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Jennifer A. Moore (SBN 206779)
jennifer@moorelawgroup.com
MOORE LAW GROUP, PLLC
1473 South 4" Street
Louisville, KY 40208
Tel: (502) 717-4080
Fax: (502) 717-4086
Attorney for Plaintiff
SUPERIOR COURT FOR THE STATE OF CALIFORNIA
COUNTY OF ALAMEDA
|
GILBERT ASTRUC, caevo This form may be used as an attachment to any summons if space doesinot permit the listing of all parties on the summons.
+ if this attachment is used, insert the following statement in the plaintiff or: ‘defendant box on the summons: "Additional Parties
Attachment form is attached.”
|
List additional parties (Check only one box. Use a separate page for each
| type of party.): .
[_] Plaintiff Defendant [_] Cross-Complainant OC Cross-Defendant
1
1. Boehringer Ingelheim USA Corporation;
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2. Boehringer Ingelheim Corporation; |
{
3. Pfizer, Inc.;
4. Sanofi US Services, Inc.;
5. Sanofi S.A.;
6. Sanofi-Aventis U.S. LLC;
7. The Vons Companies, Inc.; and
8. DOES | through 100 inclusive.
Page | of 1
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i Page 1 of 1
Form Adopted for Mandatory Use
Judicial Council of California ADDITIONAL PARTIES ATTACHMENT
SUM-200(A) [Rev. January 1, 2007] Attachment to Summons
For your protection and privacy, please press the Clear This Form | Le
| De aa 48 fe
|
t
. CM-010
Tennifer A. Moore (SBN S607 155"" State Bar number, and address): FOR courr USE ONLY
Moore Law Group, PLLC
1473 South 4th Street
Louisville, KY 40208
TeLePHoNE no.: (502) 717-4080 raxno: (502) 717-4086
ATTORNEY FOR (Name); Plainti
SUPERIOR COURT OF CALIFORNIA, COUNTY OF Alameda
sTREeT ADDRESS: 1225 Fallon Street
MAILING ADDRESS:
civy AND zIP cove: Oakland 946 12
BRANCH Name: Rene C. Davidson Courthouse
CASE NAME:
Gilbert Astruc v. GlaxoSmithKline, LLC, et al.
CIVIL CASE COVER SHEET Complex Case Designation CASE NUMBER:
Unlimited
(Amount
[_] Limited
(Amount
Oo Counter L_] Joinder
demanded demanded is Filed with first appearance by defendant wUpGE:
exceeds $25,000)
$25,000 or less) (Cal. Rules of Court, rule 3.402) DEPT:
items 1-6 below must be completed (see instructions on page 2).
1. Check one box below for the case type that best describes this case:
Auto Tort Contract Provisionally Complex Civil Litigation
Auto (22) |] Breach of contract/warranty (06) (Cal. Rules of Court, rules 3.400-3.403)
Uninsured motorist (46) L_] Rule 3.740 collections (09) [| AntitrustTrade regulation (03)
Other Pi/PD/WD (Personal Injury/Property (_] Other collections (09) L_] Construction defect (10)
Damage/Wrongful Death) Tort Lc] Insurance coverage (18) LC] Mass tort (40)
Asbestos (04) [] other contract (37) [__] Securities litigation (28)
Product liability (24) Real Property L_] Environmental/Toxic tort (30)
Medical malpractice (45) [__] Eminent domain/inverse [__] insurance coverage claims arising from the
[—] other PvPDAWD (23) condemnation (14) above listed provisionally complex case
Non-PI/PD/WD (Other) Tort L_] wrongful eviction (33) types (41)
L | Business tort/unfair business practice (07) L | Other real property (26) Enforcement of Judgment
CL] Civil rights (08) Untawful Detainer L_] Enforcement of judgment (20)
(__] Defamation (13) Commercial (31) Miscellaneous Civil Complaint
[] Fraud (16) [_] Residential (32) L_] rico (27)
(| intellectual property (19) LJ Drugs (38) L_] other complaint (not specified above) (42)
L_] Professional negligence (25) Judicial Review Miscellaneous Civil Petition
L_] other non-PuPDIWD tort (35) Asset forfeiture (05) Partnership and corporate governance (21)
Employment LC] Petition re: arbitration award (11) | Other petition (not specified above) (43)
Wrongful termination (36) L] Writ of mandate (02)
| Other employment (15) [ } Other judicial review (39) ;
2. This case L | is isnot complex under rule 3.400 of the California Rules of Court. If the case is complex, mark the
factors requiring exceptional judicial management:
a. L_] Large number of separately represented parties d. L | Large number of witnesses
b. L_] Extensive motion practice raising difficult or novel _e. L_] Coordination with related actions pending in one or more courts
issues that will be time-consuming to resolve in other counties, states, or countries, or in a federal court
c. L_] Substantial amount of documentary evidence _ ot _] substantial postijudgment judicial supervision
Remedies sought (check ail that apply): a. [v] monetary b.[] nonmonetary; declaratory or injunctive relief —_c. Lv ] punitive
aAnPrw
Number of causes of action (specify): Seven (7)
This case [] is Lv ] isnot aclass action suit.
If there are any known related cases, file and serve a notice of related case. (You may use form CM-015.)
Date: 05/11/2020 hy.
Jennifer A. Moore < eng Ue
(TYPE OR PRINT NAME) (/(SIGNATURE oer OR ATTORNEY FOR PARTY)
NOTICE
e Plaintiff must file this cover sheet with the first paper filed in the action or proceeding (except small claims cases or cases filed
under the Probate Code, Family Code, or Welfare and Institutions Code). (Cal. Rules of Court, rule 3.220.) Failure to file may result
in sanctions.
¢ File this cover sheet in addition to any cover sheet required by local court rule.
¢ If this case is complex under rule 3.400 et seq. of the California Rules of Court, you must serve a copy of this cover sheet on all
other parties to the action or proceeding.
¢ Unless this is a collections case under rule 3.740 or a complex case, this cover sheet will be used for statistical purposes only.
ge 1 of 2
Forn Adopted for Mandatory Use CIVIL CASE COVER SH EET Cal. Rules of Court, rules 2.30, 3.220, 3.400-3.403, 3.740;
Judicial Council of Catifornia Cal. Standards of Judicial Administration, std. 3.10
CM-010 [Rev. July 1, 2007] www. courtinfo.ca.gov
t ry
CM-010
INSTRUCTIONS ON HOW TO COMPLETE THE COVER SHEET
To Plaintiffs and Others Filing First Papers. If you are filing a first paper (for example, a complaint) in a civil case, you must
complete and file, along with your first paper, the Civil Case Cover Sheet contained on page 1. This information will be used to compile
statistics about the types and numbers of cases filed. You must complete items 1 through 6 on the sheet. In item 1, you must check
one box for the case type that best describes the case. If the case fits both a general and a more specific type of case listed in item 1,
check the more specific one. If the case has multiple causes of action, check the box that best indicates the primary cause of action.
To assist you in completing the sheet, examples of the cases that belong under each case type in item 1 are provided below. A cover
sheet must be filed only with your initial paper. Failure to file a cover sheet with the first paper filed in a civil case may subject a party,
its counsel, or both to sanctions under rules 2.30 and 3.220 of the California Rules of Court.
To Parties in Rule 3.740 Collections Cases. A "collections case" under rule 3.740 is defined as an action for recovery of money
owed in a sum stated to be certain that is not more than $25,000, exclusive of interest and attorney's fees, arising from a transaction in
which property, services, or money was acquired on credit. A collections case does not include an action seeking the following: (1) tort
damages, (2) punitive damages, (3) recovery of real property, (4) recovery of personal property, or (5) a prejudgment writ of
attachment. The identification of a case as a rule 3.740 collections case on this form means that it will be exempt from the general
time-for-service requirements and case management rules, unless a defendant files a responsive pleading. A rule 3.740 collections
case will be subject to the requirements for service and obtaining a judgment in rule 3.740.
To Parties in Complex Cases. -In complex cases only, parties must also use the Civil Case Cover Sheet to designate whether the
case is complex. If a plaintiff believes the case is complex under rule 3.400 of the California Rules of Court, this must be indicated by
completing the appropriate boxes in items 1 and 2. If a plaintiff designates a case as complex, the cover sheet must be served with the
complaint on all parties to the action. A defendant may file and serve no later than the time of its first appearance a joinder in the
plaintiffs designation, a counter-designation that the case is not complex, or, if the plaintiff has made no designation, a designation that
the case is complex.
CASE TYPES AND EXAMPLES
Auto Tort Contract Provisionally Complex Civil Litigation (Cal.
Auto (22}-Personal Injury/Property Breach of Contract/Warranty (06) Rules of Court Rules 3.400-3.403)
Damage/Wrongful Death Breach of Rental/Lease Antitrust/Trade Regulation (03)
Uninsured Motorist (46) (if the Contract (not unlawful detainer Construction Defect (10)
case involves an uninsured or wrongful eviction) Claims Involving Mass Tort (40)
motorist claim subject to Contract/Warranty Breach-Seller Securities Litigation (28)
arbitration, check this item Plaintiff (not fraud or negligence) Environmental/Toxic Tort (30)
instead of Auto) Negligent Breach of Contract/ Insurance Coverage Claims
Other Pi/PD/WD (Personal Injury/ Warranty (arising from provisionally complex
Property Damage/Wrongful Death) Other Breach of Contract/Warranty case type listed above) (41)
Tort Collections (e.g., money owed, open Enforcement of Judgment
Asbestos (04) book accounts) (09) Enforcement of Judgment (20)
Asbestos Property Damage Collection Case—Seller Plaintiff Abstract of Judgment (Out of
Asbestos Personal Injury/ Other Promissory Note/Collections County)
Wrongful Death Case Confession of Judgment (non-
Product Liability (not asbestos or Insurance Coverage (not provisionally domestic relations)
toxic/environmental) (24) complex) (18) Sister State Judgment
Medical Malpractice (45) Auto Subrogation Administrative Agency Award
Medical Malpractice— Other Coverage (not unpaid taxes)
Physicians & Surgeons Other Contract (37) Petition/Certification of Entry of
Other Professional Health Care Contractual Fraud Judgment on Unpaid Taxes
Malpractice Other Contract Dispute Other Enforcement of Judgment
Real Property Case
Other PI/PD/WD (23)
Premises Liability (e.g., slip Eminent Domain/Inverse Miscellaneous Civil Complaint
and fall) Condemnation (14) RICO (27)
Intentional Bodily Injury/PD/WD Wrongful Eviction (33) Other Complaint (not specified
(e.g., assault, vandalism) above) (42)
Other Real Property (e.g., quiet title) (26)
Intentional Infliction of Declaratory Relief Only
Writ of Possession of Real Property
Emotional Distress Injunctive Relief Only (non-
Mortgage Foreclosure
Negligent Infliction of harassment)
Quiet Title
Emotional Distress Mechanics Lien
Other Real Property (not eminent
Other PI/PD/WD Other Commercial Complaint
domain, landiord/tenant, or
Case (non-tort/non-complex)
Non-PI/PD/WD (Other) Tort foreclosure)
Other Civil Complaint
Business Tort/Unfair Business Unlawful Detainer
(non-tort/non-complex)
Practice (07) Commercial (31)
Miscellaneous Civil Petition
Civil Rights (e.g., discrimination, Residential (32) Partnership and Corporate
false arrest) (not civil Drugs (38) (if the case involves illegal Governance (21)
harassment) (08) drugs, check this item; otherwise, Other Petition (not specified
Defamation (e.g., slander, libel) report as Commercial or Residential) above) (43)
(13) Judicial Review Civil Harassment
Fraud (16) Asset Forfeiture (05) Workplace Violence
Intellectual Property (19) Petition Re: Arbitration Award (11) Elder/Dependent Adult
Professional Negligence (25) Writ of Mandate (02) Abuse
Legal Malpractice Writ-Administrative Mandamus
Election Contest
Other Professional Malpractice Writ-Mandamus on Limited Court
Petition for Name Change
(not medical or legal) Case Matter Petition for Relief From Late
Other Non-PI/PD/WD Tort (35) Writ-Other Limited Court Case Claim
Employment
Review Other Civil Petition
Wrongful Termination (36)
Other Judicial Review (39)
Other Employment (15) Review of Health Officer Order
Notice of Appeal-Labor
Commissioner Appeals
CM-010 (Rev. July 1, 2007) Page 2 of 2
CIVIL CASE COVER SHEET
Jennifer A. Moore (SBN 206779)
jennifer@moorelawgroup.com
MOORE LAW GROUP, PLLC
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1473 South 4" Street
Louisville, KY 40208
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Tel: (502) 717-4080
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Fax: (502) 717-4086
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Attorney for Plaintiff
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SUPERIOR COURT FOR THE STATE OF CALIFORNIA
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COUNTY OF ALAMEDA
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GILBERT ASTRUC, Case No.
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Plaintiff, COMPLAINT
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V. DEMAND FOR JURY TRIAL
12
GlaxoSmithKline, LLC; GlaxoSmithKline, ple;
13
Boehringer Ingelheim Pharmaceuticals, Inc.;
14 Boehringer Ingelheim USA Corporation;
Boehringer Ingelheim Corporation; Pfizer,
15 Inc.; Sanofi US Services, Inc.; Sanofi 8.A.;
Sanofi-Aventis U.S. LLC; The Vons
16
Companies, Inc.; and DOES 1 through 100
17 inclusive,
18 Defendants.
19
20
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] !
COMPLAINT ,
TABLE OF CONTENTS
Page
TABLE OF CONTENTS 2.00. cccccsesesesecserscenecseesecsecsessecsessesssenessesuassessesesesesensessesaecaseseeseesesseessessens 2
INTRODUCTION occ cccsesererenecsereeseesecsecseesecsecsecsessecsecsessessessessessessessesseseeeseeassaeeassasesecaseseeseeanens 3
PARTIES ounce cccccseceecnesseeeesesseescesessesevseceesesancaessecsecsecnessecaassesseceaseeseseesesenseeseesseseeseeasesessseneesessaens 4
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I. Plaintiff... cece sseseeesseseceesescecescsceeesceceecaessesessesesesesseseeesesesessenecseseeeacaesecseeecasseseenes 4
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II. Defendants 0... cece eeesssssecesseseseseenevesacacacseeeenenscsesecesenenseaeseeseeesaeaeaeeeeneeseases Pern)
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A. Manufacturer Defendant.............cecccsesseseeseeeesseestesneeneessesneeseeseenesnes veceesseeen 6
B. Retailer Defendant 0.0... cee ceeecceececeseceeesesceseseeeesesesecseeesseseeecseseseesseecsesessenes 10
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C. Doe Defendant... eescscssscseecesceceseceseseneeseseeeseseescseneseeseeecseseesesssecseseeeenes 10
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JURISDICTION AND VENUE .....cccccccsccsssesceseeseeseeseestesecsessecsecseesscseceeseseesaesseessesscsssssesecaucseeateneens 12
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FACTUAL ALLEGATIONS 000. cccccssessseesseeseeseesesseesecsesseesecsessessecseesseeeseasesseseeseesessecsseaseseeeeaeees 13
10 I. Regulatory History of Ranitidine-Containing Drugs..........cccccseseessccesecseeseesecssessenes 13
1] Il. Recalls and the FDA’S Bath... ccccscsccsceseeseeseeseeseesecsecseeseesecseesseseessesessssestssseaessseseeiekD
TI. = Dangers Of NDMA wn... ee ceececsssesessesceseeeseesesceseeseneeseesensesecssecesecsesseseseeesecssenseessseases 19
12
IV. How Ranitidine Transforms into NDMA Within the Human Body.............cccccccseees 24
13 A. Formation of NDMA in the Environment of the Human Stomach .................. 25
14 B. Formation of NDMA in the Other Organs of Human Body................ccceeeee 31
C. Formation of NDMA by Exposure to Heat and/or Time... cceeeeeseeeeeeees 33
15
D. Evidence Also Directly Links Ranitidine Exposure to Cancet...............0:0008 35
16 V. Defendants Made False Statements in the Labeling of Their Ranitidine-Containing
DYUQS. 20... eseeeeceeeeceeceeeesneceneceaeessceenseceseceseeceseeeseessaecssceseesseecsseeensecsesnseegsseseatesseeeseeens 36
17
VI. Defendants Knew or Should Have Known of the NDMA Risk ..........cecceseeesseseseesees 37
18 VII. Exemplary / Punitive Damages Allegations (Against Manufacturer Defendants) ....... 41
19 VUI. Equitable Tolling/Estoppel ....0... ccc cccccecescssscsscsseesceeeereesceseeseseeesessesseeaeesecsecseeseeseeseees 42
20
CAUSES OF ACTION 0.0... ccccccecescssesseeseeseeseeseesecseesecseesdesecseesecseseessecaesseesseecesseasecsesseeaeesseaesssenesseeseses 43
COUNT I: STRICT PRODUCTS LIABILITY — FAILURE TO WARN ........cccceeteeteees 43
21
COUNT II: STRICT PRODUCTS LIABILITY — MANUFACTURING DEFECT ................ 46
22 COUNT III: NEGLIGENCE — FAILURE TO WARN... ccececseeseeseeseeeeseeeeseeseeseeaeenseneeaes 48
23 COUNT IV: NEGLIGENT PRODUCT DESIGN o.oo ccccccccceseeseeseeeeseeeeseeseesesaeseeaeeseeneeaes 52
COUNT V: NEGLIGENT MANUFACTURING .......cccceecccsesscececseeseeseeseeaeeseesecaeeseeseeaeenseneenes 54
24
COUNT VI: NEGLIGENT MISREPRESENTATION .....00..ccccccsesceseeseeseeeeeeseeeeseeeeeesesees 56
25 COUNT VII: NEGLIGENCE .csscsssccsssssssssssssescessesssssussusisusssssasassssesesssessuesssususisssssssssssseeeees 58
26 JURY TRIAL DEMAND 000... cccccccscsecsssseseesscsecsesseeoessesseeseesesaseceseessesessessecsesssesecsesssenscsessecsecseenaes 59
PRAYER FOR RELIEF .....cccccccccscscscsssesseseceesecsessesseeoeeeeeeesessceseesessecseesesaessecsecseesessessecseesessscsecseseaees 59
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COMPLAINT
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INTRODUCTION
1. This is a personal injury action for damages relating to Defendants’ design,
manufacture, sale, marketing, advertising, promotion, testing, labeling, packaging, handling,
distribution, and storage of ranitidine-containing drugs including the brand name, Zantac, and its
various generic forms (“Ranitidine-Containing Drugs,” unless specifically identified).
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2. Plaintiff brings this action for personal injuries suffered as a result of ingesting the
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defective and unreasonably dangerous Ranitidine-Containing Drugs and developing various cancers
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and their sequelae as a result of this ingestion. |
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3. As more particularly set forth herein, Plaintiff maintains that the Ranitidine-
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10 Containing Drugs he ingested are defective, dangerous to human health, unfit and unsuitable to be
11 advertised, marketed, and sold in the United States, were manufactured improperly, and lacked
12 proper warnings of the dangers associated with their use.
13 4. N-Nitrosodimethylamine (“NDMA”) is a potent carcinogen. Discovered as a
14 byproduct in manufacturing rocket fuel in the early 1900s, today, its only use is to induce tumors in
15 animals as part of laboratory experiments. Its only function is to cause cancer. It has no business
16 being in a human body. ;
17 5. Zantac, the popular antacid medication that was used by millions of people every day,
18 leads to the production of staggering amounts of NDMA, The U.S. Food and Drug Administration’s
19 (“FDA”) allowable daily limit of NDMA is 96 ng (nanograms) and yet, in a single dose of Zantac,
20 researchers are discovering over 3 million ng. |
21 6. These recent revelations by independent researchers have caused widespread recalls of
22 Zantac and its generic forms both domestically and interhationally, including the domestic recall by
23 the current owner and controller of Zantac new drug applications (“NDA”). Recently, on April 1,
24 2020, the FDA ordered the immediate recall of all Ranitidine-Containing Drugs sold in the United
25 States citing unacceptable and unpreventable levels of NDMA accumulation. |
26 7. The high levels of NDMA observed in Ranitidine-Containing Drugs is a function of
27 the ranitidine molecule: (1) the way it breaks down in the human digestive system; (2) the way it
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COMPLAINT
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interacts with various enzymes in the human body; (3) the way it breaks down when exposed to heat,
in particular, during transport and storage; and (4) the way the molecule naturally degrades, over
time, into NDMA. As it stands, ingestion of Ranitidine-Containing Drugs leads to real-world levels
NDMA exposure that are proven to cause cancer.
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8. This lawsuit seeks to hold Defendants responsible for defective design, manufacturing,
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sale, marketing, advertising, promotion, testing, labeling, packaging, handling, distribution, and
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storage that caused Plaintiffs severe injuries.
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PARTIES
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I. Plaintiff
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10 9. Plaintiff, Gilbert Astruc, resides in California and is a citizen of California and no
11 other state. |
12 10. ‘Plaintiff started consuming brand prescription Ranitidine-Containing Drugs in 1985,
13 brand over-the-counter Ranitidine-Containing Drugs in 1995, and generic prescription and over-the-
14 counter Ranitidine-Containing Drugs in approximately 1997 until approximately 2018.
15 11. Asa direct and proximate result of consuming carcinogenic Ranitidine-Containing
16 Drugs, Plaintiff was diagnosed with bladder cancer.
17 12. Based on prevailing scientific evidence, exposure to Ranitidine-Containing Drugs (and
18 the attendant NDMA) can cause bladder cancer in humans.
19 13. | Had any Defendant warned Plaintiff that Ranitidine-Containing Drugs could lead to
20 exposure to NDMA or, in turn, cancer, Plaintiff would not have taken Ranitidine-Containing Drugs.
21 14. Plaintiff is informed and believes and based thereon alleges that as a direct and
22 proximate result of Plaintiff's use of and/or exposure to Ranitidine-Containing Drugs supplied and
23 distributed by Defendants herein, Plaintiff suffered significant harm, conscious pain and suffering,
24 physical injury and bodily impairment including, but not limited to cancer, other permanent physical
25 deficits, permanent bodily impairment and other sequelae. Plaintiff's injuries required
26 hospitalizations, in-patient surgeries, medication treatments, and other therapies to address the
27 adverse physical effects and damage caused by Plaintiff’s use of and/or exposure to Ranitidine-
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COMPLAINT
Containing Drugs.
15. Asa direct and proximate result of the wrongful conduct, acts, omissions, fraudulent
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concealments, fraudulent misrepresentations, and fraudulent business practices by Defendants and
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DOES 1 through 100, inclusive, Plaintiff used and/or was exposed to Ranitidine-Containing Drugs
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and were diagnosed with serious health injuries including bladder cancer.
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16. + Asaresult of using and/or being exposed to Defendants’ Ranitidine-Containing
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Drugs, Plaintiff has been permanently and severely injured, having suffered serious consequences
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from Ranitidine-Containing Drugs.
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17. Asa further direct and proximate result of defects in Ranitidine-Containing Drugs and
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, i.
10 the wrongful conduct, acts, omissions, and fraudulent misrepresentations of Defendants, Plaintiff
11 suffered severe mental and physical pain and have and will sustain permanent injuries and emotional
12 distress, along with economic loss due to medical expenses and living-related expenses as a result of
13 lifestyle changes.
'
14 18. Asa further direct and proximate result of defects in Ranitidine-Containing Drugs and
15 the wrongful conduct, acts, omissions, and fraudulent misrepresentations of Defendants, Plaintiff
16 required extensive emergency medical treatment, health care, attention and services, thereby
17 incurring medical, incidental, and service expenses pertaining to emergency medical treatments and
18 procedures undertaken in efforts to maintain and/or save Plaintiff
19 19. Plaintiff is an individual who suffered damages as a result of injuries resulting from
20 Plaintiff's use and/or exposure to Ranitidine-Containing Drugs and is authorized to bring an action
2] for the causes of actions alleged herein including, but not limited to, injuries and damages sustained
22 by Plaintiff, resulting from Plaintiff's use and/or exposure to Ranitidine-Containing Drugs. Said
23 injuries and damages sustained by Plaintiff were caused or substantially contributed to by the
24 wrongful conduct of Defendants and DOES 1 through 100, inclusive.
25 20. The product warnings for Ranitidine-Containing Drugs in effect during the time period
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26 Plaintiff used and/or were exposed to Ranitidine-Containing Drugs were vague, incomplete or
27 otherwise inadequate, both substantively and graphically, to alert consumers to the severe health risks
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COMPLAINT |
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associated with Ranitidine-Containing Drugs use and/or,exposure.
21. The Defendants and DOES 1 through 100, and each of them, inclusive, did not
provide adequate warnings to consumers including Plaintiff and the general public about the
increased risk of serious adverse events that are described herein.
22. Had Plaintiff been adequately warned of the potential life-threatening side effects of
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the Defendants’ and DOES 1 through 100, and each of them, inclusive, Ranitidine-Containing Drugs,
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Plaintiff would not have purchased, used or been exposed to Ranitidine-Containing Drugs.
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23. By reason of the foregoing, Plaintiff developed serious and dangerous side effects
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including bladder cancer and other cancers, related sequelae, physical pain and suffering, mental
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10 anguish, and loss of enjoyment of life. By reason of the foregoing, Plaintiff suffered economic losses
1] and special damages including, but not limited to, loss of earning and medical expenses. Plaintiffs
12 general and special damages are in excess of the jurisdictional limits of the Court.
13 24. Plaintiff has reviewed his potential legal claims and causes of action against the
14 Defendants and have intentionally chosen only to pursue claims based on state law. Any reference to
15 any federal agency, regulation or rule is stated solely as background information and does not raise a
16 federal question. Plaintiff has chosen to only pursue claims based on state law and are not making
17 any claims which raise federal questions. Accordingly, Plaintiff contends that California State
18 jurisdiction and venue is proper. |
19 iI. Defendants
20 A. Manufacturer Defendants
21 25. Defendant, Boehringer Ingelheim Pharmaceuticals, Inc., is a Delaware corporation
22 with its principal place of business located at 900 Ridgebury Road, Ridgefield, Connecticut 06877.
23 Boehringer Ingelheim Pharmaceuticals, Inc. is a citizen of Connecticut and Delaware, and not of any
24 other state. Boehringer Ingelheim Pharmaceuticals, Inc. is a subsidiary of the German company
25 Boehringer Ingelheim Corporation. Boehringer Ingelheim Pharmaceuticals, Inc. owned and
26 controlled the NDAs for over-the-counter (“OTC”) Zantac between December 2006 and January
27 2017, and manufactured and distributed the drug in the United States during that period. At all
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COMPLAINT
relevant times, Boehringer Ingelheim Pharmaceuticals, Inc. has conducted business and derived
substantial revenue from its manufacturing, advertising, distributing, selling, and marketing of Zantac
within the State of California and Alameda County.
26. Defendant, Boehringer Ingelheim USA Corporation, is a Delaware corporation with
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its principal place of business located in at 900 Ridgebury Rd., Ridgebury, Connecticut 06877.
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Boehringer Ingelheim USA Corporation is a citizen of Delaware and Connecticut and is not a citizen
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of any other state. At all relevant times, Boehringer Ingelheim USA Corporation has conducted
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business and derived substantial revenue from its manufacturing, advertising, distributing, selling,
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and marketing of Zantac within the State of California and Alameda County.
10 27. Defendant, Boehringer Ingelheim Corporation, is a German multinational
1] pharmaceutical corporation with its principal place of business located at Matthias Reinig 55216,
12 Ingelheim, Germany. Boehringer Ingelheim Corporation is the parent company of Defendants,
13 Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corporation. At all
14 relevant times, Boehringer Ingelheim Corporation has conducted business and derived substantial
15 revenue from its manufacturing, advertising, distributing, selling, and marketing of Zantac within the
16 State of California and Alameda County.
17 28. Collectively, Defendants, Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer
18 Ingelheim USA Corporation, and Boehringer Ingelheim Corporation, shall be referred to as
19 “Boehringer.”
20 29. Defendant, GlaxoSmithKline, LLC, is a Delaware limited liability company with its
21 principal place of business located at 5 Crescent Drive, Philadelphia, Pennsylvania, 19112 and Five
22 Moore Drive, Research Triangle, North Carolina, 27709. GSK is a citizen of Delaware. GSK is a
23 wholly owned subsidiary of GlaxoSmithKline, plc, which is its sole member. At all relevant times,
24 GSK has conducted business and derived substantial revenue from its manufacturing, advertising,
25 distributing, selling, and marketing of Zantac within the State of California and Alameda County.
26 30. Defendant, GlaxoSmithKline, plc, is a foreign entity and a citizen of the United
27 Kingdom, and is not a citizen of any state in the United States. GlaxoSmithKline, plc is the
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COMPLAINT
successor-in-interest to the companies that initially developed; patented, and commercialized the
molecule known as ranitidine. Ranitidine was initially developed by Allen & Hanburys Ltd., which
was a subsidiary of Glaxo Labs Ltd. Allen & Hanburys'Ltd. was awarded Patent No. 4,128,658 by
the U.S. Patent and Trademark Office in December 1978, which covered the ranitidine molecule. In
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1983, the FDA granted approval to Glaxo Holdings, Ltd. to sell Zantac in the United States. Glaxo
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Holdings, Ltd. was later absorbed into Glaxo Wellcome, PLC. And then, in 2000, GlaxoSmithKline,
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plc and GSK were created by the merger of Glaxo Wellcome and SmithKline Beecham. At all
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relevant times, GlaxoSmithKline, ple has conducted business and derived substantial revenue from its.
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manufacturing, advertising, distributing, selling, and marketing of Zantac within the State of
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10 California and Alameda County. !
i 31. Collectively, Defendants GlaxoSmithKline, LLC and GlaxoSmithKline, plc, shall be
12 referred to as “GSK.” GSK, and its predecessors, have controlled the prescription Zantac NDAs
13 since 1983.
14 32. Defendant, Pfizer, Inc. (“Pfizer”), is a Delaware corporation with its principal place of
15 business located at 235 East 42nd Street, New York, New York 10017. Pfizer is a citizen of
16 Delaware and New York and is not a citizen of any other state. In 1993, Glaxo Wellcome, ple
17 formed a joint venture with Warner-Lambert, Inc. to develop and obtain OTC approval for Zantac. In
18 1995, NDA 20-520 Zantac OTC 75 mg tablets were approved. In 1998, NDA 20-745 OTC Zantac
19 75 mg effervescent tablets were approved. Also, in 1998, Warner-Lambert and Glaxo Wellcome
20 ended their joint venture, with Warner-Lambert retaining control over the OTC NDA for Zantac and
21 the Zantac trademark in the United States and Glaxo Wellcome retaining control over the Zantac
22 trademark internationally.' In 2000, Pfizer acquired Wamer-Lambert and maintained control over
23 the Zantac OTC NDA until December 2006. At all relevant times, Pfizer has conducted business and
24 derived substantial revenue from its manufacturing, advertising, distributing, selling, and marketing
25 of Zantac within the State of California and Alameda County.
26
27 |
' See Warner-Lambert and Glaxo End A Venture on Ulcer Drug Zantac, WALL STREET JOURNAL
28 (Aug. 4, 1998), available at https://www.wsj.com/articles/SB902188417685803000.
8
COMPLAINT
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33. Defendant, Sanofi US Services, Inc., is a Delaware corporation with its principal place
of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807, and is a wholly owned
S
subsidiary of Sanofi S.A. Sanofi is a citizen of Delaware and New Jersey and is not a citizen of any
W
other state. Sanofi controlled the NDA for OTC Zantac sorting in January 2017 through the present
EP
and manufactured and distributed the drug in the United States during that period. Sanofi voluntarily
TD
recalled all brand name OTC Zantac on October 18, 2019. At all relevant times, Sanofi has conducted
Dn
business and derived substantial revenue from its manufacturing, advertising, distributing, selling,
Ss
and marketing of Zantac within the State of California and Alameda County.
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34. Defendant, Sanofi S.A., is a French multinational pharmaceutical company
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10 headquartered in Paris, France, with its principal place of business located at 54, Rue La Boetie, in
ae the 8" arrondissement. Defendant, Sanofi S.A., changed its name to Sanofi in May 2011. As of 2013,
12 Sanofi S.A. was the world’s fifth largest pharmaceutical company by prescription sales. At all
13 relevant times, Sanofi S.A. has conducted business and derived substantial revenue from its
14 manufacturing, advertising, distributing, selling, and marketing of Zantac within the State of
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{
15 California and Alameda County.
16 35. Defendant, Sanofi-Aventis U.S. LLC, was and is a Delaware limited liability company
17 with its principal place of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807.
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18 Sanofi-Aventis U.S. LLC is a citizen of Delaware and New Jersey and is not a citizen of any other
19 state. Sanofi-Aventis US LLC is a wholly owned subsidiary of Sanofi S.A. At all relevant times,
20 Sanofi-Aventis U.S. LLC has conducted business and derived substantial revenue from its
21 manufacturing, advertising, distributing, selling, and marketing of Zantac within the State of
;
22 California and Alameda County. 4
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23 36. Collectively, Defendants Sanofi US Services, Inc., Sanofi S.A., and Sanofi-Aventis
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24 U.S. LLC, shall be referred to as “Sanofi.” |
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25 37. Defendants, Boehringer, GSK, Pfizer, and Sanofi, shall be referred to collectively as
26 the “Manufacturer Defendants.” |
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