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Jeffrey C. Bogert(SBN 132778)
LAW OFFICES OF JEFFREY C. BOGERT
827 Moraga Dr.
Los Angeles, CA 90049-1633
Tel: (424) 293-2272
Email address: Bogertlaw@outlook.com
Roman Balaban
(Pro hac vice application to be submitted)
Andrew Ramos
(Pro hac vice application to be submitted)
BALABAN LAW, LLC
8055 E Tufts, Ave, Ste. 325
Denver, CO 80237
Tel: (303) 377-3474Fax: ( 303) 377-3576
Email address: balaban@denverfirm.com
Email addres ramos@denverfirm.com
Attorneys for Plaintiffs
IN THE SUPERIOR COURT OF THE STATE OF CALIFORNIA
COUNTY OF NTA CLARA
WAYNE ROBINSON; MICHAEL BENNETT Case No.:
DEANA GRAVETT; HENRYCREWS; MICHAEL
SELL; HENRY TODD; JAMES COLLIER;
ERNESTINE APONTE; JONAH MCPHAUL; COMPLAINT FOR DAMAGES;
MICHAEL DECAMP; JUDITH MONTALVO; and DEMAND FOR JURY TRIAL
MICHAEL MONTALVO;
Strict Products Liability - Design Defect
Plaintiffs, andFailure to Warn;
2. Negligent Products Liability - Design
Defect and Failure to Warn;
GILEAD SCIENCES, INC., a Delaware corporation Breach f Implied Warranty;
doing business in California;
Breach f Express Warranty
Defendants.
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
Plaintiff WAYNE ROBINSON, MICHAEL BENNETT, DEANA GRAVETT, HENRY
CREWS, MICHAEL SELL,HENRY TODD, JAMES C OLLIER, ERNESTINE APONTE, JONAH
MCPHAUL, MICHAEL DECAMP, JUDITH MONTALVO, MICHAEL MONTALVO (“Plaintiffs”
bring this personal injury action for a dangerously defective product against Defendant Gilead
Sciences, Inc. (“Gilead”) to recover monetary damages and other remedies for violations of California
law.
I. INTRODUCTION
Plaintiff ere prescribed and ingested Defendant Gilead's defectively dangerous antiviral
medications containing the active ingredient tenofovir disoproxil fumarate for many years, suffering
debilitating side effects such as kidney disease and osteoporosis. Plaintiff and the pharmaceutical and
medical industries, generally misled by Defendant Gilead’s false statements, misrepresentations,
and deliberate deceptions, to believe that these medications were the safest and most effective available,
and that no safer alternative design existed that would have saved the Plaintif from these disastrous side
effects. But Defendant Gilead Sciences not only knew of a better, safer, alternative design, it was Gilead
itself that had invented this alternative safe design and shelved it prior to 2000 , waiting at minimum
15 years torelease the safer drug.
Defendant Gilead Sciences invented, and subsequently, intentionally and knowingly
suppressed, a life saving pharmaceutical with limited side effects, far better tolerated by the body, in order
to maximize its profits from an inferior version of the same line of drugs. They thereby created a mechanism
by which to maintain high profits and pursue a monopoly on this class of drugs, at the literal cost to patients
of failed kidneys and broken bones.
Plaintiff took Gilead's drugs as part of “highly active antiretroviral therapy” (“HAART”)
to treat and manage HIV infection.
See United States Provisional Patent Application No. 60/220021; European Provisional Patent Application Number
01961695.2.
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
Tenofovir disoproxil fumarate (“TDF”) is a prodrug of the compound tenofovir. TDF
works by blocking the protein that HIV needs to replicate itself in the human body. TDF is Viread's only
active ingredient. Tenofovir based medications can also include formulations like fixed dose combination
tablets containing 300 milligrams of TDF and one or two additional drugs. Truvada, for example, combines
TDF with 200 milligrams of emtricitabine, and Atripla adds one more medication to that combination, 600
mg of efavirenz.
At the time Gilead designed, manufactured, and sold Truvada in 2004, and Atripla in 2006,
Gilead knew, or should have known, that TDF was highly toxic in the doses prescribed and risked
permanent and possibly fatal damage to the kidneys and bones. Instead of fully and completely
investigating and disclosing the known and knowable risks associated with TDF, Gilead ignored and
affirmatively misrepresented them.
Before Gilead designed, manufactured, and sold Truvada and Atripla, and years before the
U.S. Food and Drug Administration (“FDA”) approved these medications, Gilead had discovered and
begun researching a safer and more effective design for the delivery of tenofovir to the body, tenofovir
alafenamide fumarate ('TAF”). Indeed, even before Viread was approved by the FDA in 2001, Gilead knew
that a tenofovir prodrug design using TAF instead of TDF would reduce the risks of toxicity and damage
to kidney and bones.
However, because Gilead enjoyed monopoly profits on its TDF containing drugs, including
Truvada and Atripla, resulting from its patent on TDF, Gilead chose to withhold TAF from the market as
the prodrug design for Truvada and Atripla and all other tenofovir based medications until November of
By designing Tenofovir based medications with TAF in 2014 and 2016 under the names Odefsey
and Descovy, Gilead demonstrated that it could have used the superior TAF compound from the very
beginning. Such a design approach would have eliminated the need for TDF containing Truvada and
Atripla, significantly improved the tolerance of tenofovir based medications in patients and helped advance
Prodrugs are medicines that are not converted into their active form until they are processed inside the body. TDF is taken
orally and after absorption it passes into the blood.
See: U.S. Food and Drug Administration Approves Gilead's Single Tablet Regimen Genvoya (Elvitegravir, Cobicistat,
Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV 1 Infection. Gilead. 5 November 2015.
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
the state of the science in the antiviral pharmaceutical industry. This decision would have helped to avoid
countless, unnecessary injuries to the Plaintiff and all similarly situated persons. Such a pharmaceutical
design policy would have avoided the aforementioned damages, but it would have reduced Gilead's
monopoly profits from the sale of TDF. Accordingly, Gilead decided instead to inflict continuing harm
upon thousands of patients and hold back medical and scientific inquiry and development for almost 20
years by concealing the superior compound, TAF.
A design based upon TAF would have greatly improved and in some cases saved the
lives of patients compliant with the TDF based treatment regimens, many of whom, like Plaintiff were
on Gilead's medications for years. If Gilead had designed Tenofovir based medications with TAF, far fewer
people, like the Plaintiff , would have developed bone loss or kidney damage as a result of taking Gilead's
dangerously defective medications.
ilead has long known of TAF's superior safety profile but has consistently chosen to place
market share and profitability over patient safety. This Defendant has a demonstrable record, at least with
respect to the current action, of choosing profits over people a particularly odious choice in a corporation
ostensibly dedicated to producing compounds for the healing arts.
By July 21, 2000, more than a year before Viread (the first TDF containing drug Gilead
brought to market, and a predecessor and parent drug of Truvada) obtained FDA approval, Gilead
submitted provisional patent applications to the U.S. and European Patent offices describing TAF, then
called GS 7340, and stating its enhanced uptake by target cells, reduced cytotoxicity, and superior
bioavailability, stability, and concentrations as compared to TDF. (See United States Provisional Patent
Application No. 60/220021; European Provisional Patent Application Number 01961695.2). The
provisional patent applications cited Gilead research dating back to 1997 showing that Defendant Gilead
knew that TAF was 2 3 times more potent than Truvada and that it could obtain concentrations of tenofovir
in target cells that were ten to thirty times higher than those attainable with Truvada. “As shown, [TAF
is] 2 orders of magnitude more potent than all other nucleotides or nucleosides.” Id.
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
As early as April 2002, as prescriptions for TDF were growing along with Gilead's market
share, Gilead was paying doctors to conduct studies of the safer prodrug TAF in patients around the
country. These studies showed that TAF was far less toxic and confirmed that TDF's low absorption, high
dosage, and potential bone and renal toxicity were real risks. But, Gilead did not publish this research, did
not conduct clinical trialsof TAF, did not change its prescribing information, and did not instruct its sales
representatives to begin informing doctors that the toxicities associated with TDF could be eliminated with
a new, better drug.
Gilead took none of these steps because TDF sales were booming and Viread had begun to
corner the market in antiviral treatments for HIV. As Gilead kept doctors and patients in the dark about the
toxicity, kidney, and bone loss risks associated with TDF, it could continue to increase its market shar
with TDF. Gilead knew that it could hide the TAF development from the market and thereby protect its
patent and profits on TDF. Further, by keeping TDF as the focus of its antiviral offerings, Gilead knew
it would reap outsized future profits when it combined TDF with other patent protected drugs to create
newly protected combination drugs that would prolong Gilead's ability to charge monopoly prices on TDF
containing drugs.
Gilead's deliberate delay in conducting TAF clinical trials deprived those suffering from
HIV from using TAF for more than a decade and ensured that TDF would continue to dominate the market.
These patients were thus forced to take TDF, which because of TDF's lower absorption rates caused and
exacerbated higher bone and kidney toxicities. It is possible that HIV patients suffered from more than ten
years of additional and wholly unnecessary accumulated kidney and bone toxicity from using TDF, while
Gilead kept TAF hidden on the shelf.
If Gilead had chosen to develop tenofovir in the safer and more effective TAF version, TDF
would lose marketability it was less effective and had far higher risks and Gilead's profits from TDF would
decrease. By holding on to its research and shelving TAF, Gilead could patent TAF separately and save it
for development when their patent and exclusivity on TDF ran out, in twenty years.
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
In late 2003, Gilead continued to study TAF at the same time it was preparing its application
to the FDA for Truvada the first TDF combination drug it would use to extend the profitability of its TDF
patent. Also at this time, Gilead's own clinical evidence of TDF's toxicity and risks to kidneys and bones
was building along with evidence from other studies.
And yet, in spite of the clear and growing need to investigate and mitigate the risks
associated with TDF, in October 2004, Gilead's CEO John C. Martin announced, “the company is
discontinuing its development program” for TAF.
Gilead's claim that it would discontinue research into TAF was a misrepresentation intended
mislead the purchasing public, including prescribing doctors and patients taking TDF, into continuing
to prescribe and take TDF.
Indeed, Gilead did not discontinue development of TAF. Instead, between October 2004
and May 2005, Gilead applied for seven patents associated with it. By hiding research about TAF's superior
safety profile and efficacy, and by continuing to downplay the risks associated with TDF, Gilead continued
its scheme to mislead the public and maximize profits for TDF.
Gilead knew of TAF's superior profile and the risks associated with TDF at least as far back
as 2000. By the time Tenofovir based medications were submitted for approval to the FDA in 2004 and
2006, Gilead had long known that TDF toxicity led to kidney and bone damage, even in patients without
pre existing kidney or bone issues. Gilead had a duty to share its exclusive knowledge of the risks
associated with TDF. Gilead failed to do this. Instead, Gilead misrepresented the safety and benefits of
TDF and failed to provide prescribing physicians and their patients with the information they needed to
safely and reasonably prescribe and take Gilead's drugs.
Gilead's tactics have allowed it to reap outsized profits. In 2015, Gilead was able to earn
90% Non GAAP Product Gross Margins. Gilead's tactics have led the New York Times to comment,
“Gilead now is faced with figuring out what to do with all the cash it is generating.”
Truvada consists of three different fixe dose combinations of tenofovir delivered as TDF and emtricitabine.
Andrew Pollack, Sales of Solvadi, New Gilead Hepatitis C Drug, Soar to $10.3 Billion, NEW YORK TIMES (February 4,
2015) (emphasis added).
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
Gilead's high profits come from the steep costs of its drugs. High prices of drugs such as
Gilead's Truvada ($18,456 per year) limit patient access either through exorbitant out pocket costs or
pays, limitations in existing insurance, and rationing of these high priced pills.
In its 2015 earnings Guidance, Gilead stated that it anticipated spending between 2.8 and 3
billion dollars on research and development, while earning a profit of roughly 23 billion dollars. Gilead
spent approximately that much in 2015 on research and development but its profits in 2015 were $36.2
billion.
Gilead first misrepresented TDF's safety profile as early as 2001, right after Viread's
approval, through its sales representatives and CEO, claiming that TDF was a “miracle drug,” had “no
toxicities,” was “benign,” and “extremely safe.” Gilead's CEO at the time, Dr. John C. Martin, would often
refer to TDF as a miracle drug at sales meetings. He did so because he believed Gilead needed to overcome
the perception in the medical community that Viread was like Gilead's previous HIV drugs and would
likely cause kidney damage.
Even after Gilead was reprimanded by the FDA in 2002 and 2003 for falsely claiming TDF
had no toxicities and bore no risk to a patient's kidneys or bones, Gilead continued to misrepresent the risks
through its Viread, Truvada, and Atripla prescription inserts and patient information sheets, which similarly
downplayed the stated risks and misrepresented that toxicity, bone, or kidney damage was primarily a risk
for patients with pre existing kidney or bone issues.
Gilead made these misrepresentations even though it knew TDF had a high potential for
toxicity and loss of bone mineral density in all patients. In its early stages of development, TDF animal
toxicology studies showed that the bones and kidneys were the target organs for toxicity and that the bone
toxicities included osteomalacia and decreases in bone mineral density.
Clinical studies and adverse event reports from as early as 2001 and 2002 document severe
renal deficiencies and toxicity in patients without any history of kidney problems. A 2003 case reported
fatal renal insufficiency in a patient with only mild previous renal impairment. And studies as early as 2002
associate TDF with acute decreases in bone mineral density and bone loss.
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
Again, as early as 2002 and 2003, while Gilead's CEO was claiming TDF was a risk free,
miracle drug, these reports and studies advised monitoring patients closely for early signs of toxicity,
kidney failure, or bone loss, even several months after initiation of treatment and further recommended
discontinuing treatmentas soon as possible to avoid the risk of permanent changes or damage.
Long before Tenofovir based medications were submitted for approval to the FDA in 2004
and 2006, Gilead knew that TDF toxicity led to kidney and bone damage, even in patients without pr
existing kidney or bone issues. Gilead had a duty to share its exclusive knowledge of the risks and warn of
any known or scientifically knowable risks associated with use of TDF. Instead, Gilead misrepresented the
safety and benefits of TDF and failed to provide prescribing physicians and their patients with the
information they needed to safely and reasonably prescribe and take Gilead's drugs.
Gilead had a duty to design and manufacture Tenofovir based medications in a manner that
met the safety expectations of ordinary consumers and/or their prescribing physicians. Instead, Gilead
designed Tenofovir based medications to contain TDF, the prodrug it knew caused bone and kidney
damage, so that they could maximize their profits and monopoly on TDF. They deliberately avoided using
the superior form of tenofovir which they had invented, and they deliberately undertook a course of action
to suppress and conceal the existence of this superior form from the public.
Plaintiff seek general and punitive damages and seek to hold Gilead accountable for its
malicious and profit driven refusal to design tenofovir based medications in a safe and effective manner,
utilizing the compound Tenofovir Alafenamide Fumarate, which it had repeatedly proven to be safer, with
greater bioavailability and absorption than Tenofovir Disoproxil Fumarate prior to 2000.
II. THE PARTIES
Plaintiff Wayne Robinson is a resident of the State of California and the County of Los
Angeles. Plaintiff was prescribed and ingested Gilead's prescription medications containing the active
ingredient tenofovir disoproxil fumarate from approximately 200 until the present. Plaintiff was
diagnosed with bone density loss and abnormal protein levels in the urine. Plaintiff was unaware that his
injuries were caused by tenofovir disoproxil fumarate, and he was equally unaware that Defendant Gilead
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
Sciences had developed and deliberately suppressed from the market a safer form of this medication over
16 years ago, until within two (2) years of the filing of this action.
Plaintiff Michael Bennett is a resident of the State of Kentucky and the County of Jefferson
Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient
tenofovir disoproxil fumarate from approximately 20 until the present. Plaintiff was diagnosed with bone
density loss and low kidney function. Plaintiff was unaware that his injuries were caused by tenofovir
disoproxil fumarate, and he was equally unaware that Defendant Gilead Sciences had developed and
deliberately suppressed from the market a safer form of this medication over 16 years ago, until within two
(2) years of the filing of this action.
Plaintiff Deana Gravett is a resident of the State of Georgia and the County of Hall. Plaintiff
was prescribed and ingested Gilead's prescription medications containing the active ingredient tenofovir
disoproxil fumarate from approximately 201 until . Plaintiff was diagnosed with bone fractures and
kidney failure. Plaintiff was unaware that her injuries were caused by tenofovir disoproxil fumarate, and
she was equally unaware that Defendant Gilead Sciences had developed and deliberately suppressed from
the market a safer form of this medication over 16 years ago, until within two (2) years of the filing of this
action.
Plaintiff Henry Crews is a resident of the State of Alabama and the County of Jefferson
Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient
tenofovir disoproxil fumarate from approximately April 2014 until December 2014. Plaintiff was
diagnosed with chronic kidney disease and abnormal glomerular filtration rate. Plaintiff was unaware that
his injuries were caused by tenofovir disoproxil fumarate, and he was equally unaware that Defendant
Gilead Sciences had developed and deliberately suppressed from the market a safer form of this medicati
over 16 years ago, until within two (2) years of the filing of this action.
Plaintiff Michael Sell is a resident of the State of Florida and the County of Broward
Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient
tenofovir disoproxil fumarate from approximately 201 until . Plaintiff was diagnosed with brittle
bones, bone density loss, avascular necrosis/osteonecrosis, osteoporosis and kidney failure. Plaintiff was
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
unaware that his injuries were caused by tenofovir disoproxil fumarate, and he was equally unaware that
Defendant Gilead Sciences had developed and deliberately suppressed from the market a safer form of this
medication over 16 years ago, until within two (2) years of the filing of this action.
Plaintiff Henry Toddis a resident of the State of New Mexico and the County of Bernalilo
Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient
tenofovir disoproxil fumarate from approximately 2 until 201. Plaintiff was diagnosed with kidney
failure. Plaintiff was unaware that his injuries were caused by tenofovir disoproxil fumarate, and he was
equally unaware that Defendant Gilead Sciences had developed and deliberately suppressed from the
market a safer form of this medication over 16 years ago, until within two (2) years of the filing of this
action.
Plaintiff James Collier is a resident of the State of Nevada and the County of Clark. Plaintiff
was prescribed and ingested Gilead's prescription medications containing the active ingredient tenofovir
disoproxil fumarate from approximately 20 until 20. Plaintiff was diagnosed with bone fractures,
osteoporosis, and kidney failure. Plaintiff was unaware that his injuries were caused by tenofovir disoproxil
fumarate, and he was equally unaware that Defendant Gilead Sciences had developed and deliberately
suppressed from the market a safer form of this medication over 16 years ago, until within two (2) years of
the filing of this action.
PlaintiErnestine Aponte is a resident of the State of New Yorkand the County of Bronx
Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient
tenofovir disoproxil fumarate from approximately until laintiff was diagnosed with bone
density loss, osteoporosis, and kidney failure. Plaintiff was unaware that h injuries were caused by
tenofovir disoproxil fumarate, and he was equally unaware that Defendant Gilead Sciences had developed
and deliberately suppressed from the market a safer form of this medication over 16 years ago, until within
two (2) years of the filing of this action.
Plaintiff Jonah McPhaul is a resident of the State of Texas and the County of Bexar. Plaintiff
was prescribed and ingested Gilead's prescription medications containing the active ingredient tenofovir
disoproxil fumarate from approximately 2 until . Plaintiff was diagnosed with low kidney function
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
Plaintiff was unaware that his injuries were caused by tenofovir disoproxil fumarate, and he was equally
unaware that Defendant Gilead Sciences had developed and deliberately suppressed from the market a
safer form of this medication over 16 years ago, until within two (2) years of the filing of this action.
Plaintiff Michael Decamp is a resident of the State of New York and the County of New
York. Plaintiff was prescribed and ingested Gilead's prescription medications containing the active
ingredient tenofovir disoproxil fumarate from approximately 200 until 2018. Plaintiff was diagnosed with
brittle bones and bone density loss. Plaintiff was unaware that his injuries were caused by tenofovir
disoproxil fumarate, and he was equally unaware that Defendant Gilead Sciences had developed and
deliberately suppressed from the market a safer form of this medication over 16 years ago, until within two
(2) years of the filing of this action.
Plaintiff Judith Montalvo is a resident of the State of Florida and the County of Brevard
Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient
tenofovir disoproxil fumarate from approximately until present . Plaintiff was diagnosed with broken
bones, avascular necrosis/osteonecrosis, osteopenia and low kidney function. Plaintiff was unaware that
injuries were caused by tenofovir disoproxil fumarate, and he was equally unaware that Defendant
Gilead Sciences had developed and deliberately suppressed from the market a safer form of this medication
over 16 years ago, until within two (2) years of the filing of this action.
Plaintiff Michael Montalvo is a resident of the State of Florida and the County of Brevard.
Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient
tenofovir disoproxil fumarate from approximately 2010 until . Plaintiff was diagnosed with renal
issues including but not limited to high creatine levels, abnormal protein levels and abnormal glomerular
filtration rate levels. Plaintiff was unaware that h injuries were caused by tenofovir disoproxil fumarate,
and he was equally unaware that Defendant Gilead Sciences had developed and deliberately suppressed
from the market a safer form of this medication over 16 years ago, until within two (2) years of the filing
of this action.
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
Defendant Gilead Sciences, Inc., is a corporation organized and existing under the laws of
the State of Delaware, having its principal place of business at 333 Lakeside Drive, Foster City, California
94404. Gilead is a pharmaceutical company that develops and commercializes prescription medicines,
including HAART medications for the treatment of HIV, with applications for the treatment of other viral
infectious diseases. These medications include those containing tenofovir disoproxil fumarate, a dangerous
drug with debilitating side effects, and a drug which could have been readily designed with the much safer
compound, tenofovir alafenamide fumarate, invented at the same time or before TDF, by Defendant Gilead
Sciences. These drugs were prescribed for and ingested by Plaintiff
III. JURISDICTION AND VENUE
This Court has jurisdiction over the subject matter of this action pursuant to California Code
of Civil procedure§ 410.10 because a substantial portion of Gilead's acts occurred within the state of
California. This court has personal jurisdiction over Defendant Gilead Sciences, Inc. as its principal place
of business is located in the state of California.
Venue is proper in the County of Santa Clara pursuant to California Code of Civil procedure
§§ 395 because Plaintiff reside in California and a substantial portion of Gilead's negligence,
misrepresentations, incomplete and misleading warnings, and fraudulent marketing practices occurred in
the County of Santa Clara
IV. GENERAL ALLEGATIONS
Gilead Prepares TDF for Market
Tenofovir was first discovered and identified for its anti viral properties in 1984 by
scientists in the Czech Republic. Gilead purchased the right to sell Tenofovir in 1997. The original
formulation of Tenofovir had limited sales potential, because it wasan intravenous drug. Gilead scientists
later modified the chemical composition to create forms of tenofovir drugs that could be taken orally. These
modified chemical compounds include tenofovir disoproxil fumarate (“TDF”), and tenofovir alafenamide
fumarate (“TAF” and discussed later). Gilead opted to advance applications of tenofovir disoproxil
fumarate in the late 1990s/early 2000s. The Food and Drug Administration approved an initial TDF
formulation under the brand name Viread in October 2001.
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
TDF became the backbone of many HIV treatment regimes, while the alternative safe
design, TAF, sat on a shelf at Gilead Sciences.
The therapeutic use of multiple drugs operating in combination to treat HIV is known as
Highly Active Antiretroviral Therapy ('“HAART”). HAART is aimed at reducing a patient's viral load and
maintaining a patient's immune system. HAART regimens generally consist of three drugs: two drugs from
the class of drugs known as Nucleoside Reverse Transcriptase Inhibitors (“NRTls”) and one drug from
classes of drugs known as Non Nucleoside Reverse Transcriptase Inhibitors (“NNRTI”), Protease
Inhibitors (“PI”), or Integrase Nuclear Strand Transfer Inhibitors (“INST]”). This combination is thought
to be more effective at combating drug resistant strains.
Tenofovir is an NRTI and is frequently used in HAART therapies. In addition to making
TDF available as a standalone drug product under the brand name Viread, Gilead incorporated TDF in
fixed dose combination pills including Atripla, Truvada, Stribild, and Complera.
Gilead Knew of Bone and Kidney Risks Before FDA Approved TDF
Originally marketed as a stand alone medication, Gilead obtained FDA approval to
manufacture and sell TDF in October 2001 under the brand name Viread. Yet, before Gilead had finalized
Viread for FDA approval in 2001, and long before either Truvada or Atripla were approved in 2004 and
2006, Gilead knew that TDF's low absorption rate meant it had to be administered in high doses to be
effective. Before taking Viread to market, Gilead also knew that TDF in high doses placed immense
pressure on the kidneys, the body's predominate method of eliminating the drug.
Since scientists first synthesized TDF in 1997, studies of TDF showed that it could cause
significant kidney damage and bone toxicity. This damage includes decreases in bone mineral density,
osteopenia, osteoporosis, osteoporosis with pathologic fracture, Fanconi syndrome, chronic kidney disease,
and end stage kidney disease.
The toxicity of TDF known to Gilead at the time it was developing Viread in 2001 is
particularly alarming because Gilead also knew and indeed likely intended that HIV infected patients
would receive TDF treatment for decades, allowing the toxicity to build overtime, but ensuring the patient
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
would remain a purchaser of Gilead's TDF, at least until Gilead began marketing TAF, and essentially
ensuring the patient would be a long term Gilead customer.
When TDF was approved in October 2001, the FDA required Gilead to study whether it
would harm humans. The FDA noted that Gilead “did not evaluate tenofovir DF in individuals with renal
insufficiency” and “did not determine specific active secretion pathways” for the drug. Along with the
FDA's recommendations for human study, it made clear that Gilead must properly examine and disclose
the side effects TDF would have on the kidneys and whether it would build up to toxic levels in the body.
Id.
Gilead Studies Safer Prodrug TAF, Hides Results
Gilead, however, has been more interested in maximizing the profits it has derived from
TDF than it has been in disclosing the risks associated with the drug. About six or seven months before
Viread was approved, in April 2001, Gilead scientists published research on a different prodrug of
Tenofovir, called Tenofovir Alafenamide (“TAF”). In an attempt to reduce known side effects of TDF,
Gilead conducted test tube and animal research studies on the prodrug and in April 2002, Gilead paid
doctors to conduct clinical studies of TAF in HIV patients around the country.
After learning that TAF had a higher absorption rate and largely avoided the bone and
kidney toxicity associated with TDF, Gilead did not substitute TAF for TDF in the design of any of its
drugs, including Viread, Truvada, and Atripla. In an act of extreme malice, Gilead also refused to publish
its research on TAF, choosing instead to keep HIV infected patients and their doctors in the dark about the
full risks associated with TDF, along with the solution to those risks, for over a decade.
In 2014, as Gilead's patent on TDF approached its expiration and Gilead faced a sharp
decrease in profits that would result from competition entering the market for TDF containing drugs,
Gilead decided to release the results of the TAF studies it began conducting in 2001. These studies were
Food and Drug Administration, CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW, New Drug
Application (Viread) No. 21 356 pp. 1 7 (May 1, 2001).
Martin Markowitz et al., Phase I/II study of the pharmacokinetics, safety and antiretroviral activity of tenofovir alafenamide,
a new prodrug of the HIV reverse transcriptase inhibitor tenofovir, in HIV infected adults, J. ANTIMICROBIAL
CHEMOTHERAPY, 69:1362 1369 (2014).
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
cited in support of three new combination drug applications containing TAF and approved, respectively,
in November 2015 (Genvoya), March 2016 (Odefsey), and again in April 2016 (Descovy).
The FDA Reprimands Gilead for its Misleading TDF Marketing
Just after Viread's approval and in the two years leading up approval of Truvada, the FDA
twice issued warning letters to Gilead over its TDF marketing practices, stating that their sales
representatives had violated the law by giving doctors and patients false and misleading information
regarding TDF's side effects. According to a 2002 FDA Warning Letter, Gilead salespeople falsely stated
that TDF had “no toxicities,” was “benign,” and was “extremely safe.” A 2003 FDA Warning Letter to
the uncommon step of requiring Gilead to retrain its sales representatives to provide accurate information
regarding the significant side effects associated with TDF and comply with the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. § 352.
In a shareholder lawsuit filed in 2009, a former Gilead employee and complaining witness
stated that Gilead CEO Dr. John C. Martin would refer to Viread as a miracle product all the time at
meetings. Another former employee and complaining witnesses confirmed this information and stated that
Dr. Martin promoted Viread as a miracle drug because Gilead needed to overcome the perception in the
medical community that Viread was like Gilead's previous HIV drugs and would likely cause kidney
damage.
Viread's original prescribing information and patient information sheet said little about the
severe risk of toxicity in kidneys and concomitant risk of bone mineral density loss. The boxed warning
for Viread has never mentioned TDF toxicity, bone, or kidney risks. And, the current label still only
recommends assessment of bone mineral density for patients with a history of fracture or other risk factors
for osteoporosis or bone loss.
Gilead Misrepresents Risks Associated with Truvada
Gilead's prescribing information and patient information sheets for Truvada did little to
correct the tide of misrepresentations unleashed by its sales force and CEO only months before Truvada's
launch into the market in 2004. Truvada's prescribing information failed to correct prior misrepresentations
regarding the safety and efficacy of TDF and continued to misrepresent and minimize the risk of toxicity
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
and bone and kidney damage. Where Gilead did list potential patient concerns, it misrepresented the risks
as primarily for already renally impaired or bone compromised patients.
Truvada's original prescribing information insert and patient information sheet represent the
risks of toxicity and bone and kidney damage as primarily a concern for patients with a history of bone and
kidney problems. It was known to Gilead, or scientifically knowable, that the high doses of tenofovir
necessary to make it bioavailable as TDF could lead to toxicity in the kidneys in all patients, even those
without a history of renal dysfunction or other risk factors. As early as 2003, a case report had been
published showing lethal renal toxicity in a patient without any history of renal impairment.
Truvada's original prescribing information also misrepresents the risks to bone toxicity and
bone mineral density loss. Mentioning “bone effects” on the twentieth page of the prescribing information
sheet, it summarizes a 48 week clinical TDF study on baseline bone mineral density. Although it notes that
decreases in BMD were seen at the lumbar spine and hip for patients taking TDF, it claims that the “clinical
significance of the changes in BMD” were “unknown” and that bone monitoring should only be considered
for patients “with a history of pathologic bone fracture or at substantial risk for osteopenia.” Referring to
the same 48 week study, Gilead further misleadingly claimed that “there was no increased frequency of
established toxicities” associated with taking TDF.
Gilead's Truvada patient information sheet, provided at the end of the fifty six page
prescribing information packet, compounds the misrepresentations by continuing to downplay the risks
associated with Truvada, limiting its warnings to patients with “bone problems” or “kidney problems in
the past or tak[ing] other medicines that can cause kidney problems.” The patient information sheet further
falsely claims it “is not known whether long term use of TRUVADA will cause damage to your bones.”
While Truvada's prescribing information and patient information sheets have undergone
changes over the years, the current prescribing information and patient information sheets still fail to
sufficiently warn consumers and their physicians about the risk of toxicity and severe bone and kidney
problems.
Truvada's current prescribing information and patient information sheet make sparse
mention of the risks associated with long term TDF use in patients without a history of bone problems and
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
affirmatively misrepresent that such risks are primarily present for patients with a clinical history of bone
and renal issues.
Gilead knew or should have known as early as 2001 that TDF posed risks to the kidneys
and bones of all patients, not just those with a clinical history of kidney and bone problems. Gilead not
only failed to warn of these risks but made affirmative misrepresentations that such risks were posed
primarily to patients with a history of kidney and bone problems.
Gilead Misrepresents Risks Associated with Atripla
In 2006, when Gilead began marketing and selling Atripla, it provided a prescribing
information and patient information sheet with misrepresentations nearly identical to those in the Truvada
and Viread materials.
Atripla's original prescribing information generally limited its warnings to patients with a
history of bone and kidney problems and similarly inaccurately claimed that the effects of TDF on BMD,
long term bone health, and future fracture risk were “unknown.”
Atripla's patient information sheet maintained the misrepresentations contained in Truvada's
and Viread's materials, listing “kidney problems” as a possible side effect for patients with “kidney
problems in the past or tak[ing] other medicines that can cause kidney problems” and “changes in bone
mineral density” “[i]f you have had bone problems in the past,” while also claiming it was “not known
whether long term use of ATRIPLA will cause damage to your bones.”
Atripla's current prescribing information and patient information sheet continue to limit
warnings for bone and kidney problems and toxicity as risks primarily affecting patients with a history of
bone or kidney problems.
Atripla's prescribing information and patient information sheet make sparse mention of the
risks associated with long term TDF use in patients without a prior history of bone problems and
affirmatively misrepresent that such risks are primarily present for patients with a clinical history of bone
and renal issues. Gilead knew, or should have known, in 2006 that TDF posed risks to the kidneys and
All of the prescribing information and patient information sheets for both Atripla and Truvada refer back to Gilead's
materials for Viread, the single component name brand TDF that is contained in both Atripla and Truvada.
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
bones of all patients, not just those with a clinical history of kidney and bone problems. Gilead not only
failed to warn of these risks but made affirmative misrepresentations that such risks were posed primarily
to patients with a history of kidney and bone problems.
V. CAUSES OF ACTION
FIRST CAUSE OF ACTION
STRICT PRODUCTS LIABILITY DESIGN DEFECT AND FAILURE TO WARN
(By Plaintiff against Defendant)
Plaintiff fully reallege and incorporate by reference each allegation made above as if fully
set forth here and further allege as follows:
Gilead designed, developed, manufactured, fabricated, tested or failed to test, inspected or
failed to inspect, labeled, advertised, promoted, marketed, supplied, and distributed the prescription drugs
containing the active ingredient tenofovir disoproxil fumarate.
Gilead designed Tenofovir based medications to contain TDF as the prodrug formulation
of tenofovir at least three years before Gilead submitted either Truvada or Atripla to the FDA for approval,
in 2004 and 2006 respectively.
Gilead chose to design Tenofovir based medications with the TDF prodrug formulation so
that they could make maximize profits on sales of TDF. Gilead delayed releasing the TAF prodrug
formulation of Tenofovir based medications until at least 2014. Gilead delayed the release of this safer and
more effective formulation in order to maximize profits on sales of TDF and later on sales of TAF.
The Tenofovir based medications manufactured and supplied by Gilead were defective and
unsafe for their intended purpose in that the ingestion of Tenofovir based medications causes serious
injuries and/or death. The defects existed in Tenofovir based medications at the time they left Gilead's
possession.
Tenofovir based medications did, in fact, cause personal injuries as described above while
being used in a reasonably foreseeable manner, thereby rendering the Tenofovir based medications
defective, unsafe, and dangerous for use.
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
Gilead placed the Tenofovir based medications it manufactured and supplied into the stream
of commerce in a defective and unreasonably dangerous condition in that they did not meet the ordinary
safety expectations of patients and/or their prescribing physicians. Tenofovir based medications also were
defective and unreasonably dangerous because their design included TDF and presented excessive danger
that was preventable by designing the drugs to use the TAF prodrug formulation. Gilead knew that TAF
was a safer and more effective design for delivering the drug tenofovir to the body and further knew TAF
was capable of reducing the risk of bone and kidney damage to patients that occurred with using TDF as a
design for delivering tenofovir to the body.
The Tenofovir based medications Gilead manufactured and supplied was also defective due
to inadequate warning or instruction because Gilead knew or should have known that Tenofovir based
medications created a serious risk of harm to consumers and Gilead failed to adequately warn consumers
of the risks, including Plaintiff
Gilead knew and intended that Tenofovir based medications would be used by the ordinary
purchaser or user without inspection for defects therein and without knowledge of the hazards involved in
such use.
The Tenofovir based medications Gilead manufactured and supplied was defective due to
inadequate warning and inadequate testing.
The Tenofovir based medications Gilead manufactured and supplied were defective due to
inadequate post market warnings and instructions, because Gilead knew or should have known of the risk
of serious injury from Truvada and Atripla, however Gilead failed to provide adequate warnings to users
and consumers of the product, including Plaintiff , and continuedto promote the product.
On or before all times relevant to this matter, Gilead was aware that members of the general
public who would ingest their product, including Plaintiff , had no knowledge or information indicating
that use of their product could cause the alleged injuries, and Gilead further knew that members of the
general public who used their product, including Plaintiff , would assume, and in fact did assume, that said
use was safe, when said use was extremely hazardous to health and human life.
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
With this knowledge, Gilead opted to manufacture, design, label, distribute, offer for sale,
supply, sell, package, and advertise said product without attempting to protect said product users from, or
warn of, the high risk of injury or death resulting from its use.
Rather than attempting to protect users from, or warn them of, the high risk of injury or
death resulting from use of their product, Gilead intentionally failed to reveal their knowledge of the risks,
failed to warn of the risks and consciously and actively concealed and suppressed said knowledge from
members of the general public, including Plaintiff , thus impliedly representing to members of the general
public that Tenofovir based medications were safe for all reasonably foreseeable uses.
Gilead was motivated by their own financial interest in the continuing uninterrupted
manufacture, supply, sale, marketing, packaging and advertising of Truvada and Atripla.
In pursuit of this financial motivation, Gilead consciously disregarded the safety of product
users and in fact were consciously willing and intended to permit Tenofovir based medications to cause
injury to users and induced persons to purchase and use Truvada and Atripla, including Plaintiff
Gilead, their “alternate entities,” and their officers, directors and managing agents
participated in, authorized, expressly and impliedly ratified, and had full knowledge of, or should have
known, each of the acts set forth herein.
Gilead's conduct was and is willful, malicious, fraudulent, outrageous and in conscious
disregard of and indifference to the safety and health of the users of their product. Plaintiff for the sake of
example and by way of punishing said Gilead, seek punitive damages according to proof.
As a proximate and legal result of the defective and unreasonably dangerous condition of
Tenofovir based medications Gilead tested, manufactured and supplied, and the lack of adequate use
instructions and warnings, Plaintiffs werecaused to suffer the injury and damages.
COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL
SECOND CAUSE OF ACTION
NEGLIGENT PRODUCTS LIABLITY DESIGN DEFECT AND FAILURE TO WARN
(By Plaintiff against Defendant)
Plaintiff fully reallege and incorpora
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Jeffrey C. Bogert(SBN 132778) LAW OFFICES OF JEFFREY C. BOGERT 827 Moraga Dr. Los Angeles, CA 90049-1633 Tel: (424) 293-2272 Email address: Bogertlaw@outlook.com Roman Balaban (Pro hac vice application to be submitted) Andrew Ramos (Pro hac vice application to be submitted) BALABAN LAW, LLC 8055 E Tufts, Ave, Ste. 325 Denver, CO 80237 Tel: (303) 377-3474Fax: ( 303) 377-3576 Email address: balaban@denverfirm.com Email addres ramos@denverfirm.com Attorneys for Plaintiffs IN THE SUPERIOR COURT OF THE STATE OF CALIFORNIA COUNTY OF NTA CLARA WAYNE ROBINSON; MICHAEL BENNETT Case No.: DEANA GRAVETT; HENRYCREWS; MICHAEL SELL; HENRY TODD; JAMES COLLIER; ERNESTINE APONTE; JONAH MCPHAUL; COMPLAINT FOR DAMAGES; MICHAEL DECAMP; JUDITH MONTALVO; and DEMAND FOR JURY TRIAL MICHAEL MONTALVO; Strict Products Liability - Design Defect Plaintiffs, andFailure to Warn; 2. Negligent Products Liability - Design Defect and Failure to Warn; GILEAD SCIENCES, INC., a Delaware corporation Breach f Implied Warranty; doing business in California; Breach f Express Warranty Defendants. COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL Plaintiff WAYNE ROBINSON, MICHAEL BENNETT, DEANA GRAVETT, HENRY CREWS, MICHAEL SELL,HENRY TODD, JAMES C OLLIER, ERNESTINE APONTE, JONAH MCPHAUL, MICHAEL DECAMP, JUDITH MONTALVO, MICHAEL MONTALVO (“Plaintiffs” bring this personal injury action for a dangerously defective product against Defendant Gilead Sciences, Inc. (“Gilead”) to recover monetary damages and other remedies for violations of California law. I. INTRODUCTION Plaintiff ere prescribed and ingested Defendant Gilead's defectively dangerous antiviral medications containing the active ingredient tenofovir disoproxil fumarate for many years, suffering debilitating side effects such as kidney disease and osteoporosis. Plaintiff and the pharmaceutical and medical industries, generally misled by Defendant Gilead’s false statements, misrepresentations, and deliberate deceptions, to believe that these medications were the safest and most effective available, and that no safer alternative design existed that would have saved the Plaintif from these disastrous side effects. But Defendant Gilead Sciences not only knew of a better, safer, alternative design, it was Gilead itself that had invented this alternative safe design and shelved it prior to 2000 , waiting at minimum 15 years torelease the safer drug. Defendant Gilead Sciences invented, and subsequently, intentionally and knowingly suppressed, a life saving pharmaceutical with limited side effects, far better tolerated by the body, in order to maximize its profits from an inferior version of the same line of drugs. They thereby created a mechanism by which to maintain high profits and pursue a monopoly on this class of drugs, at the literal cost to patients of failed kidneys and broken bones. Plaintiff took Gilead's drugs as part of “highly active antiretroviral therapy” (“HAART”) to treat and manage HIV infection. See United States Provisional Patent Application No. 60/220021; European Provisional Patent Application Number 01961695.2. COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL Tenofovir disoproxil fumarate (“TDF”) is a prodrug of the compound tenofovir. TDF works by blocking the protein that HIV needs to replicate itself in the human body. TDF is Viread's only active ingredient. Tenofovir based medications can also include formulations like fixed dose combination tablets containing 300 milligrams of TDF and one or two additional drugs. Truvada, for example, combines TDF with 200 milligrams of emtricitabine, and Atripla adds one more medication to that combination, 600 mg of efavirenz. At the time Gilead designed, manufactured, and sold Truvada in 2004, and Atripla in 2006, Gilead knew, or should have known, that TDF was highly toxic in the doses prescribed and risked permanent and possibly fatal damage to the kidneys and bones. Instead of fully and completely investigating and disclosing the known and knowable risks associated with TDF, Gilead ignored and affirmatively misrepresented them. Before Gilead designed, manufactured, and sold Truvada and Atripla, and years before the U.S. Food and Drug Administration (“FDA”) approved these medications, Gilead had discovered and begun researching a safer and more effective design for the delivery of tenofovir to the body, tenofovir alafenamide fumarate ('TAF”). Indeed, even before Viread was approved by the FDA in 2001, Gilead knew that a tenofovir prodrug design using TAF instead of TDF would reduce the risks of toxicity and damage to kidney and bones. However, because Gilead enjoyed monopoly profits on its TDF containing drugs, including Truvada and Atripla, resulting from its patent on TDF, Gilead chose to withhold TAF from the market as the prodrug design for Truvada and Atripla and all other tenofovir based medications until November of By designing Tenofovir based medications with TAF in 2014 and 2016 under the names Odefsey and Descovy, Gilead demonstrated that it could have used the superior TAF compound from the very beginning. Such a design approach would have eliminated the need for TDF containing Truvada and Atripla, significantly improved the tolerance of tenofovir based medications in patients and helped advance Prodrugs are medicines that are not converted into their active form until they are processed inside the body. TDF is taken orally and after absorption it passes into the blood. See: U.S. Food and Drug Administration Approves Gilead's Single Tablet Regimen Genvoya (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV 1 Infection. Gilead. 5 November 2015. COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL the state of the science in the antiviral pharmaceutical industry. This decision would have helped to avoid countless, unnecessary injuries to the Plaintiff and all similarly situated persons. Such a pharmaceutical design policy would have avoided the aforementioned damages, but it would have reduced Gilead's monopoly profits from the sale of TDF. Accordingly, Gilead decided instead to inflict continuing harm upon thousands of patients and hold back medical and scientific inquiry and development for almost 20 years by concealing the superior compound, TAF. A design based upon TAF would have greatly improved and in some cases saved the lives of patients compliant with the TDF based treatment regimens, many of whom, like Plaintiff were on Gilead's medications for years. If Gilead had designed Tenofovir based medications with TAF, far fewer people, like the Plaintiff , would have developed bone loss or kidney damage as a result of taking Gilead's dangerously defective medications. ilead has long known of TAF's superior safety profile but has consistently chosen to place market share and profitability over patient safety. This Defendant has a demonstrable record, at least with respect to the current action, of choosing profits over people a particularly odious choice in a corporation ostensibly dedicated to producing compounds for the healing arts. By July 21, 2000, more than a year before Viread (the first TDF containing drug Gilead brought to market, and a predecessor and parent drug of Truvada) obtained FDA approval, Gilead submitted provisional patent applications to the U.S. and European Patent offices describing TAF, then called GS 7340, and stating its enhanced uptake by target cells, reduced cytotoxicity, and superior bioavailability, stability, and concentrations as compared to TDF. (See United States Provisional Patent Application No. 60/220021; European Provisional Patent Application Number 01961695.2). The provisional patent applications cited Gilead research dating back to 1997 showing that Defendant Gilead knew that TAF was 2 3 times more potent than Truvada and that it could obtain concentrations of tenofovir in target cells that were ten to thirty times higher than those attainable with Truvada. “As shown, [TAF is] 2 orders of magnitude more potent than all other nucleotides or nucleosides.” Id. COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL As early as April 2002, as prescriptions for TDF were growing along with Gilead's market share, Gilead was paying doctors to conduct studies of the safer prodrug TAF in patients around the country. These studies showed that TAF was far less toxic and confirmed that TDF's low absorption, high dosage, and potential bone and renal toxicity were real risks. But, Gilead did not publish this research, did not conduct clinical trialsof TAF, did not change its prescribing information, and did not instruct its sales representatives to begin informing doctors that the toxicities associated with TDF could be eliminated with a new, better drug. Gilead took none of these steps because TDF sales were booming and Viread had begun to corner the market in antiviral treatments for HIV. As Gilead kept doctors and patients in the dark about the toxicity, kidney, and bone loss risks associated with TDF, it could continue to increase its market shar with TDF. Gilead knew that it could hide the TAF development from the market and thereby protect its patent and profits on TDF. Further, by keeping TDF as the focus of its antiviral offerings, Gilead knew it would reap outsized future profits when it combined TDF with other patent protected drugs to create newly protected combination drugs that would prolong Gilead's ability to charge monopoly prices on TDF containing drugs. Gilead's deliberate delay in conducting TAF clinical trials deprived those suffering from HIV from using TAF for more than a decade and ensured that TDF would continue to dominate the market. These patients were thus forced to take TDF, which because of TDF's lower absorption rates caused and exacerbated higher bone and kidney toxicities. It is possible that HIV patients suffered from more than ten years of additional and wholly unnecessary accumulated kidney and bone toxicity from using TDF, while Gilead kept TAF hidden on the shelf. If Gilead had chosen to develop tenofovir in the safer and more effective TAF version, TDF would lose marketability it was less effective and had far higher risks and Gilead's profits from TDF would decrease. By holding on to its research and shelving TAF, Gilead could patent TAF separately and save it for development when their patent and exclusivity on TDF ran out, in twenty years. COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL In late 2003, Gilead continued to study TAF at the same time it was preparing its application to the FDA for Truvada the first TDF combination drug it would use to extend the profitability of its TDF patent. Also at this time, Gilead's own clinical evidence of TDF's toxicity and risks to kidneys and bones was building along with evidence from other studies. And yet, in spite of the clear and growing need to investigate and mitigate the risks associated with TDF, in October 2004, Gilead's CEO John C. Martin announced, “the company is discontinuing its development program” for TAF. Gilead's claim that it would discontinue research into TAF was a misrepresentation intended mislead the purchasing public, including prescribing doctors and patients taking TDF, into continuing to prescribe and take TDF. Indeed, Gilead did not discontinue development of TAF. Instead, between October 2004 and May 2005, Gilead applied for seven patents associated with it. By hiding research about TAF's superior safety profile and efficacy, and by continuing to downplay the risks associated with TDF, Gilead continued its scheme to mislead the public and maximize profits for TDF. Gilead knew of TAF's superior profile and the risks associated with TDF at least as far back as 2000. By the time Tenofovir based medications were submitted for approval to the FDA in 2004 and 2006, Gilead had long known that TDF toxicity led to kidney and bone damage, even in patients without pre existing kidney or bone issues. Gilead had a duty to share its exclusive knowledge of the risks associated with TDF. Gilead failed to do this. Instead, Gilead misrepresented the safety and benefits of TDF and failed to provide prescribing physicians and their patients with the information they needed to safely and reasonably prescribe and take Gilead's drugs. Gilead's tactics have allowed it to reap outsized profits. In 2015, Gilead was able to earn 90% Non GAAP Product Gross Margins. Gilead's tactics have led the New York Times to comment, “Gilead now is faced with figuring out what to do with all the cash it is generating.” Truvada consists of three different fixe dose combinations of tenofovir delivered as TDF and emtricitabine. Andrew Pollack, Sales of Solvadi, New Gilead Hepatitis C Drug, Soar to $10.3 Billion, NEW YORK TIMES (February 4, 2015) (emphasis added). COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL Gilead's high profits come from the steep costs of its drugs. High prices of drugs such as Gilead's Truvada ($18,456 per year) limit patient access either through exorbitant out pocket costs or pays, limitations in existing insurance, and rationing of these high priced pills. In its 2015 earnings Guidance, Gilead stated that it anticipated spending between 2.8 and 3 billion dollars on research and development, while earning a profit of roughly 23 billion dollars. Gilead spent approximately that much in 2015 on research and development but its profits in 2015 were $36.2 billion. Gilead first misrepresented TDF's safety profile as early as 2001, right after Viread's approval, through its sales representatives and CEO, claiming that TDF was a “miracle drug,” had “no toxicities,” was “benign,” and “extremely safe.” Gilead's CEO at the time, Dr. John C. Martin, would often refer to TDF as a miracle drug at sales meetings. He did so because he believed Gilead needed to overcome the perception in the medical community that Viread was like Gilead's previous HIV drugs and would likely cause kidney damage. Even after Gilead was reprimanded by the FDA in 2002 and 2003 for falsely claiming TDF had no toxicities and bore no risk to a patient's kidneys or bones, Gilead continued to misrepresent the risks through its Viread, Truvada, and Atripla prescription inserts and patient information sheets, which similarly downplayed the stated risks and misrepresented that toxicity, bone, or kidney damage was primarily a risk for patients with pre existing kidney or bone issues. Gilead made these misrepresentations even though it knew TDF had a high potential for toxicity and loss of bone mineral density in all patients. In its early stages of development, TDF animal toxicology studies showed that the bones and kidneys were the target organs for toxicity and that the bone toxicities included osteomalacia and decreases in bone mineral density. Clinical studies and adverse event reports from as early as 2001 and 2002 document severe renal deficiencies and toxicity in patients without any history of kidney problems. A 2003 case reported fatal renal insufficiency in a patient with only mild previous renal impairment. And studies as early as 2002 associate TDF with acute decreases in bone mineral density and bone loss. COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL Again, as early as 2002 and 2003, while Gilead's CEO was claiming TDF was a risk free, miracle drug, these reports and studies advised monitoring patients closely for early signs of toxicity, kidney failure, or bone loss, even several months after initiation of treatment and further recommended discontinuing treatmentas soon as possible to avoid the risk of permanent changes or damage. Long before Tenofovir based medications were submitted for approval to the FDA in 2004 and 2006, Gilead knew that TDF toxicity led to kidney and bone damage, even in patients without pr existing kidney or bone issues. Gilead had a duty to share its exclusive knowledge of the risks and warn of any known or scientifically knowable risks associated with use of TDF. Instead, Gilead misrepresented the safety and benefits of TDF and failed to provide prescribing physicians and their patients with the information they needed to safely and reasonably prescribe and take Gilead's drugs. Gilead had a duty to design and manufacture Tenofovir based medications in a manner that met the safety expectations of ordinary consumers and/or their prescribing physicians. Instead, Gilead designed Tenofovir based medications to contain TDF, the prodrug it knew caused bone and kidney damage, so that they could maximize their profits and monopoly on TDF. They deliberately avoided using the superior form of tenofovir which they had invented, and they deliberately undertook a course of action to suppress and conceal the existence of this superior form from the public. Plaintiff seek general and punitive damages and seek to hold Gilead accountable for its malicious and profit driven refusal to design tenofovir based medications in a safe and effective manner, utilizing the compound Tenofovir Alafenamide Fumarate, which it had repeatedly proven to be safer, with greater bioavailability and absorption than Tenofovir Disoproxil Fumarate prior to 2000. II. THE PARTIES Plaintiff Wayne Robinson is a resident of the State of California and the County of Los Angeles. Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient tenofovir disoproxil fumarate from approximately 200 until the present. Plaintiff was diagnosed with bone density loss and abnormal protein levels in the urine. Plaintiff was unaware that his injuries were caused by tenofovir disoproxil fumarate, and he was equally unaware that Defendant Gilead COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL Sciences had developed and deliberately suppressed from the market a safer form of this medication over 16 years ago, until within two (2) years of the filing of this action. Plaintiff Michael Bennett is a resident of the State of Kentucky and the County of Jefferson Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient tenofovir disoproxil fumarate from approximately 20 until the present. Plaintiff was diagnosed with bone density loss and low kidney function. Plaintiff was unaware that his injuries were caused by tenofovir disoproxil fumarate, and he was equally unaware that Defendant Gilead Sciences had developed and deliberately suppressed from the market a safer form of this medication over 16 years ago, until within two (2) years of the filing of this action. Plaintiff Deana Gravett is a resident of the State of Georgia and the County of Hall. Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient tenofovir disoproxil fumarate from approximately 201 until . Plaintiff was diagnosed with bone fractures and kidney failure. Plaintiff was unaware that her injuries were caused by tenofovir disoproxil fumarate, and she was equally unaware that Defendant Gilead Sciences had developed and deliberately suppressed from the market a safer form of this medication over 16 years ago, until within two (2) years of the filing of this action. Plaintiff Henry Crews is a resident of the State of Alabama and the County of Jefferson Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient tenofovir disoproxil fumarate from approximately April 2014 until December 2014. Plaintiff was diagnosed with chronic kidney disease and abnormal glomerular filtration rate. Plaintiff was unaware that his injuries were caused by tenofovir disoproxil fumarate, and he was equally unaware that Defendant Gilead Sciences had developed and deliberately suppressed from the market a safer form of this medicati over 16 years ago, until within two (2) years of the filing of this action. Plaintiff Michael Sell is a resident of the State of Florida and the County of Broward Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient tenofovir disoproxil fumarate from approximately 201 until . Plaintiff was diagnosed with brittle bones, bone density loss, avascular necrosis/osteonecrosis, osteoporosis and kidney failure. Plaintiff was COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL unaware that his injuries were caused by tenofovir disoproxil fumarate, and he was equally unaware that Defendant Gilead Sciences had developed and deliberately suppressed from the market a safer form of this medication over 16 years ago, until within two (2) years of the filing of this action. Plaintiff Henry Toddis a resident of the State of New Mexico and the County of Bernalilo Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient tenofovir disoproxil fumarate from approximately 2 until 201. Plaintiff was diagnosed with kidney failure. Plaintiff was unaware that his injuries were caused by tenofovir disoproxil fumarate, and he was equally unaware that Defendant Gilead Sciences had developed and deliberately suppressed from the market a safer form of this medication over 16 years ago, until within two (2) years of the filing of this action. Plaintiff James Collier is a resident of the State of Nevada and the County of Clark. Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient tenofovir disoproxil fumarate from approximately 20 until 20. Plaintiff was diagnosed with bone fractures, osteoporosis, and kidney failure. Plaintiff was unaware that his injuries were caused by tenofovir disoproxil fumarate, and he was equally unaware that Defendant Gilead Sciences had developed and deliberately suppressed from the market a safer form of this medication over 16 years ago, until within two (2) years of the filing of this action. PlaintiErnestine Aponte is a resident of the State of New Yorkand the County of Bronx Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient tenofovir disoproxil fumarate from approximately until laintiff was diagnosed with bone density loss, osteoporosis, and kidney failure. Plaintiff was unaware that h injuries were caused by tenofovir disoproxil fumarate, and he was equally unaware that Defendant Gilead Sciences had developed and deliberately suppressed from the market a safer form of this medication over 16 years ago, until within two (2) years of the filing of this action. Plaintiff Jonah McPhaul is a resident of the State of Texas and the County of Bexar. Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient tenofovir disoproxil fumarate from approximately 2 until . Plaintiff was diagnosed with low kidney function COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL Plaintiff was unaware that his injuries were caused by tenofovir disoproxil fumarate, and he was equally unaware that Defendant Gilead Sciences had developed and deliberately suppressed from the market a safer form of this medication over 16 years ago, until within two (2) years of the filing of this action. Plaintiff Michael Decamp is a resident of the State of New York and the County of New York. Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient tenofovir disoproxil fumarate from approximately 200 until 2018. Plaintiff was diagnosed with brittle bones and bone density loss. Plaintiff was unaware that his injuries were caused by tenofovir disoproxil fumarate, and he was equally unaware that Defendant Gilead Sciences had developed and deliberately suppressed from the market a safer form of this medication over 16 years ago, until within two (2) years of the filing of this action. Plaintiff Judith Montalvo is a resident of the State of Florida and the County of Brevard Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient tenofovir disoproxil fumarate from approximately until present . Plaintiff was diagnosed with broken bones, avascular necrosis/osteonecrosis, osteopenia and low kidney function. Plaintiff was unaware that injuries were caused by tenofovir disoproxil fumarate, and he was equally unaware that Defendant Gilead Sciences had developed and deliberately suppressed from the market a safer form of this medication over 16 years ago, until within two (2) years of the filing of this action. Plaintiff Michael Montalvo is a resident of the State of Florida and the County of Brevard. Plaintiff was prescribed and ingested Gilead's prescription medications containing the active ingredient tenofovir disoproxil fumarate from approximately 2010 until . Plaintiff was diagnosed with renal issues including but not limited to high creatine levels, abnormal protein levels and abnormal glomerular filtration rate levels. Plaintiff was unaware that h injuries were caused by tenofovir disoproxil fumarate, and he was equally unaware that Defendant Gilead Sciences had developed and deliberately suppressed from the market a safer form of this medication over 16 years ago, until within two (2) years of the filing of this action. COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL Defendant Gilead Sciences, Inc., is a corporation organized and existing under the laws of the State of Delaware, having its principal place of business at 333 Lakeside Drive, Foster City, California 94404. Gilead is a pharmaceutical company that develops and commercializes prescription medicines, including HAART medications for the treatment of HIV, with applications for the treatment of other viral infectious diseases. These medications include those containing tenofovir disoproxil fumarate, a dangerous drug with debilitating side effects, and a drug which could have been readily designed with the much safer compound, tenofovir alafenamide fumarate, invented at the same time or before TDF, by Defendant Gilead Sciences. These drugs were prescribed for and ingested by Plaintiff III. JURISDICTION AND VENUE This Court has jurisdiction over the subject matter of this action pursuant to California Code of Civil procedure§ 410.10 because a substantial portion of Gilead's acts occurred within the state of California. This court has personal jurisdiction over Defendant Gilead Sciences, Inc. as its principal place of business is located in the state of California. Venue is proper in the County of Santa Clara pursuant to California Code of Civil procedure §§ 395 because Plaintiff reside in California and a substantial portion of Gilead's negligence, misrepresentations, incomplete and misleading warnings, and fraudulent marketing practices occurred in the County of Santa Clara IV. GENERAL ALLEGATIONS Gilead Prepares TDF for Market Tenofovir was first discovered and identified for its anti viral properties in 1984 by scientists in the Czech Republic. Gilead purchased the right to sell Tenofovir in 1997. The original formulation of Tenofovir had limited sales potential, because it wasan intravenous drug. Gilead scientists later modified the chemical composition to create forms of tenofovir drugs that could be taken orally. These modified chemical compounds include tenofovir disoproxil fumarate (“TDF”), and tenofovir alafenamide fumarate (“TAF” and discussed later). Gilead opted to advance applications of tenofovir disoproxil fumarate in the late 1990s/early 2000s. The Food and Drug Administration approved an initial TDF formulation under the brand name Viread in October 2001. COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL TDF became the backbone of many HIV treatment regimes, while the alternative safe design, TAF, sat on a shelf at Gilead Sciences. The therapeutic use of multiple drugs operating in combination to treat HIV is known as Highly Active Antiretroviral Therapy ('“HAART”). HAART is aimed at reducing a patient's viral load and maintaining a patient's immune system. HAART regimens generally consist of three drugs: two drugs from the class of drugs known as Nucleoside Reverse Transcriptase Inhibitors (“NRTls”) and one drug from classes of drugs known as Non Nucleoside Reverse Transcriptase Inhibitors (“NNRTI”), Protease Inhibitors (“PI”), or Integrase Nuclear Strand Transfer Inhibitors (“INST]”). This combination is thought to be more effective at combating drug resistant strains. Tenofovir is an NRTI and is frequently used in HAART therapies. In addition to making TDF available as a standalone drug product under the brand name Viread, Gilead incorporated TDF in fixed dose combination pills including Atripla, Truvada, Stribild, and Complera. Gilead Knew of Bone and Kidney Risks Before FDA Approved TDF Originally marketed as a stand alone medication, Gilead obtained FDA approval to manufacture and sell TDF in October 2001 under the brand name Viread. Yet, before Gilead had finalized Viread for FDA approval in 2001, and long before either Truvada or Atripla were approved in 2004 and 2006, Gilead knew that TDF's low absorption rate meant it had to be administered in high doses to be effective. Before taking Viread to market, Gilead also knew that TDF in high doses placed immense pressure on the kidneys, the body's predominate method of eliminating the drug. Since scientists first synthesized TDF in 1997, studies of TDF showed that it could cause significant kidney damage and bone toxicity. This damage includes decreases in bone mineral density, osteopenia, osteoporosis, osteoporosis with pathologic fracture, Fanconi syndrome, chronic kidney disease, and end stage kidney disease. The toxicity of TDF known to Gilead at the time it was developing Viread in 2001 is particularly alarming because Gilead also knew and indeed likely intended that HIV infected patients would receive TDF treatment for decades, allowing the toxicity to build overtime, but ensuring the patient COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL would remain a purchaser of Gilead's TDF, at least until Gilead began marketing TAF, and essentially ensuring the patient would be a long term Gilead customer. When TDF was approved in October 2001, the FDA required Gilead to study whether it would harm humans. The FDA noted that Gilead “did not evaluate tenofovir DF in individuals with renal insufficiency” and “did not determine specific active secretion pathways” for the drug. Along with the FDA's recommendations for human study, it made clear that Gilead must properly examine and disclose the side effects TDF would have on the kidneys and whether it would build up to toxic levels in the body. Id. Gilead Studies Safer Prodrug TAF, Hides Results Gilead, however, has been more interested in maximizing the profits it has derived from TDF than it has been in disclosing the risks associated with the drug. About six or seven months before Viread was approved, in April 2001, Gilead scientists published research on a different prodrug of Tenofovir, called Tenofovir Alafenamide (“TAF”). In an attempt to reduce known side effects of TDF, Gilead conducted test tube and animal research studies on the prodrug and in April 2002, Gilead paid doctors to conduct clinical studies of TAF in HIV patients around the country. After learning that TAF had a higher absorption rate and largely avoided the bone and kidney toxicity associated with TDF, Gilead did not substitute TAF for TDF in the design of any of its drugs, including Viread, Truvada, and Atripla. In an act of extreme malice, Gilead also refused to publish its research on TAF, choosing instead to keep HIV infected patients and their doctors in the dark about the full risks associated with TDF, along with the solution to those risks, for over a decade. In 2014, as Gilead's patent on TDF approached its expiration and Gilead faced a sharp decrease in profits that would result from competition entering the market for TDF containing drugs, Gilead decided to release the results of the TAF studies it began conducting in 2001. These studies were Food and Drug Administration, CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW, New Drug Application (Viread) No. 21 356 pp. 1 7 (May 1, 2001). Martin Markowitz et al., Phase I/II study of the pharmacokinetics, safety and antiretroviral activity of tenofovir alafenamide, a new prodrug of the HIV reverse transcriptase inhibitor tenofovir, in HIV infected adults, J. ANTIMICROBIAL CHEMOTHERAPY, 69:1362 1369 (2014). COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL cited in support of three new combination drug applications containing TAF and approved, respectively, in November 2015 (Genvoya), March 2016 (Odefsey), and again in April 2016 (Descovy). The FDA Reprimands Gilead for its Misleading TDF Marketing Just after Viread's approval and in the two years leading up approval of Truvada, the FDA twice issued warning letters to Gilead over its TDF marketing practices, stating that their sales representatives had violated the law by giving doctors and patients false and misleading information regarding TDF's side effects. According to a 2002 FDA Warning Letter, Gilead salespeople falsely stated that TDF had “no toxicities,” was “benign,” and was “extremely safe.” A 2003 FDA Warning Letter to the uncommon step of requiring Gilead to retrain its sales representatives to provide accurate information regarding the significant side effects associated with TDF and comply with the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 352. In a shareholder lawsuit filed in 2009, a former Gilead employee and complaining witness stated that Gilead CEO Dr. John C. Martin would refer to Viread as a miracle product all the time at meetings. Another former employee and complaining witnesses confirmed this information and stated that Dr. Martin promoted Viread as a miracle drug because Gilead needed to overcome the perception in the medical community that Viread was like Gilead's previous HIV drugs and would likely cause kidney damage. Viread's original prescribing information and patient information sheet said little about the severe risk of toxicity in kidneys and concomitant risk of bone mineral density loss. The boxed warning for Viread has never mentioned TDF toxicity, bone, or kidney risks. And, the current label still only recommends assessment of bone mineral density for patients with a history of fracture or other risk factors for osteoporosis or bone loss. Gilead Misrepresents Risks Associated with Truvada Gilead's prescribing information and patient information sheets for Truvada did little to correct the tide of misrepresentations unleashed by its sales force and CEO only months before Truvada's launch into the market in 2004. Truvada's prescribing information failed to correct prior misrepresentations regarding the safety and efficacy of TDF and continued to misrepresent and minimize the risk of toxicity COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL and bone and kidney damage. Where Gilead did list potential patient concerns, it misrepresented the risks as primarily for already renally impaired or bone compromised patients. Truvada's original prescribing information insert and patient information sheet represent the risks of toxicity and bone and kidney damage as primarily a concern for patients with a history of bone and kidney problems. It was known to Gilead, or scientifically knowable, that the high doses of tenofovir necessary to make it bioavailable as TDF could lead to toxicity in the kidneys in all patients, even those without a history of renal dysfunction or other risk factors. As early as 2003, a case report had been published showing lethal renal toxicity in a patient without any history of renal impairment. Truvada's original prescribing information also misrepresents the risks to bone toxicity and bone mineral density loss. Mentioning “bone effects” on the twentieth page of the prescribing information sheet, it summarizes a 48 week clinical TDF study on baseline bone mineral density. Although it notes that decreases in BMD were seen at the lumbar spine and hip for patients taking TDF, it claims that the “clinical significance of the changes in BMD” were “unknown” and that bone monitoring should only be considered for patients “with a history of pathologic bone fracture or at substantial risk for osteopenia.” Referring to the same 48 week study, Gilead further misleadingly claimed that “there was no increased frequency of established toxicities” associated with taking TDF. Gilead's Truvada patient information sheet, provided at the end of the fifty six page prescribing information packet, compounds the misrepresentations by continuing to downplay the risks associated with Truvada, limiting its warnings to patients with “bone problems” or “kidney problems in the past or tak[ing] other medicines that can cause kidney problems.” The patient information sheet further falsely claims it “is not known whether long term use of TRUVADA will cause damage to your bones.” While Truvada's prescribing information and patient information sheets have undergone changes over the years, the current prescribing information and patient information sheets still fail to sufficiently warn consumers and their physicians about the risk of toxicity and severe bone and kidney problems. Truvada's current prescribing information and patient information sheet make sparse mention of the risks associated with long term TDF use in patients without a history of bone problems and COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL affirmatively misrepresent that such risks are primarily present for patients with a clinical history of bone and renal issues. Gilead knew or should have known as early as 2001 that TDF posed risks to the kidneys and bones of all patients, not just those with a clinical history of kidney and bone problems. Gilead not only failed to warn of these risks but made affirmative misrepresentations that such risks were posed primarily to patients with a history of kidney and bone problems. Gilead Misrepresents Risks Associated with Atripla In 2006, when Gilead began marketing and selling Atripla, it provided a prescribing information and patient information sheet with misrepresentations nearly identical to those in the Truvada and Viread materials. Atripla's original prescribing information generally limited its warnings to patients with a history of bone and kidney problems and similarly inaccurately claimed that the effects of TDF on BMD, long term bone health, and future fracture risk were “unknown.” Atripla's patient information sheet maintained the misrepresentations contained in Truvada's and Viread's materials, listing “kidney problems” as a possible side effect for patients with “kidney problems in the past or tak[ing] other medicines that can cause kidney problems” and “changes in bone mineral density” “[i]f you have had bone problems in the past,” while also claiming it was “not known whether long term use of ATRIPLA will cause damage to your bones.” Atripla's current prescribing information and patient information sheet continue to limit warnings for bone and kidney problems and toxicity as risks primarily affecting patients with a history of bone or kidney problems. Atripla's prescribing information and patient information sheet make sparse mention of the risks associated with long term TDF use in patients without a prior history of bone problems and affirmatively misrepresent that such risks are primarily present for patients with a clinical history of bone and renal issues. Gilead knew, or should have known, in 2006 that TDF posed risks to the kidneys and All of the prescribing information and patient information sheets for both Atripla and Truvada refer back to Gilead's materials for Viread, the single component name brand TDF that is contained in both Atripla and Truvada. COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL bones of all patients, not just those with a clinical history of kidney and bone problems. Gilead not only failed to warn of these risks but made affirmative misrepresentations that such risks were posed primarily to patients with a history of kidney and bone problems. V. CAUSES OF ACTION FIRST CAUSE OF ACTION STRICT PRODUCTS LIABILITY DESIGN DEFECT AND FAILURE TO WARN (By Plaintiff against Defendant) Plaintiff fully reallege and incorporate by reference each allegation made above as if fully set forth here and further allege as follows: Gilead designed, developed, manufactured, fabricated, tested or failed to test, inspected or failed to inspect, labeled, advertised, promoted, marketed, supplied, and distributed the prescription drugs containing the active ingredient tenofovir disoproxil fumarate. Gilead designed Tenofovir based medications to contain TDF as the prodrug formulation of tenofovir at least three years before Gilead submitted either Truvada or Atripla to the FDA for approval, in 2004 and 2006 respectively. Gilead chose to design Tenofovir based medications with the TDF prodrug formulation so that they could make maximize profits on sales of TDF. Gilead delayed releasing the TAF prodrug formulation of Tenofovir based medications until at least 2014. Gilead delayed the release of this safer and more effective formulation in order to maximize profits on sales of TDF and later on sales of TAF. The Tenofovir based medications manufactured and supplied by Gilead were defective and unsafe for their intended purpose in that the ingestion of Tenofovir based medications causes serious injuries and/or death. The defects existed in Tenofovir based medications at the time they left Gilead's possession. Tenofovir based medications did, in fact, cause personal injuries as described above while being used in a reasonably foreseeable manner, thereby rendering the Tenofovir based medications defective, unsafe, and dangerous for use. COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL Gilead placed the Tenofovir based medications it manufactured and supplied into the stream of commerce in a defective and unreasonably dangerous condition in that they did not meet the ordinary safety expectations of patients and/or their prescribing physicians. Tenofovir based medications also were defective and unreasonably dangerous because their design included TDF and presented excessive danger that was preventable by designing the drugs to use the TAF prodrug formulation. Gilead knew that TAF was a safer and more effective design for delivering the drug tenofovir to the body and further knew TAF was capable of reducing the risk of bone and kidney damage to patients that occurred with using TDF as a design for delivering tenofovir to the body. The Tenofovir based medications Gilead manufactured and supplied was also defective due to inadequate warning or instruction because Gilead knew or should have known that Tenofovir based medications created a serious risk of harm to consumers and Gilead failed to adequately warn consumers of the risks, including Plaintiff Gilead knew and intended that Tenofovir based medications would be used by the ordinary purchaser or user without inspection for defects therein and without knowledge of the hazards involved in such use. The Tenofovir based medications Gilead manufactured and supplied was defective due to inadequate warning and inadequate testing. The Tenofovir based medications Gilead manufactured and supplied were defective due to inadequate post market warnings and instructions, because Gilead knew or should have known of the risk of serious injury from Truvada and Atripla, however Gilead failed to provide adequate warnings to users and consumers of the product, including Plaintiff , and continuedto promote the product. On or before all times relevant to this matter, Gilead was aware that members of the general public who would ingest their product, including Plaintiff , had no knowledge or information indicating that use of their product could cause the alleged injuries, and Gilead further knew that members of the general public who used their product, including Plaintiff , would assume, and in fact did assume, that said use was safe, when said use was extremely hazardous to health and human life. COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL With this knowledge, Gilead opted to manufacture, design, label, distribute, offer for sale, supply, sell, package, and advertise said product without attempting to protect said product users from, or warn of, the high risk of injury or death resulting from its use. Rather than attempting to protect users from, or warn them of, the high risk of injury or death resulting from use of their product, Gilead intentionally failed to reveal their knowledge of the risks, failed to warn of the risks and consciously and actively concealed and suppressed said knowledge from members of the general public, including Plaintiff , thus impliedly representing to members of the general public that Tenofovir based medications were safe for all reasonably foreseeable uses. Gilead was motivated by their own financial interest in the continuing uninterrupted manufacture, supply, sale, marketing, packaging and advertising of Truvada and Atripla. In pursuit of this financial motivation, Gilead consciously disregarded the safety of product users and in fact were consciously willing and intended to permit Tenofovir based medications to cause injury to users and induced persons to purchase and use Truvada and Atripla, including Plaintiff Gilead, their “alternate entities,” and their officers, directors and managing agents participated in, authorized, expressly and impliedly ratified, and had full knowledge of, or should have known, each of the acts set forth herein. Gilead's conduct was and is willful, malicious, fraudulent, outrageous and in conscious disregard of and indifference to the safety and health of the users of their product. Plaintiff for the sake of example and by way of punishing said Gilead, seek punitive damages according to proof. As a proximate and legal result of the defective and unreasonably dangerous condition of Tenofovir based medications Gilead tested, manufactured and supplied, and the lack of adequate use instructions and warnings, Plaintiffs werecaused to suffer the injury and damages. COMPLAINT FOR DAMAGES; DEMAND FOR JURY TRIAL SECOND CAUSE OF ACTION NEGLIGENT PRODUCTS LIABLITY DESIGN DEFECT AND FAILURE TO WARN (By Plaintiff against Defendant) Plaintiff fully reallege and incorpora