FDA Insert: Shannon v. Fusco 2
The Baltimore Medical Malpractice Lawyer Blog discusses issues in Maryland medical malpractice cases. In this post, part 2, I discuss the admissibility of an FDA insert in an informed consent medical malpractice case. In Part 1, I examined expert witness testimony in an informed consent case. The case is the Court of Appeals of Maryland opinion in Shannon v. Fusco, 438 Md. 24 (2014).
Factual Background
After the patient in this case was diagnosed with prostate cancer, he consulted with the defendant radiation oncologist and proceeded with a treatment of hormone therapy and radiation. The treatment specifically included administering the drug Amifostine to protect the bladder and rectum from radiation-induced inflammation. The patient was later diagnosed with Stevens-Johnson syndrome, 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 then 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).
The defense moved in limine to exclude a package insert from the drug in reference to the FDA not approving it for prostate cancer. Afterward, the court granted the motion. (Id. at 14).
The jury then found for the defense, finding that a reasonable person, having been informed of the material risks of Amifostine, would not have refused treatment. (Id. at 15).
However, the Court of Special Appeals reversed. (Id. at 16–17). Consequently, the defendants appealed. (Id. at 2-3).
Court of Appeals
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 specifically 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 risks the doctor must disclose are material. (Id).
Negligence, however, 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).
FDA Insert & Informed Consent
An issue in this case concerned the admissibility of evidence regarding the package insert for Amifostine and its off-label use. (Id. at 33). The plaintiff attempted to introduce the package insert itself and also testimony through its expert witness, a pharmacist, that the insert cautioned against use in older patients. (Id. at 33-34). The plaintiff also attempted to introduce that the defendant doctor did not inform him of the insert’s caution. (Id. at 34).
The CA held that whether a treatment is appropriate is relevant and admissible evidence in a negligence cause of action, but not in an informed consent case. (Id. at 36). The package insert’s warning against use in older patients may have supported a negligence claim. (Id.).
The plaintiff also attempted to introduce evidence at trial through the pharmacist’s testimony and the defendant that the FDA had approved Amifostine in ovarian cancer and head and neck cancer cases, but not for prostate cancer. (Id. at 37-38). The CA again concluded that this evidence was relevant to negligence but not informed consent. (Id. at 40).
Information about off-label use does not provide the patient with any information about the treatment itself or the likelihood or severity of any risks. Therefore, it cannot be considered material information for an informed consent claim. (Id. at 42).
The CA reversed the CSA and affirmed the trial court. (Id. at 43).
Commentary By Baltimore Medical Malpractice Lawyer Mark Kopec on FDA Insert & Informed Consent
Similar to the court’s holding discussed in Part 1, the evidence in this part was not relevant to an informed consent claim. The lack of FDA approval did not go to one of the elements of information that a physician must disclose. In addition, cautioning against use in older patients did not include the specific details needed to fit into an informed consent disclosure.
Either of these pieces of evidence could be relevant in a given case. A plaintiff would have to relate them to specifics that demonstrate the probability of success of the treatment or the risk of unfortunate consequences.
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.