The Commonwealth of Kentucky Court of Appeals (“Kentucky Appellate Court”), in its unpublished opinion dated October 4, 2019, held that the Kentucky medical malpractice plaintiffs had raised genuine issues of material fact as to whether the defendants breached the standard set forth in KRS 304.40-320(1) and (2) (Kentucky’s informed consent law) and therefore summary judgment for the defendants was inappropriate.
The plaintiff wife needed a kidney transplant and her husband (the plaintiff husband) was an appropriate kidney donor. The plaintiffs discussed with their transplant surgeon the possible complications related to immunosuppressants and inquired about a Phase 1 clinical trial involving bone marrow infusion in advance of kidney transplant (the transplant surgeon was the principal investigator for the clinical trial). The plaintiffs were given a 16-page consent form which detailed the study and possible side effects; however, they claimed that a nurse told them there were virtually no side effects to be expected in the trial and that the worst-case scenario was that the trial would not work and the plaintiff wife would have to undergo a traditional kidney transplant. The plaintiffs also alleged that they were told the study had been successful in five other patients, which was not true.
The plaintiff wife participated in the clinical trial and had her kidney transplant. A little more than one year later, she was diagnosed with myelodysplastic syndrome (MDS), a blood cancer, which she was told could have been caused by the clinical trial. She had bone marrow transplants in order to treat the disease and suffered rejection of her transplanted kidney.
The plaintiffs sued the defendant health care providers for their negligent failure to adequately inform the plaintiffs regarding the risks of participating in a clinical trial, claiming that had they been properly and adequately informed of the risks of the clinical trial, then the wife would not have participated. The trial court granted summary judgment to the defendants, and the plaintiffs appealed.
Kentucky Revised Statute (KRS) 304.40-320 provides:
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;
(3) In an emergency situation where consent of the patient cannot reasonably be obtained before providing health care services, there is no requirement that a health care provider obtain a previous consent.
The Kentucky Appellate Court stated, “we conclude that Appellants provided enough evidence to show that there were genuine issues of material fact that must be determined by a jury. Appellants provided evidence that Appellees may have breached both KRS 304.40-320(1) and (2).”
“As to KRS 304.40-320(1), Appellants’ expert, Dr. Levitt, testified during his deposition that it was his opinion that Appellees breached the standard of care in gaining informed consent. He believed that the consent form should have mentioned the specific risks regarding bone marrow, such as stem cell damage, leukemia, and MDS. Dr. Levitt also claimed MDS is a known side effect when total body irradiation and chemotherapy are used in conjunction, and this risk should have been included in the consent form. While Appellees presented evidence to the contrary, the conflicting evidence made this an issue for the jury.”
“As for KRS 304.40-320(2), … Appellants testified that no one explained the possibility that there could be extreme risks associated with this trial. They stated that the only information they were verbally given was that, at most, the trial would not work, and Ms. Shwab would have to undergo a traditional kidney transplant. They also alleged that they were rushed and did not have time to fully examine the consent form. Dr. Levitt also testified that he believed the consent form was too long and confusing.”
The Kentucky Appellate Court held: “While a signed consent form may in some circumstances give rise to a presumption that patients read and understand the terms of the consent form … we believe that Appellants presented enough evidence to potentially convince a jury that Appellees did not give them enough information to reasonably understand the clinical trial or the potential risks associated. In fact, Appellants testified that they were given information that contradicted the consent form. Appellants admit that Ms. Shwab signed the form; however, they testified that they relied primarily on what they were told by the medical professionals. Examining this issue in a light most favorable to Appellants, the evidence presented by Appellants makes the KRS 304.40-320(2) issue one for the jury.”
Shwab v. Ravindra, No. 2018-CA-001188-MR.
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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*THIS CASE WAS OVERTURNED (REVERSED) BY THE KENTUCKY SUPREME COURT ON AUGUST 26, 2021.