of Steven-Johnson syndrome, causing blistering and necrosis of the skin, which a patient developed after using the prescription antibiotic Bactrim. Needham’s testimony concerning the propriety in prescribing the drug was a key to clearing the defendant physician.

The defendant, Dr. Kyoung Yoo, prescribed the medication for the plaintiff’s acne. However, the resulting toxic response scarred more than 30 percent of her body. The two main issues examined in this clip are whether this was the appropriate drug to order, and whether the physician was obligated by the standard of care to warn the plaintiff that Steven-Johnson syndrome could be a possible side effect of Bactrim.

Needham is first questioned about what a physician prescribing an antibiotic would be expected to divulge to the patient in terms of the side effects associated with that drug. The doctor states that it is common for doctors in his community prescribing any drug to tell their patients that “any medication can cause any side effect.” He explains this seemingly nebulous statement by pointing out that when he began practicing medicine over 30 years ago, he would tell patients the most common side effects of whatever drug he was prescribing. Unfortunately, he quickly learned that his patients would assume that if he had not included a particular side effect in that list, it was not necessary to consider an unlisted reaction that they were having as being related to the prescribed drug. Consequently, patients allowed side effects to persist and would not report them. He and others then adopted a different approach, telling patients, essentially “If anything happens that is unusual, you know your body… let me know.” In other words, he no longer identifies a list of specific complications to his patients, even though all commonly used antibiotics can cause severe side effects.

Needham then unequivocally states that it was appropriate for the defendant to have prescribed Bactrim in this case. The first line drugs for acne, Needham says, would be doxycycline or minocycline, but the bacteria within the acne lesions can, and frequently do, become resistant to these medicines. Even though the acne may have previously responded well to the previous administrations of doxycycline, as the plaintiff’s medical records appeared to show, it is not at all unusual that drug resistance may have developed months later.

The expert notes that the next oral medications to consider in such cases would be Bactrim or Septra (essentially the same drug), clindamycin, erythromycin, and Keflex. Although some topical treatments such as Retin-A are useful, Needham states, and oral Accutane is the most effective treatment for acne, it also causes the most severe side effects and is therefore used generally in the most severe cases of acne where the risk of bad side effects is more easily justified. Oral contraceptives can also be useful, but according to the patient’s record, Young did not want to take either Accutane or oral contraceptives.

Needham tells jurors the defendant’s deposition appeared to show that the previously ordered doxycycline was no longer working, so in his opinion, ordering the second line drug, Bactrim, was appropriate, despite the fact that the latter may not be quite as effective and may have more side effects than the former. Bactrim is “one of the normal drugs that is used for acne,” he says.

Needham’s testimony was solid in establishing that the appropriate second line medication was used once the first-line medications were no longer effective, and that the standard of care for prescribing Bactrim [or Septra] had been supported by the defendant. This, despite the fact that no discussion of the possibility of Stevens-Johnson syndrome had occurred. The jury’s verdict in favor of the defendant physician relied upon this testimony.

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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