Montoya et al v. SmithKline Beecham Corp et al

Filing 1

COMPLAINT against Glaxosmithkline, LLC, SmithKline Beecham Corp. Filing fee $ 350.00 receipt number 113C-3769323, filed by Jorge montoya. (Attachments: # 1 Civil Cover Sheet, # 2 Summon(s), # 3 Summon(s))(Fousek, Keith)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF FLORIDA
Jorge Montoya and Maria Ferrer, as the Personal
Representatives of the Estate of
Fabiola Montoya,

Plaintiffs,
DEMAND FOR JURY TRIAL
SMITHKLINE BEECHAM
CORPORATION, d/b/a GLAXOSMITHKLINE,
a Pennsylvania corporation; GLAXOSMITHKLINE, LLC,
Delaware Limited Liability Company,
Defendants.
_______________________________________/
COMPLAINT
Now come the Plaintiffs, Jorge Montoya and Maria Ferrer, as the Personal
Representatives of the Estate of Fabiola Montoya, and complaining against the defendant
SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE ("GSK"), a
Pennsylvania Corporation; GLAXOSMITHKLINE, LLC, Delaware Limited Liability
Company, state:
JURISDICTION AND VENUE
1.

Jurisdiction is based on diversity of citizenship under 28 U.S.C. § 1332. The matter in

controversy exceeds the sum of seventy five thousand ($75,000.00) dollars, exclusive of interest
and costs.
2.

This court has supplemental jurisdiction under 28 U.S.C. § 1367 with respect to claims

that form part of the same case or controversy.
3.

Venue is based on 28 U.S.C. § 1391(a)(2) because Defendant SmithKline.

Page 1 of 24

Beecham Corporation d/b/a GlaxoSmithKline ("GSK") is a Pennsylvania corporation whose
residency is in the Eastern District of Pennsylvania, but does regular business in the Southern
District of Florida and a substantial part of the events or omissions on which the claims are based
occurred in the Southern District of Florida.
PARTIES
Plaintiffs, readopt and reaver all the allegations contained in Paragraphs 1-3
above, and further alleges as follows:
4.

At all times mentioned herein at the time of the Decedent’s death, Luis Avelino Montoya

was the dependant son of the decedent and both the decedent and Luis Avelino Montoya, were
citizens of the State of Florida, Living in Miami-Dade County. Luis Avelino Montoya survives
Fabiola Montoya. Plaintiffs, Jorge Montoya and Maria Ferrer are the Personal Representatives of
the Estate of Fabiola Montoya and have been duly appointed as the personal representatives of
the Estate of Fabiola Montoya.
5.

Luis Avelino Montoya, was at all times mentioned herein, the minor or dependent child

of Fabiola Montoya in accordance with Florida Statute §768.18(2) and citizens of the State of
Florida and the aforementioned survived Fabiola Montoya in accordance with the Florida
Wrongful Death Statute.
6.

SmithKline Beecham Corporation d/b/a Glaxo SmithKline, a Pennsylvania corporation

was, and still is, a corporation duly existing under and by virtue of the laws of the State of
Pennsylvania with its principal place of business in Philadelphia, Pennsylvania.
7.

At all times relevant, defendant SmithKline Beecham Corporation d/b/a

GlaxoSmithKline was, and still is, a pharmaceutical company involved in researching,
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manufacturing, selling, merchandising, advertising, promoting, labeling, analyzing, testing,
distributing and marketing of pharmaceuticals for distribution, sale, and use by the general
public, including its antidiabetic agent rosiglitazone maleate under the trade names of Avandia
Tablets, Avandamet Tablets, and Avandaryl Tablets and sold said tablets in the State of Florida,
including to the Plaintiff.
8.

At all times relevant, defendant, GLAXOSMITHKLINE, LLC, Delaware Limited

Liability Company was, and still is, a pharmaceutical company involved in researching,
manufacturing, selling, merchandising, advertising, promoting, labeling, analyzing, testing,
distributing and marketing of pharmaceuticals for distribution, sale, and use by the general
public, including its antidiabetic agent rosiglitazone maleate under the trade names of Avandia
Tablets, Avandamet Tablets, and Avandaryl Tablets and sold said tablets in the State of Florida,
including to the Plaintiff.
9.

GLAXOSMITHKLINE, LLC, a Delaware Limited Liability Company authorized to do

business in the State of Florida, was, and still is, a public limited company existing under and by
virtue of the laws of the State of Delaware with its principal place of business in Philadelphia,
Pennsylvania and sold said tablets in the State of Florida, including to the Plaintiff.
10.

SmithKline Beecham Corporation d/b/a Glaxo SmithKline, a Pennsylvania corporation,

GLAXOSMITHKLINE, LLC, a Delaware Limited Liability Company are hereinafter shall be
collectively referred to as "GSK Defendants."
GENERAL ALLEGATIONS
Plaintiffs, readopt and reaver all the allegations contained in Paragraphs 1-10
above, and further alleges as follows:
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11.

Rosiglitazone maleate ("rosiglitazone") is researched, manufactured, sold, merchandised,

advertised, promoted, labeled, analyzed, tested, distributed and marketed by the GSK Defendants
under the trade names of Avandia Tablets, Avandamet Tablets, and Avandaryl Tablets
(hereinafter collectively referred to as "Avandia"), and is a member of the class of drugs known
as Thiazolidinediones ("TZDs"). Avandia was first approved for use in the United States by the
Food and Drug Administration ("FDA") in 1999 for the use in treatment of type 2 diabetes
mellitus, also known as non-insulin-dependent diabetes mellitus.
12.

Most people with diabetes have risk factors such as high blood pressure and cholesterol

that provide a pre-existing susceptibility for heart disease and stroke. More than 65 percent of
deaths in patients with diabetes are from cardiovascular causes. The effect of any antidiabetic
therapy is particularly important because the reason for antidiabetic therapy is to reduce the
complications of diabetes, the most serious of which is heart disease.
13.

During the past decade, drugs have been introduced for the treatment of type 2 diabetes

that, used in monotherapy or in combination therapy, are supposed to better control the disease in
patients and reduce health complications associated with diabetes, such as heart attacks, strokes,
and other cardiovascular complications.
14.

Before and on or about the time when Avandia was prescribed and used by Fabiola

Montoya, the GSK Defendants knew, or should have known, that Avandia was associated with a
significant increased risk of heart failure, myocardial ischemia and ischemic events such as
cardiovascular mortality, myocardial infarction, and stroke.
15.

The risk of heart failure, also referred to as congestive heart failure, in patients taking

Avandia led to labeling revisions as marketing experience and the results of further clinical trials
were reviewed by the Food and Drug Administration.
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16.

On August 14, 2007, the warnings, precautions, and contraindications sections of the

Avandia label were changed again regarding the potential increased risk of heart failure, and the
following new black box warning was added to the label:
WARNING: CONGESTIVE HEART FAILURE
Thiazolidinediones, including rosiglitazone, cause or exacerbate
congestive heart failure in some patients (see WARNINGS). After
initiation of AVANDIA, and after dose increases, observe patient
carefully for signs and symptoms of heart failure (including excessive,
rapid weight gain, dyspnea, and/or edema). If these signs and symptoms
develop, the heart failure should I be managed according to current
standards of care. Furthermore, discontinuation or dose reduction of
AVANDIA must be considered.
AVANDIA is not recommended in patients with symptomatic heart
failure. Initiation of AVANDIA in patients with established NYHA Class
III or IV heart failure is contraindicated. (See CONTRAINDICATIONS
and WARNINGS.)
17.

On November 19, 2007, the warnings, precautions, and indications sections of the

Avandia label were changed again regarding the potential increased risk of myocardial ischemia,
and the following language was added to the black box warning:
WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL ISCHEMIA
A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237
total patients), most of which compared AVANDIA to placebo, showed
AVANDIA to be associated with an increased risk of myocardial
ischemic events such as angina or myocardial infarction. Three other
studies (mean duration 41 months; 14,067 patients), comparing
AVANDIA to some other approved antidiabetic agents or placebo, have
not confirmed or excluded this risk. In their entirely, the available data
on the risk of myocardial ischemia are inconclusive.

18.

Before the label changes on August 14, 2007 and November 19, 2007, Fabiola Montoya

ingested Avandia and or Avandamet in or near Miami-Dade County, Florida.

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19.

As a direct, proximate, and legal cause of ingesting Avandia, Fabiola Montoya began

having problems breathing in or about October-November 2007 and suffered from myocardial
ischemia, heart attack and lethal cardiac arrhythmia including a myocardial ischemic event that
resulted in hospitalization and death on or about December 26, 2010.
20.

Before and at or about the time of Mrs. Montoya's ingestion of Avandia, the GSK

Defendants had the knowledge, the means, and the duty to provide the medical community and
the consuming public with more accurate descriptive information and more adequate warnings
regarding the association between Avandia and heart failure, and the association between
Avandia and myocardial ischemia and isehemic events such as cardiovascular mortality,
myocardial infarction, and stroke, through all means necessary, including, but not limited to,
labeling, continuing education, symposia, posters, sales calls to doctors, advertisements, and
promotional materials.
21.

At all times relevant, the GSK Defendants failed and refused to warn prescribing medical

providers, and the consuming public, of the risks associated with Avandia that were known, or
should have been known, as alleged herein.
22.

At all times relevant, the GSK Defendants engaged in extensive mass media

direct-toconsumer promotion, education, and advertising of Avandia for the purpose of
increasing sales and stimulating consumer requests for Avandia prescriptions, independent of the
advice of medical professionals.
23.

At all times relevant, defendants, and each of them, and their aggregates, corporates,

associates, and partners, and each of them, were the agent, servant, employee, assignee,

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permissive user, successor in interest, or joint venturer of each other, and were acting within the
time, purpose, or scope of such agency or employment or permission; and all acts or omissions
alleged herein of each such defendant were authorized, adopted, approved, or ratified by each of
the other defendants.
COUNT I
(Negligence)
Plaintiffs, readopt and reaver all the allegations contained in Paragraphs 1-23
above, and further alleges as follows:
24.

At all times relevant, the GSK Defendants were under a duty to exercise reasonable care

in the researching, manufacturing, selling, merchandising, advertising, promoting, labeling,
analyzing, testing, distributing and marketing of Avandia for distribution, sale, and use by the
general public, to ensure that Avandia's use did not result in avoidable injuries.
25.

Plaintiffs' injuries as described herein were caused by the negligence and

misrepresentations of the GSK Defendants though its agents, servants and/or employees acting
within the course and scope of their employment including among other things:
(a)

Carelessly and negligently researching, manufacturing, selling, merchandising,

advertising, promoting, labeling, analyzing, testing, distributing and marketing Avandia;
(b)

Failing to fully disclose the results of the testing and other information in its

possession regarding the association between Avandia and heart failure, and the association
between Avandia and myocardial ischemia and ischemic events such as cardiovascular mortality,
myocardial infarction, and stroke.

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(c)

Negligently and carelessly failing to adequately warn the medical community and

the general public, including Mrs. Montoya and his treating and prescribing medical provider(s),
of the dangers of using Avandia;
(d)

Negligently and carelessly describing and promoting Avandia as safe and

effective;
(e)

Negligently and carelessly failing to act as a reasonably prudent drug

manufacturer;
(f)

Negligently and carelessly over-promoting and promoting Avandia in a

zealous and unreasonable way, without regard to its potential dangers;
26.

As a direct and proximate cause of the conduct, acts, and omissions of the GSK

Defendants, Mrs.Montoya suffered injury to her health, strength, and activity and severe and
lasting physical and mental pain and suffering, and eventually death, all to her general damages
in an amount in excess of the minimum jurisdictional amount of this court.
27.

As a direct and proximate cause of the conduct, acts, and omissions of the GSK

Defendants, Mrs. Montoya incurred, hospital, medical, and related expenses, funeral expenses,
the reasonable and total value of which to be proven at the time of trial.
WHEREFORE, Plaintiffs pray for judgment against defendants as follows:
a.

For general damages according to proof;

b.

For special damages according to proof;

c.

For punitive and exemplary damages according to proof;

d.

For pre-judgment and post-judgment interest as allowed by law;

e.

For costs of suit incurred herein;
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f.

Funeral expenses; and

g.

For such other and further relief as this court may deem just and proper.
COUNT II
(Negligent Pharmaco-Vigilance)
Plaintiffs, readopt and reaver all the allegations contained in Paragraphs 1-23 above,

and further alleges as follows:
28.

The GSK Defendants have an ongoing duty of pharmaco-vigilance. This duty requires,

among other things, the GSK Defendants to continually monitor, test, and analyze data regarding the
safety, efficacy, and prescribing practices of its marketed drugs, including Avandia.
29.

The GSK Defendants continually receive reports from clinical trials, physicians, patients, and

regulatory authorities of adverse events that occur in patients taking Avandia. Furthermore, the GSK
Defendants continue to conduct clinical trials for its drugs after their drug is approved for use.
30.

The GSK Defendants had the means and the resources to perform its pharmaco-

vigilance duties for the entire time Avandia has been on the market in the United States.
31.

The GSK Defendants have a duty to monitor epidemiological and pharmaco-vigilance data

regarding their drugs and promptly report to the FDA, medical professionals, and the public, any
safety concerns that arise through epidemiologic study or data.
32.

The GSK Defendants breached this duty with respect to Fabiola Montoya, her treating and

prescribing medical providers, and plaintiffs. The GSK Defendants learned, or should have learned,
through various sources, including but not limited to, clinical trials and other adverse event reports,
that there was a substantial risk of heart failure, myocardial ischemia and ischemic events such as
cardiovascular mortality, myocardial infarction, and stroke associated with the use of Avandia and

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failed to inform doctors, regulatory agencies, and ordinary consumers, including Fabiola Montoya
of this risk.
33.

As a direct and proximate cause of the conduct, acts, and omissions of the GSK Defendants,

Mrs. Montoya suffered injury to her health, strength, and activity and severe and lasting physical and
mental pain and suffering, and eventually death, all to her general damages in an amount in excess
of the minimum jurisdictional amount of this court.
34.

As a direct and proximate cause of the conduct, acts, and omissions of the GSK Defendants,

Mrs. Montoya incurred, hospital, medical, and related expenses, funeral expenses, the reasonable
and total value of which to be proven at the time of trial.
WHEREFORE, Plaintiffs pray for judgment against defendants as follows:
a.

For general damages according to proof;

b.

For special damages according to proof;

c.

For punitive and exemplary damages according to proof;

d.

For pre-judgment and post-judgment interest as allowed by law;

e.

For costs of suit incurred herein;

f.

Funeral expenses; and

g.

For such other and further relief as this court may deem just and proper.
COUNT III
(Strict Liability—Failure to Warn)
Plaintiffs, readopt and reaver all the allegations contained in Paragraphs 1-23 above,

and further alleges as follows:
35.

Plaintiffs incorporate by reference each and every prior and subsequent allegation of this

complaint as if fully restated here.
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36.

The GSK Defendants' extensive direct-to-consumer promotion and advertising of Avandia

created the duty to warn ordinary consumers, including Fabiola Montoya, of the risks associated with
Avandia alleged herein, in addition to the duty the GSK Defendants owed to medical professionals.
37.

At all times relevant, ordinary consumers and prescribing medical providers would not have

recognized the potential increased risk of heart failure, myocardial ischemia and ischemic events
such as cardiovascular mortality, myocardial infarction, and stroke associated with ingestion of
Avandia in the absence of adequate warnings thereof by the GSK Defendants.
38.

At all times relevant, the GSK Defendants failed to adequately warn ordinary consumers and

medical providers, including Fabiola Montoya and his treating and prescribing medical providers,
of the potential increased risk of heart failure, myocardial ischemia and ischemic events such as
cardiovascular mortality, myocardial infarction, and stroke associated with ingestion of Avandia.
39.

As a direct and proximate cause of the conduct, acts, and omissions of the GSK Defendants,

Mrs. Montoya suffered injury to her health, strength, and activity and severe and lasting physical and
mental pain and suffering, and eventually death, all to her general damages in an amount in excess
of the minimum jurisdictional amount of this court.
40.

As a direct and proximate cause of the conduct, acts, and omissions of the GSK Defendants,

Mrs. Montoya incurred, hospital, medical, and related expenses, funeral expenses, the reasonable
and total value of which to be proven at the time of trial.
WHEREFORE, Plaintiffs pray for judgment against defendants as follows:
a.

For general damages according to proof;

b.

For special damages according to proof;

c.

For punitive and exemplary damages according to proof;

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d.

For pre-judgment and post-judgment interest as allowed by law;

e.

For costs of suit incurred herein;

f.

Funeral expenses; and

g.

For such other and further relief as this court may deem just and proper.
COUNT IV
(Breach of Express Warranty)
Plaintiffs, readopt and reaver all the allegations contained in Paragraphs 1-28 above,

and further alleges as follows:
41.

The GSK Defendants' extensive direct-to-consumer advertising of Avandia created the duty

to notify ordinary consumers, including Fabiola Montoya, that Avandia was not as represented, in
addition to the duty the GSK Defendants owed medical professionals.
42.

At all times relevant, the GSK Defendants, by directly and indirectly advertising, marketing,

and promoting Avandia for the treatment of type 2 diabetes and by placing this drug in the stream
of commerce knowing that Avandia would be prescribed to patients with type 2 diabetes in reliance
upon the representations of the GSK Defendants, expressly warranted to all foreseeable users of the
drug, including Mrs. Montoya, that Avandia was safe and effective for the treatment of patients with
type 2 diabetes without a significantly increased risk of heart failure, myocardial ischemia and
ischemic events such as cardiovascular mortality, myocardial infarction, and stroke and without a
significantly increased risk of heart failure.
43.

Mrs. Montoya and her treating and prescribing medical providers reasonably relied upon the

aforesaid express warranties by the GSK Defendants.

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44.

The GSK Defendants breached the aforesaid express warranties because Avandia was not

safe for the treatment of patients with type 2 diabetes.
45.

As a direct and proximate cause of the conduct, acts, and omissions of the GSK Defendants,

Mrs. Montoya suffered injury to her health, strength, and activity and severe and lasting physical and
mental pain and suffering, and eventually death, all to her general damages in an amount in excess
of the minimum jurisdictional amount of this court.
46.

As a direct and proximate cause of the conduct, acts, and omissions of the GSK Defendants,

Mrs. Montoya incurred, hospital, medical, and related expenses, funeral expenses, the reasonable
and total value of which to be proven at the time of trial.
WHEREFORE, Plaintiffs pray for judgment against defendants as follows:
a.

For general damages according to proof;

b.

For special damages according to proof;

c.

For punitive and exemplary damages according to proof;

d.

For pre-judgment and post-judgment interest as allowed by law;

e.

For costs of suit incurred herein;

f.

Funeral expenses; and

g.

For such other and further relief as this court may deem just and proper.

COUNT V
(Breach of Implied Warranty)
Plaintiffs, readopt and reaver all the allegations contained in Paragraphs 1-23 above,
and further alleges as follows:

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47.

The GSK Defendants' extensive direct-to-consumer advertising of Avandia created the duty

to notify ordinary consumers, including Fabiola Montoya, that Avandia was not was safe and
effective for the purposes for which it had been placed in the stream of commerce, in addition to the
duty the GSK Defendants owed medical professionals.
48.

The GSK Defendants impliedly warranted to all foreseeable users, including Mrs. Montoya

her his prescribing medical provider(s), that Avandia was safe and effective for the purposes for
which it had been placed in the stream of commerce by the GSK Defendants, and that Avandia was
reasonably safe, proper, merchantable and fit for the intended purpose.
49.

Mrs. Montoya and her prescribing medical providers reasonably relied upon the aforesaid

implied warranties by the GSK Defendants.
50.

The GSK Defendants breached the aforesaid implied warranties in that Avandia was not safe

for the treatment of patients with type 2 diabetes, among other things.
WHEREFORE, Plaintiffs pray for judgment against defendants as follows:
a.

For general damages according to proof;

b.

For special damages according to proof;

c.

For punitive and exemplary damages according to proof;

d.

For pre-judgment and post-judgment interest as allowed by law;

e.

For costs of suit incurred herein;

f.

Funeral expenses; and

g.

For such other and further relief as this court may deem just and proper.

Page 14 of 24

COUNT VI
(Fraud)
Plaintiffs, readopt and reaver all the allegations contained in Paragraphs 1-23 above,
and further alleges as follows:
51.

In deciding whether to prescribe a drug, prescribing medical providers engage in a

risk/benefit assessment in determining which drug to prescribe. Prescribing medical providers, such
as Mrs. Montoya's prescribing medical provider(s), relied, and continue to rely, on the information
received about Avandia from various sources, such as journal articles, journal advertisements,
company literature, the Physicians' Desk Reference, labels, package inserts, and discussions with the
GSK Defendants' sales people. Such information must be accurate and provide an unbiased picture
of a drug's safety and efficacy in treating a condition. If the information is false or misleading,
prescribing medical providers, such as Mrs. Montoya's prescribing medical provider(s), cannot
accurately assess the crucial risk/benefit balance for the patient or exercise proper professional
judgment that is independent. Consequently, the prescribing medical provider, including Mrs.
Montoya's treating and prescribing medical provider(s), could not, and cannot, act in accordance with
the professional and fiduciary obligations owed to the patient, nor can patients, such as Fabiola
Montoya, give informed consent to the treatment.
52.

In caring for themselves, and as part of diabetes management, type 2 diabetes patients had,

and have, the option to refrain from using certain prescription drugs or to request alternative
treatments in order to minimize health risks. In deciding whether to refrain from using Avandia, or
to request alternatives, ordinary consumers relied, and continue to rely, on information received
about Avandia from various sources, such as direct-to-consumer and other advertisements, company
literature, and package inserts. Such information must be accurate and provide an unbiased picture

Page 15 of 24

of a drug's safety and efficacy in treating a condition. If the information is false or misleading,
ordinary consumers, such as Mrs. Montoya, could not, and cannot, accurately assess their options
to refrain from using Avandia or to request alternatives.
53.

Concealing adverse information and providing inaccurate or biased information that is

material to a decision misleads the prescribing medical providers and misleads the patient, as was
the case with Mrs. Montoya and her treating and prescribing medical provider(s). This misleading
information, along with omissions of material facts related to Avandia' s safety, cause health care
providers, ordinary consumers, and the general public to be misled about Avandia' s risks and
benefits and deprive prescribing medical providers from making a proper risk/benefit assessment as
to the use of Avandia and deprive ordinary consumers from properly weighing their options.
54.

The GSK Defendants' advertising program, by affirmative misrepresentations and omissions,

falsely and deceptively sought to create the image and impression that Avandia was safe for human
use; had no unacceptable side effects; had fewer side effects than other antidiabetic agents; and
would not interfere with daily life.
55.

The GSK Defendants purposefully concealed, failed to disclose, misstated, downplayed and

understated the health hazards and risks associated with the use of Avandia. The GSK Defendants,
through promotional literature, deceived potential users and prescribers of said drug by relying on
only allegedly positive information, including testimonials from allegedly satisfied users and
celebrity spokespersons, and manipulating statistics to suggest widespread acceptability, while
concealing, misstating and downplaying the known adverse and serious health effects. The GSK
Defendants falsely and deceptively kept relevant information from potential Avandia users and
minimized prescriber concerns regarding the safety and efficacy of Avandia and over-promoted the
drug.
Page 16 of 24

56.

In particular, the GSK Defendant engaged in the following actions, although not limited to

the following actions, that constitute false and deceptive misrepresentations or omissions regarding
Avandia:
(a)

The GSK Defendants marketed and continue to market Avandia to ordinary

consumers and medical professionals as a safer and more effective antidiabetic agent than other
antidiabetic agents on the market;
(b)

The GSK Defendants attempted to silence Dr. John B. Buse, a diabetes expert and

head of endocrinology at the University of North Carolina, Chapel Hill, by threatening him with
a $4 million lawsuit and by characterizing him as a liar after he raised concerns about Avandia and
heart problems in 1999;
(c)

The GSK Defendants failed to warn consumers and the medical community about the

increased risk of heart problems associated with Avandia, and continue to do so, despite having
knowledge of these health risks;
(d)

The GSK Defendants promoted Avandia in violation of the Federal Food, Drug, and

Cosmetic Act, which was the subject of a July 17, 2001, FDA Warning Letter;
(e)

The GSK Defendants' sales representatives engaged in false or misleading promotional

activities with respect to the risk information in Avandia' s label;
57.

When said representations and/or omissions were made by the GSK Defendants, it knew those

representations and/or omissions to be false or misleading, or willfully, wantonly, recklessly, and
consciously disregarded whether the representations and/or omissions were true. These
representations and/or omissions were made by the GSK Defendants with the intent of defrauding and
deceiving the public in general and the medical community and with the intent of inducing the public

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to request and ingest Avandia and the medical community to recommend, prescribe, and dispense
Avandia.
58.

The aforementioned misrepresentations by the GSK Defendants were reasonably relied upon

by Mrs. Montoya and his prescribing medical provider(s) to their detriment.
59.

As a direct and proximate cause of the conduct, acts, and omissions of the GSK Defendants,

Mrs. Montoya suffered injury to her health, strength, and activity and severe and lasting physical and
mental pain and suffering, and eventually death, all to her general damages in an amount in excess
of the minimum jurisdictional amount of this court.
60.

As a direct and proximate cause of the conduct, acts, and omissions of the GSK Defendants,

Mrs. Montoya incurred, hospital, medical, and related expenses, funeral expenses, the reasonable and
total value of which to be proven at the time of trial.
WHEREFORE, Plaintiffs pray for judgment against defendants as follows:
a.

For general damages according to proof;

b.

For special damages according to proof;

c.

For punitive and exemplary damages according to proof;

d.

For pre-judgment and post-judgment interest as allowed by law;

e.

For costs of suit incurred herein;

f.

Funeral expenses; and

g.

For such other and further relief as this court may deem just and proper.

COUNT VII
(Loss of Consortium)
Plaintiffs, readopt and reaver all the allegations contained in Paragraphs 1-60 above
and paragraphs 63 through 78, and further alleges as follows:
Page 18 of 24

61.

Plaintiff Luis Avelino Montoya and Fabiola Montoya, were at all times mentioned herein,

were mother and dependant son and lived together as a family.
62.

As a direct and proximate cause of the injuries to Fabiola Montoya and subsequently her

death, Luis Avelino Montoya has been deprived and will continue to be deprived of the consortium,
services, society, comfort, companionship of his mother.
PRAYER
WHEREFORE, Plaintiffs pray for judgment against defendants as follows:
a.

For general damages according to proof;

b.

For special damages according to proof;

c.

For punitive and exemplary damages according to proof;

d.

For pre-judgment and post-judgment interest as allowed by law;

e.

For costs of suit incurred herein;

f.

Funeral expenses; and

g.

For such other and further relief as this court may deem just and proper.
COUNT VIII
Wrongful Death-Estate Claim
Plaintiffs, readopt and reaver all the allegations contained in Paragraphs 1-28 above,

and further alleges as follows:
63.

This is an action for Wrongful Death Action pursuant to Florida Wrongful Death Act, Sections

768.16-768.26 of the Florida Statutes.
64.

At all times relevant, the GSK Defendants were under a duty to exercise reasonable care in the

researching, manufacturing, selling, merchandising, advertising, promoting, labeling, analyzing,

Page 19 of 24

testing, distributing and marketing of Avandia for distribution, sale, and use by the general public,
to ensure that Avandia's use did not result in avoidable injuries.
65.

Plaintiffs' injuries as described herein were caused by the negligence and misrepresentations

of the GSK Defendants though its agents, servants and/or employees acting within the course and
scope of their employment including among other things:
(a)

Carelessly and negligently researching, manufacturing, selling, merchandising,

advertising, promoting, labeling, analyzing, testing, distributing and marketing Avandia;
(b)

Failing to fully disclose the results of the testing and other information in its

possession regarding the association between Avandia and heart failure, and the association between
Avandia and myocardial ischemia and ischemic events such as cardiovascular mortality, myocardial
infarction, and stroke.
(c)

Negligently and carelessly failing to adequately warn the medical community and the

general public, including Mrs. Montoya and his treating and prescribing medical provider(s), of the
dangers of using Avandia;
(d)

Negligently and carelessly describing and promoting Avandia as safe and effective;

(e)

Negligently and carelessly failing to act as a reasonably prudent drug manufacturer;

(f)

Negligently and carelessly over-promoting and promoting Avandia in a

zealous and unreasonable way, without regard to its potential dangers;
66.

As a direct and proximate cause of the conduct, acts, and omissions of the GSK Defendants,

Mrs. Montoya suffered injury to her health, strength, and activity and severe and lasting physical and
mental pain and suffering, and eventually death, all to her general damages in an amount in excess
of the minimum jurisdictional amount of this court.
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67.

As a direct and proximate cause of the conduct, acts, and omissions of the GSK Defendants,

Mrs. Montoya incurred, hospital, medical, and related expenses, funeral expenses, the reasonable and
total value of which to be proven at the time of trial.
68.

As a direct and proximate result of the GSK Defendants’, negligence, the ESTATE of Fabiola

Montoya, has sustained economic damages in the form of funeral expenses and a loss of net
accumulations to the Estate.
69.

At all times material hereto, the acts or omissions of the GSK Defendants, were done with the

knowledge of substantial likelihood of death or serious bodily injury to the Decedent, Fabiola
Montoya , and constitute gross negligence.
WHEREFORE, Jorge Montoya, Luis Avelino Montoya and Maria Ferrer as the personal
representative of THE ESTATE OF Fabiola Montoya, demands entry of judgment against the GSK
Defendants for compensatory damages, taxable costs as the prevailing party, trial by jury on all issues
so triable as a matter of right, and further relief that is deemed to be just and proper by this Court
under all of the prevailing facts and circumstances of the case, including, but not limited punitive
damages upon a proffer of appropriate conduct on the part of the GSK Defendants.
COUNT IX
Survivor Action, Luis Avelino Montoya
Plaintiffs, readopt and reaver all the allegations contained in Paragraphs 1-28 above,
and further alleges as follows:
70.

This is an action for Wrongful Death Action pursuant to Florida Wrongful Death Act,

Sections 768.16-768.26 of the Florida Statutes.

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71.

At all times relevant, the GSK Defendants were under a duty to exercise reasonable care in the

researching, manufacturing, selling, merchandising, advertising, promoting, labeling, analyzing,
testing, distributing and marketing of Avandia for distribution, sale, and use by the general public,
to ensure that Avandia's use did not result in avoidable injuries.
72.

Plaintiffs' injuries as described herein were caused by the negligence and misrepresentations

of the GSK Defendants though its agents, servants and/or employees acting within the course and
scope of their employment including among other things:
(a)

Carelessly and negligently researching, manufacturing, selling, merchandising,

advertising, promoting, labeling, analyzing, testing, distributing and marketing Avandia;
(b)

Failing to fully disclose the results of the testing and other information in its

possession regarding the association between Avandia and heart failure, and the association between
Avandia and myocardial ischemia and ischemic events such as cardiovascular mortality, myocardial
infarction, and stroke.
(c)

Negligently and carelessly failing to adequately warn the medical community and the

general public, including Mrs. Montoya and his treating and prescribing medical provider(s), of the
dangers of using Avandia;
(d)

Negligently and carelessly describing and promoting Avandia as safe and effective;

(e)

Negligently and carelessly failing to act as a reasonably prudent drug manufacturer;

(f)

Negligently and carelessly over-promoting and promoting Avandia in a

zealous and unreasonable way, without regard to its potential dangers;
73.

As a direct and proximate cause of the conduct, acts, and omissions of the GSK Defendants,

Mrs. Montoya suffered injury to her health, strength, and activity and severe and lasting physical and

Page 22 of 24

mental pain and suffering, and eventually death, all to her general damages in an amount in excess
of the minimum jurisdictional amount of this court.
74.

As a direct and proximate cause of the conduct, acts, and omissions of the GSK Defendants,

Mrs. Montoya incurred, hospital, medical, and related expenses, funeral expenses, the reasonable and
total value of which to be proven at the time of trial.
75.

As a direct and proximate result of the GSK Defendants’, negligence, the ESTATE of Fabiola

Montoya, has sustained economic damages in the form of funeral expenses and a loss of net
accumulations to the Estate.
76.

At all times material hereto, the acts or omissions of the GSK Defendants, were done with the

knowledge of substantial likelihood of death or serious bodily injury to the Decedent, Fabiola
Montoya , and constitute gross negligence.
77.

As a direct and proximate result of the GSK Defendants’, negligence, breach of warranty,

failure to warn, fraud, negligent pharmaco vigilance, the Plaintiff, Luis Avelino Montoya , as survivor
of his mother, the Decedent, Fabiola Montoya, has sustained mental pain and suffering from the
death of his, mother, under the horrifying circumstances of her death, and a future loss of support and
services, and such losses will continue in the future.
78.

At all times material hereto, the acts or omissions of the GSK Defendants, were done with the

knowledge of substantial likelihood of death or serious bodily injury to the Decedent, Fabiola
Montoya, and constitute gross negligence.
WHEREFORE, Jorge Montoya and Maria Ferrer as Personal Representatives of the Estate
of Fabiola Montoya, demands entry of judgment against the GSK Defendants for compensatory
damages, taxable costs as the prevailing party, trial by jury on all issues so triable as a matter of right,

Page 23 of 24

and further relief that is deemed to be just and proper by this Court under all of the prevailing facts
and circumstances of the case, including, but not limited punitive damages upon a proffer of
appropriate conduct on the part of the GSK Defendants.
79.

The Plaintiff demands a trial by jury on all claims triable by jury.

Dated: May 19, 2011

LAW OFFICE OF KEITH A. FOUSEK
Counsel for the Plaintiffs
6400 SW 16th Street
North Lauderdale, Florida 33068
Telephone: [phone]
Facsimile: [phone]

By:

s//Keith A. Fousek
KEITH A. FOUSEK, ESQUIRE
Florida Bar#: 0627305

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