Defendants CooperSurgical, Inc., Femcare, Ltd., and Utah Medical Products, Inc. manufacture and distribute birth control devices called Filshie Clips.
Filshie Clips are 3-5 millimeters wide and are laparoscopically placed on the fallopian tubes. Plaintiffs are individuals who had tubal ligation surgery in 2009 and 2010.
Plaintiffs Giovanna Bulox and Lorena Ahiri Merlo are sisters. Bulox underwent a tubal ligation procedure, choosing Filshie clips on July 13, 2010. Merlo underwent a tubal ligation procedure through the use of Filshie clips on July 21, 2009. Several years later, both sisters allegedly began to experience discomfort and pain.
In 2019, doctors removed two migrated Filshie Clips from Bulox’s body, one in her intestinal wall. Plaintiff Merlo had the same pain several years after her surgery, and in 2020, radiology showed the Filshie Clips migrated in her body. An attempt to remove them laparoscopically was unsuccessful; Merlo still has displaced Filshie Clips in her body. Plaintiffs sued Defendants for: (1) design defect; (2) manufacturing defect; (3) failure to warn; (4) strict liability; (5) negligence; (6) violation of consumer protection laws; (7) gross negligence; and (8) exemplary damages.
Dr. Howard Sharp opined that the Filshie Clip was not the likely cause of Plaintiffs’ pain. Sharp was retained to “offer a differential diagnosis on the complex issue of the medical cause for Plaintiffs’ claimed injuries—in essence pain allegedly caused by a Filshie Clip that migrated.”
Plaintiffs argued that he should not be allowed to testify that factors other than migrated Filshie Clips were the cause of Plaintiffs’ pain because he has “openly acknowledged the absence of any alternative reason, evidence, or cause for the pain and subsequent injuries incurred by Plaintiffs,” and, therefore, they claim his opinion does not meet the standard for reliability.
Obstetrics and Gynecology Expert Witness
Dr. Howard Taylor Sharp is a tenured professor in the Department of Obstetrics and Gynecology at the University of Utah School of Medicine, where he has practiced for over 28 years. He currently serves as the Division Chief of General Obstetrics and Gynecology and Minimally Invasive Gynecological Surgery. Additionally, he is the Vice Chair for Clinical Activities in the department. He completed his residency in obstetrics and gynecology at the University of Utah in 1994, followed by a fellowship in minimally invasive gynecology at the Greater Baltimore Medical Center in Maryland in 1995.
Moreover, Sharp has research interests which include surgical complications, medical device efficacy and complications, and pelvic pain.
Discussion by the Court
Plaintiffs did not question Sharp’s qualifications as an expert, but rather
the reliability of his opinion.
Plaintiffs argued that because Sharp did not opine as to “what, other than Filshie Clip migration, caused Plaintiffs’ injuries,” his opinion is based on speculation and conjecture and is not tied directly to the evidence.
Basically, Plaintiffs contended that, by not suggesting a plausible alternative cause, Sharp’s opinion is unreliable, lacking a proper foundation, and could mislead the jury and invite speculation.
However, Sharp examined Plaintiffs’ medical histories and medical records, and reviewed Plaintiffs’ expert materials and materials related to clip migration, including clinical reports. Sharp utilized his years of specialized knowledge as a medical doctor, specifically as an obstetrician and gynecologist familiar with Filshie Clips and human physiology, as the basis of his opinion. The Court held that Sharp satisfies the requirements
of Rule 702 and Daubert.
Regardless of whether Sharp’s opinion is correct or not, he has sufficiently articulated a basis for his opinion. That he did not physically examine both Plaintiffs is insufficient to show that his opinion should be excluded as unreliable.
The Court added that Sharp did provide alternative causes, namely, lengthy medical histories from both Plaintiffs containing other potential causes and in Bulox’s case, persistent complaints of pain before clip placement and after removal. The Court held that Plaintiffs’ complained-of deficiencies addressed Sharp’s credibility and not the reliability of his testimony.
Held
The Court denied Plaintiffs’ motion to exclude Dr. Howard Taylor Sharp’s opinion.
Key Takeaway:
Plaintiffs’ motion contains objections to the weight and not admissibility of Sharp’s testimony, which are objections best handled in vigorous cross-examination.
While Plaintiffs contended that Sharp’s opinion could mislead the jury and invite speculation by not suggesting a plausible alternative cause, the Court observed that Sharp examined Plaintiffs’ medical histories and medical records, and reviewed Plaintiffs’ expert materials and materials related to clip migration, including clinical reports. Moreover, Sharp did provide alternative causes, namely, lengthy medical histories from both Plaintiffs containing other potential causes and in Bulox’s case, persistent complaints of pain before clip placement and after removal.
Case Details:
| Case Caption: | Bulox Et Al V. Coopersurgical, Inc. Et Al |
| Docket Number: | 4:21cv2320 |
| Court: | United States District Court, Texas Southern |
| Order Date: | February 26, 2025 |
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