Plaintiff sued defendant for not providing adequate warning on their knee implant. Plaintiff hired an orthopedic surgery expert to provide testimony and the defendant filed a motion to exclude.
Facts: This case (Goldin v. Zimmer, Inc. et al – United States District Court – Northern District of Illinois – January 3rd, 2017) involves a knee implant called the NexGen Flex knee manufactured by the defendant (Zimmer). The plaintiff (Goldin) alleges that Zimmer failed to warn her that her excessive weight could cause her knee to fail. In order to prove her case, Goldin hired Dr. Sonny Bal (Orthopedic Surgery Expert Witness). Dr. Bal will opine that Goldin’s warning labels and instructions were not adequate and that Zimmer did not provide proper warnings about the risk to obese patients.
Zimmer has filed a motion to exclude the expert witness testimony of Dr. Bal. They argue that Dr. Bal is not qualified to offer an opinion on the sufficiency of the warning labels and that his opinions are not reliable.
Discussion: Zimmer argues that Dr. Bal did not receive formal education or training in the labeling of medical devices, has not presented or published on the topic, and has not drafted a warning for medical devices. In addition, Dr. Bal himself admitted that he did not know whether the NexGen Flex label violated any FDA regulations and also stated that he does not consider himself an expert on “warnings”.
The court disagreed with these arguments, stating that Dr. Bal will not be testifying about whether the warnings complained with FDA regulations or about the process of drafting warning labels. The subject matter at hand (how doctors would read the warnings and whether said warning would portray the risks to them) is within Dr. Bal’s qualifications and experience.
In addition, Zimmer also argues that Dr. Bal’s opinions be excluded because his opinions are not based on reliable methodology. They argue that Dr. Bal’s opinions are not based on any methodology, does not cite to any authority or accepted standards with regard to warning labels, and does not propose any alternative language.
The court again disagrees, stating that Dr. Bal’s proposed testimony os based on his experience as an orthopedic surgeon, which is an adequate bases for providing reliable expert witness testimony. Indeed, Dr. Bal does provide testimony about what the warning label should have said and if Zimmer had tested and found increased failure with patients with high BMI, the label should have reflected such. Also, any inadequacies in Dr. Bal’s opinion should be addressed on cross examination, not at the pre-trial stage.
In addition to the arguments above, Dr. Bal provides causation opinions regarding obesity and the relationship to the failure of the High Flexion. In addition, Zimmer argues that Dr. Bal’s exclusion of alternative causes of Goldin’s injury was not a proper differential diagnosis. The court again disagreed, stating that Dr. Bal did provide a sufficient grounds for each of the alternative causes that he considered.
The one argument that Zimmer provides, and that the court grants, is Dr. Bal’s opinions on the regulatory procedure Zimmer used to obtain FDA approval.
Conclusion: The motion to exclude the expert witness testimony of Dr. Bal is granted in part and dismissed in part.