Androgel lawyers file low testosterone lawsuit in Illinois

Low Testosterone Lawyers have filed the following Androgel lawsuit in Illinois:

UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
______________________________
Richard C. Kelly, Sr., : COMPLAINT AND DEMAND
: FOR JURY TRIAL
Plaintiff, :
:
v. :
: Case No. 1:14-cv-879
AbbVie Inc., and :
Abbott Laboratories, Inc., :
:
Defendants. :
______________________________
COMPLAINT
Plaintiff, Richard C. Kelly, Sr. (“Plaintiff”), residing in Johnstown, Pennsylvania, by and through his undersigned counsel, hereby sues Defendants AbbVie Inc. and Abbott Laboratories, Inc. (“Defendants”) and alleges as follows:
INTRODUCTION
1. This case involves the prescription drug AndroGel, which is manufactured, sold, distributed and promoted by Defendants as a testosterone replacement therapy.
2. Defendants misrepresented that AndroGel is a safe and effective treatment for hypogonadism or "low testosterone," when in fact the drug causes serious medical problems, including life threatening cardiac events, strokes, and thrombolytic events.
3. Defendants engaged in aggressive, award-winning direct-to-consumer and physician marketing and advertising campaigns for AndroGel. Further, Defendants engaged in an aggressive unbranded “disease awareness” campaign to alert men that they might be suffering from “low T.”4. As a result, diagnoses of Low T have increased exponentially. This has directly related to AndroGel’s sales increasing to over $1.37 billion per year.
5. However, consumers of AndroGel were misled as to the drug’s safety and efficacy, and as a result have suffered injuries including life-threatening cardiac events, strokes, and thrombolytic events.
PARTIES
6. Plaintiff is a natural person and a resident of the State of Pennsylvania.
7. Defendant AbbVie Inc. is a corporation organized and existing under the laws of Delaware with its principal place of business at 1 North Waukegan Road, North Chicago, Illinois 60064.
8. Defendant Abbot Laboratories, Inc. is a corporation organized and existing under the laws of the state of Illinois and maintains its principal place of business at 100 Abbot Park Road, Abbott Park, Illinois 60064.
9. By way of background, Unimed Pharmaceuticals Inc. originally developed AndroGel and sought FDA approval in 1999. Before the drug was approved by the FDA in 2000, Solvay Pharmaceuticals Inc. acquired Unimed Pharmaceuticals, Inc. and subsequently brought AndroGel to market. In 2010, Defendant Abbott Laboratories, Inc. acquired Solvay’s pharmaceutical division, which included AndroGel. Then, in 2013, Abbott created AbbVie, a company composed of Abbott’s former proprietary pharmaceutical business, which included AndroGel.
10. At all times herein mentioned, Defendants, in interstate commerce and in this judicial district, advertised, promoted, supplied, and sold to distributors and retailers for resale to
physicians, hospitals, medical practitioners, and the general public a certain pharmaceutical product, AndroGel.
JURISDICTION AND VENUE
11. This Court has jurisdiction over Defendants and this action pursuant to 28 U.S.C. § 1332 because there is complete diversity of citizenship between Plaintiff and Defendant and because the amount in controversy between Plaintiff and Defendant exceeds $75,000, exclusive of interest and cost, and because, among other reasons, Defendant has significant contacts with this district by virtue of doing business within this judicial district.
12. Venue is proper within this district pursuant to 28 U.S.C. § 1391 because Plaintiff resides in this district and because a substantial part of the acts and/or omissions giving rise to these claims occurred within this district.
GENERAL ALLEGATIONS
13. This action is for damages brought on behalf of Plaintiff who was prescribed and supplied with, received and who has taken and applied the prescription drug AndroGel, as tested, studied, researched, evaluated, endorsed, designed, formulated, compounded, manufactured, produced, processed, assembled, inspected, distributed, marketed, labeled, promoted, packaged, advertised for sale, prescribed, sold or otherwise placed in the stream of interstate commerce by Defendants. This action seeks, among other relief, general and special damages and equitable relief in order to enable Plaintiff to treat and monitor the dangerous, severe and life-threatening side effects caused by this drug.
14. Defendants’ wrongful acts, omissions, and fraudulent misrepresentations caused Plaintiff's injuries and damages.

15. At all times herein mentioned, the Defendants were engaged in the business of, or were successors in interest to, entities engaged in the business of research, licensing, designing, formulating, compounding, testing, manufacturing, producing, processing, assembling, inspecting, distributing, marketing, labeling, promoting, packaging and/or advertising for sale or selling the prescription drug AndroGel for the use and application by Plaintiff.
16. At all times herein mentioned, Defendants were authorized to do business within the state of residence of Plaintiff.
17. At all times herein mentioned, the officers and directors of Defendants participated in, authorized, and directed the production and promotion of the aforementioned product when they knew, or with the exercise of reasonable care should have known, of the hazards and dangerous propensities of said product and thereby actively participated in the tortious conduct which resulted in the injuries suffered by Plaintiff herein.
18. Plaintiff files this lawsuit within the applicable limitations period of first suspecting that said drugs caused the appreciable harm sustained by Plaintiff. Plaintiff could not, by the exercise of reasonable diligence, have discovered the wrongful case of Plaintiff's injuries at an earlier time because the injuries were caused without perceptible trauma or harm, and when Plaintiff's injuries were discovered their cause was unknown to Plaintiff. Plaintiff did not suspect, nor did Plaintiff have reason to suspect, that Plaintiff had been injured, the cause of the injuries, or the tortious nature of the conduct causing the injuries, until less than the applicable limitations period prior to the filing of this action. Additionally, Plaintiff was prevented from discovering this information sooner because Defendants herein misrepresented and continue to misrepresent to the public and to the medical profession that the drug AndroGel is safe and free Case: 1:14-cv-00879 Document #: 1 Filed:
from serious side effects, and Defendants have fraudulently concealed facts and information that could have led Plaintiff to discover a potential cause of action.
OVERVIEW
19. Hypogonadism is a specific condition of the sex glands, which in men may involve the diminished production or nonproduction of testosterone.
20. In 1999, when Unimed Pharmaceuticals Inc., one of the Defendants’ predecessor companies, asked for FDA approval of AndroGel, it asserted that hypogonadism was estimated to affect approximately "one million American men."
21. In 2000, when the FDA approved AndroGel, the company announced that the market was "four to five million American men." By 2003, the number increased to "up to 20 million men." However, a study published in the Journal of the American Medical Association (“JAMA”) in August 2013 entitled “Trends in Androgen Prescribing in the United States, 2001-2011” indicated that many men who get testosterone prescriptions have no evidence of hypogonadism. For example, one third of men prescribed testosterone had a diagnosis of fatigue, and one quarter of men did not even have their testosterone levels tested before they received a testosterone prescription.
22. Defendants coordinated a massive advertising campaign designed to convince men that they suffered from low testosterone. Defendants orchestrated a national disease awareness media blitz that purported to educate male consumers about the signs of low testosterone. The marketing campaign consisted of television advertisements, promotional literature placed in healthcare providers' offices and distributed to potential AndroGel users, and online media including the unbranded website "IsItLowT.com."

23. The television advertisements suggest that various symptoms often associated with other conditions may be caused by low testosterone and encourage men to discuss testosterone replacement therapy with their doctors if they experienced any of the "symptoms" of low testosterone. These “symptoms” include listlessness, increased body fat, and moodiness—all general symptoms that are often a result of aging, weight gain, or lifestyle, rather than low testosterone.
24. Since the FDA approved AndroGel, Defendants have also sought to convince primary care physicians that low testosterone levels are widely under-diagnosed, and that conditions associated with normal aging could be caused by low testosterone levels.
25. While running its disease awareness campaign, Defendants promote their product AndroGel as an easy to use topical testosterone replacement therapy. Defendants contrast their product's at-home topical application with less convenient prescription testosterone injections, which require frequent doctor visits.
26. Defendants convinced millions of men to discuss testosterone replacement therapy with their doctors, and consumers and their physicians relied on Defendants’ promises of safety and ease. Although prescription testosterone replacement therapy had been available for years, millions of men who had never been prescribed testosterone flocked to their doctors and pharmacies.
27. What consumers received, however, were not safe drugs, but a product which causes life-threatening problems, including strokes and heart attacks.
28. Defendants successfully created a robust and previously nonexistent market for their drug. Defendant Abbott Laboratories spent $80 million promoting AndroGel in 2012. The company also spent millions on its unbranded marketing including commercials and its websites, Case: 1:14-
www.IsItLowT.com and www.DriveForFive.com, sites which recommend that men have regular checkups with their physicians and five regular tests done: including cholesterol, blood pressure, blood sugar, prostate-specific antigen, and testosterone.
29. Defendants’ advertising paid off in a return of $1.4 billion in sales during the past year, making AndroGel the biggest selling androgen drug in the United States. Sales of replacement therapies have more than doubled since 2006, and are expected to triple to $5 billion by 2017, according to forecasts by Global Industry Analysts. Shannon Pettypiece, Are Testosterone Drugs the Next Viagra?, May 10, 2012, Bloomberg Businessweek, available at: http://www.businessweek.com/articles/2012-05-10/are-testosterone-drugs-the-next-viagra.
30. In early 2013, Medical Marketing & Media named two AbbVie executives as “the all-star large pharma marketing team of the year” for promotions of AndroGel and unbranded efforts to advance low T. See Singer, Selling That New-Man Feeling, supra; See also, Larry Dobrow, All-star large pharma marketing team of the year: Androgel. Jan. 2, 2013, Medical Marketing & Media, available at: http://www.mmm-online.com/all-star-large-pharma-marketing-team-of-the-year-androgel/article/273242/.
31. The marketing program sought to create the image and belief by consumers and physicians that low testosterone affected a large number of men in the United States and that the use of AndroGel is safe for human use, even though Defendants knew these to be false, and even though Defendants had no reasonable grounds to believe them to be true.
32. There have been a number of studies suggesting that testosterone in men increases the risk of heart attacks and strokes.

33. In 2010, a New England Journal of Medicine Study entitled “Adverse Events Associated with Testosterone Administration” was discontinued after an exceedingly high number of men in the testosterone group were suffered adverse events.
34. In November of 2013, a JAMA study was released entitled “Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men with Low Testosterone Levels” which indicated that testosterone therapy raised the risk of death, heart attack and stroke by about 30%.
35. On January 29, 2014, a study was released in PLOS ONE entitled “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men” which indicated that testosterone use doubled the risk of heart attacks in men over sixty five years old and men younger than sixty five with a previous diagnosis of heart disease.
FACTUAL ALLEGATIONS COMMON TO ALL CAUSES OF ACTION
36. The Food and Drug Administration approved AndroGel 1% on February 28, 2000 for the treatment of adult males who have low or no testosterone (AndroGel 1.62% was approved in April, 2011). After FDA approval, AndroGel was widely advertised and marketed by Defendant as a safe and effective testosterone replacement therapy.
37. AndroGel, is a hydroalcoholic gel containing testosterone in either 1% or 1.62%, applied to the chest, arms or stomach and enters the body through transdermal absorption. The AndroGel 1.62% product also contains isopropyl myristate as an ointment and ethanol for absorption enhancement.
38. Testosterone is a primary androgenic hormone responsible for normal growth, development of the male sex organs, and maintenance of secondary sex characteristics.

39. The hormone plays a role in sperm production, fat distribution, maintenance of muscle strength and mass, and sex drive.
40. In men, testosterone levels normally begin a gradual decline after the age of thirty.
41. The average testosterone levels for most men range from 300 to 1,000 nanograms per deciliter of blood. However, testosterone levels can fluctuate greatly depending on many factors, including sleep, time of day, and medication. Resultantly, many men who fall into the hypogonadal range one day will have normal testosterone levels the next.
42. AndroGel may produce undesirable side effects to patients who use the drug, including but not limited to, myocardial infarction, stroke, and death.
43. In some patient populations, AndroGel use may increase the incidence of myocardial infarctions and death by over 500%.
44. In addition to the above, AndroGel has been linked to several severe and life changing medical disorders in both users and those who come into physical contact with users or the unwashed clothes of someone who applied AndroGel. Patients taking AndroGel may experience enlarged prostates and increased serum prostate-specific antigen levels.
45. Secondary exposure to AndroGel can cause side effects in others. In 2009 the FDA issued a black box warning for AndroGel prescriptions, advising patients of reported virilization in children who were secondarily exposed to the gel. Testosterone may also cause physical changes in women exposed to the drug and cause fetal damage with pregnant women who come into secondary contact with AndroGel.
46. Defendants’ marketing strategy beginning in 2000 has been to aggressively market and sell their products by misleading potential users about the prevalence and symptoms Case: 1:14-cv-
of low testosterone and by failing to protect users from serious dangers that Defendants knew or should have known to result from use of its products.
47. Defendants successfully marketed AndroGel by undertaking a "disease awareness" marketing campaign. This campaign sought to create a consumer perception that low testosterone is prevalent among U.S. men and that symptoms previously associated with other physical and mental conditions, such as aging, stress, depression, and lethargy were actually attributable to "Low-T."
48. AbbVie's advertising program, sought to create the image and belief by consumers and their physicians that the use of AndroGel was a safe method of alleviating their symptoms, had few side effects and would not interfere with their daily lives, even though Defendants knew or should have known these to be false, and even though the Defendants had no reasonable grounds to believe them to be true.
49. Defendants purposefully downplayed, understated and outright ignored the health hazards and risks associated with using AndroGel. Defendants deceived potential AndroGel users by relaying positive information through the press, including testimonials from retired professional athletes, and manipulating hypogonadism statistics to suggest widespread disease prevalence, while downplaying known adverse and serious health effects.
50. Defendants concealed material relevant information from potential AndroGel users and minimized user and prescriber concern regarding the safety of AndroGel.
51. In particular, in the warnings Defendants give in their commercials, online and print advertisements, Defendants fail to mention any potential cardiac or stroke side effects and falsely represents that AbbVie adequately tested AndroGel for all likely side effects.

52. As a result of Defendants’ advertising and marketing, and representations about its product, men in the United States pervasively seek out prescriptions for AndroGel. If Plaintiff in this action had known the risks and dangers associated with AndroGel, Plaintiff would not have taken AndroGel and consequently would not have been subject to its serious side effects.
SPECIFIC FACTUAL ALLEGATIONS
53. Plaintiff was prescribed AndroGel and used it as directed from approximately June 2013 to November 2013.
54. Plaintiff was 60 years of age when he was prescribed and used testosterone for symptoms he attributed to low testosterone after viewing Defendants’ advertisements.
55. Plaintiff was very healthy and had no history of heart disease prior to taking testosterone. In keeping with his healthy and proactive lifestyle, Plaintiff agreed to initiate testosterone treatment. He relied on claims made by Defendants that testosterone had been clinically shown to safely and effectively raise testosterone levels.
56. Plaintiff was diagnosed with myocardial infarction on or about September 23, 2013. As a result, for the rest of his life he must undergo regular testing, adhere to a restrictive diet, and take medication. Due to his myocardial infarction he is now at markedly increased risk of additional cardiovascular disease, cerebrovascular accidents, and death.
57. Had Defendants properly disclosed the risks associated with testosterone, Plaintiff would have avoided the risk of myocardial infarction by either not using testosterone at all, severely limiting the dosage and length of use, and/or by closely monitoring the degree to which the drugs were adversely affecting his health. Case: 1:14-cv-00879 Document #: 1 Filed:
58. As alleged herein, as a direct, proximate, and legal result of Defendants’ negligence and wrongful conduct, and the unreasonably dangerous and defective characteristics of the drug testosterone, Plaintiff suffered severe and permanent physical and emotional injuries, including, but not limited to myocardial infarction. Plaintiff has endured pain and suffering, has suffered economic loss, including incurring significant expenses for medical care and treatment and will continue to incur such expenses in the future. Plaintiff seeks actual and punitive damages from Defendant as alleged herein.
FIRST CAUSE OF ACTION STRICT LIABILITY – FAILURE TO WARN
59. Plaintiff incorporates by reference herein each of the allegations heretofore set forth in this Complaint as though fully set forth herein.
60. The AndroGel manufactured and/or supplied by Defendants was defective due to inadequate warnings or instructions because Defendants knew or should have known that the product created significant risks of serious bodily harm to consumers, and they failed to adequately warn consumers and/or their health care providers of such risks. The AndroGel manufactured and/or supplied by Defendants was defective due to inadequate post-marketing warnings or instructions because, after Defendants knew or should have known of the risk of serious bodily harm from the use of AndroGel, 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.
61. As a direct and proximate result of Plaintiff’s reasonably anticipated use of AndroGel as manufactured, designed, sold, supplied, marketed and/or introduced into the stream of commerce by Defendants, Plaintiff suffered serious injury, harm, damages, economic and non-economic loss and will continue to suffer such harm, damages and losses in the future.

SECOND CAUSE OF ACTION NEGLIGENCE
62. Plaintiff incorporates by reference herein each of the allegations set forth in this Complaint as though set forth herein.
63. At all times herein mentioned, Defendants had a duty to properly manufacture, design, formulate, compound, test, produce, process, assemble, inspect, research, distribute, market, label, package, distribute, prepare for use, sell, prescribe and adequately warn of the risks and dangers of AndroGel.
64. At all times herein mentioned, Defendants negligently and carelessly manufactured, designed, formulated, distributed, compounded, produced, processed, assembled, inspected, distributed, marketed, labeled, packaged, prepared for use and sold AndroGel and failed to adequately test and warn of the risks and dangers of AndroGel.
65. Despite the fact that Defendants knew or should have known that AndroGel caused unreasonable, dangerous side effects, Defendants continued to market AndroGel to consumers including Plaintiff, when there were safer alternative methods of treating loss of energy, libido erectile dysfunction, depression, loss of muscle mass and other conditions AndroGel's advertising claims are caused by low testosterone.
66. Defendants knew or should have known that consumers such as Plaintiff would foreseeably suffer injury as a result of Defendants’ failure to exercise ordinary care as described above.
67. Defendants’ negligence was a proximate cause of Plaintiff's injuries, harm and economic loss which Plaintiff suffered, and will continue to suffer, as described and prayed for herein.

THIRD CAUSE OF ACTION FOR BREACH OF IMPLIED WARRANTY
68. Plaintiff incorporates by reference here each of the allegations heretofore set forth in this Complaint as though fully set forth herein.
69. Prior to the time that the aforementioned products were used by Plaintiff, Defendants impliedly warranted to Plaintiff and Plaintiff’s agents and physicians that AndroGel was of merchantable quality and safe and fit for the use for which it was intended.
70. Plaintiff was and is unskilled in the research, design and manufacture of the products and reasonably relied entirely on the skill, judgment and implied warranty of the Defendants in using AndroGel.
71. AndroGel was neither safe for its intended use nor of merchantable quality, as warranted by Defendants, in that AndroGel has dangerous propensities when used as intended and will cause severe injuries to users.
72. As a result of the abovementioned breach of implied warranties by Defendants, Plaintiff suffered injuries and damages as alleged herein.
FOURTH CAUSE OF ACTION FOR BREACH OF EXPRESS WARRANTY
73. Plaintiff incorporates by reference here each of the allegations set forth in this Complaint as though fully set forth here.
74. At all times mentioned, Defendants expressly represented and warranted to Plaintiff and Plaintiff’s agents and physicians, by and through statements made by Defendants or their authorized agents or sales representatives, orally and in publications, package inserts and other written materials intended for physicians, medical patients and the general public, that

AndroGel is safe, effective, fit and proper for its intended use. Plaintiff purchased AndroGel relying upon these warranties.
75. In utilizing AndroGel, Plaintiff relied on the skill, judgment, representations, and foregoing express warranties of Defendants. These warranties and representations were false in that AndroGel is unsafe and unfit for its intended uses.
76. As a result of the abovementioned breach of express warranties by Defendants, Plaintiff suffered injuries and damages as alleged herein.
FIFTH CAUSE OF ACTION FRAUD
77. Plaintiff incorporates by reference here each of the allegations set forth in this Complaint as though set forth fully herein.
78. Defendants, from the time they first tested, studied, researched, evaluated, endorsed, manufactured, marketed and distributed AndroGel, and up to the present, willfully deceived Plaintiff by concealing from them, Plaintiff’s physicians and the general public, the true facts concerning AndroGel, which the Defendants had a duty to disclose.
79. At all times herein mentioned, Defendants conducted a sales and marketing campaign to promote the sale of AndroGel and willfully deceive Plaintiff, Plaintiff’s physicians and the general public as to the benefits, health risks and consequences of using AndroGel. Defendants knew of the foregoing, that AndroGel is not safe, fit and effective for human consumption, that using AndroGel is hazardous to health, and that AndroGel has a serious propensity to cause serious injuries to its users, including but not limited to the injuries Plaintiff suffered.
80. Defendants concealed and suppressed the true facts concerning AndroGel with the intent to defraud Plaintiff, in that Defendants knew that Plaintiff physicians would not prescribe Case:
AndroGel, and Plaintiff would not have used AndroGel, if they were aware of the true facts concerning its dangers.
81. As a result of Defendants’ fraudulent and deceitful conduct, Plaintiff suffered injuries and damages as alleged herein.
SIXTH CAUSE OF ACTION NEGLIGENT MISREPRESENTATION
82. Plaintiff incorporates by reference herein each of the allegations set forth in this Complaint as though fully set forth herein.
83. From the time AndroGel was first tested, studied, researched, evaluated, endorsed, manufactured, marketed and distributed, and up to the present, Defendants made misrepresentations to Plaintiff, Plaintiff’s physicians and the general public, including but not limited to the misrepresentation that AndroGel was safe, fit and effective for human consumption. At all times mentioned, Defendants conducted a sales and marketing campaign to promote the sale of AndroGel and willfully deceive Plaintiff, Plaintiff's physicians and the general public as to the health risks and consequences of the use of the abovementioned product.
84. The Defendants made the foregoing representation without any reasonable ground for believing them to be true. These representations were made directly by Defendants, by sales representatives and other authorized agents of Defendants, and in publications and other written materials directed to physicians, medical patients and the public, with the intention of inducing reliance and the prescription, purchase and use of the subject product.
85. The representations by the Defendants were in fact false, in that AndroGel is not safe, fit and effective for human consumption, using AndroGel is hazardous to health, and AndroGel has a serious propensity to cause serious injuries to users, including but not limited to the injuries suffered by Plaintiff.

86. The foregoing representations by Defendants, and each of them, were made with the intention of inducing reliance and the prescription, purchase and use of AndroGel.
87. In reliance of the misrepresentations by the Defendants, and each of them, Plaintiff was induced to purchase and use AndroGel. If Plaintiff had known of the true facts and the facts concealed by the Defendants, Plaintiff would not have used AndroGel. The reliance of Plaintiff upon Defendants’ misrepresentations was justified because such misrepresentations were made and conducted by individuals and entities that were in a position to know the true facts.
88. As a result of the foregoing negligent misrepresentations by Defendants, Plaintiff suffered injuries and damages as alleged herein.
PUNITIVE DAMAGES ALLEGATIONS
89. Plaintiff incorporates by reference here each of the allegations set forth in this Complaint as though fully set forth herein.
90. The acts, conduct, and omissions of Defendants, as alleged throughout this Complaint were willful and malicious. Defendants committed these acts with a conscious disregard for the rights of Plaintiff and other AndroGel users and for the primary purpose of increasing Defendants’ profits from the sale and distribution of AndroGel. Defendants’ outrageous and unconscionable conduct warrants an award of exemplary and punitive damages against Defendants in an amount appropriate to punish and make an example of Defendants.
91. Prior to the manufacturing, sale, and distribution of AndroGel, Defendants knew that said medication was in a defective condition as previously described herein and knew that those who were prescribed the medication would experience and did experience severe physical, mental, and emotional injuries. Further, Defendants, through their officers, directors, managers,
and agents, knew that the medication presented a substantial and unreasonable risk of harm to the public, including Plaintiff and as such, Defendants unreasonably subjected consumers of said drugs to risk of injury or death from using AndroGel.
92. Despite its knowledge, Defendants, acting through its officers, directors and managing agents for the purpose of enhancing Defendants’ profits, knowingly and deliberately failed to remedy the known defects in AndroGel and failed to warn the public, including Plaintiff, of the extreme risk of injury occasioned by said defects inherent in AndroGel. Defendants and their agents, officers, and directors intentionally proceeded with the manufacturing, sale, and distribution and marketing of AndroGel knowing these actions would expose persons to serious danger in order to advance Defendants’ pecuniary interest and monetary profits.
93. Defendants’ conduct was despicable and so contemptible that it would be looked down upon and despised by ordinary decent people, and was carried on by Defendants with willful and conscious disregard for the safety of Plaintiff, entitling Plaintiff to exemplary damages.
PRAYER FOR RELIEF
WHEREFORE, Plaintiff prays for relief and judgment against Defendants as follows:
(a) For general damages in a sum in excess of the jurisdictional minimum of this Court;
(b) For medical, incidental, and hospital expenses according to proof;
(c) For pre-judgment and post-judgment interest as provided by law;
(d) For full refund of all purchase costs Plaintiff paid for testosterone;

(e) For compensatory damages in excess of the jurisdictional minimum of this Court;
(f) For consequential damages in excess of the jurisdictional minimum of this Court;
(g) For punitive damages in an amount in excess of any jurisdictional minimum of this Court and in an amount sufficient to impress upon Defendants the seriousness of their conduct and to deter similar conduct in the future;
(h) For attorneys’ fees, expenses, and costs of this action; and
(i) For such further relief as this Court deems necessary, just, and proper.
DEMAND FOR JURY TRIAL
Plaintiff demands a trial by jury on all counts and as to all issues.
Dated: February 7, 2014 Respectfully submitted,

Risperdal & Gynecomastia - Tricking Teenage Boys Into Transgendered Lives

The past decade has seen a rise in lawsuits surrounding gender and sex identity issues. For example, in 2012, the news followed Jenna Talackova, a transgendered beauty queen, as she battled Donald Trump to gain eligibility to compete in the Miss Universe pageant. In 2013, a Colorado court made a historical ruling when it decided that a male-to-female transgender student could not be barred from using the girls’ bathroom at school. In recent years, lawsuits have also been filed as to whether states should be obligated to fund hormone treatment for transgendered prisoners.

Some believe that, if an individual is born a male, but identifies as a female, that individual should not be forced to remain in a male’s body. No one should be forced to be something that he or she is not.

Of course, not everyone agrees that sex-change procedures should be permitted. Plenty of people tend to believe that we should all remain in the biological bodies into which we are born. No matter where you stand on the issue, at the very least, we can all certainly agree that no one should be forced to go through a sex change process against his or her will.

The great majority of males on our planet are, of course, not transgendered, and would therefore never consciously choose to transform themselves into females. In fact, most men would choose to lose a leg, an arm, his hearing, and just about anything else, before his masculinity. While there are, indeed, a minority of transgendered men in today’s world fighting for the right to transform themselves into women, there are now men out there having to fight for just the opposite. Thanks to the companies that have developed and promoted the so-called antipsychotic medications called ‘Risperdal’ and ‘Invega’, there are now men fighting to reclaim their masculinity.

We now know that Risperdal and/or Invega can, and did, cause many of its male users to grow breasts. Not only have adult men been put through this nightmare, but boys have as well—some of them as young as 3 years old. The companies that share responsibility for the development, manufacture, and promotion of these drugs include (1) Ortho-McNeil-Janssen Pharmaceuticals, Inc. (Hereinafter “Janssen”); (2) Johnson & Johnson; (3) Johnson & Johnson Pharmaceutical Research & Development, L.L.C; (4) Excerpta Medica Inc.; and (5) Elsevier Inc.

Originally, Risperdal was developed to treat symptoms related only to schizophrenia. However, in order to increase sales and profits, Janssen and the other above named companies promoted Risperdal and/or Invega for a variety of unapproved uses including autism, Attention-Deficit/Hyperactivity Disorder (ADHD), Obsessive-Compulsive Disorder (OCD), Oppositional-Defiant Disorder (ODD), Conduct Disorder (CD), Disruptive Behavior Disorder (DBD), Tourette’s syndrome, Post-Traumatic Stress Disorder (PTSD), and pervasive development disorders (PDD). Tragically, these off-label promotions came at the expense of the safety, health, and well-being of the public at large.

Many individuals who have suffered injuries and damages arising out of the use of Risperdal and/or Invega have filed lawsuits against Janssen and the other aforementioned companies for side effects caused by those drugs.

Among the side effects that the plaintiffs have had to endure include gynecomastia (which is abnormal development of breasts in males) and galactorrhea (which is lactation). The plaintiffs have suffered significant bodily and mental injury, pain and suffering, mental anguish, disfigurement, embarrassment, and inconvenience. In addition, many of the male plaintiffs have incurred past and future medical expenses because they need to undergo a mastectomy (surgery) to remove the breasts.

Had the defendant companies followed the law, the Plaintiffs’ extreme pain and suffering would not have occurred. Risperdal and Invega lawsuits allege that the companies listed above violated the Federal Food, Drug, and Cosmetic Act (the “FDCA”).  Sections 502(a) and 201(n) of the FDCA” (21 U.S.C. §§ 352(a) and 321(n)) require pharmaceutical companies to fully and accurately disclose all side effects related to a drug, including gynecomastia and other adverse effects that can be caused by Risperdal and/or Invega. In violation of the FDCA, the defendant companies did not adequately warn users of Risperdal or Invega of the risks of side effects like gynecomastia.

Furthermore, Sections 502(a) and 201(n) of the FDCA (21 U.S.C. §§ 352(a) and 321(n)) prohibit pharmaceutical companies from minimizing the risks or disseminating misleading information about a drug’s safety or efficacy. However, in violation of the FDCA once again, the defendant companies failed to disclose the true rick of the horrifying side effects associated with Risperdal and/or Invega. Instead, they promoted the drugs as being among the safest on the market. As a result, physicians prescribed the drugs to children, unaware of the serious risks of doing so.

The medical world has already acknowledged the seriousness of permitting a biological male to take a drug or hormone that will make him grow breasts. There are a number of steps that a transgendered individual must take before most medical authorities will approve him to begin the sex change process. First, the person must live for a period of a year or more in the new sex. See 1 Rights of Prisoners § 4:36 (4th ed.) quoting Gender Dysphoria (Betty Steiner ed. 1985). Only then will the person be administered hormones natural to the new sex. Id. For example, male to female transsexuals will be administered female hormones that will cause them to grow breasts.

Remember: In the above situation, we are talking about individuals who want to grow breasts. Inducing breast growth is so serious, that even biologically-born males who want to grow breasts are required to demonstrate their commitment for a year before they will be allowed to do so.  However, the victims of Risperdal and/or Invega, who had no desire to grow breasts whatsoever, had no such choice, warning, or safety measures in place before the unwanted transformations were forced upon them after ingesting the drug.

The males who took the drugs (at their doctors’ recommendations) now find themselves living in the same horrifying state that transgendered individuals find themselves— forced to live in a biological body that does not match the gender with which he identifies. An individual who is born a biological male, and who identifies as a male, should not be forced, against his will, to grow breasts.

Our law firm is currently accepting cases on behalf of men and boys who took the drug Risperdal or Invega and developed gynecomastia or other side effects as a result.

Surgical Removals of Mirena IUD Increasing

A number of lawsuits have arisen due to the complications caused by the use of intrauterine contraceptive devices (IUDs).  It has been shown that with the increase in popularity of IUDs, there has been a notable rise of cases where migration of the devices leads to a need for corrective surgery for the removal of such devices.  Besides the obvious negative consequences of the improper placement of IUDs, such as pregnancy, either uterine or ectopic, there lies the further threat of internal bleeding or infections.

A study, published by Frances R. Mosely et al. (2012) in The Journal of the Society of Laparoendoscopic Surgeons which aimed at determining the most successful surgical technique for the removal of migrated IUDs from within the peritoneal cavity determined that laparoscopic surgery was the most commonly used with a high success rate for removal.  The study further indicated that the complications that result from IUD migration into the peritoneal cavity often must involve an initial or even mid-surgery conversion to open surgery was required. 

Currently, the most popular IUD in the United States is Mirena®, a product manufactured by Bayer Pharmaceuticals, Inc. that is associated with a high rate of IUD migration and uterine perforation.  Because Bayer Pharmaceuticals has time and again failed to warn the users of its products of the relevant risks, a number of Mirena® migration lawsuits are currently being filed.

 If you have experienced negative side-effects of IUD insertion, or have required surgery due to the use of IUDs, then you may be eligible to file an IUD migration lawsuit.  We urge you to contact our law offices to receive a free consultation to help you determine if you have a case.  You may reach our offices at either by phone, at (888) 315 – 3997, or by e-mail, at justinian@justinian.us.

Migrated Mirena Perforates Uterus

Over a decade ago, a report by medical researchers K.K. Roy et al. was published in International Journal of Gynecology & Obstetrics describing the case of a woman in whom a levonorgestrel-releasing intrauterine contraceptive device (IUD) perforated the uterine wall and migrated to the pelvis.

Intrauterine contraceptive device migration is a well-known complication of IUD use.

Other complications related to the use of intrauterine contraceptive devices such as Mirena® (manufactured by Bayer Pharmaceuticals) are ectopic pregnancy, loss of pregnancy, loss of fertility, and IUD expulsion. For more information, the Mayo Clinic website has a great deal of information regarding the risks of Mirena® use.

The Roy et al. (2000) piece describes the case of a woman, aged 42 years and otherwise healthy, who had decided to use an intrauterine contraceptive device after the birth of her second child.[1]  This, in fact, is the time in life at which the Mirena® device is intended to be used.

After using her intrauterine contraceptive device for only 15 days, she came back to her doctor complaining of mild pelvic pain.  Upon examination, the removal strings of the device could not be located, and X-ray was required to locate the device.  Found to have torn through the uterine wall, the device was resting in front of the sacrum.  Using laparoscopy, a surgical procedure aided by the insertion of a tiny camera aboard surgical equipment, the device was removed and the woman recovered without injury.[2]

Due to the fact that the manufacturers of Mirena® IUD and other similar products have time and again failed to make clear the risks associated with the use of their products, a number of Mirena® lawsuits are currently being filed. 

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[1] Roy, K.K. et al. “Laparoscopic removal of translocated retroperitoneal IUD” International Journal of Gynecology & Obstetrics 71 _2000. 241]243

[2] Ibid.

Mirena migration leads to cornual pregnancy

While it has been widely documented that levonorgestrel-releasing intrauterine contraceptive devices (IUDs) may perforate the uterus and migrate to the abdomen, where they may cause a variety of problems, and that IUD migration can result in ectopic pregnancy, a 2009 report by JJ Beltman et al, published in Journal of Medical Case Reports details the case of a woman in whom her IUD migration resulted in cornual pregnancy, a kind of ectopic pregnancy.

Cornual (interstitial) pregnancy is a pregnancy that occurs in one of the fallopian tubes, rather than in the uterus, where it would normally take place. 

“Interstitial pregnancy accounts for up to 1 to 3% of all ectopic pregnancies.^[36,37] The term cornual pregnancy is used interchangeably in the United States as a synonym for interstitial pregnancies. However, it refers to a pregnancy in the interstitial segment of a unicornuate or bicornuate uterus.^[35]As the pregnancy grows in the area of the fallopian tube that enters the uterus, surrounding myometrial tissue allows for further development of the pregnancy into the second trimester. Rupture of such an advanced gestation may result in catastrophic hemorrhage, with a mortality rate of up to 2%.^[35,38,39] Diagnosis of interstitial pregnancies relies heavily on ultrasound and potentially on laparoscopic evaluation.^[40]Ultrasound frequently shows a thin rim of myometrial tissue surrounding the ectopic pregnancy sac.^[41] The interstitial line has been described as an echogenic line extending into the corneal region and abuting the gestational sac, and is highly specific for interstitial pregnancy.^[39] Risk factors for development of interstitial pregnancy include previous ectopic pregnancy, previous salpingectomy, uterine anomalies, ipsilateral salpingectomy, IVF, ovulation induction, and sexually transmitted infections.^[35,39]”[1]

For more information on cornual pregnancy, follow the link above to more medical research.  Also, WebMD provides some helpful information on pregnancies that occur in unusual locations. 

 Sadly, ectopic pregnancies can be fatal for the mother and are almost always fatal for the unborn child.

 Due to the fact that Bayer Pharmaceuticals, the maker of the Mirena® IUD has failed to warn users about the risk for pregnancy loss or ectopic pregnancy found to be associated with Mirena® use, many
Mirena® lawsuits are currently being filed.

At your convenience, you may reach our offices by phone at (888) 315 – 3997 or by e-mail at justinian@dangerousdrugs.us

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[1] http://www.medscape.com/viewarticle/557082_4