Products Liability Law Daily Dieter’s experts lack reliability, qualifications needed to show Medifast diet products caused hypothyroidism
Thursday, May 16, 2019

Dieter’s experts lack reliability, qualifications needed to show Medifast diet products caused hypothyroidism

By Pamela C. Maloney, J.D.

A user of dietary products failed to offer qualified, reliable expert testimony to support her product liability claims that her ingestion of Medifast’s soy-based dietary products caused her to develop hypothyroidism. The endocrinologist’s testimony was not supported by evidence and the nutritionist was not qualified to testify.

After striking the testimony of a dietary product user’s two experts because her endocrinologist’s testimony was not based on scientific evidence and her nutritionist was not qualified to testify as an expert, the U.S. District Court for the Eastern District of Pennsylvania granted Medifast’s motion for summary judgment on the user’s negligence and product liability claims. According to the court, without qualified, reliable expert testimony, the user could not prove that her ingestion of Medifast’s soy-based dietary products had caused her to develop hypothyroidism (Loverdi v. Medifast, Inc., May 15, 2019, Savage, T.).

A 58-year-old female with a family history of thyroid disease began a Medifast diet plan in March of 2016 in an effort to lose weight. The dietary program included Medifast calorie-restricted, meal substitution products. According to the dieter, she consumed no more than two to three Medifast products daily. In June of 2016, the dieter began to experience significant thyroid and abdominal issues and injuries for which she sought medical treatment in August of 2016 from a general practitioner and an endocrinologist. Several months later, the dieter had her first thyroid test, which showed a marked hypothyroidism and high thyroid antibody titers that were consistent with a diagnosis of Hashimoto’s or autoimmune thyroid disease. After taking thyroid medication, her thyroid function gradually returned to normal.

Claiming that her thyroid condition was linked to her ingestion of Medifast’s products, the dieter filed claims for negligence, products liability, breach of express and implied warranty, and misrepresentation against Medifast Inc. She alleged that the soy protein ingredient in Medifast’s meal plan caused her to develop hypothyroidism, and that her injuries were the result of Medifast’s unsafe dietary products that the other named defendants (Take Shape for Life, Inc., Jason Pharmaceuticals, Inc., and Optavia, LLC) knowingly had placed into the stream of commerce. She also alleged that Medifast failed to give proper warnings and/or to disclose the risk of injury, and that the company made misleading and false representations that its products were nutritious, healthy, and good for weight loss.

Experts. In support of her claims, the dieter proffered two experts: a medical doctor specializing in endocrinology and a nutritionist. Both opined that the Medifast products had increased her risk of harm and had contributed to her hypothyroid condition. Medifast moved to exclude these witnesses, arguing that their causation opinions were unreliable because they were not based on scientific evidence. It also challenged the qualifications of the nutritionist. Medifast further sought to exclude a third expert witness because he relied on the causation testimony of the endocrinologist to support his conclusions regarding the adequacy of Medifast’s warnings and labels.

Reliability of endocrinologist. The reliability requirement, as defined in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 589 (1993), ensures that an expert’s opinion is supported by appropriate validation, requiring that the process or technique used by the expert be based on the methods and procedures of science. Although the endocrinologist was fully qualified to testify as an expert, his testimony linking the dieter’s hypothyroidism to the ingestion of Medifast products was not based on reliable medical and scientific evidence. According to the endocrinologist, the dieter’s development of autoimmune-related hypothyroidism, coupled with her pre-existing risk factors, “fit” with the onset of her consumption of the soy protein-based Medifast products and provided a “tipping point” that led to her thyroid condition. Although the endocrinologist acknowledged that consumption of soy protein was generally safe, he went on to explain that the data supporting the safety of soy applied only in the context of healthy individuals. He postulated that it was less certain whether subsets of individuals who were not healthy, such as those predisposed to develop thyroid conditions, including autoimmune dysfunction, might be at an increased risk for developing overt hypothyroidism from soy exposure. However, he conceded that that there had been no specific study involving “at risk” individuals such as the dieter in this case, but merely stated that further study was needed. Thus, by his own admission, he had no scientific or medical evidence to support his opinion, nor could he cite any reliable data that supported a causal link between soy-based foods and hypothyroidism. Concluding that the endocrinologist’s testimony was unreliable, the court granted Medifast’s motion to exclude the testimony.

Qualifications of nutritionist. The court further agreed with Medifast’s argument that the dieter’s nutritionist was not qualified to offer an opinion on medical causation or to testify regarding the appropriate labeling of food products. The nutritionist was not a medical doctor and, therefore, was not qualified to make a medical diagnosis. In addition, she had no expertise in epidemiology and had admitted that she deferred to endocrinologists for information regarding the diagnosis and treatment of hypothyroidism. The nutritionist also admitted that she had no experience in reviewing product labels or websites to assess accuracy or compliance with regulations and that she had no expertise in determining an appropriate food product warning label. The court further found that there was no evidence that the nutritionist was qualified to render an opinion regarding the content or efficacy of warnings.

Reliability of nutritionist’s testimony. In addition, the court determined that the methodology used by the nutritionist to support her opinion linking soy to hypothyroidism was unreliable. Although the nutritionist testified that she could cite “massive research,” including 70 years of studies relating to “the dangers of soy to the thyroid,” she was unable to name a single study other than the one in her report, which involved only healthy individuals. Like the endocrinologist, the nutritionist conceded that soy generally was considered safe. According to the court, the whole of her testimony merely parroted the opinions offered by the endocrinologist and, therefore, her testimony was precluded as unreliable for the same reasons the court found the endocrinologist’s opinions unreliable.

Medical causation. Finally, without expert opinion showing that soy was linked to hypothyroidism, there was no basis for the dieter’s claim that Medifast had failed to provide proper warnings and/or to disclose the risk of injury associated with the use of its soy-based products. Therefore, the court did not need to address Medifast’s objection to testimony proffered by a medical professional who had opined that Medifast’s website and packaging failed to contain adequate soy-related warnings and that the website was deceptive and misleading to customers like the dieter in this case.

The case is Civil Action No. 18-2196.

Attorneys: Thomas F. Sacchetta (Sacchetta & Baldino) for Angela Loverdi and Charles Loverdi. Robert A. Limbacher (Goodell, DeVries, Leech & Dann LLP) for Medifast, Inc., Take Shape for Life, Inc., Jason Pharmaceuticals, Inc., and Optavia, LLC.

Companies: Medifast, Inc.; Take Shape for Life, Inc.; Jason Pharmaceuticals, Inc.

MainStory: TopStory ExpertEvidenceNews CausationNews WarningsNews DrugsNews PennsylvaniaNews

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