Cialis FEDERAL Court

UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF TENNESSEE

Michael A. Boles,
Plaintiff,
vs.
Pfizer Inc. and
Eli Lilly and Company,
Defendants.
) Case No.: __________________________

)
) COMPLAINT FOR DAMAGES
)
1. Negligence
)
2. Negligence Per Se
)
3. Strict Products Liability (Failure to
)
Warn/Defective Design)
)
4. Breach of Implied Warranty
)
5. Breach of Express Warranty
)
6. Fraudulent Misrepresentation
)
7. Fraudulent Concealment
)
8. Negligent Misrepresentation
)
9. Violation of Tennessee Consumer
)
Protection Act of 1977
)
DEMAND FOR JURY TRIAL
Plaintiff, Michael A. Boles, by and through his undersigned counsel, hereby submits this
Complaint and Jury Demand against Defendants, Pfizer Inc. (Pfizer) and Eli Lilly and Company
(Eli Lilly) (collectively referred to as Defendants) for compensatory damages, punitive damages,
equitable relief and such other relief deemed just and proper arising from the injuries to Michael A.
Boles resulting from the ingestion of the prescription drugs, Viagra and Cialis. In support of this
Complaint and Jury Demand, Plaintiff alleges the following:
This is an action for personal injuries and damages suffered by Plaintiff, Michael A. Boles
(Plaintiff), as a direct and proximate result of Defendants negligent and wrongful conduct in
connection with the design, development, manufacturing, testing, packaging, promoting, marketing,
distribution, labeling and/or sale of sildenafil citrate tablets sold under the brand name Viagra and
tadalafil tablets sold under the brand name Cialis.
Case 3:16-cv-01100 Document 1 Filed 06/01/16 Page 1 of 40 PageID #: 1
PARTIES
1.
Plaintiff, Michael A. Boles, resides in the County of Wilson, State of Tennessee.
2.
Defendant, Pfizer Inc., is a corporation organized and existing under the laws of the
State of Delaware with its principal place of business in the State of New York. Pfizer regularly
conducts business in the States of Delaware, New York, California, Tennessee and throughout the
United States and derives substantial revenues from drugs it sells in the States of Delaware, New
York, California, and Tennessee and throughout the United States. Pfizer is engaged in the business
of designing, developing, manufacturing, labeling, promoting, marketing, distributing and selling
pharmaceutical drugs, including the drug Viagra in New York, California, Tennessee and
throughout the United States.
3.
Pfizer may be served with process by registered mail with return receipt requested,
upon CT Corporation System, 111 Eighth Avenue, New York, New York, 10011. Pfizer may also be
served via its Registered Agent as identified at the Tennessee Secretary of State, CT Corporation
System, 800 South Gay Street, Suite 2021, Knoxville, Tennessee 37929-9710.
4.
Pfizer, including its owners, employees, parent companies, subsidiaries, affiliates and
agents, developed, designed, manufactured, assembled, tested, inspected, marketed, promoted,

advertised, warranted, distributed, labeled, sold, packaged, and/or provided warnings and instructions
for Viagra.
5.
Pfizer conducts substantial business within Delaware, New York, California,
Tennessee and throughout the United States through the marketing, distribution and sales of Viagra.
6.
Defendant, Eli Lilly, is a corporation organized and existing under the laws of the
State of Indiana with its principal place of business in the State of Indiana at Lilly Corporate Center
located in Indianapolis. Eli Lilly regularly conducts business in the States of Indiana, California,
Tennessee and throughout the United States and derives substantial revenues from drugs it sells in the
States of Indiana, California, Tennessee and throughout the United States. Eli Lilly is engaged in the
business of designing, developing, manufacturing, labeling, promoting, marketing, distributing and
selling pharmaceutical drugs, including the drug Cialis in Indiana, California, Tennessee and
throughout the United States.
7.
Eli Lilly may be served by service of process upon its registered agent, Michael J.
Harrington, at Lilly Corporate Center, Indianapolis, IN 46285. Eli Lilly may also be served via its
Registered Agent as identified at the Tennessee Secretary of State, National Registered Agents, Inc.,
800 South Gay Street, Suite 2021, Knoxville, Tennessee 37929-9710.
8.
Eli Lilly, including its owners, employees, parent companies, subsidiaries, affiliates
and agents, developed, designed, manufactured, assembled, tested, inspected, marketed, promoted,
advertised, warranted, distributed, labeled, sold, packaged, and/or provided warnings and instructions
for Cialis.
9.
Eli Lilly conducts substantial business within Indiana, California, Tennessee and
throughout the United States through the marketing, distribution and sales of Cialis.
JURISDICTION AND VENUE
10.
Plaintiff is a citizen of the State of Tennessee.
11.
Pfizer maintains its principal place of business in New York.
12.
Eli Lilly maintains its principal place of business in Indiana.
13.
The value of Plaintiffs claims exceeds the total of seventy-five thousand dollars
($75,000.000), exclusive of recoverable interest and costs. None of the causes of action stated herein
have been assigned or otherwise given to any other court or tribunal.
14.
Therefore, this Court has subject matter jurisdiction pursuant to 28 U.S.C. 1332.
15.
Plaintiff is domiciled in Tennessee, was prescribed and ingested Viagra and Cialis
in Tennessee and sustained injuries in Tennessee.

16.
Venue is proper in this Judicial District pursuant to 28 U.S.C. 1391 because a
substantial part of the events that give rise to the Plaintiffs claim took place in this Judicial District.
Additionally, Plaintiff resides is this Judicial District and Defendants market, advertise, distribute,
sell and receive substantial profits from the sales of Viagra and Cialis in this District and have
and continue to conceal and make material omissions in this District so as to subject it to in personam
jurisdiction in this Judicial District.
17.
On December 11, 2015, a Petition was filed with the Judicial Panel on Multidistrict
Litigation (JPML) seeking coordination of all such matters before the U.S. District Court for the
Northern District of California. See In Re: Viagra Products Liability Litigation, MDL No. 2691.
The Petition was fully briefed, unopposed by Pfizer and all other interested parties, and argued on
March 31, 2016. On April 7, 2016, the JPML issued a Transfer Order and consolidation of related
cases into In Re: Viagra (Sildenafil Citrate) Products Liability Litigation, MDL No. 2691 and
transferred the consolidation to the United States District Court for the Northern District of California
before The Honorable Richard Seeborg.
18.
Related Viagra and Cialis actions are pending in this and other federal judicial
districts throughout the United States. Venue is proper in Plaintiffs home District, the United States
District Court for the Middle District of Tennessee, and also in MDL No. 2691, the United States
District court for the Northern District of California, for the purpose of consolidated proceedings.
FACTS
Background - Viagra
19.
On March 27, 1998, the U.S. Food and Drug Administration approved a new drug
application (NDA) for the manufacture and sale of sildenafil citrate.

20.
Sildenafil citrate, sold under the brand name Viagra, is an oral tablet prescribed to
men with erectile dysfunction.

21.
Sildenafil citrate (Sildenafil) is the active ingredient in Viagra.
22.
Erectile dysfunction is the medical diagnosis for a condition in which a man cannot
achieve or maintain an erection sufficient for satisfactory sexual activity. Since achieving and/or
maintaining an erection involves the brain, nerves, hormones and blood vessels, any condition that
interferes with any of these functional areas of the body may be causally related to an individuals
erectile dysfunction. These problems become more common with age, but erectile dysfunction can
affect a man at any age.
23.
Viagra treats erectile dysfunction by inhibiting the secretion of phosphodiesterase
type 5 (PDE5), an enzyme responsible for the degradation of cyclic guanosine monophosphate
(cGMP). When the cGMP is not degraded by the PDE5, smooth muscles in the corpus cavernosum
relax, creating an erection.
24.
The National Institutes of Health estimate that erectile dysfunction affects as many as
thirty million men in the United States.1
NIH Consensus Development Panel on Impotence (July 7, 1993).

5
Prevalence of Viagra in the Market

25.
In its 2013 Annual Report, Pfizer states that it accumulated revenue exceeding
$1,800,000,000 from worldwide sales of Viagra. This statistic is particularly significant in light of
the fact that Pfizer lost exclusivity of Viagra throughout Europe in 2013, which in itself led to a
drop in profits from the previous calendar year.
26.
Viagra holds approximately 45% of the U.S. market share for erectile dysfunction
medications.2
27.
Pfizer estimates that Viagra has been prescribed to more than 35 million men
worldwide.3
28.
In 2012 alone, physicians wrote approximately eight million prescriptions for
Viagra.
Background - Cialis
29.
On November 21, 2003, the U.S. Food and Drug Administration approved new drug
application (NDA) 021368 from Lilly ICOS LLC for the manufacture and sale of tadalafil.4
30.
Tadalafil, sold under the brand name Cialis, is an oral tablet prescribed to men with
erectile dysfunction.
31.
Tadalafil is the active ingredient in Cialis.
Jacque Wilson, Viagra: The Little Blue Pill That Could, CNN, Mar. 27, 2013, available at:
http://www.cnn.com/2013/03/27/health/viagra-anniversary-timeline/index.html.
3
Hilary Stout, The Thrill That Was, N.Y. TIMES, June 5, 2011, available at:
http://query.nytimes.com/gst/fullpage.html?res=9B06E3DF173DF173FF936A35755C0A9679D8B63.
4
The initial FDA approval for tadalafil was issued to the entity Lilly ICOS LLC. From 1998 to 2006, Eli Lilly and ICOS
Corporation were partners in the joint venture known as Lilly ICOS LLC. This joint venture was responsible for the
manufacture, marketing, and sale of Cialis from the drugs FDA approval in 2003 until Eli Lilly acquired ICOS
Corporation in October of 2006. Press Release, Eli Lilly and Company, Lilly Announces Acquisition of ICOS
Corporation (Oct. 17, 2006), https://investor.lilly.com/releasedetail.cfm?ReleaseID=214900. Mr. Boles did not begin
taking Cialis until after the acquisition, rendering the entity Lilly ICOS LLC relevant only for explanatory purposes here.
6
32.
Erectile dysfunction is the medical designation for a condition in which a man cannot
achieve or maintain an erection sufficient for satisfactory sexual activity. Since reaching and
maintaining an erection involves an individuals brain, nerves, hormones, and blood vessels, any
condition that interferes with any of these functional areas of the body may be causally related to an
individuals erectile dysfunction. These problems become more common with age, but erectile
dysfunction can affect a man at any age.
33.
Cialis treats erectile dysfunction by inhibiting the secretion of phosphodiesterase
type 5 (PDE5), an enzyme responsible for the degradation of cyclic guanosine monophosphate
(cGMP). When the cGMP is not degraded by the PDE5, smooth muscles in the corpus cavernosum
relax; this, in turn, permits an inflow of blood to the corpus cavernosum, creating an erection.
34.
Since FDA approval of Cialis in 2003, Eli Lilly has engaged in a continuous and
expensive multimedia advertising campaign to market Cialis to men worldwide as a symbol of

regaining and enhancing ones virility.
Prevalence of Cialis in the Market
35.
In 2012, Cialis was the second largest drug in the global market of erectile
dysfunction drugs accounting for over $1,926,000,000 in revenue.

36.
In its 2013 Annual Report, Eli Lilly reported revenue exceeding $2,159,000,000 from
worldwide sales of Cialis, a 12% increase in sales from 2012 to 2013.

37.
Upon information and belief, as of May 2014 approximately 45 million men have
taken Cialis.
Defendants Knowledge
38.
Unbeknownst to users of Viagra and Cialis, studies have shown that the cellular
activity providing the mechanism of action for Viagra and Cialis is associated with the
development and/or exacerbation of melanoma.
39.
Unbeknownst to most Viagra and Cialis users, and not mentioned in any of the
advertising proliferated by Defendants, recent studies have shown that the cellular activity providing
the mechanism of action for these drugs may also be associated with the development and/or
exacerbation of melanoma.
40.
The American Cancer Society states that melanoma is the most serious type of skin
cancer.5
41.
According to the National Cancer Institute, part of the National Institutes of Health,
melanoma is more likely than other skin cancers to spread to other parts of the body, thereby causing
further tissue damage and complicating the potential for effective treatment and eradication of the
cancerous cells.6
42.
Several studies have linked the mechanism of action for Viagra and Cialis to cell
mutation cultivating melanomagenesis, or the creation of melanocytes which develop into melanoma.
43.
Upon information and belief, according to the Center for Drug Evaluation and
Research Joint Clinical Review Internal Safety Review for Viagra (Sildenafil) NDA 20-895, Pfizer
knew as early as approximately 1998 that there were people that dropped out of the clinical studies
due to the development of carcinoma, including but not limited to melanoma, after taking Viagra as
part of a study.
5
American Cancer Society, Skin Cancer Facts, last revised March 19, 2014, available at:
http://cancer.org/cancer/cancercauses/sunanduvexposure/skin-cancer-facts.
6
National Cancer Institute, Types of Skin Cancer, last updated Jan. 11, 20111, available at:
http://www.cancer.gov/cancertopics/wynthk/skin/page4.
44.
A study published in 2011 found that treatment with Viagra and Cialis can
promote melanoma cell invasion.7 Specifically, by inhibiting PDE5, Viagra mimics an effect of
gene activation and therefore may potentially function as a trigger for the creation of melanoma cells.
45.
A 2012 study published in the Journal of Cell Biochemistry also found that PDE5
inhibitors were shown to promote melanin synthesis,8 which may exacerbate melanoma
development.9
46.
On April 7, 2014, an original study (the JAMA study) was published on the website
for the Journal of the American Medical Association Internal Medicine which, in light of the
previous studies, sought to examine the direct relationship between sildenafil use and melanoma
development in men in the United States.10 The JAMA study was published in the journals June
2014 edition.
47.
Among 25,848 participants, the JAMA study reported that recent sildenafil users at
baseline had a significantly elevated risk of invasive melanoma, with a hazard ratio of 1.84; in
other words, the study participants who had recently used sildenafil exhibited an 84% increase in risk
of developing or encouraging invasive melanoma.11
48.
The JAMA study did not specifically study the effects of Cialis use specifically on
melanomagenesis, as Cialis had not yet been approved by the FDA for treatment of erectile
dysfunction. However, its central mechanism of action, the inhibition of PDE5, is the same
mechanism of action that renders sildenafil citrate effective in treating erectile dysfunction.
7
I. Aozarena, et al., Oncogenic BRAF Induces Melanoma Cell Invasion by Downregulating The cGMP-Specific
Phosphodiesterase PDE5A, 19 CANCER CELL 45 (2011).
8
X Zhang, et al., PDE5 Inhibitor Promotes Melanin Synthesis Though the PKG Pathway in B16 Melanoma Cells, 113 J.
CELL BIOCHEM. 2738 (2012).
9
F.P. Noonan, et al., Melanoma Induction by Ultraviolet A But Not Ultraviolet B Radiation Requires Melanin Pigment, 3
NATURE COMMUNICATIONS 884 (2012).
10
Wen-Qing Li, Abrar A. Qureshi, Kathleen C. Robinson & Jiali Han, Sildenafil Use and Increased Risk of Incident
Melanoma in U.S. Men: A Prospective Cohort Study, 174 JAMA INTERNAL MEDICINE 964 (2014).
11
Id.
49.
Defendants purposefully downplayed, understated and outright ignored the melanoma-
related health hazards and risks associated with using Viagra and Cialis. Defendants also
deceived potential Viagra and Cialis users by relaying positive information about the drugs
benefits through the press, while downplaying known, adverse, serious health effects.
50.
Defendants concealed material information related to melanoma development from
potential Viagra and Cialis users.

Consumer Expectations
51.
Since the FDAs approval of Viagra in 1998, Pfizer has engaged in a continuous,
expensive and aggressive advertising campaign to market Viagra to men worldwide as a symbol of
52.
Since the FDAs approval of Cialis in 2003, Eli Lilly has engaged in a continuous,
expensive and aggressive advertising campaign to market Cialis to men worldwide as a symbol of
53.
Pfizer has engaged in increasingly aggressive marketing techniques and strategies to
promote the use of Viagra in the face of increasing pharmaceutical competition. By means of
demonstration, a 2004 article in the Chicago Tribune cited industry reports stating that Pfizer spent
tens of millions of dollars each month on direct-to-consumer advertising.12
54.
Pfizer has also been criticized by regulators, physicians and consumer groups for its
attempt to target younger men in their advertising. Doctors and federal regulators stated that such
ads sen[t] a confusing message to patients who might really benefit from the drug.13
12
Bruce Japsen, Viagras 2 Rivals Grab Market Share In A Year, CHICAGO TRIBUNE, Sept. 23, 2004, available at
htpp://articles.chicagotribune.com/2004-09-23/business/0409230283_1_viagra-erectile-levitra.
13
Bruce Japsen, Toned-Down Advertising Credited for Viagra Gains, CHICAGO TRIBUTED, Feb. 8, 2007, available at
http://articles.chicagotribune.com/2007-02-08/business/0702080063_1_viagra-erectile-Pfizer-spokesman.
10
55.
For example, none of the informational documents proliferated to patients using and
physicians prescribing Cialis since the FDAs approval of the drug make any mention of the risk of
melanoma associated with ingestion of Cialis.
56.
As another example, none of the commercials or print advertisements promoting the
prescription and use of Cialis since its approval by the FDA mention any melanoma-related risks
associated with using the drug.
57.
While designing and formulating Viagra and Cialis, Defendants discovered or
should have discovered that the drugs mechanism of action, the inhibition of PDE5, also presented a
significant risk of the development and/or the exacerbation of melanoma.
58.
Despite these significant findings, Defendants have made no efforts in its ubiquitous
advertisements to warn users about the potential risk of developing and/or exacerbating melanoma
that has been scientifically linked to Viagra and Cialis.
59.
Members of the general public had no plausible means through which they could have
discovered the significant risk of melanomagenesis associated with PDE5 inhibition.

60.
Prescribing physicians would not have had the same level of access to the research and
development conducted by Defendants prior to their decision to manufacture Viagra and Cialis
for general public use.
61.
Defendants failed to communicate to the general public that the inhibition of PDE5
inherently necessary to the efficacy of Viagra and Cialis would also present a significant risk of
ones development and/or exacerbation of cancerous cells.
62.
For example, no individual prescribed to use either Viagra or Cialis would have
believed or be expected to know that his use of these drugs would expose him to an increased risk of
developing melanoma or exacerbating the growth of melanocytes already present in the body.
11
63.
Defendants expected or should have expected individuals who suffered from erectile
dysfunction to ingest Viagra and/or Cialis as a means to treat their condition.

64.
Defendants expected or should have expected physicians treating erectile dysfunction
to prescribe Viagra and/or Cialis as a means to treat this condition.

65.
The risk presented by ingesting Viagra and Cialis would be present from the
moment of manufacture; that is, the user would not need to change or alter the drug itself or the
means by which it was ingested in order for the drug to carry the same risk of harm as described
herein.
Risks and Benefits of Viagra and Cialis Use
66.
Erectile dysfunction is not fatal, nor does it present any related symptoms or
characteristics harmful to ones physical health; however, those with erectile dysfunction are unable
to achieve and maintain an erection.
67.
At all times relevant hereto, Viagra and Cialis were useful to some members of the
population; namely, men diagnosed with erectile dysfunction.

68.
However, Viagra and Cialis also encourage the development of melanoma in the
body of a user, thereby placing them at a significant health risk.

69.
Defendants manufactured, marketed and sold Viagra and Cialis as a PDE5
inhibitor; however, the mechanism of action that made the drug effective in treating erectile
dysfunction simultaneously increased the risk of the user developing melanoma.
70.
At the time Viagra and Cialis were formulated and manufactured, Defendants
knew or should have known that the drugs posed a significantly heightened risk to users, specifically
through the increased likelihood that those users would develop melanoma because of the chemical
reactions inherent to the drugs functioning.
12
71.
Through the testing and formulating of Viagra and Cialis, and before the initiation
of the drugs mass manufacturing, Defendants knew or should have known in the exercise of ordinary
care that the chemical reactions inherent to the mechanism of action for Viagra and Cialis would
present a cancer-related health hazard to potential future users.
72.
The risk presented by the use of Viagra and Cialis through PDE5 inhibition a
characteristic inherent to the drugs potential efficacy was unquestionably far more significant than
the benefit provided to its users.
73.
Because the risk of using Viagra and Cialis so greatly outweighs the benefits of
such use, the drugs present an unreasonably dangerous risk when used for its intended indication.
Facts Regarding Plaintiff
74.
Plaintiff, Michael A. Boles, began pharmaceutical treatment for erectile dysfunction in
or about July 2009, when his physician prescribed Viagra.

75.
Plaintiff continuously filled and regularly ingested Viagra until approximately
March 19, 2013.

76.
Mr. Boles, began a different pharmaceutical treatment for erectile dysfunction in or
about March 2013, when his physician prescribed Cialis.

77.
Plaintiff continuously filled and regularly ingested Cialis until approximately
September 15, 2015.

78.
On January 15, 2015, Plaintiff had a shave biopsy on his right inferior jawline and on
January 20, 2015, the pathology report confirmed invasive melanoma, Breslow depth 0.27 mm.
79.
On January 29, 2015, Plaintiff underwent a 7.4 cm excision through dermis into
adipose with permanent pathology of the right inferior jawline which later confirmed margins clear.
13
80.
Since first being diagnosed with melanoma, Plaintiff has had to remain vigilant in
monitoring his skin for lesions and must go for routine and regular check-ups in addition to regular
self-body exams.
81.
Had Defendants properly disclosed the increased risk of melanoma associated with
Viagra and Cialis, Plaintiff would have avoided the risk of developing melanoma from Viagra
and Cialis use by not taking either drug at all.
82.
As a direct, proximate and legal result of Defendants negligence and wrongful
conduct, and the unreasonably dangerous and defective characteristics of the drugs Viagra and
Cialis, Plaintiff suffered severe and permanent physical and emotional injuries. His physical
injuries have included melanoma as well as surgery necessitated by his skin cancer diagnosis.
Plaintiff has endured not only physical pain and suffering but also an economic loss, including
medical care and treatment. Because of the nature of his diagnosis, he will certainly continue to incur
such medical expenses in the future. As a result of these damages, Plaintiff seeks actual and punitive
damages from Defendants.
Summary
83.
At all times relevant to this lawsuit, Defendants engaged in the business of
researching, licensing, designing, formulating, compounding, testing, manufacturing, producing,

processing, assembling, inspecting, distributing, marketing, labeling, promoting, packaging and/or
advertising for sale or selling the prescription drugs Viagra and Cialis for use among the general
public.
84.
For the duration of these efforts, Defendants directed their advertising efforts to
consumers located across the nation, including consumers in the States of New York, Indiana,
California, Tennessee and throughout the United States. Such efforts were also aimed at prescribing
14
physicians across the nation, including prescribing physicians in the States of New York, Indiana,
California, Tennessee and throughout the United States.
85.
At all times mentioned in this Complaint, Defendants officers and directors
participated in, authorized and directed the production and aggressive promotion of Viagra and
Cialis when they knew, or with the exercise of reasonable care should have known, of the risk of
developing melanoma (and or the exacerbation of melanoma) associated with the use of Viagra and
Cialis. In doing so, these officers and directors actively participated in the tortious conduct which
resulted in the injuries suffered by many users of Viagra and Cialis, including Plaintiff.
86.
Defendants purposefully downplayed, understated and outright ignored the melanoma-
related health hazards and increased risks associated with using Viagra and Cialis. Defendants
also deceived potential users of Viagra and Cialis by relaying positive information through the
press, including testimonials from retired, popular U.S. politicians, while downplaying known
adverse and serious health consequences.
87.
Defendants concealed material information related to melanoma development from
potential users of Viagra and Cialis.

88.
In particular, in the warnings the company includes in its commercials, online and
print advertisements, Defendants failed to mention any potential risk for melanoma development
and/or exacerbation associated with the use of Viagra and Cialis.
89.
As a result of Defendants advertising and marketing, and representations about their
products, men in the United States pervasively sought prescriptions for Viagra and Cialis. If
Plaintiff in this action had known the risks and dangers associated with taking Viagra and Cialis,
15
Plaintiff would have elected not to take either drug and, consequently, would not have developed
melanoma. Similarly, if Plaintiffs physicians had been aware of the risks and dangers associated
with taking Viagra and Cialis, they would not have prescribed Viagra and Cialis to Plaintiff.
CAUSES OF ACTION
FIRST CAUSE OF ACTION
NEGLIGENCE
90.
Plaintiff repeats, reiterates and realleges each and every allegation of this Complaint
contained in each of the foregoing paragraphs inclusive, with the same force and effect as if more
fully set forth herein.
91.
At the time Viagra and Cialis were formulated and manufactured, Defendants
knew or should have known that the drugs posed a significantly heightened risk to users specifically
through the increased likelihood that those users would develop melanoma because of the chemical
reactions inherent to the functioning of these drugs.
92.
Through the testing and formulating of Viagra and Cialis, and before the initiation
of the mass manufacture of these drugs, Defendants knew or should have known in the exercise of
ordinary care that the chemical reactions inherent to the mechanism of action for Viagra and
Cialis would present a cancer-related health hazard to potential future users like Mr. Boles.
93.
In proceeding to manufacture, market and sell Viagra and Cialis, Defendants
carelessly disregarded the hazard inherently posed by these drugs.

94.
Defendants expected or should have expected individuals who suffered from erectile
dysfunction like Mr. Boles to purchase and ingest Viagra and Cialis.
95.
Defendants expected or should have expected physicians treating erectile dysfunction
like Mr. Boles physicians to prescribe Viagra and Cialis as a means to treat the condition.
16
96.
Defendants manufactured, marketed and sold Viagra and Cialis as PDE5
inhibitors; however, the mechanism of action that made these drugs effective in treating erectile
dysfunction simultaneously enhanced the risk of the user developing melanoma and/or exacerbating
the melanoma.
97.
Defendants negligently, recklessly, grossly negligently, wantonly and willfully
displayed a morally culpable and conscious disregard for the rights of others in that they failed to
exercise reasonable care and failed to fulfill the above-stated duty by the manner that Defendants
directly and indirectly advertised, marketed and promoted Viagra and Cialis for the treatment of
erectile dysfunction even though Viagra and Cialis were not reasonably safe for such use.
98.
Defendants had a duty to exercise reasonable care and comply with existing standards
of care in the testing, designing, researching, developing, manufacturing, packaging, promoting,

labeling, advertising, marketing, selling and/or distribution of Viagra and Cialis into the stream of
commerce including a duty to ensure that the product would not cause users to suffer unreasonable
and dangerous side effects such as melanoma.
99.
Defendants failed to exercise ordinary care and failed to comply with existing
standards of care in the testing, designing, researching, developing, manufacturing, packaging,

promoting, labeling, advertising, marketing, selling and/or distribution of Viagra and Cialis into
interstate commerce in that Defendants knew or should have known that using Viagra and Cialis
created an unreasonable risk of melanoma as well as other severe personal injuries which are
permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment
of life as well as the need for lifelong medical treatment, monitoring, medications and/or death.
17
100.
Defendants, their agents, servants and/or employees failed to exercise ordinary care
and failed to comply with existing standards of care in the following acts and/or omissions:
a. Failing to conduct adequate testing, including pre-clinical and clinical testing and
post-marketing surveillance to determine the safety risks of Viagra and Cialis
for treating men while promoting the use of Viagra and Cialis and providing
kickbacks to healthcare professionals to convince healthcare professionals to
prescribe Viagra and Cialis for erectile dysfunction;
b. Marketing Viagra and Cialis for the treatment of erectile dysfunction without
testing them to determine whether they were safe for this use;
c. Designing, manufacturing, producing, promoting, formulating, creating and/or
developing Viagra and Cialis without adequately and thoroughly testing it;
d. Selling Viagra and Cialis without conducting sufficient tests to identify the
dangers posed by Viagra and Cialis to men;
e. Failing to adequately and correctly warn Plaintiff, the public, the healthcare
community, including Plaintiff, Michael A. Boles, and his healthcare providers, as
well as the FDA of the dangers of Viagra and Cialis in men;
f. Failing to evaluate available data and safety information concerning use of
Viagra and Cialis in men;
g. Advertising and recommending the use of Viagra and Cialis without sufficient
knowledge as to its dangerous propensities to cause and/or exacerbate melanoma;
h. Representing that Viagra and Cialis were safe for treating men when in fact
they were and are unsafe;
i. Representing that Viagra and Cialis were safe and efficacious for treating
erectile dysfunction when Defendants were aware that neither the safety nor
efficacy for such treatment has been established;
j. Representing that Viagra and Cialis were not carcinogenic in the animal
studies conducted in rats and rabbits;
k. Failing to provide any warnings regarding melanoma;
l. Failing to accompany Viagra and Cialis with proper and/or accurate warnings
regarding all possible adverse side effects associated with their use;
m. Failing to issue sufficiently strengthened warnings following additional evidence
associating use of Viagra and Cialis with the increased risk of melanoma;
18
n. Failing to advise Plaintiff, Michael A. Boles healthcare providers, the FDA and
the healthcare community that neither the safety nor the efficacy of Viagra and
Cialis for treating erectile dysfunction has been established and that the risks of
using the drugs for that condition outweigh any putative benefit; and
o. Failing to advise Plaintiff, Michael A. Boles healthcare providers, the FDA and
the healthcare community of clinically significant adverse events, specifically
melanoma, associated with use of Viagra and Cialis for erectile dysfunction.
101.
Despite the fact that Defendants knew or should have known that Viagra and
Cialis significantly increased the risk of melanoma, they continued and still continue to negligently
market through false and misleading promotion and communication, manufacture, distribute and/or
sell Viagra and Cialis to consumers including Plaintiff, Michael A. Boles.
102.
Defendants knew or should have known that consumers such as Plaintiff would
foreseeably suffer injury as a result of its failure to exercise ordinary care as set forth above.
103.
Defendants negligence was the proximate cause of Plaintiffs injuries, harm and
economic loss which Plaintiff suffered and/or will continue to suffer.

104.
Had Plaintiff, Michael A. Boles, not taken Viagra and Cialis, he would not have
suffered those injuries and damages as described herein with particularity.

105.
As a result of the foregoing acts and omissions, Michael A. Boles was caused to suffer
injuries from melanoma that are permanent and lasting in nature, physical pain and mental anguish
including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring
and/or medication.
106.
Plaintiff, Michael A. Boles, has also sustained severe emotional distress and suffering
as a result of Defendants wrongful conduct.
19
107.
As a result of the foregoing acts and omissions, Michael A. Boles has required and
will require future medical care for which he has incurred medical, health, incidental and related
expenses. Plaintiff, Michael A. Boles, believes and further alleges that he will in the future be
required to obtain further medical and/or hospital care, attention and services.
108.
By reason of the foregoing, Plaintiff has been damaged by Defendants wrongful
conduct. Defendants conduct was willful, wanton, reckless and, at the very least, arose to the level
of gross negligence so as to indicate a complete disregard of the rights and safety of Plaintiff and
others justifying an award of punitive damages.
WHEREFORE, Plaintiff respectfully requests that this Court enter judgment in his favor for
compensatory and punitive damages together with interest, costs herein, attorneys fees and all such
other and further relief as this Court deems just and proper. Plaintiff also demands that the issues
herein contained be tried by a jury.
SECOND CAUSE OF ACTION
NEGLIGENCE PER SE
109.
110.
Defendants had a duty to exercise reasonable care and comply with existing laws in
the testing, designing, researching, developing, manufacturing, packaging, promoting, labeling,

advertising, marketing, selling and/or distribution of Viagra and Cialis into the stream of
commerce including a duty to ensure that the products would not cause users to suffer unreasonable
and dangerous side effects.
20
111.
Defendants failed to exercise ordinary care and failed to comply with existing laws in
the testing, designing, researching, developing, manufacturing, packaging, promoting, labeling,

advertising, marketing, selling and/or distribution of Viagra and Cialis into interstate commerce
in that Defendants knew or should have known that using Viagra and Cialis created an
unreasonable risk of melanoma as well as other severe personal injuries which are permanent and
lasting in nature, physical pain and mental anguish, including diminished enjoyment of life as well as
the need for lifelong medical treatment, monitoring, medications and/or death.
112.
Defendants, their agents, servants and/or employees failed to exercise ordinary care
and violated 21 U.S.C. 331, 352; 42 U.S.C. 1320a-7b; and 21 C.F.R. 201.57, 201.128 in
particular.
113.
The laws violated by Defendants were designed to protect Plaintiff and similarly
situated persons against the risks and hazards that have occurred in this case. Therefore, Defendants
conduct constitutes negligence per se.
114.
Cialis significantly increased the risk of melanoma and/or the exacerbation of melanoma, they
continue to negligently market through false and misleading promotion and communication,
manufacture, distribute and/or sell Viagra and Cialis to consumers including Plaintiff, Michael A.
Boles.
115.
Defendants knew or should have known that consumers such as Plaintiff would
foreseeably suffer injury as a result of its failure to exercise ordinary care as set forth above.
116.
Defendants negligence was the proximate cause of Plaintiffs injuries, harm and
economic loss which Plaintiff suffered and/or will continue to suffer.
21
117.
Had Plaintiff, Michael A. Boles, not taken Viagra and Cialis, he would not have
suffered those injuries and damages as described herein.

118.
including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring
and/or medication.
119.
as a result of Defendants wrongful conduct and his injuries.

120.
121.
22
THIRD CAUSE OF ACTION

STRICT PRODUCTS LIABILITY
(Failure to Warn/Design Defect)
122.
123.
Defendants formulated, manufactured, marketed and sold Viagra and Cialis with
the intent that its users take the drugs as a means of treating erectile dysfunction.
124.
While designing and formulating Viagra and Cialis, Defendants discovered or
should have discovered that the drugs mechanism of action, the inhibition of PDE5, also presented a
significant risk of developing and/or exacerbating melanoma.
125.
As a member of the general public, Mr. Boles had no plausible means through which
he could have discovered the significant risk of melanomageneis associated with PDE5 inhibition.
126.
Defendants failed to communicate to Mr. Boles or his treating healthcare providers,
that the inhibition of PDE5 inherently necessary to the efficacy of Viagra and Cialis would also
present a significant risk of development or exacerbation of cancerous cells.
127.
If Defendants had communicated the risk of developing or exacerbating
melanomagenesis directly associated with Viagra and Cialis use to Mr. Boles treating healthcare
providers, they would not have prescribed Viagra and Cialis to Mr. Boles, severely limited the
dosage prescribed and/or closely monitored the length to which the Viagra and Cialis were
adversely affecting Mr. Boles health.
128.
Mr. Boles treating healthcare providers prescribed Viagra and Cialis to Mr. Boles
with the intent that he purchase and ingest the drugs to treat his erectile dysfunction.
23
129.
Mr. Boles treating healthcare providers prescribed Viagra and Cialis with the
belief and expectation that the drugs mechanism of action the inhibition of the PDE5 enzyme
would effectuate Mr. Boles treatment goals in a foreseeable manner, i.e. that he would no longer
suffer from the symptoms of erectile dysfuntion.
130.
Following the advice of his treating healthcare providers, Mr. Boles purchased and
ingested Viagra and Cialis with the expectation that the drug would safely treat his erectile
dysfunction.
131.
The Viagra and Cialis ingested by Mr. Boles failed to treat his erectile dysfunction
in a safe manner even though he used the drugs as they were intended to be used, as the drugs
inhibition of PDE5 encouraged the development of Mr. Boles melanoma.
132.
The risk presented by the use of Viagra and Cialis through PDE5 inhibition, a
characteristic inherent to the potential efficacy of the drugs, was far more significant than the benefit
provided to its users.
133.
Because the risk of using Viagra and Cialis so greatly outweighs the benefits of
such use, the drugs present an unreasonably dangerous risk when used in their intended condition.
134.
Viagra and Cialis were tested, designed, researched, developed, manufactured,
packaged, promoted, labeled, advertised, marketed, sold, distributed and/or placed into the stream of
commerce by Defendants and were defective at the time they left Defendants control in that, and not
by way of limitation, the drugs labeling failed to include adequate warnings, instructions and
directions relating to the dangerous risks associated with the use of Viagra and Cialis to treat
erectile dysfunction. Viagra and Cialis were also defective in its design because the foreseeable
24
risks of harm posed by the products could have been reduced or avoided by the adoption of a
reasonable alternative design. Safe and effective products were available for the purpose for which
Defendants marketed Viagra and Cialis for use in men with erectile dysfunction and neither the
safety nor the efficacy of Viagra and Cialis for that purpose had been established.
135.
Defendants failed to provide adequate warnings to healthcare providers and
consumers, including Plaintiff, Michael A. Boles, and his treating healthcare providers of the
increased risk and/or exacerbation of melanoma associated with Viagra and Cialis and
aggressively promoted the products to healthcare providers, hospitals and directly to consumers.
136.
Prescribing physicians, healthcare providers and men neither knew nor had reason to
know of the existence of the aforementioned melanoma at the time of prescribing and/or ingesting of
Viagra and Cialis. Healthcare providers and/or consumers would not have recognized the
potential risks or side effects for which Defendants failed to include appropriate warnings and which
they it masked through the unbalanced promotion of Viagra and Cialis specifically for treatment
in men with erectile dysfunction.
137.
At all times herein mentioned, due to Defendants marketing of Viagra and Cialis,
the drugs were prescribed and used as intended by Plaintiff, Michael A. Boles, and in a manner
reasonably foreseeable to Defendants.
138.
Defendants are liable to Plaintiff for the negligent and/or willful failure to provide
adequate warnings and other clinically relevant information and data regarding the appropriate use of
Viagra and Cialis to Plaintiff, Michael A. Boles, and his healthcare providers.
25
139.
Defendants, as manufacturers of pharmaceutical drugs, are held to the level of
knowledge of an expert in the field. Further, Defendants knew or should have known that the
warnings and other clinically relevant information and data which they distributed, omitting the risks
of developing and/or exacerbating melanoma, associated with the use of Viagra and Cialis were
inadequate.
140.
Defendants had a continuing duty to provide consumers including Plaintiff, Michael
A. Boles, and his healthcare providers with warnings and other clinically relevant information and
data regarding the risks and dangers associated with Viagra and Cialis as they became or could
have become available to Defendants.
141.
Cialis caused and/or exacerbated melanoma, they continued to manufacture, package, promote,
label, advertise, distribute and sell Viagra and Cialis without stating that there existed safer and
more equally effective alternative drug products and/or providing adequate clinically relevant
information, warnings and data.
142.
Defendants knew or should have known that consumers and Plaintiff specifically
would foreseeably and needlessly suffer injury as a result of their failures.

143.
Pfizer breached its duty to provide timely and adequate warnings, instructions and
information in the following particulars:

a.
failing to ensure Viagra and Cialis warnings to the healthcare community,

physicians, Michael A. Boles healthcare providers and Plaintiff were accurate
and adequate despite having extensive knowledge of the risks associated with
the use of Viagra and Cialis;
b.
failing in obligation to provide the healthcare community, physicians, Michael

A. Boles healthcare providers and Plaintiff with adequate clinically relevant
information, data and warnings regarding the adverse health risks associated
with exposure to Viagra and Cialis and/or that there existed safer and more
or equally effective alternative drug products;
26
c.
failing to conduct post-market safety surveillance and report that information

to the healthcare community, Michael A. Boles healthcare providers and
Plaintiff;
d.
failing to include adequate warnings and/or providing adequate and clinically

relevant information and data that would alert the healthcare community,
Michael A. Boles healthcare providers and Plaintiff to the dangerous risks of
Viagra and Cialis including among other things the increased risk of
melanoma;
e.
failing to continually monitor, test and analyze data regarding safety, efficacy
and prescribing practices of their marketed drugs including Viagra and
Cialis;
f.
failing to review all adverse drug event information (AER) and to report any
information bearing upon the adequacy and/or accuracy of their warnings,
efficacy or safety including the risks and/or prevalence of side effects caused
by Viagra and Cialis to the healthcare community, Michael A. Boles
healthcare providers and Plaintiff;
g.
failing to provide adequate post-marketing warnings and instructions after

Defendants knew or should have known of the significant risks of, among
other things, melanoma of Viagra and Cialis;
h.
failing to periodically review all medical literature regarding Viagra and

Cialis and failing to report data, regardless of the degree of significance,
regarding the adequacy and/or accuracy of their warnings, efficacy or safety of
Viagra and Cialis;
i.
failing to disclose the results of the testing and other information in

Defendants possession regarding Viagra and Cialis and the increased risk
of melanoma and/or exacerbation of melanoma; and
j.
failing to warn adequately the healthcare community, the general public and
Plaintiff of the dangers of using Viagra and Cialis for erectile dysfunction
including the risk of melanoma and/or representing that Viagra and Cialis
were safe for erectile dysfunction when in fact Defendants knew or should
have known that Viagra and Cialis were unsafe for this use and that
Viagra and Cialis increased the risk of melanoma and/or exacerbation of
melanoma.
27
144.
As a direct and proximate result of the defective nature of Viagra and Cialis,
Michael A. Boles was caused to suffer injuries from melanoma that are permanent and lasting in
nature, physical pain and mental anguish including diminished enjoyment of life, as well as the need
for lifelong medical treatment, monitoring and/or medication.
145.
as a result of Defendants wrongful conduct resulting in his injuries.

146.
147.
FOURTH CAUSE OF ACTION
BREACH OF IMPLIED WARRANTY
148.
28
149.
Plaintiff used Viagra and Cialis in substantially the same condition they were in
when they left the control of Defendants.

150.
Prior to the time that Plaintiff used Viagra and Cialis, Defendants implicitly
warrantied to Plaintiff and his physicians that Viagra and Cialis were of merchantable quality,
safe to use and fit for the use for which they were intended.
151.
Defendants implicitly warrantied the safety of Viagra and Cialis through a
multimedia advertising campaign conducted over a span of several years, as Viagra and Cialis
had been on the market for many years prior to the time when Plaintiff was first prescribed Viagra
and Cialis.
152.
Defendants implicitly warrantied the merchantable quality of Viagra and Cialis by
opting to mass-produce and promote the prescription and sale of Viagra and Cialis.
153.
Defendants implicitly warrantied that Viagra and Cialis were fit for the use for
which they were intended by offering assertions through multimedia advertisements that the drugs
were used for the treatment of erectile dysfunction.
154.
Plaintiff was and is unskilled in the research, design and manufacture of erectile
dysfunction medications and therefore reasonably relied entirely on the skill, judgment and implied
warranty of Defendants in deciding to use Viagra and Cialis.
155.
Plaintiffs physicians would not have had the same level of access to the research and
development conducted by Defendants prior to its decision to manufacture Viagra and Cialis for
general use.
29
156.
Viagra and Cialis were neither safe for their intended use nor of merchantable
quality, as had been implicitly warranted by Defendants, in that the mechanism of action for Viagra
and Cialis the inhibition of PDE5 inherently presented a significant increased risk of developing
and/or exacerbating melanoma.
157.
As a direct and proximate result of the falsity of the warranties implicated by
Defendants actions and omissions, Plaintiff suffered significant pain, suffering, invasive procedures
and economic damages incurred for the treatment of melanoma caused by use of Viagra and
Cialis.
158.
FIFTH CAUSE OF ACTION
BREACH OF EXPRESS WARRANTY
159.
160.
At all times relevant hereto, Defendants expressly represented and warranted to
Plaintiff and his healthcare providers, by and through statements made by Defendants or their
authorized agents or sales representatives, orally and in publications, package inserts and other
30
written materials intended for physicians, medical patients and the general public, that Viagra and
Cialis were safe, effective and proper for their intended use.
161.
These representations include, but are not limited to, the information disseminated in
Defendants patient information and prescribing information publications, Defendants websites and
on the FDAs website, since the drugs entered the market.
162.
The warranties expressly made by Defendants through their marketing and labeling
were false as Viagra and Cialis are unsafe.

163.
Specifically, Viagra and Cialis are unsafe in that their mechanism of action, the
inhibition of the PDE5 enzyme, also increases the risk of the development and proliferation of
melancyotic cells in the users body.
164.
Plaintiffs physicians acted as reasonable physicians in relying on what they believed
to be the superior knowledge, judgment and access to research information possessed by Defendants
in choosing to prescribe Viagra and Cialis to Plaintiff.
165.
Plaintiff acted as a reasonable consumer, relied on what he believed to be the superior
skill, judgment, representations and express warranties of Defendants in deciding to purchase and use
Viagra and Cialis.
166.
In direct reliance upon the warranties made by Defendants that Viagra and Cialis
were safe to use in treating erectile dysfunction, Plaintiffs physicians prescribed and Plaintiff
ingested Viagra and Cialis and ultimately developed melanoma as a result.
167.
As a direct and proximate result of the breach of warranty committed by Defendants,
Plaintiff suffered significant pain, suffering, invasive procedures and economic damages incurred for
the treatment of melanoma caused by the use of Viagra and Cialis.
31
168.
SIXTH CAUSE OF ACTION
FRAUDULENT MISREPRESENTATION
169.
170.
In the patient information distributed with Viagra and Cialis to their users,
Defendants failed to mention that the drugs mechanism of action also encouraged the development
and proliferation of cancerous cells in the users body.
171.
In the prescribing information distributed to physicians who had the ability to
prescribe Viagra and Cialis to patients, Defendants failed to mention that the drugs mechanism
of action also encouraged the development and proliferation of cancerous cells in the users body.
172.
In their vast, multimedia advertising campaigns conducted since the FDA approval of
the drugs, Defendants failed to mention that the drugs mechanism of action also encouraged the
development and proliferation of cancerous cells in the users body.
32
173.
Defendants falsely and fraudulently represented to men suffering with erectile
dysfunction and the healthcare community, including Plaintiff, Michael A. Boles healthcare
providers that:
a.
Viagra and Cialis were safe and effective for treating erectile dysfunction;
b.
Viagra and Cialis had been adequately tested and studied in men with
erectile dysfunction;
c.
Viagra and Cialis use were safe by omitting knowledge of an increased risk
of melanoma; and
d.
The drugsdesignation established the safety and efficacy of Viagra and

Cialis for treating erectile dysfunction.
174.
These representations made by Defendants were material, false and misleading.
175.
When Defendants made these representations, they knew they were false.
176.
Defendants made these representations with the intent of defrauding and deceiving the
public in general, and the healthcare community in particular, and were made with the intent of
inducing the public in general, and the healthcare community in particular, including Plaintiff,
Michael A. Boles healthcare providers, to recommend, prescribe, dispense and/or purchase Viagra
and Cialis to treat erectile dysfunction, all of which evidenced a callous, reckless willful, depraved
indifference to the health, safety and welfare of Plaintiff herein.
177.
At the time the aforesaid representations were made by Defendants and at the time
Plaintiff, Michael A. Boles, was prescribed and ingested Viagra and Cialis to treat erectile
dysfunction, he was unaware of the falsity of said representations and reasonably believed them to be
true.
178.
In reliance upon said representations, Michael A. Boles prescriber was induced to
prescribe Viagra and Cialis to Plaintiff and Plaintiff, Michael A. Boles, was induced to and did
ingest Viagra and Cialis to treat erectile dysfunction.
33
179.
Defendants knew that Viagra and Cialis had not been sufficiently tested for
erectile dysfunction and that it lacked adequate warnings.

180.
Defendants knew or should have known that Viagra and Cialis increase the risk of
melanoma and/or the exacerbation of melanoma.

181.
including diminished enjoyment of life, invasive procedures, as well as the need for lifelong medical
treatment, monitoring and/or medication.
182.
as a result of Defendants wrongful conduct and the injuries from melanoma.

183.
184.
34
SEVENTH CAUSE OF ACTION

FRAUDULENT CONCEALMENT
185.
186.
In representations to Plaintiff, Michael A. Boles healthcare providers, men with
erectile dysfunction (including Plaintiff, Michael A. Boles) and the FDA, Defendants fraudulently
concealed and intentionally omitted the following material facts:
a. Defendants were illegally paying and offering to pay doctors remuneration to
promote and prescribe Viagra and Cialis;
b. Viagra and Cialis use increases the risk of developing melanoma and/or
exacerbates melanoma;
c. the risks of melanoma associated with the consumption of Viagra and Cialis by
men with erectile dysfunction were not adequately tested prior to Defendants
marketing of Viagra and Cialis;
d. the safety and efficacy of Viagra and Cialis for treating erectile dysfunction
had not been established;
e. Viagra and Cialis are not safe and effective for treating erectile dysfunction;
and
f. Defendants internal data and information associated Viagra and Cialis with
melanoma.
187.
Defendants concealment and omissions of material facts concerning, among other
things, the safety and efficacy of Viagra and Cialis for erectile dysfunction were made
purposefully, willfully, wantonly and/or recklessly to mislead physicians, hospital, healthcare
providers and men with erectile dysfunction including Plaintiff, Michael A. Boles, into reliance,
continued use of Viagra and Cialis and to cause them to promote, purchase, prescribe and/or
dispense Viagra and Cialis.
35
188.
Defendants knew that physicians, hospitals, healthcare providers and men with
erectile dysfunction such as Plaintiff, Michael A. Boles, had no way to determine the truth behind
Defendants concealment and material omissions of facts surrounding Viagra and Cialis as set
forth herein.
189.
Plaintiff, Michael A. Boles, and his healthcare providers reasonably relied on
Defendants promotional statements concerning the asserted safety and efficacy of Viagra and
Cialis for men with erectile dysfunction from which Defendants negligently, fraudulently and/or
purposefully omitted material facts.
190.
191.
as a result of Defendants wrongful conduct and the injuries from melanoma.

192.
193.
36
EIGHTH CAUSE OF ACTION
NEGLIGENT MISREPRESENTATION
194.
195.
Defendants falsely and negligently represented to the healthcare community and men
with erectile dysfunction, including Plaintiff, Michael A. Boles, and his healthcare providers that:
a.
Viagra and Cialis were safe and effective for treating erectile dysfunction;
b.
Viagra and Cialis had been adequately tested and studied in men with
erectile dysfunction;
c.
Viagra and Cialis use pursuant to Defendants labeling was safe; and
d.
The drugs designation established the safety and efficacy of Viagra and
Cialis for treating erectile dysfunction.
196.
These representations made by Defendants were, in fact, false and misleading.
197.
198.
as a result of Defendants wrongful conduct and his injuries.
37
199.
200.
WHEREFORE, Plaintiff respectfully request that this Court enter judgment in his favor for
NINTH CAUSE OF ACTION
VIOLATION OF TENNESSEE CONSUMER PROTECTION ACT OF 1977
201.
202.
Defendants knowingly, willfully and intentionally engaged in unlawful, unfair,
unconscionable, deceptive and fraudulent acts and practices injurious to the public interest, in
violation of Tenn. Code Ann. 47-18-101, et seq., for the purpose of influencing and inducing
physicians and healthcare providers to prescribe Viagra and Cialis to patients/consumers such as
38
Plaintiff, taking advantage of the lack of knowledge, ability, experience or capacity of such
patients/consumers to a grossly unfair degree and causing such patients and consumers to purchase,
acquire and ingest Viagra and Cialis for the treatment of erectile dysfunction as prescribed by
their healthcare providers.
203.
By reason of the Defendants unlawful, unfair, unconscionable, deceptive and
fraudulent acts and practices, reasonable patients/consumers acting reasonably such as Plaintiff in
ingesting Viagra and Cialis. After ingesting Viagra and Cialis, Mr. Boles was subsequently
diagnosed with melanoma on January 15, 2015, underwent an excision on January 29, 2015 and must
now be vigilant in monitoring his skin for lesions and go for routine and regular check-ups in addition
to regular self-body exams.
204.
By reason of the facts and premises aforesaid, Plaintiff sustained actual damages in a
sum which exceeds the jurisdictional limits of all lower courts which would have jurisdiction over
this matter and Plaintiff seeks treble the amount fixed by the verdict, together with reasonable
attorneys fees and costs.
WHEREFORE, Plaintiff respectfully request that this Court enter judgment in his favor for
DEMAND FOR JURY TRIAL
Plaintiff demands a trial by jury pursuant to Rule 38 of the Federal Rules of Civil Procedure
and the Seventh Amendment of the United States Constitution.
39
PRAYER FOR RELIEF

WHEREFORE, Plaintiff demands judgment against Defendants on each of the abovereferenced claims and causes of action and as follows:
a.
b.
c.
d.
e.
f.
g.
h.
i.
For general damages in a sum in excess of the jurisdictional minimum of this

Court;
For medical, incidental and hospital expenses according to proof;
For pre-judgment and post-judgment interest as provided by law;
For full refund of all purchase costs of Viagra and Cialis;
For consequential damages in excess of the jurisdictional minimum of this
Court;
For compensatory damages in excess of the jurisdictional minimum of this
Court;
For punitive damages in an amount in excess of any jurisdictional minimum of
this Court in an amount sufficient to deter similar conduct in the future and
punish the Defendant for the conduct described herein;
For attorneys fees and costs of this action; and
For equitable relief and such other and further relief as this Court deems
necessary, just and proper.
Dated: June 1, 2016
Respectfully Submitted,
/s/ Edwin E. Wallis III
Edwin E. Wallis III (TN #23950)
Glassman, Wyatt, Tuttle & Cox, P.C.
26 N. Second Street
Memphis, TN 38103
(901) 527-4673 (Phone)
(901) 521-0940 (Facsimile)
Email: ewallis@gwtclaw.com
*Motions for Pro Hac Vice to be filed
/s/ Kimberly D. Barone Baden

Kimberly D. Barone Baden (CA SBN 207731)*
Ann E. Rice Ervin*
Motley Rice LLP
28 Bridgeside Boulevard
Mount Pleasant, SC 29464
(843) 216-9265 (Phone)
(843) 216-9450 (Facsimile)
Email: kbarone@motleyrice.com
Email: ariceervin@motleyrice.com
Attorneys for Plaintiff
40

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UNITED STATES DISTRICT COURT

MIDDLE DISTRICT OF TENNESSEE

) Case No.: __________________________

Case 3:16-cv-01100 Document 1 Filed 06/01/16 Page 1 of 40 PageID #: 1

Plaintiff, Michael A. Boles, resides in the County of Wilson, State of Tennessee.

agents, developed, designed, manufactured, assembled, tested, inspected, marketed, promoted,

Pfizer conducts substantial business within Delaware, New York, California,

Case 3:16-cv-01100 Document 1 Filed 06/01/16 Page 2 of 40 PageID #: 2

Plaintiff is a citizen of the State of Tennessee.

Pfizer maintains its principal place of business in New York.

Eli Lilly maintains its principal place of business in Indiana.

Case 3:16-cv-01100 Document 1 Filed 06/01/16 Page 3 of 40 PageID #: 3

in Tennessee and sustained injuries in Tennessee.

Venue is proper in this Judicial District pursuant to 28 U.S.C. 1391 because a

Case 3:16-cv-01100 Document 1 Filed 06/01/16 Page 4 of 40 PageID #: 4

application (NDA) for the manufacture and sale of sildenafil citrate.

men with erectile dysfunction.

Sildenafil citrate (Sildenafil) is the active ingredient in Viagra.

Viagra treats erectile dysfunction by inhibiting the secretion of phosphodiesterase

thirty million men in the United States.1

NIH Consensus Development Panel on Impotence (July 7, 1993).

Case 3:16-cv-01100 Document 1 Filed 06/01/16 Page 5 of 40 PageID #: 5

Prevalence of Viagra in the Market

In 2012 alone, physicians wrote approximately eight million prescriptions for

Tadalafil is the active ingredient in Cialis.

Case 3:16-cv-01100 Document 1 Filed 06/01/16 Page 6 of 40 PageID #: 6

Cialis treats erectile dysfunction by inhibiting the secretion of phosphodiesterase

expensive multimedia advertising campaign to market Cialis to men worldwide as a symbol of

dysfunction drugs accounting for over $1,926,000,000 in revenue.

worldwide sales of Cialis, a 12% increase in sales from 2012 to 2013.

Case 3:16-cv-01100 Document 1 Filed 06/01/16 Page 7 of 40 PageID #: 7

Case 3:16-cv-01100 Document 1 Filed 06/01/16 Page 8 of 40 PageID #: 8

Case 3:16-cv-01100 Document 1 Filed 06/01/16 Page 9 of 40 PageID #: 9

Defendants purposefully downplayed, understated and outright ignored the melanoma-

Defendants concealed material information related to melanoma development from

potential Viagra and Cialis users.

Pfizer has engaged in increasingly aggressive marketing techniques and strategies to

Case 3:16-cv-01100 Document 1 Filed 06/01/16 Page 10 of 40 PageID #: 10

As another example, none of the commercials or print advertisements promoting the

While designing and formulating Viagra and Cialis, Defendants discovered or

discovered the significant risk of melanomagenesis associated with PDE5 inhibition.

Case 3:16-cv-01100 Document 1 Filed 06/01/16 Page 11 of 40 PageID #: 11

dysfunction to ingest Viagra and/or Cialis as a means to treat their condition.

Defendants expected or should have expected physicians treating erectile dysfunction

to prescribe Viagra and/or Cialis as a means to treat this condition.

population; namely, men diagnosed with erectile dysfunction.

body of a user, thereby placing them at a significant health risk.

Defendants manufactured, marketed and sold Viagra and Cialis as a PDE5

Case 3:16-cv-01100 Document 1 Filed 06/01/16 Page 12 of 40 PageID #: 12

Plaintiff, Michael A. Boles, began pharmaceutical treatment for erectile dysfunction in

or about July 2009, when his physician prescribed Viagra.

Plaintiff continuously filled and regularly ingested Viagra until approximately

March 19, 2013.

Mr. Boles, began a different pharmaceutical treatment for erectile dysfunction in or

about March 2013, when his physician prescribed Cialis.

Plaintiff continuously filled and regularly ingested Cialis until approximately

September 15, 2015.

Case 3:16-cv-01100 Document 1 Filed 06/01/16 Page 13 of 40 PageID #: 13

As a direct, proximate and legal result of Defendants negligence and wrongful

At all times relevant to this lawsuit, Defendants engaged in the business of

researching, licensing, designing, formulating, compounding, testing, manufacturing, producing,

Case 3:16-cv-01100 Document 1 Filed 06/01/16 Page 14 of 40 PageID #: 14

At all times mentioned in this Complaint, Defendants officers and directors

Defendants purposefully downplayed, understated and outright ignored the melanoma-