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Actos Complaint

Michael L. Baum, Esq. CA Bar # 119511

Cynthia L. Garber, Esq. CA Bar # 208922

Baum, Hedlund, Aristei & Goldman, APC

12100 Wilshire Blvd., Suite 950

Los Angeles, CA   90025

Tel:   (310) 207-3233

Fax:  (310) 820-7444

Attorneys for Plaintiffs

SUPERIOR COURT OF THE STATE OF CALIFORNIA

FOR THE COUNTY OF LOS ANGELES

COMES NOW, Plaintiffs GERARD AINA, an individual; and JOYCE AINA, an individual, for causes of action against Defendants and DOES 1 through 100, and each of them, inclusive, who file this Complaint and allege as follows:

GENERAL ALLEGATIONS

1. The Plaintiffs herein are competent individuals over the age of 18, residents and citizens of the United States, hereby submit to the jurisdiction of this Court and allege that Venue in this Court is proper.
   
2. Plaintiffs are residents and citizens of the State of California and currently reside in Ventura County, California. 
3. This is an action for personal injury on behalf of the Plaintiff GERARD AINA and loss of consortium on behalf of a spouse, Plaintiff  JOYCE AINA, against Defendants and DOES 1 through 100, and each of them, inclusive, who are responsible for the prescription drug Actos and pioglitazone hydrochloride, a diabetes medication used by Plaintiff  GERARD AINA that caused Plaintiff  GERARD AINA to suffer physical injuries and damages including, but not limited to, bladder cancer and related sequelae, pain and suffering, bodily impairment, mental anguish, diminished enjoyment of life as well as economic loss and other special damages.
4. At all relevant times alleged herein, one or more of the corporate Defendants was, and now is, a corporation with its principal place of business in the State of California.
5. At all relevant times alleged herein, one or more of the individual Defendants was, and now is a resident of the State of California.
6. The true names and/or capacities, whether individual, corporate, partnership, associate, governmental, or otherwise, of defendant DOES 1 through 100, inclusive, are unknown to Plaintiffs at this time, who therefore sue said defendants by such fictitious names.  Plaintiffs are informed and believe, and thereon allege, that each defend­ant designated herein as a DOE caused injuries and damages proximately thereby to Plaintiffs as hereinafter alleged; and that each DOE defendant is liable to the Plaintiffs for the acts and omissions alleged herein below, and the resulting injuries to Plaintiffs, and damages sustained by the Plaintiffs.  Plaintiffs will amend this complaint to allege the true names and capacities of said DOE defendants when that same is ascertained.
7. Plaintiffs are informed and believe, and thereon allege, that at all times herein mentioned, each of the defendants and each of the DOE defendants were the agent, servant, employee and/or joint venturer of the other co-defendants and other DOE defendants, and each of them, and at all said times, each defendant and each DOE defendant was acting in the full course, scope and authority of said agency, service, employment and/or joint venture.
8. Plaintiffs are informed and believe, and thereon allege, that all times mentioned herein, defendants and DOES 1 through 100, and each of them, inclusive, were also known as, formerly known as and/or were the successors and/or predecessors in interest/business/product line/or a portion thereof, assigns, a parent, a subsidiary (wholly or partially owned by, or the whole or partial owner), affiliate, partner, co-venturer, merged company, alter egos, agents, equitable trustees and/or fiduciaries of and/or were members in an entity or entities engaged in the funding, researching, studying, manufacturing, fabricating, designing, developing, labeling, assembling, distributing, supplying, leasing, buying, offering for sale, selling, inspecting, servicing, contracting others for marketing, warranting, rebranding, manufacturing for others, packaging and advertising a certain substance, the generic name of which is Actos.  Defendants and DOES 1 through 100, and each of them, inclusive, are liable for the acts, omissions and tortious conduct of its successors and/or predecessors in interest/business/product line/or a portion thereof, assigns, parent, subsidiary, affiliate, partner, co-venturer, merged company, alter ego, agent, equitable trustee, fiduciary and/or its alternate entities in that defendants and DOES 1 through 100, and each of them, inclusive, enjoy the goodwill originally attached to each such alternate entity, acquired the assets or product line (or portion thereof), and in that there has been a virtual destruction of Plaintiff remedy against each such alternate entity, and that each such defendant has the ability to assume the risk spreading role of each such alternate entity.
9. Plaintiffs are informed and believe, and thereon allege, that at all times herein mentioned, that Defendants and DOES 1 through 100, and each of them, inclusive, were and are corporations organized and existing under the laws of the State of California or the laws of some state or foreign jurisdiction; that each of the said Defendants and DOE defendants were and are authorized to do and are doing business in the State of California and regularly conducted business in this State, Los Angeles County and Ventura County.

10.  Upon information and belief, at relevant times, Defendants and DOES 1 through 100, and each of them, inclusive, were engaged in the business of researching, developing, designing, licensing, manufacturing, distributing, selling, marketing, and/or introducing into interstate commerce and into the State of California, and including Los Angeles County and  Ventura County either directly or indirectly through third parties or related entities, its products, including Actos and pioglitazone hydrochloride.

11.  At relevant times, Defendants and DOES 1 through 100, and each of them, inclusive, conducted regular and sustained business and engaged in substantial commerce and business activity in the State of California, which included but was not limited to selling, marketing and distributing its products including Actos and pioglitazone hydrochloride in the State of California, and including Los Angeles County and Ventura County.

12.  Upon information and belief, at all relevant times, Defendants and DOES 1 through 100, inclusive, expected or should have expected that their acts would have consequences within the United States of America including the State of California, including Los Angeles County and Ventura County, and Defendants derived and derive substantial revenue therefrom.

13.  At all relevant times alleged herein Plaintiffs GERARD AINA and JOYCE AINA were, and are, legally married and residents of Ventura County, California.

14.  Upon information and belief, Defendant TAKEDA PHARMACEUTICALS NORTH AMERICA, INC. is a Delaware corporation, having a principal place of business at One Takeda Parkway, Deerfield, Illinois  60015.  At all relevant times alleged herein, TAKEDA PHARMACEUTICALS NORTH AMERICA, INC. was involved in the research, development, sales and marketing of pharmaceutical products including Actos and pioglitazone hydrochloride.

15.  Defendant TAKEDA PHARMACEUTICAL COMPANY LIMITED is a Japanese corporation having a principal place of business at 1-1, Doshomachi 4-chome, Chuoku, Osaka, Japan. At all relevant times alleged herein, TAKEDA PHARMACEUTICAL COMPANY LIMITED was engaged in the research, development, sales, and marketing of pharmaceutical products including Actos and pioglitazone hydrochloride.

16.  Defendant TAKEDA PHARMACEUTICALS, LLC. is a Delaware limited liability company with a principal place of business at One Takeda Parkway, Deerfield, Illinois 60015. At all relevant times alleged herein, TAKEDA PHARMACEUTICALS, LLC. was involved in the business of research, development, sales and marketing of pharmaceutical products including Actos and pioglitazone hydrochloride.

17.  Defendant TAKEDA PHARMACEUTICALS INTERNATIONAL, INC. is an Illinois corporation, having a principal place of business at One Takeda Parkway, Deerfield, IL 60015. At all relevant times alleged herein TAKEDA PHARMACEUTICALS INTERNATIONAL, INC. was involved in the research, development, sales and marketing of pharmaceutical products including Actos and pioglitazone hydrochloride.

18.  Defendant TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC. is an Illinois corporation, having a principal place of business at One Takeda Parkway, Deerfield, IL 60015. At all relevant times alleged herein TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC. was involved in the research, development, sales and marketing of pharmaceutical products including Actos and pioglitazone hydrochloride.

19.  Defendant TAKEDA SAN DIEGO, INC. is a Delaware corporation, having its principal place of business at 10410 Science Center Drive, San Diego, CA 92121. At all relevant times alleged herein TAKEDA SAN DIEGO, INC. was involved in the testing, monitoring, research, development, sales and marketing of pharmaceutical products including Actos and pioglitazone hydrochloride.

20.  Upon information and belief, Defendant TAKEDA PHARMACEUTICAL COMPANY LIMITED is a company domiciled in Japan and is the parent/holding company of Defendants TAKEDA PHARMACEUTICALS INTERNATIONAL, INC., TAKEDA PHARMACEUTICALS NORTH AMERICA, INC., TAKEDA PHARMACEUTICALS, LLC., TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC., and TAKEDA SAN DIEGO, INC.

21.  Upon information and belief, at all relevant times, Defendant TAKEDA PHARMACEUTICAL COMPANY LIMITED exercised and exercises dominion and control over Defendants TAKEDA PHARMACEUTICALS INTERNATIONAL, INC., TAKEDA PHARMACEUTICALS NORTH AMERICA, INC., TAKEDA PHARMACEUTICALS, LLC., TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC., and TAKEDA SAN DIEGO, INC.

22.  Upon information and belief, at all relevant times, Defendants and DOES 1 through 100, and each of them, inclusive, including Defendant TAKEDA PHARMACEUTICAL COMPANY LIMITED expected or should have expected that its acts would have consequences within the United States of America, the State of California, Los Angeles County and Ventura County and derive substantial revenue from interstate commerce.

23.  Upon information and belief, at all relevant times, Defendants and DOES 1 through 100, and each of them, inclusive, including Defendant TAKEDA PHARMACEUTICAL COMPANY LIMITED have transacted and conducted business in the State of California and/or contracted to supply goods and services within the State of California, including Los Angeles County and Ventura County and these causes of action have arisen from same.

24.  Upon information and belief, at all relevant times, Defendants and DOES 1 through 100, and each of them, inclusive, including Defendant TAKEDA PHARMACEUTICAL COMPANY LIMITED committed a tortious act without the State of California causing injury within the State of California out of which act(s) these causes of action arise.

25.  Upon information and belief, at all relevant times, Defendants and DOES 1 through 100, and each of them, inclusive, including Defendant TAKEDA PHARMACEUTICAL COMPANY LIMITED committed tortious act(s) within the State of California out of which act(s) these causes of action arise.

FACTUAL BACKGROUND

26.  At all relevant times, Defendants and DOES 1 through 100, and each of them, inclusive, designed, researched, manufactured, tested, advertised, promoted, marketed, sold, distributed, Actos and pioglitazone hydrochloride for treatment of Type 2 Diabetes Mellitus.

27.  Actos received FDA approval in 1999 to treat Type 2 Diabetes Mellitus.

28.  Prior to applying for and obtaining approval for Actos, Defendants and DOES 1 through 100, and each of them, inclusive, knew or should have known that Actos use in humans was associated with and/or would cause the induction of bladder cancer and said Defendants possessed pre-clinical scientific studies including animal evidence, which evidence said Defendants knew or should have known was a signal that bladder cancer risk needed to be further tested and studied before placing Actos on the market.

29.  Despite bladder cancer findings in animal model carcinogenicity studies and other pre-clinical evidence, Defendants and DOES 1 through 100, and each of them, inclusive, failed to adequately conduct complete and proper testing of Actos prior to filing its New Drug Application of Actos.

30.  It is now known that additional bladder cancer evidence from human clinical trials also became known to Defendants and DOES 1 through 100, and each of them, inclusive, in the early 2000’s.

31.  From the date of approval to market Actos, Defendants and DOES 1 through 100, and each of them, inclusive, made, distributed, marketed and sold Actos without adequate warning to Plaintiff’s prescribing physicians or Plaintiff that Actos was associated with and/or could cause bladder cancer and presented a risk of bladder cancer in patients who used it and without adequate warning that said Defendants had not adequately conducted complete and proper testing and studies of Actos with regard to carcinogenicity.

32.  For over 10 years and to date, Defendants and DOES 1 through 100, and each of them, inclusive, concealed and failed to completely disclose its knowledge that Actos was associated with or could cause bladder cancer or its knowledge that it had failed to fully study and test regarding that risk.

33.  By the Defendants’ and DOES 1 through 100, and each of their, inclusive, failure to disclose information that they possessed regarding the failure to adequately study and test Actos for bladder cancer risk further rendered warnings for this medication inadequate.

34.  Upon information and belief, Defendants and DOES 1 through 100, and each of them, inclusive, ignored the association between the use of Actos and pioglitazone hydrochloride and the risk of developing bladder cancer.

35.  On June 7, 2011, the Caisse nationale de l’assurance maladie, at the request of the French regulatory agency, published a report concluding that there is a statistically significant association between exposure to pioglitazone (Actos) and bladder cancer and that the risk increased with exposure longer than one year.

36.  On June 9, 2011, the European Medicine Agency suspended the use of Actos in light of the French Marketing Authorization Committee and the French National Pharmacovigilance Committee’s findings regarding the increased risk of bladder cancer.

37.  On June 10, 2011, Germany’s Federal Institute for Drugs and Medical Devices suspended the use of Actos.

38.  On June 15, 2011, the FDA informed the public that use of the diabetes medication Actos for more than one year may be associated with an increased risk of bladder cancer. The Actos label was then changed to reflect this information in the Warnings and Precautions section as well as the patient Medication Guide to include information regarding the risk of bladder cancer. 

39.  FDA further recommended on June 15, 2011 that healthcare professionals discontinue pioglitazone use in patients with active bladder cancer. 

40.  On June 17, 2011, Health Canada Press Release indicated that in light of studies suggesting an increased risk of bladder cancer with the diabetes drug pioglitazone, as well as actions taken by other regulatory agencies, Health Canada informed healthcare professionals and Canadians that it is undertaking a review of the drug's status.

41.  As a proximate result of Defendants’ and DOES 1 through 100, inclusive, and each of their conduct, Plaintiff  GERARD AINA’s physician prescribed Actos to said Plaintiff and said Plaintiff used Actos from approximately February of 2010 through approximately June of 2011 and the Defendants’ wrongful conduct was just recently discovered in or about August 2011.

42.  As result of using Defendants’ and DOES 1 through 100, inclusive, and each of their product Actos, Plaintiff was caused to suffer bodily injury in or about August 2010 and March 2011, and continuing thereafter, including cancerous tumor(s) in his bladder, and reoccurrence of same, and was thus caused to sustain severe and permanent personal injuries, pain, suffering, and mental anguish.  Plaintiffs could not, by the exercise of reasonable care, have discovered the causal relationship between Actos and Plaintiffs’ injuries until in or about August 2011.

43.  The injuries and damages sustained by Plaintiff were caused or substantially contributed to by Defendants’ and DOES 1 through 100, and each of their, inclusive, Actos and the said Defendants’ wrongful conduct.

44.  The product warnings for Actos in effect during the time period Plaintiff used Actos were vague, incomplete or otherwise inadequate, both substantively and graphically, to alert prescribing physicians as well as Plaintiff of the bladder cancer risk associated with this drug.

45.  The Defendants and DOES 1 through 100, and each of them, inclusive, did not provide adequate warnings to Plaintiff’s doctors, Plaintiff, the health care community and the general public about the increased risk of serious adverse events that are described herein.

46.  Had Plaintiff been adequately warned of the potential life-threatening side effects of the Defendants’ and DOES 1 through 100, and each of their, inclusive, Actos, Plaintiff would not have purchased or taken Actos and would have chosen to request other treatments or prescription medications.

47.  By reason of the foregoing, Plaintiff  has developed serious and dangerous side effects including bladder cancer, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and suffering, mental anguish, including diminished loss enjoyment of life, a risk of future cancer(s), reasonable fear of future cancer, any and all life complications caused by Plaintiff’s bladder cancer, as well as the need for lifelong medical treatment, monitoring and/or medications, and the loss of earnings, earning capacity and attendant medical expenses; all to the Plaintiff’s general and special damages in excess of the jurisdictional limits of the unlimited Court.

FIRST CAUSE OF ACTION

NEGLIGENCE

(Against All Defendants and DOES 1 through 100)

48.  Plaintiffs re-allege and incorporate here by reference, as though fully set forth at length herein, all of the allegations of all of the preceding paragraphs above.

49.  Defendants and DOES 1 through 100, and each of them, inclusive, had a duty to Plaintiffs to exercise reasonable care in the designing, researching, testing, manufacturing, marketing, supplying, promoting, packaging, sale and/or distribution of Actos and pioglitazone hydrochloride into the stream of commerce, including a duty to assure that Actos and pioglitazone hydrochloride would not cause users to suffer unreasonable, dangerous side effects such as cancer.

50.  Defendants and DOES 1 through 100, and each of them, inclusive, failed to exercise ordinary care and/or were reckless in designing, researching, manufacturing, marketing, supplying, promoting, packaging, sale, testing, quality assurance, quality control, and/or distribution of Actos into interstate commerce in that Defendants knew or should have known that using Actos caused a risk of unreasonable, dangerous side effects, including bladder cancer.

51.  Despite the fact that Defendants and DOES 1 through 100, and each of them, inclusive, knew or should have known that Actos was associated with and caused bladder cancer, Defendants continued to market, manufacture, distribute and/or sell Actos to consumers, including the Plaintiff.

52.  Defendants and DOES 1 through 100, and each of them, inclusive, knew or should have known that consumers such as the Plaintiff would foreseeably suffer injury as a result of said Defendants’ failure to exercise ordinary care, as set forth above.

53.  Defendants’ and DOES 1 through 100, and each of their, inclusive, negligence and/or recklessness was a substantial factor and legal and proximate cause of Plaintiff’s injuries, harm and economic loss which he suffered and/or will continue to suffer.

54.  The conduct of the Defendants and DOES 1 through 100, and each of them, inclusive, as described in this cause of action was a substantial factor and legal and proximate cause of the injuries and damages sustained by Plaintiff, and that said Defendants demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of Plaintiff  GERARD AINA, and that such intentional acts and omissions were substantial factors in causing his disease and injuries.

55.  As a foreseeable, direct and proximate result of the aforesaid con­duct of Defendants and DOES 1 through 100, and each of them, inclusive, Plaintiff  GERARD AINA has suf­fer­ed, and continues to suffer, permanent injuries to his person, body and health, including but not limited to, serious and dangerous side effects including bladder cancer, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, a risk of future cancer(s), reasonable fear of future cancer, any and all life complications caused by Plaintiff’s bladder cancer, all to his general damage in a sum in excess of the jur­isdictional limits of this Court.

56.  As a foreseeable, direct and proximate result of the aforesaid con­duct of Defendants and DOES 1 through 100, and each of them, inclusive, Plaintiff GERARD AINA was and will be compelled to and did employ medical and/or hospital care, attention, and services, including but not limited to, lifelong medical treatment, monitoring and/or medications, in an amount which has not as yet been fully ascer­tained and which will be asserted according to proof at trial.

57.  As a foreseeable, direct and proximate result of the aforesaid con­duct of Defendants and DOES 1 through 100, and each of them, inclusive, Plaintiffs have and/or will suffer loss of income and earnings, past, present and future and earning capacity in an amount which has not as yet been fully ascer­tained and which will be asserted according to proof at trial.

58.  As a foreseeable, direct and proximate result of the aforesaid con­duct of Defendants and DOES 1 through 100, and each of them, inclusive, Plaintiffs did necessarily incur and in the future will incur incidental expenses and dam­ages in an amount which has not as yet been fully ascer­tained and which will be asserted according to proof at trial.

59.  In particular, Plaintiffs would show that, as alleged here in this cause of action and throughout this complaint, that such intentional, grossly wanton acts and omissions by defendants and DOES 1 through 100, and each of them, inclusive, were substantial factors in causing his disease and injuries.  As the above referenced conduct complained of in this complaint of said Defendants was and is vile, base, willful, malicious, oppressive, and outrageous, and said Defendants demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of Plaintiff GERARD AINA, such that, Plaintiff, for the sake of example, and by way of punishing said defendants, seeks punitive damages according to proof at trial.

1. Plaintiffs are informed and believe and based thereon allege that in doing the acts alleged in this complaint, the Defendants, and each of them, acted with oppression, fraud, and malice, and Plaintiffs are therefore entitled to punitive damages to deter the Defendants, and each of them, and others from engaging in similar conduct in the future. The wrongful conduct described herein was undertaken with the advance knowledge, authorization, or ratification of an officer, director, or managing agent of Defendants, and each of them.
2. Plaintiffs maintain and reserve their rights to plead additional facts, theories of liability, causes of action in their complaint, and/or to present evidence pertaining to the acts and omissions of Defendants as may be subsequently identified through discovery and investigation in this matter.  Plaintiffs reserve the right to present such evidence at the time of trial based upon such subsequently discovered acts, omissions or damages that are heretofore unknown or unidentified prior to the date of service of this complaint and maintain and reserve their rights to thereafter move the court to conform pleadings to proof in this matter.

SECOND CAUSE OF ACTION

 STRICT LIABILITY - FAILURE TO WARN

(Against All Defendants and DOES 1 through 100)

62.  Plaintiffs re-allege and incorporate here by reference, as though fully set forth at length herein, all of the allegations of all of the preceding paragraphs above. 

63.  Defendants and DOES 1 through 100, and each of them, inclusive, researched, tested, developed, designed, licensed, manufactured, packaged, labeled, distributed, sold, marketed, and/or introduced Actos into the stream of commerce, and in the course of same, directly advertised or marketed Actos and pioglitazone hydrochloride to consumers or persons responsible for consumers, and therefore, had a duty to both the Plaintiff directly and Plaintiff’s physician to warn of risks associated with the use of the Product.

64.  Defendants and DOES 1 through 100, and each of them, inclusive, had a duty to warn of adverse drug reactions, which they know or have reason to know can be caused by the use of Actos and pioglitazone hydrochloride and/or are associated with the use of Actos and pioglitazone hydrochloride.

65.  The Actos and pioglitazone hydrochloride manufactured and/or supplied by the Defendants and DOES 1 through 100, and each of them, inclusive, was defective due to inadequate post-marketing warnings and/or instructions because, after the said Defendants knew or should have known of the risks of bladder cancer from Actos use, they failed to provide adequate warnings to consumers of the product, including Plaintiff and Plaintiff’s physicians, and continued to aggressively promote Actos.

66.  Due to the inadequate warning regarding bladder cancer, Actos was in a defective condition and unreasonably dangerous at the time that it left the control of the Defendants and DOES 1 through 100, and each of them, inclusive.

67.  Defendants and DOES 1 through 100, and each of them, inclusive, failed to adequately warn Plaintiff and Plaintiff’s prescribing physicians of human and animal results in preclinical studies pertaining to bladder cancer and Actos.

68.  Defendants’ and DOES 1 through 100, and each of their, inclusive, failure to adequately warn Plaintiff and Plaintiff’s prescribing physicians of a bladder cancer risk prevented Plaintiff’s prescribing physicians and Plaintiff from correctly and fully evaluating the risks and benefits of Actos and pioglitazone hydrochloride.

69.  Had Plaintiff been adequately warned of the potential life-threatening side effects of the Defendants’ and DOES 1 through 100, and each of them, inclusive, Actos and pioglitazone hydrochloride, Plaintiff would not have purchased or taken Actos and could have chosen to request other treatments or prescription medications.

70.  Upon information and belief, had Plaintiff’s prescribing physicians been adequately warned of the potential life-threatening side effects of the Defendants’ and DOES 1 through 100, and each of their, inclusive, Actos and pioglitazone hydrochloride, Plaintiff’s prescribing physicians would have discussed the risks of bladder cancer and Actos with the Plaintiff and/or would not have prescribed it.

71.  As a foreseeable and proximate result of the aforementioned wrongful acts and omissions of Defendants and DOES 1 through 100, and each of them, inclusive, Plaintiff was caused to suffer from the aforementioned injuries and damages.

72.  The failure to warn by Defendants and DOES 1 through 100, and each of them, inclusive, was a substantial factor and legal and proximate cause of Plaintiff GERARD AINA’s injuries and damages thereby sustained by Plaintiff, and that said Defendants demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of Plaintiff  GERARD AINA, and that such intentional acts and omissions were substantial factors in causing his disease and injuries.

73.  As a foreseeable, direct and proximate result of the aforesaid con­duct of Defendants and DOES 1 through 100, and each of them, inclusive, Plaintiff GERARD AINA suffered severe and permanent injuries to his person, and Plaintiff suffered damages as alleged above.

74.  In particular, Plaintiff would show that, as alleged here in this cause of action and throughout this complaint, that such intentional, grossly wanton acts and omissions by defendants and DOES 1 through 100, and each of them, inclusive, were substantial factors in causing his disease and injuries.  As the above referenced conduct complained of in this complaint of said Defendants was and is vile, base, willful, malicious, oppressive, and outrageous, and said Defendants demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of Plaintiff such that, Plaintiff, for the sake of example, and by way of punishing said defendants, seeks punitive damages according to proof.

THIRD CAUSE OF ACTION

 STRICT LIABILITY - DEFECTIVE DESIGN

(Against All Defendants and DOES 1 through 100)

75.  Plaintiffs re-allege and incorporate here by reference, as though fully set forth at length herein, all of the allegations of all of the preceding paragraphs above.

76.  Actos was expected to, and did, reach the intended consumers, handlers, and persons coming into contact with the product without substantial change in the condition in which it was produced, manufactured, sold, distributed, labeled, and marketed by Defendants and DOES 1 through 100, and each of them, inclusive.

77.  At all times relevant, Actos was manufactured, designed, and labeled in an unsafe, defective, and inherently dangerous condition, which was dangerous for use by the public, and, in particular, by Plaintiff.

78.  Actos and pioglitazone hydrochloride as researched, tested, developed, designed, licensed, manufactured, packaged, labeled, distributed, sold, and marketed by Defendants and DOES 1 through 100, and each of them, inclusive, was defective in design and formulation in that when it left the hands of the manufacturers and/or suppliers the foreseeable risks exceeded the alleged benefits associated with the design and formulation of Actos.

79.  Actos and pioglitazone hydrochloride as researched, tested, developed, designed, licensed, manufactured, packaged, labeled, distributed, sold, and marketed by Defendants and DOES 1 through 100, and each of them, inclusive, was defective in design and formulation, because when it left the hands of said Defendants’ manufacturers and suppliers it was unreasonably dangerous and was also more dangerous than the ordinary consumer would expect.

80.  At all times herein mentioned, Actos and pioglitazone hydrochloride was in a defective condition and was unsafe, and Defendants and DOES 1 through 100, and each of them, inclusive, knew and had reason to know that the product was defective and inherently unsafe, especially when Actos was used in a form and manner instructed and provided by said Defendants.

81.  Defendants and DOES 1 through 100, and each of them, inclusive, had a duty to create a product that was not unreasonably dangerous for its normal, common, intended use.

82.  At the time of Plaintiff’s use of Actos, it was being used for its intended purpose, and in a manner normally intended, namely for the treatment of Type 2 Diabetes Mellitus.

83.  Defendants and DOES 1 through 100, and each of them, researched, tested, developed, designed, licensed, manufactured, packaged, labeled, distributed, sold and marketed a defective product that caused an unreasonable risk to the health of consumers, and to Plaintiff in particular, and said Defendants are therefore strictly liable for the injuries and damages sustained by Plaintiff.

84.  At the time Defendants’ and DOES 1 through 100, and each of their, inclusive, product left their control, there was a practical, technically feasible, and safer alternative design that would have prevented the harm without substantially impairing the reasonably anticipated or intended function of Actos.  This was demonstrated by the existence of other Type 2 Diabetes Mellitus medications which had a more established safety profile and a considerably lower risk profile.

85.  Plaintiff could not, by the reasonable exercise of care, have discovered Actos’ defects and perceived its danger.

86.  The defects in the product of Defendants and DOES 1 through 100, and each of them, inclusive, were substantial and contributing factors in causing Plaintiff’s injuries.

87.  As a foreseeable, direct, and proximate result of the aforementioned wrongful acts and omissions of Defendants and DOES 1 through 100, and each of them, inclusive, Plaintiff was caused to suffer from the aforementioned injuries and damages.

88.  Due to the unreasonably dangerous condition of Actos, Defendants and DOES 1 through 100, and each of them, inclusive, are strictly liable to Plaintiff.

89.  The product defect in the product of the Defendants and DOES 1 through 100, and each of them, inclusive, was a substantial factor and legal and proximate cause of Plaintiff  GERARD AINA’s injuries and damages thereby sustained by Plaintiff, and that said Defendants demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of Plaintiff and that such intentional acts and omissions were substantial factors in causing his disease and injuries.

90.  As a foreseeable, direct and proximate result of the aforesaid con­duct of Defendants and DOES 1 through 100, and each of them, inclusive, Plaintiff GERARD AINA suffered severe and permanent injuries to his person, and Plaintiff suffered damages as alleged herein above.

91.  In particular, Plaintiff would show that, as alleged here in this cause of action and throughout this complaint, that such intentional, grossly wanton acts and omissions by defendants and DOES 1 through 100, and each of them, inclusive, were substantial factors in causing his disease and injuries.  As the above referenced conduct complained of in this complaint of said Defendants was and is vile, base, willful, malicious, oppressive, and outrageous, and said Defendants demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of Plaintiff such that, Plaintiff, for the sake of example, and by way of punishing said defendants, seeks punitive damages according to proof.

FOURTH CAUSE OF ACTION

 BREACH OF EXPRESS WARRANTY

            (Against All Defendants and DOES 1 through 100)

92.  Plaintiffs re-allege and incorporate here by reference, as though fully set forth at length herein, all of the allegations of all of the preceding paragraphs above.  

93.  Defendants and DOES 1 through 100, and each of them, inclusive, expressly warranted that Actos was safe for its intended use and as otherwise described in this complaint.  Actos did not conform to these express representations, including, but not limited to, the representation that it was well accepted in patient and animal studies, the representation that it was safe, and the representation that it did not have high and/or unacceptable levels of life-threatening side effects like bladder cancer, that it would improve health, maintain health, and potentially prolong life.

94.  The express warranties represented by the Defendants and DOES 1 through 100, and each of them, inclusive, were a part of the basis for Plaintiff’s use of Actos and Plaintiff relied on these warranties in deciding to use Actos.

95.  At the time of the making of the express warranties, the Defendants and DOES 1 through 100, and each of them, inclusive, had knowledge of the purpose for which the Actos and pioglitazone hydrochloride was to be used, and warranted same to be in all respects safe, effective and proper for such purpose.

96.  Defendants and DOES 1 through 100, and each of them, inclusive, breached the above‑described express warranty in that Actos does not conform to these express representations because Actos is not safe or effective and may produce serious side effects, including among other things bladder cancer, degrading Plaintiff’s health, and shrinking his life expectancy.

97.  The breaches of warranty by Defendants and DOES 1 through 100, and each of them, inclusive, as described in this cause of action was a substantial factor and legal and proximate cause of the injuries and damages sustained by Plaintiff.

98.  The breaches of warranty by Defendants and DOES 1 through 100, and each of them, inclusive, was a substantial factor and legal and proximate cause of Plaintiff GERARD AINA’s injuries and damages thereby sustained by Plaintiff, and that said Defendants demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of Plaintiff GERARD AINA, and that such intentional acts and omissions were substantial factors in causing his disease and injuries.

99.  As a foreseeable, direct and proximate result of the aforesaid con­duct of Defendants and DOES 1 through 100, and each of them, inclusive, Plaintiff GERARD AINA suffered severe and permanent injuries to his person, and Plaintiff suffered damages as alleged above in paragraphs 51 through 54.

1. In particular, Plaintiff would show that, as alleged here in this cause of action and throughout this complaint, that such intentional, grossly wanton acts and omissions by Defendants and DOES 1 through 100, and each of them, inclusive, were substantial factors in causing his disease and injuries.  As the above referenced conduct complained of in this complaint of said Defendants was and is vile, base, willful, malicious, oppressive, and outrageous, and said Defendants demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of Plaintiff  GERARD AINA, such that, Plaintiff, for the sake of example, and by way of punishing said defendants, seeks punitive damages according to proof.

FIFTH CAUSE OF ACTION

BREACH OF IMPLIED WARRANTY FOR A PARTICULAR PURPOSE

            (Against All Defendants and DOES 1 through 100)

1. Plaintiffs re-allege and incorporate here by reference, as though fully set forth at length herein, all of the allegations of all of the preceding paragraphs above.
2. At all times herein men­tioned, the Defendants and DOES 1 through 100, and each of them, inclusive, manufactured, compounded,  portrayed, distributed, recom­mended, merchandized, advertised, promoted and sold Actos and pioglitazone hydrochloride, to treat Type 2 Diabetes Mellitus.
3. The Defendants and DOES 1 through 100, and each of them, inclusive, implied­ly repre­sented and warranted to the users of Actos that Actos was safe and fit for the particular purpose for which said product was to be used, namely treating diabetes, improving health, maintaining health, and potentially prolonging life.
4. These representations and warranties aforemen­tioned were false, misleading, and inaccurate in that Actos and pioglitazone hydrochloride were unsafe, degraded Plaintiff’s health and shortened his life expectancy.
5. Plaintiff relied on the implied warranty of fitness for a particular use and purpose.
6. Plaintiff reasonably relied upon the skill and judgment of Defendants and DOES 1 through 100, and each of them, inclusive, as to whether Actos was safe and fit for its intended use.
7. Actos and pioglitazone hydrochloride were injected into the stream of commerce by the Defendants and DOES 1 through 100, and each of them, inclusive, in a defective, unsafe, and inherently dangerous condition and the products and materials were expected to and did reach users, handlers, and persons coming into contact with said products without substantial change in the condition in which they were sold.
8. Defendants and DOES 1 through 100, and each of them, inclusive, breached the aforesaid implied warranty, as their drug Actos was not fit for its intended purposes and uses.
9. The breaches of warranty by Defendants and DOES 1 through 100, and each of them, inclusive, as described in this cause of action was a substantial factor and legal and proximate cause of the injuries and damages sustained by Plaintiff.
10. The breaches of warranty by Defendants and DOES 1 through 100, and each of them, inclusive, was a substantial factor and legal and proximate cause of Plaintiff  GERARD AINA’s injuries and damages thereby sustained by Plaintiff, and that said Defendants demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of Plaintiff GERARD AINA, and that such intentional acts and omissions were substantial factors in causing his disease and injuries.
11. The breaches of warranty by Defendants and DOES 1 through 100, and each of them, inclusive, was a substantial factor and legal and proximate cause of Plaintiff ’s injuries and damages thereby sustained by Plaintiff, and that said Defendants demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of Plaintiff GERARD AINA and that such intentional acts and omissions were substantial factors in causing his disease and injuries.
12. As a foreseeable, direct and proximate result of the aforesaid con­duct of Defendants and DOES 1 through 100, and each of them, inclusive, Plaintiff GERARD AINA suffered severe and permanent injuries to his person, and Plaintiff suffered damages as alleged herein above.
13. In particular, Plaintiff would show that, as alleged here in this cause of action and throughout this complaint, that such intentional, grossly wanton acts and omissions by Defendants and DOES 1 through 100, and each of them, inclusive, were substantial factors in causing his disease and injuries.  As the above referenced conduct complained of in this complaint of said Defendants was and is vile, base, willful, malicious, oppressive, and outrageous, and said Defendants demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of Plaintiff  GERARD AINA such that, Plaintiff, for the sake of example, and by way of punishing said defendants, seeks punitive damages according to proof.

SIXTH CAUSE OF ACTION

BREACH OF IMPLIED WARRANTY OF MERCHANTABILITY

            (Against All Defendants and DOES 1 through 100)

1. Plaintiffs re-allege and incorporate here by reference, as though fully set forth at length herein, all of the allegations all of the preceding paragraphs above.
2. Defendants and DOES 1 through 100, and each of them, inclusive, manufactured, compounded, portrayed, distributed, recom­mended, merchandized, advertised, promoted and sold Actos and pioglitazone hydrochloride, to treat Type 2 Diabetes Mellitus.
3. Defendants and DOES 1 through 100, and each of them, inclusive, marketed, sold and distributed Actos and knew and promoted the use for which Actos was being used by Plaintiff and impliedly warranted to Plaintiff that Actos was of merchantable quality and fit for the ordinary purpose for which it was intended, namely treating diabetes, improving health, maintaining health, and potentially prolonging life.
4. These representations and warranties aforemen­tioned were false, misleading, and inaccurate in that Actos and pioglitazone hydrochloride were unsafe, degraded Plaintiff’s health and shortened his life expectancy.
5. Plaintiff reasonably relied on the skill, expertise and judgment of the Defendants and DOES 1 through 100, and each of their, inclusive, and its representations as to the fact that Actos was of merchantable quality.
6. The Actos and pioglitazone hydrochloride manufactured and supplied by the Defendants and DOES 1 through 100, and each of them, inclusive, was not of merchantable quality, as warranted by the Defendants in that the drug had dangerous and life threatening side effects and was thus not fit for the ordinary purpose for which it was intended.
7. The breaches of warranty by Defendants and DOES 1 through 100, and each of them, inclusive, as described in this cause of action was a substantial factor and legal and proximate cause of the injuries and damages sustained by Plaintiff.
8. The breaches of warranty by Defendants and DOES 1 through 100, and each of them, inclusive, was a substantial factor and legal and proximate cause of Plaintiff  GERARD AINA’s injuries and damages thereby sustained by Plaintiff, and that said Defendants demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of Plaintiff GERARD AINA and that such intentional acts and omissions were substantial factors in causing his disease and injuries.
9. The breaches of warranty by Defendants and DOES 1 through 100, and each of them, inclusive, was a substantial factor and legal and proximate cause of Plaintiff  GERARD AINA’s injuries and damages thereby sustained by Plaintiff, and that said Defendants demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of Plaintiff GERARD AINA and that such intentional acts and omissions were substantial factors in causing his disease and injuries.
10. As a foreseeable, direct and proximate result of the aforesaid con­duct of Defendants and DOES 1 through 100, and each of them, inclusive, Plaintiff GERARD AINA suffered severe and permanent injuries to his person, and Plaintiff suffered damages as alleged above in paragraphs 51 through 54.
11. In particular, Plaintiff would show that, as alleged here in this cause of action and throughout this complaint, that such intentional, grossly wanton acts and omissions by Defendants and DOES 1 through 100, and each of them, inclusive, were substantial factors in causing his disease and injuries.  As the above referenced conduct complained of in this complaint of said Defendants was and is vile, base, willful, malicious, oppressive, and outrageous, and said Defendants demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of Plaintiff GERARD AINA such that, Plaintiff, for the sake of example, and by way of punishing said defendants, seeks punitive damages according to proof.

SEVENTH CAUSE OF ACTION

VIOLATION OF CAL. BUSINESS & PROFESSIONS CODE §17200, et seq.

            (Against All Defendants and DOES 1 through 100)

1. Plaintiffs re-allege and incorporate here by reference, as though fully set forth at length herein, all of the allegations of all of the preceding paragraphs above.
2. Plaintiffs bring this cause of action pursuant to Business & Professions Code §17204, in an individual capacity, and not on behalf of the general public.
3. California Business & Professions Code §17200 provides that unfair competition shall mean and include “all unlawful, unfair or fraudulent business practices and unfair, deceptive, untrue or misleading advertising.”
4. The acts and practices described in Paragraphs 1 through 118 above, were and are likely to mislead the general public and therefore constitute unfair business practices within the meaning of Business and Professions Code §17200.  The acts of untrue and misleading advertising set forth in presiding paragraphs are incorporated by reference and are, by definition, violations of Business & Professions Code §17200.  This conduct includes, but is not limited to:
5. Representing to Plaintiff, Plaintiff’s physicians and the general public that Actos and pioglitazone hydrochloride were safe, fit and effective for human consumption, knowing that said representations were false, and concealing from the Plaintiff,  Plaintiff’s physicians and the general public that said products had a serious propensity to cause injuries to users;
6. Engaging in advertising programs designed to create the image, impression and belief by consumers, physicians that the use of Actos and pioglitazone hydrochloride was safe for human use, had fewer side effects and adverse reactions than other Type 2 Diabetes medications, constituted a convenient safe form even though the Defendants and DOES 1 through 100, and each of them, inclusive, knew these to be false, and even though the Defendants had no reasonable grounds to believe them to be true;
7. Purposely downplaying and understating the health hazards and risks associated with Actos and pioglitazone hydrochloride;
8. As a result of their conduct described above Defendants and DOES 1 through 100, and each of them, inclusive, have been and will be unjustly enriched.  Specifically, said Defendants have been unjustly enriched by receipt of billions of dollars in ill-gotten gains from the sale and prescription of said drugs in California, sold in large part as a result of the acts and omissions described herein.
9. Because of the misrepresentations made by Defendants and DOES 1 through 100, and each of them, inclusive, as detailed above, and the inherently unfair practice of committing a misrepresentations against the public by intentionally misrepresenting and concealing material information, the acts of said Defendants described herein constitute unfair or fraudulent business practices.
10. Plaintiff, pursuant to California Business & Professions Code §17203, seeks an order of this court compelling the Defendants and DOES 1 through 100, and each of them, inclusive, to provide restitution, and to disgorge the monies collected and profits realized by said Defendants as a result of their unfair business practices, and injunctive relief calling for said Defendants, and each of them, to cease such unfair business practices in the future.

EIGHTH CAUSE OF ACTION

VIOLATION OF CAL. BUSINESS & PROFESSIONS CODE §17500, et seq.

(Against All Defendants and DOES 1 through 100)

1. Plaintiffs re-allege and incorporate here by reference, as though fully set forth at length herein, all of the allegations of all of the preceding paragraphs above.
2. Plaintiffs bring this cause of action pursuant to Business & Professions Code §17535, in an individual capacity and not on behalf of the general public.
3. California Business & Professions Code §17500 provides that it is unlawful for any person, firm, corporation or association to dispose of property or perform services, or to induce the public to enter into any obligation relating thereto, through the use of untrue or misleading statements.
4. At all times herein mentioned Defendants and DOES 1 through 100, and each of them, inclusive, have committed acts of disseminating untrue and misleading statements as defined by Business & Professions Code §17500 by engaging in the following acts and practices with intent to induce members of the public to purchase and use Actos and pioglitazone hydrochloride:
5. Representing to Plaintiff, Plaintiff’s physicians and the general public that Actos and pioglitazone hydrochloride were safe, fit and effective for human consumption, knowing that said representations were false, and concealing from the Plaintiff, Plaintiff’s physicians and the general public that said products had a serious propensity to cause injuries to users;
6. Engaging in advertising programs designed to create the image, impression and belief by consumers and physicians that the use of Actos and pioglitazone hydrochloride was safe for human use, had fewer side effects and adverse reactions than other Type 2 Diabetes medications, constituted a convenient safe form even though the Defendants knew these to be false, and even though the Defendants had no reasonable grounds to believe them to be true;
7. Purposely downplaying and understating the health hazards and risks associated with Actos and pioglitazone hydrochloride;
8. The foregoing practices constitute false and misleading advertising within the meaning of California Business & Professions Code §17500.
9. The acts of untrue and misleading statements by Defendants and DOES 1 through 100, and each of them, inclusive, described herein above present a continuing threat to members of the public in that the acts alleged herein are continuous and ongoing, and the public will continue to suffer the harm alleged herein.
10. As a result of their false and misleading statements described above, Defendants and DOES 1 through 100, and each of them, inclusive, have been and will be unjustly enriched.  Specifically, said Defendants have been unjustly enriched by billions of dollars in ill-gotten gains from the sale and prescription of Actos and pioglitazone hydrochloride, sold in large part as a result of the false or misleading statements described herein.
11. Pursuant to California Business & Professions Code §17535, Plaintiff seek an order of this court compelling the Defendants and DOES 1 through 100, and each of them, inclusive, to provide restitution, and to disgorge the monies collected and profits realized by said Defendant, and each of them, as a result of their unfair business practices, and injunctive relief calling for said Defendants, and each of them, to cease such unfair business practices in the future.  Plaintiff seeks the imposition of a constructive trust over, and restitution and disgorgement of, monies collected and profits realized by said Defendants, and each of them, to cease such false and misleading advertising in the future.

NINTH CAUSE OF ACTION

DECEIT BY CONCEALMENT - CALIFORNIA CIVIL CODE §§ 1709, 1710

1. Plaintiffs reallege and incorporate herein by reference the foregoing paragraphs of this Complaint and further states as follows:
2. From the time that Actos was first tested, studied, researched, evaluated, endorsed, manufactured, marketed and distributed, and up to the present, Defendants and DOES 1 through 100, and each of them, inclusive, willfully deceived Plaintiff by concealing from the Plaintiff, Plaintiff’s health care providers and the general public, the true facts concerning the Actos, which the Defendants had a duty to disclose.
3. At all times relevant hereto, Defendants, and each of them, conducted a sales and marketing campaign to promote the sale of Actos and pioglitazone hydrochloride (hereinafter “PRODUCT”) and willfully deceived Plaintiff, Plaintiff’s physicians and the general public as to the health risks and consequences of the use of the PRODUCT was hazardous to health, and that the PRODUCT has a significant propensity to cause serious injuries to users including, but not limited to, the injuries suffered by Plaintiff as described herein.  
4. Defendants intentionally concealed and suppressed the true facts concerning the PRODUCT with the intent to defraud Plaintiff, in that Defendants knew that Plaintiff’s physicians would not have prescribed the PRODUCT and Plaintiff would not have used the PRODUCT if Plaintiff had known the true facts concerning the dangers of the PRODUCT. 
5. As a result of the foregoing fraudulent and deceitful conduct by Defendants, and each of them, Plaintiffs suffered injuries and damages as described herein.

TENTH CAUSE OF ACTION

NEGLIGENT MISREPRESENTATION

1. Plaintiffs reallege and incorporate herein by reference the foregoing paragraphs of this Complaint and further states as follows:
2. Defendants, and each of them, from the time that the PRODUCT was first tested, studied, researched, manufactured, marketed and distributed, and up to the present, made false representations, as previously set forth herein, to Plaintiff, Plaintiff’s health care providers, and the general public including, but not limited to, the misrepresentation that the PRODUCT was safe, fit, and effective for human consumption.
3. At all times relevant hereto, Defendants, and each of them, conducted a sales and marketing campaign to promote the sale of the PRODUCT and willfully deceive Plaintiff, Plaintiff’s health care providers, and the general public as to the health risks and consequences of the use of the PRODUCT.
4. Defendants made the foregoing misrepresentations without any reasonable ground for believing them to be true. These misrepresentations were made directly by Defendants, by sales representatives and other authorized agents of said Defendants, and in publications and other written materials directed to physicians, patients, and the general public, with the intention of inducing reliance and the prescription, purchase, and use of the PRODUCT.
5. The foregoing representations by Defendants, and each of them, were in fact false, in that the PRODUCT is not, and at all relevant times alleged herein, was not safe, fit, and effective for human consumption, the use of the PRODUCT is hazardous to health, and the PRODUCT has a significant propensity to cause serious injuries to users including, but not limited to, the injuries suffered by Plaintiffs as described herein.  The foregoing misrepresentations by Defendants, and each of them, were made with the intention of inducing reliance and inducing the prescription, purchase, and use of the PRODUCT.
6. In reliance on the misrepresentations by Defendants, and each of them, Plaintiffs were induced to purchase and use the PRODUCT.  If Plaintiffs had known of the true facts concealed by Defendants, Plaintiffs would not have used the PRODUCT. The reliance by Plaintiffs upon Defendants’ misrepresentations was justified because such misrepresentations were made by Defendants through individuals and entities that were in a position to know the true facts.
7. As a result of the foregoing negligent misrepresentations by Defendants, and each of them, Plaintiffs suffered injuries and damages as described above.  Defendants’ conduct was and is vile, base, willful, malicious, oppressive, and outrageous, and said Defendants demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of Plaintiff such that, Plaintiff, for the sake of example, and by way of punishing said defendants, seeks punitive damages according to proof.

ELEVENTH CAUSE OF ACTION

VIOLATION OF CALIFORNIA CIVIL CODE §§ 1750 ET. SEQ

1. Plaintiffs reallege and incorporate herein by reference each of the foregoing paragraphs of this Complaint as though fully set forth herein.
2. Plaintiffs are informed and believe and thereon alleges that Defendants, and each of them, by the acts and misconduct alleged herein, violated the Consumers Legal Remedies Act, California Civil Code  §§ 1750 et. seq. (“CLRA”).
3. Plaintiffs hereby seek injunctive relief as appropriate against Defendants, and each of them, for their violations of California Civil Code §§ 1750 et. seq. The CLRA applies to Defendants’ actions and conduct described herein because it extends to transactions which are intended to result, or which have resulted, in the sale of goods to consumers.
4. Plaintiffs are “consumers” within the meaning of California Civil Code § 1761(d).
5. Defendants have violated, and continue to violate, the CLRA in representing that goods have characteristics and benefits which they do not have, in violation of California Civil Code § 1770(a)(5).
6. At all times herein alleged Defendants have committed acts of disseminating untrue and misleading statements as defined by California Civil Code § 1770, by engaging in the following acts and practices with intent to induce members of the public to purchase and use the PRODUCT: by engaging in the following acts and practices with intent to induce members of the public to purchase and use Actos and pioglitazone hydrochloride;
7. Representing to Plaintiff, Plaintiff’s physicians and the general public that Actos and pioglitazone hydrochloride were safe, fit and effective for human consumption, knowing that said representations were false, and concealing from the Plaintiff, Plaintiff’s physicians and the general public that said products had a serious propensity to cause injuries to users;
8. Engaging in advertising programs designed to create the image, impression and belief by consumers and physicians that the use of Actos and pioglitazone hydrochloride was safe for human use, had fewer side effects and adverse reactions than other Type 2 Diabetes medications, constituted a convenient safe form even though the Defendants knew these to be false, and even though the Defendants had no reasonable grounds to believe them to be true;
9. Purposely downplaying and understating the health hazards and risks associated with Actos and pioglitazone hydrochloride.
10. The foregoing practices constitute false and misleading advertising and representations within the meaning of California Civil Code § 1770. The acts of untrue and misleading statements by Defendants described herein present a continuing threat to members of the public and individual consumers in that the acts alleged herein are continuous and ongoing, and the public and individual consumers will continue to suffer harm as alleged herein.
11. Unless Defendants are enjoined from continuing to engage in these violations of the CLRA, Plaintiffs will continue to be harmed by the wrongful actions and conduct of Defendants. Pursuant to California Civil Code § 1780, Plaintiffs seek an order of this court for injunctive relief calling for Defendants, and each of them, to cease such deceptive business practices in the future. 

TWELFTH CAUSE OF ACTION

 LOSS OF CONSORTIUM

(Against All Defendants and DOES 1 through 100)

1. Plaintiffs reallege and incorporate herein by reference each of the foregoing paragraphs of this Complaint as though fully set forth herein.
2. Plaintiff GERARD AINA became legally married to Plaintiff JOYCE AINA on September 27, 1958 and, at all relevant times alleged herein the Plaintiffs were, and are, legally married to one another.
3. As a direct and proximate result of the injuries and damages alleged herein, Plaintiff JOYCE AINA was deprived of the comfort and enjoyment of the services and society of her legal spouse Plaintiff GERARD AINA, and has suffered and will continue to suffer general and special damages including, but not limited to, economic loss, and has otherwise been emotionally and economically injured.  The Plaintiff’s injuries and damages are permanent and will continue into the future.  The Plaintiffs seek general, compensatory, special and punitive damages from the Defendant as alleged herein.
4. At all relevant times alleged herein Plaintiff JOYCE AINA was and is the lawful spouse of Plaintiff GERARD AINA and, as such, was and is entitled to the comfort, enjoyment, society and services.
5. Plaintiff GERARD AINA sustained injuries caused by Actos.  Prior to the aforesaid injuries, Plaintiff GERARD AINA was able to and did perform duties as a spouse to Plaintiff JOYCE AINA.
6. Subsequent to the injuries, and as a proximate result thereof, Plaintiff GERARD AINA was unable to perform the necessary duties as a spouse and the work and service usually performed in the care, maintenance and management of the family home, and therefore has sustained special damages in an amount which has not as yet been fully ascer­tained and which will be asserted according to proof at trial.
7. Subsequent to the injuries, and as a proximate result thereof, Plaintiff  JOYCE AINA suffered loss of consortium, including, but not by way of limitation, loss of services, marital relations, society, comfort, companionship, love and affection of her said spouse, and has suffered severe mental and emotional distress and general nervousness as a result thereof.
8. As the above referenced conduct complained of in this complaint of Defendants and DOES 1 through 100, and each of them, inclusive, was and is vile, base, willful, malicious, fraudulent, oppressive, outrageous, and that said defendants, and each of them, demonstrated such an entire want of care as to establish that their acts and omissions were the result of actual conscious indifference to the rights, safety, and welfare of plaintiff  GERARD AINA, such that plaintiff, for the sake of example, and by way of punishing said defendants, seeks punitive damages according to proof.

PRAYER FOR RELIEF

WHEREFORE, Plaintiffs pray judgment against Defendants, and DOES 1 through 100, and each of them, inclusive, as follows:

            1.  For general damages according to proof; 

            2.  For special damages according to proof;

            3.  For medical and related expenses according to proof; 

            4.  For loss of income, earning capacity, earning potential according to proof; 

            5.  For loss of consortium damages according to proof;

            6.  For exemplary or punitive damages according to proof; 

            7.  For costs of suit herein;

8.  For prejudgment interest on all damages as allowed by laws;

9.  For injunctive relief, enjoining Defendants from the acts of unfair competition and untrue and misleading advertising;

10.  For disgorgement of profits according to proof; and

            11.  For such other and further relief as the Court deems just and proper.

Dated:  December 27, 2011

Baum, Hedlund, Aristei & Goldman, P.C.   

Michael L. Baum, Esq.

Cynthia L. Garber, Esq.

Attorneys for Plaintiffs      

DEMAND FOR JURY TRIAL

Plaintiffs demand a jury trial on all issues.  

Dated:  December 29, 2011

Baum, Hedlund, Aristei & Goldman, P.C.

Michael L. Baum, Esq.

Cynthia L. Garber, Esq.

Attorneys for Plaintiffs