Over a 32-month period a woman received five Pap smear tests. Her doctor took scrapings from her cervix, put them on a slide, and sent that slide to a laboratory for review to determine if there were abnormalities in the cells on the slide. The woman was not diagnosed with cervical cancer until eleven months after her last Pap smear, when she went to her doctor complaining of vaginal bleeding. By then, the cancer had metastasized in her lymph nodes.
The laboratory followed its usual method of reviewing samples when reviewing the woman’s slides. A cytotechnologist, who is not a doctor, but rather a laboratory professional trained to examine cells using microscopes and to recognize cells that appear abnormal, reviewed each Pap smear slide by examining it under a microscope. If any of the cells on the slide had precancerous abnormalities or other indications of cancer, the cytotechnologist would send the slide to a pathologist, a doctor specializing in the structural and functional manifestations of disease, for review. If the cytotechnologist did not see or recognize any abnormal cells, no pathologist reviewed the slide.
The woman and her husband sued the laboratory. The lawsuit alleged that the laboratory’s cytotechnologists who viewed slides of the woman's cells failed to properly identify the abnormal cells on those slides that indicated precancerous conditions or cancer. The complaint argued that those mistakes by the laboratory's employees delayed the diagnosis and treatment of her condition for several years until after her cancer had developed and metastasized.
The couple retained a board certified pathologist as an expert witness to testify about whether the laboratory's employees breached the standard of care for cytotechnologists when reviewing the woman's slides. The expert formed her opinion by reviewing the woman's slides at the laboratory's facility. She spent about 90 minutes examining the woman's Pap smear slides, using the same model of microscope that the laboratory's cytotechnologists used. She did not mix in slides from other patients, and she already knew that the woman had been diagnosed with cervical cancer.
The laboratory moved to exclude the testimony of the couple’s expert concerning the alleged breach of the cytotechnologists' standard of care contending that her review of the woman's Pap smear slides was tainted by an unreliable methodology. The laboratory also moved for summary judgment based on the resulting absence of evidence regarding the standard of care.
The United States District Court for the Northern District of Georgia granted the laboratory's motion to exclude the testimony of the couple’s expert and entered summary judgment for the laboratory. The court characterized her methodology as an ipse dixit assessment that could not be meaningfully reviewed by other experts. It insisted that she should have used a blinded review to evaluate the woman's slides, citing the litigation guidelines approved by the College of American Pathologists (CAP) and American Society of Cytopathology (ASC) as evidence that a blinded review was the standard set by the profession. The district court was troubled by the risk of bias in the expert's assessment, based on the general risk of review bias in non-blinded reviews, as well as her deposition statements about her “philosophical bent” toward patients later diagnosed with cancer. Finally, the district court observed that the expert's methodology did not adequately simulate a cytotechnologist's working conditions and circumstances, and that her role as a pathologist was materially different in function and scope from that of a cytotechnologist.
The Eleventh Circuit United States Court of Appeals reversed the district court’s ruling excluding the opinion of the couple’s expert on the standard of care for cytotechnologists, vacated the district court's grant of summary judgment to the laboratory, and remanded. The court held that the opinion of the couple's expert was based on widely accepted methodology and grounded in available physical evidence; the district court erred when it excluded the expert’s testimony on the ground that her methodology did not satisfy the generally accepted standards set by the profession based on the litigation guidelines created by the CAP and ASC; any shakiness in the expert's testimony went to the weight of her testimony, not its admissibility; and the expert's testimony was admissible as to the cytotechnologists' alleged breach of their standard of care.
The opinion of the couple's expert was based on widely accepted methodology and grounded in available physical evidence. The expert witness did not make an ipse dixit assessment of the laboratory cytotechnologists' review of patient's cells from Pap smears. She personally reviewed the woman's Pap smear slides that had been sent to the laboratory. The expert applied a well-established diagnostic system in which she was well versed, which was the same diagnostic system applied by the cytotechnologists. In addition to the diagnostic system, the expert used her extensive experience in the fields of cytopathology and cytotechnology to assess whether the cytotechnologists' failure to identify abnormal cells fell below the standard of care.
The district court erred when it excluded the expert’s testimony on the ground that her methodology did not satisfy the generally accepted standards set by the profession based on the litigation guidelines created by the CAP and ASC. The appellate court held that Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993) and Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 152, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999), which applied the Daubert rule to all expert testimony, did not allow courts to delegate to potential defendants, including a scientific or medical community, decisions about when and how they may be held civilly liable for their mistakes. The CAP’s and ASC’s litigation guidelines focus not on how cytotechnologists should go about their duties in examining slides, but instead on how courts should go about their duty to adjudicate claims against cytotechnologists and similar professionals. The court explained that the litigation guidelines were not objective, scientific findings, were not guidelines followed by laboratories to screen for pre-cancerous or cancerous cells, but were policy proposals to limit how the courts can find the members of the organizations liable for professional negligence when they are sued. The court noted that the members of the CAP and ASC have a substantial interest in making it more difficult for plaintiffs to sue based on alleged negligence in their Pap smear screening. The guidelines seek to skew the evidentiary rules in civil litigation against plaintiffs in at least two ways. First, the guidelines would skew the evidentiary rules against plaintiffs by imposing a requirement on expert testimony for a plaintiff that an expert witness must eliminate any potential “review bias” in her opinion. Bias in an expert witness's testimony is usually a credibility issue for the jury. Second, the guidelines would skew the evidentiary rules against plaintiffs by imposing a one-sided standard for reliability. Both sets of guidelines require a blinded review to establish a breach of the standard of care, but neither one requires defense experts to base their opinions on a blinded review. Moreover, the court reasoned that while Daubert did acknowledge that, where expert testimony was based on a scientific technique or theory, courts may consider the particular degree of acceptance it has in a relevant scientific community as an indicator of its reliability, the “acceptance” to which Daubert referred was the acceptance that the technique or theory had in the community's own field of practice when the science was being applied outside of the litigation context, not the scientific community's opinion about the standard or type of proof that should be required in litigation.
Any risk of bias in the expert's testimony went to the weight of her testimony, not its admissibility. The court noted that all of the bias concerns that the district court raised could have been presented to and considered by the jury. The district court supplanted the jury's fact-finding role when it excluded the expert’s testimony.
The expert's testimony was admissible as to the cytotechnologists' alleged breach of the standard of care. The district court erred in excluding the expert’s testimony on the ground that she had not stood in the shoes of the cytotechnologists because she had not recreated the conditions and circumstances cytotechnologists face because she did not look at a large number of slides without already knowing whether they contained cells that were abnormal. First, the court overlooked the expert's experience in training cytotechnologists and her deposition testimony explaining that when she reviews slides she does consider the conditions under which the cytotechnologists conduct their review. Second, Georgia courts have not interpreted their malpractice standard to require that expert witnesses “stand in the shoes of the defendant” as the district court said they must, nor does Rule 702. The court concluded that the couple’s witness was qualified to testify about the cytotechnologists' standard of care, her methodology was reliable, and her testimony would assist the trier of fact.
The Eleventh Circuit United States Court of Appeals reversed the district court’s ruling excluding the opinion of the couple’s expert on the standard of care for cytotechnologists, vacated the district court's grant of summary judgment to the laboratory, and remanded.
See: Adams v. Laboratory Corp. of America, 2014 WL 3724190, 25 Fla. L. Weekly Fed. C 197 (C.A.11 (Ga.), July 29, 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
See also Medical Law Perspectives, June 2013 Report: Independent Medical Evaluations: Legal Risks and Responsibilities