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Yaz Lawsuit Filed In Illinois Discussed History of Yaz and Yasmin

Posted in Yaz, Yasmin & Ocella

The following Yaz lawsuit was filed in August of 2008 in the U.S. District Court for the Southern District of Illinois:

13. Yaz and Yasmin are birth control pills manufactured and marketed by
Defendants. They are combination oral contraceptives, or “COCs,” meaning that they
contain an estrogen component and a progestin component. Together, these steroidal
components work together in COCs to suppress ovulation, fertilization, and implantation and thus prevent pregnancy.

14. Yaz and Yasmin were approved by the Food and Drug Administration for marketing
in 2006 and 2001, respectively.

15. The estrogen component in Yaz/ Yasmin is known generically as ethinyl estradiol. The progestin component is known as drospirenone. Yasmin contains 0.03 milligrams of ethinyl estradiol, and Yaz contains 0.02 milligrams of ethinyl estradiol. Both products contain 3 milligrams of drospirenone.

16. Yaz and Yasmin are different from other combined hormonal birth control pills in that they contain drospirenone, a progestin that is unlike other progestins available in the United States and was never before marketed in the United States prior to its use in Yaz/ Yasmin.

17. Shortly after the introduction of combined oral contraceptives in the 1960’s, doctors and researchers found that women using birth control pills had a higher risk of blood clots, heart attacks, and strokes than women not using the pill. As a result, the various brands of birth control pills were reformulated to reduce the amounts of estrogen. As the amounts of estrogen levels reduced, so too did the risk of blood clots, heart attacks, and strokes.

18. During this time, new progestins were being developed, which became known as
“second generation” progestins (e.g. lovenorgestrel). These second generation progestins, when combined with the lower amounts of the estrogen, ethinyl estradiol, helped to reduce the risk of blood clots, heart attacks, and strokes and were considered safer for women.

19. During the 1990’s, new “third generation” progestins were developed. Unfortunately, these “third generation” progestins (e.g. gestodene and desogestrel) have been associated with a greater risk of blood clots in the deep veins (deep vein thrombosis or “DVT”) and lungs (Pulmonary Embolismsm or “PE”). As a result of this increased risk of blood clots, the FDA has required that products containing third generation progestins include a Warning of the potentially increased risk of thrombosis.

20. Yaz and Yasmin contain the same estrogen component, ethinyl estradiol which has been used in the lower dose birth control pills for decades.

21. However, drospirenone is a new type of progestin and is considered a “fourth generation” progestin. No other birth control pills contain drospirenone, except for a recently approved generic version of Yaz/ Yasmin marketed under the trade name Ocella.

22. Since drospirenone is new, there is insufficient data available to support its safe use, particularly compared with second generation progestins. In fact, studies performed prior to FDA approval indicate that drospirenone has certain effects that are different from those of traditional second generation progestins, and potentially more dangerous.

23. One possible mechanism of action is that drospirenone causes an increase in potassium levels in the blood, which can lead to a condition known as hyperkalemia if the potassium levels become too high. Hyperkalemia can cause heart rhythm disturbances, such as extrasystolies, pauses, or bradycardia. If left untreated, hyperkalemia can be fatal. If hyperkalemia disrupts the normal heart rhythms, the flow of blood through the heart can be slowed to the point that it permits blood clots to form. Blood clots in the heart can then lead to heart attacks, or the clots can break off and travel to the lungs where they can cause a pulmonary embolism, or can travel to the brain causing stroke.

24. During the brief time that Yaz/ Yasmin have been sold in the United States, hundreds of reports of injury and death have been submitted to the FDA in association with defendants’ products.

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 ThromboEmbolismsm Associated with the New contraceptive Yasmin was published in the British Medical Journal detailing a Netherlands Pharmacovigilance Centre report of five additional reports of thrombo Embolismsm where Yasmin was suspected as the cause, including two deaths.

27. In fact, in less than a five-year period, from the first quarter of 2004 through the third quarter of 2008, over 50 reports of death among users of Yaz / Yasmin have been filed with the FDA.

28. These reports include deaths associated with cardiac arrhythmia, cardiac arrest, intracardiac thrombus, heart attack, and stroke in women in their child bearing years.

29. Some deaths reported occurred in women as young as 17 years old.

30. Significantly, reports of elevated potassium levels are frequently included among the symptoms of those suffering death while using Yaz/ Yasmin.


United States District Court, S.D. Illinois.

Christina DOLBEARE, Plaintiff,

v.

BAYER CORPORATION, an Indiana corporation c/o Illinois Corporation Service C Bayer
Healthcare Pharmaceuticals Inc., a Delaware corporation c/o Illinois Corporation
Service C Bayer Healthcare, LLC, a Delaware corporation c/o Illinois Corporation
Service C, Defendants.

No. 09-643.

August 20, 2008.

Complaint and Jury Demand

Christopher L. Schnieders, IL Bar # 6290700, Thomas P. Cartmell, Jeffrey M. Kuntz,
Wagstaff & Cartmell, LLP, 4740 Grand Avenue, Suite 300, Kansas City, Missouri
64112, Telephone: 816-701-1100, Facsimile: 816-531-2372, cschnieders @wcllp.com,
tcartmell@wcllp.com, jkuntz@wcllp.com, -and- Steven R. Maher, The Maher Law Firm,
A Professional Association, 631 West Morse Boulevard, Suite 200, Winter Park, FL
32789, Phone: (407) 839-0866, Fax: (407) 425-7958, smaher @maherlawfirm.com.

COMPLAINT

Plaintiff Christina Dolbeare, of Adams County Illinois, by and through counsel,
and for her Complaint against Defendants, alleges as follows:

PARTIES AND JURISDICTION

1. This is an action brought by Plaintiff Christina Dolbeare, who used the
combination oral contraceptive Yasmin, also known generically as drospirenone and
ethinyl estradiol (hereinafter collectively referred to as ” Yaz/ Yasmin”).

2. Plaintiff Christina Dolbeare was prescribed and purchased and ingested Yaz/
Yasmin and while using Yaz/ Yasmin suffered a Pulmonary Embolism (PE) on July 28,
2008.

3. Plaintiff Christina Dolbeare is a resident and citizen of Illinois.

4. Jurisdiction in this Court is appropriate pursuant to 28 U.S.C. s 1332 as
Plaintiff Christina Dolbeare alleges an amount in controversy in excess of
Seventy-Five Thousand Dollars ($75,000.00), exclusive of interest and costs and
Plaintiff and Defendants are residents of different states.

5. Defendant Bayer Corporation is an Indiana corporation with its principal place
of business at 100 Bayer Road, Pittsburgh, Pennsylvania 15205. Defendant Bayer
Corporation is the sole member of Bayer Healthcare LLC, which owns 100% of
Schering Berlin, Inc., which owns 100% of Defendant Bayer HealthCare
Pharmaceuticals, Inc. As such, Defendant Bayer Corporation is a parent of
Defendant Bayer Healthcare Pharmaceuticals, Inc.

6. At relevant times, Defendant Bayer Corporation was engaged in the business of
researching, developing, designing, licensing, manufacturing, distributing,
selling, marketing, and/or introducing into interstate commerce, either directly
or indirectly through third parties or related entities, its products, including
the prescription drug Yaz/ Yasmin. At relevant times, Defendant Bayer Corporation
conducted regular and sustained business in Illinois by selling and distributing
its products in Illinois and engaged in substantial commerce and business activity
in Adams County.

7. Defendant Bayer Healthcare Pharmaceuticals, Inc., formerly known as Bayer
Pharmaceuticals Corporation, and also formerly known Berlex Laboratoires, Inc.,
which was formerly known as Berlex, 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. Defendant Bayer Healthcare Pharmaceuticals,
Inc. is the U.S.-based pharmaceuticals unit of Schering Berlin, Inc. and is a
division of Bayer AG.

8. Defendant Bayer Healthcare Pharmaceuticals, Inc. is a corporate successor to
Berlex Laboratories, Inc. (Berlex), which was formerly known as Berlex, Inc., and
as such is obligated for its predecessor’s liabilities. Berlex was engaged in the
business of designing, developing, manufacturing, testing, packaging, promoting,
marketing, distributing, labeling, and/or selling directly and indirectly through
third parties or related entities, the drug Yaz/ Yasmin.

9. Defendant Bayer Healthcare Pharmaceuticals, Inc. is engaged in the business of
researching, developing, designing, licensing, manufacturing, distributing,
selling, marketing, and/or introducing into interstate commerce, either directly
or indirectly through third parties or related entities, its products, including
the prescription drug Yaz/ Yasmin. At relevant times, Defendant Bayer Healthcare
Pharmaceuticals, Inc. conducted regular and sustained business in Illinois by
selling and distributing its products in Illinois and engaged in substantial
commerce and business activity in Adams County.

10. 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. Defendant Bayer Healthcare, LLC is engaged in the
business of researching, developing, designing, licensing, manufacturing,
distributing, selling, marketing, and/or introducing into interstate commerce,
either directly or indirectly through third parties or related entities, its
products, including the prescription drug Yaz/ Yasmin. At relevant times,
Defendant Bayer Healthcare, LLC conducted regular and sustained business in
Illinois by selling and distributing its products in Illinois and engaged in
substantial commerce and business activity in Adams County.

11. Defendants Bayer Corporation, Bayer Healthcare Pharmaceuticals, Inc., and
Bayer Healthcare, LLC, are collectively referred to herein as “Bayer” or “Bayer
Defendants.”

FACTUAL BACKGROUND

Nature of the Case

12. Plaintiff Christina Dolbeare brings this case against Defendants for damages
associated with Plaintiff Christina Dolbeare’s ingestion of the pharmaceutical
drug Yaz/ Yasmin (ethinyl estradiol and drospirenone), an oral contraceptive
designed, manufactured, marketed, and distributed by Defendants. Specifically, as
a direct result of her use of Yaz/ Yasmin, Plaintiff Christina Dolbeare suffered
from a pulmonary Embolism (PE).

Bayer’s Combined Oral Contraceptives – Yaz and Yasmin

13. Yaz and Yasmin are birth control pills manufactured and marketed by
Defendants. They are combination oral contraceptives, or “COCs,” meaning that they
contain an estrogen component and a progestin component. Together, these steroidal
components work together in COCs to suppress ovulation, fertilization, and
implantation and thus prevent pregnancy.

14. Yaz and Yasmin were approved by the Food and Drug Administration for marketing
in 2006 and 2001, respectively.

Yaz and Yasmin contain a Fourth Generation Progestin.

15. The estrogen component in Yaz/ Yasmin is known generically as ethinyl
estradiol. The progestin component is known as drospirenone. Yasmin contains 0.03
milligrams of ethinyl estradiol, and Yaz contains 0.02 milligrams of ethinyl
estradiol. Both products contain 3 milligrams of drospirenone.

16. Yaz and Yasmin are different from other combined hormonal birth control pills
in that they contain drospirenone, a progestin that is unlike other progestins
available in the United States and was never before marketed in the United States
prior to its use in Yaz/ Yasmin.

17. Shortly after the introduction of combined oral contraceptives in the 1960’s,
doctors and researchers found that women using birth control pills had a higher
risk of blood clots, heart attacks, and strokes than women not using the pill. As
a result, the various brands of birth control pills were reformulated to reduce
the amounts of estrogen. As the amounts of estrogen levels reduced, so too did the
risk of blood clots, heart attacks, and strokes.

18. During this time, new progestins were being developed, which became known as
“second generation” progestins (e.g. lovenorgestrel). These second generation
progestins, when combined with the lower amounts of the estrogen, ethinyl
estradiol, helped to reduce the risk of blood clots, heart attacks, and strokes
and were considered safer for women.

19. During the 1990’s, new “third generation” progestins were developed.
Unfortunately, these “third generation” progestins (e.g. gestodene and
desogestrel) have been associated with a greater risk of blood clots in the deep
veins (deep vein thrombosis or “DVT”) and lungs (Pulmonary Embolismsm or “PE”). As
a result of this increased risk of blood clots, the FDA has required that products
containing third generation progestins include a Warning of the potentially
increased risk of thrombosis.

20. Yaz and Yasmin contain the same estrogen component, ethinyl estradiol which
has been used in the lower dose birth control pills for decades.

21. However, drospirenone is a new type of progestin and is considered a “fourth
generation” progestin. No other birth control pills contain drospirenone, except
for a recently approved generic version of Yaz/ Yasmin marketed under the trade
name Ocella.

22. Since drospirenone is new, there is insufficient data available to support its
safe use, particularly compared with second generation progestins. In fact,
studies performed prior to FDA approval indicate that drospirenone has certain
effects that are different from those of traditional second generation progestins,
and potentially more dangerous.

23. One possible mechanism of action is that drospirenone causes an increase in
potassium levels in the blood, which can lead to a condition known as hyperkalemia
if the potassium levels become too high. Hyperkalemia can cause heart rhythm
disturbances, such as extrasystolies, pauses, or bradycardia. If left untreated,
hyperkalemia can be fatal. If hyperkalemia disrupts the normal heart rhythms, the
flow of blood through the heart can be slowed to the point that it permits blood
clots to form. Blood clots in the heart can then lead to heart attacks, or the
clots can break off and travel to the lungs where they can cause a pulmonary
embolism, or can travel to the brain causing stroke.

24. During the brief time that Yaz/ Yasmin have been sold in the United States,
hundreds of reports of injury and death have been submitted to the FDA in
association with Defendants’ products.

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 ThromboEmbolismsm Associated with the New
Contraceptive Yasmin was published in the British Medical Journal detailing a
Netherlands Pharmacovigilance Centre report of five additional reports of
thromboEmbolismsm where Yasmin was suspected as the cause, including two deaths.

27. In fact, in less than a five-year period, from the first quarter of 2004
through the third quarter of 2008, over 50 reports of death among users of Yaz/
Yasmin have been filed with the FDA.

28. These reports include deaths associated with cardiac arrhythmia, cardiac
arrest, intracardiac thrombus, heart attack, and stroke in women in their child
bearing years.

29. Some deaths reported occurred in women as young as 17 years old.

30. Significantly, reports of elevated potassium levels are frequently included
among the symptoms of those suffering death while using Yaz/ Yasmin.

Over-Promotion of Yasmin and Yaz

31. Defendants market Yaz/ Yasmin as providing the same efficacy as other birth
control pills in preventing pregnancy, but with additional benefits.

32. However, because Yaz/ Yasmin contain the fourth generation progestin
drospirenone, they present additional health risks not associated with other birth
control pills.

33. For example, prior to its sale to Defendant Bayer in 2006, Defendant Berlex
Laboratories promoted Yasmin’s fourth generation progestin, drospirenone, by
stating, “Ask about Yasmin, and the difference a little chemistry can make.”

34. In response, on July 10, 2003, the FDA objected to the characterization that
drospirenone was a benefit compared to the progestin used in other combined oral
contraceptives, and issued a warning letter stating, “FDA is not aware of
substantial evidence of substantial clinical experience demonstrating that Yasmin
is superior to other COCs or that the drospirenone in Yasmin is clinically
beneficial. On the contrary, FDA is aware of the added clinical risks associated
with drospirenone [.]”

35. The FDA’s warning letter continued by stating that the advertisement failed
“to communicate that the potential to increase potassium is a risk” or that
“increased serum potassium can be dangerous.”

36. More recently, Defendants advertised that its product Yaz/ Yasmin was
indicated for treatment of premenstrual syndrome or “PMS,” as opposed to the less
serious condition of premenstrual dysphoric disorder or “PMDD.”

37. Defendants also advertised that Yaz/ Yasmin contained the added benefit of
preventing or reducing acne.

38. In response, on October 3, 2008, the FDA issued another warning letter to
Defendant Bayer for the misleading advertisement, reiterating that the marketing
was misleading because it promoted Yaz/ Yasmin for medical conditions beyond the
limits of the FDA approval, and adding that ” Yaz/ Yasmin has additional risks
because it contains the progestin, drospirenone … which can lead to hyperkalemia
in high risk patients, which may result in potentially serious heart and health
problems.”

39. The FDA further warned in its October 3, 2008 letter that Yaz/ Yasmin “does
not result in completely clear skin” and that Defendants’ “TV Ads misleadingly
overstate the efficacy of the drug.”

40. Indeed, the FDA felt Defendants’ over-promotion was so severe that it required
Bayer to run new TV advertisements to correct the previous misleading Yaz/ Yasmin
advertisements regarding acne and premenstrual syndrome.

41. Bayer ultimately agreed to spend at least $20 million on corrective TV
advertisements and to submit all Yaz/ Yasmin advertisements to the FDA for
advanced screening for the next six years.

Plaintiff’s Use of Yaz/ Yasmin and Resulting Injuries

42. As a result of Defendants’ claims regarding the effectiveness and safety of
Yaz/ Yasmin, Plaintiff Christina Dolbeare’s medical provider prescribed and
Plaintiff Christina Dolbeare began using Yaz/ Yasmin in or about June 2008.

43. As a direct and proximate result of using Yaz/ Yasmin, Plaintiff Christina
Dolbeare suffered from a Pulmonary Embolism (PE) and resulting injuries described
herein.

44. Prior to Plaintiff Christina Dolbeare’s use of Yaz/ Yasmin, Defendants knew or
should have known that use of Yaz/ Yasmin created a higher risk of a Pulmonary
Embolism (PE) than other oral contraceptives on the market, including but not
limited to second generation oral contraceptives, and that, when taken as
directed, such use was unreasonably dangerous to consumers.

45. Therefore, at the time Plaintiff Christina Dolbeare used Yaz/ Yasmin,
Defendants knew or should have known that the use of Yaz/ Yasmin created an
increased risk to consumers of serious personal injury, including a Pulmonary
Embolism (PE) and a Deep Vein Thrombosis (DVT), heart attacks, stroke, and even
death.

46. Despite the fact that Defendants knew or should have known of the serious
health risks associated with the use of Yaz/ Yasmin, Defendants failed to warn
Plaintiff Christina Dolbeare and/or her health care providers of said serious
risks before she used the product.

47. Had Plaintiff Christina Dolbeare and/or her heath care providers known the
risks and dangers associated with Yaz/ Yasmin, she would not have used Yaz/ Yasmin
and would not have suffered a Pulmonary Embolism.

48. As a direct and proximate result of her use of Yaz/ Yasmin, Plaintiff
Christina Dolbeare suffered physical injury, including but not limited to,
conscious pain and suffering, as a result of her PE.

49. As a direct and proximate result of Plaintiff Christina Dolbeare’s use of Yaz/
Yasmin, Plaintiff Christina Dolbeare has suffered and will continue to suffer
pecuniary losses.

FIRST CAUSE OF ACTION

Strict Products Liability Defective Manufacturing

50. Plaintiff Christina Dolbeare incorporates by reference, as if fully set forth
herein, each and every allegation set forth in the preceding paragraphs and
further allege as follows.

51. Defendants are the manufacturers, designers, distributors, sellers, or
suppliers of Yaz/ Yasmin.

52. The Yaz/ Yasmin birth control pills manufactured, designed, sold, distributed,
supplied and/or placed in the stream of commerce by Defendants were expected to
and did reach the consumer without any alterations or changes.

53. The Yaz/ Yasmin birth control pills manufactured, designed, sold, distributed,
supplied and/or placed in the stream of commerce by Defendants, were defective in
their manufacture and construction when they left the hands of Defendants in that
they deviated from product specification such that they were unreasonably
dangerous to an ordinary user or consumer and posed a serious risk of injury and
death.

54. As a direct and proximate result of Plaintiff Christina Dolbeare’s use of Yaz/
Yasmin as manufactured, designed, sold, supplied and introduced into the stream of
commerce by Defendants, Plaintiff Christina Dolbeare suffered personal injuries,
and Plaintiff suffered economic and non-economic damages.

55. Defendants’ actions and omissions as identified in this Complaint show that
Defendants acted maliciously, with aggravated or egregious fraud, and/or
intentionally disregarded Plaintiff Christina Dolbeare’s rights, so as to warrant
the imposition of punitive damages.

SECOND CAUSE OF ACTION

Strict Products Liability Design Defect

56. Plaintiff Christina Dolbeare incorporates by reference, as if fully set forth
herein, each and every allegation set forth in the preceding paragraphs and
further allege as follows.

57. Defendants are the manufacturers, designers, distributors, sellers, or
suppliers of Yaz/ Yasmin.

58. The Yaz/ Yasmin birth control pills manufactured, designed, sold, distributed,
supplied and/or placed in the stream of commerce by Defendants were expected to
and did reach the consumer without any alterations or changes.

59. The Yaz/ Yasmin birth control pills manufactured and supplied by Defendants
were defective in design or formulation in that, when it left the hands of the
Defendants, the foreseeable risks of the product exceeded the benefits associated
with its design or formulation, or they were more dangerous than an ordinary
consumer would expect.

60. The foreseeable risks associated with the design or formulation of the Yaz/
Yasmin birth control pills, include, but are not limited to, the fact that the
design or formulation of Yaz/ Yasmin is more dangerous than a reasonably prudent
consumer would expect when used in an intended or reasonably foreseeable manner.

61. As a direct and proximate result of Plaintiff Christina Dolbeare’s use of Yaz/
Yasmin as manufactured, designed, sold, supplied and introduced into the stream of
commerce by Defendants, Plaintiff Christina Dolbeare suffered personal injuries,
economic and non-economic damages, including pain and suffering.

62. Defendants’ actions and omissions as identified in this Complaint show that
Defendants acted maliciously, with aggravated or egregious fraud, and/or
intentionally disregarded Plaintiff Christina Dolbeare’s rights, so as to warrant
the imposition of punitive damages.

THIRD CAUSE OF ACTION

Strict Products Liability Defect Due to Inadequate Warning

63. Plaintiff Christina Dolbeare incorporates by reference, as if fully set forth
herein, each and every allegation set forth in the preceding paragraphs and
further allege as follows.

64. The Yaz/ Yasmin birth control pills manufactured and supplied by Defendants
were defective due to inadequate warning or instruction and was unreasonably
dangerous to the ordinary user or consumer because Defendants knew or should have
known that the product created significant risks of serious bodily harm and death
to consumers and they failed to adequately warn consumers and/or their health care
providers of such risks.

65. The Yaz/ Yasmin birth control pills manufactured and supplied by Defendants
were defective due to inadequate post-marketing warning or instruction and were
unreasonably dangerous to the ordinary user or consumer because, after Defendants
knew or should have known of the risk of serious bodily harm and death from the
use of Yaz/ Yasmin, Defendants failed to provide an adequate warning to consumers
and/or their health care providers of the product, knowing the product could cause
serious injury and death.

66. As a direct and proximate result of Plaintiff Christina Dolbeare’s use of Yaz/
Yasmin as manufactured, designed, sold, supplied and introduced into the stream of
commerce by Defendants, Plaintiff Christina Dolbeare suffered personal injuries,
economic and non-economic damages.

67. Defendants’ actions and omissions as identified in this Complaint show that
Defendants acted maliciously, with aggravated or egregious fraud, and/or
intentionally disregarded Plaintiff Christina Dolbeare’s rights, so as to warrant
the imposition of punitive damages.

FOURTH CAUSE OF ACTION

Negligence

68. Plaintiff Christina Dolbeare incorporates by reference, as if fully set forth
herein, each and every allegation set forth in the preceding paragraphs and
further allege as follows.

69. Defendants had a duty to exercise reasonable care in the design, manufacture,
sale and/or distribution of Yaz/ Yasmin into the stream of commerce, including a
duty to assure that its product did not pose a significantly increased risk of
bodily harm and adverse events.

70. Defendants failed to exercise ordinary care in the design, formulation,
manufacture, sale, testing, quality assurance, quality control, labeling,
marketing, promotions and distribution of Yaz/ Yasmin into interstate commerce in
that Defendants knew or should have known that the product caused such significant
bodily harm or death and was not safe for use by consumers.

71. Defendants also failed to exercise ordinary care in the labeling of Yaz/
Yasmin and failed to issue to consumers and/or their health care providers
adequate warnings of the risk of serious bodily injury or death due to the use of
Yaz/ Yasmin.

72. Despite the fact that Defendants knew or should have known that Yaz/ Yasmin
posed a serious risk of bodily harm to consumers, Defendants continued to
manufacture and market Yaz/ Yasmin for use by consumers.

73. Defendants knew or should have known that consumers, including Plaintiff
Christina Dolbeare, would foreseeably suffer injury as a result of Defendants’
failure to exercise ordinary care as described above.

74. As a direct and proximate result of Defendants’ negligence, Plaintiff
Christina Dolbeare suffered personal injuries, economic and non-economic damages.

75. Defendants’ conduct as described above, including but not limited to its
failure to adequately test Yaz/ Yasmin, to provide adequate warnings, and its
continued manufacture, sale and marketing of the product when it knew or should
have known of the serious health risks it created, evidences malicious actions,
aggravated or egregious fraud, and/or intentional disregard of the rights of
Plaintiff Christina Dolbeare, so as to warrant the imposition of punitive damages.

FIFTH CAUSE OF ACTION

Negligent Misrepresentation and/or Fraud

76. Plaintiff Christina Dolbeare incorporates by reference, as if fully set forth
herein, each and every allegation set forth in the preceding paragraphs and
further allege as follows:

77. Defendants are the manufacturers, designers, distributors, sellers or
suppliers of Yaz/ Yasmin and made representations to Defendant and her healthcare
providers regarding the character or quality of Yaz/ Yasmin for guidance in their
decision to select Yaz/ Yasmin.

78. Specifically, Defendants represented that their product was just as safe or
safer, and just as effective or more effective, than other birth control products
on the market.

79. Defendants’ representations regarding the character or quality of Yaz/ Yasmin
were untrue.

80. Defendants had actual knowledge based upon studies, published reports and
clinical experience that its product Yaz/ Yasmin created an unreasonable risk of
serious bodily injury and death to consumers, or should have known such
information.

81. Defendants negligently and/or intentionally misrepresented or omitted this
information in its product labeling, promotions and advertisements and instead
labeled, promoted and advertised its product as safer and more effective than
other types of oral contraceptives in order to avoid losses and sustain profits in
its sales to consumers.

82. In supplying the false information, Defendants failed to exercise reasonable
care or competence in obtaining or communicating information to Plaintiff
Christina Dolbeare and her healthcare providers.

83. Plaintiff Christina Dolbeare and her healthcare providers reasonably relied to
Plaintiff’s detriment upon Defendants’ misrepresentations and/or omissions in its
labeling, advertisements, and promotions concerning the serious risks posed by the
product. Plaintiff Christina Dolbeare reasonably relied upon Defendants’
representations to her and/or her healthcare providers that Yaz/ Yasmin was safer
than other tyPE of oral contraceptives for human consumption and/or use and that
Defendants’ labeling, advertisements and promotions fully described all known
risks of the product.

84. As a direct and proximate result of Defendants’ negligent and/or intentional
misrepresentations or omissions, Plaintiff Christina Dolbeare suffered personal
injuries and economic and non-economic damages, including pain and suffering.

85. Defendants’ actions and omissions as identified in this Complaint demonstrate
malicious actions, aggravated or egregious fraud, and/or intentional disregard of
Plaintiff Christina Dolbeare’s rights so as to warrant the imposition of punitive
damages.

SIXTH CAUSE OF ACTION

Intentional and Wanton Conduct and Request for Punitive Damages

86. Plaintiff Christina Dolbeare hereby adopts and incorporates by reference all
the above allegations.

87. At all material times, the Defendants knew or should have known that Yaz/
Yasmin was inherently dangerous.

88. Despite their knowledge, the Defendants continued to aggressively market Yaz/
Yasmin to consumers, including Plaintiff Christina Dolbeare, without disclosing
its dangerous side effects when there existed safer alternative products.

89. Despite Defendants’ knowledge of Yaz/ Yasmin’s defective and unreasonably
dangerous nature, Defendants continued to test, design, develop, manufacture,
label, package, promote, market, sell and distribute, it so as to maximize sales
and profits at the expense of the health and safety of the public, including
Plaintiff Christina Dolbeare, in conscious disregard of the foreseeable harm
caused by Yaz/ Yasmin.

90. The Defendants’ conduct was intentional and/or wanton.

91. The Defendants’ conduct as described above, including, but not limited to,
their failure to adequately test their product, to provide adequate warnings, and
their continued manufacture, sale, and marketing or their products when they knew
or should have known of the serious health risks created, evidences a flagrant
disregard of human life as to warrant the imposition of punitive damages as the
acts or omissions were committed with knowing, conscious and deliberate disregard
for the rights and safety of consumers, including Plaintiff Christina Dolbeare.

SEVENTH CAUSE OF ACTION

Breach of Express Warranty as to Bayer Defendants

92. Plaintiff Christina Dolbeare incorporates by reference, as if fully set forth
herein, each and every allegation set forth in the preceding paragraphs.

93. The Bayer Defendants expressly warranted that Yaz/ Yasmin was a safe and
effective prescription contraceptive.

94. The Yaz/ Yasmin birth control pill manufactured and sold by Defendants did not
conform to these express representations because it caused serious injury to
consumers when taken in recommended dosages.

95. As a direct and proximate result of the Bayer Defendants’ breach of warranty,
Plaintiff Christina Dolbeare has suffered harm, damages and economic loss and will
continue to suffer such harm, damages and economic loss in the future.

EIGHTH CAUSE OF ACTION

Breach of Implied Warranty as to Bayer Defendants

96. Plaintiff Christina Dolbeare incorporates by reference, as if fully set forth
herein, each and every allegation set forth in the preceding paragraphs.

97. At the time the Defendants designed, manufactured, marketed, sold, and
distributed Yaz/ Yasmin for use by Plaintiff Christina Dolbeare, Defendants knew
of the use for which Yaz/ Yasmin was intended and impliedly warranted the product
to be of merchantable quality and safe for such use.

98. Plaintiff Christina Dolbeare reasonably relied upon the skill and judgment of
the Defendants as to whether Yaz/ Yasmin was of merchantable quality and safe for
its intended use and upon the Defendants’ implied warranty as to such matters.

99. Contrary to such implied warranty, Yaz/ Yasmin was not of merchantable quality
or safe for its intended use, because the product was reasonably dangerous as
described above.

100. As a direct and proximate result of the Defendants’ breach of warranty,
Plaintiff Christina Dolbeare has suffered harm, damages and economic loss and will
continue to suffer such harm, damages and economic loss in the future.

NINETH CAUSE OF ACTION

Violation of the Illinois Consumer Fraud and Deceptive Business Practices Act

101. Plaintiff Christina Dolbeare incorporates by reference, as if fully set forth
herein, each and every allegation set forth in the preceding paragraphs.

102. At all times relevant, the Illinois Consumer Fraud & Deceptive Practices Act,
, (hereinafter “IFCA”) prohibits “the use of any deception, fraud, false pretense,
false promise, misrepresentation or concealment, suppression or omission of any
material fact…in the conduct of any trade or commerce” and declares such acts or
practices as unlawful.

103. Defendants violated the IFCA by the use of false and misleading
misrepresentations or omissions of material fact in connection with the marketing,
promotion, and sale of Yaz/ Yasmin. Defendants communicated the purported benefits
of Yaz/ Yasmin while failing to disclose the serious and dangerous side effects
related to the use of Yaz/ Yasmin with the intent that consumers, like Plaintiff,
and their healthcare providers rely upon the omissions and misrepresentations and
purchase or prescribe Yaz/ Yasmin, respectively.

104. As a result of violating the ICFA, Defendants caused Plaintiff to be
prescribed and to use Yaz/ Yasmin, causing severe injuries and damages as
previously described herein.

WHEREFORE, Plaintiff Christina Dolbeare prays for relief as follows:

1. Compensatory and punitive damages in excess of the jurisdictional amount,
including, but not limited to non-economic damages in excess of $350,000.00;

2. Medical expenses and other economic damages in an amount to be determined at
trial of this action;

3. Attorneys’ fees, expenses, and costs of this action;

4. Punitive damages in excess of twice the compensatory damages award;

5. Pain and suffering; and

6. Such further relief as this Court deems necessary, just, and proper.

JURY DEMAND

Plaintiff Christina Dolbeare hereby demands a trial by jury on all issues so
triable.

Dated: August 20th, 2009