A Pennsylvania plaintiff is suing Penn Herb Co., claiming that the company's Gluco-Ease plus supplement caused cholestatic hepatitis and liver disease.
Isaac Shaw, of Philadelphia, blames Uva Ursi, or bearberry, leaves for his illness. According to the suit, Uva Ursi is “listed on the FDA Poisonous Plant Database” and “contains Hydroquinone, a chemical which is known to be toxic and and a cause of serious liver damage.”
The Gluco-Ease bottle “lists no warnings whatsoever regarding the toxicity of the product or the potential for serious liver problems,” according to the complaint. Rather, Shaw says, “the Gluco-Ease Plus bottle instructions suggest consumption of three to six 525 mg. pills per day, for an unlimited period of time, to 'maintain healthy blood sugar levels and join lot's [sic] of people who are living healthy lives.'”
Suit: Penn Herb received FDA warning
Further, the suit says that the Food and Drug Administration (FDA) issued a formal “Warning Letter” to Penn Herb in October 2005, telling the company that it was violating federal law “by suggesting that Gluco-Ease Plus, and other Penn Herb products were intended for use in the cure, mitigation, treatment or prevention of disease.” The letter was addressed to Penn Herb and its CEO, Ronald Betz, the suit says.
According to the suit, Penn Herb responded to the letter by “merely re-word[ing] the marketing literature to exclude the words diabetes and insulin,” rather than having the drug evaluated by the FDA. And in spite of the letter, the suit says, Penn Herb “continues to violate [federal law] by advertising and marketing their untested and dangerous product to regulate blood sugar abnormalities.”
Diabetic plaintiff
Shaw, the plaintiff, says he started taking Gluco-Ease in March 2009 to try and manage his diabetes. After taking a total of around 70 pills, Shaw says he “began to experience itchiness of his skin all over his body which eventually got so intense that it required [him] to seek medical attention,” resulting in an emergency room trip and eventually a period of inpatient care. A liver biopsy showed that Shaw had “drug-induced hepatitis” as a result of taking the supplement, according to the suit.
Penn Herb's Website, which lists Gluco-Ease under the “sugar balance” category, contains an all-capitals alert warning diabetics to “use only under a physician's supervision.”
Shaw's complaint, filed in the Court of Common Pleas in Philadelphia County, alleges negligence, strict liability, and breach of implied warranty. It demands compensatory and special damages in excess of $50,000 and unspecified equitable relief.
