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Michael L. Baum, Esq. (SBN: 119511)
mbaum@baumhedlundlaw.com ;
R. Brent Wisner (SBN: 276023) |
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rbwisner@baumhedlundlaw.com |
Pedram Esfandiary (SBN 312569)
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Adam Foster (SBN 301507) | ALAMEDA COUNTY
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afoster@baumhedlundlaw.com
Nicole K.H. Maldonado, Esq. (SBN 207715) | 7 MAY 1 1 3900
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nmaldonado@baumhedlundlaw. com CLERK OF THE SUEE
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BAUM, HEDLUND, ARISTEI & GOLDMAN, P.C. | B we 6
10940 Wilshire Blvd., 17th Floor ‘by
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Los Angeles, CA 90024 i
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Tel: (310) 207-3233 / Fax: (310) 820-7444 t
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Jennifer A. Moore (SBN 206779) \
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jennifer@moorelawgroup.com a t
10 MOORE LAW GROUP, PLLC
1473 South 4th Street ,
11 Louisville, KY 40208
Tel: (502) 717-4080 / Fax: (502) 717-4086 |
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Attorneys for Plaintiff i
13 i
14 SUPERIOR COURT FOR THE STATE OF CALIFORNIA
COUNTY OF ALAMEDA
15
16 Albert Muesse Cage No.
17
Plaintiff, COMPLAINT
18
v. DEMAND FOR JURY TRIAL
19 (
1
20 GlaxoSmithKline, LLC; GlaxoSmithKline,
PLC; Boehringer Ingelheim Pharmaceuticals,
21 INC.; Boehringer Ingelheim Corporation;
Boehringer Ingelheim USA Corporation;
22 Pfizer, INC.; Sanofi US Services INC.; Sanofi
23 S.A.; Sanofi-Aventis U.S. LLC; Kaiser
Permanente International; and Does 1 through
24 100 inclusive,
25
MAY 1 1 RECD
Defendants.
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27
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TABLE OF CONTENTS
Page
TABLE OF CONTENTS........esceesssteseeesseestessneeseesseeeneesneseneeenessncenssensseneessenssuseansessneesssearecssesesneranees 2
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INTRODUCTION ......ccecesceescecceceseeseetsceseseeseseeseeacsecseceesetsesecsecseeeseeaeeeesessceesaseeeserseseesseseesssasaesseaseneaes 4
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PARTIES o.oo. seeeeeccecsecececeseeeseescseenenscuessesaeseescecseeceeeseescessesecssesenerseeecsessaesessssusssesesesessscaseseseseasseneseenees 5
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I. Plaintiff .......eesessecsesesseseseessesseeesseeseenssnseeseceaseeseseeceeenecnceesaseneencansaseeceneassesenenseesentatsucnntantecs 5
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Il. Defendant ..........cceccsesseecseseeeeecescesevscesessesesesessesacescesesaessessessessessesaeeseeaessessesaesneeasenseseeats 7
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A. Manufacturer Defendants... esc sesecseeeeeeeeeercsersceessesessetssssessenenseseeaseeens 7
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B. Retailer Defendants........ssssssscsssssssssssssesessssesssssssssusesesssetsssessnsssessesesssessnenen 10
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10 C. Doe Defendants... eeeeseeeseeseeseserseeersesseecseceessesessesessessssassesessusseeeesneasees 10
11 JURISDICTION AND VENUE oo .eecceceecesceseseeeesecsceseneesceeeseeaeseesesecsesseeaesesseaceesseessaeesessenenseeersesaseees 12
12 FACTUAL ALLEGATIONS ...0.. escent teseteetsneesneseneeseesneseneeeseessnessneeeneeeaeesanseanecsnecsanenanecsae 13
13 I. Regulatory History of Ranitidine-Containing Products...............:cccccssceeseeseeeeeeereeeeenees 13
14 I. Recalls and the FDA’S Bana... ceececescesesesesseneceeesecsecsecssesseesessesscnecsesesecseeneeaecaseneeats 15
15 TH. Dangers of NDMA....... ccc eccccccesesssescenceenecesecseeesecenenseseeeeaecseeeseseaesseesseeseceaesscenseseaseanenas 19
16 IV. How Ranitidine Transforms into NDMA Within the Human BOdy.....eececcceseeereeeeees 24
17 A. Formation of NDMA in the Environment of the Human Stomach .................. 25
18 B. Formation of NDMA in the Other Organs of Human Body...........cccssseeeees 32
19 C. Formation of NDMA by Exposure to Heat and/or Time..............ceeeeeseeeeeeeee 34
20 D. Evidence Also Directly Links Ranitidine Exposure to Cancer... eee 36
21 V. Defendants Made False Statements in the Labeling of Their Ranitidine-Containing
PLOMUCES......:.cececsescesseseeetseeeeseeseenecseeatenevseeaecseeeesseesasseeseeedceeeseesseeeeteesaseseeeeeaetseteeeaensesags 37
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VI. Defendants Knew or Should Have Known of the NDMA Risk uu... cece cseeseereeneeeee 38
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VU. Exemplary / Punitive Damages Allegations (Against Manufacturer Defendants) ....... 42
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VII. Equitable Tolling/Estoppel occ eceececeeeeessesseessecssesnsceeeseeseseessessesseeseeessesseesneeses 43
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CAUSES OF ACTION ......ceceeccecssseceseeseseeseseeseeneesenesaeeeesesseceeeessenecesaeeeens Vesceaeceeaeeseseseneeceteseaeseeeneaes 44
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COUNT I: STRICT PRODUCTS LIABILITY — FAILURE TO WARN ...... cece 44
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COUNT II: STRICT PRODUCTS LIABILITY — MANUFACTURING DEFECT ............... 47
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COMPLAINT
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1 COUNT III: NEGLIGENCE — FAILURE TO WARN vwvsssssssssssesssssssssstesssssssunssetenessseneese 49
2 COUNT IV: NEGLIGENT PRODUCT DESIGN ii.sscscscscsssssssssssessesessssssssseseee esseeeeenseeeene52
3 COUNT V: NEGLIGENT MANUFACTURING).......ceccseeeee cssitststussssstasessstecsasessaseseasesessees 55
4 COUNT VI: NEGLIGENT MISREPRESENTATION eocssscescscsccsssssesevsscesssssesevessesssesesevesssesse 56
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5 COUNT VII: NEGLIGENCE .. .eeccccscssssesssessssesssees scssussisecsissstussatessisssisssiusssuessissssesssuesssessseseses 58
6 || JURY TRIAL DEMAND ooeeccccccccscccssecsseecseee: sestsessees sufpaseessnanseesuansneessnnnseessnnnseesennaseeesinnsseeseaneee 59
7 || PRAYER FOR RELIEF ceccsssescssscssesssssssssssscsssesessvessesssecs Iaenseeeeteevessesnsateeseesaseeeensesaseeeesesenestee 59
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COMPLAINT
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INTRODUCTION
1. This is a personal injury action for damages relating to Defendants’ design,
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manufacture, sale, marketing, advertising, promotion, testing, labeling, packaging, handling,
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distribution, and storage of ranitidine-containing drugs including the brand name, Zantac, and its
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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 they ingested are defective, dangerous to human health, unfit and unsuitable to be
1] 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 biproduct 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 when it is digested by the human body. The
19 U.S. Food and Drug Administration’s (“FDA”) allowable daily limit of NDMA is 96 ng (nanograms)
20 and yet, in a single dose of Zantac, 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 internationally, including the domestic recall by
23 the current owner and controller of the Zantac new drug application (“NDA”). Recently, on April 1,
24 2020, the FDA banned all Ranitidine-Containing Drugs sold in the United States.
25 7. The high levels of NDMA observed in Ranitidine-Containing Drugs is a function of
26 the ranitidine molecule: (1) the way it breaks down in the human digestive system; and (2) the way it
27 breaks down when exposed to heat, in particular, during transport and storage.
28 8. This lawsuit seeks to hold Defendants responsible for defective design, manufacturing,
4
COMPLAINT
sale, marketing, advertising, promotion, testing, labeling, packaging, handling, distribution, and
storage that caused Plaintiff's severe injuries.
PARTIES
I. Plaintiff
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9. Plaintiff resides in California and is a citizen of California and no other state.
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10. Plaintiff consumed brand-name and generic OTC and prescription Ranitidine-
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Containing Drugs starting in approximately 1987 until approximately 2019.
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11. Asadirect and proximate result of consuming carcinogenic Ranitidine-Containing
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Drugs, Plaintiff was diagnosed with kidney cancer.
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10 12. Based on prevailing scientific evidence, exposure to Ranitidine-Containing Drugs (and
11 the attendant NDMA) can cause kidney cancer in humans.
12 13. Had any Defendant warned Plaintiff that Ranitidine-Containing Drugs could lead to
13 exposure to NDMA or, in turn, cancer, Plaintiff would not have taken Ranitidine-Containing Drugs.
14 14. Plaintiff is informed and believes and based thereon alleges that as a direct and
15 proximate result of Plaintiff's use of and/or exposure to Ranitidine-Containing Drugs supplied and
16 distributed by Defendants herein, Plaintiff suffered significant harm, conscious pain and suffering,
17 physical injury and bodily impairment including, but not limited to cancer, other permanent physical
18 deficits, permanent bodily impairment and other sequelae. Plaintiffs injuries required
19 hospitalizations, in-patient surgeries, medication treatments, and other therapies to address the
20 adverse physical effects and damage caused by Plaintiff's use of and/or exposure to Ranitidine-
21 Containing Drugs.
22 15. As a direct and proximate result of the wrongful conduct, acts, omissions, fraudulent
23 concealments, fraudulent misrepresentations, and fraudulent business practices by Defendants and
24 DOES 1 through 100, inclusive, Plaintiff used and/or was exposed to Ranitidine-Containing Drugs
25 and were diagnosed with serious health injuries including cancer.
26 16. Asaresult of using and/or being exposed to Defendants’ Ranitidine-Containing
27 Drugs, Plaintiff has been permanently and severely injured, having suffered serious consequences
28 from Ranitidine-Containing Drugs
5
COMPLAINT
17. Asa further direct and proximate result of defects in Ranitidine-Containing Drugs and
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the wrongful conduct, acts, omissions, and fraudulent misrepresentations of Defendants, Plaintiff
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suffered severe mental and physical pain and have and will sustain permanent injuries and emotional
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distress, along with economic loss due to medical expenses and living-related expenses as a result of
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lifestyle changes. |
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18. Asa further direct and proximate result of defects in Ranitidine-Containing Drugs and
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the wrongful conduct, acts, omissions, and fraudulent misrepresentations of Defendants, Plaintiff
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required extensive emergency medical treatment, health care, attention and services, thereby
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incurring medical, incidental, and service expenses pertaining to emergency medical treatments and
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procedures undertaken in efforts to maintain and/or save Plaintiff.
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19. Plaintiff's an individual who suffered damages as a result of injuries resulting from
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Plaintiff's use and/or exposure to Ranitidine-Containing Drugs and is authorized to bring an action
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for the causes of actions alleged herein including, but not limited to, injuries and damages sustained
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by Plaintiffs, resulting from Plaintiffs’ use and/or exposure to Ranitidine-Containing Drugs. Said
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injuries and damages sustained by Plaintiff were caused or substantially contributed to by the
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wrongful conduct of Defendants and DOES 1 through 100, inclusive.
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20. The product warnings for Ranitidine-Containing Drugs in effect during the time period
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Plaintiff used and/or were exposed to Ranitidine-Containing Drugs were vague, incomplete or
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otherwise inadequate, both substantively and graphically, to alert consumers to the severe health risks
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associated with Ranitidine-Containing Drugs use and/or exposure.
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21. The Defendants and DOES 1 through 100, and each of them, inclusive, did not
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provide adequate warnings to consumers including Plaintiff and the general public about the
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increased risk of serious adverse events that are described herein.
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NO
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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NO
23. By reason of the foregoing, Plaintiff developed serious and dangerous side effects
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including cancer and other cancers, related sequelae, physical pain and suffering, mental anguish, and
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NO
6
COMPLAINT
loss of enjoyment of life. By reason of the foregoing, Plaintiff suffered economic losses and special
damages including, but not limited to, loss of earning and medical expenses. Plaintiffs general and
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special damages are in excess of the jurisdictional limits of the Court.
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24. Plaintiff has reviewed their potential legal claims and causes of action against the
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Defendants and have intentionally chosen only to pursue claims based on state law. Any reference to
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any federal agency, regulation or rule is stated solely as background information and does not raise a
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federal question. Plaintiff has chosen to only pursue claims based on state law and are not making
any claims which raise federal questions. Accordingly, Plaintiff contends that California State
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jurisdiction and venue is proper.
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10 i. Defendants
11 A. Manufacturer Defendants
12 25. | Defendant Boehringer Ingelheim Pharmaceuticals, Inc., is a Delaware corporation
13 with its principal place of business located at 900 Ridgebury Road, Ridgefield, Connecticut 06877.
14 Boehringer Ingelheim Pharmaceuticals, Inc. is a citizen of Connecticut and Delaware, and not of any
15 other state. Boehringer Ingelheim Pharmaceuticals, Inc. is a subsidiary of the German company
16 Boehringer Ingelheim Corporation. Boehringer Ingelheim Pharmaceuticals, Inc. owned and
17 controlled the NDA for over-the-counter (“OTC”) Zantac between December 2006 and January 2017,
18 and manufactured and distributed the drug in the United States during that period. At all relevant
19 times, Boehringer Ingelheim Pharmaceuticals, Inc. has conducted business and derived substantial
20 revenue from its manufacturing, advertising, distributing, selling, and marketing of Zantac within the
21 State of California and Alameda County.
22 26. Defendant, Boehringer Ingelheim Corporation, is a German multinational
23 pharmaceutical corporation with its principal place of business located at Matthias Reinig 55216,
24 Ingelheim, Germany. Boehringer Ingelheim Corporation is the parent company of Defendant,
25 Boehringer Ingelheim Pharmaceuticals, Inc. At all relevant times, Boehringer Ingelheim
26 Pharmaceuticals, Inc. has conducted business and derived substantial revenue from its manufacturing,
27 advertising, distributing, selling, and marketing of Zantac within the State of California and Alameda
28 County.
7
COMPLAINT
27. Defendant Boehringer Ingelheim USA Corporation, is a Delaware corporation with 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.
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28. Collectively, Defendants Boehringer Ingelheim Pharmaceuticals, Inc. and Defendant
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Boehringer Ingelheim USA Corporation shall be referred to as “Boehringer”.
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29. Defendant GlaxoSmithKline, LLC (“GSK”), is a Delaware limited liability company
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10 with its principal place of business located at 5 Crescent Drive, Philadelphia, Pennsylvania, 19112
1 and Five Moore Drive, Research Triangle, North Carolina, 27709. GSK is a citizen of Delaware.
12 GSK is a wholly owned subsidiary of GlaxoSmithKline, plc, which is its sole member. At all
13 relevant times, GSK has conducted business and derived substantial revenue from its manufacturing,
14 advertising, distributing, selling, and marketing of Zantac within the State of California and Alameda
15 County.
16 30. Defendant GlaxoSmithKline, ple, is a foreign entity and a citizen of the United
17 Kingdom, and is not a citizen of any state in the United States. GlaxoSmithKline, plc is the
18 successor-in-interest to the companies that initially developed, patented, and commercialized the
19 molecule known as ranitidine. Ranitidine was initially developed by Allen & Hanburys Ltd., which
20 was a subsidiary of Glaxo Labs Ltd. Allen & Hanburys Ltd. was awarded Patent No. 4,128,658 by
21 the U.S. Patent and Trademark Office in December 1978, which covered the ranitidine molecule. In
22 1983, the FDA granted approval to Glaxo Holdings, Ltd. to sell Zantac in the United States. Glaxo
23 Holdings, Ltd. was later absorbed into Glaxo Wellcome, PLC. And then, in 2000, GlaxoSmithKline,
24 plc and GSK were created by the merger of Glaxo Wellcome and SmithKline Beecham. At all
25 relevant times, GlaxoSmithKline, plc has conducted business and derived substantial revenue from its
26 manufacturing, advertising, distributing, selling, and marketing of Zantac within the State of
27 California and Alameda County.
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COMPLAINT
31. Collectively, Defendants GlaxoSmithKline, LLC and GlaxoSmithKline, plc shall be
referred to as “GSK.” GSK, and its predecessors, have controlled the prescription Zantac NDAs
since 1983.
32. Defendant, Pfizer, Inc. (“Pfizer”), is a Delaware corporation with its principal place of
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business located at 235 East 42nd Street, New York, New York 10017. Pfizer is a citizen of
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Delaware and New York and is not a citizen of any other state. In 1993, Glaxo Wellcome, plc
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formed a joint venture with Warner-Lambert, Inc. to develop and obtain OTC approval for Zantac. In
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1995, NDA 20-520 Zantac OTC 75 mg tablets were approved. In 1998, NDA 20-745 OTC Zantac
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75 mg effervescent tablets were approved. Also, in 1998, Warner-Lambert and Glaxo Wellcome
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10 ended their joint venture, with Warner-Lambert retaining control over the OTC NDA for Zantac and
11 the Zantac trademark in the United States and Glaxo Wellcome retaining control over the Zantac
12 trademark internationally.! In 2000, Pfizer acquired Warner-Lambert and maintained control over
13 the Zantac OTC NDA until December 2006. At all relevant times, Pfizer has conducted business and
14 derived substantial revenue from its manufacturing, advertising, distributing, selling, and marketing
15 of Zantac within the State of California and Alameda County.
16 33. | Defendant Sanofi US Services Inc., is a Delaware corporation with its principal place
17 of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807, and is a wholly owned
18 subsidiary of Sanofi S.A. Sanofi is a citizen of Delaware and New Jersey and is not a citizen of any
19 other state. Sanofi controlled the NDA for OTC Zantac starting in January 2017 through the present
20 and manufactured and distributed the drug in the United States during that period. Sanofi voluntarily
21 recalled all brand name OTC Zantac on October 18, 2019. At all relevant times, Sanofi has conducted
22 business and derived substantial revenue from its manufacturing, advertising, distributing, selling,
23 and marketing of Zantac within the State of California and Alameda County.
24 34. Defendant Sanofi S.A., is a French multinational pharmaceutical company
25 headquartered in Paris, France, with its principal place of business located at 54, Rue La Boetie, in
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.
9
COMPLAINT
1 || the 8" arrondissement. Defendant, Sanofi S.A., changed its name to Sanofi in May 2011. As of 2013,
2 |} Sanofi S.A. was the world’s fifth largest pharmaceutical company by prescription sales. At all
3 || relevant times, Sanofi S.A. has conducted business and derived substantial revenue from its
4 || manufacturing, advertising, distributing, selling, and marketing of Zantac within the State of
5 || California and Alameda County.
6 35. Defendant Sanofi-Aventis U.S. LLC, was and is a Delaware limited liability company
7 || with its principal place of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807.
8 || Sanofi-Aventis U.S. LLC is a citizen of Delaware and New Jersey and is not a citizen of any other
9 || state. Sanofi-Aventis US LLC is a wholly owned subsidiary of Sanofi S.A. At all relevant times,
10 || Sanofi-Aventis U.S. LLC has conducted business and derived substantial revenue from its
11 || manufacturing, advertising, distributing, selling, and marketing of Zantac within the State of
12 || California and Alameda County.
13 36. Collectively, Defendants Sanofi US Services Inc., Sanofi S.A., and Sanofi-Aventis
14 || U.S. LLC, shall be referred to as “Sanofi.”
15 37. Defendants, Boehringer, GSK, Pfizer, and Sanofi, shall be referred to collectively as
16 || the “Manufacturer Defendants.”
17 B. Retailer Defendants
18 38. Defendant Kaiser Permanente International (“Kaiser’’) is a California corporation with
19 || its headquarters and principal place of business located at One Kaiser Plaza, Oakland, California
20 ||94612. At all relevant times, Kaiser has conducted business and derived substantial revenue from its
21 || selling of Ranitidine-Containing Drugs within the State of California and Alameda County by
22 || operating a pharmacy which sells Ranitidine-Containing Drugs. Specifically, Kaiser supplied
23 || Plaintiff with the Ranitidine-Containing Drugs which caused Plaintiff's injuries.
24 C. Doe Defendants
25 39. The true names and/or capacities, whether individual, corporate, partnership,
26 |} associate, governmental, or otherwise, of Defendants DOES 1 through 100, inclusive, and each of
27 || them, are unknown to Plaintiff at this time, who therefore sues said Defendants by such fictitious
28 ||names. Plaintiffis informed and believes, and thereon alleges, that each Defendant designated herein
10
COMPLAINT
as a DOE caused injuries and damages proximately thereby to Plaintiff as hereinafter alleged; and
that each DOE Defendant is liable to the Plaintiff for the acts and omissions alleged herein below,
and the resulting injuries to Plaintiff, and damages sustained by Plaintiff. Plaintiff will amend this
Complaint to allege the true names and capacities of said DOE Defendants when that same is
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ascertained.
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40. Plaintiff is informed and believes, and thereon alleges, that at all times herein
mentioned, each of the Defendants and each of the DOE Defendants was the agent, servant,
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employee and/or joint venturer of the other co-Defendants and other DOE Defendants, and each of
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them, and at all said times, each Defendants and each DOE Defendant was acting in the full course,
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10 scope and authority of said agency, service, employment and/or joint venture.
11 41. Plaintiff is informed and believes and alleges that at all times mentioned herein,
12 Defendants and DOES 1 through 100, inclusive, and each of them, were also known as, formerly
13 known as and/or were the successors and/or predecessors in interest/business/product line/or a
14 | portion thereof, assigns, a parent, a subsidiary (wholly or partially owned by, or the whole or partial
15 owner), affiliate, partner, co-venturer, merged company, alter egos, agents, equitable trustees and/or
16 fiduciaries of and/or were members in an entity or entities engaged in the funding, researching,
17 studying, manufacturing, fabricating, designing, developing, labeling, assembling, distributing,
18 supplying, leasing, buying, offering for sale, selling, inspecting, servicing, contracting others for
19 marketing, warranting, rebranding, manufacturing for others, packaging and advertising of
20 Ranitidine-Containing Drugs. Defendants and DOES 1 through 100, inclusive, and each of them, are
21 liable for the acts, omissions and tortious conduct of its successors and/or predecessors in
22 interest/business/product line/or a portion thereof, assigns, parent, subsidiary, affiliate, partner, co-
23 venturer, merged company, alter ego, agent, equitable trustee, fiduciary and/or its alternate entities in
24 that Defendants and DOES 1 through 100, inclusive, and each of them, enjoy the goodwill originally
25 attached to each such alternate entity, acquired the assets or product line (or portion thereof), and in
26 that there has been a virtual destruction of Plaintiff's remedy against each such alternate entity, and
27 that each such Defendants has the ability to assume the risk spreading role of each such alternate
28 entity.
11
COMPLAINT
42. Plaintiff is informed and believes, and thereon alleges, that at all times herein
mentioned, that Defendants and DOES 1 through 100, inclusive, and each of them, were and are
corporations organized and existing under the laws of the State of California or the laws of some state
or foreign jurisdiction; that each of the said Defendants and DOE Defendants were and are authorized
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to do and are doing business in the States of California and Missouri and regularly conducted
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business in these States and in Alameda County.
43. Upon information and belief, at relevant times, Defendants and DOES 1 through 100,
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and each of them, inclusive, were engaged in the business of researching, developing, designing,
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licensing, manufacturing, distributing, selling, marketing, and/or introducing into interstate
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10 commerce and into the State of California, including in Alameda County, either directly or indirectly
1] through third parties or related entities, Ranitidine-Containing Drugs.
12 44. Atrelevant times, Defendants and DOES 1 through 100, inclusive, and each of them,
13 conducted regular and sustained business and engaged in substantial commerce and business activity
14 in the State of California, which included but was not limited to selling, marketing and distributing
15 Ranitidine-Containing Drugs in the State of California and Alameda County.
16 45. At all relevant times, Defendants and DOES 1 through 100, inclusive, and each of
17 them, expected or should have expected that their acts would have consequences within the United
18 States of America including the State of California and including Alameda County, said Defendants
19 derived and derive substantial revenue therefrom.
20 JURISDICTION AND VENUE
21 46. This Court has jurisdiction over this action pursuant to the California Constitution
22 Article VI, Section 10, which grants the Superior Court “original jurisdiction in all causes except
23 those given by statute to other trial courts.” The Statutes under which this action is brought do not
24 specify any other basis for jurisdiction. |
25 47. This Court has personal jurisdiction over each Defendant insofar as each Defendant is
26 authorized and licensed to conduct business in the State of California, a resident of the State of
27 California, maintains and carries on systematic and continuous contacts in the State of California,
28 regularly transacts business within the State of California, and regularly avails itself of the benefits of
12
COMPLAINT
the State of California.
48. Additionally, Defendants caused tortious injury by acts and omissions in this judicial
jurisdiction and caused tortious injury in this jurisdiction by acts and omissions outside this
jurisdiction while regularly doing and soliciting business, engaging in a persistent course of conduct,
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and deriving substantial revenue from goods used or consumed and services rendered in this
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jurisdiction.
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49. Venue 1s proper in this Court pursuant to California Code of Civil Procedure Section
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395(a) in that the headquarters and principal place of business of Defendant Kaiser is in Alameda
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County. |
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10 50. Plaintiff seeks relief that is within the jurisdictional limits of the Court.
ol FACTUAL ALLEGATIONS
12 L Regulatory History of Ranitidine-Containing Products
13 51. Defendants marketed and sold Ranitidine-Containing Drugs under the brand name
14 “Zantac” or its generic version by either prescription or OTC. Defendants sold Ranitidine-
15 Containing Drugs in the following forms: injection, syrup, and/or tablets and capsules.
16 52. Zantac (ranitidine) was originally discovered and developed by scientist John
17 Bradshaw on behalf of GSK? in 1976. |
18 53. The drug belongs to a class of medications called histamine H2-receptor antagonists
19 (or H2 blockers), which decrease the amount of acid produced by cells in the lining of the stomach. ©
20 Other drugs within this class include cimetidine (Tagamet), famotidine (Pepcid), and nizatidine
21 (Tazac). |
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22 | 54. Cimetidine (Tagamet), discovered and developed by Smith, Kline and French’, was
23 the first Hz blocker to be developed and is the prototypical histamine H2 receptor antagonist from
24 |
25 * Dr. Bradshaw was working for Glaxo Inc. at the time. Glaxo Inc. later merged with the Wellcome
| 26 Foundation in 1995 to become Glaxo Wellcome plc. Then, in 2000, Glaxo Wellcome plc merged
: with Smithkline Beecham plc to form GlaxoSmithKline plc one of the defendants in this MDL. For
the purposes of this PIMC, these entities will be referred to as GSK.
3 Smith, Kline and French later merged with the Beecham Group in 1989 to form SmithKline
28 .
Beecham plc. And, as discussed above, SmithKline Beecham plc was merged into GSK in 2000.
| 13
| COMPLAINT
|
which the later members of the class were developed. Indeed, Zantac was specifically developed by
&
GSK in response to the success of cimetidine.
NO
55. | Zantac was approved by the FDA, pursuant to the New Drug Application (“NDA”) |
W
process in 1983 (NDA 18-703) and, quickly, became one of GSK’s most successful products, being
BP
the first prescription drug in history to reach $1 billion in sales, which in the pharmaceutical industry
WNW
is referred to as a “Blockbuster.”
DB
56. In 1993, GSK entered into a joint venture with Pfizer* to develop an OTC version of
TD
Zantac. That joint venture led to FDA approval of an OTC version of Zantac in 1995. Zantac OTC
oOo
was approved through an NDA process (NDA 20-520).
Oo
57. In 1997, GSK’s patent on ranitidine expired, and generic Ranitidine-Containing Drugs
SDS
el
entered the market. Despite generic entry, however, brand name prescription and OTC Zantac
FH
ee
continued to be sold. Although sales of brand-name Zantac declined as a result of generic and
YO
eee
alternative products, Ranitidine-Containing Drug sales remained strong over time. As recently as
WD
2018, Zantac was one of the top 10 antacid tablet brands in the United States, with sales of Zantac
FF
Re
150 totaling $128.9 million—a 3.1% increase from the previous year.
DO
58. In 1998, the joint venture between GSK and Pfizer dissolved. As part of the
RoR
separation, GSK retained the rights to sell all forms of Zantac internationally and prescription Zantac
IDA
RO
in the U.S., while Pfizer retained the rights to sell OTC Zantac domestically and retained ownership
BH
over the Zantac trademark. Under this agreement, GSK retained control and responsibility over the
BO
=
prescription Zantac NDA and Pfizer retained control and responsibility over the OTC Zantac NDA.
OD
KN
59. In October 2000, Pfizer obtained full rights to OTC Zantac in the United States and
|-
KN
Canada from GSK pursuant to a divestiture and transfer agreement. As part of this agreement, GSK
NY
KN
divested all domestic Zantac OTC assets to Pfizer including all trademark rights and removed the
WHY
KH
restrictions on Pfizer’s ability to seek product line extensions or the approval for higher doses of OTC
FF
NHN
AH
NO
HN
NO
* The joint venture was between Glaxo Wellcome plc and Warner-Lambert, Inc. Warner-Lambert
st
wo
was later acquired by Pfizer, Inc. in 2000. For the purposes of this PIMC, Warner-Lambert will be
ao
NO
referred to as Pfizer.
14
COMPLAINT
Zantac. GSK retained the right to exclusive use of the Zantac name for any prescription ranitidine-
containing product in the US.
bd
60. ‘In October 2003, Pfizer submitted NDA 21-698 for approval to market OTC Zantac
WH
150 mg. The FDA approved NDA 21-698 OTC Zantac 150 mg on August 31, 2004.
b
61. In 2006, Pfizer through a divestiture agreement, transferred all assets pertaining to its
MN
Zantac OTC line of products, including the rights to sell and market all formulations of OTC Zantac
DW
in the United States and Canada, as well as all intellectual property, research and development, and
NS
customer and supply contracts to Boehringer Ingelheim Pharmaceuticals, Inc. As part of this deal,
CO
Boehringer obtained control and responsibility over all of the Zantac OTC NDAs.
oO
10 62. In 2009, GSK ceased marketing prescription Zantac in the U.S. and abandoned the
11 Zantac prescription NDA. Although, according to GSK’s recent annual report (2019), GSK claims to
12 have “discontinued making and selling prescription Zantac tablets in 2017 ... in the U.S.”
13 63. In 2016, Boehringer sold the rights of OTC Zantac to Sanofi US Services, Iric. As part
14 of this deal, Sanofi obtained control and responsibility over the OTC NDA and currently retains that
15 control and responsibility.
16 64. To date, the FDA has approved numerous generic manufacturers for the sale of
17 prescription and OTC Ranitidine-Containing Drugs through an Abbreviated New Drug Application
18 (“ANDA”) process.
19 II. Recalls and the FDA’s Ban
20 65. On September 9, 2019, pharmacy and testing laboratory Valisure LLC and
21 ValisureRX LLC (collectively, “Valisure”) filed a Citizen Petition calling for the recall of all
22 ranitidine-containing products due to exceedingly high levels of NDMA found in ranitidine pills.
23 FDA and European regulators started reviewing the safety of ranitidine with specific focus on the
24
25
26
27
> GlaxoSmithKline, ple, Annual Report at 37 (2019), available at
28 https://www.gsk.com/media/5894/annual-report.pdf
15
COMPLAINT
presence of NDMA.° This triggered a cascade of recalls by the makers and retailers of Ranitidine-
Containing Drugs. |
bN
66. On September 13, 2019, the FDA’s Director for Drug Evaluation and Research, Dr.
W
Janet Woodcock, issued a statement that some ranitidine medicines may contain NDMA.
BR
67. On September 24, 2019, generic manufacturer Sandoz Inc. voluntarily recalled all of
WN
its ranitidine-containing products due to concerns of a “nitrosamine impurity, N-
DWN
nitrosodimethylamine (NDMA), which was found in the recalled medicine.”
~~
68. On September 26, 2019, Walgreens, Walmart, and Rite-Aid and Apotex Corp.—
CO
makers of generic OTC ranitidine—voluntarily recalled all ranitidine-containing products and
oO
10 removed the products from the shelves.® Apotex issued a statement, noting that “Apotex has learned
11 from the U.S. Food and Drug Administration and other Global regulators that some ranitidine
12 medicines including brand and generic formulations of ranitidine regardless of the manufacturer,
13 contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA)[.]”?
14 | 69. On September 28, 2019, CVS Health Corp. stated that it would stop selling Zantac and
15 its own generic ranitidine-containing products out of concern that it might contain a carcinogen.
16 70. On October 2, 2019, the FDA ordered testing on Zantac and specified a protocol to be
17 used that did not involve the use of heat.!°
18 71. On October 8, 2019, GSK voluntarily recalled all Zantac and ranitidine-containing
19 products internationally.'’ As part of the recall, GSK publicly acknowledged that unacceptable levels
20
21 ° https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-
ndma-zantac-ranitidine; https://www.ema.europa.eu/en/news/ema-review-ranitidine-medicines-
22
following-detection-ndma.
23 7 https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-sandoz-
ranitidine-capsules-following-detection-impurity.
24 ® https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-
ndma-zantac-ranitidine. ;
25
* https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-
26 nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes-and.
'0 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-
27 ndma-zantac-ranitidine
" https://www.gov.uk/government/news/zantac-mhra-drug-alert-issued-as-glaxosmithkline-recalls-
28
all-unexpired-stock
16
COMPLAINT
. A ’
|
|
Preview
OEY PINT Ve: aN Adee sf Michael L. Baum, Esq. (SBN: 119511) mbaum@baumhedlundlaw.com ; R. Brent Wisner (SBN: 276023) | bv rbwisner@baumhedlundlaw.com | Pedram Esfandiary (SBN 312569) Ww cctandintyCubsatakodlandlav com F | L E D Adam Foster (SBN 301507) | ALAMEDA COUNTY &, afoster@baumhedlundlaw.com Nicole K.H. Maldonado, Esq. (SBN 207715) | 7 MAY 1 1 3900 WT nmaldonado@baumhedlundlaw. com CLERK OF THE SUEE DW BAUM, HEDLUND, ARISTEI & GOLDMAN, P.C. | B we 6 10940 Wilshire Blvd., 17th Floor ‘by sD Los Angeles, CA 90024 i { Tel: (310) 207-3233 / Fax: (310) 820-7444 t Oo ft 1 Jennifer A. Moore (SBN 206779) \ Oo jennifer@moorelawgroup.com a t 10 MOORE LAW GROUP, PLLC 1473 South 4th Street , 11 Louisville, KY 40208 Tel: (502) 717-4080 / Fax: (502) 717-4086 | 12 ' i Attorneys for Plaintiff i 13 i 14 SUPERIOR COURT FOR THE STATE OF CALIFORNIA COUNTY OF ALAMEDA 15 16 Albert Muesse Cage No. 17 Plaintiff, COMPLAINT 18 v. DEMAND FOR JURY TRIAL 19 ( 1 20 GlaxoSmithKline, LLC; GlaxoSmithKline, PLC; Boehringer Ingelheim Pharmaceuticals, 21 INC.; Boehringer Ingelheim Corporation; Boehringer Ingelheim USA Corporation; 22 Pfizer, INC.; Sanofi US Services INC.; Sanofi 23 S.A.; Sanofi-Aventis U.S. LLC; Kaiser Permanente International; and Does 1 through 24 100 inclusive, 25 MAY 1 1 RECD Defendants. 26 27 28 TABLE OF CONTENTS Page TABLE OF CONTENTS........esceesssteseeesseestessneeseesseeeneesneseneeenessncenssensseneessenssuseansessneesssearecssesesneranees 2 Ww INTRODUCTION ......ccecesceescecceceseeseetsceseseeseseeseeacsecseceesetsesecsecseeeseeaeeeesessceesaseeeserseseesseseesssasaesseaseneaes 4 KR PARTIES o.oo. seeeeeccecsecececeseeeseescseenenscuessesaeseescecseeceeeseescessesecssesenerseeecsessaesessssusssesesesessscaseseseseasseneseenees 5 SN I. Plaintiff .......eesessecsesesseseseessesseeesseeseenssnseeseceaseeseseeceeenecnceesaseneencansaseeceneassesenenseesentatsucnntantecs 5 HD Il. Defendant ..........cceccsesseecseseeeeecescesevscesessesesesessesacescesesaessessessessessesaeeseeaessessesaesneeasenseseeats 7 TT A. Manufacturer Defendants... esc sesecseeeeeeeeeercsersceessesessetssssessenenseseeaseeens 7 CO B. Retailer Defendants........ssssssscsssssssssssssesessssesssssssssusesesssetsssessnsssessesesssessnenen 10 Oo 10 C. Doe Defendants... eeeeseeeseeseeseserseeersesseecseceessesessesessessssassesessusseeeesneasees 10 11 JURISDICTION AND VENUE oo .eecceceecesceseseeeesecsceseneesceeeseeaeseesesecsesseeaesesseaceesseessaeesessenenseeersesaseees 12 12 FACTUAL ALLEGATIONS ...0.. escent teseteetsneesneseneeseesneseneeeseessnessneeeneeeaeesanseanecsnecsanenanecsae 13 13 I. Regulatory History of Ranitidine-Containing Products...............:cccccssceeseeseeeeeeereeeeenees 13 14 I. Recalls and the FDA’S Bana... ceececescesesesesseneceeesecsecsecssesseesessesscnecsesesecseeneeaecaseneeats 15 15 TH. Dangers of NDMA....... ccc eccccccesesssescenceenecesecseeesecenenseseeeeaecseeeseseaesseesseeseceaesscenseseaseanenas 19 16 IV. How Ranitidine Transforms into NDMA Within the Human BOdy.....eececcceseeereeeeees 24 17 A. Formation of NDMA in the Environment of the Human Stomach .................. 25 18 B. Formation of NDMA in the Other Organs of Human Body...........cccssseeeees 32 19 C. Formation of NDMA by Exposure to Heat and/or Time..............ceeeeeseeeeeeeee 34 20 D. Evidence Also Directly Links Ranitidine Exposure to Cancer... eee 36 21 V. Defendants Made False Statements in the Labeling of Their Ranitidine-Containing PLOMUCES......:.cececsescesseseeetseeeeseeseenecseeatenevseeaecseeeesseesasseeseeedceeeseesseeeeteesaseseeeeeaetseteeeaensesags 37 22 VI. Defendants Knew or Should Have Known of the NDMA Risk uu... cece cseeseereeneeeee 38 23 VU. Exemplary / Punitive Damages Allegations (Against Manufacturer Defendants) ....... 42 24 VII. Equitable Tolling/Estoppel occ eceececeeeeessesseessecssesnsceeeseeseseessessesseeseeessesseesneeses 43 25 CAUSES OF ACTION ......ceceeccecssseceseeseseeseseeseeneesenesaeeeesesseceeeessenecesaeeeens Vesceaeceeaeeseseseneeceteseaeseeeneaes 44 26 COUNT I: STRICT PRODUCTS LIABILITY — FAILURE TO WARN ...... cece 44 27 COUNT II: STRICT PRODUCTS LIABILITY — MANUFACTURING DEFECT ............... 47 28 2 COMPLAINT | I 1 1 COUNT III: NEGLIGENCE — FAILURE TO WARN vwvsssssssssssesssssssssstesssssssunssetenessseneese 49 2 COUNT IV: NEGLIGENT PRODUCT DESIGN ii.sscscscscsssssssssssessesessssssssseseee esseeeeenseeeene52 3 COUNT V: NEGLIGENT MANUFACTURING).......ceccseeeee cssitststussssstasessstecsasessaseseasesessees 55 4 COUNT VI: NEGLIGENT MISREPRESENTATION eocssscescscsccsssssesevsscesssssesevessesssesesevesssesse 56 { 5 COUNT VII: NEGLIGENCE .. .eeccccscssssesssessssesssees scssussisecsissstussatessisssisssiusssuessissssesssuesssessseseses 58 6 || JURY TRIAL DEMAND ooeeccccccccscccssecsseecseee: sestsessees sufpaseessnanseesuansneessnnnseessnnnseesennaseeesinnsseeseaneee 59 7 || PRAYER FOR RELIEF ceccsssescssscssesssssssssssscsssesessvessesssecs Iaenseeeeteevessesnsateeseesaseeeensesaseeeesesenestee 59 g | 9 10 11 t 12 | 13 | 14 | | 15 : J 16 ( 17 18 19 20 | 21 22 23 { 24 ! 25 | 26 27 - 28 3 COMPLAINT { INTRODUCTION 1. This is a personal injury action for damages relating to Defendants’ design, WN manufacture, sale, marketing, advertising, promotion, testing, labeling, packaging, handling, Ww distribution, and storage of ranitidine-containing drugs including the brand name, Zantac, and its E, various generic forms (“Ranitidine-Containing Drugs,” unless specifically identified). WN 2. Plaintiff brings this action for personal injuries suffered as a result of ingesting the DW defective and unreasonably dangerous Ranitidine-Containing Drugs and developing various cancers A and their sequelae as a result of this ingestion. CO 3. As more particularly set forth herein, Plaintiff maintains that the Ranitidine- Oo 10 Containing Drugs they ingested are defective, dangerous to human health, unfit and unsuitable to be 1] 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 biproduct 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 when it is digested by the human body. The 19 U.S. Food and Drug Administration’s (“FDA”) allowable daily limit of NDMA is 96 ng (nanograms) 20 and yet, in a single dose of Zantac, 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 internationally, including the domestic recall by 23 the current owner and controller of the Zantac new drug application (“NDA”). Recently, on April 1, 24 2020, the FDA banned all Ranitidine-Containing Drugs sold in the United States. 25 7. The high levels of NDMA observed in Ranitidine-Containing Drugs is a function of 26 the ranitidine molecule: (1) the way it breaks down in the human digestive system; and (2) the way it 27 breaks down when exposed to heat, in particular, during transport and storage. 28 8. This lawsuit seeks to hold Defendants responsible for defective design, manufacturing, 4 COMPLAINT sale, marketing, advertising, promotion, testing, labeling, packaging, handling, distribution, and storage that caused Plaintiff's severe injuries. PARTIES I. Plaintiff £& 9. Plaintiff resides in California and is a citizen of California and no other state. AN 10. Plaintiff consumed brand-name and generic OTC and prescription Ranitidine- HD Containing Drugs starting in approximately 1987 until approximately 2019. TF 11. Asadirect and proximate result of consuming carcinogenic Ranitidine-Containing CO Drugs, Plaintiff was diagnosed with kidney cancer. Oo 10 12. Based on prevailing scientific evidence, exposure to Ranitidine-Containing Drugs (and 11 the attendant NDMA) can cause kidney cancer in humans. 12 13. Had any Defendant warned Plaintiff that Ranitidine-Containing Drugs could lead to 13 exposure to NDMA or, in turn, cancer, Plaintiff would not have taken Ranitidine-Containing Drugs. 14 14. Plaintiff is informed and believes and based thereon alleges that as a direct and 15 proximate result of Plaintiff's use of and/or exposure to Ranitidine-Containing Drugs supplied and 16 distributed by Defendants herein, Plaintiff suffered significant harm, conscious pain and suffering, 17 physical injury and bodily impairment including, but not limited to cancer, other permanent physical 18 deficits, permanent bodily impairment and other sequelae. Plaintiffs injuries required 19 hospitalizations, in-patient surgeries, medication treatments, and other therapies to address the 20 adverse physical effects and damage caused by Plaintiff's use of and/or exposure to Ranitidine- 21 Containing Drugs. 22 15. As a direct and proximate result of the wrongful conduct, acts, omissions, fraudulent 23 concealments, fraudulent misrepresentations, and fraudulent business practices by Defendants and 24 DOES 1 through 100, inclusive, Plaintiff used and/or was exposed to Ranitidine-Containing Drugs 25 and were diagnosed with serious health injuries including cancer. 26 16. Asaresult of using and/or being exposed to Defendants’ Ranitidine-Containing 27 Drugs, Plaintiff has been permanently and severely injured, having suffered serious consequences 28 from Ranitidine-Containing Drugs 5 COMPLAINT 17. Asa further direct and proximate result of defects in Ranitidine-Containing Drugs and — the wrongful conduct, acts, omissions, and fraudulent misrepresentations of Defendants, Plaintiff LP suffered severe mental and physical pain and have and will sustain permanent injuries and emotional WD distress, along with economic loss due to medical expenses and living-related expenses as a result of FP lifestyle changes. | TA 18. Asa further direct and proximate result of defects in Ranitidine-Containing Drugs and Dn the wrongful conduct, acts, omissions, and fraudulent misrepresentations of Defendants, Plaintiff SI required extensive emergency medical treatment, health care, attention and services, thereby oOo incurring medical, incidental, and service expenses pertaining to emergency medical treatments and oo procedures undertaken in efforts to maintain and/or save Plaintiff. @D ele 19. Plaintiff's an individual who suffered damages as a result of injuries resulting from | Plaintiff's use and/or exposure to Ranitidine-Containing Drugs and is authorized to bring an action YP eee for the causes of actions alleged herein including, but not limited to, injuries and damages sustained WY by Plaintiffs, resulting from Plaintiffs’ use and/or exposure to Ranitidine-Containing Drugs. Said FP RPO injuries and damages sustained by Plaintiff were caused or substantially contributed to by the Dn wrongful conduct of Defendants and DOES 1 through 100, inclusive. Fe 20. The product warnings for Ranitidine-Containing Drugs in effect during the time period aI ee Plaintiff used and/or were exposed to Ranitidine-Containing Drugs were vague, incomplete or OH OBO otherwise inadequate, both substantively and graphically, to alert consumers to the severe health risks He associated with Ranitidine-Containing Drugs use and/or exposure. DBD NO 21. The Defendants and DOES 1 through 100, and each of them, inclusive, did not KY§ NV provide adequate warnings to consumers including Plaintiff and the general public about the NHN NY increased risk of serious adverse events that are described herein. WY NO 22. Had Plaintiff been adequately warned of the potential life-threatening side effects of Ff NO the Defendants’ and DOES 1 through 100, and each of them, inclusive, Ranitidine-Containing Drugs, Wn WH Plaintiff would not have purchased, used or been exposed to Ranitidine-Containing Drugs. DW NO 23. By reason of the foregoing, Plaintiff developed serious and dangerous side effects SS NO including cancer and other cancers, related sequelae, physical pain and suffering, mental anguish, and oOo NO 6 COMPLAINT loss of enjoyment of life. By reason of the foregoing, Plaintiff suffered economic losses and special damages including, but not limited to, loss of earning and medical expenses. Plaintiffs general and bd special damages are in excess of the jurisdictional limits of the Court. Ww 24. Plaintiff has reviewed their potential legal claims and causes of action against the , Defendants and have intentionally chosen only to pursue claims based on state law. Any reference to WN any federal agency, regulation or rule is stated solely as background information and does not raise a DW federal question. Plaintiff has chosen to only pursue claims based on state law and are not making any claims which raise federal questions. Accordingly, Plaintiff contends that California State Oo jurisdiction and venue is proper. oO 10 i. Defendants 11 A. Manufacturer Defendants 12 25. | Defendant Boehringer Ingelheim Pharmaceuticals, Inc., is a Delaware corporation 13 with its principal place of business located at 900 Ridgebury Road, Ridgefield, Connecticut 06877. 14 Boehringer Ingelheim Pharmaceuticals, Inc. is a citizen of Connecticut and Delaware, and not of any 15 other state. Boehringer Ingelheim Pharmaceuticals, Inc. is a subsidiary of the German company 16 Boehringer Ingelheim Corporation. Boehringer Ingelheim Pharmaceuticals, Inc. owned and 17 controlled the NDA for over-the-counter (“OTC”) Zantac between December 2006 and January 2017, 18 and manufactured and distributed the drug in the United States during that period. At all relevant 19 times, Boehringer Ingelheim Pharmaceuticals, Inc. has conducted business and derived substantial 20 revenue from its manufacturing, advertising, distributing, selling, and marketing of Zantac within the 21 State of California and Alameda County. 22 26. Defendant, Boehringer Ingelheim Corporation, is a German multinational 23 pharmaceutical corporation with its principal place of business located at Matthias Reinig 55216, 24 Ingelheim, Germany. Boehringer Ingelheim Corporation is the parent company of Defendant, 25 Boehringer Ingelheim Pharmaceuticals, Inc. At all relevant times, Boehringer Ingelheim 26 Pharmaceuticals, Inc. has conducted business and derived substantial revenue from its manufacturing, 27 advertising, distributing, selling, and marketing of Zantac within the State of California and Alameda 28 County. 7 COMPLAINT 27. Defendant Boehringer Ingelheim USA Corporation, is a Delaware corporation with its principal place of business located in at 900 Ridgebury Rd., Ridgebury, Connecticut 06877. bw Boehringer Ingelheim USA Corporation is a citizen of Delaware and Connecticut and is not a citizen Ww of any other state. At all relevant times, Boehringer Ingelheim USA Corporation has conducted E, business and derived substantial revenue from its manufacturing, advertising, distributing, selling, Nr and marketing of Zantac within the State of California and Alameda County. DW 28. Collectively, Defendants Boehringer Ingelheim Pharmaceuticals, Inc. and Defendant NS Boehringer Ingelheim USA Corporation shall be referred to as “Boehringer”. CO 29. Defendant GlaxoSmithKline, LLC (“GSK”), is a Delaware limited liability company Oo 10 with its principal place of business located at 5 Crescent Drive, Philadelphia, Pennsylvania, 19112 1 and Five Moore Drive, Research Triangle, North Carolina, 27709. GSK is a citizen of Delaware. 12 GSK is a wholly owned subsidiary of GlaxoSmithKline, plc, which is its sole member. At all 13 relevant times, GSK has conducted business and derived substantial revenue from its manufacturing, 14 advertising, distributing, selling, and marketing of Zantac within the State of California and Alameda 15 County. 16 30. Defendant GlaxoSmithKline, ple, is a foreign entity and a citizen of the United 17 Kingdom, and is not a citizen of any state in the United States. GlaxoSmithKline, plc is the 18 successor-in-interest to the companies that initially developed, patented, and commercialized the 19 molecule known as ranitidine. Ranitidine was initially developed by Allen & Hanburys Ltd., which 20 was a subsidiary of Glaxo Labs Ltd. Allen & Hanburys Ltd. was awarded Patent No. 4,128,658 by 21 the U.S. Patent and Trademark Office in December 1978, which covered the ranitidine molecule. In 22 1983, the FDA granted approval to Glaxo Holdings, Ltd. to sell Zantac in the United States. Glaxo 23 Holdings, Ltd. was later absorbed into Glaxo Wellcome, PLC. And then, in 2000, GlaxoSmithKline, 24 plc and GSK were created by the merger of Glaxo Wellcome and SmithKline Beecham. At all 25 relevant times, GlaxoSmithKline, plc has conducted business and derived substantial revenue from its 26 manufacturing, advertising, distributing, selling, and marketing of Zantac within the State of 27 California and Alameda County. 28 8 COMPLAINT 31. Collectively, Defendants GlaxoSmithKline, LLC and GlaxoSmithKline, plc shall be referred to as “GSK.” GSK, and its predecessors, have controlled the prescription Zantac NDAs since 1983. 32. Defendant, Pfizer, Inc. (“Pfizer”), is a Delaware corporation with its principal place of & business located at 235 East 42nd Street, New York, New York 10017. Pfizer is a citizen of WN Delaware and New York and is not a citizen of any other state. In 1993, Glaxo Wellcome, plc DB formed a joint venture with Warner-Lambert, Inc. to develop and obtain OTC approval for Zantac. In ~~ 1995, NDA 20-520 Zantac OTC 75 mg tablets were approved. In 1998, NDA 20-745 OTC Zantac CO 75 mg effervescent tablets were approved. Also, in 1998, Warner-Lambert and Glaxo Wellcome Oo 10 ended their joint venture, with Warner-Lambert retaining control over the OTC NDA for Zantac and 11 the Zantac trademark in the United States and Glaxo Wellcome retaining control over the Zantac 12 trademark internationally.! In 2000, Pfizer acquired Warner-Lambert and maintained control over 13 the Zantac OTC NDA until December 2006. At all relevant times, Pfizer has conducted business and 14 derived substantial revenue from its manufacturing, advertising, distributing, selling, and marketing 15 of Zantac within the State of California and Alameda County. 16 33. | Defendant Sanofi US Services Inc., is a Delaware corporation with its principal place 17 of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807, and is a wholly owned 18 subsidiary of Sanofi S.A. Sanofi is a citizen of Delaware and New Jersey and is not a citizen of any 19 other state. Sanofi controlled the NDA for OTC Zantac starting in January 2017 through the present 20 and manufactured and distributed the drug in the United States during that period. Sanofi voluntarily 21 recalled all brand name OTC Zantac on October 18, 2019. At all relevant times, Sanofi has conducted 22 business and derived substantial revenue from its manufacturing, advertising, distributing, selling, 23 and marketing of Zantac within the State of California and Alameda County. 24 34. Defendant Sanofi S.A., is a French multinational pharmaceutical company 25 headquartered in Paris, France, with its principal place of business located at 54, Rue La Boetie, in 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. 9 COMPLAINT 1 || the 8" arrondissement. Defendant, Sanofi S.A., changed its name to Sanofi in May 2011. As of 2013, 2 |} Sanofi S.A. was the world’s fifth largest pharmaceutical company by prescription sales. At all 3 || relevant times, Sanofi S.A. has conducted business and derived substantial revenue from its 4 || manufacturing, advertising, distributing, selling, and marketing of Zantac within the State of 5 || California and Alameda County. 6 35. Defendant Sanofi-Aventis U.S. LLC, was and is a Delaware limited liability company 7 || with its principal place of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807. 8 || Sanofi-Aventis U.S. LLC is a citizen of Delaware and New Jersey and is not a citizen of any other 9 || state. Sanofi-Aventis US LLC is a wholly owned subsidiary of Sanofi S.A. At all relevant times, 10 || Sanofi-Aventis U.S. LLC has conducted business and derived substantial revenue from its 11 || manufacturing, advertising, distributing, selling, and marketing of Zantac within the State of 12 || California and Alameda County. 13 36. Collectively, Defendants Sanofi US Services Inc., Sanofi S.A., and Sanofi-Aventis 14 || U.S. LLC, shall be referred to as “Sanofi.” 15 37. Defendants, Boehringer, GSK, Pfizer, and Sanofi, shall be referred to collectively as 16 || the “Manufacturer Defendants.” 17 B. Retailer Defendants 18 38. Defendant Kaiser Permanente International (“Kaiser’’) is a California corporation with 19 || its headquarters and principal place of business located at One Kaiser Plaza, Oakland, California 20 ||94612. At all relevant times, Kaiser has conducted business and derived substantial revenue from its 21 || selling of Ranitidine-Containing Drugs within the State of California and Alameda County by 22 || operating a pharmacy which sells Ranitidine-Containing Drugs. Specifically, Kaiser supplied 23 || Plaintiff with the Ranitidine-Containing Drugs which caused Plaintiff's injuries. 24 C. Doe Defendants 25 39. The true names and/or capacities, whether individual, corporate, partnership, 26 |} associate, governmental, or otherwise, of Defendants DOES 1 through 100, inclusive, and each of 27 || them, are unknown to Plaintiff at this time, who therefore sues said Defendants by such fictitious 28 ||names. Plaintiffis informed and believes, and thereon alleges, that each Defendant designated herein 10 COMPLAINT as a DOE caused injuries and damages proximately thereby to Plaintiff as hereinafter alleged; and that each DOE Defendant is liable to the Plaintiff for the acts and omissions alleged herein below, and the resulting injuries to Plaintiff, and damages sustained by Plaintiff. Plaintiff will amend this Complaint to allege the true names and capacities of said DOE Defendants when that same is a ascertained. DN 40. Plaintiff is informed and believes, and thereon alleges, that at all times herein mentioned, each of the Defendants and each of the DOE Defendants was the agent, servant, SN employee and/or joint venturer of the other co-Defendants and other DOE Defendants, and each of CO them, and at all said times, each Defendants and each DOE Defendant was acting in the full course, mo 10 scope and authority of said agency, service, employment and/or joint venture. 11 41. Plaintiff is informed and believes and alleges that at all times mentioned herein, 12 Defendants and DOES 1 through 100, inclusive, and each of them, were also known as, formerly 13 known as and/or were the successors and/or predecessors in interest/business/product line/or a 14 | portion thereof, assigns, a parent, a subsidiary (wholly or partially owned by, or the whole or partial 15 owner), affiliate, partner, co-venturer, merged company, alter egos, agents, equitable trustees and/or 16 fiduciaries of and/or were members in an entity or entities engaged in the funding, researching, 17 studying, manufacturing, fabricating, designing, developing, labeling, assembling, distributing, 18 supplying, leasing, buying, offering for sale, selling, inspecting, servicing, contracting others for 19 marketing, warranting, rebranding, manufacturing for others, packaging and advertising of 20 Ranitidine-Containing Drugs. Defendants and DOES 1 through 100, inclusive, and each of them, are 21 liable for the acts, omissions and tortious conduct of its successors and/or predecessors in 22 interest/business/product line/or a portion thereof, assigns, parent, subsidiary, affiliate, partner, co- 23 venturer, merged company, alter ego, agent, equitable trustee, fiduciary and/or its alternate entities in 24 that Defendants and DOES 1 through 100, inclusive, and each of them, enjoy the goodwill originally 25 attached to each such alternate entity, acquired the assets or product line (or portion thereof), and in 26 that there has been a virtual destruction of Plaintiff's remedy against each such alternate entity, and 27 that each such Defendants has the ability to assume the risk spreading role of each such alternate 28 entity. 11 COMPLAINT 42. Plaintiff is informed and believes, and thereon alleges, that at all times herein mentioned, that Defendants and DOES 1 through 100, inclusive, and each of them, were and are corporations organized and existing under the laws of the State of California or the laws of some state or foreign jurisdiction; that each of the said Defendants and DOE Defendants were and are authorized aN to do and are doing business in the States of California and Missouri and regularly conducted DN business in these States and in Alameda County. 43. Upon information and belief, at relevant times, Defendants and DOES 1 through 100, SS and each of them, inclusive, were engaged in the business of researching, developing, designing, Oo licensing, manufacturing, distributing, selling, marketing, and/or introducing into interstate oOo 10 commerce and into the State of California, including in Alameda County, either directly or indirectly 1] through third parties or related entities, Ranitidine-Containing Drugs. 12 44. Atrelevant times, Defendants and DOES 1 through 100, inclusive, and each of them, 13 conducted regular and sustained business and engaged in substantial commerce and business activity 14 in the State of California, which included but was not limited to selling, marketing and distributing 15 Ranitidine-Containing Drugs in the State of California and Alameda County. 16 45. At all relevant times, Defendants and DOES 1 through 100, inclusive, and each of 17 them, expected or should have expected that their acts would have consequences within the United 18 States of America including the State of California and including Alameda County, said Defendants 19 derived and derive substantial revenue therefrom. 20 JURISDICTION AND VENUE 21 46. This Court has jurisdiction over this action pursuant to the California Constitution 22 Article VI, Section 10, which grants the Superior Court “original jurisdiction in all causes except 23 those given by statute to other trial courts.” The Statutes under which this action is brought do not 24 specify any other basis for jurisdiction. | 25 47. This Court has personal jurisdiction over each Defendant insofar as each Defendant is 26 authorized and licensed to conduct business in the State of California, a resident of the State of 27 California, maintains and carries on systematic and continuous contacts in the State of California, 28 regularly transacts business within the State of California, and regularly avails itself of the benefits of 12 COMPLAINT the State of California. 48. Additionally, Defendants caused tortious injury by acts and omissions in this judicial jurisdiction and caused tortious injury in this jurisdiction by acts and omissions outside this jurisdiction while regularly doing and soliciting business, engaging in a persistent course of conduct, & and deriving substantial revenue from goods used or consumed and services rendered in this AN jurisdiction. HD 49. Venue 1s proper in this Court pursuant to California Code of Civil Procedure Section ~s 395(a) in that the headquarters and principal place of business of Defendant Kaiser is in Alameda CO County. | oO 10 50. Plaintiff seeks relief that is within the jurisdictional limits of the Court. ol FACTUAL ALLEGATIONS 12 L Regulatory History of Ranitidine-Containing Products 13 51. Defendants marketed and sold Ranitidine-Containing Drugs under the brand name 14 “Zantac” or its generic version by either prescription or OTC. Defendants sold Ranitidine- 15 Containing Drugs in the following forms: injection, syrup, and/or tablets and capsules. 16 52. Zantac (ranitidine) was originally discovered and developed by scientist John 17 Bradshaw on behalf of GSK? in 1976. | 18 53. The drug belongs to a class of medications called histamine H2-receptor antagonists 19 (or H2 blockers), which decrease the amount of acid produced by cells in the lining of the stomach. © 20 Other drugs within this class include cimetidine (Tagamet), famotidine (Pepcid), and nizatidine 21 (Tazac). | | 22 | 54. Cimetidine (Tagamet), discovered and developed by Smith, Kline and French’, was 23 the first Hz blocker to be developed and is the prototypical histamine H2 receptor antagonist from 24 | 25 * Dr. Bradshaw was working for Glaxo Inc. at the time. Glaxo Inc. later merged with the Wellcome | 26 Foundation in 1995 to become Glaxo Wellcome plc. Then, in 2000, Glaxo Wellcome plc merged : with Smithkline Beecham plc to form GlaxoSmithKline plc one of the defendants in this MDL. For the purposes of this PIMC, these entities will be referred to as GSK. 3 Smith, Kline and French later merged with the Beecham Group in 1989 to form SmithKline 28 . Beecham plc. And, as discussed above, SmithKline Beecham plc was merged into GSK in 2000. | 13 | COMPLAINT | which the later members of the class were developed. Indeed, Zantac was specifically developed by & GSK in response to the success of cimetidine. NO 55. | Zantac was approved by the FDA, pursuant to the New Drug Application (“NDA”) | W process in 1983 (NDA 18-703) and, quickly, became one of GSK’s most successful products, being BP the first prescription drug in history to reach $1 billion in sales, which in the pharmaceutical industry WNW is referred to as a “Blockbuster.” DB 56. In 1993, GSK entered into a joint venture with Pfizer* to develop an OTC version of TD Zantac. That joint venture led to FDA approval of an OTC version of Zantac in 1995. Zantac OTC oOo was approved through an NDA process (NDA 20-520). Oo 57. In 1997, GSK’s patent on ranitidine expired, and generic Ranitidine-Containing Drugs SDS el entered the market. Despite generic entry, however, brand name prescription and OTC Zantac FH ee continued to be sold. Although sales of brand-name Zantac declined as a result of generic and YO eee alternative products, Ranitidine-Containing Drug sales remained strong over time. As recently as WD 2018, Zantac was one of the top 10 antacid tablet brands in the United States, with sales of Zantac FF Re 150 totaling $128.9 million—a 3.1% increase from the previous year. DO 58. In 1998, the joint venture between GSK and Pfizer dissolved. As part of the RoR separation, GSK retained the rights to sell all forms of Zantac internationally and prescription Zantac IDA RO in the U.S., while Pfizer retained the rights to sell OTC Zantac domestically and retained ownership BH over the Zantac trademark. Under this agreement, GSK retained control and responsibility over the BO = prescription Zantac NDA and Pfizer retained control and responsibility over the OTC Zantac NDA. OD KN 59. In October 2000, Pfizer obtained full rights to OTC Zantac in the United States and |- KN Canada from GSK pursuant to a divestiture and transfer agreement. As part of this agreement, GSK NY KN divested all domestic Zantac OTC assets to Pfizer including all trademark rights and removed the WHY KH restrictions on Pfizer’s ability to seek product line extensions or the approval for higher doses of OTC FF NHN AH NO HN NO * The joint venture was between Glaxo Wellcome plc and Warner-Lambert, Inc. Warner-Lambert st wo was later acquired by Pfizer, Inc. in 2000. For the purposes of this PIMC, Warner-Lambert will be ao NO referred to as Pfizer. 14 COMPLAINT Zantac. GSK retained the right to exclusive use of the Zantac name for any prescription ranitidine- containing product in the US. bd 60. ‘In October 2003, Pfizer submitted NDA 21-698 for approval to market OTC Zantac WH 150 mg. The FDA approved NDA 21-698 OTC Zantac 150 mg on August 31, 2004. b 61. In 2006, Pfizer through a divestiture agreement, transferred all assets pertaining to its MN Zantac OTC line of products, including the rights to sell and market all formulations of OTC Zantac DW in the United States and Canada, as well as all intellectual property, research and development, and NS customer and supply contracts to Boehringer Ingelheim Pharmaceuticals, Inc. As part of this deal, CO Boehringer obtained control and responsibility over all of the Zantac OTC NDAs. oO 10 62. In 2009, GSK ceased marketing prescription Zantac in the U.S. and abandoned the 11 Zantac prescription NDA. Although, according to GSK’s recent annual report (2019), GSK claims to 12 have “discontinued making and selling prescription Zantac tablets in 2017 ... in the U.S.” 13 63. In 2016, Boehringer sold the rights of OTC Zantac to Sanofi US Services, Iric. As part 14 of this deal, Sanofi obtained control and responsibility over the OTC NDA and currently retains that 15 control and responsibility. 16 64. To date, the FDA has approved numerous generic manufacturers for the sale of 17 prescription and OTC Ranitidine-Containing Drugs through an Abbreviated New Drug Application 18 (“ANDA”) process. 19 II. Recalls and the FDA’s Ban 20 65. On September 9, 2019, pharmacy and testing laboratory Valisure LLC and 21 ValisureRX LLC (collectively, “Valisure”) filed a Citizen Petition calling for the recall of all 22 ranitidine-containing products due to exceedingly high levels of NDMA found in ranitidine pills. 23 FDA and European regulators started reviewing the safety of ranitidine with specific focus on the 24 25 26 27 > GlaxoSmithKline, ple, Annual Report at 37 (2019), available at 28 https://www.gsk.com/media/5894/annual-report.pdf 15 COMPLAINT presence of NDMA.° This triggered a cascade of recalls by the makers and retailers of Ranitidine- Containing Drugs. | bN 66. On September 13, 2019, the FDA’s Director for Drug Evaluation and Research, Dr. W Janet Woodcock, issued a statement that some ranitidine medicines may contain NDMA. BR 67. On September 24, 2019, generic manufacturer Sandoz Inc. voluntarily recalled all of WN its ranitidine-containing products due to concerns of a “nitrosamine impurity, N- DWN nitrosodimethylamine (NDMA), which was found in the recalled medicine.” ~~ 68. On September 26, 2019, Walgreens, Walmart, and Rite-Aid and Apotex Corp.— CO makers of generic OTC ranitidine—voluntarily recalled all ranitidine-containing products and oO 10 removed the products from the shelves.® Apotex issued a statement, noting that “Apotex has learned 11 from the U.S. Food and Drug Administration and other Global regulators that some ranitidine 12 medicines including brand and generic formulations of ranitidine regardless of the manufacturer, 13 contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA)[.]”? 14 | 69. On September 28, 2019, CVS Health Corp. stated that it would stop selling Zantac and 15 its own generic ranitidine-containing products out of concern that it might contain a carcinogen. 16 70. On October 2, 2019, the FDA ordered testing on Zantac and specified a protocol to be 17 used that did not involve the use of heat.!° 18 71. On October 8, 2019, GSK voluntarily recalled all Zantac and ranitidine-containing 19 products internationally.'’ As part of the recall, GSK publicly acknowledged that unacceptable levels 20 21 ° https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements- ndma-zantac-ranitidine; https://www.ema.europa.eu/en/news/ema-review-ranitidine-medicines- 22 following-detection-ndma. 23 7 https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-sandoz- ranitidine-capsules-following-detection-impurity. 24 ® https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements- ndma-zantac-ranitidine. ; 25 * https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary- 26 nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes-and. '0 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements- 27 ndma-zantac-ranitidine " https://www.gov.uk/government/news/zantac-mhra-drug-alert-issued-as-glaxosmithkline-recalls- 28 all-unexpired-stock 16 COMPLAINT . A ’ | |