The lawsuit of Adams v. Bayer was filed in July of 2009 in the U.S. District Court for the Eastern District of Pennsylvania. The lawsuit alleges that the Yaz birth control product is defective and dangerous. Here is some background on Yaz from the lawsuit:
B. Yasmin and Yaz Contain a “Fourth Generation” Progestin
34. Yaz and Yasmin are birth control pills manufactured and marketed by Bayer. 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.
35. Yasmin received FDA approval first in 2001. It is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen.
36. Yaz received approval from the FDA in 2006 and is essentially the same as Yasmin with the only difference being a slightly smaller amount of ethinyl estradiol.
37. Yasmin and Yaz were approved by the Food and Drug Administration for marketing in 2001 and 2006 respectively.
38. Yasmin and Yaz Contain a “Fourth Generation” Progestin
39. The estrogen component in Yasmin and Yaz is known generically as ethinyl estradiol.
40. The progestin component is known as drospirenone.
41. Yasmin contains 0.03 milligrams of ethinyl estradiol, and Yaz contains 0.02 milligrams of ethinyl estradiol.
42. Both products contain 3 milligrams of drospirenone.
43. Yasmin and Yaz 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 Yasmin.
44. 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.
45. 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.
46. During the 1990's, new “third generation” progestins were developed.
47. 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 embolism 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.
48. Yasmin and Yaz contain the same estrogen component, ethinyl estradiol, that has been used in the lower dose birth control pills for decades. 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 Yasmin and Yaz marketed under the trade name Ocella.
49. Since drospirenone is new, there are not decades of data available to support its safe use as there are with second generation progestins. Studies that were done prior to FDA approval, however, indicate that drospirenone has certain effects that are different from those of traditional second generation progestins, and potentially more dangerous.
50. 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.
51. Hyperkalemia can cause heart rhythm disturbances, such as extra systolies, pauses, or bradycardia. If left untreated, hyperkalemia can be fatal.
52. 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 pulmonary embolism, or can travel to the brain causing stroke.
53. Indeed, during the brief time that Yasmin and Yaz 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.
54. In April 2002, THE British Medical Journ 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.
55. In February 2003, a paper entitled Thromboembolism Associated With the New 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. 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 Yasmin and Yaz have been filed with the FDA.
56. These reports include deaths associated with cardiac arrhythmia, cardiac arrest, intracardiac thrombus, pulmonary embolism, and stroke in women in their child bearing years.
57. Some deaths reported occurred in women as young as 17 years old.
58. Significantly, reports of elevated potassium levels are frequently included among the symptoms of those suffering death while using Yasmin or Yaz.
COMPLAINT
Plaintiffs, by and through counsel, and for their Complaint against Defendants, allege as follows:
I. THE PARTIES
1. Plaintiff, Robin Adams (“Plaintiff”) resides in Virginia.
2. Plaintiff, Thomas E. Adams, (“Plaintiff”) resides in Virginia.
3. Plaintiff was prescribed and ingested Yaz and/or Yasmin and suffered injury, including, but not limited to, Deep Vein Thrombosis (DVT) and a Pulmonary Embolism (PE).
4. At all times relevant hereto, Plaintiff Thomas E. Adams, was married to Plaintiff, Robin Adams.
5. Defendant Bayer Corporation is, and at all times relevant was, a corporation organized under the laws of the State of Indiana with its headquarters and principal place of business at 100 Bayer Rd., Pittsburgh, Pennsylvania 15205.
6. Defendant Bayer Healthcare LLC, is, and at times relevant was, a limited liability corporation organized under the laws of the State of Delaware with its headquarters and principal place of business at 100 Bayer Road, Pittsburgh, Pennsylvania 15205.
7. Defendant Bayer Healthcare LLC is wholly owned by Defendant Bayer Corporation.
8. Defendant Bayer Pharmaceutical Corporation is, and at times relevant was, a corporation organized under the laws of the State of Delaware with its headquarters and principal place of business at 1400 Morgan Lane, West Haven, Connecticut.
9. As of January 1, 2008, Defendant Bayer Pharmaceuticals Corporation was merged into Defendant Bayer Healthcare Pharmaceuticals Inc.
10. Defendant Bayer HealthCare Pharmaceuticals Inc., is and at times relevant was, a corporation organized and existing under the laws of the State of Delaware, having a principal place of business at 340 Changebridge Road, P.O. Box 1000, Montville, New Jersey 07045-1000.
11. Defendant Bayer HealthCare Pharmaceuticals Inc. was formerly known as Berlex, Inc., which was formerly known as Berlex Laboratories, Inc., and is the same corporate entity as Berlex, Inc. and Berlex Laboratories, Inc.
12. Defendant Bayer HealthCare Pharmaceutical. is the holder of approved New Drug Application (“NDA”) for Yaz
13. Defendant Bayer HealthCare Pharmaceuticals Inc. is the holder of approved New Drug Application (“NDA”) for Yasmin.
14. Defendants Berlex Laboratories, Inc. and Berlex, Inc. are, and at all times relevant were, foreign corporations with their headquarters and principal places of business at Montville, New Jersey and with a post office address of P.O. Box 1000, Montville, New Jersey, 07045 and places of business located at 6 West Belt Road, Wayne, New Jersey 07470.
15. Defendants Berlex Laboratories, Inc. and Berlex, Inc. were integrated into Bayer HealthCare AG and operate as an integrated specialty pharmaceuticals business under the new name, Defendant Bayer Healthcare Pharmaceuticals, Inc.
16. Defendant Bayer Schering Pharma AG, formerly known as Schering AG, is a pharmaceutical company that is organized and existing under the laws of the Federal Republic of German, having a principal place of business at Mullerstrasse 178, 13353 Berlin, Germany.
17. Defendant Bayer Schering Pharma AG is a corporate successor to Schering AG.
18. Schering AG was renamed Bayer Schering Pharma AG effective December 29, 2006.
19. Defendant Bayer Schering Pharma AG's headquarters and principal place of business in the United States is located at 100 Bayer Road, Pittsburgh, Pennsylvania, 15205.
20. Defendant Bayer Schering Pharma AG is the current owner of the patent(s) relating to the oral contraceptive, Yasmin.
21. Defendant Bayer Schering Pharma AG is the current owner of the patent(s) relating to the oral contraceptive, Yaz.
22. Defendant Bayer AG is a German chemical and pharmaceutical company that is headquartered in Leverkusen, North Rhine-Westphalia, Germany.
23. Defendant Bayer AG is the third largest pharmaceutical company in the world.
24. Defendant Bayer AG is the parent/holding company of all other named Defendants.
25. Defendant Bayer AG's headquarters and principal place of business in the United States is located at 100 Bayer Road, Pittsburgh, Pennsylvania, 15205.
26. Defendants Bayer Corporation, Bayer Healthcare LLC, Bayer Pharmaceuticals Corporation, Bayer Healthcare Pharmaceuticals, Inc., Berlex Laboratories, Inc. and Berlex, Inc., Bayer Schering Pharma AG, and Bayer AG, shall be referred to herein individually by name or jointly as “Defendants.”
27. At all times alleged herein, Defendants include 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.
28. At all times herein mentioned, each of the Defendants was the agent, servant, partner, predecessors in interest, aider and abettor, co-conspirator and joint venturer of each of the remaining Defendants herein and was at all times operating and acting with the purpose and scope of said agency, service, employment, partnership, conspiracy and joint venture.
29. At all times relevant, Defendants were engaged in the business of developing, designing, licensing, manufacturing, distributing, selling, marketing, and/or introducing into interstate commerce throughout the United States, either directly or indirectly through third parties, subsidiaries or related entities, the oral contraceptives, Yaz and Yasmin.
II. JURISDICTION AND VENUE
30. Plaintiff alleges damages in excess of one hundred fifty thousand dollars ($150,000.00), exclusive of costs and interests.
31. This Court has jurisdiction over this action pursuant to 28 U.S.C.A. § 1332, as there is complete diversity of citizenship between Plaintiff and Defendants, and the amount in controversy exceeds $150,000.00, exclusive of interest and costs.
32. Venue is proper in the Eastern District of Pennsylvania pursuant to 28 U.S.C.A. § 1391, as a substantial part of the events or omissions giving rise to the claim occurred within this District, including, but not limited to, the development, design, licensing, labeling, manufacturing and/or marketing of the defective drug, as well as Defendant's fraud and conspiracy to actively concealed and/or misrepresent information concerning the safety and efficacy of YASMIN and YAZ with the intention and specific desire to mislead the medical, pharmaceutical and/or scientific communities, and users and/or consumers of the drug, including Plaintiff.
III. FACTUAL ALLEGATIONS
A. Nature of the Case
33. Plaintiffs brings this case against Defendants for damages associated with Plaintiff, Robin Adams' ingestion of the pharmaceutical drug Yaz or Yasmin (ethinyl estradiol and drospirenone), an oral contraceptive designed, manufactured, marketed, and distributed by Defendants. Specifically, Plaintiff suffered a DVT and Pulmonary Embolism, and other injuries on April 28, 2008 as a direct result of her use of Yaz. Her husband, Thomas E. Adams has suffered a loss of consortium.
B. Yasmin and Yaz Contain a “Fourth Generation” Progestin
34. Yaz and Yasmin are birth control pills manufactured and marketed by Bayer. 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.
35. Yasmin received FDA approval first in 2001. It is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen.
36. Yaz received approval from the FDA in 2006 and is essentially the same as Yasmin with the only difference being a slightly smaller amount of ethinyl estradiol.
37. Yasmin and Yaz were approved by the Food and Drug Administration for marketing in 2001 and 2006 respectively.
38. Yasmin and Yaz Contain a “Fourth Generation” Progestin
39. The estrogen component in Yasmin and Yaz is known generically as ethinyl estradiol.
40. The progestin component is known as drospirenone.
41. Yasmin contains 0.03 milligrams of ethinyl estradiol, and Yaz contains 0.02 milligrams of ethinyl estradiol.
42. Both products contain 3 milligrams of drospirenone.
43. Yasmin and Yaz 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 Yasmin.
44. 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.
45. 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.
46. During the 1990's, new “third generation” progestins were developed.
47. 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 embolism 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.
48. Yasmin and Yaz contain the same estrogen component, ethinyl estradiol, that has been used in the lower dose birth control pills for decades. 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 Yasmin and Yaz marketed under the trade name Ocella.
49. Since drospirenone is new, there are not decades of data available to support its safe use as there are with second generation progestins. Studies that were done prior to FDA approval, however, indicate that drospirenone has certain effects that are different from those of traditional second generation progestins, and potentially more dangerous.
50. 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.
51. Hyperkalemia can cause heart rhythm disturbances, such as extra systolies, pauses, or bradycardia. If left untreated, hyperkalemia can be fatal.
52. 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 pulmonary embolism, or can travel to the brain causing stroke.
53. Indeed, during the brief time that Yasmin and Yaz 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.
54. In April 2002, THE British Medical Journ 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.
55. In February 2003, a paper entitled Thromboembolism Associated With the New 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. 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 Yasmin and Yaz have been filed with the FDA.
56. These reports include deaths associated with cardiac arrhythmia, cardiac arrest, intracardiac thrombus, pulmonary embolism, and stroke in women in their child bearing years.
57. Some deaths reported occurred in women as young as 17 years old.
58. Significantly, reports of elevated potassium levels are frequently included among the symptoms of those suffering death while using Yasmin or Yaz.
C. Over-Promotion of Yasmin and Yaz
59. Defendants market Yasmin and Yaz as providing the same efficacy as other birth control pills in preventing pregnancy, but with additional benefits.
60. However, because Yasmin and Yaz contain the fourth generation progestin drospirenone which is a diuretic they present additional health risks not associated with other birth control pills.
61. 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.”
62. 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 [.]”
63. 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.”
64. More recently, Defendants advertised that its product Yaz was indicated for treatment of premenstrual syndrome or “PMS,” as opposed to the less serious condition of premenstrual dysphoric disorder or “PMDD.”
65. Defendants also advertised that Yaz contained the added benefit of preventing or reducing acne.
66. 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 for medical conditions beyond the limits of the FDA approval, and adding that “Yaz 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.”
67. The FDA further warned in its October 3, 2008 letter that Yaz “does not result in completely clear skin” and that Defendants' “TV Ads misleadingly overstate the efficacy of the drug.”
68. Indeed, the FDA felt Defendants' overpromotion of Yasmin was so severe that it required Bayer to run new TV advertisements to correct the previous misleading Yaz advertisements regarding acne and premenstrual syndrome.
69. Bayer ultimately agreed to spend at least $20 million on corrective TV advertisements and to submit all Yaz advertisements to the FDA for advanced screening for the next six years.
70. Defendants did not provide adequate warnings to doctors, the health care community and the public about the risk of serious adverse events that are described in this complaint.
71. As a result of the manufacture, marketing, advertising, promotion, distribution, the sale of Yaz / Yasmin without adequate warnings about the risks of serious injuries, Plaintiff has sustained severe and permanent personal injuries.
72. As a result of Defendants' claim regarding the effectiveness and safety of Yaz/Yasmin, Plaintiff medical provider prescribed her and she ingested Yaz/Yasmin.
D. Plaintiff's Use and Resulting Injuries
73. In or around while taking Yaz/Yasmin Plaintiff suffered a DVT and PE.
74. As a direct and proximate result of using Yaz/Yasmin, Plaintiff suffered the injuries described above.
75. Prior to Plaintiff's use of Yaz/Yasmin, Defendants knew or should have known that use of Yaz/Yasmin created a higher risk of deaths, cardiac arrhythmia, cardiac arrest, intracardiac thrombus, pulmonary embolism, deep vein thrombosis and stroke gallbladder removal 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.
76. Therefore, at the time Plaintiff 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 gallbladder removal, deep vein thrombosis, pulmonary embolism, heart attacks, stroke, and even death.
77. 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 and/or her health care providers of said serious risks before she used the product
78. Had Plaintiff 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 injuries described above.
79. As a direct and proximate result of her use of Yaz/Yasmin, Plaintiff suffered physical injury, including but not limited to, conscious pain and suffering, as a result of her injuries as described herein.
80. As a direct and proximate result of her use of Yaz/Yasmin, Plaintiff has suffered and will continue to suffer pecuniary and other losses.
81. As a direct and proximate result of Plaintiff' use of Yaz/Yasmin and resulting injuries, her, Plaintiff , has suffered damages and harm, including but not limited to, emotional distress and has incurred other medical expenses and other economic harm, as well as loss of consortium, services, society, companionship, love and comfort.
IV. CAUSES OF ACTION
COUNT I FRAUDULENT CONCEALMENT
82. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further alleges on information and belief as follows.
83. Prior to Plaintiff's use of Yaz/Yasmin and during the period in which Plaintiff actually used Yaz/Yasmin, Defendants fraudulently suppressed material information regarding the safety and efficacy of Yaz/Yasmin, including information regarding increased adverse events, pre and post marketing deaths, a high rate of severe adverse event reports compared to other birth control pills, deaths, cardiac arrhythmia, cardiac arrest, intracardiac thrombus, pulmonary embolism, deep vein thrombosis and stroke. Furthermore, Defendants fraudulently concealed the safety information about the use of drospirenone, the only birth control pill using this ingredient. As described above, drospirenone has several well known serious side effects that are not seen in other forms of birth control. Plaintiff believes that the fraudulent misrepresentation described herein was intentional to keep the sales volume of Yaz/Yasmin strong.
84. Defendants fraudulently concealed safety issues with Yaz/Yasmin in order to induce physicians to prescribe and patients, including Plaintiff, to purchase and use Yaz/Yasmin.
85. At the time Defendants concealed the fact that Yaz/Yasmin was not safe, Defendants were under a duty to communicate this information to physicians, the FDA, the Healthcare community, and the general public in such a manner that they could appreciate the risks associated with using Yaz/Yasmin
86. Plaintiff and the Plaintiff's prescribing doctor relied upon the Defendants' outrageous untruths regarding the safety of Yaz/Yasmin.
87. As a direct and proximate result of Defendants' malicious and or intentional concealment of material life altering information from Plaintiff and Plaintiff's prescribing doctor, Defendants caused or contributed to Plaintiff's injuries.
88. It is unconscionable and outrageous that Defendants would risk the lives of consumers. Despite this knowledge, the Defendants made conscious decisions not to redesign, label, warn or inform the unsuspecting consuming public. Defendants' outrageous conduct rises to the level necessary that Plaintiff should be awarded punitive damages to deter Defendants from this type of outrageous conduct in the future and to discourage Defendants from placing profits above the safety of patients in the United States of America.
89. Defendants' fraudulent concealment tolled the statute of limitations because only Defendants knew the true dangers associated with the use of Yaz/Yasmin as described herein. Defendants did not disclose this information to the Plaintiff, the prescribing doctor, the Healthcare community and the general public. Without full knowledge of the dangers of Yaz/Yasmin, Plaintiff and Plaintiff's lawyer could not evaluate whether a person who was injured by Yaz/Yasmin had a valid claim.
COUNT II STRICT LIABILITY
90. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further alleges on information and belief as follows.
91. At the time of Plaintiff's injury, Defendants' pharmaceutical, Yaz/Yasmin, was defective and unreasonably dangerous to foreseeable consumers, including Plaintiff.
92. The Yaz/Yasmin used by Plaintiff was in the same or substantially similar condition as it was when it left the possession of Defendants.
93. Plaintiff did not misuse or materially alter the Yaz/Yasmin.
94. Defendants are strictly liable for Plaintiff's injury in the following ways:
a. The pharmaceutical Yaz/Yasmin as designed, manufactured, sold and/or supplied by the Defendants, was defectively designed and placed into the stream of commerce by Defendants in a defective and unreasonably dangerous condition;
b. Defendants failed to properly market, design, manufacture, distribute, supply and sell Yaz/Yasmin;
c. Defendants failed to warn and/or place adequate warnings and instructions on Yaz/Yasmin;
d. Defendants failed to adequately test Yaz/Yasmin;
e. Defendants failed to provide timely and adequate post-marketing warnings and instructions after they knew of the risk of injury associated with the use of Yaz/Yasmin; and
f. A feasible alternative design existed that was capable of preventing Plaintiffs injury.
95. Defendants' actions and omissions were the direct and proximate cause of Plaintiffs injury.
96. Defendants' conduct, as described above, was extreme and outrageous. Defendants risked the lives of the consumers and users of their products, including Plaintiff, with knowledge of the safety and efficacy problems and suppressed this knowledge from the general public. Defendants made conscious decisions not to redesign, re-label, warn or inform the unsuspecting consuming public. Defendants' outrageous conduct warrants an award of punitive damages.
COUNT III BREACH OF IMPLIED WARRANTY OF MERCHANTABILITY
97. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further alleges on information and belief as follows.
98. At the time Defendants marketed, distributed and sold Yaz/Yasmin to Plaintiff, Defendants warranted that Yaz/Yasmin was merchantable and fit for the ordinary purposes for which it was intended.
99. Members of the consuming public, including consumers such as Plaintiff, were intended third party beneficiaries of the warranty.
100. Yaz/Yasmin was not merchantable and fit for its ordinary purpose, because it has a propensity to lead to the serious personal injuries described in this complaint.
101. Plaintiff reasonably relied on Defendants' representations that Yaz/Yasmin was safe and free of defects and was a safe means of birth control.
102. Defendants' breach of the implied warranty of merchantability was the direct and proximate cause of Plaintiff's injury.
103. Defendants' conduct, as described above, was extreme and outrageous. Defendants risked the lives of the consumers and users of their products, including Plaintiff, with knowledge of the safety and efficacy problems and suppressed this knowledge from the general public. Defendants made conscious decisions not to redesign, re-label, warn or inform the unsuspecting consuming public. Defendants' outrageous conduct warrants an award of punitive damages.
COUNT IV BREACH OF IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE
104. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further alleges on information and belief as follows.
105. Defendants sold Yaz/Yasmin with an implied warranty that it was fit for the particular purpose of safe birth control, which offered other benefits, such as reduced bloating, reduced mood swings, improved complexion, and reduced the severity of women's menstruation.
106. Members of the consuming public, including Plaintiff, were intended third party beneficiaries of the warranty.
107. Yaz/Yasmin was not fit for the particular purpose of a safe birth control pill without serious risk of personal injury, which risk is much higher than other birth control pills.
108. Plaintiff reasonably relied on Defendants' representations that Yaz/Yasmin was safe and effective for use as a birth control method.
109. Defendants' breach of the implied warranty of fitness for a particular purpose was the direct and proximate cause of Plaintiff's injury.
110. Defendants' conduct, as described above, was extreme and outrageous. Defendants risked the lives of the consumers and users of their products, including Plaintiff, with knowledge of the safety and efficacy problems and suppressed this knowledge from the general public. Defendants made conscious decisions not to redesign, re-label, warn or inform the unsuspecting consuming public. Defendants' outrageous conduct warrants an award of punitive damages.
COUNT V NEGLIGENT FAILURE TO WARN
111. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further alleges on information and belief as follows.
112. Before Plaintiff used Yaz/Yasmin, and during the period in which she used it, Defendants knew or had reason to know that Yaz/Yasmin was dangerous and created an unreasonable risk of bodily harm to consumers.
113. Defendants had a duty to exercise reasonable care to warn end users of the dangerous conditions or of the facts that made Yaz/Yasmin likely to be dangerous.
114. Despite the fact that Defendants knew or had reason to know that Yaz/Yasmin was dangerous, Defendants failed to exercise reasonable care in warning the medical community and consumers, including Plaintiff, of the dangerous conditions and facts that made Yaz/Yasmin likely to be dangerous.
115. The Plaintiff's injury was a direct and proximate result of Defendants' failure to warn of the dangers of Yaz/Yasmin.
116. Defendants' conduct, as described above, was extreme and outrageous. Defendants risked the lives of consumers and users of their products, including Plaintiff, with knowledge of the safety and efficacy problems and suppressed this knowledge from the general public. Defendants made conscious decisions not to redesign, re-label, warn or inform the unsuspecting consuming public. Defendants' outrageous conduct warrants an award of punitive damages.
COUNT VI NEGLIGENCE
117. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further alleges on information and belief as follows.
118. Defendants had a duty to exercise reasonable care in the manufacture, sale and distribution of Yaz/Yasmin, including a duty to assure that the product did not cause unreasonable, dangerous side effects to users.
119. Defendants failed to exercise ordinary care in the manufacture, sale, warnings, quality assurance, quality control, and distribution of Yaz/Yasmin in that Defendants knew or should have known that the drug created a high risk of unreasonable harm.
120. Defendants were negligent in the design, manufacture, advertising, warning, marketing and sale of Yaz/Yasmin in that, among other things, they:
a. Failed to use due care in designing and manufacturing Yaz/Yasmin so as to avoid the aforementioned risks to individuals;
b. Failed to accompany the drug with proper warnings regarding all possible adverse side effects associated with its use, and the comparative severity and duration of such adverse effects. The warnings given did not reflect accurately the symptoms, scope or severity of the side effects;
c. Failed to provide adequate training and instruction to medical care providers for appropriate use of Yaz/Yasmin;
d. Placed an unsafe product into the stream of commerce; and
e. Were otherwise careless or negligent.
121. Despite the fact that Defendants knew or should have known that Yaz/Yasmin caused unreasonable, dangerous side effects which many users would be unable to remedy by any means, Defendants continued to market Yaz/Yasmin to consumers, including the medical community and Plaintiff.
122. Defendants' conduct, as described above, was extreme and outrageous. Defendants risked the lives of the consumers and users of their products, including Plaintiff, with the knowledge of the safety and efficacy problems and suppressed this knowledge from the general public. Defendants made conscious decisions not to redesign, re-label, warn or inform the unsuspecting consuming public. Defendants' outrageous conduct warrants an award of punitive damages.
COUNT VII NEGLIGENT MISREPRESENTATION
123. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further alleges on information and belief as follows.
124. Prior to Plaintiff first using Yaz/Yasmin and during the period in which she used Yaz/Yasmin, Defendants misrepresented that Yaz/Yasmin was a safe and effective means of birth control. Defendants also failed to disclose material facts regarding the safety and efficacy of Yaz/Yasmin, including information regarding increased adverse events, harmful side effects, and results of clinical studies showing that use of the medication could be life threatening.
125. Defendants had a duty to provide Plaintiff, physicians, and other consumers with true and accurate information and warnings of any known risks and side effects of the pharmaceuticals they marketed, distributed and sold.
126. Defendants knew or should have known, based on their prior experience, adverse event reports, studies and knowledge of the efficacy and safety failures with Yaz/Yasmin, that their representations regarding Yaz/Yasmin were false, and that they had a duty to disclose the dangers of Yaz/Yasmin.
127. Defendants made the representations and failed to disclose the material facts with the intent to induce consumers, including Plaintiff, to act in reliance by purchasing Yaz/Yasmin.
128. Plaintiff justifiably relied on Defendants' representations and nondisclosures by purchasing and using Yaz/Yasmin.
129. Defendants' misrepresentations and omissions regarding the safety and efficacy of Yaz/Yasmin was the direct and proximate cause of Plaintiff's injuries.
130. Defendants' conduct, as described above, was extreme and outrageous. Defendants risked the lives of the consumers and users of their products, including Plaintiff, with knowledge of the safety and efficacy problems and suppressed this knowledge from the general public. Defendants made conscious decisions not to redesign, re-label, warn or inform the unsuspecting consuming public. Defendants' outrageous conduct warrants an award of punitive damages.
COUNT VIII BREACH OF EXPRESS WARRANTY
131. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further alleges on information and belief as follows.
132. Defendants expressly warranted that Yaz/Yasmin was safe and effective to members of the consuming public, including Plaintiff.
133. Members of the consuming public, including consumers such as Plaintiff, were intended third party beneficiaries of the warranty.
134. Defendants marketed, promoted and sold Yaz/Yasmin as a safe method of birth control.
135. Yaz/Yasmin does not conform to these express representations because Yaz/Yasmin is not safe and has serious side effects, including death.
136. Defendants breached their express warranty in one or more of the following ways:
a. Yaz/Yasmin, as designed, manufactured, sold and/or supplied by the Defendants, was defectively designed and placed in to the stream of commerce by Defendants in a defective and unreasonably dangerous condition;
b. Defendants failed to warn and/or place adequate warnings and instructions on Yaz/Yasmin;
c. Defendants failed to adequately test Yaz/Yasmin; and
d. Defendants failed to provide timely and adequate post-marketing warnings and instructions after they knew the risk of injury from Yaz/Yasmin.
137. Plaintiff reasonably relied upon Defendants' warranty that Yaz/Yasmin was safe and effective when she purchased and used the medication.
138. Plaintiff's injuries were the direct and proximate result of Defendants' breach of their express warranty.
139. Defendants' conduct, as described above, was extreme and outrageous. Defendants risked the lives of the consumers and users of their products, including Plaintiff, with knowledge of the safety and efficacy problems and suppressed this knowledge from the general public. Defendants made conscious decisions not to redesign, re-label, warn or inform the unsuspecting consuming public. Defendants' outrageous conduct warrants an award of punitive damages.
COUNT IX FRAUD
140. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further alleges on information and belief as follows.
141. Defendants widely advertised and promoted Yaz/Yasmin as a safe and effective medication.
142. Defendants had a duty to disclose material information about serious side effects to consumers such as Plaintiff.
143. Additionally, by virtue of Defendants' partial disclosures about the medication, in which Defendants' touted Yaz/Yasmin as a safe and effective medication, Defendants had a duty to disclose all facts about the risks associated with use of the medication, including the risks described in this complaint. Defendants intentionally failed to disclose this information for the purpose of inducing consumers, such as Plaintiff, to purchase Defendants' dangerous product.
144. Had Plaintiff been aware of the hazards associated with Yaz/Yasmin, Plaintiff would not have consumed the product that led proximately to Plaintiffs adverse health effects.
145. Defendants' advertisements regarding Yaz/Yasmin made material misrepresentations to the effect that Yaz/Yasmin was a safe and effective medication, which misrepresentations Defendants knew to be false, for the purpose of fraudulently inducing consumers, such as Plaintiff, to purchase such product. Plaintiff relied on these material misrepresentations when deciding to purchase and consumer Yaz/Yasmin.
146. Upon information and belief, Plaintiff avers that Defendants actively and fraudulently concealed information in Defendants' exclusive possession regarding the hazards associated with Yaz/Yasmin with the purpose of preventing consumers, such as Plaintiff, from discovering these hazards.
COUNT X LOSS OF CONSORTIUM
147. Plaintiff incorporates by reference all preceding paragraphs as if fully set forth herein and further alleges on information and belief as follows.
148. As a result of the foregoing acts and omissions, and the resulting injuries, including but not limited to, personal injuries, medical expenses, and pain and suffering sustained by Plaintiff, Plaintiff Thomas E. Adams suffered the loss of companionship, society, services, and consortium of his wife.
V. PRAYER FOR RELIEF
WHEREFORE, Plaintiffs 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. Such further relief as this Court deems necessary, just, and proper.
Date: 7/2,2009
JURY DEMAND
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