This Yasmin lawsuit was filed in March of 2009 in the Northern District of California:
21. Yasmin, known generically as drospirenone and ethinyl estradiol, is a combination birth control pill containing the hormones estrogen and progestin and was approved by the FDA in April 2001. In the case of Yasmin, the estrogen is ethinyl estradiol and the progestin is drospirenone.
22. Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.
23. Combination birth control pills are referred to as combined hormonal oral contraceptives.
24. The difference between Yasmin and other birth control pills on the market is that drospirenone has never before been marketed in the United States and is unlike other progestins available in the United States.
25. In April 2002, the British Medical Journal reported that the Dutch College of General Practitioners recommended that older second generation birth control pills be prescribed in lieu of Yasmin as a result of 40 cases of venous thrombosis among women taking Yasmin.
26. In February 2003, a paper entitled Thromboembolism associated with the newly contraceptive Yasmin was published in the British Medical Journal detailing a Netherlands Pharmacovigilance Centre report of five additional reports of thromboembolism where Yasmin was suspected as the cause, including two deaths.27. Defendants have twice been warned by the FDA, in 2003 and 2008, for misleading the public through the use of television ads which overstate the efficacy of Yasmin and minimize serious risks associated with the drug.
28. The use of Yasmin has a prothrombotic effect resulting in thrombosis such as the pulmonary embolism suffered by Plaintiff.
29. Defendants failed or neglected to recognize the correlation between the use of Yasmin and increased thrombosis formation despite the wealth of scientific information available.
30. Upon information and belief, Defendants knew or should have known about the correlation between Yasmin use and a prothrombotic effect and still promoted, sold, advertised, and marketed the use of Yasmin.
31. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of Yasmin to Plaintiff herein, Plaintiff was prescribed with and ingested Yasmin, sustaining severe and permanent personal injuries, to wit: pulmonary embolism and all resulting damages, including the potential for future thrombembolic events.
United States District Court, N.D. California.
TANNER et al,
v.
BAYER CORPORATION et al.
No. 09CV01558.
April 9, 2009.
Complaint for Damages and Demand for Jury Trial
Note: This document was obtained from the above titled case. (PDF information
below.)
Court: Superior Court of California.
Title: BRIDGET RENEE TANNER and RUSSELL TANNER, wife and husband, Plaintiffs, v.
BAYER CORPORATION, an Indiana corporation; BAYER HEALTHCARE PHARMACEUTICALS INC.,
a Delaware corporation; BAYER HEALTHCARE, LLC, a Delaware limited liability
company; BERLEX LABORATORIES INTERNATIONAL, INC., a Delaware corporation; BAYER
SCHERING PHARMA AG, a German corporation; BAYER AG, a German corporation; SCHERING
AG, a German corporation; MCKESSON Corporation, a Delaware corporation; and Does
1-50, Defendants.
Docket Number: No. CGC-09-486035.
Date: March 11, 2009.
Robert F. Clarke, Esq. (CA Bar ID 79881), Lowell W. Finson, Esq. (AZ Bar ID
010872), Phillips & Associates, 3030 North Third Street, Suite 1100, Phoenix,
Arizona 85012, Tel: (602) 258-8900 ext. 295, Fax: (602) 279-9155, Attorneys for
Plaintiffs.
For their Complaint against the defendants, Plaintiffs allege:
NATURE OF THE ACTION
1. This is an action for strict products liability, breach of express and implied
warranty, negligence, negligence per se, fraudulent misrepresentation, fraudulent
concealment, fraud and negligent misrepresentation brought by Plaintiffs for
damages associated with plaintiff BRIDGET RENEE TANNER'S (hereinafter, singularly,
"Plaintiff") ingestion of the pharmaceutical drug Yasmin (drospirenone and ethinyl
estradiol) (hereinafter, "Yasmin"), an oral contraceptive designed, manufactured,
marketed, and distributed by Defendants. As a result of the ingestion of the
pharmaceutical drug Yasmin, Plaintiff has suffered injuries to her person
including but not limited to pulmonary embolism.
PARTIES
2. Plaintiffs BRIDGET RENEE TANNER and RUSSELL TANNER, wife and husband, are, and
at all relevant times were, citizens and residents of the City of Evergreen,
Avoyelles Parish, State of Louisiana.
3. Plaintiff BRIDGET RENEE TANNER was prescribed and ingested Yasmin, and as a
result suffered severe injuries and other damages, including but not limited to
pulmonary embolism.
4. Defendant BAYER CORPORATION is an Indiana corporation, with its principal place
of business at 100 Bayer Road, Pittsburgh, Pennsylvania 15205. BAYER CORPORATION
researches, develops, manufactures and markets pharmaceutical products, including
Yasmin. At all relevant times, Defendant BAYER CORPORATION conducted regular and
sustained business in California by selling and distributing its products in
California, and engaged in substantial commerce and business activity in the
County of San Francisco.
5. Defendant BAYER HEALTHCARE PHARMACEUTICALS, INC., is a Delaware corporation,
with its principal place of business at 6 West Belt Road, Wayne, New Jersey 07470.
BAYER HEALTHCARE PHARMACEUTICALS, INC., was created by the integration of Bayer
Healthcare and Berlex Laboratories. BAYER HEALTHCARE PHARMACEUTICALS, INC.,
researches, develops, manufactures and markets pharmaceutical products, including
Yasmin. At all relevant times, Defendant BAYER HEALTHCARE PHARMACEUTICALS, INC.,
conducted regular and sustained business in California by selling and distributing
its products in California, and engaged in substantial commerce and business
activity in the County of San Francisco.
6. Defendant BAYER HEALTHCARE, LLC, is a Delaware limited liability company, with
its principal place of business at 555 White Plains Road, Tarrytown, New York
10591. BAYER HEALTHCARE, LLC, was involved in the integration of Bayer HealthCare
and Berlex Laboratories. BAYER HEALTHCARE, LLC, researches, develops, manufactures
and markets pharmaceutical products, including Yasmin. At all relevant times,
Defendant BAYER HEALTHCARE, LLC, conducted regular and sustained business in
California by selling and distributing its products in California, and engaged in
substantial commerce and business activity in the County of San Francisco.
7. Upon information and belief, Defendant BERLEX LABORATORIES INTERNATIONAL, INC.,
was a Delaware corporation with its principal place of business in Montville, New
Jersey. BERLEX LABORATORIES INTERNATIONAL, INC., was integrated with Bayer
HealthCare, leading to the creation of Bayer Healthcare Pharmaceuticals, Inc.
BERLEX LABORATORIES INTERNATIONAL, INC., was involved in the research,
development, manufacturing and marketing of the pharmaceutical product Yasmin. At
all relevant times, Defendant BERLEX LABORATORIES INTERNATIONAL, INC., conducted
regular and sustained business in California by selling and distributing its
products in California, and engaged in substantial commerce and business activity
in the County of San Francisco.
8. Upon information and belief, Defendant BAYER SCHERING PHARMA AG is a global
pharmaceutical corporation headquartered in Germany. BAYER SCHERING PHARMA AG was
created in 2006 when Bayer AG acquired Schering AG. Through its subsidiaries and
divisions, BAYER SCHERING PHARMA AG researches, develops, manufactures, and
markets pharmaceutical products, including Yasmin. At all relevant times,
Defendant BAYER SCHERING PHARMA AG conducted regular and sustained business in
California by selling and distributing its products in California, and engaged in
substantial commerce and business activity in the County of San Francisco.
9. Upon information and belief, Defendant BAYER AG was a global pharmaceutical
corporation headquartered in Germany. BAYER AG was merged into Bayer Schering AG
in 2006 when BAYER AG acquired Schering AG. Through its subsidiaries and
divisions, BAYER AG researched, developed, manufactured, and marketed
pharmaceutical products, including Yasmin. At all relevant times, Defendant BAYER
AG conducted regular and sustained business in California by selling and
distributing its products in California, and engaged in substantial commerce and
business activity in the County of San Francisco.
10. Upon information and belief, Defendant SCHERING AG was a global pharmaceutical
corporation headquartered in Germany. SCHERING AG was merged into Bayer Schering
AG in 2006 when SCHERING AG was acquired by Bayer AG. Through its subsidiaries and
divisions, SCHERING AG researched, developed, manufactured, and marketed
pharmaceutical products, including Yasmin. At all relevant times, Defendant
SCHERING AG conducted regular and sustained business in California by selling and
distributing its products in California, and engaged in substantial commerce and
business activity in the County of San Francisco.
11. Defendants BAYER CORPORATION, BAYER HEALTHCARE PHARMACEUTICALS, INC., BAYER
HEALTHCARE, LLC, BERLEX LABORATORIES INTERNATIONAL, INC., BAYER SCHERING PHARMA
AG, BAYER AG, and SCHERING AG are collectively referred to herein as "Bayer".
12. At all times alleged herein, Bayer includes and included any and all parents,
subsidiaries, affiliates, divisions, franchises, partners, joint venturers, and
organizational units of any kind, their predecessors, successors and assigns and
their officers, directors, employees, agents, representatives and any and all
other persons acting on their behalf.
13. Defendant MCKESSON CORPORATION was and is a corporation organized and existing
under the laws of the State of Delaware, with its principal place of business at
One Post Street, San Francisco, California 94104. MCKESSON CORPORATION was and is
authorized to do business in the State of California and was engaged in
substantial commerce and business activity in the County of San Francisco.
14. At all times alleged herein, MCKESSON CORPORATION includes and included any
and all parents, subsidiaries, affiliates, divisions, franchises, partners, joint
venturers, and organizational units of any kind, their predecessors, successors
and assigns and their officers, directors, employees, agents, representatives and
any and all other persons acting on their behalf.
15. The true names or capacities, whether individual, corporate, or otherwise, of
Defendants Does 1-50, are unknown to Plaintiffs who therefore sue said Defendants
by such fictitious names. Plaintiffs believe and allege that each of the
Defendants designated herein by fictitious names is in some manner legally
responsible for the events and happenings herein referred to and proximately
caused foreseeable damages to Plaintiffs as alleged herein.
16. As used herein, "Defendants" includes all named Defendants as well as Does
1-50.
17. Defendants, either directly or through their agents, apparent agents, servants
or employees, at all relevant times, sold and distributed Yasmin in the States of
California, Louisiana, and in other states and foreign countries.
18. Defendants derive substantial revenue from pharmaceutical products used or
consumed in the State of California.
19. Defendants expected or should have expected, that their business activities
could or would have consequences within the State of California, as well as
throughout the United States.
FACTUAL BACKGROUND
20. At all relevant times, defendants designed, manufactured, marketed, and
distributed Yasmin, an oral contraceptive.
21. Yasmin, known generically as drospirenone and ethinyl estradiol, is a
combination birth control pill containing the hormones estrogen and progestin and
was approved by the FDA in April 2001. In the case of Yasmin, the estrogen is
ethinyl estradiol and the progestin is drospirenone.
22. Yasmin is indicated for the prevention of pregnancy in women who elect to use
an oral contraceptive.
23. Combination birth control pills are referred to as combined hormonal oral
contraceptives.
24. The difference between Yasmin and other birth control pills on the market is
that drospirenone has never before been marketed in the United States and is
unlike other progestins available in the United States.
25. In April 2002, the British Medical Journal reported that the Dutch College of
General Practitioners recommended that older second generation birth control pills
be prescribed in lieu of Yasmin as a result of 40 cases of venous thrombosis among
women taking Yasmin.
26. In February 2003, a paper entitled Thromboembolism associated with the newly
contraceptive Yasmin was published in the British Medical Journal detailing a
Netherlands Pharmacovigilance Centre report of five additional reports of
thromboembolism where Yasmin was suspected as the cause, including two deaths.
27. Defendants have twice been warned by the FDA, in 2003 and 2008, for misleading
the public through the use of television ads which overstate the efficacy of
Yasmin and minimize serious risks associated with the drug.
28. The use of Yasmin has a prothrombotic effect resulting in thrombosis such as
the pulmonary embolism suffered by Plaintiff.
29. Defendants failed or neglected to recognize the correlation between the use of
Yasmin and increased thrombosis formation despite the wealth of scientific
information available.
30. Upon information and belief, Defendants knew or should have known about the
correlation between Yasmin use and a prothrombotic effect and still promoted,
sold, advertised, and marketed the use of Yasmin.
31. As a result of the manufacture, marketing, advertising, promotion,
distribution and/or sale of Yasmin to Plaintiff herein, Plaintiff was prescribed
with and ingested Yasmin, sustaining severe and permanent personal injuries, to
wit: pulmonary embolism and all resulting damages, including the potential for
future thrombembolic events.
FIRST CAUSE OF ACTION
(Negligence and Negligence Per Se)
32. Plaintiffs restate the allegations set forth above as if fully rewritten
herein.
33. Defendants, directly or indirectly, negligently and/or defectively designed,
tested, inspected, manufactured, assembled, developed, labeled, sterilized,
licensed, marketed, advertised, promoted, sold, packaged, supplied and/or
distributed Yasmin.
34. At all times material hereto, defendants had a duty to users and/or consumers
of Yasmin, including Plaintiff, to exercise reasonable care in the design,
testing, inspection, manufacture, assembly, development, labeling, sterilization,
licensing, marketing, advertising, promotion, sale, packaging, supply and/or
distribution of Yasmin.
35. Defendants breached that duty and were negligent in the design, testing,
inspection, manufacture, assembly, development, labeling, sterilization,
licensing, marketing, advertising, promotion, sale, packaging, supply and/or
distribution of Yasmin in that: Yasmin was defective when put on the market by
defendants; that with such defect, Yasmin was reasonably certain to be dangerous
when put to normal use; and that defendants failed to use reasonable care in
designing or making Yasmin or in inspecting it for defects. Specifically,
defendants breached their duty by, among other things:
a. Failing to include adequate warnings that would alert the medical,
pharmaceutical and/or scientific communities, and users and/or consumers of the
drug, including Plaintiff, to the potential risks and serious side effects of the
drug;
b. Failing to adcquatcly and properly test and inspect the drug before placing the
drug on the market;
c. Failing to conduct sufficient testing and inspection of the drug which, if
properly performed, would have shown that the drug had serious side effects,
including, but not limited to, pulmonary embolus, deep venous thrombosis and/or
death and other serious and life threatening side effects;
d. Failing to adequately warn the medical, pharmaceutical and/or scientific
communities, and users and/or consumers of the drug, including Plaintiff, of the
potential risks and other serious side effects associated with the drug,
including, among other things, pulmonary embolus, deep venous thrombosis and/or
death and other serious and life threatening side effects;
e. Failing to provide adequate post-marketing warnings or instructions after
Defendants knew or should have known of the significant risks associated with the
use of the drug;
f. Failing to recall and/or remove the drug from the stream of commerce despite
the fact that Defendants knew or should have known of the defective and
unreasonably dangerous nature of the drug, including the significant health risks
associated with the use of the drug;
g. Encouraging misuse and overuse while failing to disclose the side effects of
the drug to the medical, pharmaceutical and/or scientific communities, and users
and/or consumers, including Plaintiff, in order to maximize profit from sales.
36. Defendants knew or should have known that Yasmin caused unreasonably dangerous
risks and serious side effects of which users and/or consumers of the drug,
including Plaintiff, was not aware. Defendants nevertheless advertised, promoted,
marketed, sold, distributed and/or supplied Yasmin knowing that there were safer
methods for contraception.
37. By reason of the foregoing, Plaintiff experienced and is at risk of
experiencing serious and life-threatening side effects including but not limited
to, pulmonary emboli, as well as other severe and personal injuries, including
future thromboembolic events, which are permanent and lasting in nature, physical
pain and mental anguish, including diminished enjoyment of life, as well as the
need for lifelong medical treatment, monitoring and/or medications, and fear of
developing any of the above named health consequences.
38. By reason of the foregoing, Plaintiff was damaged by the negligence and wanton
and willful recklessness of the Defendants.
39. As a direct, legal, proximate and producing result of the negligence of
defendants, Plaintiff sustained injuries as set forth above.
40. As a result of the foregoing acts and omissions, Plaintiff requires and/or
will require more health care and services and did incur medical, health,
incidental and related expenses. Plaintiffs are informed and believe and further
allege that Plaintiff will in the future be required to obtain further medical
and/or hospital care, attention, and services.
SECOND CAUSE OF ACTION
(Strict Products Liability -- Unreasonably Dangerous Design)
41. Plaintiffs restate the allegations set forth above as if fully rewritten
herein.
42. At all times material hereto, Defendants have engaged in the business of
designing, testing, inspecting, manufacturing, assembling, developing, labeling,
sterilizing, licensing, marketing, advertising, promoting, selling, packaging,
supplying and/or distributing the drug Yasmin, which is defective and unreasonably
dangerous to users and/or consumers of the drug, including Plaintiff.
43. At all times material hereto, Yasmin was designed, tested, inspected,
manufactured, assembled, developed, labeled, sterilized, licensed, marketed,
advertised, promoted, sold, packaged, supplied and/or distributed by Defendants in
a defective and unreasonably dangerous condition in ways which include, but are
not limited to, one or more of the following:
a. When placed in the stream of commerce, the drug contained unreasonably
dangerous design defects and was not reasonably safe and fit for its intended or
reasonably foreseeable purpose or as intended to be used, thereby subjecting users
and/or consumers of the drug, including Plaintiff, to risks which exceeded the
benefits of the drug;
b. The drug was insufficiently tested;
c. The drug caused harmful side effects that outweighed any potential utility;
d. The drug was not accompanied by adequate labeling or instructions for use to
fully apprise the medical, pharmaceutical and/or scientific communities, and users
and/or consumers of the drug, including Plaintiff, of the potential risks and
serious side effects associated with its use;
e. In light of the potential and actual risk of harm associated with the drug's
use, a reasonable person who had actual knowledge of this potential and actual
risk of harm would have concluded that Yasmin should not have been marketed in
that condition.
44. At all times the drug Yasmin was designed, tested, inspected, manufactured,
assembled, developed, labeled, sterilized, licensed, marketed, advertised,
promoted, sold, packaged, supplied and/or distributed, it was expected to reach,
and did reach, users and/or consumers of the drug across the United States,
including Plaintiff, without substantial change in the defective and unreasonably
dangerous condition in which it was sold.
45. At all times, Plaintiff used Yasmin (drospirenone and ethinyl estradiol) for
its intended or reasonably foreseeable purpose.
46. As a direct, legal, proximate and producing result of the defective and
unreasonably dangerous condition of Yasmin, Plaintiff sustained injuries as set
forth above.
THIRD CAUSE OF ACTION
(Strict Products Liability -- Failure to Warn)
47. Plaintiffs restate the allegations set forth above as if fully rewritten
herein.
48. Yasmin was defective and unreasonably dangerous when it left the possession of
Defendants in that it contained warnings insufficient to alert the medical,
pharmaceutical and/or scientific communities, and users and/or consumers of the
drug, including Plaintiff, to the dangerous risks and reactions associated with
Yasmin when used for its intended or reasonably foreseeable purpose. Those
dangerous risks and reactions included, but were not limited to, pulmonary
embolus, deep venous thrombosis and/or death and other serious and lire
threatening side effects.
49. At all times, Plaintiff used the drug for its intended or reasonably
foreseeable purpose.
50. Plaintiff could not have discovered any defect in the drug through the
exercise of care.
51. Defendants, as manufacturers of a prescription drug, are held to the level of
knowledge of an expert in the field.
52. The warnings that were given by Defendants were not accurate or clear and/or
were ambiguous.
53. Defendants had a continuing duty to warn the medical, pharmaceutical and/or
scientific communities, and users and/or consumers of Yasmin, including Plaintiff,
of the potential risks and serious side effects associated with the use of the
drug.
54. As a direct, legal, proximate and producing result of Defendants' failure to
warn, Plaintiff sustained injuries as set forth above.
FOURTH CAUSE OF ACTION
(Breach of Express Warranty)
55. Plaintiffs restate the allegations set forth above as if fully rewritten
herein.
56. Defendants made express representations to the consuming public at large
through their aggressive marketing and advertising campaigns relative to their
product, Yasmin.
57. Defendants through their detail sales representatives, made representations of
the safety and efficacy of their product, Yasmin.
58. Yasmin does not conform to the express representations made through
Defendants' advertising and marketing efforts.
59. Yasmin does not conform to the express representations made by Defendants'
agents/sales representatives.
60. Defendants' conduct in this matter was a contributing cause of injuries and
damages suffered by plaintiff.
FIFTH CAUSE OF ACTION
(Breach of Im??lled Warranties)
61. Plaintiffs restate the allegations set forth above as if fully rewritten
herein.
62. At the time that Defendants designed, tested, inspected, manufactured,
assembled, developed, labeled, sterilized, licensed, marketed, advertised,
promoted, sold, packaged, supplied and/or distributed the drug Yasmin, Defendants
knew of the intended, reasonably foreseeable and/or ordinary use of Yasmin and
impliedly warranted the drug to be of merchantable quality and safe and fit for
such use.
63. Plaintiff, in ingesting Yasmin, reasonably relied upon the skill and judgment
of Defendants as to whether Yasmin was of merchantable quality and safe and fit
for its intended, reasonably foreseeable and/or ordinary use.
64. In breach of the implied warranty given by Defendants, Yasmin was not of
merchantable quality or safe or fit for its intended, reasonably foreseeable
and/or ordinary use because the product was and is unmerchantable, in a defective
condition and unreasonably dangerous and unfit for the intended, reasonably
foreseeable and/or ordinary purpose for which it was intended as described above.
65. In breach of the implicd warranty given by defendants, Yasmin was not of
merchantable quality or safe or fit for its intended, reasonably foreseeable
and/or ordinary use because, among other things:
a. Use of Yasmin carried a risk of, among other things, pulmonary embolus, deep
venous thrombosis and/or death and other serious and life threatening side
effects;
b. Defendants failed to include adequate warnings with the drug that would alert
the medical, pharmaceutical and/or scientific communities, and users and/or
consumers of the drug, including Plaintiff, of the potential risks and serious
side effects of the drug; and
c. Defendants failed to provide adequate post-marketing warnings or instructions
after defendants knew or should have known of the potential risks and serious side
effects associated with the use of the drug.
66. As a direct, legal, proximate and producing result of defendants' breach of
warranty, Plaintiff sustained injuries as set forth above.
SIXTH CAUSE OF ACTION
(Fraudulent Misrepresentation)
67. Plaintiffs restate the allegations set forth above as if fully rewritten
herein.
68. The Defendants falsely and fraudulently represented to the medical and
healthcare community, and to Plaintiff and/or the FDA, and/or the public in
general, that Yasmin had been tested and was found to be safe and/or effective for
its indicated use.
69. That representations made by Defendants were, in fact, false.
70. When said representations were made by Defendants, they knew those
representations to be false and they willfully, wantonly and recklessly
disregarded whether the representations were true.
71. These representations were made by Defendants with the intent of defrauding
and deceiving the Plaintiff, the public in general, and the medical and healthcare
community in particular, and were made with the intent of inducing the public in
general, and the medical and healthcare community in particular, to recommend,
dispense and/or purchase Yasmin for use as a contraceptive, all of which evinced a
callous, reckless, willful, depraved indifference to the health, safety and
welfare of the Plaintiff.
72. At the time the aforesaid representations were made by the Defendants and, at
the time Plaintiff ingested Yasmin, Plaintiff was unaware of the falsity of said
representations and reasonably believed them to be true.
73. In reliance upon said representations, Plaintiff was induced to and did use
Yasmin, thereby sustaining severe and permanent personal injuries, and/or being at
an increased risk of sustaining severe and permanent personal injuries in the
future.
74. Defendants knew and were aware or should have been aware that Yasmin had not
been sufficiently tested, was defective in nature, and/or that it lacked adequate
and/or sufficient warnings.
75. Defendants knew or should have known that Yasmin had a potential to, could,
and would cause severe and grievous injury to the users of said product, and that
it was inherently dangerous in a manner that exceeded any purported, inaccurate,
and/or down-played warnings.
76. Defendants brought Yasmin to the market, and acted fraudulently, wantonly and
maliciously to the detriment of the Plaintiff.
77. By reason of the foregoing, Plaintiff experienced and is at risk of
experiencing serious and life-threatening side effects including but not limited
to, pulmonary emboli, as well as other severe and personal injuries, including
future thromboembolic events, which are permanent and lasting in nature, physical
pain and mental anguish, including diminished enjoyment of life, as well as the
need for lifelong medical treatment, monitoring and/or medications, and fear of
developing any of the above named health consequences.
78. As a result of the foregoing acts and omissions, Plaintiff requires and/or
will require more health care and services and did incur medical, health,
incidental and related expenses. Plaintiffs are informed and believe and further
allege that Plaintiff will in the future be required to obtain further medical
and/or hospital care, attention, and services.
SEVENTH CAUSE OF THE ACTION
(Fraudulent Concealment)
79. Plaintiffs restate the allegations set forth above as if fully rewritten
herein.
80. At all times during the course of dealing between Defendants and Plaintiff
and/or Plaintiffs healthcare providers, and/or the FDA, Defendants misrepresented
the safety of Yasmin for its intended use.
81. Defendants knew or were reckless in not knowing that its representations were
false.
82. In representations to Plaintiff and/or Plaintiff's healthcare providers and/or
the FDA, Defendants fraudulently concealed and intentionally omitted the following
material information:
a. That Yasmin is not as safe as other available contraceptives;
b. That the risks of adverse events with Yasmin (drospirenone and ethinyl
estradiol) was higher than those with other available contraceptives;
c. That the risks of adverse events with Yasmin was not adequately tested and/or
known by Defendants;
d. Plaintiff was put at risk of experiencing serious and dangerous side effects
including but not limited to, pulmonary emboli, as well as other severe and
personal injuries, including future thromboembolic events, which are permanent and
lasting in nature, physical pain and mental anguish;
e. That patients needed to be monitored more regularly than normal while using
Yasmin;
f. That Yasmin was manufactured, marketed, produced, and distributed negligently;
g. That Yasmin was manufactured, marketed, produced, and distributed defectively;
h. That Yasmin was manufactured, marketed, produced, and distributed improperly;
i. That Yasmin was designed negligently;
j. That Yasmin was designed defectively;
k. That Yasmin was designed improperly.
83. Defendants were under a duty to disclose to Plaintiff and/or her physicians,
hospitals, healthcare providers, and/or the FDA the defective nature of Yasmin.
84. Defendants had sole access to material facts concerning the defective nature
of the product and its propensity to cause serious and dangerous side effects, and
hence, cause damage to persons who used Yasmin, including the Plaintiff in
particular.
85. Defendants' concealment and omissions of material facts concerning, inter
alia, the safety of the use of Yasmin was made purposefully, willfully, wantonly,
and/or recklessly, to mislead Plaintiff and/or her physicians, hospitals and/or
healthcare providers into reliance, continued use of Yasmin, and actions thereon,
and to cause them to purchase, recommend, and/or dispense Yasmin and/or use the
drug.
86. Defendants knew that Plaintiff and/or her physicians, hospitals, healthcare
providers, and/or the FDA had no way to determine the truth behind Defendants'
concealment and omissions, and that these included material omissions of facts
surrounding Yasmin, as set forth herein.
87. Plaintiff as well as her doctors, healthcare providers, and/or hospitals
reasonably relied on facts revealed which negligently, fraudulently and/or
purposefully did not include facts that were concealed and/or omitted by
Defendants.
88. By reason of the foregoing, Plaintiff experienced and is at risk of
experiencing serious and life-threatening side effects including but not limited
to, pulmonary emboli, as well as other severe and personal injuries, including
future thromboembolic events, which are permanent and lasting in nature, physical
pain and mental anguish, including diminished enjoyment of life, as well as the
need for lifelong medical treatment, monitoring and/or medications, and fear of
developing any of the above named health consequences.
89. As a result of the foregoing acts and omissions Plaintiff requires and/or will
require more health care and services and did incur medical, health, incidental
and related expenses. Plaintiffs are informed and believe and further allege that
Plaintiff will in the future be required to obtain further medical and/or hospital
care, attention, and services.
EIGHTH CAUSE OF ACTION
(Negligent Misrepresentation)
90. Plaintiffs restate the allegations set forth above as if fully rewritten
herein.
91. Defendants had a duty to represent to the medical and healthcare community,
and to the Plaintiff, the FDA and/or the public in general that Yasmin had been
tested and found to be safe and effective for its intended use.
92. The representations made by Defendants were, in fact, false.
93. Defendants failed to exercise ordinary care in the representation of Yasmin,
while involved in its manufacture, sale, testing, quality assurance, quality
control, and/or distribution into interstate commerce, in that Defendants
negligently misrepresented Yasmin's high risk of unreasonable, dangerous side
effects.
94. Defendants breached their duty in representing Yasmin's serious side effects
to the medical and healthcare community, to the Plaintiff, the FDA and/or the
public in general.
95. By reason of the foregoing, Plaintiff experienced and is at risk of
experiencing serious and life-threatening side effects including but not limited
to, pulmonary emboli, as well as other severe and personal injuries, including
future thromboembolic events, which are permanent and lasting in nature, physical
pain and mental anguish, including diminished enjoyment of life, as well as the
need for lifelong medical treatment, monitoring and/or medications, and fear of
developing any of the above named health consequences.
96. As a result of the foregoing acts and omissions Plaintiff requires and/or will
require more health care and services and did incur medical, health, incidental
and related expenses. Plaintiffs are informed and believe and further allege that
Plaintiff will in the future be required to obtain further medical and/or hospital
care, attention, and services.
NINTH CAUSE OF ACTION
(Fraud and Deceit)
97. Plaintiffs restate the allegations set forth above as if fully rewritten
herein.
98. Defendants recklessly, knowingly, intentionally, and fraudulently
misrepresented to the medical, pharmaceutical and/or scientific communities, and
users and/or consumers of the drug, including Plaintiff, the safety and efficacy
of the drug and/or recklessly, knowingly, intentionally and fraudulently concealed
from the medical, pharmaceutical and/or scientific communities, and users and/or
consumers of the drug, including Plaintiff, material, adverse information
regarding the safety and efficacy of Yasmin.
99. Defendants' misrepresentations were communicated to the medical,
pharmaceutical and/or scientific communities, and users and/or consumers of the
drug, including Plaintiff, with the intent that they reach users and/or consumers
of the drug, including Plaintiff.
100. Defendants either knew or should have known that the representations were
false.
101. Defendants made the misrepresentations and/or actively concealed information
concerning the safety and efficacy of the drug with the intention and specific
desire that the medical, pharmaceutical and/or scientific communities, and users
and/or consumers of the drug, including Plaintiff, would rely on such in selecting
Yasmin as a contraceptive.
102. Defendants made these misrepresentations and/or actively concealed
information concerning the safety and efficacy of Yasmin in its labeling,
advertising, product inserts, promotional materials or other marketing efforts.
103. Defendants made these misrepresentations and actively concealed adverse
information at a time when Defendants knew or should have known that its drug
product had defects, dangers and characteristics that were other than what
Defendants had represented to the medical, pharmaceutical and/or scientific
communities, and users and/or consumers of the drug, including Plaintiff.
Specifically, Defendants misrepresented to and/or actively concealed from the
medical, pharmaceutical and/or scientific communities, and users and/or consumers
of the drug, including Plaintiff, that:
a. There had been insufficient studies regarding the safety and efficacy of the
drug;
b. The drug was fully and adequately tested, despite knowing that there had been
insufficient or inadequate testing of the drug;
c. Prior studies, research, reports and/or testing had been conducted linking the
use of the drug to serious prothrombotic reactions, including, but not limited to,
adverse cardiovascular events such as pulmonary embolus and vascular events such
as deep venous thrombosis;
d. Defendants knew or should have known of reports of increased prothrombotic
events associated with the use of the drug;
e. Defendants knew or should have known of the greatly increased risk of
developing pulmonary embolus and/or deep venous thrombosis associated with use of
Yasmin; yet, despite this they were downplaying the risk of the drug.
104. The misrepresentations of and/or active concealment by Defendants were
perpetuated directly and/or indirectly by defendants, its sales representatives,
employees, distributors, agents and/or detail persons.
105. The misrepresentations of and/or active concealment by Defendants constitute
a continuing tort. Indeed, through Defendants' product inserts, Defendants
continue to misrepresent the potential risks and serious side effects associated
with the use of Yasmin. Moreover, Defendants had a post-sale duty to warn the
medical, pharmaceutical and/or scientific communities, and users and/or consumers
of the drug, including Plaintiff, about the potential risks and serious side
effects associated with the use of Yasmin in a timely manner, yet they failed to
provide such warning.
106. Plaintiff justifiably relied on and/or was induced by the misrepresentations
and/or active concealment of Defendants to purchase and ingest Yasmin to her
detriment.
107. As a direct, legal, proximate and producing result of the misrepresentations
of Defendants, Plaintiff sustained injuries as set forth above.
TENTH CAUSE OF ACTION
(Loss of Consortium)
108. Plaintiffs restate the allegations set forth above as if fully rewritten
herein.
109. Plaintiff RUSSELL TANNER brings this cause of action for loss of consortium.
110. By reason of the injuries sustained by Plaintiff BRIDGET RENEE TANNER,
Plaintiffs RUSSELL TANNER, has been and will continue to be deprived of
consortium, society, comfort, protection, and service, thereby causing and
continuing to cause grief, sorrow, mental anguish, emotional distress and pain and
suffering.
ELEVENTH CAUSE OF ACTION
(Punitive Damages)
111. Plaintiffs restate the allegations set forth above as if fully rewritten
herein.
112. Defendants have repeatedly engaged in the patterns of conduct described
herein for the express purpose of maximizing their profits from the sale of
Yasmin, at the expense of the health and safety of the public, including
Plaintiff, who already uses, or might be enticed into using, the product for birth
control.
113. Defendants' acts were willful and malicious in that Defendants' conduct was
carried on with a conscious disregard for the safety and rights of Plaintiff and
all others taking Yasmin. Defendants' unconscionable conduct thereby warrants an
assessment of exemplary and punitive damages in an amount appropriate to punish
Defendants and deter similar conduct in the future.
PRAYER FOR RELIEF
WHEREFORE, Plaintiffs pray for judgment against Defendants, jointly and/or
severally, as follows:
a. Awarding compensatory damages to Plaintiffs for past and future damages,
including but not limited to pain and suffering for severe and permanent personal
injuries sustained by Plaintiff, health care costs, medical monitoring, together
with interest and costs as provided by law;
b. Punitive and/or exemplary damages for the wanton, willful, fraudulent, reckless
acts of the Defendants who demonstrated a complete disregard and reckless
indifference for the safety and welfare of the general public and to the Plaintiff
in an amount sufficient to punish defendants and deter future similar conduct;
c. Awarding Plaintiffs reasonable attorney's fees;
d. Awarding Plaintiffs the costs of these proceedings; and
e. Such other and further relief as this Court deems just and proper.
DEMAND FOR JURY TRIAL
Plaintiffs demand a trial by jury on all claims so triable in this action.
