`
`
`
`Robert C. Hilliard (pro hac vice to be filed)
`HILLIARD MARTINEZ GONZALES LLP
`719 S. Shoreline Blvd.
`Corpus Christi, TX 78401
`Telephone: (361) 882-1612
`Facsimile: (361) 882-3015
`Email: bobh@hmglawfirm.com
`
`
`
`Steve W. Berman (pro hac vice to be filed)
`HAGENS BERMAN SOBOL SHAPIRO LLP
`1301 Second Avenue, Suite 2000
`Seattle, WA 98101
`Telephone: (206) 623-7292
`Facsimile: (206) 623-0594
`Email: steve@hbsslaw.com
`
`Shana E. Scarlett (SBN 217895)
`HAGENS BERMAN SOBOL SHAPIRO LLP
`715 Hearst Avenue, Suite 202
`Berkeley, CA 94710
`Telephone: (510) 725-3000
`Facsimile: (510) 725-3001
`Email: shanas@hbsslaw.com
`
`Attorneys for Plaintiffs
`[Additional Counsel Listed on Signature Page]
`
`
`UNITED STATES DISTRICT COURT
`
`NORTHERN DISTRICT OF CALIFORNIA
`
`No. ____________________
`AARON K. HOOPER, ALEATHEA BOWEN,
`ANDRE CURRENT, ANGELA VENABLE,
`
`ANTHONY HOLSTON, ARTHUR HAYES III,
`
`BRANDY POSPISIL, BRIDELEE GITTENS,
`COMPLAINT FOR DAMAGES
`CHRISTOPHER JONES, CORY M. BYNUM,
`
`CRAIG M. RIXNER, CURTIS HARVEY WATTS,
`
`DAVID HEARD, DIANE CLARK CHAVIS,
`JURY TRIAL DEMANDED
`DWAYNE SMITH, EDWARD N. DODSON,
`FLOYD EVANS, GREGORY J. WALKER,
`
`ILENE M. BELTON, JAMES W. TERRY,
`JAMISON D. MCGLOTHLEN, JESSE HODSON,
`JOHN KLIMOWICZ, LARY BANK, MARILYN
`FAULKS, MAURICE ROYAL, MONICA
`THOMPSON, NORMAN J. NESMITH, REGINA
`THOMPSON-XADU, RICHARD BERRYMAN,
`RICHARD J. TREITNER, ROBIN WARREN,
`RYAN L. ALLEN, TERRI BELL, TERRY
`BOURN, THOMAS L. GIST, TIMOTHY JOHN
`GAUB, TIMOTHY M. HOLLAND, TODD
`BAKER, TRACY OXENDINE, WILLIE
`BRASLEY, and YUSEF MOORE,
`
`v.
`
`GILEAD SCIENCES, INC.,
`
`
`
`
`Plaintiffs,
`
`Defendant.
`
`
`
`
`COMPLAINT FOR DAMAGES
`Case No.:
`010759-11/1558273 V1
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`Case 4:21-cv-04283 Document 1 Filed 06/04/21 Page 2 of 109
`
`TABLE OF CONTENTS
`
`Page
`NATURE OF THE ACTION .................................................................................................. 1
`JURISDICTION AND VENUE .............................................................................................. 5
`INTRADISTRICT ASSIGNMENT ........................................................................................ 5
`PARTIES ................................................................................................................................. 5
`FACTUAL ALLEGATIONS ................................................................................................ 21
`A.
`Background ................................................................................................................ 21
`Laws and regulations governing the approval and labeling of
`1.
`prescription drugs. ......................................................................................... 21
`Tenofovir and Gilead’s TDF- and TAF- containing drug
`products indicated for use in treating HIV. ................................................... 24
`Gilead knew before Viread was approved that TDF posed a significant
`safety risk. .................................................................................................................. 29
`Gilead’s knowledge of TDF toxicity grew as patients’ kidneys and
`bones were damaged by the TDF Drugs. .................................................................. 32
`Before Gilead developed Stribild, it knew that renal adverse events
`were more likely when patients took TDF as part of a boosted regimen. ................. 36
`Before Gilead developed each of the TDF Drugs, it knew that TAF
`was less toxic to kidneys and bones than TDF. ......................................................... 37
`Gilead withheld its safer TAF design to protect its TDF sales and
`extend profits on its HIV franchise. .......................................................................... 44
`Gilead knowingly designed its TDF drugs to be unreasonably
`dangerous and unsafe to patients’ kidneys and bones. .............................................. 46
`Gilead obtained FDA approval for its TAF-based products by relying
`on studies demonstrating TAF’s superiority over TDF. ............................................ 49
`Gilead markets TAF as superior to TDF. .................................................................. 51
`Gilead failed to adequately warn about the risks of TDF. ......................................... 56
`Gilead failed to adequately warn doctors about the risks of
`1.
`TDF. ............................................................................................................... 56
`Gilead failed to adequately warn patients about the risks of
`TDF. ............................................................................................................... 70
`Gilead could have unilaterally strengthened its TDF drug
`labels. ............................................................................................................. 72
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`H.
`
`I.
`J.
`
`2.
`
`2.
`
`3.
`
`
`
`
`I.
`II.
`III.
`IV.
`V.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`COMPLAINT FOR DAMAGES – i
`Case No.:
`010759-11/1558273 V1
`
`
`
`Case 4:21-cv-04283 Document 1 Filed 06/04/21 Page 3 of 109
`
`
`
`a.
`
`b.
`
`Gilead could have unilaterally strengthened its warnings
`before FDA approval. ........................................................................ 72
`Gilead could have unilaterally strengthened its warnings
`after FDA approval. ........................................................................... 73
`(1)
`Before August 22, 2008 ......................................................... 73
`(2)
`On and after August 22, 2008 through July 2012 ................. 74
`TOLLING OF THE STATUTE OF LIMITATIONS ........................................................... 79
`VI.
`VII. CLAIMS FOR RELIEF ......................................................................................................... 81
`COUNT I STRICT PRODUCTS LIABILITY – DESIGN DEFECT UNDER THE
`LAWS OF THE DISTRICT OF COLUMBIA AND THE STATES OF
`ARKANSAS, COLORADO, GEORGIA, NEW YORK, RHODE ISLAND,
`SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, WEST
`VIRGINIA, AND WISCONSIN ........................................................................................... 81
`COUNT II STRICT PRODUCTS LIABILITY – FAILURE TO WARN UNDER
`THE LAWS OF THE DISTRICT OF COLUMBIA AND OF THE STATES
`OF ARKANSAS, COLORADO, GEORGIA, NEW YORK, RHODE
`ISLAND, SOUTH CAROLINA SOUTH DAKOTA, TENNESSEE, WEST
`VIRGINIA, AND WISCONSIN ........................................................................................... 83
`COUNT III CONNECTICUT PRODUCTS LIABILITY ACT, CONN. GEN. STAT.
`52-572N ET SEQ .................................................................................................................. 85
`COUNT IV LOUISIANA PRODUCTS LIABILITY ACT, LA. R.S. §§ 9:2800.51, ET
`SEQ. ....................................................................................................................................... 87
`COUNT V WASHINGTON PRODUCTS LIABILITY ACT, REV. CODE WASH.
`§§ 7.72-010 ET SEQ. ............................................................................................................ 88
`COUNT VI NEGLIGENCE AND GROSS NEGLIGENCE UNDER THE LAWS OF
`THE DISTRICT OF COLUMBIA AND THE STATES OF ARKANSAS,
`COLORADO, GEORGIA, MASSACHUSETTS, NEW YORK, NORTH
`CAROLINA, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA,
`TENNESSEE, TEXAS, WEST VIRGINIA, AND WISCONSIN ........................................ 89
`COUNT VII FRAUD BY OMISSION UNDER THE LAWS OF THE DISTRICT OF
`COLUMBIA AND THE STATES OF ARKASNAS, COLORADO,
`GEORGIA, MASSACHUSETTS, NEW YORK, NORTH CAROLINA,
`RHODE ISLANDS, SOUTH CAROLINA, SOUTH DKOTA, TENNESSEE,
`TEXAS, WASHINGTON, WEST VIRGINIA, AND WISCONSIN ................................... 93
`COUNT VIII BREACH OF IMPLIED WARRANTY OF MERCHANTABILITY
`UNDER THE LAWS OF THE DISTRICT OF COLUMBIA AND THE
`STATES OF ARKANSAS, COLORADO, MASSACHUSETTS, NEW
`YORK, NORTH CAROLINA, RHODE ISLAND, SOUTH CAROLINA,
`SOUTH DAKOTA, TENNESSEE, TEXAS, AND WEST VIRGINIA ............................... 95
`COUNT IX VIOLATION OF STATE CONSUMER PROTECTION LAWS ................................ 97
`
`COMPLAINT FOR DAMAGES – ii
`Case No.:
`010759-11/1558273 V1
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`Case 4:21-cv-04283 Document 1 Filed 06/04/21 Page 4 of 109
`
`
`
`Arkansas, Ark. Code Ann. §§ 4-88-101 et seq. ................................. 99
`a.
`Colorado, Colo. Rev. Stat. §§ 6-1-101 et seq. ................................... 99
`b.
`Massachusetts, Mass. Gen. Laws Ch. 93A § 1 et seq. .................... 100
`c.
`New York: N.Y. Gen. Bus. Law § 349 ........................................... 100
`d.
`North Carolina, N.C. Gen. Stat. §§ 75-1.1 et seq. ........................... 101
`e.
`Rhode Island, R.I. Gen. Laws §§ 6-13.1 et seq. .............................. 101
`f.
`South Carolina, S.C. Code Ann. §§ 39-5-10 et seq. ........................ 102
`g.
`South Dakota, S.D. Codified Laws §§ 37-24-1 et seq. .................... 102
`h.
`Texas: Tex. Bus. & Com. Code Ann. §§ 17.41 et seq. .................... 103
`i.
`PRAYER FOR RELIEF .................................................................................................................. 104
`JURY DEMAND ............................................................................................................................. 105
`
`
`
`
`COMPLAINT FOR DAMAGES – iii
`Case No.:
`010759-11/1558273 V1
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`Case 4:21-cv-04283 Document 1 Filed 06/04/21 Page 5 of 109
`
`
`
`Plaintiffs bring this civil action for damages against Defendant Gilead Sciences, Inc.
`(“Gilead” or “Defendant”). Based on the investigation of counsel, Plaintiffs allege on information
`and belief as follows:
`
`I.
`NATURE OF THE ACTION
`1.
`This action arises out of injuries Plaintiffs sustained as a result of ingesting one or more
`of the prescription drugs Viread, Truvada, Atripla, Complera, and Stribild, which are manufactured
`and marketed by Gilead for the treatment of Human Immunodeficiency Virus-1 (“HIV”) infection.1
`2.
`Gilead designed each of the drugs to contain a form of the compound tenofovir that
`Gilead knew was toxic to patients’ kidneys and bones. Tenofovir is a nucleotide analogue reverse
`transcriptase inhibitor (“NRTI”), one of the classes of antiretroviral drugs used to treat HIV. NRTIs
`work by blocking an enzyme HIV needs to replicate. Gilead did not discover tenofovir. Scientists in
`Europe discovered tenofovir in the 1980s, and though the anti-HIV properties of tenofovir were
`promising, it had a downside: it cannot not be administered effectively by mouth.
`3.
`Because an intravenous tenofovir formulation had little sales potential, Gilead
`developed a form of tenofovir, tenofovir disoproxil, which can be taken orally.2 The fumaric acid salt
`of tenofovir disoproxil is tenofovir disoproxil fumarate (“TDF”). When a patient takes a pill containing
`TDF, the patient’s body converts TDF into tenofovir. Although TDF can be taken by mouth, a high
`dose of 300 mg is typically required to achieve the desired therapeutic effect.
`4.
`Gilead designed TDF 300 mg to be an active ingredient in five drugs that are approved
`to treat HIV: Viread (TDF 300 mg tablets), approved October 26, 2001; Truvada (TDF 300
`mg/emtricitabine 200 mg tablets), approved August 2, 2004; Atripla (TDF 300 mg/emtricitabine 200
`mg/efavirenz 600 mg tablets), approved July 12, 2006; Complera (TDF 300 mg/emtricitabine 200
`mg/rilpivirine 25 mg tablets), approved August 10, 2011; and Stribild (TDF 300 mg/emtricitabine 200
`
`
`1 Viread is also indicated to treat Hepatitis B. And Truvada is also indicated for use in combination
`with safe sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired
`HIV-1 in adults at high risk.
`2 Tenofovir disoproxil is a prodrug form of tenofovir. Prodrugs are pharmacologically inactive
`compounds that can be more efficiently absorbed into the bloodstream and then converted into the
`active form of the drug within the body.
`COMPLAINT FOR DAMAGES – 1
`Case No.:
`010759-11/1558273 V1
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`Case 4:21-cv-04283 Document 1 Filed 06/04/21 Page 6 of 109
`
`
`
`mg/elvitegravir 150 mg/cobicistat 150 mg tablets), approved August 27, 2012 (collectively, these are
`the “TDF Drugs”).
`5.
`Before Gilead began selling its first TDF Drug, Viread, in 2001, Gilead knew that TDF
`posed a safety risk to patients’ kidneys and bones. Gilead knew that two of its other antiviral drugs
`with structures similar to tenofovir, cidofovir and adefovir dipivoxil, had been highly nephrotoxic (i.e.,
`toxic to kidneys) and that preclinical data for TDF showed that it could cause significant kidney and
`bone damage. Gilead also knew that the relatively high dose of TDF created a greater risk of toxic
`effects, and that bone and kidney toxicities were even more likely to be seen with long-term use of
`TDF for the treatment of a virus that, for the foreseeable future, has no cure.
`6.
`Gilead’s knowledge of the toxic effects of TDF only grew as patients began treatment
`with and were injured by each successive TDF product. By the time Gilead designed Stribild, it had
`ten years’ worth of cumulative evidence that TDF injured patients’ kidneys and bones.
`7.
`Gilead also knew, before it obtained approval to market Viread and Gilead’s subsequent
`TDF Drugs, that it had discovered a safer tenofovir prodrug, tenofovir alafenamide fumarate (“TAF”).
`TAF is absorbed into the cells HIV targets much more efficiently than TDF. As a result, TAF can be
`administered at a dramatically reduced dose compared to TDF, but still achieve the same or higher
`concentrations of active tenofovir in the target cells. Because TAF can be administered at a much lower
`dose than TDF, its use is associated with less toxicity and fewer side effects. A 25 mg dose of TAF
`achieves the same therapeutic effect as a 300 mg dose of TDF, with a better safety profile. Despite
`knowing that TAF could be given at a much lower, safer dose, Gilead designed Viread, Truvada,
`Atripla, Complera, and Stribild to contain TDF rather than safer TAF.
`8.
`Falsely claiming that TAF was not different enough from TDF, Gilead abruptly shelved
`its TAF design in 2004. However, as John Milligan, Gilead’s President and Chief Executive Officer,
`later admitted to investment analysts, the real reason Gilead abandoned the TAF design was that TAF
`was too different from TDF. Once Gilead’s first TDF product, Viread, was on the market, Gilead did
`not want to hurt TDF sales by admitting that its TDF-based products are unreasonably and
`unnecessarily unsafe.
`
`COMPLAINT FOR DAMAGES – 2
`Case No.:
`010759-11/1558273 V1
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`Case 4:21-cv-04283 Document 1 Filed 06/04/21 Page 7 of 109
`
`
`
`9.
`It was crucial at that time for Gilead to increase Viread sales, which comprised 53% of
`Gilead’s total product sales in 2002, and 68% of Gilead’s total product sales in 2003. Gilead was so
`desperate to expand Viread sales that when promoting the drug to doctors, it called Viread a “miracle
`drug” with “no toxicities.” Gilead did not tell doctors the facts: that Viread posed significant risks to
`patients’ kidneys and bones.
`10.
`In addition, Gilead knew that by withholding the safer TAF design, it could extend the
`longevity of its HIV drug franchise and make billions two times over: first, with TDF medications
`until TDF patent expiration, which would begin by no later than 2018, and second, with TAF
`medications until TAF patent expiration as late as 2032. Only once Gilead realized billions in sales
`through most of the TDF patent life did it seek to market safer TAF-based versions of its HIV
`medications.
`11.
`Finally, in 2015, Gilead began selling the first of its TAF-designed medicines and
`convinced doctors to switch their patients from TDF-based to TAF-based regimens by demonstrating
`TAF’s superior safety profile over TDF with respect to kidney and bone toxicity—the very benefits
`that Gilead could have and should have incorporated into its prior product designs but withheld from
`doctors and patients for over a decade.
`12.
`Gilead also made Stribild even more dangerous to Plaintiffs when it designed the drug
`to include cobicistat in combination with 300 mg TDF. Cobicistat is a pharmacoenhancer or “booster”
`that inhibits the breakdown of elvitegravir, another active ingredient in Stribild. Cobicistat allows
`elvitegravir to persist in the patient’s system long enough to permit once-daily dosing.
`13.
`Gilead knew years before it developed Stribild that: (a) higher tenofovir concentrations
`in patients’ blood, as opposed to the target cells, endangers the kidneys; (b) tenofovir concentrations
`in patients’ blood increase significantly when patients take tenofovir with a booster; and (c) TDF-
`associated renal toxicity occurs more frequently in patients taking TDF as part of a boosted regimen.
`14. When Gilead developed its first TAF-based antiviral product, Genvoya—which is
`Stribild with TAF in place of TDF—Gilead reduced the dose of TAF from 25 mg to 10 mg to account
`for the fact that cobicistat significantly increases tenofovir concentrations. Gilead knew to reduce the
`dose of TAF in Genvoya before it submitted Stribild to the FDA for marketing approval. Despite this
`COMPLAINT FOR DAMAGES – 3
`Case No.:
`010759-11/1558273 V1
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`Case 4:21-cv-04283 Document 1 Filed 06/04/21 Page 8 of 109
`
`
`
`knowledge, Gilead did not reduce the dose of TDF when it designed Stribild. Stribild is even more
`toxic to patients’ kidneys and bones than Gilead’s other TDF-based products.
`15.
`In addition to withholding safer designs, Gilead failed to adequately warn physicians
`and patients about the risks and safe use of TDF. Gilead provided only the weakest, inadequate
`warnings to doctors and patients about the need for frequent monitoring of all patients for TDF-
`associated kidney and bone damage—preventing doctors from detecting early signs of TDF toxicity.
`16.
`Gilead provides stronger monitoring warnings to physicians and patients in the
`European Union (EU) than it does in the United States for the exact same TDF products. Contrary to
`its U.S. labeling, Gilead has consistently recommended, since the approval of its first TDF Drug in the
`EU, that doctors in the EU monitor all TDF Drug patients for multiple markers of TDF toxicity on a
`frequent, specified schedule. There is no scientific or medical rationale for these differences. Gilead
`was more concerned with increasing or maintaining crucial U.S. sales than it was in safeguarding
`patients from the known risks of TDF.
`17.
`Gilead could have strengthened the warnings in its U.S. labels at any time, including
`before FDA approval for all TDF Drugs and after FDA approval for Viread, Truvada, Atripla, and
`Complera. After August 2008 through July 2012, Gilead could have unilaterally strengthened the
`warnings in its TDF Drug labels after approval based on: increasing evidence that patients with and
`without preexisting risk factors were experiencing adverse effects with a frequency and severity greater
`than reported in Gilead’s Viread clinical trials; expanding evidence that all patients are at risk for TDF-
`induced nephrotoxicity; and Gilead’s own determinations to give stronger warnings regarding the
`exact same TDF Drugs in the EU. This post-approval information demonstrated risks of a different
`frequency and severity than information previously presented to the FDA.
`18.
`Gilead intentionally withheld a safer alternative design of TDF Drugs it knew to be
`dangerously toxic to patients’ kidneys and bones, while failing to adequately warn about the risks and
`safer use of the defective drugs, solely to make more money. Accordingly, Plaintiffs bring this action
`to recover damages for their personal injuries and seek punitive damages arising from Gilead’s willful
`and wanton conduct.
`
`COMPLAINT FOR DAMAGES – 4
`Case No.:
`010759-11/1558273 V1
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`Case 4:21-cv-04283 Document 1 Filed 06/04/21 Page 9 of 109
`
`
`
`II.
`JURISDICTION AND VENUE
`19.
`Jurisdiction exists under 28 U.S.C. § 1332(a) because all Plaintiffs and Gilead are
`citizens of different states and the matter in controversy exceeds the sum or value of $75,000, exclusive
`of interests and costs.
`20.
`Venue is proper in this District under 28 U.S.C. § 1391(1)–(2). Defendant resides in
`this District and a substantial part of the events and omissions giving rise to Plaintiffs’ claims occurred
`in this District.
`
`III.
`INTRADISTRICT ASSIGNMENT
`21.
`Pursuant to Civil L.R. 3-2(c), this action shall be assigned to the San Francisco Division
`or the Oakland Division because Gilead resides and has its principal place of business in San Mateo
`County. This action is related to another action pending before Judge Jon S. Tigar in the Northern
`District of California.
`
`IV.
`PARTIES
`22.
`Plaintiffs are consumers who ingested one or more of the following TDF Drugs: Viread,
`Truvada, Atripla, Complera, or Stribild.
`23.
`Plaintiffs suffered personal injuries caused by ingesting TDF.
`24.
`Plaintiff Aaron K. Hooper is and was at all relevant times a citizen of the State of
`Tennessee and domiciled in Nashville, Tennessee. Plaintiff Aaron K. Hooper purchased and ingested
`the following TDF Drug for an FDA-approved use of the drug: Truvada beginning in 2010. As a result
`of Gilead’s wrongful conduct with respect to the defective TDF Drug, Plaintiff ingested and was
`injured by the foregoing TDF Drug. Plaintiff’s ingestion of the TDF Drug caused and/or contributed
`to Plaintiff suffering Chronic Kidney Disease. Plaintiff required and incurred and will continue to
`require and incur expenses in connection with medical treatment as a result of these injuries. Plaintiff
`has endured and will continue to endure pain, suffering, mental anguish, and loss of enjoyment of life
`as a result of their injuries, has suffered lost earnings and/or a loss of earning capacity, and other
`injuries and damages to be proven at trial.
`25.
`Plaintiff Aleathea Bowen is and was at all relevant times a citizen of the State of North
`Carolina and domiciled in Greensboro, North Carolina. Plaintiff Aleathea Bowen purchased and
`COMPLAINT FOR DAMAGES – 5
`Case No.:
`010759-11/1558273 V1
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`Case 4:21-cv-04283 Document 1 Filed 06/04/21 Page 10 of 109
`
`
`
`ingested the following TDF Drugs for an FDA-approved use of the drugs: Viread, Truvada and Atripla
`beginning in 2005. As a result of Gilead’s wrongful conduct with respect to the defective TDF Drugs,
`Plaintiff ingested and was injured by the foregoing TDF Drugs. Plaintiff’s ingestion of the TDF Drugs
`caused and/or contributed to Plaintiff suffering Chronic Kidney Disease. Plaintiff required and
`incurred and will continue to require and incur expenses in connection with medical treatment as a
`result of these injuries. Plaintiff has endured and will continue to endure pain, suffering, mental
`anguish, and loss of enjoyment of life as a result of her injuries, has suffered lost earnings and/or a loss
`of earning capacity, and other injuries and damages to be proven at trial.
`26.
`Plaintiff Andre Current is and was at all relevant times a citizen of the State of Arkansas
`and domiciled in Hensley, Arkansas. Plaintiff Andre Current purchased and ingested the following
`TDF Drug for an FDA-approved use of the drug: Truvada beginning in 2005. As a result of Gilead’s
`wrongful conduct with respect to the defective TDF Drug, Plaintiff ingested and was injured by the
`foregoing TDF Drug. Plaintiff’s ingestion of the TDF Drug caused and/or contributed to Plaintiff
`suffering bone density loss. Plaintiff required and incurred and will continue to require and incur
`expenses in connection with medical treatment as a result of these injuries. Plaintiff has endured and
`will continue to endure pain, suffering, mental anguish, and loss of enjoyment of life as a result of his
`injuries, and has suffered other injuries and damages to be proven at trial.
`27.
`Plaintiff Angela Venable is and was at all relevant times a citizen of and domiciled in
`Washington, District of Columbia. Plaintiff Angela Venable purchased and ingested the following
`TDF Drugs for an FDA-approved use of the drugs: Truvada and Atripla beginning in 2004. As a result
`of Gilead’s wrongful conduct with respect to the defective TDF Drugs, Plaintiff ingested and was
`injured by the foregoing TDF Drugs. Plaintiff’s ingestion of the TDF Drugs caused and/or contributed
`to Plaintiff suffering bone demineralization, which resulted in a diagnosis of osteoporosis. Plaintiff
`required and incurred and will continue to require and incur expenses in connection with medical
`treatment as a result of these injuries. Plaintiff has endured and will continue to endure pain, suffering,
`mental anguish, and loss of enjoyment of life as a result of her injuries, and has suffered other injuries
`and damages to be proven at trial.
`
`COMPLAINT FOR DAMAGES – 6
`Case No.:
`010759-11/1558273 V1
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`Case 4:21-cv-04283 Document 1 Filed 06/04/21 Page 11 of 109
`
`
`
`28.
`Plaintiff Anthony Holston is and was at all relevant times a citizen of the State of
`Wisconsin and domiciled in Milwaukee, Wisconsin. Plaintiff Anthony Holston purchased and ingested
`the following TDF Drug for an FDA-approved use of the drug: Viread beginning in 2001. As a result
`of Gilead’s wrongful conduct with respect to the defective TDF Drug, Plaintiff ingested and was
`injured by the foregoing TDF Drug. Plaintiff’s ingestion of the TDF Drug caused and/or contributed
`to Plaintiff suffering high creatinine levels. Plaintiff required and incurred and will continue to require
`and incur expenses in connection with medical treatment as a result of these injuries. Plaintiff has
`endured and will continue to endure pain, suffering, mental anguish, and loss of enjoyment of life as a
`result of his injuries, and has suffered other injuries and damages to be proven at trial.
`29.
`Plaintiff Arthur Hayes, III, is and was at all relevant times a citizen of the State of
`Georgia and domiciled in Decatur, Georgia. Plaintiff Arthur Hayes, III, purchased and ingested the
`following TDF Drug for an FDA-approved use of the drug: Atripla beginning in 2014. As a result of
`Gilead’s wrongful conduct with respect to the defective TDF Drug, Plaintiff ingested and was injured
`by the foregoing TDF Drug. Plaintiff’s ingestion of the TDF Drug caused and/or contributed to
`Plaintiff suffering low kidney function. Plaintiff required and incurred and will continue to require and
`incur expenses in connection with medical treatment as a result of these injuries. Plaintiff has endured
`and will continue to endure pain, suffering, mental anguish, and loss of enjoyment of life as a result of
`their injuries, has suffered lost earnings and/or a loss of earning capacity, and other injuries and
`damages to be proven at trial.
`30.
`Plaintiff Brandy Pospisil is and was at all relevant times a citizen of the State of New
`York and domiciled in Waverly, New York. Plaintiff Brandy Pospisil purchased and ingested the
`following TDF Drug for an FDA-approved use of the drug: Truvada beginning in 2004. As a result of
`Gilead’s wrongful conduct with respect to the defective TDF Drug, Plaintiff ingested and was injured
`by the foregoing TDF Drug. Plaintiff’s ingestion of the TDF Drug caused and/or contributed to
`Plaintiff suffering high creatinine levels. Plaintiff required and incurred and will continue to require
`and incur expenses in connection with medical treatment as a result of these injuries. Plaintiff has
`endured and will continue to endure pain, suffering, mental anguish, and loss of enjoyment of life as a
`
`COMPLAINT FOR DAMAGES – 7
`Case No.:
`010759-11/1558273 V1
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`Case 4:21-cv-04283 Document 1 Filed 06/04/21 Page 12 of 109
`
`
`
`result of his injuries, has suffered lost earnings and/or a loss of earning capacity, and other injuries and
`damages to be proven at trial.
`31.
`Plaintiff Bridelee Gittens is and was at all relevant times a citizen of the State of New
`York and domiciled in New York, New York. Plaintiff Bridelee Gittens purchased and ingested the
`following TDF Drug for an FDA-approved use of the drug: Viread beginning in 2002. As a result of
`Gilead’s wrongful conduct with respect to the defective TDF Drug, Plaintiff ingested and was injured
`by the foregoing TDF Drug. Plaintiff’s ingestion of the TDF Drug caused and/or contributed to
`Plaintiff suffering Chronic Kidney Disease. Plaintiff required and incurred and will continue to require
`and incur expenses in connection with medical treatment as a result of these injuries. Plaintiff has
`endured and will continue to endure pain, suffering, mental anguish, and loss of enjoyment of life as a
`result of her injuries, has suffered lost earnings and/or a loss of earning capacity, and other injuries and
`damages to be proven at trial.
`32.
`Plaintiff Christopher Jones is and was at all relevant times a citizen of the State of
`Tennessee and domiciled in Jonesborough, Tennessee. Plaintiff Christopher Jones purchased and
`ingested the following TDF Drug for an FDA-approved use of the drug: Truvada beginning in 2012.
`As a result of Gilead’s wrongful conduct with respect to the defective TDF Drug, Plaintiff ingested
`and was injured by the foregoing TDF Drug. Plaintiff’s ingestion of the TDF Drug caused and/or
`contributed to Plaintiff suffering low kidney function. Plaintiff required and incurred and will continue
`to require and incur expenses in connection with medical treatment as a result of these injuries. Plaintiff
`has endured and will continue to endure pain, suffering, mental anguish, and loss of enjoyment of life
`as a result of his injuries, has suffered lost earnings and/or a loss of earning capacity, and other injuries
`and damages to be proven at trial.
`33.
`Plaintiff Cory M. Bynum is and was at all relevant times a citizen of the State of North
`Carolina and domiciled in Greensboro, North Carolina. Plaintiff Cory M. Bynum purchased and
`ingested the following TDF Drug for an FDA-approved use of the drug: Atripla beginning in 2009. As
`a result of Gilead’s wrongful conduct with respect to the defective TDF Drug, Plaintiff ingested and
`was injured by the foregoing TDF Drug. Plaintiff’s ingestion of the TDF Drug caused and/or
`contributed to Plaintiff suffering end-stage renal disease, requiring dialysis treatments and a kidney
`COMPLAINT FOR DAMAGES – 8
`Case No.:
`010759-11/1558273 V1
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`
`
`
`Case 4:21-cv-04283 Document 1 Filed 06/04/21 Page 13 of 109
`
`
`
`transplant. Plaintiff required and incurred and will continue to require and incur expenses in connection
`with medical treatment as a result of these injuries, including surgery. Plaintiff has endured and will
`continue to endure pain, suffering, mental anguish, and loss of enjoyment of life as a result of his
`injuries, has suffered lost earnings and/or a loss of earning capacity, and other injuries and damages to
`be proven at trial.
`34.
`Plaintiff Craig M. Rixner is and was at all relevant times a citizen of the State of
`Louisiana and domiciled in New Orleans, Louisiana. Plaintiff Craig M. Rixner purchased and ingested
`the following TDF Drugs for an FDA-approved use of the drugs: Viread beginning in 2001. As a result
`of Gilead’s wrongful conduct with respect to the defective TDF Drugs, Pl