During an annual screening mammogram, a radiologist noticed a six millimeter nodule in a woman’s breast and recommended a follow-up screening. A second radiologist, performed the follow-up screening three days later. The second radiologist told the woman that there was no evidence of malignancy and that she should return for another mammogram in one year.
A copy of the second radiologist's report was sent to the woman's OB/GYN, who called her four days after the follow up mammogram to discuss the results. During the phone call, the woman indicated that she was not comfortable with waiting a full year before the next screening, so the OB/GYN scheduled another mammogram in six months. That follow up screening occurred about six months later and revealed that the nodule had grown to eight millimeters. A surgeon performed a biopsy two weeks later and determined that the nodule was malignant, and diagnosed the woman with breast cancer.
A week after the diagnosis, the woman met with a breast cancer multi-disciplinary team to discuss treatment options. At the time of this meeting, her breast cancer stage was unknown pending further testing. At the meeting her treating oncologist recommended a lumpectomy to remove the tumor. The woman understood her treating oncologist’s explanation of her treatment plan to mean that she would need both radiation and chemotherapy if her tumor, when removed, was larger than eight millimeters, but that she would need only radiation and not chemotherapy if her tumor was eight millimeters or less. Her treating oncologist later testified that the woman's understanding was not accurate and that he was only trying to provide her with a general framework about possible treatment options, not a specific treatment recommendation that could be determined solely by the size of the tumor.
The woman underwent a lumpectomy two weeks after the team meeting. The tumor was removed and determined to be 11 millimeters at its largest dimension. Her treating oncologist diagnosed the woman with Stage I, Grade III breast cancer and recommended that she undergo twelve weeks of chemotherapy. It was also recommended that she undergo localized breast radiation therapy following chemotherapy, but she never received radiation therapy. She tested positive for a genetic mutation that increases the risk of recurrence of breast cancer and elected to undergo prophylactic bilateral mastectomies (complete removal of both breasts). As a result, no radiation was needed.
The woman sued her radiologist, her gynecologist, and medical clinic for medical malpractice. She claimed that had the breast cancer been diagnosed six months earlier, she would not have had to undergo chemotherapy and could have been treated with radiation alone. She argued that chemotherapy was more disfiguring, disabling, painful, and fatiguing than radiation. She testified that she suffered greatly as a result of the chemotherapy, by experiencing symptoms including hair and fingernail loss, severe aches and pains, nausea, headaches, fatigue, sleeplessness, dry mouth, sore throat, and digestive problems.
The woman identified four medical experts who would testify in her case, an OB/GYN, a radiologist, her treating surgeon, and her treating oncologist. Her treating oncologist was the only expert that she designated to testify about the causation issue. During her treating oncologist’s discovery deposition, he testified that he could not say that if a biopsy had been performed on the nodule six months earlier it would have revealed her breast cancer, because that would be pure speculation. He also testified that he could not say whether her prognosis had changed, explaining that eight millimeters was not a bright line cut-off measurement for determining whether chemotherapy was required or appropriate.
When discovery was complete, her radiologist, her gynecologist, and medical clinic filed a joint motion for summary judgment, arguing that the woman had not presented sufficient evidence to establish that their alleged negligence caused her alleged injury. The New Castle County Superior Court denied that motion, based on representations from her counsel that her treating oncologist’s testimony at trial would be sufficient to buttress a jury verdict that she would have undergone a different treatment plan if not for the delay in her diagnosis.
The woman confirmed that the change in treatment options from radiation to chemotherapy was the only issue for trial, and that her treating oncologist was her only expert who would be testifying on the causation issue. Her treating oncologist was unavailable for the trial, so his videotaped trial deposition was taken. During his trial deposition, he testified that he could not make a treatment recommendation until after the tumor was removed and its pathological stage could be confirmed. Thus, he could not state with a reasonable degree of medical certainty what her diagnosis or treatment would have been six months earlier.
After the treating oncologist's deposition and before the trial began, her radiologist, her gynecologist, and medical clinic filed a motion for judgment as a matter of law. The Superior Court was able to consider all of the medical expert testimony that would be submitted to the jury on the issue of causation. After a hearing, the Superior Court granted the motion.
The Supreme Court of Delaware affirmed. The court held that the treating oncologist’s trial deposition testimony was not sufficient to establish causation and the affidavit of merit signed by the woman’s OB/GYN expert was not sufficient to establish a prima facie case.
The treating oncologist's deposition testimony was not sufficient to establish causation, as was required for the woman's malpractice claim. The woman was required to proffer testimony that a six-month delay in her breast cancer diagnosis was the proximate cause of her change in treatment that required her to undergo chemotherapy. Her treating oncologist’s testimony did not support her claim that her treatment or prognosis had changed because of the alleged six-month delay in her diagnosis. The treating oncologist could not opine on the woman’s diagnosis or treatment to a reasonable degree of medical probability and he went on to testify that any opinion about those issues would be speculative. The treating oncologist could not and did not say, to a reasonable degree of medical probability, that he would have recommended radiation, instead of chemotherapy, even if the tumor had been smaller than eight millimeters in size when it was removed.
The woman also argued that, even if her treating oncologist's testimony was not enough, her affidavit of merit was legally sufficient to establish a prima facie case. The court rejected her argument, holding that the affidavit of merit signed by the woman’s OB/GYN medical expert was not sufficient to establish a prima facie case. The Delaware General Assembly intended the affidavit of merit, which accompanied all medical negligence lawsuits, to operate as a prophylactic measure to reduce the filing of meritless medical negligence claims, and as a result, the requirements for the affidavit of merit were purposefully minimal. Although the affidavit of merit may establish a prima facie case sufficient to get through the courthouse doors, it was not enough to meet a plaintiff's legal burden to submit trial evidence sufficient to support a jury verdict in her favor in a medical malpractice action. Although the woman’s OB/GYN medical expert might have been able to testify that the tumor had grown, the woman had no expert testimony to support her argument that her treatment for breast cancer changed because of that growth. The woman’s OB/GYN medical expert did not give treatment recommendations to cancer patients, did not administer chemotherapy, and was not qualified to issue an opinion about whether the six-month delay in her diagnosis caused her to have to undergo chemotherapy.
The Supreme Court of Delaware affirmed the trial court’s grant of the radiologist, gynecologist, and medical clinic’s motion for judgment as a matter of law.
See: Mammarella v. Evantash, 2014 WL 1945621 (Del.Supr., May 15, 2014) (not designated for publication).
See also Medical Law Perspectives, October 2012 Report: Mistakes in Diagnosing Cancer: Liability Concerns for Misdiagnosis, Failure to Diagnose, and Delayed Diagnosis