Kava Kava Sellers Sued for Wrongful Death.

Stephen Barrett, M.D.


The estate of Laura Starks has filed suit against Nutraceutical International Corporation of Park City, Utah, and Chamberlin Natural Foods, which in operates a retail outlet in Orlando, Florida. Kava-containing products have been associated with liver-related injuries including hepatitis, cirrhosis, and liver failure. In 2002, the FDA issued a consumer advisory and asked doctors who encounter patients with liver failure to determine whether they were kava users. The suit, filed by Attorney Joe Saunders of Piunellas Park, Florida, charges that in November 2005, Starks died of liver failure caused by ingesting a kava product called "Happy Camper" that had been purchased at Chamberlin. The product was and still is marketed with claims that it "helps reduce tension so you can relax" and "enhances your overall well-being." The suit (shown below) charges that the product was unreasonably dangerous and should have carried a warning label.


IN THE CIRCUIT COURT FOR THE NINTH JUDICIAL CIRCUIT
ORANGE COUNTY, FLORIDA
Civil Division
Case No. 06-CA-10911

ANTHONY STARKS, as personal
Representative of the estate of
LAURA STARKS, deceased,

Plaintiff,

vs.

NATURAL BALANCE, INC., a Colorado corporation,
NUTRACEUTICAL CORP., a Delaware corporation,
and CHAMBERLIN NATURAL FOODS, INC., a Florida
corporation, doing business as CHAMBERLIN’S
MARKET & CAFÉ,

Defendants.

___________________________________________________/

COMPLAINT

The Plaintiff, ANTHONY STARKS, as personal representative of the estate of LAURA STARKS, deceased, sues the Defendants, NATURAL BALANCE, INC., NUTRACEUTICAL CORP. and CHAMBERLIN NATURAL FOODS, INC., and alleges:

GENERAL ALLEGATIONS

1. This is an action for damages that exceed the sum of Fifteen Thousand ($15,000.00) Dollars, exclusive of interest and costs.

2. This action arises out of the wrongful death of LAURA STARKS, caused by her ingestion of an herbal supplement known as “Happy Camper” that was manufactured, marketed, packaged, labeled, distributed and/or sold by the Defendants.

3. At all times material to this cause, Plaintiff, ANTHONY STARKS, resided in Seminole County, Florida and was married to LAURA STARKS, who died on November 29, 2005. On December 7, 2006, ANTHONY STARKS was appointed personal representative of the estate of LAURA STARKES in Case No. 2006-CD-1963 in Seminole County, Florida. A copy of the Letters of Administration is attached hereto as Exhibit “A”.

4. At all relevant times, Defendant, NATURAL BALANCE, INC. (hereinafter called “NATURAL BALANCE”) was a Colorado corporation with its principal place of business in Castle Rock, Colorado.

5. Until at least May 14, 2004, Defendant, NATURAL BALANCE, developed, manufactured, packaged, labeled, marketed and sold an herbal supplement known as “Happy Camper” to retailers throughout the United States and in 21 countries worldwide, and sold and distributed “Happy Camper” to CHAMBERLIN NATURAL FOODS, INC. for retail distribution and sale in Orange County, Florida.

6. At all relevant times, Defendant, NUTRACEUTICAL CORP. (hereinafter called “NUTRACEUTICAL”), was a Delaware corporation with its principal place of business in Park City, Utah.

7. On or about May 14, 2004, Defendant, NUTRACEUTICAL, purchased substantially all of the operating assets of the Defendant, NATURAL BALANCE, including the product and brand name of the “Happy Camper” herbal supplement, and continued the manufacture, packaging, labeling and/or marketing and sales during all relevant times of “Happy Camper” to retailers throughout the United States and worldwide, and sold and distributed “Happy Camper” to CHAMBERLIN NATURAL FOODS, INC. for retail distribution and sale in Orange County, Florida.

8. At all relevant times, Defendant, CHAMBERLIN NATURAL FOODS, INC., was a Florida corporation with its principal place of business in Tulsa, Oklahoma and did business as CHAMBERLIN’S MARKET & CAFÉ, a retail store in Winter Park, Orange County, Florida, and marketed and sold health foods and herbal products, including the “Happy Camper” supplement to the general public in and around Orange County, Florida.

9. From 2004 through approximately October, 2005, Plaintiff, LAURA STARKES, purchased “Happy Camper” from CHAMBERLIN’S MARKET & CAFÉ in Winter Park, Orange County, Florida, and ingested those capsules as directed.

10. On or about October 10, 2005, after she had ingested “Happy Camper” from 2004 to October, 2005, LAURA STARKS was hospitalized for acute liver failure in Orlando, Florida. On October 15, 2005, she was transferred to Shands Hospital in Gainesville, Florida, where she underwent a liver transplant and died on November 29, 2005.

“Happy Camper” Background

11. The product “Happy Camper” is an herbal supplement that was initially manufactured and distributed by Defendant, NATURAL BALANCE, INC. and later by NUTRACEUTICAL CORP. It was and is, packaged and distributed in capsule form and contains, among other ingredients, the substance piper methysticum, more commonly known as kava kava or kava root. Kava kava is found in plants indigenous to islands in the South Pacific and is usually promoted for relaxation (e.g., to relieve stress, anxiety, tension, sleeplessness, and menopausal symptoms).

12. The Natural Balance website www.naturalbalance.com, represents “Happy Camper” supplement as “the good mood formula that brightens your day”, stating that it “helps reduce tension and anxiety so you can relax” and “enhances your overall well-being”. It further describes kava kava, one of the main ingredients of “Happy Camper”, describing it as a “relaxing herb from the South Pacific that produces a pleasant, cheerful, sociable feeling.”

13. The Natural Balance label on the bottle of “Happy Camper” capsules carries a warning: “Not for use by persons under the age of 18. If pregnant, nursing, taking a prescription drug or have a medical condition, consult a health care practitioner prior to use. Do not exceed recommended dose. Excessive consumption may impact ability to drive or operate heavy equipment. Not recommended for consumption with alcoholic beverages. Keep out of the reach of children. Store at room temperature.” There was and is no warning concerning hepatic or liver toxicity and no warning to consumers with existing hepatic or liver conditions.

14. At all relevant times, the herbal supplement, “Happy Camper”, was not regulated by the U. S. Food & Drug Administration.

15. As early as January, 2001, a British medical journal published an article containing a report of a 50-year old man who had taken kava kava capsules and suffered acute liver failure which required a liver transplant, and warned that kava has been associated with increased risk of potential hepatotoxicity, causing liver failure.

16. On December 19, 2001, the United States Food & Drug Administration (FDA) issued a Letter to Health Care Professionals seeking information on liver injury and kava products, stating that there were approximately 25 reports in Germany and Switzerland where “products containing herbal extracts of kava have been implicated in cases of serious liver toxicity”, at least one of which required a liver transplant, and that the regulatory authority in Switzerland has prohibited the sale of products containing kava extract.

17. On January 16, 2002, Health Canada issued a nationwide advisory to consumers not to use products containing kava kava, stating that “there have been at least 24 reports of liver toxicity associated with the use of kava products internationally, including one reported death and several cases which required liver transplantation.”

18. In December, 2002, the United Kingdom banned the import and sale of foods and herbal medicines containing kava kava, following data supplied to its Medicines and Healthcare Products Regulatory Authority (MHRA). That ban went into effect on January 13, 2003. Reinstatement of its import and sale was considered and denied on July, 27, 2006 by the UK’s Food Standards Agency (FSA) who agreed that “in rare cases, the use of unlicensed medicines containing kava kava could lead to liver damage,” and that the law banning kava kava was “the only means by which we can adequately protect public health.”

19. In 2002, Germany banned the sale of kava kava, due to reports of serious liver toxicity. That ban was lifted in 2005 under the condition that all kava-containing products be registered with the appropriate regulatory authorities.

20. France, Ireland and Portugal have withdrawn kava kava from sale, to varying degrees. Australia has advised against consumption while a risk assessment takes place, and New Zealand also initiated safety assessments although kava products remain on sale.

21. Despite the lack of regulation of “Happy Camper” by the U. S. Food & Drug Administration, on March 25, 2002, the U. S. Food & Drug Administration issued a Consumer Advisory warning that “Kava-containing products have been associated with liver-related injuries – including hepatitis, cirrhosis, and liver failure -- in over 25 reports of adverse events in other countries. Four patients required liver transplants. In the U.S., FDA has received a report of a previously healthy young female who required liver transplantation, as well as several reports of liver-related injuries.” This Advisory was issued after regulatory agencies in other countries, including Germany, Switzerland, France, Canada, and the United Kingdom, received reports of liver injury and deaths following the ingestion of kava kava supplements, and took actions which ranged from issuing similar warnings about kava kava supplements to the complete ban of kava kava supplements from the market.

COUNT I
(Strict Liability, Defective Manufacture and Design
by NATURAL BALANCE)

22. Plaintiff realleges and incorporates the allegations contained in Paragraphs 1 through 21 in Count I of this Complaint.

23. At all times relevant to this cause, Defendant, NATURAL BALANCE, INC., engaged in the business of manufacturing, packaging, labeling, marketing, distributing and selling the herbal supplement known as “Happy Camper” to retailers with the intent to have it sold to and ingested by ultimate consumers such as LAURA STARKS.

24. At all relevant times, the “Happy Camper” supplement was expected to reach, and did reach, consumers in the state of Florida, including Laura Starks, without substantial change in the condition in which it was sold.

25. At all relevant times, the “Happy Camper” supplement was defective and unreasonably dangerous at the time it was placed into the stream of commerce in that:

a) When placed in the stream of commerce, the product contained unreasonably dangerous design defects and was not reasonably safe as intended to be used, subjecting Laura Starks to an unreasonably high risk of irreversible liver damage and death which far exceeded the benefits of the product;

b) When placed in the stream of commerce, the product contained unreasonably dangerous manufacture defects and was not reasonably safe as intended to be used, subjecting Laura Starks to an unreasonably high risk of irreversible liver damage and death, with far exceeded the benefits of the product;

c) Prior to and after placing the product on the market, Defendant failed to test the product, or adequately test the product, for potentially harmful effects of kava on the liver;

d) Prior to and after placing the product on the market, Defendant failed to test the product, or adequately test the product, for potentially harmful effects of kava on consumers with prior or existing renal or liver conditions;

e) The product was manufactured, designed, packaged, labeled and marketed to be used in such a way that was known to the Defendant to cause harmful side effects which far outweighed any potential benefit.

f) Defendant continued to design and manufacture the product for use by the general public, including Mrs. Starks, long after Defendant had been made aware that kava kava had been associated with acute liver failure.

26. The product “Happy Camper” that was ingested by Mrs. Starks had not been materially altered or modified prior to her ingestion of the supplement.

27. Laura Starks was a foreseeable user of the product and ingested the product as directed by Defendant’s labeling for its intended purpose, i.e. relaxation and stress relief, and it was a foreseeable that she would ingest the supplement as directed and as Defendant would reasonably expect.

28. Had the “Happy Camper” product not been defective, Mrs. Starks would not have sustained acute liver failure and would not have died.

29. As a direct and proximate result of the defective condition of the supplement, Mrs. Starks ingested “Happy Camper” as directed from 2004 until approximately October, 2005 and suffered acute liver failure and died on November 29, 2005.

30. As a further proximate result of the defective condition of the supplement, Plaintiff, ANTHONY STARKS, has incurred medical and funeral expenses on behalf of Laura Starks; loss of the decedent’s support and services from the date of her liver failure until the time that she died; past and future loss of support and services from her date of death; loss of companionship and protection of the decedent; mental pain and suffering from the date the decedent was injured; and loss of prospective income of the decedent’s estate which would have been expected had she not died.

WHEREFORE, Plaintiff, ANTHONY STARKS, as personal representative of the estate of LAURA STARKS, deceased, demands judgment against Defendant, NATURAL BALANCE, INC. for damages, as well as all costs of this action and a trial by jury of all issues to be tried.

COUNT II
Strict Liability – Failure to Warn by
NATURAL BALANCE, INC.

31. Plaintiff realleges and incorporates the allegations contained in Paragraphs 1 through 21 in Count II of this Complaint.

32. The “Happy Camper” supplement that was ingested by Laura Starks was defective and unreasonably dangerous when it left the possession of the Defendant, NATURAL BALANCE, INC., in that:

a) The product contained insufficient warnings to alert consumers, including Mrs. Starks, of an unreasonably high risk of hepatic toxicity and acute liver failure and death.

b) Defendant’s advertisements and promotions of the product concerning its benefits were misleading to consumers in that there was a complete lack of warning as to its accompanying risks of hepatic injury or liver complications.

c) Even after Defendant knew or should have known of the significant risk of hepatic injury and acute liver failure associated with the product, Defendant failed to warn consumers of those risks and continued to aggressively promote and advertise the product.

d) Even after Defendant knew or should have known of prior reports of hepatic toxicity associated with the kava kava ingredient contained in the supplement, Defendant continued to aggressively promote and advertise the product with no warning concerning possible liver damage associated with kava kava, and no warning concerning the potential risk of liver failure to consumers who may have prior or existing renal or liver conditions.

33. The Defendant, as manufacturer of the “Happy Camper” supplement, is held to the level of knowledge of an expert in the field of that type of herbal supplement.

34. As an expert in the field, Defendant had a continuing duty to warn consumers of “Happy Camper” that the kava kava ingredient was associated with a risk or significant risk of hepatic toxicity.

35. Laura Starks purchased and consumer “Happy Camper’ for its intended purpose, i.e., stress relief.

36. At the time Mrs. Starks ingested the product, she did not have substantially the same knowledge as the Defendant about the risks of hepatic injury or liver failure associated with the kava kava ingredient because Defendant failed to provide adequate warnings of those risks to her.

37. Had Mrs. Starks been properly warned by Defendant of the risk of liver failure associated with the supplement, Mrs. Starks would not ingested the supplement and would not have sustained acute liver failure and died.

38. As a direct and proximate result of the Defendant’s failure to warn of the defective condition of the supplement, Mrs. Starks ingested “Happy Camper” as directed from 2004 until approximately October, 2005 and suffered acute liver failure and died on November 29, 2005.

39. As a further proximate result of Defendant’s failure to warn of the defective condition of the supplement, Plaintiff, ANTHONY STARKS, has incurred medical and funeral expenses on behalf of Laura Starks; loss of the decedent’s support and services from the date of her liver failure until the time that she died; past and future loss of support and services from her date of death; loss of companionship and protection of the decedent; mental pain and suffering from the date the decedent was injured; and loss of prospective income of the decedent’s estate which would have been expected had she not died.

WHEREFORE, Plaintiff, ANTHONY STARKS, as personal representative of the estate of LAURA STARKS, deceased, demands judgment against Defendant, NATURAL BALANCE, INC. for damages, as well as all costs of this action and a trial by jury of all issues to be tried.

COUNT III
(Negligence of NATURAL BALANCE)

40. Plaintiff realleges and incorporates the allegations contained in Paragraphs 1 through 21 in Count III of this Complaint.

41. Until at least May 14, 2004, Defendant, NATURAL BALANCE, INC., directly or indirectly, designed, manufactured, packaged, labeled, marketed, promoted, advertised, sold and/or distributed the “Happy Camper” herbal supplement to retail suppliers within the state of Florida, and specifically to CHAMBERLIN NATURAL FOODS, INC. d/b/a CHAMBERLIN’S MARKET & CAFÉ in Winter Park, Florida.

42. At all relevant times, Defendant owed a duty to the consuming public and to the decedent, LAURA STARKS, to exercise reasonable care in the design, manufacture, packaging, labeling, marketing, distribution and sales of the product.

43. Defendant negligently breached that duty to Laura Starks in that:

a.) Defendant designed, manufactured and sold the supplement that it knew or should have known created an unreasonably high risk of hepatic injury and/or acute liver failure and even death to consumers who ingested the product.

b.) Defendant failed and/or refused to include adequate warnings about the product that would alert retailers and ultimate consumers to the potential risks of liver failure associated with the ingredient kava kava contained within the product.

c.) Defendant failed to test, or adequately test, the product both before and after the it was placed on the market which, if properly performed, would have shown that the product posed an unreasonably high risk of adverse side effects, including, but not limited to, hepatic injury, acute liver failure and even death.

d.) Defendant failed to adequately warn consumers, including Laura Starks, that ingestion of the product was associated with an unreasonably high risk of hepatic injury and/or liver failure.

e.) Defendant failed or refused to adequately label the product sufficient to warn consumers, including Laura Starks, of the risk of liver injury associated with the use of the product.

f.) Defendant failed or refused to warn consumers, including Laura Starks, that the product had not been tested, or adequately tested, for adverse side affects associated with the ingestion of the product.

g.) Defendant failed or refused to warn consumers, including Laura Starks, that the kava kava ingredient in the product has been known to be associated with acute liver failure and even death.

h.) Defendant underplayed the significant risk that was known to Defendant of acute liver failure associated with the ingestion of the kava kava ingredient contained in the product to consumers and to Mrs. Starks in order to make a profit from its sales.

44. Defendant knew or should have known that the “Happy Camper” caused an unreasonably dangerous risk of serious adverse side effects of which Mrs. Starks would not be aware, but nevertheless advertised, marketed, sold and distributed the supplement knowing that there were safer methods and products for stress relief.

45. As a direct and proximate result of the negligence of Defendant, NATURAL BALANCE, INC., Mrs. Starks ingested “Happy Camper” as directed from 2004 until approximately October, 2005 and suffered acute liver failure and died on November 29, 2005.

46. As a further proximate result of Defendant’s negligence, Plaintiff, ANTHONY STARKS, has incurred medical and funeral expenses on behalf of Laura Starks; loss of the decedent’s support and services from the date of her liver failure until the time that she died; past and future loss of support and services from her date of death; loss of companionship and protection of the decedent; mental pain and suffering from the date the decedent was injured; and loss of prospective income of the decedent’s estate which would have been expected had she not died.

WHEREFORE, Plaintiff, ANTHONY STARKS, as personal representative of the estate of LAURA STARKS, deceased, demands judgment against Defendant, NATURAL BALANCE, INC. for damages, as well as all costs of this action and a trial by jury of all issues to be tried.

COUNT IV
(Negligent Misrepresentation
by NATURAL BALANCE)

47. Plaintiff realleges and incorporates the allegations contained in Paragraphs 1 through 21 in Count IV of this Complaint.

48. At all times material hereto, Defendant, NATURAL BALANCE, INC., directly or indirectly, designed, manufactured, packaged, labeled, promoted, marketed, advertised, distributed and/or sold the “Happy Camper” herbal supplement within the State of Florida.

49. At all relevant times, Defendant owed a duty to the public and to the decedent, LAURA STARKS, to accurately represent the safety and efficacy of the supplement.

50. Defendant negligently breached that duty to Mrs. Starks by misrepresenting the safety and efficacy of the product and by misrepresenting or omitting material information concerning the significant risk of hepatic injury and acute liver failure associated with the ingestion of the kava kava ingredient contained in the product.

51. Defendant’s misrepresentations were communicated over the internet to the general public and were marketed through the retail store from which the product was ultimately purchased by Mrs. Starks, with the intent that they reach the consuming public, including Mrs. Starks, and would cause her to purchase and ingest the “Happy Camper” supplement for stress relief.

52. Defendant’s misrepresentations were also communicated directly to Mrs. Starks through its advertising, labeling, package inserts and warnings on the supplement product itself.

53. Defendant made these misrepresentations concerning the significant risks of hepatic injury and liver failure caused by the product, and actively concealed that adverse information at a time when Defendant knew, or should have known, that the kava kava ingredient in the supplement had been associated with serious adverse effects upon the liver and that the risks were other than what Defendant had represented to the consuming public, including Mrs. Starks.

54. Plaintiff’s decedent, Mrs. Starks, justifiably relied upon and was induced by the misrepresentations of the Defendant to her detriment and demise.

55. As a direct and proximate result of the negligent misrepresentations of Defendant, NATURAL BALANCE, INC., Mrs. Starks ingested “Happy Camper” as directed from 2004 until approximately October, 2005 and suffered acute liver failure and died on November 29, 2005.

56. As a further proximate result of Defendant’s negligent misrepresentations, Plaintiff, ANTHONY STARKS, has incurred medical and funeral expenses on behalf of Laura Starks; loss of the decedent’s support and services from the date of her liver failure until the time that she died; past and future loss of support and services from her date of death; loss of companionship and protection of the decedent; mental pain and suffering from the date the decedent was injured; and loss of prospective income of the decedent’s estate which would have been expected had she not died.

WHEREFORE, Plaintiff, ANTHONY STARKS, as personal representative of the estate of LAURA STARKS, deceased, demands judgment against Defendant, NATURAL BALANCE, INC. for damages, as well as all costs of this action and a trial by jury of all issues to be tried.

COUNT V
(Strict Liability, Defective Manufacture and Design
by NUTRACEUTICAL CORP.)

57. Plaintiff realleges and incorporates the allegations contained in Paragraphs 1 through 21 in Count V of this Complaint.

58. From at least May 14, 2004 and all times relevant to this cause, Defendant, NUTRACEUTICAL CORP., engaged in the business of manufacturing, packaging, labeling, marketing, distributing and selling the herbal supplement known as “Happy Camper” to retailers with the intent to have it sold to and ingested by ultimate consumers such as LAURA STARKS.

59. At all relevant times, the “Happy Camper” supplement was expected to reach, and did reach, consumers in the state of Florida, including Laura Starks, without substantial change in the condition in which it was sold.

60. At all relevant times, the “Happy Camper” supplement was defective and unreasonably dangerous at the time it was placed into the stream of commerce in that:

a) When placed in the stream of commerce, the product contained unreasonably dangerous design defects and was not reasonably safe as intended to be used, subjecting Laura Starks to an unreasonably high risk of irreversible liver damage and death which far exceeded the benefits of the product;

b) When placed in the stream of commerce, the product contained unreasonably dangerous manufacture defects and was not reasonably safe as intended to be used, subjecting Laura Starks to an unreasonably high risk of irreversible liver damage and death, with far exceeded the benefits of the product;

c) Prior to and after placing the product on the market, Defendant failed to test the product, or adequately test the product, for potentially harmful effects of kava on the liver;

d) Prior to and after placing the product on the market, Defendant failed to test the product, or adequately test the product, for potentially harmful effects of kava on consumers with prior or existing renal or liver conditions;

e) The product was manufactured, designed, packaged, labeled and marketed to be used in such a way that was known to the Defendant to cause harmful side effects which far outweighed any potential benefit.

f) Defendant continued to design and manufacture the product for use by the general public, including Mrs. Starks, long after Defendant had been made aware that kava kava had been associated with acute liver failure.

61. The product “Happy Camper” that was ingested by Mrs. Starks had not been materially altered or modified prior to her ingestion of the supplement.

62. Laura Starks was a foreseeable user of the product and ingested the product as directed by Defendant’s labeling for its intended purpose, i.e. relaxation and stress relief, and it was a foreseeable that she would ingest the supplement as directed and as Defendant would reasonably expect.

63. Had the “Happy Camper” product not been defective, Mrs. Starks would not have sustained acute liver failure and would not have died.

64. As a direct and proximate result of the defective condition of the supplement, Mrs. Starks ingested “Happy Camper” as directed from 2004 until approximately October, 2005 and suffered acute liver failure and died on November 29, 2005.

65. As a further proximate result of the defective condition of the supplement, Plaintiff, ANTHONY STARKS, has incurred medical and funeral expenses on behalf of Laura Starks; loss of the decedent’s support and services from the date of her liver failure until the time that she died; past and future loss of support and services from her date of death; loss of companionship and protection of the decedent; mental pain and suffering from the date the decedent was injured; and loss of prospective income of the decedent’s estate which would have been expected had she not died.

WHEREFORE, Plaintiff, ANTHONY STARKS, as personal representative of the estate of LAURA STARKS, deceased, demands judgment against Defendant, NUTRACEUTICAL CORP., for damages, as well as all costs of this action and a trial by jury of all issues to be tried.

COUNT VI
(Strict Liability – Failure to Warn by
NUTRACEUTICAL CORP.)

66. Plaintiff realleges and incorporates the allegations contained in Paragraphs 1 through 21 in Count VI of this Complaint.

67. The “Happy Camper” supplement that was ingested by Laura Starks was defective and unreasonably dangerous when it left the possession of the Defendant, NUTRACEUTICAL CORP., in that:

a) The product contained insufficient warnings to alert consumers of an unreasonably high risk of hepatic toxicity and acute liver failure and death.

b) Defendant’s advertisements and promotions of the product concerning its benefits were misleading to consumers in that there was a complete lack of warnings as to its accompanying risks.

c) Even after Defendant knew or should have known of the significant risk of hepatic injury and acute liver failure associated with the product, Defendant failed to warn consumers of those risks and continued to aggressively promote and advertise the product.

d) Even after Defendant knew or should have known of prior reports of hepatic toxicity associated with the kava kava ingredient contained in the supplement, Defendant continued to aggressively promote and advertise the product with no warning concerning possible liver damage associated with kava kava.

e) Even after Defendant knew or should have known of prior reports of hepatic toxicity associated with the kava kava ingredient contained in the supplement, Defendant continued to aggressively promote and advertise the product with no warning as to possible liver damage to consumers who may have had existing hepatic or liver conditions prior to ingesting the supplement.

68. The Defendant, as manufacturer of the “Happy Camper” supplement, is held to the level of knowledge of an expert in the field of that type of herbal supplement.

69. As an expert in the field, Defendant had a continuing duty to warn consumers of “Happy Camper” that the kava kava ingredient was associated with a risk or significant risk of hepatic toxicity.

70. Laura Starks purchased and consumer “Happy Camper’ for its intended purpose, i.e., stress relief.

71. At the time Mrs. Starks ingested the product, she did not have substantially the same knowledge as the Defendant about the risks of hepatic injury or liver failure associated with the kava kava ingredient because Defendant failed to provide adequate warnings of those risks to her.

72. Had Mrs. Starks been properly warned by Defendant of the risk of liver failure associated with the supplement, Mrs. Starks would not ingested the supplement and would not have sustained acute liver failure and died.

73. As a direct and proximate result of the Defendant’s failure to warn of the defective condition of the supplement, Mrs. Starks ingested “Happy Camper” as directed from 2004 until approximately October, 2005 and suffered acute liver failure and died on November 29, 2005.

74. As a further proximate result of Defendant’s failure to warn of the defective condition of the supplement, Plaintiff, ANTHONY STARKS, has incurred medical and funeral expenses on behalf of Laura Starks; loss of the decedent’s support and services from the date of her liver failure until the time that she died; past and future loss of support and services from her date of death; loss of companionship and protection of the decedent; mental pain and suffering from the date the decedent was injured; and loss of prospective income of the decedent’s estate which would have been expected had she not died.

WHEREFORE, Plaintiff, ANTHONY STARKS, as personal representative of the estate of LAURA STARKS, deceased, demands judgment against Defendant, NUTRACEUTICAL CORP., for damages, as well as all costs of this action and a trial by jury of all issues to be tried.

COUNT VII
(Negligence of NUTRACEUTICAL CORP.)

75. Plaintiff realleges and incorporates the allegations contained in Paragraphs 1 through 21 in Count VII of this Complaint.

76. From at least May 14, 2004 and at all relevant times, Defendant, NUTRACEUTICAL CORP., directly or indirectly, designed, manufactured, packaged, labeled, marketed, promoted, advertised, sold and/or distributed the “Happy Camper” herbal supplement to retail suppliers within the state of Florida, and specifically to CHAMBERLIN NATURAL FOODS, INC. d/b/a CHAMBERLIN’S MARKET & CAFÉ in Winter Park, Florida.

77. At all relevant times, Defendant owed a duty to the consuming public and to the decedent, LAURA STARKS, to exercise reasonable care in the design, manufacture, packaging, labeling, marketing, distribution and sales of the product.

78. Defendant negligently breached that duty to Laura Starks in that:

a.) Defendant designed, manufactured and sold the supplement that it knew or should have known created an unreasonably high risk of hepatic injury and/or acute liver failure and even death to consumers who ingested the product.

c.) Defendant failed and/or refused to include adequate warnings about the product that would alert retailers and ultimate consumers to the potential risks of liver failure associated with the ingredient kava kava contained within the product.

i.) Defendant failed to test, or adequately test, the product both before and after the it was placed on the market which, if properly performed, would have shown that the product posed an unreasonably high risk of adverse side effects, including, but not limited to, hepatic injury, acute liver failure and even death.

j.) Defendant failed to adequately warn consumers, including Laura Starks, that ingestion of the product was associated with an unreasonably high risk of hepatic injury and/or liver failure.

k.) Defendant failed or refused to adequately label the product sufficient to warn consumers, including Laura Starks, of the risk of liver injury associated with the use of the product.

l.) Defendant failed or refused to warn consumers, including Laura Starks, that the product had not been tested, or adequately tested, for adverse side affects associated with the ingestion of the product.

m) Defendant failed or refused to warn consumers, including Laura Starks, that the kava kava ingredient in the product has been known to be associated with acute liver failure and even death.

n.) Defendant underplayed the significant risk that was known to Defendant of acute liver failure associated with the ingestion of the kava kava ingredient contained in the product to consumers and to Mrs. Starks in order to make a profit from its sales.

79. Defendant knew or should have known that the “Happy Camper” caused an unreasonably dangerous risk of serious adverse side effects of which Mrs. Starks would not be aware, but nevertheless advertised, marketed, sold and distributed the supplement knowing that there were safer methods and products for stress relief.

80. As a direct and proximate result of the negligence of Defendant, NUTRACEUTIAL CORP., Mrs. Starks ingested “Happy Camper” as directed from 2004 until approximately October, 2005 and suffered acute liver failure and died on November 29, 2005.

81. As a further proximate result of Defendant’s negligence, Plaintiff, ANTHONY STARKS, has incurred medical and funeral expenses on behalf of Laura Starks; loss of the decedent’s support and services from the date of her liver failure until the time that she died; past and future loss of support and services from her date of death; loss of companionship and protection of the decedent; mental pain and suffering from the date the decedent was injured; and loss of prospective income of the decedent’s estate which would have been expected had she not died.

WHEREFORE, Plaintiff, ANTHONY STARKS, as personal representative of the estate of LAURA STARKS, deceased, demands judgment against Defendant, NUTRACEUTICAL CORP., for damages, as well as all costs of this action and a trial by jury of all issues to be tried.

COUNT VIII
(Negligent Misrepresentation
by NUTRACEUTICAL CORP.)

82. Plaintiff realleges and incorporates the allegations contained in Paragraphs 1 through 21 in Count VIII of this Complaint.

83. From at least May 14, 2004 and at all relevant times, Defendant, NUTRACEUTICAL CORP., directly or indirectly, designed, manufactured, packaged, labeled, promoted, marketed, advertised, distributed and/or sold the “Happy Camper” herbal supplement within the State of Florida.

84. At all relevant times, Defendant owed a duty to the public and to the decedent, LAURA STARKS, to accurately represent the safety and efficacy of the supplement.

85. Defendant negligently breached that duty to Mrs. Starks by misrepresenting the safety and efficacy of the product and by misrepresenting or omitting material information concerning the significant risk of hepatic injury and acute liver failure associated with the ingestion of the kava kava ingredient contained in the product.

86. Defendant’s misrepresentations were communicated over the internet to the general public and were marketed through the retail store from which the product was ultimately purchased by Mrs. Starks, with the intent that they reach the consuming public, including Mrs. Starks, and would cause her to purchase and ingest the “Happy Camper” supplement for stress relief.

87. Defendant’s misrepresentations were also communicated directly to Mrs. Starks through its advertising, labeling, package inserts and warnings on the supplement product itself.

88. Defendant made these misrepresentations concerning the significant risks of hepatic injury and liver failure caused by the product, and actively concealed that adverse information at a time when Defendant knew, or should have known, that the kava kava ingredient in the supplement had been associated with serious adverse effects upon the liver and that the risks were other than what Defendant had represented to the consuming public, including Mrs. Starks.

89. Plaintiff’s decedent, Mrs. Starks, justifiably relied upon and was induced by the misrepresentations of the Defendant to her detriment and demise.

90. As a direct and proximate result of the negligent misrepresentations of Defendant, NUTRACEUTICAL CORP., Mrs. Starks ingested “Happy Camper” as directed from 2004 until approximately October, 2005 and suffered acute liver failure and died on November 29, 2005.

91. As a further proximate result of Defendant’s negligent misrepresentations, Plaintiff, ANTHONY STARKS, has incurred medical and funeral expenses on behalf of Laura Starks; loss of the decedent’s support and services from the date of her liver failure until the time that she died; past and future loss of support and services from her date of death; loss of companionship and protection of the decedent; mental pain and suffering from the date the decedent was injured; and loss of prospective income of the decedent’s estate which would have been expected had she not died.

WHEREFORE, Plaintiff, ANTHONY STARKS, as personal representative of the estate of LAURA STARKS, deceased, demands judgment against Defendant, NUTRACEUTICAL CORP., for damages, as well as all costs of this action and a trial by jury of all issues to be tried.

COUNT IX
(Negligence of CHAMBERLIN NATURAL FOODS)

92. Plaintiff realleges and incorporates the allegations contained in Paragraphs 1 through 21 in Count IX of this Complaint.

93. At all times relevant to this cause, Defendant, CHAMBERLIN NATURAL FOODS, INC. did business as CHAMBERLIN’S MARKET & CAFÉ in Winter Park, Florida and marketed, promoted, advertised and sold the “Happy Camper” herbal supplement to consumers in Orange County, Florida and to the decedent, LAURA STARKS.

94. At all relevant times, Defendant owed a duty to the consuming public and to Mrs. Starks to exercise reasonable care in the marketing and sales of the product.

95. Defendant negligently breached that duty to Laura Starks in that:

a.) Defendant advertised and sold the supplement that it knew or should have known contained kava kava and was associated with an unreasonably high risk of hepatic injury and/or acute liver failure and even death to consumers who ingested the product.

Defendant failed and/or refused to warn its consumers, including Mrs. Starks, that the supplement contained kava kava which was associated with a significant risk of acute liver failure and even death.

Defendant failed and/or refused to warn its consumers, including Mrs. Starks, that the supplement may be even more harmful to people with existing renal conditions due to the significant risk of acute liver failure posed by the kava kava ingredient contained in the supplement.

Defendant underplayed to consumers and to Mrs. Starks the significant risk that was known to Defendant of acute liver failure associated with the ingestion kava kava contained in the supplement in order to make a profit from its sales.

96. Defendant knew or should have known that the “Happy Camper” caused an unreasonably dangerous risk of serious adverse side effects of which Mrs. Starks would not be aware, but nevertheless advertised, marketed and sold the supplement to Mrs. Starks without disclosing those serious health risks.

97. As a direct and proximate result of the negligence of Defendant, CHAMBERLIN NATURAL FOODS, INC., Mrs. Starks purchased “Happy Camper” from Defendant and ingested it as directed from 2004 until approximately October, 2005 and suffered acute liver failure and died on November 29, 2005.

98. As a further proximate result of Defendant’s negligence, Plaintiff, ANTHONY STARKS, has incurred medical and funeral expenses on behalf of Laura Starks; loss of the decedent’s support and services from the date of her liver failure until the time that she died; past and future loss of support and services from her date of death; loss of companionship and protection of the decedent; mental pain and suffering from the date the decedent was injured; and loss of prospective income of the decedent’s estate which would have been expected had she not died.

WHEREFORE, Plaintiff, ANTHONY STARKS, as personal representative of the estate of LAURA STARKS, deceased, demands judgment against Defendant, CHAMBERLIN NATURAL FOODS, INC., for damages, as well as all costs of this action and a trial by jury of all issues to be tried.

COUNT X
(Culpable Negligence and Fraud
by NATURAL BALANCE, INC. and NUTRACEUTICAL CORP.)

99. Plaintiff realleges and incorporates the allegations contained in Paragraphs 1 through 21 in Count X of this Complaint.

100. From 2004 through approximately October, 2005, Laura Starks purchased and ingested the “Happy Camper” supplement that was manufactured, packaged, labeled, marketed, distributed and sold by either NATURAL BALANCE, INC. or NUTRACEUTICAL CORP.

101. During those times, Defendants, NATURAL BALANCE, INC., and/or NUTRACEUTICAL CORP. manufactured, packaged, labeled, marketed, promoted, advertised, distributed and sold, either directly or indirectly, the “Happy Camper” supplement to retailers in Orange County, Florida.

102. At all times material to this cause, Defendants, directly or indirectly, had actual knowledge that the supplement sold to Mrs. Starks was defective in that it contained kava kava, which was associated with life-threatening hepatic injury or acute liver failure and even death to people who consumed it as directed.

103. Despite Defendant's actual knowledge of hepatic injury and liver failure associated with kava kava and, despite the FDA warnings that were issued in 2002 and other regulatory actions worldwide concerning supplements that contained kava kava, Defendants acted with gross negligence and willful and wanton disregard of the safety of the general public and of Mrs. Starks, in that they knowingly and intentionally continued to manufacture, market, advertise and sell “Happy Camper” with no relevant warnings so as to maximize their sales and profits at the expense of the health and safety of the public and of Mrs. Starks.

104. Defendants’ culpable negligence includes, but is not limited to:

a) Failing or refusing to conduct adequate pre-market and post-market testing of the product;

b) Failing or refusing to test the product for impact upon the renal system and liver that would have, if properly and timely performed, shown that “Happy Camper” caused a significant risk of acute liver failure and even death.

c) Failing or refusing to test the supplement for hepatic injury, despite Defendants’ concerns that such testing might have shown significantly high rates of acute liver failure in consumers who ingested the supplement.

d) Failing or refusing to test the product for hepatic consequences as soon as the FDA Consumer Advisory concerning kava kava was issued in 2002.

e) Failing or refusing to warn retailers and consumers, including Mrs. Starks, that kava kava had been associated with acute liver failure;

f) Intentionally denying and/or downplaying and/or misrepresenting the fact that the ingestion of kava kava in capsule-form has been associated with a significantly high risk of hepatic injury and/or acute liver failure, despite the fact that Defendants were made aware of adverse event reports and FDA advisories long before Mrs. Starks began to take the supplement.

g) Intentionally failing and refusing to change the “Happy Camper” label to reflect any mention of hepatic injury or adverse affects on the liver associated with the ingestion of kava kava.

h) Engaging in a promotional campaign for “Happy Camper” that minimized the potentially serious hepatic findings by the FDA and embarking on a campaign that discounted reports of acute liver failure associated with kava kava, and by discounting the findings and concerns by the FDA as early as 2001.

i) Continuing to aggressively promote and vigorously defend the safety of “Happy Camper” and kava kava despite having received FDA warnings as well as reports and warnings by regulatory agencies in other countries, without first performing any medically acceptable tests or studies to support their contentions.

105. All of the above actions taken by the Defendants were intentional acts specifically directed to keep safety concerns about the supplement from decreasing the sales of “Happy Camper”.

106. If the representations and warnings concerning “Happy Camper” had been accurate and truthful, such representations and warnings would have dissuaded consumers, including Laura Starks, from purchasing or ingesting the supplement and Mrs. Starks would not have ingested the supplement had she known of its severe adverse side effects.

107. The aforementioned actions of Defendants, NATURAL BALANCE, INC. and NUTRACEUTICAL CORP., constituted knowing and intentional misconduct, and/or conduct undertaken with reckless, willful and wanton disregard for the safety of the public and of LAURA STARKS, and such conduct was at all times ratified by the Defendants.

108. Mrs. Starks relied upon the intentional and fraudulent misrepresentations of the Defendants concerning the safety of “Happy Camper” to Mrs. Starks’ detriment and demise.

109. As a direct and proximate result of the culpable acts of the Defendants, Mrs. Starks ingested “Happy Camper” as directed from 2004 until approximately October, 2005 and suffered acute liver failure and died on November 29, 2005.

110. As a further proximate result of Defendants’ culpable acts, Plaintiff, ANTHONY STARKS, has incurred medical and funeral expenses on behalf of Laura Starks; loss of the decedent’s support and services from the date of her liver failure until the time that she died; past and future loss of support and services from her date of death; loss of companionship and protection of the decedent; mental pain and suffering from the date the decedent was injured; and loss of prospective income of the decedent’s estate which would have been expected had she not died.

WHEREFORE, Plaintiff, ANTHONY STARKS, as personal representative of the estate of LAURA STARKS, deceased, demands judgment against Defendants, NATURAL BALANCE, INC. and NUTRACEUTICAL CORP., for damages, as well as all costs of this action and a trial by jury of all issues to be tried.

COUNT X
(Consortium Claim)

111. Plaintiff realleges and incorporates paragraphs 1 through 109 into Count XI of this Complaint.

112. At all relevant times, Plaintiff, ANTHONY STARKS, was the husband of LAURA STARKS, and, as a result of the injuries sustained by his wife which led to her demise as hereinabove alleged, ANTHONY STARKS, has lost the services, support, protection, companionship, affection and consortium of his wife, and will continue to lose said services, companionship, affection and consortium in the future.

113. In addition, as the decedent=s husband, ANTHONY STARKS, has been obligated to pay medical, funeral and estate expenses on behalf of his wife.

WHEREFORE, Plaintiff, ANTHONY STARKS, demands judgment for damages, costs and interest against the Defendants, NATURAL BALANCE, INC., NUTRACEUTICAL CORP. and CHAMBERLIN NATURAL FOODS, INC., a trial by jury and such other relief to which the Plaintiff may be justly entitled.

DATED this 19th day of December, 2006.

_____________________________
Joseph H. Saunders, Esquire
SAUNDERS & WALKER, P.A.
Post Office Box 1637
Pinellas Park, FL 33780-1637
(727) 579-4500 FAX: (727) 577-9696
FBN 341746 SPN 228977

Attorney for Plaintiff

This page was posted on January 3, 2007..

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