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.
Defendants designated Dr. Janesh K. Gupta as a witness to assist their defense but Plaintiffs sought to exclude several of Gupta’s opinions, namely any opinion regarding: (1) Bulox’s medical condition; (2) Merlo’s medical condition; (3) the design and/or manufacture of Filshie Clips; (4) the adequacy of warnings promulgated with Filshie Clips; and (5) FDA regulations or how they apply to Filshie Clips.
Obstetrics and Gynecology Expert Witness
Dr. Janesh Gupta is an Honorary Professor of Obstetrics and Gynaecology at Birmingham Women’s and Children’s Hospital.
Gupta has published over 175 research papers in scientific journals, book chapters, reviews and books and over 100 lectures and presentations to learned societies in the fields of fetal medicine, benign gynaecology (including abnormal uterine bleeding, fibroids, endometriosis, endometrial hyperplasia), minimal access surgery, induction of labour and abortion. He has received grants from WellBeing of Women, Department of Health National Institute for Health Research (Health Technology Assessment), Medical Research Council and various industry partners.
Discussion by the Court
Defendants designated Gupta as a witness to assist their defense because he is “an experienced English OB/GYN who has used the Filshie Clip for decades, has both written and reviewed published literature on the Filshie Clip, specifically on Filshie Clip migration, and has since 2012 served as the independent medical consultant for Femcare Ltd.—reviewing complaints and assisting with risk reviews and other studies of the Filshie Clips.”
The Parties Resolved Several Issues Raised in the Motion
Plaintiffs argued that Gupta is unqualified to testify about: (1) the injuries sustained by Plaintiffs because he never treated or examined Plaintiffs and did not review their medical records; and (2) Defendants’ FDA compliance because he does not practice medicine in the United States and possesses no knowledge of the FDA regulations or manufacturing or developing a medical device. Plaintiffs continued that Gupta’s opinions are unreliable and unhelpful because he is not an FDA expert yet offers opinions regarding what is a “serious injury” and “reportable event” according to FDA standards, and he did not form his opinions according to objective independent methodology.
However, Defendants explained that they did not intend to offer several of the objected-to opinions, making them moot. First, “Gupta did not intend
to provide any specific testimony on Plaintiffs.” Second, Gupta provided no opinion on manufacturing or designing Filshie Clips, but rather he discussed how the design “physiologically accomplishes . . . female sterilization and result in migration,” and he also pointed out that Plaintiffs’ expert had no experience in designing medical devices. Based on the Court’s review, the above issues were denied as moot.
Third, Defendants have a separate FDA expert and did not intend to use Gupta as such—instead, Gupta discussed his own review of adverse event complaints as Defendants’ independent medical consultant.
Defendants clarified that “Gupta’s opinions . . . are really about his medical review of adverse event complaints in the context of FDA definitions.” Plaintiffs asserted that this clarification is insufficient because Gupta cannot offer the above testimony without also testifying about Defendants’ FDA compliance. But that is the exact same testimony that they stated that they intended to elicit from him. The Court held that this argument is insufficient for the exclusion of Gupta’s testimony.
Plaintiffs Failed to Carry their Burden To Exclude Gupta’s Testimony
Gupta May Testify About Reviewing Adverse Event Complaints
Plaintiffs argued that Gupta’s opinions regarding his review of reportable events are not backed by any independent methodology and therefore should be excluded. They argued that because Gupta lacked knowledge of the FDA and did not conduct independent research, he “relied only on his subjective interpretation of a definition of ‘serious injury’ provided to him by Femcare to make his determinations regarding serious injuries/reportable events,” which led to inconsistent findings. Plaintiffs also argued that Gupta rejected medical reports and made unfounded assumptions to discount patient reports of migration.
In his report, Gupta gave a detailed overview of his extensive medical experience and experience as a reviewer and of the applicable FDA regulations. Gupta first ascertained whether there was a serious injury in accordance to the regulatory body definitions and then determined whether there is a reasonable suggestion that the product may have caused the injury.
Gupta explained that that long-lasting chronic pain, the most common complaint with Filshie Clip migration, requires additional review due to the complexity of pain in the body, which for him, includes searching for additional physiological evidence in the medical history suggesting that the device caused or contributed to the reported problem. The Court held that Plaintiffs’ arguments are insufficient to exclude Gupta’s testimony as
unreliable. Plaintiffs’ arguments largely relate to the bases of Gupta’s review decisions, not the underlying methodology, and are therefore more suitable for cross examination.
Gupta May Testify About Filshie Clip Warnings
Plaintiffs contended that Gupta’s opinions that the Filshie Clip instructions for use (“IFU”) are based on accurate and reliable data is unreliable and unsupported because these opinions are “based on his own erroneous understanding of the language included in the documents and a rate of incidence (0.13%) provided to him by Defendants and not based on any peer-reviewed science or accepted medical principles.”
The parties disagreed on the underlying facts of Gupta’s opinion that the Filshie Clip IFUs are based on accurate and reliable data. Without deciding the correctness of Gupta’s opinion, the Court found that his opinion is reliable: Gupta has extensive experience with implanting Filshie Clips and reviewing the IFUs—his testimony is based on this experience.
Held
The Court denied Plaintiffs’ motion to limit Defendants’ fact and expert witness, Dr. Janesh K. Gupta’s testimony.
Key Takeaways:
- Unlike Plaintiffs’ contentions, Gupta has adequate knowledge of the applicable FDA regulations and has educated himself independently of Femcare’s provided material, citing to a wide body of literature in the field of chronic pelvic pain.
- Gupta has employed his education and experience as a clinical expert who has implanted Filshie Clips for decades and counseled countless patients on the procedure. He also employs his own research, writing, and review of literature in reviewing the warnings for Filshie Clips to come to a conclusion as to whether they adequately warn of clip migration.
Please refer to the blog previously published about this case:
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 27, 2025 |
