The opinion of the court was delivered by: DAVID N. HURD
This matter is before the court pursuant to defendant's motions in limine. Defendant seeks to preclude admission of plaintiff's proffered expert testimony as to causation, as well as Food and Drug Administration ("FDA") complaint records. Plaintiff filed responses in opposition to the motions, and defendant replied. Oral arguments were heard by the court.
Defendant National Health Products, Inc. ("National Health") made and distributed Hot Stuff "anabolic activator." The product is touted as a muscle-building amino acid supplement for body builders. Plaintiff ingested Hot Stuff according to the label directions for a period of approximately two months. Thereafter, plaintiff suffered a perforated diverticulum,
and underwent colon resection and colostomy surgery. Plaintiff claims that his diverticulosis and diverticulitis was caused by his ingestion of Hot Stuff, and proffers the testimony of two expert witnesses. Plaintiff further claims that National Health knew of the danger posed by its product, and proffers reports of complaints made to the FDA in support.
Hot Stuff contains Mexican wild yams, digestive enzymes, sterol complex, yohimbe bark, smilax and pyridoxine. The proffered testimony of plaintiff's two experts, Drs. Victor Herbert and Heidi Goldberg, will be discussed. The qualifications of the two experts are not at issue.
Dr. Herbert's expected testimony, derived from deposition testimony, is as follows. Dr. Herbert stated his opinion, with a reasonable degree of medical certainty, that plaintiff did not have diverticula prior to taking Hot Stuff. Hot Stuff contains digestive enzymes, which caused a weakening of plaintiff's intestinal wall. Diverticula were then formed by increased digestinal pressure acting on the weakened intestinal wall. Mexican wild yams, also found in Hot Stuff, contain Diosgenin, a pharmacologic steroid precursor of adrenocorticoids, which prevent inflammation from healing. The inflammation in this case was in the diverticula, and failure to heal led to the perforation of a diverticulum. Ginseng is also an ingredient of Hot Stuff. A variety of ginseng contains Diosgenin, which could also have had the same effect, of preventing healing, as did the Diosgenin found in Mexican wild yams.
Hot Stuff contains free amino acids, in particular lysine, which was declared not Generally Recognized as Safe (non-"GRAS") by the FDA in 1974. However, Dr. Herbert was not aware of any correlation between the free amino acids and diverticulosis or diverticulitis.
Dr. Herbert based his opinion that plaintiff did not have diverticulosis prior to taking Hot Stuff on plaintiff's age. Since plaintiff was in his twenties when he had diverticulitis, the progressive formation of diverticula with increasing age could not have been a factor in development of plaintiff's diverticulosis. Thus, Dr. Herbert ruled out the usual causes of diverticulosis and diverticulitis: constipation, low fiber diet, or genetic predisposition, usually not expressing itself until age fifty or older. Further, Dr. Herbert attributed plaintiff's diverticulosis and diverticulitis to the steroid component of Mexican wild yams and the digestive enzymes, based upon his review of plaintiff's medical records, review of several medical publications, including Goodman & Gillman, The Pharmacological Basis of Therapeutics, and the known pharmacologic actions of catabolic steroids and digestive enzymes.
Dr. Goldberg is also expected to testify that plaintiff's diverticulosis, diverticulitis, and diverticulum perforation was caused by Hot Stuff. She lists digestive enzymes, Mexican wild yam, yohimbe bark, Smilax, Sterol complex, ginseng, and pyridoxine as Hot Stuff ingredients which contributed to plaintiff's injury. Mexican wild yam, yohimbe bark, Smilax, ginseng, and Sterol complex contain catabolic steroids, which cause inflammation of the colon and weakness in the colonic musculature. There are documented cases of steroids producing ulcers and localized areas of inflammation in the colon. Continued use of steroids also prevents inflammation from healing.
The digestive enzymes, pancreatin, amylase, bromelain, and papain, made a two part contribution to plaintiff's injury. First, the digestive enzymes digest the colonic mucosa, weakening the intestinal wall. Second, the digestive enzymes reduce the amount of fat in the stool, thus decreasing the bulk of the stool. When the stool bulk is decreased, constipation results. The constipation then irritates the intestinal wall and causes increased intraluminal pressure. The increased intraluminal pressure leads to formation of diverticulum at areas where the intestinal wall is weakened.
Dr. Goldberg bases these findings upon research and clinical experience. Peer-reviewed literature regarding hyperamylasemia, or excessive amylase, document colonic motility disorders. In clinical practice, papain is used by physicians to dissolve bezoars.
It is ...