in the united states district court for the district of ... -- amended complaint.pdf ·...

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF ILLINOIS

SOUTHERN DIVISION

) IN RE YASMIN AND YAZ (DROSPIRENONE) ) 3:09-md-02100-DRH-PMF MARKETING, SALES PRACTICES AND ) Chief Judge David R. Herndon PRODUCTS LIABILITY LITIGATION ) Magistrate Phillip M. Frazier )

) THIS DOCUMENT RELATES TO: ) ) PHILADELPHIA FIREFIGHTERS UNION ) 3:09-cv-20071-DRH-PMF LOCAL NO. 22 HEALTH AND WELFARE ) Chief Judge David R. Herndon FUND, ET AL., on behalf of themselves and all ) Magistrate Phillip M. Frazier others similarly situated, ) (Originally filed as 2:09-cv-04567-HB ) in the Eastern Division of the United

Plaintiffs, ) States District Court for the District of ) Pennsylvania)

v. ) ) BAYER HEALTHCARE ) First Amended Complaint – PHARMACEUTICALS, INC., ET AL.. ) Class Action ) Defendants. ) )

FIRST AMENDED CLASS ACTION COMPLAINT I.

NATURE OF ACTION

1. Plaintiffs and proposed class representatives, Philadelphia Firefighters Union

Local No. 22 Health and Welfare Fund (“Local No. 22”) and American Federation of State,

County and Municipal Employees, District Council 47 Health and Welfare Fund (“District

Council 47”), bring this action on behalf of themselves and all other similarly situated entities to

recover damages arising from Defendants’ fraudulent and unlawful scheme to market and sell

the drug YAZ®.

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Case 3:09-cv-20071-DRH -PMF Document 21 Filed 02/02/10 of 46

2. This is action is brought as a class action pursuant to Federal Rule of Civil

Procedure 23 on behalf of a Class, described more fully below, that includes all third party

payors in the United States and its territories that purchased, reimbursed, and/or paid for all or

part of the cost of YAZ dispensed pursuant to prescriptions in the United States.

3. The United States Food and Drug Administration (“FDA”) has approved YAZ for

use as an oral contraceptive and to treat symptoms of moderate acne vulgaris and premenstrual

dysphoric disorder (“PMDD”) in women who chose to use an oral contraceptive as their method

of contraception.

4. Beginning on approximately March 17, 2006, when YAZ was first approved for

use as an oral contraceptive, Defendants associated and conspired with others to implement and

carry out a fraudulent, misleading, and unlawful marketing scheme that misrepresented YAZ’s

safety and benefits to a wide range of consumers/patients, physicians, third party payors, and

others involved in the selection, approval, distribution, and payment of the costs for prescription

drugs in order to increase YAZ sales and price YAZ at a substantial but unwarranted premium as

compared to safer, equally effective, and cheaper oral contraceptives, resulting in the fleecing of

Plaintiffs’ and Class Members’ funds.

5. Plaintiffs and Class Members have been injured by the payment of hundreds of

millions of dollars in excessive prescription costs as a result of Defendants’ fraudulent and

unlawful promotion of YAZ.

II. PARTIES

6. Plaintiff Philadelphia Firefighters Union Local 22 Health and Welfare Fund is a

health and welfare trust fund providing medical benefits, including prescription drug coverage, to

members of the local and their dependents, representing active or retired employees of the Fire

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Department of the City of Philadelphia, with offices in Philadelphia at 415-427 North 5th Street,

Philadelphia, Pennsylvania 19123.

7. Plaintiff American Federation of State, County and Municipal Employees,

District Council 47 Health and Welfare Fund, is a health and welfare trust fund providing

medical benefits, including prescription drug coverage, to its participants and their dependents,

representing active or retired employees of the City of Philadelphia, with offices in Philadelphia

at 1606 Walnut Street, Philadelphia, Pennsylvania 19103.

8. During the relevant time period, the Plaintiffs either purchased YAZ for use by

their participants or their dependents, or reimbursed participants or their dependents for their

purchases of YAZ. Plaintiffs were injured as a result of the unlawful conduct alleged herein.

9. Defendant Bayer HealthCare Pharmaceuticals, Inc. is, and at all times relevant,

was a corporation organized and existing under the laws of the State of Delaware, having a

principal place of business in Montville, New Jersey.

10. Defendant Bayer HealthCare Pharmaceuticals, Inc. is the holder of approved New

Drug Application (“NDA”) for YAZ, and manufactures and markets YAZ in the United States.

11. 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 Road, Pittsburgh, Pennsylvania 15205.

12. Defendant Bayer HealthCare LLC is, and at all 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.

13. Defendant Bayer HealthCare LLC is wholly owned by Defendant Bayer

Corporation.

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14. Defendant Bayer AG is a German chemical and pharmaceutical company that is

headquartered in Leverkusen, North Rhine-Westphalia, Germany.

15. Defendant Bayer AG is the third largest pharmaceutical company in the world.

16. Defendant Bayer AG is the parent/holding company of all other named

defendants.

17. Defendant Bayer AG’s headquarters and principal place of business in the United

States is located at 100 Bayer Road, Pittsburgh, Pennsylvania 15205.

18. Defendants Bayer Corporation, Bayer HealthCare LLC, Bayer HealthCare

Pharmaceuticals, Inc., and Bayer AG shall be referred to by name or jointly as “Bayer” or

“Defendants.”

19. At all times alleged herein, Defendants 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.

20. At all times relevant hereto, Bayer acted through its agents and employees and the

acts of its agents and employees were within the scope of their agency and employment. The

policies and practices alleged in this complaint were, on information and belief, set or ratified at

Defendants’ highest corporate levels.

21. At all times relevant hereto, Bayer was engaged in the business of developing,

designing, licensing, manufacturing, distributing, selling, marketing, and/or introducing the oral

contraceptive YAZ into interstate commerce throughout the United States, including the

Commonwealth of Pennsylvania and every other state, either directly or indirectly through third

parties, subsidiaries, or related entities.

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III. JURISDICTION AND VENUE

22. This Court has subject-matter jurisdiction pursuant to 28 U.S.C. § 1331 because

this action arises under the laws of the United States, including 28 U.S.C. § 1964(c), as this

action alleges violations of the Racketeer Influence and Corrupt Organizations Act (“RICO”), 18

U.S.C. § 1961, et seq.

23. This Court also has subject-matter jurisdiction pursuant to 28 U.S.C. §

1332(d)(2), which provides federal district courts with original jurisdiction over civil actions in

which the matter in controversy exceeds the sum or value of $5,000,000, exclusive of interest

and costs, many Class Members are citizens of states other than Delaware, Pennsylvania, New

Jersey, and Indiana, where Defendants are citizens or have their principal places of business, and

the Class consists of more than one hundred members.

24. This Court also has supplemental jurisdiction over Plaintiffs’ state-law claims

pursuant to 28 U.S.C. § 1367(a).

25. Venue is proper in this District pursuant to 28 U.S.C. § 1391(b) and (c) and 18

U.S.C. § 1965 because Defendants transact business, reside, and/or have agents in this District,

and because a substantial part of the events or omissions giving rise to Plaintiffs’ claims occurred

within this District, including Defendants’ fraudulent scheme and conspiracy to actively conceal

and misrepresent information concerning the safety and efficacy of YAZ in order to mislead

consumers, third-party payors, and the medical, pharmaceutical, and scientific communities.

26. Defendants reside in this District for purposes of 28 U.S.C. § 1391 because they

are subject to general personal jurisdiction in this District. Defendants have continuous and

systematic contacts with the Commonwealth of Pennsylvania, including this District, through

marketing and selling YAZ and other products in the Commonwealth of Pennsylvania to

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Pennsylvania residents, including residents of this District. Defendant is also subject to specific

personal jurisdiction in this District because its contacts with this District gave rise to the instant

action.

IV. GENERAL ALLEGATIONS

A. Regulatory Framework

27. In the United States, the marketing and sale of prescription drugs is strictly

regulated by the FDA. A manufacturer may distribute a drug only if it is approved by the FDA.

21 U.S.C. § 355(a). In order to secure the FDA’s approval, a manufacturer must show that the

drug is “safe for use” for “all conditions prescribed, recommended or suggested” on a drug’s

label. 21 U.S.C. § 355(d). Drug manufacturers, such as Bayer, are required to demonstrate the

safety and effectiveness of drugs for specific intended uses through extensive preclinical studies

and clinical trials, a process that typically takes years.

28. Under the Food and Drug Administration Modernization Act of 1997 (“FAME”),

if a manufacturer wishes to market or promote an approved drug for additional uses—i.e., uses

not listed on the approved label—the manufacturer must resubmit the drug for another series of

clinical trials similar to those for the initial approval. Until subsequent approval of the new use

has been granted, the unapproved use is considered to be “off-label.”

29. All advertisements for an FDA-approved prescription drug must present “a true

statement in brief summary” relating to the drug’s side effects, contraindications, and

effectiveness. 21 C.F.R. § 202.1(e)(1). Advertisements may not recommend or suggest any off-

label use. 21 C.F.R. § 202.1(e)(4).

30. An advertisement does not satisfy the requirement that it present a true statement

of information in brief summary relating to side effects, contraindications, and effectiveness if:

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(i) it is false or misleading with respect to side effects, contraindications, and effectiveness; or

(ii) it fails to present a fair balance between information relating to side effects and

contraindications and information relating to effectiveness; or (iii) it fails to reveal facts material

in the light of its representations or material with respect to consequences that may result from

the use of the drug as recommended or suggested in the advertisement. 21 C.F.R. § 202.1 (e)(5).

31. No advertisement concerning a particular prescription drug may be disseminated

without the approval of the FDA if the sponsor has received information that has not been widely

publicized in medical literature that the use of the drug may cause fatalities or serious damage.

21 C.F.R. § 202.1(j)(1)(i). Dissemination of an advertisement not in compliance with this

requirement is deemed to be an act that causes the drug to be misbranded in violation of the

Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C § 301, et seq., and its implementing

regulations, 21 C.F.R. § 1.1, et seq.

32. The FDA also strictly regulates the labeling of drugs that it approves. Pursuant to

the FDCA and its implementing regulations, labeling must contain “adequate directions for use,”

which must include a statement of all conditions, purposes, and uses for which the drug is

intended. 31 U.S.C. § 352(f); 21 C.F.R. § 201.5. Labeling must also contain “adequate warnings

against use” when taking or administering the drug may be dangerous. 31 U.S.C. § 352(f). A

drug that fails to comply with the foregoing regulations is deemed misbranded and may not be

distributed in interstate commerce. 21 U.S.C. § 331.

33. Although Bayer promoted YAZ for off-label uses in violation of the FDCA,

Plaintiffs’ claims are based on Bayer’s fraudulent, misleading, and otherwise unlawful

promotion of YAZ for on- and off-label uses, and on Bayer’s failure to conduct itself fairly,

ethically, and honestly in establishing pricing for YAZ based on its actual therapeutic benefits

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and safety-related risks in relation to safer, equally effective, and cheaper oral contraceptives.

B. Background on YAZ

34. At all relevant times, Bayer manufactured, marketed, distributed, and sold YAZ.

35. YAZ was distributed and sold by Bayer with National Drug Code (“NDC”)

numbers 12866-0405, 50419-*405, 54868-5535, and 64259-0405.

36. YAZ is a combined hormonal oral contraceptive consisting of estrogen and

progestin.

37. The estrogen is ethinyl estradiol and the progestin is drospirenone.

38. YAZ is provided as an oral contraceptive regimen consisting of 24 active firm

coated tablets, each containing 3.0 mg of drospirenone and 0.02 mg of ethinyl estradiol stabilized

by betadex as a clathrate (molecular inclusion complex), and 4 inert film coated tablets.

39. The FDA approved YAZ as an oral contraceptive on March 17, 2006.

40. On October 5, 2006, YAZ received FDA approval for the treatment of

premenstrual dysphoric disorder (“PMDD”) in women who choose to use an oral contraceptive.

41. On January 28, 2007, YAZ received FDA approval for the treatment of moderate

acne vulgaris in women who choose to use an oral contraceptive.

42. The current FDA-approved indications for YAZ are as follows:

YAZ is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.

* * * YAZ is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of YAZ for PMDD when used for more than three menstrual cycles has not been evaluated.

* * * YAZ is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy, and have achieved

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menarche. YAZ should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

43. The essential features of PMDD, according to the Diagnostic and Statistical

Manual-4th edition (“DSM-IV”), include markedly depressed mood, anxiety or tension, affective

lability, and persistent anger or irritability. Other features include decreased interest in usual

activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of

control. Physical symptoms associated with PMDD include breast tenderness, headache, joint

and muscle pain, bloating, and weight gain.

44. PMDD is a condition associated with severe emotional and physical problems that

are closely linked to the menstrual cycle. Symptoms occur regularly in the second half of the

cycle and end when menstruation begins or shortly thereafter. PMDD is estimated to affect only

about 5% of menstruating women.

45. In contrast, premenstrual syndrome (“PMS”) is a common condition that affects

as many as 75% of menstruating women. PMDD is not another name for PMS.

46. PMDD and PMS have some common symptoms such as depression, anxiety,

tension, irritability, and moodiness. However, the severity of the symptoms distinguishes PMDD

from PMS.

47. Bayer markets YAZ as providing the same efficacy and safety as other birth

control pills, but with additional benefits.

48. However, YAZ presents additional health risks because it contains the progestin

drospirenone, which is a new type of progestin that is considered a “fourth generation” progestin.

No other birth control pills contain drospirenone, except for Yasmin, which is also manufactured

by Bayer, and a recently approved generic version of Yasmin and YAZ, marketed under the

trade name Ocella, that is cheaper than both Yasmin and YAZ.

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49. Shortly after the introduction of combined oral contraceptives in the 1960s,

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.

50. During that 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.

51. During the 1990s, 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 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.

52. Studies have indicated that drospirenone has certain side effects that are different

from and more dangerous than the side effects associated with first, second, and third generation

progestins.

53. 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.

54. Hyperkalemia can cause heart rhythm disturbances, such as extrasystolies, pases,

or bradycardia. If left untreated, hyperkalemia can be fatal.

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55. 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 travel to the brain causing stroke.

56. Another side-effect is a substantially increased risk of gallbladder complications. 57. During the period that YAZ has been sold in the United States, numerous reports

of injury and death have been submitted to the FDA in association with YAZ.

58. These reports include deaths associated with cardiac arrhythmia, cardiac arrest,

intracardiac thrombus, pulmonary embolism, and stroke in women in their child bearing years.

59. Significantly, reports of elevated potassium levels are frequently included among

the symptoms of those suffering death while using YAZ.

60. Nonetheless, Bayer has concealed material information about YAZ’s association

with the above-described side effects when promoting the drug.

C. Bayer’s Advertising and Marketing of YAZ

61. As part of its business strategy, Bayer sought to produce the greatest possible

return on its investment in YAZ. At all relevant times, Bayer intended and expected to increase

consumer demand for YAZ by distinguishing it from ordinary oral contraceptives, leading to

greater YAZ sales and allowing Bayer to falsely inflate the market price for YAZ.

62. However, Bayer knew that the only additional indications for YAZ that were

actually supported by well-controlled clinical studies and approved by the FDA, and that could

legally be promoted, were limited to a small proportion of the potential market, namely, the 5%

of women who suffer from PMDD, and the subset of oral contraceptive users who have moderate

acne.

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63. Bayer also had sole access to material facts concerning YAZ’s propensity to cause

serious and dangerous side effects that are different from and more dangerous than the side

effects associated with ordinary oral contraceptives that do not contain drospirenone.

64. Bayer knew that an advertising and marketing campaign that complied with the

legal restrictions of the FDA approval was unlikely to influence the vast majority of potential

users who did not have PMDD or moderate acne, and would not produce a significant increase in

YAZ usage or sustain a falsely inflated price for YAZ. Bayer thus knew that such a campaign

would not produce an effective return on its investment in YAZ.

65. Accordingly, Bayer planned and implemented a scheme to (1) misrepresent that

YAZ could treat and eliminate the entire range of premenstrual symptoms, rather than just the

severe symptoms of PMDD, and (2) fraudulently conceal and intentionally omit the following

material information:

a. That YAZ is not as safe as other available contraceptives because it is

associated with side effects that are different from and more dangerous than

the side effects associated with oral contraceptives that do not contain

drospirenone;

b. That the risk of adverse events with YAZ (drospirenone and ethinyl estradiol)

is higher than that of other available contraceptives;

c. That YAZ users are at risk of experiencing serious and dangerous side effects

including, but not limited to, a pulmonary embolism, as well as other severe

personal injuries and physical pain; and

d. That patients need to be monitored more regularly than normal while using

YAZ.

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66. Bayer’s scheme to increase YAZ sales and falsely inflate and sustain the market

price for YAZ consisted of elaborate and clandestine efforts as well as deliberate

misrepresentations regarding, and omissions of, critical information related to YAZ’s risk

profile.

67. Bayer associated with marketing firms and other third parties in order to create

and carry out its scheme to increase YAZ sales and falsely inflate and sustain the market price.

68. With the help of its associates, Bayer engaged in a direct-to-consumer (“DTC”)

television advertising campaign that fraudulently, misleadingly, and unlawfully concealed and

minimized serious health risks associated with the use of YAZ, and promoted YAZ as safe and

effective for unapproved off-label uses lacking scientific support, including PMS, acne, anxiety,

tension, irritability, moodiness, fatigue, headaches, and muscle aches; and

69. Bayer consulted and hired the marketing firm Young & Rubicam to create the

“Beyond Birth Control” DTC advertising campaign.

70. A key element of Bayer’s marketing strategy, reflected in the “Beyond Birth

Control” slogan, was to emphasize the additional purported benefits of YAZ in order to

distinguish it from many competing oral contraceptives and create the consumer perception that

YAZ enhanced usefulness and benefits. Bayer expected and intended that such perception would

increase consumer demand for YAZ in the form of increased consumption and willingness of

consumers to pay more for YAZ than ordinary oral contraceptives in consideration of the

purported extra benefits.

71. Bayer approved and paid for the repeated nationwide broadcasts of several

television commercials as part of the “Beyond Birth Control” campaign.

72. One commercial, “Not Gonna Take It,” ran in 2007 and was set to the song

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“We’re Not Gonna Take It” by Twisted Sister, a song whose lyrics glorify independence and

resistance to oppressive forces. A voiceover promoted YAZ as a “pill that goes beyond the rest”

with benefits such as the ability to maintain clear skin. The commercial’s visual featured

fashionably dressed women who kicked or punctured floating words such as “irritability,”

“feeling anxious,” “moodiness,” and “bloating” away from the screen. The narrator stated, “It’s

YAZ! And there’s no other birth control like it.” The screen then displayed a list of symptoms

including irritability, increased appetite, moodiness, fatigue, feeling anxious, headaches,

bloating, and muscle aches.

73. Another commercial, “Balloons,” began running in 2008 and was set to the song

“Goodbye to You” by the Veronicas, a song whose chorus repeats a woman’s dismissal of an ex-

lover in an affirming, upbeat manner. The commercial showed women releasing balloons

labeled with symptoms including “irritability,” “moodiness,” “headaches,” “acne,” “feeling

anxious,” “muscle aches,” and “increased appetite.” After being released, the balloons floated

up and away, thereby representing that YAZ takes away those common pre-menstrual symptoms

and that women could say “Goodbye” to them. “Balloons” misrepresented that YAZ was more

effective than had been demonstrated by scientific evidence or clinical experience.

74. “Not Gonna Take It” and “Balloons” fraudulently and misleadingly represented

that YAZ is effective in a broader range of patients and conditions than has been demonstrated

by scientific evidence or clinical experience. Specifically, given the overlap in certain symptoms

between PMS and PMDD, and the material limitation on YAZ’s PMDD indication (that it has

not been evaluated for the treatment of a less serious condition, PMS), the television

advertisements misrepresented that YAZ is appropriate for women with PMS, who may not be

appropriate candidates for this drug.

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75. “Not Gonna Take It” and “Balloons” also misrepresented that YAZ could

successfully treat acne of all severities. In “Not Gonna Take It,” the word “Acne” appeared in

large print in the middle of the screen along with the image of a woman. The word “Acne” then

faded from view and the woman turned her face to the side showing viewers that she has no

visible signs of acne as an audio claim stated that YAZ “can also help keep your skin clear.”

Similarly, in “Balloons,” an “Acne” balloons floated by a smiling woman with completely clear

skin accompanied by the audio claim that YAZ “also helps keep skin clear” and the background

song “Goodbye to you.”

76. In addition, “Not Gonna Take It” and “Balloons” fraudulently and misleadingly

represented that YAZ is safer than it is by bombarding viewers with distracting visuals, graphics,

supers, and background music while serious risk information is being conveyed.

77. Bayer also sponsored a link for its YAZ-promoting website (www.Yaz-US.com)

on internet search engines, including Google.com, that made fraudulent representations and

omissions. The sponsored link for YAZ misrepresented that YAZ is useful in a broader range of

conditions and patients than has been demonstrated by substantial evidence or substantial clinical

experience by indicating that all patients with moderate acne were candidates for YAZ therapy

when this was not the case. Moreover, the sponsored link for YAZ failed to communicate any

safety information, and thus misrepresented that YAZ is safer than it is.

78. In all the above acts and omissions, Bayer had the intention and specific desire

that the medical, pharmaceutical, scientific community, pharmacy benefit managers, third-party

payors including Plaintiffs, and users of YAZ including Plaintiffs’ members and their dependents

would rely on Bayer’s misrepresentations and otherwise improper promotion, and as a result,

select YAZ as a contraceptive and/or for off-label indications, when they would instead have

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http://www.yaz-us.com/

used a cheaper, safer, and equally effective alternative oral contraceptive that did not contain

drospirenone.

79. Bayer’s clear aim from the outset was to mask YAZ’s flaws and overstate YAZ’s

benefits so as to increase its sales and justify its falsely inflated price over what were, in reality,

equally effective, safer, and cheaper alternative oral contraceptives. Bayer had this aim despite

the fact that it was aware of numerous health problems associated with YAZ and the lack of

clinical trial evidence supporting YAZ’s efficacy for treating PMS, acne, anxiety, tension,

irritability, moodiness, fatigue, headaches, muscle aches, or increased appetite.

80. Bayer and other pharmaceutical manufacturers have a duty to conduct themselves

fairly, ethically, and honestly in establishing pricing for their drugs based upon the drugs’ actual

therapeutic benefits and safety-related risks in relation to other available medications with

comparable safety and efficacy profiles. Plaintiffs and Class Members rely on manufacturers

like Bayer to conduct themselves accordingly. However, Bayer aggressively exploited its

position, its superior knowledge of YAZ’s characteristics, and its knowledge that third party

payors such as Plaintiffs and Class Members rely on manufacturers to comply with governing

regulations and legal and equitable duties. As a result, Plaintiffs and Class Members have been

forced to overpay for YAZ prescriptions by hundreds of millions of dollars.

81. Bayer was also under a duty to disclose the truth about YAZ to physicians,

hospitals, healthcare providers, and third party payors including Plaintiffs. In addition, Bayer’s

DTC advertising gave rise to a duty to disclose the truth about YAZ to consumers including

Plaintiffs’ members and their dependents.

82. When presenting information about YAZ, Bayer had a duty to provide fair and

balanced information. Fair balance is not limited to written materials but all presentations.

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Bayer knew that whenever it was were required to provide fair and balanced information,

industry standards required that it provide any negative information as well as positive

information about YAZ.

83. In the context of describing properties of approved prescriptions drugs, the terms

“effective” and “efficacy” have specific and well understood meanings. Because the FDA will

only find a drug product to be effective if the proposed use is supported by well designed,

placebo-controlled clinical trials that establish a causal relationship to a statistically significant

degree, a statement that a drug is “effective,” or “works,” or “has been proven to . . . ” is

understood to mean that well controlled clinical studies support the use. To make such a

statement without such clinical trial proof is misleading. Further, failure to inform physicians, or

patients through direct-to-consumer advertising, that no placebo-controlled clinical trials support

a representation of drug efficacy is a violation of a pharmaceutical company’s obligation to

disclose.

84. Further, any presentation concerning YAZ’s use for indications other than those

approved by the FDA that purports to rely on clinical or published evidence must also describe

those countervailing clinical studies that have found that YAZ is not effective for such off-label

uses. Where such information is not provided, any statements about YAZ’s efficacy in treating

off-label use is false, misleading, distorted, inaccurate, unfair, imbalanced, and omits material

facts necessary to be disclosed.

85. Industry standards also prohibit Bayer from misrepresenting scientific evidence

that supports (or fails to support) claims that YAZ is effective for a specific condition. Thus,

anecdotal evidence of a drug’s usefulness for a given condition could not be presented as the

equivalent of the findings of a well-designed clinical trial. Failure to comply with these

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standards violated Bayer’s legal duty to provide accurate and non-misleading information.

86. Furthermore, Bayer had specific, personal knowledge that misrepresentations and

promotion of off-label uses were illegal. As part of a 2007 settlement agreement arising from

Bayer’s fraudulent and misleading marketing of Baycol®, a drug used to lower cholesterol that

was withdrawn from the market in 2001, a court-entered judgment prohibited Bayer from

making false and misleading claims about any of their products.

87. On October 3, 2008, the FDA issued a warning letter to Bayer for the above

described misleading television commercials that promoted YAZ for off-label uses, overstated

YAZ’s benefits, and understated YAZ’s risks.

88. On February 9, 2009, Bayer entered into a settlement agreement with the

attorneys general of twenty-seven states regarding allegations that Bayer’s 2008 marketing

campaign violated the terms of the 2007 settlement agreement by misleading patients about

YAZ’s approved uses. The 2009 settlement agreement supplemented the requirements of a 2007

court-entered judgment against Bayer.

89. The 2009 settlement agreement required Bayer to conduct a $20 million

corrective advertising campaign to remedy false and misleading information from earlier YAZ

advertisements. The 2009 settlement agreement also required Bayer to submit all television

advertisements for the next six years to the FDA for pre-approval, comply with FDA’s

suggestions on television and print advertisements, and disclose YAZ’s approved uses in print

ads.

90. On March 26, 2009, the FDA issued a warning letter to Bayer concerning the

above-described Bayer-sponsored link for YAZ.

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D. Kickbacks and “Educational” Programs

91. Bayer has provided monetary incentives to doctors who are high-prescribers of

YAZ by paying lucrative fees to them to serve as “opinion leaders” who speak at lectures, dinner

meetings, and teleconferences.

92. The lucrative speaking fees are rewards for past high-prescribing and inducements

to write future prescriptions for off-label uses of YAZ. The benefits are also inducements to

influence the high-prescribing speakers to tout the off-label uses of YAZ to audiences of

influential physicians.

93. The Bayer-compensated speakers direct their off-label messages at the targeted

audience of high-prescribing and influential physicians, who are induced by expense-paid

weekends, dinners at high-end restaurants, and purported reimbursement for time spent on

teleconferences. Bayer intends that those audiences be made receptive to the Bayer message that

YAZ can and should be used off-label. Bayer has provided its speakers with materials

promoting the off-label uses of YAZ for the purpose of market expansion.

94. Bayer also targets such influential doctors to be attendees of lectures. The

lectures typically take place at attractive locations. These events are in reality little more than

paid vacations for high-prescribing physicians to speak on or to receive Bayer’s promotional

messages regarding the off-label uses of YAZ.

95. To the same end, Bayer also holds smaller programs involving dinners at high-

end restaurants. Similarly, Bayer organizes teleconferences where invitees may be paid,

purportedly, for their time.

96. Kickbacks have the effect of compromising a patient’s healthcare choices because

physicians have incentives to prescribe off-label products based on the influence of the drug

19


company’s promotions, rather than the patient’s medical needs. In other words, kickbacks

undermine the independence of a physician’s medical judgment as to the appropriate drug to

prescribe.

97. Bayer also engaged in direct marketing under the guise of presenting legitimate,

independent Continued Medical Education (“CME”) programs, such as the CME program on

PMDD at the University of Wisconsin-Madison that Bayer began funding in 2008. Bayer

influenced and controlled the dates, locations, and audience selection. Bayer influenced and

controlled the content of CME programs through medical education companies Bayer hired to

put together course materials. The Bayer speakers invariably move into telling how they really

prescribe YAZ for off-label uses. That is the purpose of the lectures, dinners and

teleconferences.

98. Bayer’s off-label information is false or misleading regarding YAZ’s safety and

benefits. At its lectures, dinners, teleconferences, and CMEs, Bayer has incompletely described

the potential adverse effects of YAZ and overstated YAZ’s benefits.

E. Bayer’s Use of Sales Representatives and Other Means To Carry Out Its Fraudulent, Misleading, and Otherwise Unlawful Promotion of YAZ

99. Bayer perpetuated its misrepresentations and active concealment regarding YAZ’s

safety and benefits through its sales representatives, employees, distributors, and agents.

100. Bayer instructed and trained its sales representatives to promote YAZ to

physicians for off-label uses and conceal and misrepresent information concerning YAZ’s safety

and benefits.

101. Bayer’s sales representatives misrepresented to physicians that YAZ is safe and

effective for treating PMS and acne of all severities.

102. Bayer made misrepresentations and actively concealed information concerning

20


the safety and benefits of YAZ in its labeling, advertising, product inserts, promotional materials,

and other marketing efforts.

103. Bayer also gave funding to pharmacy chains such as Caremark to craft “Dear

Doctor” letters that fraudulently and misleadingly represented that YAZ should be prescribed to

treat PMS, such as a May 2008 Dear Doctor letter that only identifies “common symptoms of

PMDD” that are also symptoms of PMS.

104. Through these efforts, Bayer sought to reinforce the DTC message that YAZ

could treat a broad range of PMS symptoms and prepare physicians so they would be receptive

to prescribing YAZ when patients asked for it.

F. Effects of Bayer’s Fraudulent and Misleading Conduct

105. Physicians rely on information supplied by a drug’s manufacturer in deciding

whether an unapproved use of a drug is appropriate. If information provided by a drug’s

manufacturer is false or misleading, a physician cannot accurately assess the crucial risk-benefit

balance for the patient or exercise independent professional judgment.

106. Concealment of important information by a drug manufacturer, or providing

inaccurate, biased information, misleads patients and their physicians.

107. Bayer’s campaign to mislead, influence, deceive, and defraud consumers

including Plaintiffs’ and Class Members’ participants and their dependents, as well as the

physicians who prescribed YAZ to them, Plaintiffs and Class Members, and Plaintiffs’ and Class

Members’ agents who administer prescription benefit programs by promoting YAZ for what are

primarily off-label uses for which the drug was not legitimately proven safe and effective and

concealing material safety information about the drug deprived them of the information

necessary to evaluate the risks and benefits associated with prescribing YAZ for off-label uses.

21


108. At all times, Bayer knew and intended that its fraudulent and unlawful

promotional campaign would influence and distort the judgment of patients and physicians,

causing them to prescribe, suggest, request, and/or consume YAZ when they would not have

done so but for Bayer’s improper promotion of off-label uses and other fraudulent, misleading,

and otherwise unlawful conduct.

109. At all times, Bayer knew and intended that its fraudulent and misleading

promotion would influence patients and the medical community generally, and thereby sustain

increase demand for and acceptance of both off-label YAZ uses and a falsely inflated price for

YAZ by all those involved in the distribution of the prescription drugs, including patients such as

Plaintiffs’ and Class Members’ participants and their dependents, physicians, prescription benefit

managers, and third-party payors such as Plaintiffs and Class Members.

110. Bayer designed and implemented its fraudulent and unlawful promotional

campaign with the express purpose of obtaining greater YAZ sales and profits than it could

achieve by limiting its promotion to approved uses and not concealing safety information, and it

succeeded in doing so.

111. As a direct result of Bayer’s misleading marketing scheme, sales of YAZ

increased from approximately $262 million in 2007 to approximately $616 million in 2008.

112. Plaintiff Local No. 22 spent $45,894.90 on YAZ from May 2006 through mid-

September 2009, and Plaintiff District Council 47 spent $47,362.56 on YAZ prescriptions from

April 2006 through February 2009. The number of YAZ prescriptions Plaintiffs paid for

increased significantly in 2007 and 2008 during the peak of Bayer’s fraudulent and unlawful

promotional campaign.

113. Plaintiff Local No. 22 spent: $2,268.99 on 64 YAZ prescriptions from May 2006

22


through December 2006; $8,151.53 on 206 YAZ prescriptions in 2007; $17,276.24 on 390 YAZ

prescriptions in 2008; and $18,198.14 on 345 YAZ prescriptions from January 2009 through

mid-September 2009.

114. Plaintiff District Council 47 spent: $2,333.25 on 69 YAZ prescriptions from April

2006 through December 2006; $13,975.19 on 370 YAZ prescriptions in 2007; $26,131.41 on

621 YAZ prescriptions in 2008; and $4,992.71 on 108 YAZ prescriptions from January 2009

through February 2009.

115. Consumers across the country, including Plaintiffs’ and Class Members’

participants and their dependents, viewed the above-described YAZ commercials and www.Yaz-

US.com and purchased YAZ as a result of Bayer’s fraudulent, misleading, and otherwise

unlawful promotion of YAZ. If Bayer had not misrepresented YAZ’s benefits and concealed

important safety information about YAZ in the commercials described above and on www.Yaz-

US.com, patients with PMDD and/or moderate acne who chose to take an oral contraceptive,

including Plaintiffs’ and Class Members’ participants and their dependents who fit that

description, would have taken a safer, equally effective and cheaper oral contraceptive that did

not contain drospirenone instead of taking YAZ.

116. The medical, scientific, and pharmaceutical communities had no choice but to

rely on information about YAZ provided by Bayer or its associates because YAZ contains the

novel progestin drospirenone that has not been subject to extensive clinical studies or

observation by practicing physicians.

117. Users of YAZ including Plaintiffs’ and Class Members’ participants and their

dependents, third-party payors including Plaintiffs, and the medical, pharmaceutical, and

scientific communities including the physicians who prescribed YAZ to Plaintiffs’ and Class

23






Members’ participants and their dependents justifiably relied on Bayer’s fraudulent and

misleading representations and omissions.

118. As a result of Bayer’s fraudulent representations and omissions about YAZ, Bayer

has reaped millions of dollars in profits at the expense of Plaintiffs and Class Members.

Plaintiffs and Class Members were forced to spend excessive and unnecessary sums of money on

the reimbursement of YAZ prescriptions for their participants and dependents of their

participants who were prescribed YAZ. Bayer manipulated virtually all sources of clinical

information about the effectiveness and side effects of YAZ. This pattern of activity was

national in scope and affected Plaintiffs and Class Members. The price that Plaintiffs and Class

Members paid for YAZ was falsely inflated and sustained through Bayer’s false representations,

as compared to the value that payers would have attached to YAZ had its true safety and efficacy

profile been disclosed. Based on comparative safety and efficacy data, YAZ’s price should have

been comparable to or lower than oral contraceptives that do not contain drospirenone.

119. Bayer thus intended to, and did, cause Plaintiffs and Class Members to spend

greater amounts for prescriptions of YAZ than they would have if Bayer had confined its

promotional efforts to approved usages and had not concealed safety information about YAZ.

120. In particular, Bayer directly and proximately caused Plaintiffs and Class Members

to spend excessive and unnecessary sums of money for the purchase, payment, or reimbursement

YAZ prescriptions that would not have been purchased, paid, or reimbursed if Bayer had not

misrepresented and concealed YAZ’s true safety and efficacy profile.

121. Bayer also directly and proximately cased Plaintiffs and Class Members to spend

excessive and unnecessary sums of money for YAZ sold at a falsely inflated price that would

have been significantly lower if Bayer had not misrepresented and concealed YAZ’s true safety

24


and efficacy profile.

122. In addition, any applicable statutes of limitations have been tolled by Bayer’s’

knowing and active concealment and denial of material facts as alleged herein. With respect to

Bayer’s omissions, Plaintiffs and Class Members could not reasonably have discovered the

fraudulent nature of Bayer’s conduct. Accordingly, Bayer is estopped from relying on any

statute of limitations to defeat any of Plaintiffs’ or Class Members’ claims.

V. CLASS ALLEGATIONS

123. Plaintiffs bring this action pursuant to Rule 23(b)(3) of the Federal Rules of Civil

Procedure, on behalf of themselves and a Class defined as follows:

All third party payors in the United States and its territories that purchased, reimbursed, and/or paid for all or part of the cost of YAZ dispensed pursuant to prescriptions in the United States. The term “third party payor” includes, but is not limited to, any self-funded employer plan, private insurance provider, managed care organization, insurance company, employee benefit plan, health and welfare fund, union plan, workers compensation entities, HMO, PPO, entity with a self-funded plan, and any other entity that is a party to a contract, issuer of a policy, or sponsor of a plan, and is at risk, under such contract, policy, or plan, to provide prescription drug benefits or to pay or reimburse all or part of the cost of prescription drugs dispensed to covered natural persons.

Excluded from the Class are Bayer and any of its officers and directors and any governmental

entity. “Governmental entity” includes benefit plans whereby a governmental body pays

medical benefits for its employees as a self-insurer.

124. The definition of the Class is unambiguous. Plaintiffs are members of the Class

that they seek to represent. Class Members can be identified from an available database of third-

party payors maintained by a nationally recognized class action administration company. This

database has been approved and successfully used in numerous previous class actions.

25


125. Plaintiffs’ claims are typical of the claims of the other Class Members because

Plaintiffs and all Class Members were similarly affected by having purchased, paid, and/or

reimbursed for excessive YAZ prescriptions at a falsely inflated price as a result of Bayer’s

fraudulent, misleading, and otherwise unlawful conduct, and the relief sought herein is for the

benefit of Plaintiffs and Class Members.

126. There are more than one hundred members in the Class, making the Class

Members so numerous that their individual joinder is impracticable.

127. Common questions of law and fact predominate over questions affecting only

individual Class Members. Some of the common legal and factual questions include:

a) Whether Bayer misrepresented that YAZ was safe and effective for off-label

uses for which the drug was not legitimately proven safe and effective;

b) Whether Bayer concealed that YAZ different and more dangerous risks and

side effects than ordinary oral contraceptive that do not contain drospirenone;

c) Whether Bayer made fraudulent and misleading representations and omissions

about YAZ’s true safety and efficacy profile in order to induce patients to

seek YAZ prescriptions;

d) Whether Bayer made fraudulent and misleading representations and

omissions about YAZ’s true safety and efficacy profile in order to induce

physicians to prescribe YAZ;

e) Whether the price Plaintiffs and Class members paid for YAZ was falsely

inflated and sustained through Bayer’s fraudulent and misleading

representations and omissions;

f) Whether the YAZ DTC Enterprise is an association in fact enterprise under

26


RICO;

g) Whether the YAZ Medical Marketing Enterprise is an association in fact

enterprise under RICO;

h) Whether Bayer conducted or participated in the conduct of the YAZ DTC

Enterprise through a pattern of racketeering activity;

i) Whether Bayer conducted or participated in the conduct of the YAZ Medical

Marketing Enterprise through a pattern of racketeering activity;

j) Whether Bayer conspired with others to violate 18 U.S.C. § 1962(c);

k) Whether Bayer violated the common law of unjust enrichment; and

l) The nature and extent of damages and other remedies to which Bayer’s

conduct entitles the Class.

128. Bayer engaged in a common course of conduct giving rise to the legal rights

sought to be enforced by Plaintiffs and Class Members. Similar or identical statutory and

common law violations are involved. Individual questions, if any, pale in comparison to the

numerous common questions that predominate.

129. The injuries sustained by Plaintiffs and Class Members flow, in each instance,

from a common nucleus of operative facts—Bayer’s misconduct. In each case, Bayer marketed

YAZ for off-label indications, uses, and benefits not approved by the FDA or supported by

substantial scientific evidence or substantial clinical experience, fraudulently omitting material

information about YAZ’s efficacy and safety.

130. Plaintiffs and the Class Members have been damaged by Bayer’s misconduct. In

the absence of Bayer’s fraudulent marketing scheme, Plaintiffs and the Class Members would

not have sustained the economic damages and losses described above.

27


131. Plaintiffs will fairly and adequately protect the interests of the Class. Plaintiffs

are familiar with the basic facts that form the bases of the Class Members’ claims. Plaintiffs’

interests do not conflict with and are not antagonistic to the interests of the other Class Members

that Plaintiffs seek to represent. Plaintiffs have retained counsel competent and experienced in

Class action litigation and intend to prosecute this action vigorously. Plaintiffs’ counsel has

successfully prosecuted complex Class actions, including third-party payor actions for

prescription costs and consumer protection Class actions. Plaintiffs and Plaintiffs’ counsel will

fairly and adequately protect the interests of the Class Members.

132. The class action device is superior to other available means for the fair and

efficient adjudication of the claims of Plaintiffs and the Class Members. The relief sought per

individual Class member is small given the burden and expense of individual prosecution of the

potentially extensive litigation necessitated by Bayer’s wrongful conduct. Furthermore, it would

be virtually impossible for Class Members to seek redress on an individual basis. Even if Class

Members themselves could afford such individual litigation, the court system could not.

133. Individual litigation of the legal and factual issues raised by Bayer’s wrongful

conduct would increase delay and expense to all parties and to the court system. The class

action device presents far fewer management difficulties and provides the benefits of a single,

uniform adjudication, economies of scale and comprehensive supervision by a single court.

Given the similar nature of the Class Members’ claims, the uniform application of RICO, and the

absence of material differences in the laws upon which the Class Members’ claims are based, a

nationwide Class will be easily managed by the Court and the parties.

28


VI. CAUSES OF ACTION

COUNT I

VIOLATION OF 18 U.S.C. § 1962(C)

134. Plaintiffs incorporate by reference all preceding paragraphs as if set forth at length

herein and further allege as follows.

135. Each Defendant is a “person” within the meaning of 18 U.S.C. § 1961(3).

136. Bayer conducted the affairs of the YAZ Direct-to-Consumer Marketing

Enterprise (the “YAZ DTC Enterprise”) through a pattern of racketeering activity in violation of

18 U.S.C. § 1962(c).

137. The YAZ DTC Enterprise is an association-in-fact within the meaning of 18

U.S.C. § 1961(4), consisting of Bayer, including its employees and agents, the marketing firm

Young & Rubicam, other marketing and publication firms that Bayer associated with to market

YAZ directly to patients, and the web designers who created www.YazUS.com.

138. Defendants are RICO “persons” distinct from the YAZ DTC Enterprise.

139. Bayer used the YAZ DTC Enterprise to carry out its scheme to obtain money by

means of false and fraudulent pretenses, representations, and omissions.

140. The YAZ DTC Enterprise was an ongoing organization that functioned as a

continuing unit.

141. Bayer and the other members of the YAZ DTC Enterprise created and maintained

systematic links for the common purpose of gaining revenue from marketing YAZ for on- and

off-label uses. Each of the members of the YAZ DTC Enterprise received substantial revenue

from marketing YAZ. Such revenue was exponentially greater than it would have been if YAZ

were marketed appropriately.

29


http://www.yazus.com/

142. The YAZ DTC Enterprise has a hub and spoke organizational, decision-making

structure, with Bayer serving as the hub.

143. All members of the YAZ DTC Enterprise were aware of Bayer’s control over the

activities of the YAZ DTC Enterprise. Furthermore, each member of the YAZ DTC Enterprise

benefited from the existence of the other members.

144. The YAZ DTC Enterprise engaged in and affected interstate commerce, because,

inter alia, it marketed, distributed, sold, and provided YAZ to thousands of individuals and

entities throughout the United States.

145. Bayer has exerted control over the YAZ DTC Enterprise and has managed the

Enterprise’s affairs through a pattern of racketeering activity that includes acts indictable under

18 U.S.C. § 1341 (mail fraud), § 1343 (wire fraud), and § 1952 (use of interstate facilities to

conduct unlawful activity).

146. Bayer’s use of the mails and wires to perpetrate its fraud through the YAZ DTC

Enterprise involved hundreds of communications including, but not limited to:

a. marketing materials and advertisements aimed at patients that misrepresented

that YAZ was safe and effective for off-label uses for which the drug was not

legitimately proven safe and effective;

b. communications with patients including Plaintiffs’ and Class Members’

participants and their dependents, as well as third-party payors including

Plaintiffs and Class Members, inducing payments for YAZ to be made based

on misrepresentations concerning the risks and benefits of YAZ; and,

c. receiving the proceeds of its improper scheme.

147. In addition, Defendants’ corporate headquarters have communicated by United

30


States mail, telephone, and facsimile with various local district managers, medical liaisons, and

sales representatives in order to use the YAZ DTC Enterprise to carry out their scheme to obtain

money by means of false and fraudulent pretenses, representations, and omissions.

148. Further, Bayer has traveled in interstate or foreign commerce or used the mail and

facilities in interstate or foreign commerce, with the intent to distribute the proceeds of the

unlawful activity described above or otherwise promote, manage, establish, carry on, or facilitate

the promotion, management, establishment, or carrying on of the unlawful activity described

above.

149. Bayer’s racketeering activities related to the YAZ DTC Enterprise amounted to a

common course of conduct intended to deceive and harm Plaintiffs and Class Members. Each

racketeering activity was related, had similar purposes, involved the same or similar members

and methods of commission, and had similar results affecting similar victims, including

Plaintiffs and Class Members. Defendants’ racketeering activities are part of their ongoing

business and constitute a continuing threat to the property of Plaintiffs and Class Members.

150. Bayer’s repeated use of the YAZ DTC Enterprise to implement and carry out its

fraudulent scheme constitutes a “pattern of racketeering activity” within the meaning of 18

U.S.C. §§ 1961(5) and 1962(c). Through that pattern of racketeering activity, Bayer conducted

and participated in the conduct of the affairs of the YAZ DTC Enterprise.

151. Plaintiffs and Class Members have been injured in their business and property by

reason of Bayer’s violations of 18 U.S.C. § 1962(c) in that the pattern of racketeering activity

that Bayer used to conduct the affairs of the YAZ DTC Enterprise directly and proximately

caused Plaintiffs and Class Members to spend excessive, ascertainable sums of money for the

purchase, payment, or reimbursement of YAZ prescriptions that would not have been purchased,

31


paid, or reimbursed if Bayer had not conducted or participated in the conduct of the affairs of the

YAZ DTC Enterprise through a pattern of racketeering activity.

152. Plaintiffs and Class Members have also been injured in their business and

property by reason of Bayer’s violations of 18 U.S.C. § 1962(c) in that the pattern of

racketeering activity that Bayer used to conduct the affairs of the YAZ DTC Enterprise directly

and proximately caused Plaintiffs and Class Members to spend excessive, ascertainable sums of

money for the purchase or reimbursement of YAZ sold at a falsely inflated price that would have

been significantly lower if Bayer had not conducted or participated in the conduct of the affairs

of the YAZ DTC Enterprise through a pattern of racketeering activity.

153. By virtue of these violations of 18 U.S.C. § 1962(c), Defendants are liable to

Plaintiffs and Class Members for three times the damages they have sustained, plus the cost of

this suit, including reasonable attorney’s fees.

154. Bayer also conducted the affairs of the YAZ Medical Marketing Enterprise

through a pattern of racketeering activity in violation of 18 U.S.C. § 1962(c).

155. The YAZ Medical Marketing Enterprise is an association-in-fact within the

meaning of 18 U.S.C. § 1961(4), consisting of Bayer including its employees and agents,

medical education companies, pharmacy chains, and speakers paid by Bayer to promote YAZ for

off-label uses at lunches, dinners, videoconferences, CMEs, and other “educational” programs.

156. Defendants are RICO “persons” distinct from the YAZ Medical Marketing

Enterprise.

157. Bayer used the YAZ Medical Marketing Enterprise to carry out its scheme to

obtain money by means of false and fraudulent pretenses, representations, and omissions.

158. The YAZ Medical Marketing Enterprise was an ongoing organization that

32


functioned as a continuing unit.

159. Bayer and the other members of the YAZ Medical Marketing Enterprise created

and maintained systematic links for the common purpose of gaining revenue from marketing

YAZ for on- and off-label uses. Each of the members of the YAZ Medical Marketing Enterprise

received substantial revenue from marketing YAZ for off-label uses. Such revenue was

exponentially greater than it would have been if YAZ were marketed appropriately. All

members of the YAZ Medical Marketing Enterprise were aware of Bayer’s control over the

activities of the YAZ Medical Marketing Enterprise. Furthermore, each member of the

Enterprise benefited from the existence of other members.

160. The YAZ Medical Marketing Enterprise engaged in and affected interstate

commerce, because, inter alia, it marketed, distributed, sold, and provided YAZ to thousands of

individuals and entities throughout the United States.

161. The YAZ Medical Marketing Enterprise has a hub and spoke organizational,

decision-making structure, with Bayer serving as the hub.

162. Bayer has exerted control over the YAZ Medical Marketing Enterprise and has

managed the Enterprise’s affairs through a pattern of racketeering activity that includes acts

indictable under 18 U.S.C. § 1341 (mail fraud), § 1343 (wire fraud), and § 1952 (use of interstate

facilities to conduct unlawful activity).

163. Bayer’s use of the mails and wires to perpetrate its fraud through the YAZ

Medical Marketing Enterprise involved hundreds of communications, including, but not limited

to:

a. marketing materials and advertisements aimed at patients and physicians that

misrepresented that YAZ was safe and effective for off-label uses for which

33


the drug was not proven to be safe, medically efficacious, and useful;

b. communications, including financial payments, with physicians discussing

and relating to paid speaking engagements to promote YAZ as safe and

effective for off-label uses for which the drug was not proven to be safe,

medically efficacious, and useful;

c. communications with physicians that misrepresented that YAZ was

scientifically proven to be safe, medically efficacious, and useful for off-label

uses;

d. communications with health insurers, prescription benefit managers, and

third-party payors including Plaintiffs, inducing payments to be made for

YAZ based on misrepresentations concerning the safety, efficacy, and

usefulness of YAZ; and,

e. receiving the proceeds of its improper scheme.

164. In addition, Defendants’ corporate headquarters have communicated by United

States mail, telephone, and facsimile with various local district managers, medical liaisons, and

sales representatives in order to use the YAZ Medical Marketing Enterprise to carry out their

scheme to obtain money by means of false and fraudulent pretenses, representations, and

omissions.

165. Further, Bayer has traveled in interstate or foreign commerce or used the mail and

facilities in interstate or foreign commerce, with the intent to distribute the proceeds of unlawful

activity described above or otherwise promote, manage, establish, carry on, or facilitate the

promotion, management, establishment, or carrying on of the unlawful activity described above.

34


166. Bayer’s racketeering activities related to the YAZ Medical Marketing Enterprise

amounted to a common course of conduct intended to deceive and harm Plaintiffs and Class

Members. Each racketeering activity was related, had similar purposes, involved the same or

similar participants and methods of commission, and had similar results affecting similar

victims, including Plaintiffs and Class Members. Defendants’ racketeering activities are part of

their ongoing business and constitute a continuing threat to the property of Plaintiffs and Class

Members.

167. Bayer’s repeated use of the YAZ Medical Marketing Enterprise to implement and

carry out its fraudulent scheme constitutes a “pattern of racketeering activity” within the

meaning of 18 U.S.C. §§ 1961(5) and 1962(c). Through that pattern of racketeering activity,

Bayer conducted and participated in the conduct of the affairs of the YAZ Medical Marketing

Enterprise.


reason of Bayer’s violations of 18 U.S.C. § 1962(c) in that the pattern of racketeering activity

that Bayer used to conduct the affairs of the YAZ Medical Marketing Enterprise directly and

proximately caused Plaintiffs and Class Members to expend substantial, ascertainable sums for

the purchase of YAZ prescriptions that would not have been prescribed if Bayer had not

conducted or participated in the conduct of the affairs of the YAZ Medical Marketing Enterprise

through a pattern of racketeering activity.


property by reason of Bayer’s violations of 18 U.S.C. § 1962(c) in that the pattern of

racketeering activity that Bayer used to conduct the affairs of the YAZ Medical Marketing

Enterprise directly and proximately caused Plaintiffs and Class Members to expend substantial

35


ascertainable sums for the purchase of YAZ sold at a falsely inflated price that would have been

significantly lower if Bayer had not conducted or participated in the conduct of the affairs of the

YAZ Medical Marketing Enterprise through a pattern of racketeering activity.

170. By virtue of these violations of 18 U.S.C. § 1962(c), Defendants are liable to

Plaintiffs and Class Members for three times the damages they have sustained, plus the cost of

this suit, including reasonable attorney’s fees.

171. The fraudulent scheme that Bayer perpetrated by conducting the affairs of the

YAZ DTC Enterprise and the YAZ Medical Marketing Enterprise, consisted of, inter alia:

deliberately misrepresenting the uses for which YAZ was legitimately proven safe and effective,

deliberately misrepresenting material information about YAZ’s safety and efficacy, and

fraudulently omitting material information about YAZ’s true safety and efficacy.

172. In implementing its fraudulent scheme, Defendants were acutely aware that

Plaintiffs, Class Members, and physicians depended on the honesty and integrity of Defendants

in representing the medical efficacy of YAZ’s uses. It is impractical and unduly expensive for

Plaintiffs, Class Members, patients, and physicians to perform their own clinical trials or

assemble all known medical evidence relating to YAZ’s uses. Plaintiffs, Class Members,

patients, and physicians also rely on federal law obligating Bayer to provide fair and balanced

information about its prescription drug products and reasonably presume that when marketing of

YAZ was conducted, it complied with Bayer’s obligations under federal law.

173. Defendants’ scheme was calculated to ensure that Plaintiffs and Class Members

would pay for YAZ to treat conditions that Defendants knew were not appropriately treated with

YAZ, and that Plaintiffs and Class Members would pay for YAZ at a falsely inflated price.

36


COUNT II

VIOLATION OF 18 U.S.C. § 1962(D) BY CONSPIRING TO VIOLATE 18 U.S.C. § 1962(C)

174. Plaintiffs incorporate by reference the foregoing allegations as if set forth at

length herein and further allege as follows.

175. Section 1962(d) of RICO provides that it “shall be unlawful for any person to

conspire to violate any of the provisions of subsection (a), (b), or (c) of this section.”

176. Bayer violated § 1962(d) by conspiring to violate 18 U.S.C. § 1962(c) with

physicians and other persons who participated in the YAZ Medical Marketing Enterprise. The

object of this conspiracy has been and is to conduct or participate in, directly or indirectly, the

conduct of the affairs of the YAZ Medical Marketing Enterprise, described above, through a

pattern of racketeering activity.

177. Bayer and its co-conspirators have engaged in numerous overt predicate

racketeering acts in furtherance of the conspiracy, including material misrepresentations and

omissions designed to defraud Plaintiffs and Class Members.

178. The nature of the Bayer’s co-conspirators’ acts, material misrepresentations, and

omissions in furtherance of the conspiracy gives rise to an inference that they not only agreed to

the objective of an 18 U.S.C. § 1962(d) violation of RICO by conspiring to violate 18 U.S.C. §

1962(c), but that they were also aware that their ongoing fraudulent and extortionate acts have

been and are part of an overall pattern of racketeering activity.

179. Bayer and its co-conspirators sought to and have engaged in the commission of

and continue to commit overt acts, including the following unlawful racketeering predicate acts:

a. multiple instances of mail and wire fraud violations of 18 U.S.C. §§ 1341 and

1342;

37


b. multiple instances of mail fraud violation of 18 U.S.C. §§ 1341 and 1346;

c. multiple instances of wire fraud violations of 18 U.S.C. §§ 1341 and 1346;

and,

d. multiple instances of unlawful activity in violation of 18 U.S.C. § 1952.


reason of Bayer’s violations of 18 U.S.C. § 1962(d) by conspiring to violate 18 U.S.C. 1962(c)

in that the overt predicate racketeering acts Bayer and its co-conspirators engaged in to further

their conspiracy directly and proximately caused Plaintiffs and Class Members to expend

substantial, ascertainable sums for the purchase or reimbursement of YAZ prescriptions that

would not have been paid or reimbursed if Bayer had not engaged in those overt and predicate

fraudulent racketeering acts in furtherance of the conspiracy.


property by reason of Bayer’s violations of 18 U.S.C. § 1962(d) for conspiring to violate 18

U.S.C. 1962(c) in that the overt and predicate fraudulent racketeering acts Bayer and its co-

conspirators engaged in to further the conspiracy directly and proximately caused Plaintiffs and

Class Members to expend substantial, ascertainable sums for the purchase or reimbursement of

YAZ sold at a falsely inflated price that would have been significantly lower if Bayer and its co-

conspirators not engaged in those overt and predicate fraudulent racketeering acts in furtherance

of the conspiracy.

182. Bayer’s violations of the above federal laws and the effects thereof, described

more fully above, are continuing and will continue.

183. By virtue of these violations of 18 U.S.C. § 1962(d), Defendants are liable to

Plaintiffs and Class Members for three times the damages Plaintiffs and members of the Class

38


have sustained, plus the cost of this suit, including reasonable attorney’s fees.

COUNT III

NEGLIGENCE



185. Bayer owed Plaintiffs and Class Members a duty to use reasonable care in the

marketing of YAZ. Specifically, Bayer owed Plaintiffs and the Class a duty to refrain from

promoting off-label uses, misrepresenting safety and efficacy, and inducing demand for YAZ by

improper means. Further, Bayer owed Plaintiffs and the Class a duty to accurately disclose

known risks associated with YAZ.

186. Bayer also owed Plaintiffs and Class Members the duties described above.

187. Bayer negligently, carelessly, recklessly, willfully, and/or intentionally violated

its respective duties by the conduct, acts, and omissions described above.

188. Bayer’s negligent, careless, reckless, willful, and/or intentional conduct was the

proximate cause of injuries and damages sustained by Plaintiffs and the Class.

189. As a direct and proximate result of the negligent, careless, reckless, willful, and/or

intentional conduct of Bayer described above, Plaintiffs and the Class spent excessive and

unnecessary sums of money for YAZ prescriptions that would not have been purchased, paid, or

reimbursed if Bayer had not misrepresented and concealed YAZ’s true safety and efficacy

profile.

190. Furthermore, as a direct and proximate result of the negligent, careless, reckless,

willful, and/or intentional conduct of Bayer described above, Plaintiffs and the Class spent

excessive and unnecessary sums of money for YAZ sold at a falsely inflated price that would

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have been significantly lower if Bayer had not misrepresented and concealed YAZ’s true safety

and efficacy profile.

191. The reprehensible nature of Bayer’s conduct entitles Plaintiffs to an award of

punitive damages.

COUNT IV

FRAUD & MISREPRESENTATION



193. As described more fully above, as part of its statements about YAZ, Bayer

willfully, knowingly, and fraudulently communicated a false safety and efficacy profile to

Plaintiffs and Class Members, as well as physicians who prescribed YAZ to Plaintiffs’ and Class

Members’ participants and their dependents, impacting and falsely inflating the cost of YAZ

prescriptions and causing Plaintiffs and Class Members to pay or reimburse for YAZ

prescriptions that would not have been prescribed if YAZ’s true safety and efficacy profile had

been disclosed by Bayer.

194. Bayer had a duty to disclose known risks and side effects associated with the use

of YAZ.

195. Bayer also had a duty to disclose the conditions for which YAZ was not

legitimately proven safe and effective, and not to represent the use of YAZ as safe and effective

for those indications.

196. In addition, Bayer had a duty to conduct itself fairly, ethically, and honestly in

establishing pricing for its drugs based upon the drugs’ actual therapeutic benefits and safety-

related risks in relation to other available medications with comparable safety and efficacy

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profiles. Plaintiffs and Class Members justifiably relied on Defendant to communicate full and

accurate information about Seroquel, and not to misrepresent the true nature of Seroquel’s

benefits and risks.

197. As described more fully above, Bayer intentionally misrepresented and withheld

material information regarding YAZ’s risks, side effects, and benefits YAZ with the intention of

inducing patients to choose YAZ and physicians to prescribe YAZ more often than they

otherwise would have or was otherwise appropriate.

198. By controlling and directing the marketing of YAZ to patients and physicians,

Bayer knew and intended that patients, physicians, and third-party payors would rely on its

representations and promotions, including the “peer to peer” schemes described above. By so

doing, Bayer expected and intended that the Plaintiffs and Class Members would incur excessive

and unnecessary expenses for the purchase of YAZ as a result of its fraudulent representations

and omissions.

199. Physicians, patients, Plaintiffs, and Class Members justifiably relied on Bayer to

present accurate information to physicians and the public as to the appropriate uses, indications,

and contraindications for YAZ, and to refrain from misleading them or concealing information

about the risks and side effects associated with the use of YAZ.

200. Bayer knew that the representations that were relied on by patients, physicians,

Plaintiffs, and Class Members were false or were made recklessly without any knowledge of

their truth.

201. Bayer knew that patients, physicians, Plaintiffs, and Class Members would not be

in a position to discover and understand the true risks and benefits of using YAZ, and that the

public relied upon the misleading information that Bayer promulgated nationwide, to the

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detriment of Plaintiffs and Class Members.

202. Bayer was also under a duty to conduct itself fairly, ethically, and honestly in

establishing pricing for its drugs based on the drugs’ actual therapeutic benefits and safety-

related risks in relation to other available medication with comparable safety and efficacy

profiles. Plaintiffs and Class Members justifiably relied on Bayer to communicate full and

accurate information about YAZ, and not to misrepresent the true nature of YAZ’s benefits and

risks. As explained more fully above, Defendant has aggressively exploited its position, its

superior knowledge of Seroquel’s characteristics, and its knowledge that payers such as Plaintiffs

and Class Members rely on manufacturers to comply with governing regulations and legal and

equitable duties.

203. Each of Defendants’ fraudulent and misleading representations and omissions was

material to Plaintiffs’ and Class Members’ purchase and reimbursement of YAZ prescriptions in

that Plaintiffs and Class Members spent millions of dollars purchasing and reimbursing for YAZ

prescriptions that would not have purchased, paid, or reimbursed if Defendants had not made

those representations and omissions.

204. Each of Defendants’ fraudulent and misleading representations and omissions was

also material to Plaintiffs’ and Class Member’s purchase and reimbursement of YAZ

prescriptions in that Plaintiffs and Class Members spent millions of dollars purchasing and

reimbursing for YAZ sold at a falsely inflated price that would have been significantly lower if

Defendants had not made those representations and omissions.

205. Plaintiffs and Class Members have been injured by expending substantial sums

for the purchase of YAZ that was prescribed for their participants and their dependents, where

such prescriptions were directly and proximately resulted from Bayer’s fraudulent and

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misleading representations and omissions.

206. Plaintiffs and Class Members have also been injured by being forced to expend

excessive amounts of money for YAZ prescriptions purchased, paid, or reimbursed by Plaintiffs

and Class Members at a falsely inflated price that directly and proximately resulted from Bayer’s

fraudulent and misleading representations and omissions.

COUNT V

UNJUST ENRICHMENT



208. Bayer knowingly, willfully, and intentionally represented YAZ in a false and

misleading manner.

209. Bayer received a financial windfall from Plaintiffs and Class Members as a direct

result of Bayer’s deceptive conduct by virtue of Plaintiffs’ and Class Members’ excessive

expenditures for the purchase of YAZ.

210. Plaintiffs and Class Members paid, reimbursed, and/or otherwise conferred a

benefit on Bayer to the extent of the excessive YAZ prescriptions purchased, paid, or reimbursed

as a direct result of Bayer’s fraudulent, deceptive, and otherwise unlawful statements and

conduct.

211. Bayer has been unjustly enriched to the extent of the increased revenue received

from prescriptions for YAZ that were ultimately paid or reimbursed by Plaintiffs and Class

Members, where such prescriptions directly resulted from Bayer’s fraudulent, misleading, and

otherwise unlawful statements and conduct.

212. Plaintiffs and Class Members also paid, reimbursed, and/or otherwise conferred a

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benefit on Bayer to the extent of YAZ prescriptions paid or reimbursed at a falsely inflated price

that directly resulted from Bayer’s fraudulent, misleading, and otherwise unlawful statements

and conduct.

213. Bayer has also been unjustly enriched to the extent of the increased revenue

received from prescriptions for YAZ that were ultimately paid or reimbursed at falsely inflated

prices that resulted from Bayer’s fraudulent, misleading, and otherwise unlawful statements and

conduct.

214. Bayer must therefore disgorge its unjustly acquired profits and other monetary

benefits resulting from its fraudulent, misleading, and otherwise unlawful statements and

conduct and provide restitution to Plaintiffs and Class Members.

215. Accordingly, Plaintiffs and Class Members are entitled to restitution of the funds

they expended on excessive YAZ prescriptions as a result of Bayer’s fraudulent, misleading, and

otherwise unlawful statements and conduct. Alternatively, Plaintiffs and Class Members are

entitled to restitution of excessive expenditures made for YAZ prescriptions over the value that

payers would have paid for YAZ had its true safety and efficacy profile had been disclosed by

Bayer.

VII. PRAYER FOR RELIEF

Plaintiffs, on behalf of themselves and all others similarly situated, pray for:

• An order certifying this matter as a class action with Plaintiffs as Class

representatives and designating Plaintiffs’ counsel as Class Counsel;

• Judgment in favor of Plaintiffs and the Class on each of the foregoing causes of

action;

• An award of all statutorily available damages under RICO;

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• An award of compensatory and punitive damages for negligence;

• An award of compensatory and punitive damages for fraud and misrepresentation;

• An award of restitution of the increased revenue by which Bayer has been unjustly

enriched;

• Pre-judgment and post judgment interest on such monetary relief;

• An award of reasonable attorney’s fees and costs of Plaintiffs and the Class; and

• Such other and further relief as the nature of the case may require or as may be

determined to be just, equitable, and proper by this Court.

Respectfully submitted,

DATED: February 2, 2010 By: /s/ Fletcher V. Trammell__________

Fletcher V. Trammell BAILEY PERRIN BAILEY

440 Louisiana, Suite 2100 Houston, Texas 77002 [email protected] (713) 425-7100

Stewart L. Cohen

William D. Marvin COHEN, PLACITELLA & ROTH A Professional Corporation Two Commerce Square, Suite 2900 2001 Market St. Philadelphia, PA 19103 [email protected] [email protected] (215) 567-3500

Deborah R. Willig

WILLIG, WILLIAMS & DAVIDSON 1845 Walnut Street, 24th Floor Philadelphia, Pennsylvania 19103 [email protected] (215) 656-3600

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mailto:[email protected]




46

Attorneys for Plaintiffs, Philadelphia Firefighters Union Local No. 22 Health and Welfare Fund and American Federation of State, County and Municipal Employees, District Council 47 Health and Welfare Fund

CERTIFICATE OF SERVICE

I HEREBY CERTIFY that on this 2nd day February, 2010, I electronically filed the

foregoing: FIRST AMENDED CLASS ACTION COMPLAINT with the Clerk of the Court by using the CM/ECF system which will send a Notice of Electronic Filing to all counsel of record that are registered with the Court’s CM/ECF system.

/s/ Fletcher V. Trammell________________ Fletcher V. Trammell

CERTIFICATE OF WRITTEN CONSENT

I HEREBY CERTIFY that on this 2nd day February, 2010, counsel for Defendants gave written consent for Plaintiffs to amend their complaint.

/s/ Fletcher V. Trammell________________ Fletcher V. Trammell


in the united states district court for the district of ... -- amended complaint.pdf ·...

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