Yaz and Yasmin Lawyers, Lawsuits, and Side Effects

Bayer Sued by pension funds over marketing of Yaz, Yazmin, and Yasminelle

In addition to the many personal injury lawsuits against the makers of Yaz, they are now being sued by pension funds that lost money investing in Bayer.

Oct. 6 (Bloomberg) -- Bayer AG, Germany’s largest drugmaker, was sued by two Pennsylvania pension funds and accused of misrepresenting the safety and effectiveness of the Yaz contraceptive to boost sales.

Bayer unlawfully promoted the drug from March 2006 to March 2009 by concealing side effects including blood clots, heart attacks and pulmonary embolisms, two health and welfare funds for firefighters and city employees said in a federal court complaint made public today in Philadelphia.

The Yasmin family of birth control pills, known as Yaz, Yasmin and Yasminelle, were Bayer’s top-selling drugs last year, bringing in about $1.8 billion, a 17 percent increase over 2007.

About 300 cases have been filed against the company over Yaz. Roughly 200 have been filed in federal litigation consolidated in East St. Louis, Illinois. Another 50 have been consolidated in state court in Philadelphia.

Source: Bayer Sued, Accused of Hiding Yaz Risk to Boost Sales (Update2) - Bloomberg.com

Plaintiff Suffered Pulmonary Embolism After Using Yaz

The Ohio lawsuit of Beck v. Bayer alleges that the embolism was caused by Yaz:

40. 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.

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

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

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

44. 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).

45. 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.

46. 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.

47. 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.

48. 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.

49. The use of YAZ has a prothrombotic effect resulting in thrombosis such as the pulmonary embolism suffered by Plaintiff.

50. Defendants ignored the correlation between the use of YAZ and increased thrombosis formation despite the wealth of scientific information available.

51. Upon information and belief, Defendants knew or should have known about the correlation between the use of YAZ and a prothrombotic effect and still promoted, sold, advertised, and marketed the use of YAZ.

52. 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.

53. 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.

54. 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.

55. 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.

56. 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, a pulmonary embolism, 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.

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

Yaz Lawyers Allege That Yaz and Yasmin Are Not Safe Or Effective

These allegations come from the case of Shafer v. Bayer:

40. YASMIN, 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.

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

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

43. YASMIN was approved by the FDA in April, 2001.

44. 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).

45. The difference between YASMIN /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.

46. YAZ/YASMIN's use of drospirenone, a diuretic, creates unique risks for compared to other oral contraceptives and is known to cause medical problems, including severe heart arrhythmias.

47. Upon information and belief, Defendants knew or should have known about the correlation between the use of YASMIN and YAZ and significantly increased risk of severe heart arrhythmias.

48. Yet, despite the wealth of scientific information available, Defendant ignored the correlation between the use of YASMIN and YAZ and significantly increased risk of severe heart arrhythmias and still promoted, sold, advertised, and marketed the use of YAZ/YASMIN without sufficient warnings.

49. 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 YASMIN and YAZ, and minimize serious risks associated with the drug.

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

51. 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 YASMIN and YAZ for use as a contraceptive, all of which evinced a callous, reckless, willful, depraved indifference to the health, safety and welfare of Plaintiff.

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

53. Defendants knew or should have known that YASMIN and 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.

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

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

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

C. That the risks of adverse events with YASMIN and 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, severe heart arrhythmias, 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 YASMIN and YAZ; and

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

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

56. 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 YASMIN and YAZ, including Plaintiff.

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

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

59. 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.

60. 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 YASMIN and YAZ, as set forth herein.

61. The misrepresentations of and/or active concealment by Defendants constitute a continuing tort. Indeed, through Defendants' product inserts, Defendants continue to misrepresent the potential risks and serious side effects associated with the use of YASMIN and YAZ.

62. Moreover, Defendants had a post-sale duty to warn the medical, pharmaceutical and/or scientific communities, and users and/or consumers of the drug, including Plaintiff, about the potential risks and serious side effects associated with the use of YASMIN and YAZ in a timely manner, yet they failed to provide such warning.

Yasmin Lawsuit Alleges Yaz and Yasmin Are Defectively Designed and Manufactured

The Texas lawsuit of Klarquist v. Bayer alleges that Yaz and Yasmin are defectively designed and manufactured:

FIRST CAUSE OF ACTION

Strict Products Liability Defective Manufacturing

54. Plaintiff incorporates by reference, as if fully set forth herein, each and every allegation set forth in the preceding paragraphs and further alleges as follows.

55. Defendants are the manufacturers, designers, distributors, sellers, or suppliers of Yasmin.

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

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

58. As a direct and proximate result of Plaintiff's use of Yasmin as manufactured, designed, sold, supplied and introduced into the stream of commerce by Defendants, Plaintiff Alaina Klarquist suffered personal injury, economic and non-economic damages, and will continue to suffer such harm, damages, and economic loss in the future.

59. Defendants' actions and omissions as identified in this Complaint show that Defendants acted maliciously, with aggravated or egregious fraud, and/or flagrantly disregarded Plaintiff's safety and rights, so as to warrant the imposition of punitive damages.

SECOND CAUSE OF ACTION

Strict Products Liability Design Defect

60. Plaintiff incorporates by reference, as if fully set forth herein, each and every allegation set forth in the preceding paragraphs and further alleges as follows.

61. Defendants are the manufacturers, designers, distributors, sellers, or suppliers of Yasmin.

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

63. The Yasmin birth control pills manufactured and supplied by Defendants was 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 it was more dangerous than an ordinary consumer would expect.

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

65. As a direct and proximate result of Plaintiffs use of Yasmin as manufactured, designed, sold, supplied and introduced into the stream of commerce by Defendants, Plaintiff Alaina Klarquist suffered personal injury, economic and non-economic damages, and will continue to suffer such harm, damages, and economic loss in the future.

66. Defendants' actions and omissions as identified in this Complaint show that Defendants acted maliciously, with aggravated or egregious fraud, and/or flagrantly disregarded Plaintiff's safety and rights, so as to warrant the imposition of punitive damages.

THIRD CAUSE OF ACTION

Strict Products Liability Defect Due to Inadequate Warning

67. Plaintiff incorporates by reference, as if fully set forth herein, each and every allegation set forth in the preceding paragraphs and further alleges as follows.

68. The Yasmin birth control pills manufactured and supplied by Defendants was 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.

69. The Yasmin birth control pills manufactured and supplied by Defendants was defective due to inadequate post-marketing warning or instruction and was 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 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.

70. As a direct and proximate result of Plaintiffs use of Yasmin as manufactured, designed, sold, supplied and introduced into the stream of commerce by Defendants, Plaintiff Alaina Klarquist suffered personal injury, economic and non-economic damages, and will continue to suffer such harm, damages, and economic loss in the future.

71. Defendants' actions and omissions as identified in this Complaint show that Defendants acted maliciously, with aggravated or egregious fraud, and/or flagrantly disregarded Plaintiffs safety and rights, so as to warrant the imposition of punitive damages.

Yaz Lawyers File Lawsuit Against Bayer In Pennsylvania

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.