Saturday, May 02, 2009

Hydroxycut Lawsuit from 2003

Found this from 2003, a press release from the then Missouri A.G.:


Attorney General Jay Nixon today filed a lawsuit in St. Louis against the maker of Hydroxycut, marketed to consumers as a safe and tested over-the-counter way to lose bodyfat rapidly. Hydroxycut is sold in several retail store chains, through television ads and on several Web sites.

Nixon said manufacturer MuscleTech Research and Development Inc., based in Mississauga, Ontario, did not disclose safety risks associated with Hydroxycut containing ephedra, and that claims that Hydroxycut was "clinically proven" to be a "fat-burner" were false.

"MuscleTech's own consultants had serious concerns about the safety of Hydroxycut, but the company continued to market the product," Nixon said. "The disclaimers and warnings on the bottle label are so small as to be useless to many consumers, so they would not be able to read that the disclaimers would preclude use of Hydroxycut by most of the adult population of the United States, including anyone who drinks coffee or cola containing caffeine."

The lawsuit claims that in order to obtain the research results it sought, MuscleTech would replace research subjects who had to drop out of the company's studies because they could no longer tolerate the Hydroxycut or because it became too dangerous for them to continue. In at least one study, Nixon said, those dropouts were concealed and not treated as an adverse effect of Hydroxycut. In another study cited in the lawsuit, one subject was rushed to the hospital due to a serious change in heartbeat. This incident was not treated as an adverse reaction in the final study.

From the Complaint:

JEREMIAH W. (JAY) NIXON,
Attorney General of the State of Missouri
Plaintiff

Vs

MUSCLETECH RESEARCH &
DEVELOPMENT, INC.,
Defendant.


1. Defendant MuscleTech Research and Development, Inc. (“MuscleTech”) has made and sold purported weight loss products under the name “Hydroxycut” containing ephedra alkaloids. Such products continue to be sold at least at the retail level. The product is not “clinically proven” to be a “fat-burner,” as MuscleTech claims. MuscleTech’s own study showed that Hydroxycut has no efficacy as compared to placebo with the possible exception of an appetite-suppressing effect. Moreover, the serious adverse health risks of Hydroxycut with ephedra – including death – were not adequately described or disclosed in marketing and labeling of the product. This conduct violated the Missouri Merchandising
Practices Act.

16. MuscleTech used deception, misrepresentation, unfair practice and/or the concealment, suppression, or omission of material fact in connection with the sale and advertisement of MuscleTech in regard to Hydroxycut’s safety – or lack of safety – including but not limited to the following:

a. MuscleTech’s web site and advertisements [b]did not adequately disclose safety risks associated with Hydroxycut.[b/] Some advertisements or material supplied by MuscleTech to magazine publishers specifically stated that Hydroxycut is effective in reducing bodyfat “without any unwanted side effects,” that it is “extremely safe” and that “studies” have shown the herbal equivalents to ephedrine and caffeine to be “very safe,” that potential users can be “reassured” that Hydroxycut is “safe,” and that even prescription drugs do not yield as much fat loss as the ingredients in Hydroxycut “with as little negative side effects.”

iii. In at least one instance, a subject was rushed to a hospital for atrial fibrillation, which is a precursor to ventricular fibrillation (a lethal arrythmia that results in sudden cardiac death). The study of which he was a subject did not treat this event as an adverse event for purposes of its statistical analysis.


However, the results of MuscleTech’s studies regarding safety did not accurately indicate the safety risks for most consumers of Hydroxycut because MuscleTech carefully screened all study subjects for health risks. This screening meant that there was no testing done on persons with physical and health characteristics of many consumers purchasing Hydroxycut over the counter (such as high blood pressure), making the results of such studies misleading for those consumers. Moreover, even after this screening was performed, MuscleTech’s studies were still tainted in at least the following respects:

c. MuscleTech has not disclosed in any of its marketing or advertising materials that its own consultants believe there are serious concerns as to the safety of Hydroxycut. At least one person whom MuscleTech hired as an expert in litigation stated under oath that he believes people should not take products with ephedra and caffeine, such as Hydroxycut, and that he cautions people not to take these “drugs.” Both he and another expert hired by MuscleTech testified separately that they would not recommend Hydroxycut to anyone.

17. a) Another study commissioned by MuscleTech showed that the subjects using a “new and improved” version of Hydroxycut showed no statistically significant weight loss that was greater than the placebo group, and even lost less weight than the placebo group. MuscleTech misrepresented the true results of this study by having one of its marketing persons submit a letter to the researcher suggesting that the researcher attribute the study’s result to the horrific events of 9-11-01. The researcher complied, without explaining why the events of 9-11-01 would affect the placebo group differently.

b) b. MuscleTech ran advertisements using deceptive “before” and “after” pictures. The pictures are deceptive in that, among other things:

i. The pictures use different lighting to convey an artificial fattening and slimming effect.

ii. The models in the pictures use different poses to convey an artificial fattening and slimming effect.

iii. The pictures and the accompanying copy do not fully disclose the extent of weight loss and muscle toning activities used by the models in conjunction with the use of Hydroxycut.

iv. MuscleTech has used one picture (in multiple advertisements) showing a “before” photograph of a woman with a much larger abdomen than in the after picture. A copy of one such advertisement is attached as Exhibit B. [b]The advertisements identify the woman as Marla Duncan and tout that she lost 35 pounds. At least some advertisements did not indicate that the “before” picture reflected post-pregnancy weight. Nor did the advertisements state that Marla Duncan has been a swimsuit and fitness model since at least 1983 (when she was 19 years old), has appeared on more than 100 magazine covers, and was Miss Fitness USA in 1990.

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