Oncology Expert May Opine on Product Labeling from Physician’s Perspective, Not as to FDA Compliance

ByWendy Ketner, M.D.

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Updated onFebruary 23, 2021

Oncology Expert May Opine on Product Labeling from Physician’s Perspective, Not as to FDA Compliance

In this product liability case, the court must determine whether the oncology expert witness’s testimony is admissible under the Daubert standard. Specifically, the drugmaker defendant asserts the expert’s opinions on alternate dosing schedules and product labeling oversteps his area of expertise. The court, however, notes that the expert did rely on empirical research studies per Daubert’s terms.

The expert, however, did err by making conclusions per FDA regulations for product labeling. The court explains that the expert may opine on product labeling as it pertains to his experience as a prescribing physician, but his opinions on FDA compliance fall outside his scope.

Facts

The estate of the deceased brought this product liability lawsuit against the defendant drugmaker, alleging its drugs caused the fatal injuries. The deceased had been diagnosed with multiple myeloma and their treating oncologist recommended the defendant’s bisphosphonate medications. At the time the drugs were administered, the oncologist was unaware of the risk of osteonecrosis of the jaw (bone tissue death caused by a lack of blood supply) associated with the medications. The deceased later developed osteonecrosis and eventually died of cancer. This prompted the lawsuit and the plaintiff retained an oncology expert witness to help support their case. The defendant brought a Daubert motion to exclude the expert’s testimony.

The Plaintiff’s Oncology Expert Witness

The oncology expert witness was a Professor of Medicine at the University of Minnesota Medical School, specializing in research on fundamental biological aspects of cancer and surgical radiation therapy. The expert had considerable experience as a peer reviewer and author published in scientific publications. The expert was also involved in an ongoing study using an antibody to prevent the growth of a rare bone tumor.

The expert opined that intravenous bisphosphonate could cause osteonecrosis whether one had cancer or not. He also opined that extending dosing intervals and pre-treatment preventative dentistry could reduce the occurrence of osteonecrosis when taking the defendant’s drugs. He further testified that the warnings and labeling on the drugs were misleading because they did not disclose the incidence rate of osteonecrosis as 5% or more as was indicated by 10 studies he consulted to form his opinions.

Discussion

The defendant sought to exclude the expert’s opinions pertaining to the drugs’ labeling, his opinions on alternative dosing and dentistry, and other opinions not set out in his report or during deposition.

On the product labeling issue, the court excluded the testimony regarding why warnings or labels were insufficient because they did not conform with FDA regulations. This did not mean, however, that the expert could not judge the adequacy of labeling and warnings from his perspective as a prescribing oncologist and practicing physician.

The court noted that arguments on the efficacy of alternate dosing and preventative dentistry (based on research studies) should affect the weight and not the admissibility of the expert’s views on these preventive steps. The court further noted that the opinions not present in the expert’s submitted report were inadmissible.

Held

The motion to exclude the oncology expert witness testimony was granted in part and denied in part.

Key Takeaways for Experts

This case highlights a few important lessons for experts. First, make sure every point in your report is data- or researched-backed. Second, conclusions outside your direct area of expertise stand to be excluded. Third, opinions not included in your report can also be subject to expulsion.

About the author

Wendy Ketner, M.D.

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.

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