Court: United States District Court for the District of OregonJurisdiction: FederalCase Name: McClellan v. I-Flow Corp.Citation: 710 F. Supp. 2d 1092
Facts
In this product liability case, the plaintiffs alleged that they had developed glenohumeral chondrolysis, the rapid and irreversible loss of cartilage in the shoulder joint, through the use of pain pumps. These are medical devices used to deliver local anesthetics during and after arthroscopic operations. Each of the plaintiffs claimed non-economic, economic, and punitive damages against the medical device manufacturer defendant. Some of the plaintiffs also demand damages for consortium loss. The plaintiffs retained an orthopedic surgery expert witness to support their case.
The Orthopedic Surgery Expert Witness
The orthopedic surgery expert witness was a board certified orthopedic surgeon. He graduated from Iowa University and completed his internship at the Harborview Medical Center in Seattle, Washington. He established an orthopedic surgery private practice after completing his orthopedic surgery residency. He was actively practicing occupational orthopedics with additional experience in performing clinical medical tests, independent consulting, and examining patient records.
Prior to his involvement in this case, the orthopedic surgery expert witness had initially observed shoulder chondrolysis while conducting independent medical examinations for workers’ compensation cases. Based on these examinations, his analysis of medical records involving patients with chondrolysis, and research of relevant medical literature, the expert concluded that the intra-articular use of pain pumps to administer local anesthetics can cause glenohumeral chondrolysis.
The orthopedic surgeon also based his opinions on a study conducted by another expert retained by the plaintiffs. This study determined that chondrolysis occurred in the majority of patients receiving intra-articular continuous anesthetic infusion in their shoulders through a pain pump. The study also observed that shoulders not treated with pain pumps had not resulted in any cases of chondrolysis. The study was bolstered by the Bradford Hill criteria: nine criteria used by researchers when assessing whether an interaction represents a genuine relationship between cause and effect. This includes temporal relation, interaction intensity, and dose-response relationship.
Discussion
The defendants claimed that the expert’s opinion was lacking peer review, general recognition in the scientific community, and empirical evidence from medical literature. In response, the court acknowledged that even though the scientific evidence only suggests some connection between continuous infusion and chondrolysis, the testimony of the plaintiffs’ expert could not be excluded. The court found sufficient support of correlation and how causation can be derived, citing Kennedy v. Collagen Corp.
The defendants also challenged the expert’s interpretation of the epidemiology study and the implementation of the Bradford Hill criteria. The expert had concluded that the two identified patient groups in the study were similar to another cohort. The expert then performed an epidemiological assessment using the data from the study. Defendants argued strenuously that the expert could not provide a credible epidemiological review based on his interpretation of the study.
The court agreed and ruled that the orthopedic surgery expert was not uniquely qualified to give an opinion based on the study’s application of the Bradford Hill criterion, as that research was epidemiological. Aside from his use of epidemiology and the Bradford Hill criterion, the defendant’s other arguments affected the weight and not the admissibility of the expert’s testimony.
Held
The motion to exclude the orthopedic surgery expert witness’s testimony was granted in part and denied in part.
About the author
Wendy Ketner, M.D.
Dr. Wendy Ketner is a distinguished medical professional with a comprehensive background in surgery and medical research. Currently serving as the Senior Vice President of Medical Affairs at the Expert Institute, she plays a pivotal role in overseeing the organization's most important client relationships. Dr. Ketner's extensive surgical training was completed at Mount Sinai Beth Israel, where she gained hands-on experience in various general surgery procedures, including hernia repairs, cholecystectomies, appendectomies, mastectomies for breast cancer, breast reconstruction, surgical oncology, vascular surgery, and colorectal surgery. She also provided care in the surgical intensive care unit.
Her research interests have focused on post-mastectomy reconstruction and the surgical treatment of gastric cancer, including co-authoring a textbook chapter on the subject. Additionally, she has contributed to research on the percutaneous delivery of stem cells following myocardial infarction.
Dr. Ketner's educational background includes a Bachelor's degree from Yale University in Latin American Studies and a Doctor of Medicine (M.D.) from SUNY Downstate College of Medicine. Moreover, she is a member of the Board of Advisors for Opollo Technologies, a fintech healthcare AI company, contributing her medical expertise to enhance healthcare technology solutions. Her role at Expert Institute involves leveraging her medical knowledge to provide insights into legal cases, underscoring her unique blend of medical and legal acumen.
