The Supreme Court of Kentucky held in its opinion rendered on August 26, 2021 in a kidney transplant malpractice case involving a clinical trial: “While the Kentucky General Assembly could have deferred to federal authorities such as the FDA in defining the informed consent duty in a clinical trial or articulated a different standard for informed consent in clinical trials, it did not. Because the judiciary’s role in statutory construction cases is to see that “the will of the legislature” is applied … we decline to impose a different standard of informed consent for clinical trials.”
The Underlying Facts
Reagan Brooke Shwab (Brooke) was diagnosed with a kidney disease which became severe in 2007, necessitating a kidney transplant. Interested in avoiding the need for lifetime immunosuppressant drugs following the transplant, Brooke consented to participate in a Phase I clinical trial that had as its goal participants achieving tolerance of a transplanted kidney and avoiding a continuing regimen of immunosuppressant drugs. Shortly after participating in the clinical trial, Brooke developed myelodysplastic syndrome (MDS), a rare form of blood cancer.
Brooke and her husband filed suit against the clinical trial’s medical providers alleging that her consent to the medical treatment involved in the trial was invalid pursuant to Kentucky Revised Statute (KRS) 304.40-320, the statute that provides the framework for determining when informed consent has been properly given in an action involving medical care. After eight years of discovery, the trial court found that the informed consent in this case complied with Kentucky statutory authority and federal regulations and granted summary judgment to the medical defendants.
Kentucky’s Informed Consent Law
KRS 304.40-320 provides the informed consent standard:
In any action brought for treating, examining, or operating on a claimant wherein the claimant’s informed consent is an element, the claimant’s informed consent shall be deemed to have been given where:
(1) The action of the health care provider in obtaining the consent of the patient or another person authorized to give consent for the patient was in accordance with the accepted standard of medical or dental practice among members of the profession with similar training and experience; and
(2) A reasonable individual, from the information provided by the health care provider under the circumstances, would have a general understanding of the procedure and medically or dentally acceptable alternative procedures or treatments and substantial risks and hazards inherent in the proposed treatment or procedures which are recognized among other health care providers who perform similar treatments or procedures . . .
Subsection (1) covers the means employed by the health care provider to obtain the patient’s consent. The “action of the health care provider” in obtaining consent must be “in accordance with the accepted standards of [the relevant] medical or dental practice[.]” The Kentucky Supreme Court stated in the case it was deciding, “Our review of the record reflects that Brooke had ample opportunity to review the consent form and ensure that she understood its contents … While the Shwabs did not meet their burden under KRS 304.40-320(1), we note that it would be a difficult task for any plaintiff given the extra vetting that occurs where informed consent is sought in the context of a clinical trial subject to federal regulation.”
“As for the particular informed consent form Brooke signed, the record reflects that Dr. Ildstad, Dr. Ravindra and Dr. Herzig collaborated to draft the consent form at an eighth-grade reading level to make it easy to understand. The initial draft of the consent form was then provided to the FDA for review. The form was next sent to a local IRB, which is a group formally designated to review and monitor biomedical research involving human subjects. An IRB has the authority to approve, require modifications, or disapprove research. The U.S. Department of Defense’s own IRB also reviewed the informed consent form because the Department of Defense provided funding for the clinical trial. The Department of Defense reviewed the consent form and trial protocol to ensure both were in accordance with federal regulations.”
The Kentucky Supreme Court held: “The Shwabs did not present evidence that the information given to Brooke failed to provide a reasonable person a “general understanding” of any “substantial risks” that were “recognized among other health care providers” performing similar research and treatment. Moreover, our own review, like the trial court’s, satisfies us that no issue of material fact exists as to the applicability of subsection (2) of KRS 304.40-320 to this case. MDS was not a “substantial risk” at the time Brooke entered the trial given its low prevalence generally in young females, and the fact that no other patient in the clinical trial or similar study had developed MDS. In any event, a reasonable person would certainly understand from even a casual reading of the informed consent form that developing cancer (of which MDS is one type) was a risk of the clinical trial procedure and treatment.”
Source University Medical Center, Inc. v. Shwab, 2019-SC-0641-DG.
If you or a loved one suffered harm as a result of a clinical trial in Kentucky or in another U.S. state, you should promptly find a Kentucky medical malpractice lawyer, or a medical malpractice lawyer in your state, who may investigate your clinical trial malpractice claim for you and represent you or your loved one in a clinical trial malpractice case, if appropriate.
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