Pediatrics Expert Witness Testimony Limited Despite Thorough Medical Literature Review

Gerber Products Company sells several infant formula products. This case concerns Gerber Good Start Gentle (sometimes referred to below as “GSG”). Unlike most other infant formulas, which are made with “intact” cow’s milk protein, GSG uses cow’s milk protein that has been partially broken down (the technical term is “100% Whey-Protein Partially Hydrolyzed”).

Good Start Gentle was the first formula that the U.S. Food and Drug Administration permitted to make a “qualified health claim” — that is, a limited health claim. Specifically, in response to a petition from Gerber, the FDA advised that it would exercise its enforcement discretion not to challenge certain specified, modest claims about GSG. The claims related to atopic dermatitis, otherwise known as eczema. Atopic dermatitis is the most common allergic disease in infants.

The relief the FDA accorded Gerber was indeed very limited in scope. Gerber responded to the FDA’s permitting this qualified health claim by launching new advertising for GSG: it implemented packaging that stated, among other things, that GSG was the first and “only” formula “to reduce” an infant’s “risk of developing allergies.”

Plaintiffs asserted that Gerber falsely advertised that GSG (a) could reduce the risk of developing allergies and (b) had earned the FDA’s endorsement.

The Plaintiffs moved to exclude the testimony of Gerber’s proposed expert witness, Jose M. Saavedra.

Pediatrics Expert Witness

Jose M. Saavedra is Associate Professor of Pediatrics, at the Johns Hopkins University School of Medicine. He is a pediatrician, gastroenterologist, investigator, educator, and medical and scientific business executive. Saavedra carried out seminal and groundbreaking work in the area of probiotics in pediatrics, and has an extensive record of publications in nutrition, and in the area of intestinal microbiota, immunity, and preventive nutritional strategies. In the latter part of his career, he also worked as Medical Director for Nestlé Nutrition in North America, and until recently as Global Chief Medical Officer for Nestlé Nutrition, in Vevey, Switzerland. Saavedra is Chairman of the Board of the Nestlé Nutrition Institute. During that time, he expanded scientific innovation, and enhanced Nestlé’s educational and research activities focused on infant and childhood health.

He spearheaded a number of collaborative initiatives, many on education and dissemination of nutrition knowledge, focused on Early Childhood Nutrition Education, with pediatric and nutrition societies and organizations globally, including NASPGHAN, ESPGHAN, the American Academy of Pediatrics, the National Academies of Science in Washington DC., and UNESCO. He recently published a book entirely dedicated to the impact of early life nutrition on life-long health consequences, focusing on nutrition in the first 1,000 days.

Discussion by the Court

According to his report, Saavedra was expected to opine that “Gerber had, and has, a scientifically sound basis” to represent that “feeding [GSG] instead of intact cow milk protein formula (CMF) to infants with a family history of allergy in the first month of life can reduce the risk that said infants will develop allergies, particularly and specifically atopic dermatitis.” He was also expected to opine that “there was a significant and substantial body of scientific evidence to support the representations in the Challenged Advertisements.” These opinions, of course, were more forceful than the claims the FDA permitted Gerber to make on the same subject.

The Plaintiffs articulated multiple bases for excluding Saavedra’s opinion: alleging bias, stating that his opinions relied on inadequate data from studies that had been criticized for their methodology and data reporting, and asserting that his testimony would be both prejudicial and confusing.

Alleged Bias

The Plaintiffs argued that Saavedra should be disqualified because he has worked for Nestlé, Gerber’s parent company, for two decades, during which he endeavored to prove that “100% Whey-Protein Partially Hydrolyzed” formula reduces allergy risk.

The Court held that an expert witness’s employment with a party, however, “does not automatically disqualify him from rendering expert testimony in a case” involving that party. Gerber may seek to impeach Saavedra with his relationship with Gerber, but it did not warrant excluding his opinion.

Adequacy of Data, Methodology and Studies

The Plaintiffs argued that Saavedra did not conduct any of the research himself, and hence his expert opinions warranted exclusion.

Saavedra’s report is at base a literature review. He considered “twenty peer-reviewed publications of prospective, controlled clinical trials in 12 distinct healthy infant cohorts” — studies that assessed “the reduction in the incidence of allergy” when GSG or another partially hydrolyzed formula is used instead of traditional cow’s milk protein formula.

Saavedra called four of these studies “high quality,” in light of the “size of the study population, the rigor of randomization, rigor of feeding intervention, adequacy of definition of outcomes, diagnostic criteria and clinical diagnosis, follow up, and data integrity.” Three of these “high quality” studies expressly compared outcomes between infants fed GSG (or the equivalent) versus cow’s milk protein formulas without confounding variables. Those three studies all reported that the subjects receiving GSG or its equivalent saw statistically significant reductions in atopic dermatitis or other allergic diseases for at least a short time. Other studies that Saavedra reviewed showed no reduction in allergies from feeding GSG analogs instead of cow’s milk formula, or at least no statistically significant reduction.

Review of Medical Literature

A review of medical literature is a reliable methodology for Daubert purposes. It is axiomatic that experts can rely on hearsay. 

The Plaintiffs’ motion compelled the Court to determine whether Saavedra had “extrapolated his conclusions from the medical literature in a scientifically reliable fashion.”

Saavedra included findings published after Gerber disseminated the challenged advertisements in his literature review. For example, Saavedra justified his opinions in part because, since the challenged ads appeared, a study had reported that allergy-risk-reduction benefits from GSG could persist into adolescence. Moreover, he relied on a 2018 “meta-analysis” of data published through 2017 that “reported a 39% incidence reduction in all allergies with exclusive feeding of” GSG or the equivalent.

These studies were too recent to be relevant. Here, the operative question was whether Gerber’s challenged ads were misleading when made, not whether they would be misleading if made today.

The challenged ads all impliedly represented that Gerber believed them, and by extension, that Gerber “knew facts which justified” that belief.

Where only part of an expert’s testimony meets the Rule 702 standard of admissibility, the Court should limit the expert’s testimony, rather than “throw the good out with the bad.”

Beyond the temporal issue, the Plaintiffs leveled numerous criticisms of the studies on which Saavedra relied most heavily. The Plaintiffs argued that Saavedra’s studies were not “high quality” because multiple groups contended they had significant methodological and reporting issues.

The Court held that these criticisms did not demonstrate that Saavedra’s proffered opinions extrapolated from “studies that were simply inadequate to support the conclusions reached.” 

Dual Testimony

Plaintiffs argued that the Court should not permit Saavedra to testify both as an expert and as a fact witness. The Court may exclude such dual testimony if the danger of unfair prejudice substantially outweighs its probative value.

The Plaintiffs argued that Saavedra’s dual testimony was objectionable because Saavedra, in his deposition conceded  that he would not differentiate between fact and expert testimony at trial. Even assuming such a concession could change the Rule 403 calculus, Saavedra did not make it. When  Saavedra said he would not “differentiate” between his two capacities, he was discussing his right to compensation, not how he would testify. In any event, the Court is free to revisit this question as trial approaches.

Held

Plaintiffs’ motion to exclude the expert testimony of Jose Saavedra was denied in substantial part. The Court ordered Gerber to submit a revised expert report from Saavedra that limited his methodology to publications available at the time Plaintiff made particular claims in GSG advertising. 

Key Takeaways:

1. Bias Considerations: Employment history or affiliations with a party involved in the case do not automatically disqualify an expert from providing testimony. The opposing party may attempt to impeach the expert’s credibility based on such relationships, but it doesn’t necessarily warrant exclusion of their opinion.
2. Adequacy of Data and Methodology: Experts may rely on literature reviews to form their opinions. The Court may scrutinize the quality of studies cited by the expert, but if the expert adequately demonstrates the reliability of their methodology and the relevance of the data, their testimony may be admissible.
3. Review of Medical Literature: The Court may consider a review of medical literature a reliable methodology for expert testimony, provided it meets certain standards of reliability and relevance.
4. Dual Testimony: Courts may scrutinize the admissibility of dual testimony, where an expert acts both as an expert and a fact witness. The Court should weigh the potential for unfair prejudice against the probative value of such testimony. Additionally, experts should be clear about their roles and capacities in providing testimony to avoid confusion or potential objections.

Case Details:

Case Caption:	Hasemann Et Al V. Gerber Products Co.
Docket Number:	1:15cv2995
Court:	United States District Court, New York Eastern
Order Date:	March 25, 2024