Breast Cancer – An In-Depth Analysis of 3 Delayed Diagnosis Cases

When it comes to medical malpractice litigation, errors in diagnosis account for 46% of all cases. According to Ed Milstein, Partner at Dankner, Milstein & Ruffo, delays in diagnosis are particularly prevalent with cancer cases. “By far the most common type of this genre of malpractice cases involve delays in the diagnosis of cancer,” he added, “misread diagnostic tests frequently involving imaging or biopsy interpretations are often the culprits in these situations. Sometimes the abnormal results of these studies go unappreciated by the ordering physician resulting in the failure to pursue further investigation.”

Of particular concern are cases of breast cancer, which account for the largest indemnity payments of any single medical condition. Still, a delay in the diagnosis of breast cancer alone does not provide grounds for a malpractice claim. According to Shirin Harrell of New Orleans-based firm Harrell & Nowak, it must be clear that the delay in diagnosis lead directly to a less favorable outcome for the patient. “Typically, there won’t be a case unless the delay in diagnosis resulted in the patient not receiving treatment for a period longer than 6 months, since it’s unlikely that breast cancer will develop into something more threatening over a shorter period of time.”

To this end, Stewart Eisenberg of the Philadelphia-based firm Eisenberg Rothweiler Winkler Eisenberg and Jeck regularly employs multiple experts when working on delay in diagnosing breast cancer cases. Mr. Eisenberg states, “I will usually use two experts in these types of cases, a radiology or imaging expert to assess the misdiagnosis itself, and a separate expert in oncology to determine if the delay resulted in a worse outcome for the patient.”

The causes of a missed diagnosis in breast cancer are varied but often center on radiology and misread imaging studies such as mammograms. Often, errors arise from miscommunication between different healthcare providers – something that is especially true when radiological analysis is outsourced to a remote physician. Although teleradiology can help smaller hospitals that don’t have 24-hour radiology staffs to provide patients with a higher level of care, the lack of direct communication between the radiologist, patient, and treating physician can lead to dangerous mistakes.

Below, we’ve researched and compiled three case studies in which expert witnesses made a decisive difference in cases involving the delayed diagnosis of breast cancer.

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1.) Failure to Perform a Mammogram

Case:

Larry Greer v. Lammico 779 So.2d 894 (La. App. 2 Cir. 12/22/00), 779 So. 2d 894 writ denied, 2001-0445 (La. 4/27/01), 791 So. 2d 116

Facts:

Patient sued physician, alleging that his failure to perform mammography materially reduced patient’s chances of recovering from cancer. The plaintiff contended that after Mrs. Greer asked Dr. Barrett whether a mammogram should be done on the right breast, Dr. Barrett failed to order it. The test was finally performed by order of Dr. McDonald about 5 ½ months after the cancer in the left breast was found. Subsequently, after the discovery of the cancer in the right breast, and the determination that the cancer had spread to Mrs. Greer’s bones and was incurable, she took legal action against Dr. Barrett.

Issue:

The issue at trial was whether the delay in obtaining the mammogram decreased the decedent’s chance of survival.

Experts:

Dr. Hightower, Dr. Paine, Dr. Grosbach, Dr. McDonald, Dr Mansour

The plaintiff argued that “it was impossible to retroactively stage the cancer years later to determine when it metastasized” and thus that “the testimony as to how far the cancer in the right breast had progressed was based on unfounded speculation”.

According to the plaintiffs, it was established at trial that four factors are necessary in order to make this determination. They claim that the tumor had to be examined under a microscope, the size had to be determined, as well as whether it was an invasive type and whether it had dead cells around it. The plaintiffs contend that, because the tumor in the right breast was not seen and examined during the several months between the first and second surgeries, none of these four factors were known.

Therefore, they claim that it was impossible to retroactively stage the cancer years later to determine when it metastasized. According to the plaintiffs, the defendant expert witness did not comply with the requirements of Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), and State v. Foret, 628 So.2d 1116 (La.1993), in laying a foundation for the introduction of testimony regarding when the cancer became incurable.

Basis:

The court rejected a similar challenge to the admissibility of expert testimony as to when the plaintiff’s breast cancer would have metastasized and said this argument is without merit. The admissibility of scientific and technical evidence is regulated by La. C.E. art. 702 which provides: If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise.

The reliability of expert testimony is to be ensured by a requirement that there be “a valid scientific connection to the pertinent inquiry as a precondition to admissibility.” This connection is to be examined in light of “a preliminary assessment” by the trial court “of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether the reasoning or methodology properly can be applied to the facts in issue.” Joseph CROSBY, as Trustee for the next of kin of James Floyd Hall, Plaintiff, v. Karla G. MYHRA-BLOOM, M.D., and Consulting Radiologists, Ltd., Defendant., 2008 WL 8130385 (Minn.Dist.Ct.)

In this case, the plaintiffs have failed to show that the expert opinions as to when Mrs. Greer’s cancer metastasized did not comply with the admissibility requirements of Daubert. The experts had extensive pathology reports and laboratory analyses of the tumor removed from the right breast upon which to base their opinions. The opinions were shown to be both relevant and reliable. In essence, the plaintiffs argue that because the tumor was not examined at the time of the first surgery, no determination could be made after its removal a few months later as to how long it had been in place or when it metastasized. However, this argument is simply not supported by the record.

Conclusion:

The trial court rejected the plaintiffs’ argument that the expert testimony and evidence were not admissible.

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2.) Failing to Test a Palpable Mass

Case:

Tracy Edry v. Marc Adelman 486 Mich. 634

Edry v. Adelman, 486 Mich. 634, 786 N.W.2d 567 (2010)

Facts:

Patient brought action against obstetrician and gynecologist (OB/GYN) alleging that OB/GYN breached the applicable standard of care by failing to test a lump on patient’s arm for cancer. In June 2003, plaintiff noticed an approximately three-millimeter lump under her arm. Before noticing the lump, plaintiff had been seeing defendant, an obstetrician and gynecologist (OB/GYN), for routine check-ups.

According to plaintiff, she brought the lump to defendant’s attention in 2003, and defendant told her to check back with him if the lump increased in size, but he did not order any tests, consult with a surgeon, or schedule a follow-up appointment. In 2005, plaintiff was diagnosed with breast cancer. The initial biopsy indicated that the cancer was invasive and had spread to 16 lymph nodes. Plaintiff then had a radical mastectomy, three rounds of chemotherapy, and radiation therapy. She filed a suit against defendant, alleging that defendant breached the applicable standard of care by failing to test for cancer when plaintiff first brought the lump to defendant’s attention in 2003. Plaintiff alleged that her opportunity for long-term survival was substantially diminished by the delay in diagnosis and treatment and that she was subjected to more invasive, severe, and disfiguring medical treatment as a result of defendant’s negligence.

Issue:

Whether a delay in diagnosis and treatment significantly diminished chances for long term survival.

Expert:

Dr. Barry Singer testified at a deposition as a plaintiff’s oncology expert. He stated that plaintiff’s chances of surviving five years would have been 95 percent if she had been diagnosed in June 2003 and that the delay in diagnosis reduced her five-year survival chance to 20 percent. Dr. Singer acknowledged that the American Joint Cancer Commission (AJCC) manual was authoritative on this subject and reported a 60 percent five-year survival rate for breast cancer patients when the cancer has spread to four or more lymph nodes. Dr. Singer stated, however, that the manual was not applicable to plaintiff’s case because the cancer had spread to 16 lymph nodes, and he believed that the more lymph nodes involved, the poorer the chance of survival. During his deposition, Dr. Singer referred to textbooks and journal articles that supported his theory, but plaintiff never produced those authorities to support his testimony.

Objection:

Defendant moved for summary disposition on the basis that Dr. Singer’s testimony was not admissible under MRE 702 (Michigan Rules of Evidence).

Basis:

This Court has stated that MRE 702 incorporates the standards of reliability that the United States Supreme Court described to interpret the equivalent federal rule of evidence in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). Gilbert v. DaimlerChrysler Corp., 470 Mich. 749, 781, 685 N.W.2d 391 (2004). Under Daubert, “the trial judge must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable.”

In this case, Dr. Singer’s testimony failed to meet the cornerstone requirements of MRE 702. Dr. Singer’s opinion was not based on reliable principles or methods; his testimony was contradicted by both the defendant’s oncology expert’s opinion and the published literature on the subject that was admitted into evidence, which even Dr. Singer acknowledged as authoritative. Moreover, no literature was admitted into evidence that supported Dr. Singer’s testimony.

Although he made general references to textbooks and journals during his deposition, plaintiff failed to produce that literature, even after the court provided plaintiff a sufficient opportunity to do so. Plaintiff eventually provided some literature in support of Dr. Singer’s opinion in her motion to set aside the trial court’s order, but the material consisted only of printouts from publicly accessible websites that provide general statistics about survival rates of breast cancer patients. The fact that material is publicly available on the Internet is not, alone, an indication that it is unreliable. Also these materials were not peer-reviewed and did not directly support Dr. Singer’s testimony. Moreover, plaintiff never provided an affidavit explaining how Dr. Singer used the information from the websites to formulate his opinion or whether Dr. Singer ever even reviewed the articles.

Conclusion:

The Court ordered to exclude the expert witness evidence as inadmissible.

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3.) Misread Mammogram and Ultrasound

Case:

Sandra Harris v. John Hanson 349 Mont. 29

Harris v. Hanson, 2009 MT 13, 349 Mont. 29, 201 P.3d 151

Facts:

Patient brought medical malpractice action against doctors, claiming they were professionally negligent in failing to diagnose her breast cancer from a mammogram and an ultrasound. Sandra K. Harris (Harris) brought suit against John V. Hanson, M.D. (Hanson), Anne W. Giuliano, M.D. (Giuliano), and Joe Dillard, M.D. (Dillard), claiming they were professionally negligent in failing to diagnose her breast cancer from a mammogram performed in February of 2002, a mammogram performed in January of 2004, and an ultrasound performed in March of 2004. Between February 2000 and January 2004, Harris had four mammograms performed.

The mammogram of February of 2002 was read by both Dr. Giuliano and Dr. Hanson. The process of having two radiologists read a mammogram is known as double reading. It is a standard practice in the field to increase accuracy. Dr. Hanson and Dr. Giuliano did not speak with each other prior to interpreting the February 2002 mammogram. Both Giuliano and Hanson read the mammogram as negative and without significant new findings since a prior mammogram of November 2000.

In June of 2004 Harris herself discovered an abnormality in her left breast and consulted with her internist, Dr. Fishburn. Dr. Fishburn ordered a diagnostic mammogram, which was interpreted by Hanson in late July of 2004. Hanson interpreted the July 2004 mammogram as showing a change, a palpable abnormality, from the exam done in January of 2004. Due to this abnormality Hanson performed an ultrasound of the left breast and determined the changed region was suspicious for malignancy. He recommended a core needle biopsy, which was performed on August 2, 2004. The results of the biopsy confirmed Harris had a malignancy in her left breast. Consequently, on August 12, 2004, Harris underwent a left breast mastectomy. She also underwent aggressive chemotherapy and radiation therapy after her surgery.

Expert:

William H. Rodgers, M.D., is a pathologist from the University of Maryland who testified as an expert for the defendants. Rodgers’ background includes both a Ph.D. in cell biology and embryology and an M.D. He performed extensive research programs in breast cancer fields and taught at Vanderbilt University. Rodgers held the position of Director of Anatomic Pathology at both Oregon Health and Sciences University and University of Maryland.

Rodgers’ involvement in breast cancer research included twenty years in the study of stromoepithelial interactions, which is the basic biology of breast cancer and other cancers involving how the cancer cells interact with normal tissue elements in the breast to allow tumors to form, and clinical research in cyto-pathology which has to do with the interpretation of breast biopsies and the interaction of radiology and pathology in mammography. He was not board certified in radiology, but he regularly viewed mammograms with radiologists as part of his practice of cyto-pathology.

Objection:

Over plaintiff’s objection that he was not a radiologist, Rodgers testified that it was his opinion Harris’s particular cancer would be invisible on x-ray and that it had been present for ten years prior to July of 2004. Harris argues that since Rodgers only examined a miniscule sampling of Harris’s cancerous tissue at a single instant in time, did not use the mammographically measured size of the mass determined to be a lymph node from 2002–2004, nor the ultrasound measurements of March and August 2004.

Considering that her cancer was infiltrating ductal cancer which is more easily detectable mammographically than lobular cancer, and because his opinions were prepared for use in litigation, Rodgers’ conclusions about the visibility and growth rate of Harris’s cancer constitutes novel scientific theories were actually junk science. Harris goes on to argue that Rodgers’ opinion was overreaching, mislead the jury and constituted expert opinion without a legitimate scientific foundation, which was admitted into evidence contrary to M.R. Evid. 702.

Legal Basis:

In Montana, an expert’s reliability is tested in three ways under Rule 702, M.R. Evid.: (1) whether the expert field is reliable, (2) whether the expert is qualified, and (3) whether the qualified expert reliably applied the reliable field to the facts.

Conclusion:

Dr. Rodgers is a pathologist. Pathology is a recognized field of scientific study. He is admittedly well qualified in that field. Specifically, the record reveals that Rodgers has a significant amount of knowledge and experience in the study of breast cancer, including how it develops, how it is detected and how it is treated. He also has significant experience in the use of mammography. The District Court acted within its discretion when it allowed Dr. Rodgers’ testimony over Ms. Harris’ objection of lack of foundation.

Dr. Rodgers’ testified about his professional credentials and his research activities into breast cancer, the pathology of breast cancer cells and whether certain tumors were or were not visible on radiologic studies. He based his opinion on explanation that tumor has many areas that have this arrangement of cells and stroma that is typical of the patterns that doctors can see lobular carcinomas which are recognized as being sometimes invisible by mammography.

The reason for it is that the density of the tissue, in this particular type of tumor is so similar to the density of normal fibrotic tissue in women that don’t have cancer, that you don’t see images radiologically that are typical of common breast cancer, which is what you’re looking for in mammography, which is a screening test. It’s not a test designed to identify tubular cancers or medullary cancers or special types of cancers, it’s designed to detect the most common type of cancer, which is infiltrating ductal carcinoma. He also expressed an opinion that the tumor was likely present in Ms. Harris’ breast for “at least ten years.” He also concluded that this is mainly because of the low-grade features of the tumor and the low growth rate.

The court concluded that Dr. Rodgers’ opinions were not novel scientific theories, and his testimony met the requirements of Rule 702, M.R.Evid. The expert field, pathology, is established as reliable, and Rodgers is qualified in that field. Therefore, whether Rodgers gathered and examined sufficient facts, and correctly applied the facts to reach his opinions, was a question for the jury to decide after cross-examination, presentation of contrary evidence, and application of the law. Based on the fact that the pathology expert testimony was deemed admissible, it was accepted that this patient’s breast cancer would have been invisible on x-ray and that it could have been present for ten years prior to the date of her mammogram.