Informed Consent Expert: Shannon v. Fusco 1
The Baltimore Medical Malpractice Lawyer Blog discusses issues in Maryland medical malpractice cases. In this post, I discuss expert testimony in an informed consent case. In addition, the differences between negligence and informed consent claims. The case is the Court of Appeals of Maryland opinion in Shannon v. Fusco, 438 Md. 24 (2014).
Factual Background
The patient in this case was diagnosed with prostate cancer. He then consulted with the defendant radiation oncologist and proceeded with a treatment of hormone therapy and radiation. The treatment included the doctor’s administration of the drug Amifostine. This drug was supposed to protect the bladder and rectum from radiation inflammation. The patient was later diagnosed with Stevens-Johnson syndrome. This syndrome is a disease involving skin irritation and blisters, which causes the top layer of skin to die and shed. Shortly after that, he died from pneumonia. (Op. at 4).
The patient’s estate and his family filed wrongful death and survival actions against the doctor and his medical group in the Circuit Court for Prince George’s County. They brought an informed consent action, alleging that the doctor failed to disclose material risks of administering the radiation therapy, as well as the drug, before obtaining the patient’s consent. (Id. at 5).
Expert Testimony
The plaintiffs designated a pharmacist as an expert witness in drug therapy as it applies to oncology. (Id. at 5-6).
In a de bene esse deposition, the pharmacist then testified that the doctor should not have used Amifostine in a patient getting radiation for prostate cancer. He also supported his opinion by testifying that the FDA had not approved it for prostate cancer, and warned against it in older patients. (Id. at 6-7).
The circuit court excluded the pharmacist’s de bene esse testimony. The court found that the pharmacist was not a medical doctor and did not address informed consent standards. (Id. at 9).
The plaintiffs then proffered:
The pharmacist would testify to, inter alia, the risk factors associated with Amifostine; that Amifostine has only benefited patients suffering from head, neck and kidney cancer; that the efficacy of Amifostine in treating prostate cancer was unknown; that the package insert cautions against use in older patients; that there are no other known alternatives to Amifostine, and that the Food and Drug Administration did not approve Amifostine for the treatment of prostate cancer. (Id. at 10-11).
The judge excluded the pharmacist from testifying at trial. (Id. at 11). The jury found for the defense. It specifically determined that a reasonable person, having been informed of the material risks of Amifostine, would not have refused treatment. (Id. at 15).
The Court of Special Appeals reversed. (Id. at 16–17). The defendants then appealed. (Id. at 2-3).
Court of Appeals on Informed Consent Expert Testimony
The elements of an informed consent cause of action generally include the duty to disclose to the patient material information that a physician knows or ought to know would be significant to a reasonable person in the patient’s position in deciding whether or not to submit to a particular medical treatment or procedure; breach of that duty by failing to make an adequate disclosure; and that the violation was the proximate cause of the patient’s injuries. (Id. at 18).
The information includes the nature of the ailment, the nature of the proposed treatment, the probability of success of the contemplated therapy and its alternatives, and the risk of unfortunate consequences associated with such treatment. (Id. at 19). The doctor must disclose material risks. (Id).
Negligence is a different claim from informed consent. Evidence that a medical procedure or treatment is not for a patient is relevant in a negligence case but is not applicable in an informed consent action. (Id. at 21-22).
The CA held that expert testimony is necessary to assist the trier of fact in understanding the severity and likelihood of the risk, so that the trier of fact may assess the material risks of the proposed treatment. (Id. at 24).
The pharmacist may have qualified to testify about the material risks of administering Amifostine. Still, he did not render such an opinion in his de bene esse deposition or in the proffer of his trial testimony. (Id. at 26).
The pharmacist did not address the severity or likelihood of the risks of administering Amifostine; instead, he opined only on the existence of risk. (Id. at 31).
Therefore, the trial judge did not abuse his discretion in excluding the testimony. (Id. at 32-22).
The CA reversed the CSA and affirmed the trial court. (Id. at 43).
Commentary By Baltimore Medical Malpractice Lawyer Mark Kopec on Informed Consent Expert Testimony
Informed consent claims are not nearly as prevalent as negligence-based claims in medical malpractice cases. When a plaintiff pursues an informed consent claim, they must closely examine the elements they must meet.
In this case, the plaintiff submitted testimony that sounded in negligence. The deposition and proffer did not satisfy the elements of an informed consent claim.
This decision and others specifically provide the roadmap and checklist for a plaintiff seeking to put on an informed consent claim successfully.
Another point to emphasize in informed consent cases is that it is an objective standard. The jury does not have to accept the plaintiff’s testimony that they would not have pursued the treatment if the doctor had provided all of the information. The jury makes its own determination.
We get calls from plaintiffs who have experienced significant side effects from treatments and then claim the doctor did not disclose those effects. In many instances, however, the entire picture reveals that the treatment was so critical to the patient’s ability to regain health that it would be unlikely that a jury would find the risk of side effects was not worth it.
Mark Kopec is a top-rated Baltimore medical malpractice lawyer. Contact us at 800-604-0704 to speak directly with Attorney Kopec in a free consultation. The Kopec Law Firm is in Baltimore and helps clients throughout Maryland and Washington, D.C. Thank you for reading the Baltimore Medical Malpractice Lawyer Blog.