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Peters v. DCL Medical Laboratories, LLC

United States District Court, S.D. Ohio, Eastern Division

March 30, 2018

JOHN C. PETERS, JR., individually and as Administrator of the Estate of Amanda J. Peters, Deceased, Plaintiff,
v.
DCL MEDICAL LABORATORIES LLC, et al., Defendants.

          Elizabeth P. Deavers, Magistrate Judge.

          OPINION AND ORDER

          EDMUND A. SARGUS, JR. CHIEF UNITES STATES DISTRICT JUDGE.

         This matter is before the Court on three motions. Defendants DCL Medical Laboratories LLC, Laboratory Corporation of America Holdings (as successor of interest to DCL Medical Laboratories LLC) (collectively, "LabCorp"), and Cathy King (collectively "Defendants") have filed a Motion to Exclude Plaintiffs Expert (ECF No. 61) and a Motion for Summary Judgment (ECF No. 63). Plaintiff John C. Peters, Jr. has filed a Motion for Partial Summary Judgment (ECF No. 64). For the following reasons, Defendants' motions are DENIED, and Plaintiffs motion is GRANTED IN PART and DENIED IN PART.

         I. BACKGROUND

         A. Pap Tests

         This case stems from the purported misinterpretation of a Pap test, which is a screening tool for abnormalities to identify premalignant and malignant changes for cervical cancer. (Defs.' Omnibus Statement of Facts ("Statement of Facts") at 14, ECF No. 75-1.) A Pap test has two steps. (Id.) First, the ordering physician collects a sample of cells from the outer layer of the cervix. (Id.) And second, the sample is sent to a laboratory where a slide is prepared from the sample and examined under a microscope for cellular characteristics and abnormalities. (Id.)

         Pap slides are initially screened by a cytotechnologist. (Statement of Facts ¶ 14.) Many laboratories, including LabCorp's, utilize image-guided technology to assist cytotechnologists in their screening, (Mem. in Supp. of Mot. to Exclude at 4 n.l, ECF No. 61-1.) This automated technology pre-screens a slide using complex algorithms to identify certain fields of view for a cytotechnologist to review. (Id.) The cytotechnologist then reviews the slide using a microscope with an automated stage that walks her through the fields of view identified by the imager. (Id.)

         If the cytotechnologist determines that the slide is negative for signs of cellular abnormalities (normal), a report is sent back to the ordering physician and no further action is taken by the laboratory. (See Statement of Facts ¶ 14.) If, by contrast, the cytotechnologist sees any suspected cellular abnormalities on the slide, the cytotechnologist sends the slide to a cytopathologist (a physician) for further review. (Id.) The cytopathologist makes the final interpretation of the slide. (See Id. at 15.)

         Cytopathologists utilize the Bethesda System to classify abnormalities. (Statement of Facts ¶ 16.) The Bethesda System can be depicted as a pyramid, where each step up the pyramid represents an increase in the abnormal character of the observed cervical cells. (Id. at 17.) The Bethesda System classifications range from cells that are within normal limits (NIL) to cancer. (Id.) Between these two extremes are benign cellular changes; atypical cellular changes, including atypical squamous cells of undetermined significance (ASCUS) and atypical glandular cells (AGC); low-grade squamous intraepithelial lesions (LSIL); high-grade squamous intraepithelial lesions (HSIL); and carcinoma in situ (CIS). (Id.; Bethesda System Pyramid at PageID 763, ECF No. 16-14.) A finding of NIL or benign cellular changes is considered a normal result. (Statement of Facts ¶ 17.) Anything else is considered abnormal. (Id.)

         B. Factual Background

         On July 9, 2008, Amanda Peters went to her gynecologist for a Pap test. (Statement of Facts ¶ 1, ECF No. 75-1.) The gynecologist collected a sample from Mrs. Peters and then sent the sample to LabCorp for interpretation and diagnosis. (Id.) Defendant Cathy King, a LabCorp cytotechnologist, reviewed the sample (identified as slide L8-P-49705) for one minute and nineteen seconds and signed it out as "negative for intraepithelial lesion and malignancy" (NIL or normal). (Id. at 1-2.)

         Mrs, Peters had her next Pap test on October 26, 2009. (Statement of Facts ¶ 2.) The slide was again examined by LabCorp personnel, and, this time, the sample was interpreted as containing "atypical squamous cells of undetermined significance" (ASCUS). (Id. at 2-3.) On the same day as her Pap test, a nurse practitioner saw a mass on Mrs. Peters' cervix. (Id.)

         On December 7, 2009, Mrs. Peters saw an obstretrician/gynecologist, Dr. Danielle Martter. (Statement of Facts ¶ 3.) Dr. Martter visualized a 2 cm x 2 cm cervical mass on Mrs. Peters' cervix. (Id.) Several days later, Mrs. Peters underwent a colposcopic exam, and Dr. Martter biopsied the cervical mass. (Id.) Mrs. Peters was diagnosed as having cervical squamous cell carcinoma (cervical cancer) on December 21, 2009. (Id. at 3-4.)

         Following her diagnosis, Mrs. Peters was referred to a gynecologic oncologist who recommended a hysterectomy. (Id. at 4.) Mrs. Peters underwent a radical hysterectomy and pelvic and periaortic lymph node dissection on January 7, 2010. (Id.)

         Despite undergoing surgical, radiation, and chemotherapy treatments, Mrs. Peters developed metastatic cervical cancer. (Statement of Facts ¶ 4.) She died from metastatic cancer on August 21, 2014. (Id.)

         C. Procedural History

         On July 28, 2015, Plaintiff John C. Peters, Jr., husband of Mrs. Peters and administrator of her estate, filed this case, alleging that Defendants' misreading of the July 2008 Pap slide delayed Mrs. Peters being diagnosed with cervical cancer and that this delay caused her death. (Compl. at 2, ECF No. 1.) Plaintiff asserted claims of negligence, medical negligence, and wrongful death against Defendants LabCorp and Cathy King. (See Id. at 1-2; Notices of Voluntary Dismissal at 1, ECF Nos. 12, 13.) However, in response to Defendants' current Motion for Summary Judgment, Plaintiff withdrew his negligence and medical negligence claims. (Resp. to Defs.' Mot. for Summ. J. at 2, ECF No. 72.) Consequently, Plaintiffs only remaining claim is for wrongful death. (See id.)

         In their Motion to Exclude, Defendants challenge the expert testimony of Dr. Martha Bishop Pitman, a cytopathologist and one of Plaintiff s standard-of-care experts. (See Mem. in Supp. of Mot. to Exclude at 1, ECF No. 61-1; Statement of Facts ¶ 8, ECF No. 75-1.) Arguing that Dr. Pitman fails to present a reliable methodology for her expert opinions, Defendants have moved to exclude her opinions and to bar Plaintiff from offering her testimony. (Mem. in Supp. of Mot. to Exclude at 1, 19.) And because Plaintiff purportedly cannot succeed on his claims without Dr. Pitman's opinion and testimony, Defendants request summary judgment. (See Mem. in Supp. of Defs.' Mot. for Summ. J. at 1, ECF No. 63-1.)

         Plaintiff moves for summary judgment only on liability. (See Reply in Supp. of Pl.'s Mot. for Summ. J. at 1-2, ECF No. 73.) Plaintiff contends that Defendants' duty and subsequent breach of that duty is undisputed and that the only issue left to be determined at trial is the amount of damages Defendants owe. (See Pl.'s Mot. for Summ. J. at 1, 12-13, ECF No. 64.) The Court will first address Defendants' Motion to Exclude. It then considers the parties' cross-motions for summary judgment.

         II. MOTION TO EXCLUDE

         Federal Rule of Evidence 702 governs the testimony of expert witnesses. The Rule allows for a witness, "qualified as an expert by knowledge, skill, experience, training, or education, " to testify in the form of an opinion or otherwise if:

(a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods; and
(d) the expert has reliably applied the principles and methods to the facts of the case.

Fed. R. Evid. 702. This rule reflects the Supreme Court's decisions in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), and Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999). In re Scrap Metal Antitrust Litig., 527 F.3d 517, 528 (6th Cir. 2008).

         Under Daubert, Kumho, and Rule 702, the district court acts as the gatekeeper of expert testimony. In re Scrap Metal, 527 F.3d at 528-29. This role, however, is not intended to supplant the adversary system or the role of the jury. See Id. at 531-32. Arguments regarding the weight to be given any testimony or opinions of an expert witness are properly left to the jury. See id. "Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence." Id. at 532 (quoting Daubert, 509 U.S. at 596).

         To be found admissible, expert testimony must satisfy three requirements. First, the witness providing the testimony must be qualified by knowledge, skill, experience, training, or education. In re Scrap Metal, 527 F.3d at 529. Second, the testimony must be relevant, meaning that the testimony must help the trier of fact to understand the evidence or to determine a fact in issue. Id. The testimony, in other words, must have some "fit" with the issues to be resolved at trial. Greenwell v. Boatwright, 184 F.3d 492, 496 (6th Cir. 1999). And third, the testimony must be reliable. In re Scrap Metal, 527 F.3d at 529. In determining the reliability of expert testimony, the district court's role, and the offering party's responsibility, "is to make certain that an expert. .. employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field." Kumho, 526 U.S. at 152. Generally, the expert's opinions must reflect '"scientific knowledge'... derived by the scientific method." Daubert, 509 U.S. at 590. The test of reliability is, however, a flexible one. Kumho, 526 U.S. at 141. Any doubts regarding the admissibility of an expert's testimony should be resolved in favor of admissibility. Fed.R.Evid. 702 advisory committee's notes, 2000 amend. ("A review of the caselaw after Daubert shows that the rejection of expert testimony is the exception rather than the rule."); John v. Equine Servs., PSC, 233 F.3d 382, 388 (6th Cir. 2000) (stating that in Daubert "[t]he Court explained mat Rule 702 displays a 'liberal thrust' with the 'general approach of relaxing the traditional barriers to "opinion" testimony"' (quoting Daubert, 509 U.S. at 588)).

         The party proffering the expert testimony carries the burden of establishing, by a preponderance of the evidence, the testimony's admissibility. See Nelson v. Tenn. Gas Pipeline Co., 243 F, 3d 244, 251 (6th Cir. 2001).

         A. Dr. Pitman

         Dr. Pitman is the Director of Cytopathology at Massachusetts General Hospital (Mass General). (Statement of Facts ¶ 23, ECF No. 75-1.) She assumed the position in 2011. (Pitman Dep. at 15, ECF No. 61-8.) Since 1991, when Dr. Pitman became an Assistant Pathologist at Mass. General, she has reviewed tens of thousands of Pap slides. (See Id. at 48; Pitman CV at 2, ECF No. 61-6.)

         Dr. Pittman is also a Professor of Pathology at Harvard Medical School. (Pitman Dep. at 18-19; Pitman CV at 2.) She teaches doctors (residents) who come to Mass. General for their training in pathology or cytopathology. (Pitman Dep. at 19.) And through seminars, she instructs doctors around the world on pathology. (See id.)

         To reach her opinions in this case, Dr. Pitman reviewed an affidavit outlining the data records for Mrs. Peters' July 2008 Pap slide, and she evaluated the slide through three different reviews. (Pitman Report at 1-4, ECF No. 61-6.) Dr. Pitman evaluated the slide through a blinded review. (Id. at 1-2.) She analyzed the results of a blinded review of the slide conducted by seven cytotechnologists at Mass. General. (Id. at 2-3.) And she traveled to the LabCorp facility in West Virginia to perform a focused review of the slide using the image-guided technology that Ms. King used to screen the slide. (Id. at 3.)

         Ronald Arpin, a cytotechnologist at Mass. General, set up the blinded review for Dr. Pitman and the cytotechnologists. (Statement of Facts ¶ 25, 31.) The blinded review included ten slides: Mrs. Peters' July 2008 slide; two of Mrs. Peters' slides from a 2007 Pap test; and seven distractor slides. (Id. at 25.) Before conducting their blinded reviews, neither Dr. Pitman nor the cytotechnologists looked at Mrs. Peters' slides or knew how many of her slides they would be reviewing. (See Pitman Dep. 85-86; Pitman Report at 1.) When Dr. Pitman received a FedEx package from Plaintiffs counsel, she handed it unopened to Mr. Arpin and instructed him to choose distractor slides for a blinded review. (See Pitman Dep. at 85-88.)

         In designing the blinded review, Mr. Arpin reviewed the instructions Dr. Pitman provided him and followed the lead of how Nora Popp, a former co-worker, set up prior blinded reviews. (See Arpin Dep. at 111-12, 154, ECF No. 61-12.) Ms. Popp left examples of slides that she would include in blinded reviews. (Id. at 111-12.) Mr. Arpin, moreover, researched the American Society of Cytopathology (ASC) Guidelines for Review of Gyn Cytology Samples in the Context of Litigation or Potential Litigation (Guidelines), (id. at 155), which advise practitioners to analyze violations of the standard of care for analyzing Pap slides through a blinded review "that includes the contested case as one of a number of normal and abnormal GYN cytology samples representing a variety of disease states, " (Statement of Facts ¶ 22).

         Mr. Arpin obtained the distractor slides from Mass. General's archive. (Statement of Facts ¶ 29.) When choosing distractor slides for blinded reviews, Mr. Arpin chooses slides that a cytotechnologist would encounter on a normal screening day-that is, slides featuring a mix of diagnoses, which range from normal to invasive cancer. (See Arpin Dep. at 116-17.) Mr. Arpin also ensures that all of the distractor slides are the same preparation (ThinPrep or SurePath) as the litigation slides. (See Id. at 127.) And for the blinded review of Mrs. Peters' slides, Mr. Arpin chose distractor slides with normal and abnormal diagnoses, including two slides with an HSIL diagnosis, the same diagnosis that Dr. Pitman eventually assigned to Mrs. Peters' July 2008 slide. (Statement of Facts ¶ 31; Answer Key at PageID 633, ECF No. 61-8.)

         After selecting the distractor slides, Mr. Arpin created an answer key for the blinded review. (See Arpin Dep. at 132-33.) The answer key listed each slide's identification number, source (Mass General or LabCorp), and Bethesda System classification (assigned by the original reviewer). (See Statement of Facts ¶ 29.) To determine the distractor slides' original Bethesda classifications, Mr. Arpin looked up in Mass. General's computer system the cytology report associated with each slide. (See id.; Arpin Dep. at 112, 132-33.) Mr. Arpin provided this answer key to Dr. Pitman after she had conducted the blinded review. (Arpin Dep. at 141; Pitman Dep. at 96-97.)

         Dr. Pitman conducted her blinded review of the ten slides on May 13, 2013, over the course of 45 minutes. (Statement of Facts ¶ 32.) She determined that Mrs. Peters' My 2008 slide had abnormal cells, which she classified as high-grad squamous intraepithelial lesion (HSIL). (Id.)

         Between July 18, 2013, and August 5, 2013, the cytotechnologists reviewed the same set often slides prepared by Mr. Arpin. (See Statement of Facts ¶ 25, 33, 35.) They were asked to determine whether each slide was normal or abnormal. (Id.) So that the cytotechnologists would not know that they were conducting a blinded review for a legal matter, they were told that they were conducting a quality assessment. (See id.; Arpin Dep. at 158; Pitman Dep. at 165.) Six out of the seven cytotechnologists determined that Mrs. Peters' July 2008 slide contained abnormal cells. (Pitman Report at 2-3.)

         Following the blinded reviews, the slides were unblinded, and Dr. Pitman analyzed the results. (Pitman Report at 3.) In Dr. Pitman's opinion, any competent cytotechnologist would have identified the slide as containing abnormal cells and passed the ...


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