The following Phospho-Soda lawsuit gives a good amount of background information about the product, about its recall, and about the problems it can cause. For example:
25. On December 11, 2008 the FDA responded to Fleet's June 2003 Citizen Petition seeking formal approval of doses ranging from 2 x 30mL to 2 x 45mL in 10 to 12 hours of FPS as a bowel cleanser prior to colonoscopy or other medical procedures. The FDA soundly rejected Fleet's petition. The FDA also stated that “[a]lthough the true incidence of acute phosphate nephropathy is unknown, it may occur in up to 1 in 1000 patients who receive OSP products and is probably under-recognized.” Additionally, the FDA explained that acute phosphate nephropathy can occur from ingesting oral sodium phosphate products even “in patients with no pre-existing health factors that would have put them at risk for developing kidney injury.” The FDA further stated that the product's warnings are currently inadequate; doctors and patients are not fully informed about the risks and inherent dangers of Phospho-soda, including acute phosphate nephropathy and death, and consequently the FDA revoked Fleet's OTC status for Phospho-soda when used as a bowel cleanser. Specifically, the FDA “concluded that the current labeling of OSP products does not adequately warn healthcare providers and patients about this serious event [acute phosphate nephropathy].” The FDA also required increased warnings for any oral sodium phosphate product sold as a bowel cleanser, including black-box warnings that Fleet previously refused to include on its Product packaging.
26. As of December 15, 2008, Fleet continued to actively maintain information located on its website (www.fleetlabs.com) promoting 2 x 45mL of Phospho-soda separated by 6 to 12 hours, and claiming that said dosing regimen is “safe” in patients without contraindications. As of the date of this complaint, Fleet maintains a “Q&A” document on its website stating that there is “nothing” wrong with the Product.
I’m always extremely skeptical when a company recalls a product and then claims there was nothing wrong with the product… especially when they haven’t returned the product to market.
PLAINTIFFS BARBARA I. CAYO, DOUGLAS D. CROWTHER, DOROTHY M. WILLCOX AND PATSY WYANT for their Complaint against Defendants, state and allege as follows:
JURISDICTION AND VENUE
1. This action is a civil action of which this Court has original jurisdiction under 28 U.S.C. § 1332, in that it is a civil action between citizens of different states and the matter in controversy exceeds the sum of $75,000, exclusive of interests and costs. Defendant C.B. Fleet Company, Inc. (“Fleet”) is a citizen of the State of Virginia, with its corporate headquarters located in Lynchburg, Virginia. Plaintiff Barbara I. Cayo (“Cayo”) is a citizen of the state of California. Plaintiff Douglas D. Crowther (“Crowther”) is a citizen of the state of California. Plaintiff Dorothy M. Willcox (“Willcox”) is a citizen of the state of California. Plaintiff Patsy Wyant (“Wyant”) is a citizen of the state of California. Plaintiffs, individually, each claim damages in excess of $75,000, exclusive of interests and costs.
2. Venue is proper in this judicial district pursuant to 28 U.S.C. § 1391 (a & c) because the events giving rise to the claims occurred within the District and because defendant Fleet conducts business within the District, and has engaged in, and continues to engage in, acts of selling and promoting goods and products to consumers in the District.
3. Jurisdiction for Plaintiffs' cause of action for violation of California's statutory unfair competition law and false advertising claim under Business and Professions Code §§ 17200, 17500 is proper under 28 U.S.C. § 1367(a) because the claims result from the same common nucleus of operative facts.
PARTIES AND COMMON FACTUAL ALLEGATIONS
4. Plaintiff Cayo is a resident of Riverside County and is a citizen of the State of California.
5. Plaintiff Crowther is a resident of Contra Costa County and is a citizen of the State of California.
6. Plaintiff Willcox is a resident of Kern County and is a citizen of the State of California.
7. Plaintiff Wyant is a resident of Los Angeles County and is a citizen of the State of California.
8. Defendant C.B. Fleet Company, Inc. is a citizen of the State of Virginia, with its corporate headquarters located in Lynchburg, Virginia.
9. The true names and capacities, whether individual, corporate, partnership, associate or otherwise, of Defendants DOES 1 through 10 inclusive, are presently unknown to Plaintiffs, who therefore sue these defendants by fictitious names. Plaintiffs are informed and believe and thereupon allege that each of the fictitiously named defendants is responsible in some manner for the occurrences alleged herein and Plaintiffs' damages were proximately caused by such Defendant's acts or omissions. Each reference in this complaint to “Defendant(s),” “Defendants,” or a specifically named Defendant shall also refer to all defendants sued under fictitious names. Plaintiffs will amend the complaint to assert the true names and capacities of fictitiously named defendants when such has been ascertained.
10. Fleet and DOES 1 through 10 (collectively “Defendants”) at all times mentioned herein where the agents, employees, associates, partners, joint venturers, shareholders, owners and/or representatives of each other and, in engaging in the acts alleged herein, where acting within the course and scope of such agency and with the consent of the other Defendants.
11. At all times relevant, Fleet manufactured, promoted, distributed and sold for profit an over-the-counter (OTC) product known as Fleet Phospho-soda (hereafter “Phospho-soda” or the “Product”), an oral sodium phosphate (OSP) product. Fleet promoted, distributed, and sold Phospho-soda as a “laxative, for the relief of occasional constipation” and “purgative, for use as part of a bowel cleansing regimen in preparing for surgery, x-ray or endoscopic examination.” Fleet commenced marketing the Product as a purgative in 1992 to be used in two 45mL doses separated by some duration.
12. Plaintiffs in this action are individuals who have sustained acute renal failure by precisely the same mechanism: the ingestion of the Product as a bowel cleanser prior to a colonoscopy or endoscopy.
13. The Product ingested by each Plaintiff and manufactured, distributed, supplied or sold by Fleet is defective for identical reasons: the dose recommended by Fleet exceeds a safe dose.
14. The allegations of each cause of action against Fleet arise from a common issue of law: that a reasonable consumer would not expect the Product to cause acute renal failure.
15. All of Plaintiffs' claims arise out of a similar series of occurrences: the ingestion of the Product as a bowel cleanser prior to a colonoscopy.
16. These cases involve the same series of transactions or occurrences because they all involve the course of conduct taken by Fleet after it became apparent that Phospho-soda was harmful to people if ingested in an amount not determined to be safe.
17. Each Plaintiff claims damages for acute rental failure arising from an identical series of occurrences not dependent on each individual Plaintiffs ingestion of the Product but on the fact that when ingested in the manner intended, the Product caused serious acute renal failure. Plaintiffs' allegations regarding the nature of their acute renal failure, the nature of Phospho-soda, the main component of the Product, the propensity of Phospho-soda to cause acute renal failure and the criteria for the diagnosis of the disease are all identical.
18. At the time Fleet manufactured, marketed and sold the Product that Plaintiffs used, Fleet had actual notice of a serious risk of bodily injury and harm, including, inter alia, the risk of hyperphosphatemia, nephrocalcinosis, acute phosphate nephropathy (APN), and acute renal failure (ARF) to reasonably foreseeable users. Prior to 2004, Defendants received direct communication and information from qualified medical professionals, including the FDA and others, of the aforesaid risks to users. Yet Fleet, willfully and with conscious disregard for the rights and safety of consumers, disregarded and downplayed such information and withheld such information from intended users and from physicians whom Defendants knew were reasonably likely to recommend the Product to their patients prior to medical procedures.
19. On information and belief, Fleet never undertook appropriate medical studies or other research to determine the true risk of serious adverse health effects, including APN and ARF, from using the Product in the concentrated dose of 2 x 45mL separated by some duration. Defendants affirmatively represented that the Product was safe for all users not specifically designated as “contraindicated” in the dose regimen described above (to wit, 2 x 45mL of Phospho-soda separated by some duration). Fleet also misrepresented serious adverse events from the Product to the FDA between the 1990s and December 2008 in a successful effort to avoid regulation of the Product as a prescription product versus retaining its OTC status. Fleet's conduct as described above was done in order to maximize Fleet's financial gain.
20. On information and belief Fleet affirmatively mislead customers and physicians about known or suspected health risks from use of the Product and sponsored seminars and research by persons it paid or sponsored to produce favorable reports on the Product. Fleet did not fully disclose its connection to such persons and the inherent conflict of interest created thereby. Fleet knew that full disclosure of the risks from using the Product in the doses described above would dramatically reduce its sales of the Product, its market share and profits, and might cause the FDA to regulate the Product other than as an OTC bowel preparation. In fact, Fleet's own studies, and other information at its disposal, stated that two 30mL doses of Phospho-soda taken at some duration apart was safer than the recommended regimen, and the efficacy was substantially similar. Fleet's conduct described above was done with the intent to induce physicians and users to rely on Fleet's positive representations and deliberate omissions of safety information in order to become a product of choice for people undergoing certain medical procedures that may require a purgative.
21. On information and belief, prior to 2005, Fleet did provide additional and more detailed instructions and warnings regarding the risk of serious adverse effects from use of the Product to users and physicians in countries other than the United States, but Fleet deliberately failed to provide such additional instructions and warnings to users and physicians in the United States in order to avoid a reduction in sales of the Product and a reduction in its profits. Fleet had no reason to believe that users and physicians in the United States would have known of the serious adverse risks of use of the Product which it warned about in other countries, and it had no reason to believe that users in the United States were any less susceptible to adverse reactions from the Product. There was no basis for the use of different warnings in the United States except to deceive and mislead users in the United States and increase Fleet's profits and market share.
22. Plaintiffs are informed and allege that during 2003 and continuing to the present Fleet has actively sought to avoid full disclosure of the risks of the Product to gastroenterologists who routinely recommend bowel purgatives that otherwise healthy individuals could develop renal failure and acute phosphate nephropathy after ingesting Fleet Phospho-soda in the manner and at the dose Fleet recommends. Plaintiffs are further informed and believe that Fleet has yet to warn consumers that its Product can cause ARF and APN in otherwise healthy individuals after ingesting the Product as Fleet recommends, and has never included such a warning on its product packaging or label. Fleet knowingly and intentionally engaged in a campaign to minimize, downplay, and obscure the risks of the Product so that unwitting healthcare professionals and consumers would continue using the Product without knowledge of the Product's risks. Fleet further engaged in a campaign to “thwart” any conduct that threatened to expose the Product's risks.
23. Plaintiffs are informed and allege that from 2002 to the present Fleet has represented to the medical community that use of Phospho-soda in the dosing regimen recommended by Fleet (2 x 45mL) is safe and would not cause permanent renal failure in any person who was not contraindicated or overdosed, and that if Phospho-soda induced any electrolyte shifts in persons not specifically described as contraindicated such electrolyte shifts would be transient and of no clinical significance. In 2006, 2007, and 2008 Plaintiffs were not persons contraindicated for use of Phospho-soda based on Fleet's labels, warnings, and instructions.
24. Fleet's conduct as described in the preceding paragraphs was done in part to hide and conceal information which might cause physicians and consumers to discover or suspect a causal link between permanent renal failure occurring as a result of ingesting the Product as directed in preparation for medical procedures. This active concealment and the misrepresentation in “Dear Doctor” letters written by Fleet, which state that any renal insufficiency arising from use of the product would be transient, and would only occur in persons contraindicated or overdosed, was intended by Fleet and had the effect known to it, that physicians would not recognize the risks of the Product or make a connection between use of the Product and permanent renal failure in persons not contraindicated or overdosed. The acts and omissions of the Defendant as described above constitute malice, oppression and fraud.
25. On December 11, 2008 the FDA responded to Fleet's June 2003 Citizen Petition seeking formal approval of doses ranging from 2 x 30mL to 2 x 45mL in 10 to 12 hours of FPS as a bowel cleanser prior to colonoscopy or other medical procedures. The FDA soundly rejected Fleet's petition. The FDA also stated that “[a]lthough the true incidence of acute phosphate nephropathy is unknown, it may occur in up to 1 in 1000 patients who receive OSP products and is probably under-recognized.” Additionally, the FDA explained that acute phosphate nephropathy can occur from ingesting oral sodium phosphate products even “in patients with no pre-existing health factors that would have put them at risk for developing kidney injury.” The FDA further stated that the product's warnings are currently inadequate; doctors and patients are not fully informed about the risks and inherent dangers of Phospho-soda, including acute phosphate nephropathy and death, and consequently the FDA revoked Fleet's OTC status for Phospho-soda when used as a bowel cleanser. Specifically, the FDA “concluded that the current labeling of OSP products does not adequately warn healthcare providers and patients about this serious event [acute phosphate nephropathy].” The FDA also required increased warnings for any oral sodium phosphate product sold as a bowel cleanser, including black-box warnings that Fleet previously refused to include on its Product packaging.
26. As of December 15, 2008, Fleet continued to actively maintain information located on its website (www.fleetlabs.com) promoting 2 x 45mL of Phospho-soda separated by 6 to 12 hours, and claiming that said dosing regimen is “safe” in patients without contraindications. As of the date of this complaint, Fleet maintains a “Q&A” document on its website stating that there is “nothing” wrong with the Product.
COMMON FACTUAL ALLEGATIONS OF PLAINTIFF CAYO
27. Plaintiffs incorporate by reference Paragraphs 1 through 26, inclusive.
28. Prior to July 20, 2006, Cayo purchased two 45mL bottles of Phospho-soda in preparation for a colonoscopy. Cayo used the Phospho-soda as directed by the instructions on the package as well as those instructions provided by her Gastroenterologist prior to her colonoscopy on or about July 20, 2006.
29. The package contained no product insert and there were no warnings regarding kidney damage, kidney or renal failure, or risk to diabetics. Cayo did not fall into any of the categories regarding those at risk for kidney damage from ingestion of the Product. The Product lacked adequate warnings and instructions to properly advise expected and intended users of the reasonably foreseeable risks of adverse outcomes as a result of using the Product as intended, including the risk of severe and permanent kidney damage.
30. Following ingestion of the Product, Cayo developed nausea, vomiting, and diarrhea, which she attributed to the “flu.” Cayo was subsequently hospitalized on July 23, 2006 and diagnosed with renal failure and anemia secondary to renal failure.
31. Cayo's treating physicians did not inform her of the cause of her sudden and irreversible kidney damage. Cayo was thereafter referred to a nephrologist (“kidney doctor”) who similarly did not inform Cayo of the cause of her sudden and irreversible kidney damage. A kidney biopsy was not performed on Cayo. Plaintiffs treating physicians informed her that any such biopsy would probably be of little benefit.
32. Even though Cayo had no suspicion of wrongdoing related to her kidney injury, upon learning of her injury, Cayo immediately exercised reasonable diligence in attempting to ascertain the cause of her kidney injury. She consulted her medical doctors who did not indicate to her or otherwise raise a concern or suspicion that the use of Phospho-soda by Cayo in preparation for her colonoscopy in July of 2006 could have caused her injury.
33. Cayo is informed and believes that Fleet has never directly informed purchasers of its products that otherwise healthy individuals could develop sudden and irreversible kidney failure from ingestion of the Product in the dose and duration recommended by Fleet.
34. On or about the week of January 26, 2009, Cayo's brother saw a commercial regarding the connection between renal/kidney failure and oral sodium phosphate solution (i.e., Fleet Phospho-soda). Based on this newly discovered information, Cayo immediately commenced the instant lawsuit.
35. Cayo is informed and believes that in 2006 and prior, the risk of phosphate induced renal failure was not widely known to the general population or the medical profession, but was known to Fleet.
36. On or about March of 2003 Fleet received a telephone call from Columbia-Presbyterian renal pathologist, Dr. Glen Markowitz, about five cases of Fleet Phospho-soda induced renal failure recently observed in his lab, and Fleet subsequently met with him and others at Columbia about these cases and Markowitz's hypothesis. Dr. Markowitz published his findings in June of 2004 (Glen S. Markowitz, et. al. Renal Failure Due to Acute Nephrocalcinosis Following Oral Sodium Phosphate Bowel Cleansing, Human Pathology, Vol. 35, No. 6 (June 2004)).
37. Cayo is informed and alleges that since 2003 to the present Fleet actively worked to downplay, dispute, or negate Markowitz's findings as well as all other reports of phosphate induced renal failure associated with its Product, and to that end Fleet has sponsored speakers at medical seminars and papers which were published in the medical literature advocating the safety of its Product. Fleet represented to the medical community and the public that reports of renal failure attributed to its Product occurred in overdosed or contraindicated patients, and that any problems associated with the Product were transient, and not permanent.
38. Cayo is informed and alleges that gastroenterologists, colo-rectal surgeons and nephrologists are not regular readers or subscribers to the Journal of Human Pathology. Cayo is further informed and believes that until very recently the dangers associated with the use of oral sodium phosphate solution were not widely known by the gastroenterology community; the population most likely to recommend Fleet Phospho-soda.
39. Fleet was informed in November of 2007 that specialists in nephrology were only just becoming aware of a link between oral sodium phosphate solutions and renal failure. Fleet received email communication in November of 2007 from its outside contractor sales representative (Santarus, Inc.) attaching a letter from University of Rochester nephrology physicians in 2007 stating: “[w]ithin the past several months, publications in the nephrology and pathology literature suggests that oral sodium phosphate solutions or tablets (Visicol) can result in acute and irreversible renal failure in patients with normal creatinine values….”
40. Letters such as those referenced in paragraph 39 reflect the lack of widely dispersed evidence or knowledge regarding the risk of harm from OSP solutions among trained specialists in the field. Physicians whose specialty is not kidney disease are still unaware of the risks of injury associated with the Product when used as recommended by Fleet, due to the active concealment and fraudulent representations of Fleet published in its advertising, its public statements, and by its sponsored speakers and authors of published literature. Fleet's active fraud continues to today, and is reflected in an email discussing ways to rebut the concerns expressed by the University of Rochester physicians as set out in paragraph 39.
41. Cayo is informed and believes that Fleet did not widely disperse its knowledge regarding the hazards of Fleet Phospho-soda but instead actively sought to counter or “fight” physicians who requested unbiased, accurate, and transparent full disclosure and information regarding the harms of Fleet Phospho-soda on non-contraindicated patient populations.
42. Cayo is informed and believes that during 2003 and continuing to the present Fleet has actively sought to avoid full disclosure of the risks of the Product to gastroenterologists who routinely recommend bowel purgatives that otherwise healthy individuals could develop renal failure after ingesting Fleet Phospho-soda in the manner and at the dose Fleet recommends. Cayo is further informed and believes that Fleet has yet to warn the consumers of its Product that otherwise healthy individuals could develop renal failure after ingesting the Product as Fleet recommends, and has never included such a warning on its product packaging or label.
43. Cayo is further informed and believes that on December 11, 2008 the FDA responded to Fleet's June 2003 Citizen Petition seeking formal approval of doses ranging from 2 x 30mL to 2 x 45mL in 10 to 12 hours of FPS as a bowel cleanser prior to colonoscopy or other medial procedures. In soundly rejecting Fleet's petition the FDA stated, the FDA concluded that “the current labeling of OSP products does not adequately warn healthcare providers and patients about this serious event [acute phosphate nephropathy].” The FDA's conclusions reflect that as of December of 2008 physicians who recommend the Product and customers of Fleet were not adequately warned or informed about the dangers of the Product.
44. The Product caused Cayo's acute renal failure and subsequent development of chronic kidney disease and anemia necessitating regular Procrit injections. Cayo is further informed and believes that the Product has caused a dramatic alteration in her diet as well as general fatigue. Cayo is informed and believes that her chronic kidney disease will progressively worsen.
45. Prior to her use of the Product, Cayo had not been diagnosed with, nor did she have any, pre-existing renal conditions or kidney problems.
46. As a result of her use of the Product, Cayo has suffered severe permanent injury and damage to her person, including pain and suffering, disability, and mental and emotional distress, and has incurred medical and hospital expenses, the exact amount which has yet to be ascertained. Cayo's life has further been dramatically changed by her having to be compelled to take medications and alter her diet and lifestyle.
COMMON FACTUAL ALLEGATIONS OF PLAINTIFF CROWTHER
47. Plaintiffs incorporate by reference Paragraphs 1 through 46, inclusive.
48. Prior to July 25, 2007, Crowther purchased two 45mL bottles of Phospho-soda in preparation for a colonoscopy. Crowther used the Phospho-soda as directed by the instructions on the package as well as those instructions provided by his Gastroenterologist prior to his colonoscopy on or about July 26, 2007.
49. The package contained no product insert and there were no warnings regarding kidney damage, kidney or renal failure. Crowther did not fall into any of the categories regarding those at risk for kidney damage from ingestion of the Product. The Product lacked adequate warnings and instructions to properly advise expected and intended users of the reasonably foreseeable risks of adverse outcomes as a result of using the Product as intended, including the risk of severe and permanent kidney damage.
50. Crowther underwent a colonoscopy without complication on or about July 26, 2007.
51. Immediately following ingestion of the Product, Crowther developed bloating, stomach cramps and “flu-like” symptoms generally characterized as phosphate-toxicity. A blood test taken seven days after ingestion of the Product revealed that Crowther's kidneys were functioning improperly. Crowther was diagnosed with renal failure and anemia secondary to ingestion of “Na phosphate colon prep….”
52. The Product caused Crowther's acute renal failure and subsequent development of chronic kidney disease. Plaintiff is further informed and believes that the Product has caused a dramatic alteration in his diet, and general fatigue, as well as alterations in Crowther's medication. Crowther is informed and believes that his chronic kidney disease will progressively worsen.
53. Prior to his use of the Product, Crowther had not been diagnosed with, nor did he have any, pre-existing renal conditions or kidney problems.
54. As a result of his use of the Product, Crowther has suffered severe permanent injury and damage to his person, including pain and suffering, disability, and mental and emotional distress, and has incurred medical and hospital expenses, the exact amount which has yet to be ascertained. Crowther's life has further been dramatically changed by his having to be compelled to take medications and alter his diet and lifestyle.
COMMON FACTUAL ALLEGATIONS OF PLAINTIFF WILLCOX
55. Plaintiffs incorporate by reference Paragraphs 1 through 54, inclusive.
56. Prior to November 6, 2007, Willcox was provided two 45mL bottles of Phospho-soda in preparation for a colonoscopy. Willcox used the Phospho-soda as directed by the instructions on the package as well as those instructions provided to her by her Gastroenterologist prior to her colonoscopy on or about November 6, 2007.
57. The package contained no product insert and there were no warnings regarding kidney damage, kidney or renal failure. Willcox did not fall into any of the categories regarding those at risk for kidney damage from ingestion of the Product. The Product lacked adequate warnings and instructions to properly advise expected and intended users of the reasonably foreseeable risks of adverse outcomes as a result of using the Product as intended, including the risk of severe and permanent kidney damage.
58. Willcox underwent a routine colonoscopy on November 6, 2007.
59. Soon after using the Product, Willcox began to have complications as a result of taking the Product, generally characterized as phosphate toxicity, including but not limited to, fatigue, nausea, chills, abdominal pain/bloating and general “flu like” symptoms.
60. On November 15, 2007, Willcox was admitted to the hospital complaining of the above referenced symptoms and was subsequently hospitalized until or about November 19, 2007. Willcox was immediately diagnosed with acute renal failure.
61. The Product caused Willcox's acute renal failure and subsequent development of chronic kidney disease. Willcox is further informed and believes that the Product has resulted in a dramatic alteration in her diet and medication, general fatigue, increased hypertension/high blood pressure and loss of earnings and future loss earning capacity. Willcox is informed and believes that her chronic kidney disease will progressively worsen.
62. Prior to her use of the Product, Willcox had not been diagnosed with, nor did she have any, pre-existing renal conditions or kidney problems.
63. As a result of her use of the Product, Willcox has suffered severe permanent injury and damage to her person, including pain and suffering, disability, and mental and emotional distress, and has incurred medical and hospital expenses, the exact amount which has yet to be ascertained. Willcox's life has further been dramatically changed by her having to be compelled to take medications and alter her diet and lifestyle.
COMMON FACTUAL ALLEGATIONS OF PLAINTIFF WYANT
64. Plaintiffs incorporate by reference Paragraphs 1 through 63, inclusive.
65. Prior to April 20, 2006, Wyant purchased two 45mL bottles of Phospho-soda in preparation for a colonoscopy. Wyant used the Phospho-soda as directed by the instructions on the package as well as those instructions provided by her Gastroenterologist prior to her colonoscopy on or about April 20, 2006.
66. The package contained no product insert and there were no warnings regarding kidney damage, kidney or renal failure, or risk to diabetics. Wyant did not fall into any of the categories regarding those at risk for kidney damage from ingestion of the Product. The Product lacked adequate warnings and instructions to properly advise expected and intended users of the reasonably foreseeable risks of adverse outcomes as a result of using the Product as intended, including the risk of severe and permanent kidney damage.
67. Wyant underwent a colonoscopy on or about April 20, 2006.
68. In May of 2006 a blood panel taken from Wyant revealed that her kidneys were functioning improperly. Wyant was thereafter hospitalized and diagnosed with renal failure. Wyant's treating physicians could not determine the cause of Wyant's sudden and irreversible kidney damage. Wyant was thereafter referred to a nephrologist (“kidney doctor”) who similarly could not determine the cause of Wyant's sudden and irreversible kidney damage. To the extent any opinion was offered, Wyant's physician's opined that Wyant's kidney damage was likely the result of her hypertension medication. A kidney biopsy was not performed on Wyant. Plaintiffs treating physicians informed her that any such biopsy would probably of little benefit as it would likely not explain the reason for Wyant's renal failure.
69. Even though Wyant had no suspicion of wrongdoing related to her kidney injury, upon learning of her injury, Wyant immediately exercised reasonable diligence in attempting to ascertain the cause of her kidney injury. She consulted her medical doctors who did not indicate to her or otherwise raise a concern or suspicion that the use of Phosho-Soda by Wyant in preparation for her colonoscopy in April of 2006 could have caused her injury.
70. Wyant is informed and believes that Fleet has never directly informed purchasers of its products that otherwise healthy individuals could develop sudden and irreversible kidney failure from ingestion of the Product in the dose and duration recommended by Fleet.
71. On or about January 14, 2009 Wyant saw a commercial regarding the connection between renal/kidney failure and oral sodium phosphate solution (i.e., Fleet Phospho-Soda). Based on this newly discovered information Wyant immediately commenced the instant lawsuit.
72. Wyant is informed and believes that in the year of 2006 and prior to that date the risk of phosphate induced renal failure was not widely known to the general population or the medical profession, but was known to Fleet.
73. On or about March of 2003 Fleet received a telephone call from Columbia-Presbyterian renal pathologist, Dr. Glen Markowitz, about five cases of Fleet Phospho-soda induced renal failure recently observed in his lab, and Fleet subsequently met with him and others at Columbia about these cases and Markowitz's hypothesis. Dr. Markowitz published his findings in June of 2004 (Glen S. Markowitz, et. al. Renal Failure Due to Acute Nephrocalcinosis Following Oral Sodium Phosphate Bowel Cleansing, Human Pathology, Vol. 35, No. 6 (June 2004).
74. Wyant is informed and alleges that since 2003 to the present Fleet actively worked to downplay, dispute, or negate Markowitz's findings as well as all other reports of phosphate induced renal failure associated with its Product, and to that end Fleet has sponsored speakers at medical seminars and papers which were published in the medical literature advocating the safety of its Product. Fleet represented to the medical community and the public that reports of renal failure attributed to its Product occurred in overdosed or contra-indicated patients, and that any problems associated with the Product were transient, and not permanent.
75. Wyant is informed and alleges that gastroenterologists, colo-rectal surgeons and nephrologists are not regular readers or subscribers to the Journal of Human Pathology. Wyant is further informed and believes that until very recently the dangers associated with the use of oral sodium phosphate solution were not widely known by the gastroenterology community; the population most likely to recommend Fleet Phospho-Soda.
76. Fleet was informed in November of 2007 that specialists in nephrology were only just becoming aware of a link between oral sodium phosphate solutions and renal failure. Fleet received email communication in November of 2007 from its outside contractor sales representative (Santarus, Inc.) attaching a letter from University of Rochester nephrology physicians in 2007 stating: “[w]ithin the past several months, publications in the nephrology and pathology literature suggests that oral sodium phosphate solutions or tablets (Visicol) can result in acute and irreversible renal failure in patients with normal creatinine values…”
77. Letters such as those referenced in paragraph 75 reflect the lack of widely dispersed evidence or knowledge regarding the risk of harm from oral sodium phosphate solutions among trained specialists in the field. Physicians whose specialty is not kidney disease are still unaware of the risks of injury associated with the Product when used as recommended by Fleet, in part due to the active concealment and fraudulent representations of Fleet published in its advertising, its public statements, and by its sponsored speakers and authors of published literature. Fleet's active fraud continues to today, and is reflected in an email discussing ways to rebut the concerns expressed by the University of Rochester physicians as set out in paragraph 75.
78. Wyant is informed and believes that Fleet did not widely disperse its knowledge regarding the hazards of Fleet Phospho-soda but instead actively sought to counter or “fight” physicians who requested unbiased, accurate, and transparent full disclosure and information regarding the harms of Fleet Phospho-soda on non-contraindicated patient populations.
79. Wyant is informed and believes that during 2003 and continuing to the present Fleet has actively sought to avoid full disclosure of the risks of the Product to gastroenterologists who routinely recommend bowel purgatives that otherwise healthy individuals could develop renal failure after ingesting Fleet Phospho-soda in the manner and at the dose Fleet recommends. Plaintiff is further informed and believes that Fleet has yet to warn the consumers of its product that otherwise healthy individuals could develop renal failure after ingesting the Product as Fleet recommends, and has never included such a warning on its product packaging or label.
80. Wyant is further informed and believes that on December 11, 2008 the FDA responded to Fleet's June 2003 Citizen Petition seeking formal approval of doses ranging from 2 x 30mL to 2 x 45mL in 10 to 12 hours of FPS as a bowel cleanser prior to colonoscopy or other medial procedures. In soundly rejecting Fleet's petition the FDA stated, the FDA concluded that “the current labeling of OSP products does not adequately warn healthcare providers and patients about this serious event [acute phosphate nephropathy].” The FDA's conclusions reflect that as of December of 2008 physicians who recommend the Product and customers of Fleet were not adequately warned or informed about the dangers of the Product.
81. The Product caused Wyant's acute renal failure and subsequent development of chronic kidney disease. Wyant is further informed and believed that the Product has caused a dramatic alteration in her diet, and general fatigue. Wyant is informed and believes that her chronic kidney disease will progressively worsen.
82. Prior to her use of the Product, Wyant had not been diagnosed with, nor did she have any, pre-existing renal conditions or kidney problems.
83. As a result of her use of the Product, Wyant has suffered severe permanent injury and damage to her person, including pain and suffering, disability, and mental and emotional distress, and has incurred medical and hospital expenses, the exact amount which has yet to be ascertained. Wyant's life has further been dramatically changed by her having to be compelled to take medications and alter her diet and lifestyle.
FIRST CLAIM FOR RELIEF
(Strict Liability-Defective Design)
84. Plaintiffs incorporate by reference Paragraphs 1 through 83, inclusive.
85. Defendants sold the Product in a defective condition because it was not reasonably safe for use in its intended or reasonably foreseeable purposes as a bowel cleanser.
86. A reasonable person who knew of the Product's potential for causing injury would have concluded that the Product, which was not reasonably safe for its intended use or reasonably foreseeable purposes because of a design defect, should not have been marketed in that condition.
87. Plaintiffs used the Product for its intended or reasonably foreseeable purpose.
88. Defendants knew or otherwise expected that the Product would reach the ultimate user, including Plaintiffs, without substantial change from or alteration of, the condition in which it was originally manufactured and sold, and it did reach Plaintiffs in an unaltered condition from its originally manufactured condition.
89. As a proximate result of Defendants' distribution of a defective product to Plaintiffs, they suffered permanent injury and damage, including but not limited to pain and suffering, emotional distress, disfigurement and a dramatic degradation in their quality of life, as well as special damages for medical care and intervention, substitute services and other damage, and will continue to suffer all such general damages into the future and will continue to incur special damages into the future.
90. By reason of the foregoing, Defendants are strictly liable to Plaintiffs.
91. Plaintiffs are entitled to punitive damages from Defendants because Defendants' conduct was malicious, oppressive, fraudulent and in conscious disregard of Plaintiffs' rights and the rights of other users of the Product.
SECOND CLAIM FOR RELIEF
(Strict Liability-Failure to Warn)
92. Plaintiffs incorporate by reference Paragraphs 1 through 91, inclusive.
93. Defendants sold the Product in a defective condition because it was not reasonably safe for use in its intended or reasonably foreseeable purpose as a bowel cleanser.
94. A reasonable person who knew of the Product's potential for causing injury would have concluded that the product, which was not reasonably safe for use in its intended or reasonably foreseeable purpose because it did not have a correct, fully descriptive, and complete warning issued in language that was direct, unequivocal and sufficiently forceful, should not have been marketed in that condition. Indeed, the FDA concluded on December 11, 2008, that Fleet's warnings are inadequate to alert patients and healthcare professionals about the serious health risks posed by the Product. The FDA stated, “[W]e have now concluded that the current labeling of OSP products does not adequately warn healthcare providers and patients about this serious event [acute phosphate nephropathy].”
95. Plaintiffs used the Product in the manner as directed by Defendants.
96. Plaintiffs used the Product for its intended or reasonably foreseeable purpose, i.e., as a bowel cleanser prior to a colonoscopy.
97. Defendants knew or otherwise expected that the Product would reach the ultimate user, including Plaintiffs, without substantial change from, or alteration of, the condition in which it was originally manufactured and sold.
98. As a proximate result of Defendants' sale and distribution of the defective product to Plaintiffs, they suffered permanent injury and damage, acute phosphate nephropathy and a dramatic degradation in their quality of life.
99. By reason of the foregoing, Defendants are strictly liable to Plaintiffs.
100. Plaintiffs are entitled to punitive damages from Defendants because Defendants' conduct was malicious, oppressive, fraudulent and in conscious disregard of Plaintiffs' rights and the rights of other users of the Product.
THIRD CLAIM FOR RELIEF
(Negligence – Design Defect)
101. Plaintiffs incorporate by reference Paragraphs 1 through 100, inclusive.
1021. Defendants were under a duty to use reasonable care in designing a product so that it did not have a defect that made the product unreasonably dangerous when put to its normal use.
103. Despite Defendants' knowledge of the unsafe and dangerous nature of the Product, Defendants recklessly and negligently put the defective product on the market.
104. A reasonable person who knew of the Product's potential for causing injury would have concluded that the product should not have been marketed and sold in that condition. Indeed, the FDA concluded on December 11, 2008, that the Product may not be sold OTC as a bowel cleanser due to its dangerous nature and lack of adequate warnings to patients and healthcare professionals.
105. Defendants breached their duty to Plaintiffs.
106. Defendants were otherwise negligent.
107. As a proximate result of Defendants' negligent acts, omissions, and breaches of duty, Plaintiffs suffered permanent injury and damage, advanced kidney disease and a dramatic degradation in their quality life.
108. Plaintiffs are entitled to punitive damages against Defendants as their conduct was malicious, oppressive, fraudulent and in conscious disregard of Plaintiffs' rights and the rights of other users of the Product.
FOURTH CLAIM FOR RELIEF
(Negligence – Failure to Warn)
109. Plaintiffs incorporate by reference Paragraphs 1 through 108, inclusive.
110. The Product was reasonably certain to be dangerous when used in the way that was directed on the Package.
111. Defendants were under a duty to use reasonable care to give adequate warning of any dangers known to them or which in the use of reasonable care they should have known and which the user of the Product ordinarily would not discover.
112. Despite their knowledge of the unsafe and dangerous nature of the Product, Defendants recklessly and negligently failed to provide needed, accurate and adequate warnings and information as to the health hazards of the Product to those foreseeable users of the Product, including Plaintiffs, who would reasonably use the product. Indeed, the FDA concluded on December 11, 2008, that Fleet's warnings are inadequate to alert patients and healthcare professionals about the serious health risks posed by the Product, and revoked Phospho-soda's OTC status when used as a bowel cleanser at doses above 45mL in 24 hours. The FDA stated, “[W]e have now concluded that the current labeling of OSP products does not adequately warn healthcare providers and patients about this serious event [acute phosphate nephropathy].”
113. A reasonable person who knew of the Product's potential for causing injury would have concluded that the Product should not have been marketed in that condition.
114. Defendants breached their duty to Plaintiffs.
115. Defendants were otherwise negligent.
116. As a proximate result of Defendants' acts, omissions, recklessness, negligence and breaches of duty, Plaintiffs suffered permanent injury and damage, advanced kidney disease and a dramatic degradation in their quality of life.
117. Plaintiffs are entitled to punitive damages against Defendants as their conduct was malicious, oppressive, fraudulent and in conscious disregard of Plaintiffs' rights and the rights of other users of the Product.
FIFTH CLAIM FOR RELIEF
(Breach of Express Warranty)
118. Plaintiffs incorporate by reference Paragraphs I through 117, inclusive.
119. Through advertising, labeling on the Package, and in other ways, Defendants expressly warranted to the public that the Product was of good and merchantable quality, reasonably fit for its intended use, and safe for its intended purpose.
120. Defendants expressly warranted the Product in such a way as to induce its purchase and use, thereby making an express warranty that it would conform to Defendants' representations.
121. The Product did not conform to Defendants' express representations because the Product was defective, dangerous, not merchantable, and not safe for its intended, ordinary, and foreseeable use by Plaintiffs.
122. Plaintiffs used the Product as intended by following the dosage instructions recommended by Defendants.
123. Through the use of reasonable care, Plaintiffs could not have discovered Defendants' breach and realize the danger of using the Product.
124. As a result of Defendants' breach of their express warranties, Plaintiffs suffered permanent injuries and damages, including acute phosphate nephropathy, and such breach was a substantial factor in bringing about Plaintiffs' injuries and damages.
SIXTH CLAIM FOR RELIEF
(Breach of Implied Warranty)
125. Plaintiffs incorporate by reference Paragraphs 1 through 124, inclusive.
126. The law implies a warranty by manufacturers and companies in the chain of distribution, who place a product on the market, that the product is reasonably fit for the ordinary purposes for which such product is used.
127. The Product was not reasonably fit to be used for its ordinary purposes, and accordingly Defendants breached the implied warranty.
128. As a proximate result of Defendants' breach of the implied warranty, Plaintiffs suffered permanent injuries and damages, including acute phosphate nephropathy, and such breach was a substantial factor in bringing about Plaintiffs' injuries and damages.
SEVENTH CLAIM FOR RELIEF
(Fraud)
129. Plaintiffs incorporate by reference Paragraphs I through 128, inclusive.
130. Defendants represented to Plaintiffs and the public that the Product could be safely used as a bowel cleanser in preparation for a colonoscopy.
131. Defendants' representations and omissions as alleged above were knowingly and recklessly false and made with the intent to induce Plaintiffs into using the Product.
132. Plaintiffs believed, and justifiably relied on, said misrepresentations and omissions and were thereby induced into using the Product in a reasonably foreseeable manner.
133. As a direct and proximate result of Defendants' misrepresentations, Plaintiffs suffered permanent injury and damage, renal failure, acute phosphate nephropathy, advanced kidney disease and a dramatic degradation in their quality of life.
134. Plaintiffs are entitled to punitive damages because Defendants' conduct was malicious, oppressive, fraudulent and in conscious disregard of Plaintiffs' rights and the rights of other users of the Product.
EIGHTH CLAIM FOR RELIEF
(Violation of California's Statutory Unfair Competition Law)
135. Plaintiffs incorporate by reference Paragraphs 1 through 134, inclusive.
136. In 2002, Fleet's distributor in Canada, Johnson & Johnson/Merck, informed its customers of the following: “[e]lectrolyte shifts may occur in patients 18 with or without risk factors for electrolyte shifts if the maximum recommended dose of 45mL in a 24 hour period is exceeded…the maximum recommended daily dose for any indication for adults is 45mL of sodium phosphate oral solution in a 24 hour period.” As of December 15, 2008, Fleet maintained information on its website recommending that consumers ingest a 90mL dose of Phospho-soda in six to 12 hours to cleanse the bowel prior to colonoscopy, which Fleet advertised to its customers and healthcare professionals as safe and effective.
137. On May 28, 1998, the FDA issued its final rule, codified in 21 CFR Part 201, requiring Fleet to warn its consumers that ingestion of greater than 45mL of Phospho-soda in a 24 hour period could be harmful. Fleet failed to warn its customers. The FDA also issued a final rule limiting the container size of sodium phosphates oral solution and required warning and direction statements to inform consumers that exceeding the maximum recommended dose of 45mL of oral and rectal sodium phosphate products in a 24-hour period can be harmful. The FDA stated that ingesting more than 45mL of sodium phosphates oral solution may be harmful, yet Fleet continued to recommend a 90mL dose, which Fleet advertised to its customers as safe and effective.
138. Fleet is aware and concedes that the FDA has determined that Fleet Phospho-soda is generally recognized as safe and effective when the end user ingests no more than 45mL in a 24-hour period, yet Fleet continued to market as safe and effective its Fleet Phospho-soda, which Fleet recommended ingestion of 90mL in a 10-to-12 hour period. Indeed, on December 11, 2008, the FDA rejected Fleet's 2003 Citizen Petition seeking approval of Phospho-soda dosing between 2 x 30mL and 2 x 45mL in 10 to 12 hours. The FDA concluded that such dosing is not safe, and, in fact, poses serious risks to patients including acute phosphate nephropathy and death. The FDA expressly found that Fleet failed to adequately warn consumers and healthcare professionals of the Product's dangers when dosed in excess of 45mL in 24 hours, and that data show that acute phosphate nephropathy may occur in up to 1 in 1000 patients who take the Product, and the injury is still likely under-recognized. As a result, the FDA revoked Phospho-soda's OTC status when dosed in excess of 45mL in 24 hours, and will require new black box warnings for all OSP bowel cleansing products.
139. As of December 15, 2008, Fleet continued to actively maintain information located on its website (www.fleetlabs.com) promoting 2 x 45mL of Phospho-soda separated by 6 to 12 hours, and claiming that said dosing regimen is “safe” in patients without contraindications. As of the date of this complaint Fleet maintains a “Q&A” document posted on its website stating that there is “nothing” wrong with the Product.
140. By being warned by the FDA about the hazards associated with ingestion of greater than 45mL of Phospho-soda in a 24 hour period, continuing to sell packages containing greater than 45mL total doses, recommending consumers ingest more than 45mL of the Product in a 24-hour period and failing to warn its consumers of the risks, Defendants engaged in business acts that were unlawful, unfair or fraudulent within the meaning of California Business & Professions Code § 1700 and thereby violated California's statutory unfair competition law, California Business & Professions Code § 1720, et seq. (the UCL). Defendants also violated California's statutory false and misleading advertising law, California Business & Professions Code § 17500, et seq. Plaintiffs are entitled to the remedies specified by the Business & Professions Code as a result of such violations, including, without limitations, restitution from Defendants in such amount to be proven at trial.
PRAYER FOR RELIEF
WHEREFORE, Plaintiffs, individually, pray for judgment on their complaint against Defendants, jointly and severally, as follows:
1. For special damages according to proof;
2. For general damages according to proof;
3. For punitive damages against Defendants;
4. For costs of suit;
5. For attorney's fees pursuant to Code Civ. Proc. § 1021.5; and
6. For such other and further relief as the court deems equitable, just and proper.
DATED: April 20, 2009