Hydroxycut Law Library

Adverse Event Reports

An adverse event is an adverse medical reaction or complication that may be attributed to the supplement. Dietary Supplement Firms are required to report adverse events within 15 days from the event. The reporting system has been updated and continues to be updated to provide for the most efficient means of reporting these events. The timely submission of the adverse event are critical to a timely public health response. The manufacturers of Hydroxycut waited more than two years to report the death linked to its product.

Contingency Fee

The fee is based upon a percentage that is only recovered in the event the case is successful. If the case is successful, the legal fees are an agreed upon percentage of the total recovery. If the case is not successful, the client is not charged a legal fee for the work.

Dietary Ingredient

Defined by Congress under DSEAH as one or any combination of (a vitamin, a mineral, an herb or other botanical, an amino acid, or a concentrate, metabolite, constituent or extract.

Dietary Supplements

Defined by Congress under DSHEA as a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. Dietary supplements, including Hydroxycut products, come in many forms: tablets, capsules, powders, energy bars, and liquids. Many supplements contain ingredients that have strong biological effects and affect people in different ways depending on the individual's health and biologic makeup.

Fraud

Fraud claims are based upon a manufacturer knowingly making a false representation about the product. If the manufacturer knew Hydroxycut increased the risk of liver damage and failed to inform the consumer or otherwise misrepresented the safety of the product, then a Fraud claim will arise.

Hydroxycut Regulatory History

Prior to 2004, Hydroxycut contained Ephedra or Ma Huang as an active ingredient. Ephedra was eliminated after 2004.

Hydroxycut Marketing

Hydroxycut was marketed as the "highest quality" and "most effective" weight loss product formulated by "medical professionals" through extensive research.

Negligence

Liability is based upon the manufacturer's failure to act as a reasonable and prudent manufacturer under the same or similar circumstances. In this case, it appears that the manufacturers of Hydroxycut may have been negligent in the testing, reporting, and labeling of the product.

New Dietary Ingredient

One that meets that definition of "dietary ingredient" but was not sold in the US as a dietary supplement prior to October 15, 1994.

Strict Liability

Liability is based not any particular fault but rather on the fact that the product is "defective". Strict liability law can vary from state to state but most states provide for causes of actions based upon design, manufacturing, or failure to warn. In general the standard is that the product was unreasonably dangerous for its intended use. The standard for "unreasonable" can be based upon a risk benefit analysis or on the availability and feasibility of an alternative design or warning.

The likely cause of action in the Hydroxycut litigation will be the failure to warn of the heightened risk of liver damage.

The Dietary Supplement Health and Education Act (DSHEA) of 1994

DSEHA created a framework for the safety and labeling of dietary supplements. The primary difference in the regulation between foods and drugs is that the manufacturer is not required to seek FDA approval prior to placing the products on the market. In other words, the FDA's role with supplements begins post market. The manufacturer is responsible for ensuring that the products are safe and effective for the purposes for which they are being marketed.

Wrongful Death

A cause of action arises where a product kills a consumer. The case is brought on behalf of the estate by an appointed representative, which is usually a close family member. The amount of damages available varies from state to state.

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The FDA reported 23 cases of liver damage due to hydroxycut (including 1 death). Candidates experiencing the following active symptoms of Liver Disease should contact us immediately.

  • Jaundice
  • Elevated Liver Enzymes
  • Brown Urine
  • Excessive Fatigue
  • Nausea/Vomiting
  • Stomach and Abdominal Pain
  • Light colored stools
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