Nutraceutical Facing Wrongful Death Suit over Kava

ORLANDO, Fla.A lawsuit filed in Circuit Court here alleges Nutraceutical Corp. and its Happy Camper dietary supplement were to blame for the death of an Orlando woman. The civil lawsuit claims Nutraceutical, Natural Balance Inc. (a company Nutraceutical acquired in late 2004), and retailer Chamberlin Natural Foods sold the dietary supplement, which contained kava, without appropriate warnings of possible liver toxicity, which led to the death of Laura Starks.

Filed in the Circuit Court for the Ninth Judicial Circuit, Orange County, the lawsuit claims Starks consumed Happy Camper as directed from late 2004 through October 2005; she was hospitalized for acute liver failure in mid-October and died in late November 2005 after undergoing a liver transplant. The suit alleges Starks was unaware of potential hepatotoxicity linked to kava usage; the Food and Drug Administration (FDA) issued a consumer warning to that effect in 2002, following bans in several European nations after reports linking kava intake to liver failure were reported. Among the counts in the suit are:

Defective manufacture of an unreasonably dangerous product with harmful side effects that outweighed any potential benefit;

Insufficient and misrepresenting label warnings that misled consumers;

Negligence in failing to test the product for safety and labeling it appropriately, particularly after safety concerns were made public; and

Culpable negligence and fraud.

FDA issued its consumer advisory in early 2002, noting the agency would continue to examine the situation and take further action if necessary. Shortly thereafter, the American Herbal Products Association (AHPA) expanded its existing kava labeling recommendationwhich suggests it not be used by persons under 18 or pregnant womento note: Caution: U.S. FDA advises that a potential risk of rare, but severe, liver injury may be associated with kava-containing dietary supplements. Ask a healthcare professional before use if you have or have had liver problems, frequently use alcoholic beverages, or are taking any medication. Stop use and see a doctor if you develop symptoms that may signal liver problems.

Marc Ullman, an industry attorney who is not involved with the case, noted in a wrongful death case, it is necessary to show causation; in this case, the plaintiff would be obliged to definitely link use of the kava product to the liver failure and death, to the exclusion of any other possible causes.

Dan Gerber, an Orlando-based attorney with Rumberger, Kirk & Caldwell, is representing Nutraceutical in the suit and stated: Nutraceutical has reviewed the complaint and intends to defend this lawsuit vigorously.