March 22, 2013

162017_132140396847214_292624_nOn March 20, 2013, the Court of Special Appeals of Maryland (“Court of Special Appeals,” Maryland’s intermediate appellate court) issued its written opinion in a case in which it held that a pharmacist was qualified to testify regarding a prescription drug in an informed consent case (“The doctrine of informed consent . . . imposes on a physician, before he or [she] subjects his [or her] patient to medical treatment, the duty to explain the procedure to the patient and to warn of any material risks or dangers inherent in or collateral to the therapy, so as to enable the patient to make an intelligent and informed choice about whether or not to undergo such treatment”).

The Court of Special Appeals noted that the Maryland Health Care Malpractice Act requires that “when a defendant health care provider is board certified in a specialty, an expert witness attesting that the defendant deviated from (or complied with) the standard of care must be board certified in the same or a related specialty, with certain exceptions.” However, concerning a qualified expert witness in an informed consent case, the “qualification” restrictions that apply to a medical malpractice action do not pertain in an informed consent case because “a patient complains that a healthcare provider breached a duty to obtain effective consent to a treatment or procedure by failing to divulge information that would be material to his/her decision about whether to submit to, or to continue with, that treatment or procedure.”

The Underlying Facts

On June 26, 2001, an 82-year-old man was diagnosed with prostate cancer. On December 27, 2002, a urologist examined the man and determined that the cancer was “low-risk,” so the man selected “watchful waiting” as his treatment plan. On February 21, 2003, the man and his urologist discussed additional options, after which he elected a combination of radiotherapy and hormone treatment. The urologist provided the hormone regimen but referred the man to another physician for radiotherapy treatment.

On March 6, 2003, the physician to whom the man was referred for radiotherapy treatment explained the nature of radiation, including the need for a commonly used radiation protectant, which would possibly eliminate inflammation of the bladder and rectum. That physician referred the man to another physician, who discussed the radiation protectant regimen (using the drug Amifostine, which is a cytoprotective agent, to reduce the risk of radiation induced injury to the bladder and the rectum).

Between April 15, 2003 and May 16, 2003, the man underwent approximately twenty-three injections of 500 milligrams of Amifostine. On May 17, 2003, the man was hospitalized for symptoms of acute onset of systemic rash and lip swelling, possibly due to a reaction to the Amifostine. The reaction resulted in Stevens-Johnson Syndrome (an acute eruption of macules, papules, or subdermal vesicles presenting a multiform appearance, the characteristic lesion being the target or iris lesion over the dorsal aspect of the hands and forearms; its origin may be allergic, seasonal, or from drug sensitivity, and the eruption may be recurrent, may run a severe course, and may be fatal).

On May 20, 2003, the man was transferred to The Johns Hopkins Burn Center in Baltimore, Maryland, for further treatment. He was informed that his condition advanced to Toxic Epidermal Necrolysis Syndrome (a syndrome in which a large portion of the skin becomes intensely erythematous, relating to or marked by inflammatory redness, and peels off in the manner of a second-degree burn, often simultaneous with the formation of flaccid bullae).

On December 4, 2003, the man died from a stroke. No autopsy was performed, but the medical examiner listed arteriosclerotic cardiovascular disease with a contributing factor of Toxic Epidermal Necrolysis Syndrome as the cause of death.

A Maryland medical malpractice lawsuit was subsequently filed. One of the plaintiff’s experts was a pharmacist whose opinion was that Amifostine was inappropriately used or should not have been used for the man, since he was undergoing radiation therapy for prostate cancer. The medical malpractice defendants argued that the pharmacist’s testimony should have been excluded because (1) he was not a physician, and thereby not qualified to render opinions concerning a physician’s advisement to obtain informed consent and (2) his testimony offered criticisms sounding in standard of care.

The Court of Special Appeals held that the pharmacist was qualified to testify about the drug’s properties, possible side effects, and known material risks, which are factors in informed consent actions (the pharmacist in the present case had demonstrated that he possessed sufficient experience to opine about the material risks of Amifostine: the pharmacist was well qualified in oncology pharmacy practice, as he received a Bachelor of Science in Pharmacy from Massachusetts College of Pharmacy, a Doctor of Pharmacy degree from Purdue University, and completed an oncology pharmacy residency training program at the University of Texas. He was an associate professor with the Department of Pharmacy Practice & Science at the University of Maryland School of Pharmacy and was the director the University’s residency program. He provided teaching and lectures to pharmacy students in the areas of oncology therapeutics. He was also an oncology clinical specialist and was involved in countless aspects of oncology medication at the University’s cancer center. Although he was not a medical doctor, he proffered that he was familiar with Amifostine therapy. Thus, the Court of Special Appeals held that the pharmacist was a qualified expert witness regarding the question of the material risks of Amifostine).

However, the Court of Special Appeals noted that although the pharmacist indicated that he counseled and educated patients on the use of oncology medications, including Amifostine, informed consent encompasses more than the potential benefits and risks of Amifostine: there is an overall treatment plan, including the patient’s past medical, social, and family history, tobacco and alcohol intake, physical examinations, laboratory studies, anatomy demonstrations via diagrams and pictures, x-ray films, and lifestyle management, all of which are a part of a recommended course of treatment. Therefore, portions of the pharmacist’s proffered testimony regarding informed consent were not admissible, as exceeding the scope of his expertise in an informed consent case. In that regard, the pharmacist’s testimony regarding the nature of the material risks associated with the particular regimen of treatment provided to the man, and any alternative treatment options, would exceed the extent of the pharmacist’s expertise relative to informed consent.

Source Mafalda Fusco, et al. v. Kevin J. Shannon, et al., No. 2819.

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