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Yaz Lawyers List Yaz Side Effects in Lawsuit

The following Yaz lawsuit was filed in the Southern District of Ohio in May of 2009:

39. Yasmin, (a predecessor to YAZ), known generically as drospirenone and ethinyl estradiol, is a combination birth control pill originally developed by Defendant BERLEX LABORATORIES, INC. and/or Defendant BERLEX, INC containing the hormones estrogen and progestin.

40. The estrogen is ethinyl estradiol and the progestin is drospirenone, (3 mg of drospirenone and 0.03 mg of ethinyl estradiol per tablet).

41. Combination birth control pills are referred to as combined hormonal oral contraceptives.

42. Yasmin was approved by the FDA in April, 2001.

43. In 2006, Bayer acquired Defendant BERLEX LABORATORIES, INC. and/or Defendant BERLEX, INC, and began marketing an almost identical drug, YAZ (which contains 3 mg of drospirenone and 0.02 mg of ethinyl estradiol per tablet).

44. The difference between YAZ/ 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.

45. YAZ/ YASMIN's use of drospirenone, a diuretic, creates unique risks for compared to other oral contraceptives and is known to cause problems with the gallbladder that may require surgical intervention.

46. Defendants have been warned at least three times by the FDA; in 2003, 2008 and 2009, for misleading the public through the use of ads which overstate the efficacy of YAZ and/or its predecessor Yasmin, and minimize serious risks associated with the drug.

47. Defendants ignored the correlation between the use of YAZ and significantly increased risk of gallbladder complications despite the wealth of scientific information available.

48. Defendants knew or should have known about the correlation between the use of YAZ and significantly increased risk of gallbladder complications and still promoted, sold, advertised, and marketed the use of YAZ.

49. Defendants falsely and fraudulently represented to the medical and healthcare community, to Plaintiff, the FDA, and the public in general, that YAZ had been tested and was found to be safe and/or effective for its indicated use.

50. These false representations were made by Defendants with the intent of defrauding and deceiving 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 YAZ for use as a contraceptive, all of which
evinced a callous, reckless, willful, depraved indifference to the health, safety and welfare of Plaintiff.

51. Defendants knew and were aware or should have been aware that YAZ had not been sufficiently tested, was defective in its design and testing, and/or that it lacked adequate and/or sufficient warnings.

52. Defendants knew or should have known that YAZ had a potential to, could, and would cause severe and grievous injury and death 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.

53. In representations to Plaintiff, her healthcare providers, and/or the FDA, Defendants also fraudulently concealed and intentionally omitted the following material information:

A. That YAZ is not as safe as other available contraceptives;

B. That the risks of adverse events with YAZ (drospirenone and ethinyl estradiol) was higher than those of other available contraceptives;

C. That the risks of adverse events with YAZ 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, gallbladder complications, as well as other severe and personal injuries, physical pain, and mental anguish;

E. That patients needed to be monitored more regularly than normal while using YAZ ; and

F. That YAZ was designed, tested, manufactured, marketed, produced, distributed and advertised negligently, defectively, fraudulently and improperly.

54. Defendants were under a duty to disclose to Plaintiff and her physicians, hospitals, healthcare providers and/or the FDA the defective nature of YAZ.

55. 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 person who used YAZ, including Plaintiff.

56. Defendants made the misrepresentations and/or actively concealed information concerning the safety and efficacy of YAZ 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 YAZ as a contraceptive.

57. Defendants made these misrepresentations and/or actively concealed information concerning the safety and efficacy of YAZ in their labeling, advertising, product inserts, promotional material or other marketing efforts.

58. The misrepresentations of and/or active concealment by Defendants were perpetuated directly and/or indirectly by Defendants, its sales representative, employees, distributors, agents and/or detail persons.

59. Defendants knew that Plaintiff, her 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 YAZ, as set forth herein.

60. 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 YAZ.

61. 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 YAZ in a timely manner, yet they failed to provide such warning.

Yasmin Lawyers File Yasmin Lawsuit in California

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.

Yaz Attorneys File Lawsuit Against Makers of Yaz and Yasmin

This lawsuit was filed in May of 2009, and explains some of the risks associated with taking Yaz or Yasmin.

15. YASMIN received FDA approval first in 2001. It is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen.

16. 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.

17. YAZ and YASMIN are indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.

18. Combination birth control pills are referred to as combined hormonal oral contraceptives.

19. The difference between YAZ 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.

20. 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 YAZ/YASMIN.

21. In February 2003, a paper entitled Thromboembolism associated with the new contraceptive YAZ/YASMIN was published in the British Medical Journal detailing a Netherlands Pharmacovigilance Centre report of additional reports of thromboembolism where YAZ/YASMIN was suspected as the cause, including two deaths.

22. Defendants have twice been warned by the FDA, in 2003 and 2008, for misleading the public through the use of television advertisements which overstate the efficacy of the drugs and minimize the serious risks associated with the drugs.

23. The use of YAZ/YASMIN has a prothrombotic effect resulting in the development of thromboses, such as pulmonary emboli and deep vein thrombosis.

24. Defendants failed to recognize the correlation between the use of YAZ/YASMIN and increased thrombosis formation despite the wealth of scientific information available.

25. Upon information and belief, Defendants knew or should have known about the correlation between YAZ/YASMIN use and a prothrombotic effect and still promoted, sold, advertised, and marketed the use of YAZ/YASMIN without sufficient warnings.

26. YAZ/YASMIN use of drospirenone, a diuretic, creates unique risks for compared to other oral contraceptives. These risks include heart arrhythmias, myocardial infarction, and other adverse cardiovascular events, including sudden death.

27. The diuretic in YAZ/YASMIN is also known to cause problems with the gallbladder; the problems sometimes require surgical intervention. The diuretic also causes kidney stone formation.

Yaz Lawsuit Filed In Illinois Discussed History of Yaz and Yasmin

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.