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Maryland’s Court of Appeals recently ruled that a trial court judge did not abuse his discretion in excluding the standard of care testimony of a plaintiff’s expert pharmacist in an informed consent case involving the cancer treatment drug Amifostine.  The Court of Appeals majority opinion in Shannon v. Fusco overturned a previous ruling by Maryland’s intermediate appellate court that held the pharmacist’s testimony should have been admitted.

Anthony Fusco was diagnosed with prostate cancer in 2001, and shortly thereafter began radiation treatments.  He was seen by Dr. Kevin Shannon, to obtain a radiation protectant regimen to prevent inflammation from the radiation therapy.  Dr. Shannon started Mr. Fusco on a regimen of the drug Amifostine, which he began in April of 2003.  In May of 2003, after receiving his twenty-fourth dose of Amifostine, Mr. Fusco was hospitalized with a severe allergic reaction, and was diagnosed with Stephens-Johnson syndrome, which Dr. Shannon believed to be a reaction to the Amifostine.  By May 20, 2003, Mr. Fusco’s condition had advanced to Toxic Epidermal Necrolysis Syndrome.  He continued to deteriorate and died on December 4, 2003.

Mr. Fusco’s widow and children filed suit against Dr. Shannon in the Circuit Court for Prince George’s County, alleging that Dr. Shannon had failed to failed to adequately inform Mr. Fusco of the risks of Amifostine.  Under Maryland law, and the seminal case of Sard v. Hardy, 281 Md. 432, 379 A.2d 1014 (1977), the doctrine of informed consent requires a doctor to explain to his or her patient a procedure (or in this case, a medication), and to advise them of any material risks or dangers of the therapy, prior to subjecting the patient to medical treatment, in order to enable the patient to make an intelligent and informed decision about whether or not to undergo treatment.

Among other expert witnesses, the plaintiffs retained Dr. James Trovato, a pharmacist, who testified that the known common side effect of Amifostine nausea, vomiting, hypertension, dizziness, respiratory affects, and various skin reactions,” including Steven–Johnson’s Syndrome.  Dr. Trovato also opined that Amifostine was an inappropriate drug for a patient receiving radiation for prostate cancer.

The trial court excluded Dr. Trovato’s testimony, reasoning that, because Dr. Trovata he was a pharmacist and not a medical doctor, he could not testify about the full extent of what is involved in informed consent, and therefore, his testimony would only serve to confuse the jury.  The case went to trial, and the jury returned a verdict in favor of the defense.

The Fuscos first appealed to the Court of Special Appeals, Maryland’s intermediate appellate court, which reversed the trial court’s decision and agreed that Dr. Fusco should have been permitted to testify because he had substantial experience studying and advising patients regarding oncology medications, including Amifostine.

The Court of Appeals granted certiorari, reversed the Court of Special Appeals, and affirmed the judgment of the trial court, holding that Dr. Trovata’s testimony was properly excluded.  In so holding, the Court relied in part on previous decisions  holding that evidence that a medical procedure or treatment is contraindicated for a patient is not relevant in an informed consent action.

The Court made it clear, however, that its holding was not to say that a pharmacist is per se unqualified to testify in an informed consent action when a physician has been sued.  Under the right circumstances, therefore, a pharmacist’s testimony will still be useful in an informed consent action, especially in order to explain the known risks, side effects, and complications of a particular drug.

The attorneys at Bekman, Marder, Hopper, Malarkey & Perlin have significant experience with informed consent cases.  If you believe you or one of your loved ones was a victim of medical negligence, contact us today.