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Jennifer A. Moore (SBN 206779)
jennifer@moorelawgroup.com
MOORE LAW GROUP, PLLC
FILED
| ALAMEDA COUNT TY
NO
1473 South 4th Street
Louisville, KY 40208 APR 27. 2021
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Tel: (502) 717-4080 / Fax: (502) 717-4086
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Attorney for Plaintiff
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SUPERIOR COURT FOR THE STATE OF CALIFORNIA
COUNTY OF ALAMEDA |
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GARY CAMPBELL,’ Case No. RG20061371
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Plaintiff, FIRST AMENDED COMPLAINT
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Vv. DEMAND FOR JURY TRIAL
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GLAXOSMITHKLINE, LLC; PFIZER, INC.;
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BOEHRINGER INGELHEIM
PHARMACEUTICALS, INC. ;
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BOEHRINGER INGELHEIM USA
CORPORATION; SANOFI US SERVICES
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INC.; SANOFI-AVENTIS U.S. LLC; THE -
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VONS COMPANIES, INC.; KAISER
PERMANENTE INTERNATIONAL; and
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DOES | through 100 inclusive,
Defendants.
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FIRST AMENDED COMPLAINT
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TABLE OF CONTENTS |
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TABLE OF CONTENTS ........sesccsccssssseeessssseeessneeseesnnneeeeesnesesssnneess sestnseesseessvssnteceessuneeceeessnneteseeeesneees 2
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INTRODUCTION .csccscscescversessetsseeviesnsnetntnesneeeteeteecece sestststnetsesesnteetneeerneetneee 4
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PARTIES 00. ceccecccccccceceeececeecececesesenevseaeeteseseeeecsesecacseseseeertecscseeeenens titties 5
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I. Plaintiff ooo... eee ceceeceecceeeecececeesesenescesensecenecceceacsceacseecssesseeeseseeeeaesceaeseeceeeaeseeeeaeeeseseeceaeaes 5
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Il. Defendant ..........ccccccccccsceccssesceceessesceseesesecsesceseescscessesessseceseeaesecaesseeaeacsaeaceaesaeetateeeneeaees 7
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A. Manufacturer Defendants............0.0.0.0ceee | veceeeeaeaeesecseneeacscseeeseeeceeetastsneseseeens 7
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B. Retailer Defendats......cncennennnnnnny vesaeescesseseessessessessesaeaeseeneeeeaeeaeeatens 9
C. Doe Defendants. ..............:e:cescesceseeceereeeeeeneeees saseseeeueseeesesesesesescenetetenseseneneceenens 10
JURISDICTION AND VENUE ...0.0......ccecececcececeseeseseeeeeeseeeeseeeeeeeeeees ! eesesesscseseeseasseceasssseseecaeseeseeeseeees 11
FACTUAL ALLEGATIONS ..00...ecccececeeneeeeseseeeeneeeeeseeeeececereeeeens pst 12
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I Regulatory History of Ranitidine-Containing Products eccesessesseeseseneceaceseeseeseeseeseeseees 12
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IL. Recalls and the FDA’s Banh... eeceseeeteeeeeeeeeeeees cessessunussssseseesensssuasasssseeeneeetee 15
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TH. Dangers of NOMA... ccc ccccccceseeseessesseeteteeeee! | ceeesceseessssssusecsessesessssssssseesseeee 19
IV. How Ranitidine Transforms into NDMA Within the'Human Body ...........ccececeeeeeee 24
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A. Formation of NDMA in the Environment of the Human Stomach ............0--. 25
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B. Formation of NDMA in the Other Organs of ‘Human Body .......cccccceceeeeeeeeeees 31
C. Formation of NDMA by Exposure to Heat and/or Time.........0..0.....0c:cceseees 33
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D. Evidence Also Directly Links Ranitidine Exposure to Cancer... cee 35
V. Defendants Made False Statements in the Labeling of Their Ranitidine-Containing
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PrOUct...00....0..cceccecesceseseeceseeceeceseseesceceeceseeeeeeeeeeaeaeeaees soseeeeeecensanescencennnnneceeseennnnnsenesen 37
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VI. Defendants Knew or Should Have Known of the NDMA Risk ...........cecsccssessseseeeeeeees 37
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VII. Exemplary / Punitive Damages Allegations (Against Manufacturer Defendants) ....... 42
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VIII. Equitable Tolling/Estoppel .........0...ccccescseeeeseeeeseeseeee eeesssssesceesssseecessnessessstenesessseesees 42
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CAUSES OF ACTION ............ saeneaceseseesereseseeseseeesteseeeaeeseseteeseeteeteeie acscueescaceeesesceaeseeeeseseeeecessereaeneeeas 43
COUNT I: STRICT PRODUCTS LIABILITY - FAILURE TO WARN 0... 43
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COUNT I: STRICT PRODUCTS LIABILITY - MANUFACTURING DEFECT ..............- 47
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FIRST AMENDED COMPLAINT
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COUNT II: NEGLIGENCE — FAILURE TO WARN |... ccceeeseneeeeeeeeeeeesestisteneeneees
COUNT IV: NEGLIGENT PRODUCT DESIGN ..00.ooccec ices eeeeeteeeeeeececeeeetecnenersetenetaeees
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COUNT V: NEGLIGENT MANUFACTURING ...00....cecec
cece e ceeeseseeeeeeaceceaeeceeescseeeseeneenes
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COUNT VI: NEGLIGENT MISREPRESENTATION ....0.0o..ccccccseseseeseceseseeeseecesescseeseseneenenenes
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COUNT VIE: STRICT LIABILITY. ecececceeeseeseeeeseceeeeesecseeaeseeaeeecseeaeeeseseeeters
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COUNT VII: STRICT PRODUCTS LIABILITY —DISTRIBUTION DEFECT ..........00.0.....
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COUNT IX: NEGLIGENCE o......eccceccecceceeeceeeeeeeseseesceecensaeseseesstseatsacasecesseseseeseeseeeeeeeateeteeees
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JURY TRIAL DEMAND 200i ccc ec cee ceceeesereeseesessesscsesecscsecsessaesesaseessataseesesaesesaceessessstasseeaceaentens
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PRAYER FOR RELIEF
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FIRST AMENDED COMPLAINT
INTRODUCTION
Plaintiff, Gary Campbell, by counsel, and pursuant to California Code of Civil Procedure 472,
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files his First Amended Complaint and alleges as follows:
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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, transportation, and storage of ranitidine-containing drugs including the brand name,
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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 cancer and its
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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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Containing Drugs he ingested are defective, dangerous to human health, unfit and unsuitable to be
advertised, marketed, and sold in the United States, were manufactured improperly, and lacked
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proper warnings of the dangers associated with their use.
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4, N-Nitrosodimethylamine (“NDMA”) is a potent carcinogen. Discovered as a
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biproduct in manufacturing rocket fuel in the early 1900s, today, its only use is to induce tumors in
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animals as part of laboratory experiments. Its only function is to cause cancer. It has no business
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being in a human body.
5. Zantac, the popular antacid medication that was used by millions of people every day,
leads to the production of staggering amounts of NDMA when it is digested by the human body. The
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U.S. Food and Drug Administration’s (“FDA”) allowable daily limit of NDMA is 96 ng (nanograms)
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and yet, in a single dose of Zantac, researchers are discovering over 3 million ng.
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6. These revelations by independent researchers have caused widespread recalls of
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Zantac and its generic forms both domestically and internationally, including the domestic recall by
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the current owner and controller of the Zantac new drug application (“NDA”). On April 1, 2020, the
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FDA banned all Ranitidine-Containing Drugs sold in the United States.
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FIRST AMENDED COMPLAINT
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7. The high levels of NDMA observed in Ranitidine-Containing Drugs is a function of
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the ranitidine molecule: (1) the way it breaks down in the human digestive system; and (2) the way it
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breaks down when exposed to heat, in particular, during transport and storage.
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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,
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transportation, and storage that caused Plaintiffs severe injuries.
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PARTIES
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1. Plaintiff
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9. Plaintiff, Gary Campbell, resides in California and is a citizen of California and no
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other state. |
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10. Plaintiff started consuming generic prescription Ranitidine-Containing Drugs in
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approximately 2000, until approximately 2019. Plaintiff also consumed brand name over-the-counter
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Ranitidine-Containing Drugs on occasion from approximately 2000 until approximately 2019.
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Plaintiff purchased Ranitidine-Containing Drugs from Defendants, The Vons Companies, Inc. and
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Kaiser Permanente International.
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> 11. Asa direct and proximate result of consuming carcinogenic Ranitidine-Containing
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Drugs, Plaintiff was diagnosed with prostate and kidney cancer. |
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12. Based on prevailing scientific evidence, exposure to Ranitidine-Containing Drugs (and
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the attendant NDMA) can cause cancer in humans.
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13. Had any Defendant warned Plaintiff that Ranitidine-Containing Drugs could lead to
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exposure to NDMA or, in turn, cancer, Plaintiff would not have taken Ranitidine-Containing Drugs.
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14. Plaintiff is informed and believes and based thereonialleges that as a direct and
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proximate result of Plaintiff’s use of and/or exposure to Ranitidine-Containing Drugs supplied and
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distributed by Defendants herem, Plaintiff suffered significant harm, conscious pain and suffering,
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physical injury and bodily impairment including, but not limited to ‘cancer, other permanent physical
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deficits, permanent bodily impairment and other sequelae. PlaintifP’s injuries required
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hospitalizations, in-patient surgeries, medication treatments, and other therapies to address the
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adverse physical effects and damage caused by Plaintiff's use of and/or exposure to Ranitidine-
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FIRST AMENDED COMPLAINT
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Containing Drugs.
15. | Asadirect 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 was diagnosed with serious health injuries including cancer. '
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16. As aresult 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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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 Ranitidime-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
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's life.
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19. _ Plaintiff is an individual who suffered damages as a result of injuries resulting from
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Plaintiffs 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, juries and damages sustained
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by Plaintiff, 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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FIRST AMENDED COMPLAINT
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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
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increased risk of serious adverse events that are described herein. i
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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. Byreason 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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loss of enjoyment of life. By reason of the foregoing, Plaintiff suffered economic losses and special
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damages including, but not limited to, loss of earning and medical expenses. Plaintiff's 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
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any claims which raise federal questions. Accordingly, Plaintiff contends that California State
jurisdiction and venue is proper. |
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Il. Defendants
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A. Manufacturer Defendants |
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25. Defendant, GlaxoSmithKline, LLC (“GSK”), is a Delaware limited liability company
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with its principal place of business located at 5 Crescent Drive, Philadelphia, Pennsylvania, 19112
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and Five Moore Drive, Research Triangle, North Carolina, 27709. GSK is a citizen of Delaware.
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GSK 1s a wholly owned subsidiary of GlaxoSmithKline, plc, which is its sole member. At all
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relevant times, GSK has conducted business and derived substantial revenue from its manufacturing,
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advertising, distributing, selling, and marketing of Zantac within the State of California and Alameda
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1| County.
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26. GSK, and its predecessors, have controlled the prescription Zantac NDAs since 1983.
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FIRST AMENDED COMPLAINT
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27. 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
Delaware and New York and is not a citizen of any other state. At all relevant times, Pfizer has
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conducted business and derived substantial revenue from its manufacturing, advertising, distributing,
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selling, and marketing of Zantac within the State of California and Alameda County.
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28. Defendant, Boehringer Ingelheim Pharmaceuticals, Inc., is a Delaware corporation
with its principal place of business located at 900 Ridgebury Road, Ridgefield, Connecticut 06877.
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Boehringer Ingelheim Pharmaceuticals, Inc. is a citizen of Connecticut and Delaware, and not of any
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other state. Boehringer Ingelheim Pharmaceuticals, Inc. is a subsidiary of the German company
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Boehringer Ingelheim Corporation. Boehringer Ingelheim Pharmaceuticals, Inc. owned and
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controlled the NDA for over-the-counter (“OTC”) Zantac between December 2006 and January 2017,
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and manufactured and distributed the drug in the United States during that period. At all relevant
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times, Boehringer Ingelheim Pharmaceuticals, Inc. has conducted business and derived substantial
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revenue from its manufacturing, advertising, distributing, selling, and marketing of Zantac within the
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State of California and Alameda County. :
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29. 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.
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30. 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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31. Defendant, Sanofi US Services Inc., is a Delaware corporation with its principal place
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of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807, and is a wholly owned
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subsidiary of Sanofi S.A. Sanofi is a citizen of Delaware and New Jersey and is not a citizen of any
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other state. Sanofi controlled the NDA for OTC Zantac starting in January 2017 through the present
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FIRST AMENDED COMPLAINT
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and manufactured and distributed the drug in the United States during that period. Sanofi voluntarily
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recalled all brand name OTC Zantac on October 18, 2019. At all relevant times, Sanofi 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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32. Defendant, Sanofi-Aventis U.S. LLC, was and is a Delaware limited liability company
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with its principal place of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807.
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Sanofi-Aventis U.S. LLC is a citizen of Delaware and New Jersey and 1S not a citizen of any other
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state. Sanofi-Aventis US LLC is a wholly owned subsidiary of Sanofi S.A. At all relevant times,
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Sanofi-Aventis U.S. LLC 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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California and Alameda County.
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33. Collectively, Defendants Sanofi US Services Inc., and Sanofi-Aventis U.S. LLC, shall
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be referred to as “Sanofi.”
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B. Retailer Defendants
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34. Defendant, The Vons Companies, Inc. (““Vons”), is a Michigan corporation with its
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headquarters and principal place of business located at 11555 Dublin Canyon Rd., Pleasanton,
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California 94588. Vons is a wholly owned subsidiary of Albertsons Companies, Inc. Vons is a
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citizen of California and Delaware and is not a citizen of any other state. At all relevant times, Vons
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has conducted business and derived substantial revenue from its advertising, selling, and marketing of
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Ranitidine-Containing Drugs within the State of California and Alameda County.
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35. Defendant, Kaiser Permanente International (“Kaiser”), is a California corporation
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with its headquarters and principal place of business located at One Kaiser Plaza, Alameda County,
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Oakland, California 94612. At all relevant times, Kaiser has conducted business and derived
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substantial revenue from its selling of Ranitidine-Containing Drugs within Alameda County and the
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State of California by operating a pharmacy that dispenses Ranitidine-Containing Drugs.
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FIRST AMENDED COMPLAINT
C. Doe Defendants ;
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36. | The true names and/or capacities, whether individual, corporate, partnership,
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associate, governmental, or otherwise, of Defendants DOES 1 through 100, inclusive, and each of
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them, are unknown to Plaintiff at this time, who therefore sues said Defendants by such fictitious
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names. Plaintiff is informed and believes, and thereon alleges, that each Defendant designated herein
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as a DOE caused injuries and damages proximately thereby to Plaintiff as hereinafter alleged; and
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that each DOE Defendant is liable to the Plaintiff for the acts and omissions alleged herein below,
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and the resulting injuries to Plaintiff, and damages sustained by Plaintiff. Plaintiff will amend this
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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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37. Plaintiff is informed and believes, and thereon alleges, that at all times herein
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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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scope and authority of said agency, service, employment and/or joint venture.
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38. Plaintiff is informed and believes and alleges that at,all times mentioned herein,
Defendants and DOES 1 through 100, inclusive, and each of them, were also known as, formerly
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known as and/or were the successors and/or predecessors in interest/business/product line/or a
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portion thereof, assigns, a parent, a subsidiary (wholly or partially owned by, or the whole or partial
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owner), affiliate, partner, co-venturer, merged company, alter egos, agents, equitable trustees and/or
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fiduciaries of and/or were members in an entity or entities engaged in the funding, researching,
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studying, manufacturing, fabricating, designing, developing, labeling, assembling, distributing,
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supplying, leasing, buying, offering for sale, selling, inspecting, servicing, contracting others for
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marketing, warranting, rebranding, manufacturing for others, packaging, transportation, storage, and
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advertising of Ranitidine-Containing Drugs. Defendants and DOES 1 through 100, inclusive, and
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each of them, are liable for the acts, omissions and tortious conduct of its successors and/or
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predecessors in interest/business/product line/or a portion thereof, assigns, parent, subsidiary,
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affiliate, partner, co-venturer, merged company, alter ego, agent, equitable trustee, fiduciary and/or its
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FIRST AMENDED COMPLAINT
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alternate entities in that Defendants and DOES 1 through 100, inclusive, and each of them, enjoy the
goodwill originally attached to each such alternate entity, acquired the assets or product line (or
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portion thereof), and in that there has been a virtual destruction of Plaintiffs remedy against each
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such alternate entity, and that each such Defendants has the ability to assume the risk spreading role
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of each such alternate entity.
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39. Plaintiff is informed and believes, and thereon alleges, that at all tumes herein
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mentioned, that Defendants and DOES 1 through 100, inclusive, and each of them, were and are
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corporations organized and existing under the laws of the State of California or the laws of some state
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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 State of California and regularly conducted business in Alameda
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County and the State of California.
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40. 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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commerce and into the State of California, including in Alameda County, either directly or indirectly
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through third parties or related entities, Ranitidine-Containing Drugs.
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4l. At relevant times, Defendants and DOES | through 100, inclusive, and each of them,
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conducted regular and sustained business and engaged in substantial commerce and business activity
in the State of California, which included but was not limited to selling, marketing and distributing
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Ranitidine-Containing Drugs in Alameda County and the State of California.
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42. — Atall relevant times, Defendants and DOES 1 through 100, inclusive, and each of
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them, expected or should have expected that their acts would have consequences within the United
States of America including the State of California and including Alameda County, said Defendants
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derived and derive substantial revenue therefrom.
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JURISDICTION AND VENUE
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43. This Court has jurisdiction over this action pursuant to the California Constitution
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Article VI, Section 10, which grants the Superior Court “original jurisdiction in all causes except
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those given by statute to other trial courts.” The Statutes under which this action is brought do not
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FIRST AMENDED COMPLAINT
specify any other basis for jurisdiction. Further, diversity jurisdiction pursuant to 28 U.S.C. § 1332
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does not exist based upon the citizenship of Plaintiff and Defendants.
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44. This Court has personal jurisdiction over each Defendant insofar as each Defendant is
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authorized and licensed to conduct business in the State of California, a resident of the State of
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California, maintains and carries on systematic and continuous contacts in the State of California,
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regularly transacts business within the State of California, and regularly avails itself of the benefits of
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the State of California.
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45. Additionally, Defendants caused tortious injury by acts and omissions in this judicial
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jurisdiction and caused tortious injury in this jurisdiction by acts and omissions outside this
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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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46. Venue is 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 Defendants, The Vons Companies,
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Inc. and Kaiser Permanente International, are in Alameda County.
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47. Plaintiff seeks relief that is within the jurisdictional limits of the Court.
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FACTUAL ALLEGATIONS
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I Regulatory History of Ranitidine-Containing Products
48. Defendants marketed and sold Ranitidine-Containing Drugs under the brand name
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“Zantac” or its generic version by either prescription or over-the-counter (“OTC”). Defendants sold
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Ranitidine-Containing Drugs in the following forms: injection, syrup, and/or tablets and capsules.
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49. Zantac (ranitidine) was originally discovered and developed by scientist John
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Bradshaw on behalf of GlaxoSmithKline (“GSK”)' in 1976.”
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' Dr. Bradshaw was working for Glaxo Inc. at the time. Glaxo Inc. later merged with the Wellcome
Foundation in 1995 to become Glaxo Wellcome plc. Then, in 2000, Glaxo Wellcome plc merged with
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Smithkline Beecham plc to form GlaxoSmithKline plc. For the purposes of this Complaint, these
entities will be referred to as “GSK.”
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?GlaxoSmithK line, plc, is a foreign entity and a citizen of the United Kingdom, and is not a citizen of
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FIRST AMENDED COMPLAINT
50. The drug belongs to a class of medications called histamine H2-receptor antagonists
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(or Hz blockers), which decrease the amount of acid produced by cells in the lining of the stomach.
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Other drugs within this class include cimetidine (Tagamet), famotidine (Pepcid), and nizatidine
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(Tazac).
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51. Cimetidine (Tagamet), discovered and developed by Smith, Kline and French,’ was
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the first H2 blocker to be developed and is the prototypical histamine H2 receptor antagonist from
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which the later members of the class were developed. Indeed, Zantac was specifically developed by
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GSK in response to the success of cimetidine.
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52. | Zantac was approved by the FDA, pursuant to the New Drug Application (“NDA”)
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process in 1983 (NDA 18-703) and, quickly, became one of GSK’s most successful products, being
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the first prescription drug in history to reach $1 billion in sales, which in the pharmaceutical industry
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is referred to as a “Blockbuster.” |
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53. In 1993, GSK formed a joint venture with Pfizer* to\develop an OTC version of
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Zantac. This joint venture led to FDA approval of an OTC versionof Zantac in 1995. Zantac OTC
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was approved through an NDA process (NDA 20-520).
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54. In 1997, GSK’s patent on ranitidine expired, and generic Ranitidine-Containing Drugs
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entered the market. Despite generic entry, however, brand name prescription and OTC Zantac
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continued to be sold. Although sales of brand-name Zantac declined as a result of generic and
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any state in the United States. GlaxoSmithKline, plc is the successor-in-interest to the companies that
initially developed, patented, and commercialized the molecule known as ranitidine. Ranitidine was
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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
We
December 1978, which covered the ranitidine molecule. In 1983, the FDA granted approval to Glaxo
Holdings, Ltd. to sell Zantac in the United States. Glaxo Holdings, Ltd. was later absorbed into Glaxo
ek
Wellcome, PLC. And then, in 2000, GlaxoSmithKline, plc and GSK were created by the merger of
HW
Glaxo Wellcome and SmithKline Beecham.
3 Smith, Kline and French later merged with the Beecham Group in 1989 to form SmithKline Beecham
DN
plc. And, as discussed above, SmithKline Beecham plc was merged into GSK in 2000.
4 The joint venture was between Glaxo Wellcome plc and Warner—Lambert, Inc. Warner-Lambert
oN
was later acquired by Pfizer, Inc. in 2000. For the purposes of this PIMC, Warner-Lambert will be
referred to as Pfizer.
13
FIRST AMENDED COMPLAINT
alternative products, Ranitidine-Containing Drug sales remained strong over time. As recently as
2018, Zantac was one of the top 10 antacid tablet brands in the United States, with sales of Zantac
YN
150 totaling $128.9 million—a 3.1% increase from the previous year.
WY
55. In 1998, the joint venture between GSK and Pfizer dissolved. As part of the
F&F
separation, GSK retained the rights to sell all forms of Zantac internationally and prescription Zantac
AO
in the U.S., while Pfizer retained the rights to sell OTC Zantac domestically and retained ownership
DK
over the Zantac trademark. Under this agreement, GSK retained control and responsibility over the
tN
prescription Zantac NDA and Pfizer retained control and responsibility over the OTC Zantac NDA.
Oo
56. In October 2000, Pfizer obtained full rights to OTC Zantac in the United States and
Oo
Canada from GSK pursuant to a divestiture and transfer agreement. As part of this agreement, GSK
OS
divested all domestic Zantac OTC assets to Pfizer including all trademark rights and removed the
|
restrictions on Pfizer’s ability to seek product line extensions or the approval for higher doses of OTC
NY
Zantac. GSK retained the right to exclusive use of the Zantac name for any prescription ranitidine-
WD
containing product in the United States.
FF
57. In October 2003, Pfizer submitted NDA 21-698 for approval to market OTC Zantac
DH
150 mg. The FDA approved NDA 21-698 OTC Zantac 150 mg on August 31, 2004.
HR
58. In 2006, Pfizer through a divestiture agreement, transferred all assets pertaining to its
HN
Zantac OTC line of products, including the nghts to sell and market all formulations of OTC Zantac
Oo
in the United States and Canada, as well as all intellectual property, research and development, and
Oo
| customer and supply contracts to Boehringer Ingelheim Pharmaceuticals, Inc. As part of this deal,
Oo
Boehringer obtained control and responsibility over all of the Zantac OTC NDAs.
K§F
59. In 2009, GSK ceased marketing prescription Zantac in the U.S. and abandoned the
PP
Zantac prescription NDA. Although, according to GSK’s recent annual report (2019), GSK claims to
WO
have “discontinued making and selling prescription Zantac tablets in 2017 ... in the U.S."
BR
A
ON
nN
> GlaxoSmithKline, plc, Annual Report at 37 (2019), available at
oOo
https://www.gsk.com/media/5894/annual-report.pdf
14
FIRST AMENDED COMPLAINT
t
60. In 2016, Boehringer sold the rights of OTC Zantac to Sanofi US Services, Inc. As part
Fe
of this deal, Sanofi obtained control and responsibility over the OTC NDA and currently retains that
NY
control and responsibility.
W
61. To date, the FDA has approved numerous generic manufacturers for the sale of
fF
prescription and OTC Ranitidine-Containing Drugs through an Abbreviated New Drug Application
Wn
(“ANDA”) process.
Dn
II. Recalls and the FDA’s Ban i
on
62. On September 9, 2019, pharmacy and testing laboratory Valisure LLC and
ValisureRX LLC (collectively, “Valisure”) filed a Citizen Petition calling for the recall of all
Oo
ranitidine-containing products due to exceedingly high levels of NDMA found in ranitidine pills.
OS
FDA and European regulators started reviewing the safety of ranitidine with specific focus on the
KF
presence of NDMA.° This triggered a cascade of recalls by the makers and retailers of Ranitidine-
NY
Containing Drugs.
W
63. On September 13, 2019, the FDA’s Director for Drug Evaluation and Research, Dr.
FP
Janet Woodcock, issued a statement that some ranitidine medicines;may contain NDMA.
AH
64. On September 24, 2019, generic manufacturer Sandoz Inc. voluntarily recalled all of
WD
its ranitidine-containing products due to concerns of a “nitrosamine impurity, N-
ND
nitrosodimethylamine (NDMA), which was found in the recalled medicine.”
Oo
65. On September 26, 2019, Walgreens, Walmart, and Rite-Aid and Apotex Corp.—
ODO
makers of generic OTC ranitidine—voluntarily recalled all ranitidine-containing products and
DOD
removed the products from the shelves.* Apotex issued a statement, noting that “Apotex has learned
KF&
from the U.S. Food and Drug Administration and other Global regulators that some ranitidine
NY
WO
BR
UH
ndma-zantac-ranitidine; https://www.ema.europa.eu/en/news/ema-review-ranitidine-medicines-
following-detection-ndma.
OBO
7 https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-sandoz-
ranitidine-capsules-following-detection-impunty.
nN
8 https://www.fda.gov/drugs/drug-safety-and-availabilit /fda-updates-and-press-announcements-
ao
ndma-zantac-ranitidine.
15
FIRST AMENDED COMPLAINT
medicines including brand and generic formulations of ranitidine régardless of the manufacturer,
FY
contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA)[.]”?
NY
66. On September 28, 2019, CVS Health Corp. stated that it would stop selling Zantac and
WD
its own generic ranitidine-containing products out of concern that it might contain a carcinogen.
BP
67. On October 2, 2019, the FDA ordered testing on Zantac and specified a protocol to be
wD
used that did not involve the use of heat.'° |
BDH
68. On October 8, 2019, GSK voluntarily recalled all Zantac and ranitidine-containing
NY
products internationally.'! As part of the recall, GSK publicly acknowledged that unacceptable levels
co
of NDMA were discovered in Zantac and noted that “GSK is continuing with investigations into the
Oo
potential source of the NDMA.”? | |
OO
69. On October 23, 2019, Dr. Reddy’s Laboratories Ltd'and Sanofi voluntarily recalled all
|
of their ranitidine-containing products.
NY
70. On October 28, 2019, Perrigo Company ple, Novitium Pharma LLC, and Lannet
WY
Company Inc., voluntarily recalled all their ranitidine-containing products from the market.'*
Fe
71. | On November 1, 2019, the FDA announced the results of recent testing, finding
nH
“unacceptable levels” of NDMA in ranitidine-containing products, and requested that drug makers
DH
begin to voluntarily recall their ranitidine-containing products.!° |
ON
72. Between November 1, 2019 and February 27, 2020, the following ranitidine makers
recalled their products from the market, citing NDMA concerns: Aurobindo Pharma USA, Amneal
OO
OD
° https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-volunt
KF
nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes-and.
NY
10 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-
ndma-zantac-ranitidine
WwW
"| https://www.gov.uk/government/news/zantac-mhra-drug-alert-issued-as-glaxosmithkline-recalls-
all-unexpired-stock
BR
!2 Justin George Varghese, GSK recalls popular heartburn drug Zantac globally after cancer scare,
Reuters (Oct. 8, 2019), available at https://www.reuters.com/article/us-gsk-heartburn-zantac/gsk-
NAN
recalls-popular-heartburn-drug-zantac-globally-after-cancer-scare-id USK BNIWNISL.
13 hetps://www fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-
ndma-zantac-ranitidine.
on
14 Iq.
15 https://www.fda.gov/drugs/drug-safety-and-availability/laboratory-tests-ranitidine.
16
FIRST AMENDED COMPLAINT
Pharmaceuticals, LLC, American Health Packaging, Golden State Medical Supply, Precision Dose
Inc., Glenmark Pharmaceutical Inc., Appco Pharma LLC, and Northwind Pharmaceuticals. !°
YY
73. On January 2, 2020, research laboratory, Emery Pharma, submitted a Citizen Petition
WD
to the FDA, showing that NDMA accumulates in ranitidine at unsafe rates when exposed to heat
Fe
levels that would occur during transport and storage.
AWN
74. _Emery’s Citizen Petition outlined its substantial concern that Ranitidine is a time- and
DH
temperature-sensitive pharmaceutical product that develops a known carcinogen, NDMA, when
aI
exposed to heat, a common occurrence during shipping, handling, and storage. In addition to
Oo
warning about this condition, Emery requested agency directives to manufacturers and distributors to
oO
ship Ranitidine-Containing Products in temperature-controlled vehicles.
SG
75. Inresponse,'’ on April 1, 2020, the FDA recounted that a recall is an “effective
FSF
methods [sic.] of removing or correcting defective FDA-regulated products . . . particularly when
NY
those products present a danger to health.”!® The FDA sought the voluntary consent of
Ww
manufacturers to accept the recall “to protect the public health from products that present a risk of
FF
injury.”!? The FDA found that the recall of all Ranitidine-Containing Products and public warning of
DH
the recall was necessary because the “product being recalled presents a serious health risk.”?° The
DH
FDA therefore sent Information Requests to all applicants and pending applicants of Ranitidine-
ND
Containing Products “requesting a market withdrawal.””!
DOD
76. The FDA found its stability testing raised concerns that NDMA levels in some
O6O
ranitidine products stored at room temperature can increase with time to unacceptable levels. Other
DOD
testing conducted by FDA revealed a correlation between NDMA levels and expiration date. The
K&
NY
WO
ress-announcements-
ndma-zantac-ranitidine.
F&F
'7 Letter of Janet Woodcock, Docket No. FDA-2020-P-0042 (April 1, 2020), available at
nA
https://emerypharma.com/wp-content/uploads/2020/04/FDA-2020-P-0042-CP-Response-4-1-
2020.pdf.
DWN
18 Tq, citing 21 CFR 7.40(a).
19 Td.
on
20 Td.
1 7q., fn. 43.
17
FIRST AMENDED COMPLAINT
FDA’s testing eroded the agency’s confidence that any ranitidine product could remain stable through
its labeled expiration date. Consequently, the FDA was compelled to order the products off the
NY
market. The FDA’s decision to ban the dmg rendered moot Emery’s request for temperature-
W
controlled sales conditions.
BP
77. The FDA therefore issued
Preview
e AK i vee Jennifer A. Moore (SBN 206779) jennifer@moorelawgroup.com MOORE LAW GROUP, PLLC FILED | ALAMEDA COUNT TY NO 1473 South 4th Street Louisville, KY 40208 APR 27. 2021 WY Tel: (502) 717-4080 / Fax: (502) 717-4086 F&F Attorney for Plaintiff vA BHO NY SUPERIOR COURT FOR THE STATE OF CALIFORNIA COUNTY OF ALAMEDA | fo GARY CAMPBELL,’ Case No. RG20061371 o | Plaintiff, FIRST AMENDED COMPLAINT OS | KF Vv. DEMAND FOR JURY TRIAL NY GLAXOSMITHKLINE, LLC; PFIZER, INC.; Ww BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. ; RP BOEHRINGER INGELHEIM USA CORPORATION; SANOFI US SERVICES AW INC.; SANOFI-AVENTIS U.S. LLC; THE - DO VONS COMPANIES, INC.; KAISER PERMANENTE INTERNATIONAL; and OSD DOES | through 100 inclusive, Defendants. OO Ke Ne OW BR AN TN on qant3 l FIRST AMENDED COMPLAINT | TABLE OF CONTENTS | \ Page YN TABLE OF CONTENTS ........sesccsccssssseeessssseeessneeseesnnneeeeesnesesssnneess sestnseesseessvssnteceessuneeceeessnneteseeeesneees 2 WD INTRODUCTION .csccscscescversessetsseeviesnsnetntnesneeeteeteecece sestststnetsesesnteetneeerneetneee 4 FP TW PARTIES 00. ceccecccccccceceeececeecececesesenevseaeeteseseeeecsesecacseseseeertecscseeeenens titties 5 DH I. Plaintiff ooo... eee ceceeceecceeeecececeesesenescesensecenecceceacsceacseecssesseeeseseeeeaesceaeseeceeeaeseeeeaeeeseseeceaeaes 5 INT Il. Defendant ..........ccccccccccsceccssesceceessesceseesesecsesceseescscessesessseceseeaesecaesseeaeacsaeaceaesaeetateeeneeaees 7 CoO A. Manufacturer Defendants............0.0.0.0ceee | veceeeeaeaeesecseneeacscseeeseeeceeetastsneseseeens 7 Oo B. Retailer Defendats......cncennennnnnnny vesaeescesseseessessessessesaeaeseeneeeeaeeaeeatens 9 C. Doe Defendants. ..............:e:cescesceseeceereeeeeeneeees saseseeeueseeesesesesesescenetetenseseneneceenens 10 JURISDICTION AND VENUE ...0.0......ccecececcececeseeseseeeeeeseeeeseeeeeeeeeees ! eesesesscseseeseasseceasssseseecaeseeseeeseeees 11 FACTUAL ALLEGATIONS ..00...ecccececeeneeeeseseeeeneeeeeseeeeececereeeeens pst 12 SS I Regulatory History of Ranitidine-Containing Products eccesessesseeseseneceaceseeseeseeseeseeseees 12 © IL. Recalls and the FDA’s Banh... eeceseeeteeeeeeeeeeeees cessessunussssseseesensssuasasssseeeneeetee 15 ~ TH. Dangers of NOMA... ccc ccccccceseeseessesseeteteeeee! | ceeesceseessssssusecsessesessssssssseesseeee 19 IV. How Ranitidine Transforms into NDMA Within the'Human Body ...........ccececeeeeeee 24 © A. Formation of NDMA in the Environment of the Human Stomach ............0--. 25 © oS B. Formation of NDMA in the Other Organs of ‘Human Body .......cccccceceeeeeeeeeees 31 C. Formation of NDMA by Exposure to Heat and/or Time.........0..0.....0c:cceseees 33 © > D. Evidence Also Directly Links Ranitidine Exposure to Cancer... cee 35 V. Defendants Made False Statements in the Labeling of Their Ranitidine-Containing OE PrOUct...00....0..cceccecesceseseeceseeceeceseseesceceeceseeeeeeeeeeaeaeeaees soseeeeeecensanescencennnnneceeseennnnnsenesen 37 EE VI. Defendants Knew or Should Have Known of the NDMA Risk ...........cecsccssessseseeeeeeees 37 © VII. Exemplary / Punitive Damages Allegations (Against Manufacturer Defendants) ....... 42 CO VIII. Equitable Tolling/Estoppel .........0...ccccescseeeeseeeeseeseeee eeesssssesceesssseecessnessessstenesessseesees 42 ©, SE En ©) OE CAUSES OF ACTION ............ saeneaceseseesereseseeseseeesteseeeaeeseseteeseeteeteeie acscueescaceeesesceaeseeeeseseeeecessereaeneeeas 43 COUNT I: STRICT PRODUCTS LIABILITY - FAILURE TO WARN 0... 43 me COUNT I: STRICT PRODUCTS LIABILITY - MANUFACTURING DEFECT ..............- 47 (ovo 2 FIRST AMENDED COMPLAINT @ | i COUNT II: NEGLIGENCE — FAILURE TO WARN |... ccceeeseneeeeeeeeeeeesestisteneeneees COUNT IV: NEGLIGENT PRODUCT DESIGN ..00.ooccec ices eeeeeteeeeeeececeeeetecnenersetenetaeees YN COUNT V: NEGLIGENT MANUFACTURING ...00....cecec cece e ceeeseseeeeeeaceceaeeceeescseeeseeneenes WY COUNT VI: NEGLIGENT MISREPRESENTATION ....0.0o..ccccccseseseeseceseseeeseecesescseeseseneenenenes FP COUNT VIE: STRICT LIABILITY. ecececceeeseeseeeeseceeeeesecseeaeseeaeeecseeaeeeseseeeters UW COUNT VII: STRICT PRODUCTS LIABILITY —DISTRIBUTION DEFECT ..........00.0..... NH COUNT IX: NEGLIGENCE o......eccceccecceceeeceeeeeeeseseesceecensaeseseesstseatsacasecesseseseeseeseeeeeeeateeteeees NY JURY TRIAL DEMAND 200i ccc ec cee ceceeesereeseesessesscsesecscsecsessaesesaseessataseesesaesesaceessessstasseeaceaentens Oo PRAYER FOR RELIEF Oo OC KF NY WD FF HW DH aI oO OO OG K& PY WO BP A N ont 3 FIRST AMENDED COMPLAINT INTRODUCTION Plaintiff, Gary Campbell, by counsel, and pursuant to California Code of Civil Procedure 472, NY files his First Amended Complaint and alleges as follows: W 1. This is a personal injury action for damages relating to Defendants’ design, F&F manufacture, sale, marketing, advertising, promotion, testing, labeling, packaging, handling, AWA distribution, transportation, and storage of ranitidine-containing drugs including the brand name, HD Zantac, and its various generic forms (“Ranitidine-Containing Drugs,” unless specifically identified). NN 2. Plaintiff brings this action for personal injuries suffered as a result of ingesting the wo defective and unreasonably dangerous Ranitidine-Containing Drugs and developing cancer and its Oo sequelae as a result of this ingestion. LO 3. As more particularly set forth herein, Plaintiff maintains that the Ranitidine- NYE Containing Drugs he ingested are defective, dangerous to human health, unfit and unsuitable to be advertised, marketed, and sold in the United States, were manufactured improperly, and lacked YD proper warnings of the dangers associated with their use. Se 4, N-Nitrosodimethylamine (“NDMA”) is a potent carcinogen. Discovered as a OH biproduct in manufacturing rocket fuel in the early 1900s, today, its only use is to induce tumors in ON animals as part of laboratory experiments. Its only function is to cause cancer. It has no business OOOH being in a human body. 5. Zantac, the popular antacid medication that was used by millions of people every day, leads to the production of staggering amounts of NDMA when it is digested by the human body. The ODO U.S. Food and Drug Administration’s (“FDA”) allowable daily limit of NDMA is 96 ng (nanograms) EF and yet, in a single dose of Zantac, researchers are discovering over 3 million ng. YY 6. These revelations by independent researchers have caused widespread recalls of WwW Zantac and its generic forms both domestically and internationally, including the domestic recall by Bh the current owner and controller of the Zantac new drug application (“NDA”). On April 1, 2020, the AH FDA banned all Ranitidine-Containing Drugs sold in the United States. ON nN oo 4 FIRST AMENDED COMPLAINT @ ' t 7. The high levels of NDMA observed in Ranitidine-Containing Drugs is a function of = the ranitidine molecule: (1) the way it breaks down in the human digestive system; and (2) the way it NH breaks down when exposed to heat, in particular, during transport and storage. WD 8. This lawsuit seeks to hold Defendants responsible for defective design, manufacturing, FF sale, marketing, advertising, promotion, testing, labeling, packaging, handling, distribution, DH transportation, and storage that caused Plaintiffs severe injuries. DO PARTIES SI 1. Plaintiff fo 9. Plaintiff, Gary Campbell, resides in California and is a citizen of California and no oOo other state. | SO 10. Plaintiff started consuming generic prescription Ranitidine-Containing Drugs in — approximately 2000, until approximately 2019. Plaintiff also consumed brand name over-the-counter NY Ranitidine-Containing Drugs on occasion from approximately 2000 until approximately 2019. WY Plaintiff purchased Ranitidine-Containing Drugs from Defendants, The Vons Companies, Inc. and SF Kaiser Permanente International. DH > 11. Asa direct and proximate result of consuming carcinogenic Ranitidine-Containing HD Drugs, Plaintiff was diagnosed with prostate and kidney cancer. | aI 12. Based on prevailing scientific evidence, exposure to Ranitidine-Containing Drugs (and BH the attendant NDMA) can cause cancer in humans. BO 13. Had any Defendant warned Plaintiff that Ranitidine-Containing Drugs could lead to DD exposure to NDMA or, in turn, cancer, Plaintiff would not have taken Ranitidine-Containing Drugs. K& 14. Plaintiff is informed and believes and based thereonialleges that as a direct and NY proximate result of Plaintiff’s use of and/or exposure to Ranitidine-Containing Drugs supplied and WD distributed by Defendants herem, Plaintiff suffered significant harm, conscious pain and suffering, F&F physical injury and bodily impairment including, but not limited to ‘cancer, other permanent physical UN deficits, permanent bodily impairment and other sequelae. PlaintifP’s injuries required NAN hospitalizations, in-patient surgeries, medication treatments, and other therapies to address the 41 ono adverse physical effects and damage caused by Plaintiff's use of and/or exposure to Ranitidine- 5 FIRST AMENDED COMPLAINT j Containing Drugs. 15. | Asadirect and proximate result of the wrongful conduct, acts, omissions, fraudulent NY concealments, fraudulent misrepresentations, and fraudulent business practices by Defendants and WD DOES 1 through 100, inclusive, Plaintiff used and/or was exposed to Ranitidine-Containing Drugs FP and was diagnosed with serious health injuries including cancer. ' AW 16. As aresult of using and/or being exposed to Defendants’ Ranitidine-Containing . DBD Drugs, Plaintiff has been permanently and severely injured, having suffered serious consequences NHN from Ranitidine-Containing Drugs. fo 17. Asa further direct and proximate result of defects in Ranitidine-Containing Drugs and oOo the wrongful conduct, acts, omissions, and fraudulent misrepresentations of Defendants, Plaintiff CO suffered severe mental and physical pain and have and will sustain permanent injuries and emotional S| distress, along with economic loss due to medical expenses and living-related expenses as a result of NY lifestyle changes. WD 18. Asa further direct and proximate result of defects in Ranitidime-Containing Drugs and FP the wrongful conduct, acts, omissions, and fraudulent misrepresentations of Defendants, Plaintiff DH required extensive emergency medical treatment, health care, attention and services, thereby incurring medical, incidental, and service expenses pertaining to emergency medical treatments and ND procedures undertaken in efforts to maintain and/or save Plaintiff's life. OW 19. _ Plaintiff is an individual who suffered damages as a result of injuries resulting from OO Plaintiffs use and/or exposure to Ranitidine-Containing Drugs and is authorized to bring an action ODO for the causes of actions alleged herein including, but not limited to, juries and damages sustained KK by Plaintiff, resulting from Plaintiffs use and/or exposure to Ranitidine-Containing Drugs. Said NY injuries and damages sustained by Plaintiff were caused or substantially contributed to by the WO wrongful conduct of Defendants and DOES 1 through 100, inclusive. PF 20. The product warnings for Ranitidine-Containing Drugs in effect during the time period AH Plaintiff used and/or were exposed to Ranitidine-Containing Drugs were vague, incomplete or NWN otherwise inadequate, both substantively and graphically, to alert consumers to the severe health risks oN associated with Ranitidine-Containing Drugs use and/or exposure. ° 6 FIRST AMENDED COMPLAINT e @ 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 NY increased risk of serious adverse events that are described herein. i WY 22. Had Plaintiff been adequately warned of the potential life-threatening side effects of FP the Defendants and DOES 1 through 100, and each of them, inclusive, Ranitidine-Containing Drugs, UW Plaintiff would not have purchased, used or been exposed to Ranitidine-Containing Drugs. NH 23. Byreason of the foregoing, Plaintiff developed serious and dangerous side effects NN including cancer and other cancers, related sequelae, physical pain and suffering, mental anguish, and fo loss of enjoyment of life. By reason of the foregoing, Plaintiff suffered economic losses and special Oo damages including, but not limited to, loss of earning and medical expenses. Plaintiff's general and O&O special damages are in excess of the jurisdictional limits of the Court. | 24. Plaintiff has reviewed their potential legal claims and causes of action against the NY Defendants and have intentionally chosen only to pursue claims based on state law. Any reference to W any federal agency, regulation or rule is stated solely as background information and does not raise a FR federal question. Plaintiff has chosen to only pursue claims based on state law and are not making DH any claims which raise federal questions. Accordingly, Plaintiff contends that California State jurisdiction and venue is proper. | HD Il. Defendants DOB A. Manufacturer Defendants | Oo 25. Defendant, GlaxoSmithKline, LLC (“GSK”), is a Delaware limited liability company Oo with its principal place of business located at 5 Crescent Drive, Philadelphia, Pennsylvania, 19112 KF and Five Moore Drive, Research Triangle, North Carolina, 27709. GSK is a citizen of Delaware. NY WOH GSK 1s a wholly owned subsidiary of GlaxoSmithKline, plc, which is its sole member. At all Rh relevant times, GSK has conducted business and derived substantial revenue from its manufacturing, l AH advertising, distributing, selling, and marketing of Zantac within the State of California and Alameda | BN 1| County. ' { 26. GSK, and its predecessors, have controlled the prescription Zantac NDAs since 1983. oN | 4 FIRST AMENDED COMPLAINT | | 27. Defendant, Pfizer, Inc. (“Pfizer’’), is a Delaware corporation with its principal place of NF business located at 235 East 42nd Street, New York, New York 10017. Pfizer is a citizen of Delaware and New York and is not a citizen of any other state. At all relevant times, Pfizer has WY fF conducted business and derived substantial revenue from its manufacturing, advertising, distributing, UW selling, and marketing of Zantac within the State of California and Alameda County. DH 28. Defendant, Boehringer Ingelheim Pharmaceuticals, Inc., is a Delaware corporation with its principal place of business located at 900 Ridgebury Road, Ridgefield, Connecticut 06877. N Oo Boehringer Ingelheim Pharmaceuticals, Inc. is a citizen of Connecticut and Delaware, and not of any 0 other state. Boehringer Ingelheim Pharmaceuticals, Inc. is a subsidiary of the German company CO Boehringer Ingelheim Corporation. Boehringer Ingelheim Pharmaceuticals, Inc. owned and KF controlled the NDA for over-the-counter (“OTC”) Zantac between December 2006 and January 2017, YN and manufactured and distributed the drug in the United States during that period. At all relevant WY times, Boehringer Ingelheim Pharmaceuticals, Inc. has conducted business and derived substantial F&F revenue from its manufacturing, advertising, distributing, selling, and marketing of Zantac within the TH State of California and Alameda County. : DH 29. Defendant, Boehringer Ingelheim USA Corporation, is a Delaware corporation with HD its principal place of business located in at 900 Ridgebury Rd., Ridgebury, Connecticut 06877. OO Boehringer Ingelheim USA Corporation is a citizen of Delaware and Connecticut and is not a citizen OD of any other state. At all relevant times, Boehringer Ingelheim USA Corporation has conducted OD business and derived substantial revenue from its manufacturing, advertising, distributing, selling, K-&— and marketing of Zantac within the State of California and Alameda County. NY 30. Collectively, Defendants Boehringer Ingelheim Pharmaceuticals, Inc. and Defendant WwW Boehringer Ingelheim USA Corporation shall be referred to as “Boehringer”. ek 31. Defendant, Sanofi US Services Inc., is a Delaware corporation with its principal place OW of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807, and is a wholly owned BN subsidiary of Sanofi S.A. Sanofi is a citizen of Delaware and New Jersey and is not a citizen of any nN other state. Sanofi controlled the NDA for OTC Zantac starting in January 2017 through the present o 8 FIRST AMENDED COMPLAINT @ @ and manufactured and distributed the drug in the United States during that period. Sanofi voluntarily — recalled all brand name OTC Zantac on October 18, 2019. At all relevant times, Sanofi has conducted YN business and derived substantial revenue from its manufacturing, advertising, distributing, selling, Ww F&F and marketing of Zantac within the State of California and Alameda County. vn 32. Defendant, Sanofi-Aventis U.S. LLC, was and is a Delaware limited liability company DBD with its principal place of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807. 1 Sanofi-Aventis U.S. LLC is a citizen of Delaware and New Jersey and 1S not a citizen of any other fo state. Sanofi-Aventis US LLC is a wholly owned subsidiary of Sanofi S.A. At all relevant times, Oo Sanofi-Aventis U.S. LLC has conducted business and derived substantial revenue from its SO manufacturing, advertising, distributing, selling, and marketing of Zantac within the State of KF California and Alameda County. NY 33. Collectively, Defendants Sanofi US Services Inc., and Sanofi-Aventis U.S. LLC, shall WD be referred to as “Sanofi.” FR B. Retailer Defendants DH 34. Defendant, The Vons Companies, Inc. (““Vons”), is a Michigan corporation with its DH headquarters and principal place of business located at 11555 Dublin Canyon Rd., Pleasanton, HN California 94588. Vons is a wholly owned subsidiary of Albertsons Companies, Inc. Vons is a WO citizen of California and Delaware and is not a citizen of any other state. At all relevant times, Vons ODO has conducted business and derived substantial revenue from its advertising, selling, and marketing of ODO Ranitidine-Containing Drugs within the State of California and Alameda County. KK 35. Defendant, Kaiser Permanente International (“Kaiser”), is a California corporation NY with its headquarters and principal place of business located at One Kaiser Plaza, Alameda County, WY Oakland, California 94612. At all relevant times, Kaiser has conducted business and derived BRP substantial revenue from its selling of Ranitidine-Containing Drugs within Alameda County and the A State of California by operating a pharmacy that dispenses Ranitidine-Containing Drugs. HN sy oo 9 FIRST AMENDED COMPLAINT C. Doe Defendants ; KS 36. | The true names and/or capacities, whether individual, corporate, partnership, NY associate, governmental, or otherwise, of Defendants DOES 1 through 100, inclusive, and each of WY them, are unknown to Plaintiff at this time, who therefore sues said Defendants by such fictitious FP names. Plaintiff is informed and believes, and thereon alleges, that each Defendant designated herein AW as a DOE caused injuries and damages proximately thereby to Plaintiff as hereinafter alleged; and DBO that each DOE Defendant is liable to the Plaintiff for the acts and omissions alleged herein below, NN and the resulting injuries to Plaintiff, and damages sustained by Plaintiff. Plaintiff will amend this Oo Complaint to allege the true names and capacities of said DOE Defendants when that same is oOo ascertained. | O&O 37. Plaintiff is informed and believes, and thereon alleges, that at all times herein KF mentioned, each of the Defendants and each of the DOE Defendants was the agent, servant, NY employee and/or joint venturer of the other co-Defendants and other DOE Defendants, and each of WY them, and at all said times, each Defendants and each DOE Defendant was acting in the full course, FF scope and authority of said agency, service, employment and/or joint venture. DH 38. Plaintiff is informed and believes and alleges that at,all times mentioned herein, Defendants and DOES 1 through 100, inclusive, and each of them, were also known as, formerly I known as and/or were the successors and/or predecessors in interest/business/product line/or a DW portion thereof, assigns, a parent, a subsidiary (wholly or partially owned by, or the whole or partial Ob owner), affiliate, partner, co-venturer, merged company, alter egos, agents, equitable trustees and/or DO fiduciaries of and/or were members in an entity or entities engaged in the funding, researching, KF studying, manufacturing, fabricating, designing, developing, labeling, assembling, distributing, NY supplying, leasing, buying, offering for sale, selling, inspecting, servicing, contracting others for Ww marketing, warranting, rebranding, manufacturing for others, packaging, transportation, storage, and BP advertising of Ranitidine-Containing Drugs. Defendants and DOES 1 through 100, inclusive, and Wn each of them, are liable for the acts, omissions and tortious conduct of its successors and/or DB predecessors in interest/business/product line/or a portion thereof, assigns, parent, subsidiary, nN affiliate, partner, co-venturer, merged company, alter ego, agent, equitable trustee, fiduciary and/or its o 10 FIRST AMENDED COMPLAINT t alternate entities in that Defendants and DOES 1 through 100, inclusive, and each of them, enjoy the goodwill originally attached to each such alternate entity, acquired the assets or product line (or YN portion thereof), and in that there has been a virtual destruction of Plaintiffs remedy against each WD such alternate entity, and that each such Defendants has the ability to assume the risk spreading role FF of each such alternate entity. AW 39. Plaintiff is informed and believes, and thereon alleges, that at all tumes herein DBD mentioned, that Defendants and DOES 1 through 100, inclusive, and each of them, were and are SIN corporations organized and existing under the laws of the State of California or the laws of some state Oo or foreign jurisdiction; that each of the said Defendants and DOE Defendants were and are authorized oOo to do and are doing business in the State of California and regularly conducted business in Alameda SO County and the State of California. KF 40. Upon information and belief, at relevant times, Defendants and DOES 1 through 100, NY and each of them, inclusive, were engaged in the business of researching, developing, designing, W licensing, manufacturing, distributing, selling, marketing, and/or introducing into interstate Fe commerce and into the State of California, including in Alameda County, either directly or indirectly DH through third parties or related entities, Ranitidine-Containing Drugs. DH 4l. At relevant times, Defendants and DOES | through 100, inclusive, and each of them, OND conducted regular and sustained business and engaged in substantial commerce and business activity in the State of California, which included but was not limited to selling, marketing and distributing GO Ranitidine-Containing Drugs in Alameda County and the State of California. DO 42. — Atall relevant times, Defendants and DOES 1 through 100, inclusive, and each of NF them, expected or should have expected that their acts would have consequences within the United States of America including the State of California and including Alameda County, said Defendants We derived and derive substantial revenue therefrom. PhP JURISDICTION AND VENUE UN 43. This Court has jurisdiction over this action pursuant to the California Constitution ONO Article VI, Section 10, which grants the Superior Court “original jurisdiction in all causes except nN those given by statute to other trial courts.” The Statutes under which this action is brought do not ao 11 FIRST AMENDED COMPLAINT specify any other basis for jurisdiction. Further, diversity jurisdiction pursuant to 28 U.S.C. § 1332 = does not exist based upon the citizenship of Plaintiff and Defendants. YN 44. This Court has personal jurisdiction over each Defendant insofar as each Defendant is W authorized and licensed to conduct business in the State of California, a resident of the State of F&F California, maintains and carries on systematic and continuous contacts in the State of California, AW regularly transacts business within the State of California, and regularly avails itself of the benefits of HN the State of California. HN 45. Additionally, Defendants caused tortious injury by acts and omissions in this judicial Oo jurisdiction and caused tortious injury in this jurisdiction by acts and omissions outside this Oo jurisdiction while regularly doing and soliciting business, engaging in a persistent course of conduct, OC and deriving substantial revenue from goods used or consumed and services rendered in this | jurisdiction. YP 46. Venue is proper in this Court pursuant to California Code of Civil Procedure Section WY 395(a) in that the headquarters and principal place of business of Defendants, The Vons Companies, F&F Inc. and Kaiser Permanente International, are in Alameda County. DH 47. Plaintiff seeks relief that is within the jurisdictional limits of the Court. DH FACTUAL ALLEGATIONS ONAN I Regulatory History of Ranitidine-Containing Products 48. Defendants marketed and sold Ranitidine-Containing Drugs under the brand name 0 “Zantac” or its generic version by either prescription or over-the-counter (“OTC”). Defendants sold DBD Ranitidine-Containing Drugs in the following forms: injection, syrup, and/or tablets and capsules. &—&— 49. Zantac (ranitidine) was originally discovered and developed by scientist John NY Bradshaw on behalf of GlaxoSmithKline (“GSK”)' in 1976.” WD fF nN ' Dr. Bradshaw was working for Glaxo Inc. at the time. Glaxo Inc. later merged with the Wellcome Foundation in 1995 to become Glaxo Wellcome plc. Then, in 2000, Glaxo Wellcome plc merged with DN Smithkline Beecham plc to form GlaxoSmithKline plc. For the purposes of this Complaint, these entities will be referred to as “GSK.” ny ?GlaxoSmithK line, plc, is a foreign entity and a citizen of the United Kingdom, and is not a citizen of on 12 FIRST AMENDED COMPLAINT 50. The drug belongs to a class of medications called histamine H2-receptor antagonists = (or Hz blockers), which decrease the amount of acid produced by cells in the lining of the stomach. NO Other drugs within this class include cimetidine (Tagamet), famotidine (Pepcid), and nizatidine WOW (Tazac). F&F 51. Cimetidine (Tagamet), discovered and developed by Smith, Kline and French,’ was AW the first H2 blocker to be developed and is the prototypical histamine H2 receptor antagonist from DBD which the later members of the class were developed. Indeed, Zantac was specifically developed by HN GSK in response to the success of cimetidine. Oo 52. | Zantac was approved by the FDA, pursuant to the New Drug Application (“NDA”) oO process in 1983 (NDA 18-703) and, quickly, became one of GSK’s most successful products, being CO the first prescription drug in history to reach $1 billion in sales, which in the pharmaceutical industry | is referred to as a “Blockbuster.” | YY 53. In 1993, GSK formed a joint venture with Pfizer* to\develop an OTC version of WY Fe Zantac. This joint venture led to FDA approval of an OTC versionof Zantac in 1995. Zantac OTC HH was approved through an NDA process (NDA 20-520). DH 54. In 1997, GSK’s patent on ranitidine expired, and generic Ranitidine-Containing Drugs HN entered the market. Despite generic entry, however, brand name prescription and OTC Zantac Oo continued to be sold. Although sales of brand-name Zantac declined as a result of generic and Oo Oo K—&— any state in the United States. GlaxoSmithKline, plc is the successor-in-interest to the companies that initially developed, patented, and commercialized the molecule known as ranitidine. Ranitidine was NY 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 We December 1978, which covered the ranitidine molecule. In 1983, the FDA granted approval to Glaxo Holdings, Ltd. to sell Zantac in the United States. Glaxo Holdings, Ltd. was later absorbed into Glaxo ek Wellcome, PLC. And then, in 2000, GlaxoSmithKline, plc and GSK were created by the merger of HW Glaxo Wellcome and SmithKline Beecham. 3 Smith, Kline and French later merged with the Beecham Group in 1989 to form SmithKline Beecham DN plc. And, as discussed above, SmithKline Beecham plc was merged into GSK in 2000. 4 The joint venture was between Glaxo Wellcome plc and Warner—Lambert, Inc. Warner-Lambert oN was later acquired by Pfizer, Inc. in 2000. For the purposes of this PIMC, Warner-Lambert will be referred to as Pfizer. 13 FIRST AMENDED COMPLAINT alternative products, Ranitidine-Containing Drug sales remained strong over time. As recently as 2018, Zantac was one of the top 10 antacid tablet brands in the United States, with sales of Zantac YN 150 totaling $128.9 million—a 3.1% increase from the previous year. WY 55. In 1998, the joint venture between GSK and Pfizer dissolved. As part of the F&F separation, GSK retained the rights to sell all forms of Zantac internationally and prescription Zantac AO in the U.S., while Pfizer retained the rights to sell OTC Zantac domestically and retained ownership DK over the Zantac trademark. Under this agreement, GSK retained control and responsibility over the tN prescription Zantac NDA and Pfizer retained control and responsibility over the OTC Zantac NDA. Oo 56. In October 2000, Pfizer obtained full rights to OTC Zantac in the United States and Oo Canada from GSK pursuant to a divestiture and transfer agreement. As part of this agreement, GSK OS divested all domestic Zantac OTC assets to Pfizer including all trademark rights and removed the | restrictions on Pfizer’s ability to seek product line extensions or the approval for higher doses of OTC NY Zantac. GSK retained the right to exclusive use of the Zantac name for any prescription ranitidine- WD containing product in the United States. FF 57. In October 2003, Pfizer submitted NDA 21-698 for approval to market OTC Zantac DH 150 mg. The FDA approved NDA 21-698 OTC Zantac 150 mg on August 31, 2004. HR 58. In 2006, Pfizer through a divestiture agreement, transferred all assets pertaining to its HN Zantac OTC line of products, including the nghts to sell and market all formulations of OTC Zantac Oo in the United States and Canada, as well as all intellectual property, research and development, and Oo | customer and supply contracts to Boehringer Ingelheim Pharmaceuticals, Inc. As part of this deal, Oo Boehringer obtained control and responsibility over all of the Zantac OTC NDAs. K§F 59. In 2009, GSK ceased marketing prescription Zantac in the U.S. and abandoned the PP Zantac prescription NDA. Although, according to GSK’s recent annual report (2019), GSK claims to WO have “discontinued making and selling prescription Zantac tablets in 2017 ... in the U.S." BR A ON nN > GlaxoSmithKline, plc, Annual Report at 37 (2019), available at oOo https://www.gsk.com/media/5894/annual-report.pdf 14 FIRST AMENDED COMPLAINT t 60. In 2016, Boehringer sold the rights of OTC Zantac to Sanofi US Services, Inc. As part Fe of this deal, Sanofi obtained control and responsibility over the OTC NDA and currently retains that NY control and responsibility. W 61. To date, the FDA has approved numerous generic manufacturers for the sale of fF prescription and OTC Ranitidine-Containing Drugs through an Abbreviated New Drug Application Wn (“ANDA”) process. Dn II. Recalls and the FDA’s Ban i on 62. On September 9, 2019, pharmacy and testing laboratory Valisure LLC and ValisureRX LLC (collectively, “Valisure”) filed a Citizen Petition calling for the recall of all Oo ranitidine-containing products due to exceedingly high levels of NDMA found in ranitidine pills. OS FDA and European regulators started reviewing the safety of ranitidine with specific focus on the KF presence of NDMA.° This triggered a cascade of recalls by the makers and retailers of Ranitidine- NY Containing Drugs. W 63. On September 13, 2019, the FDA’s Director for Drug Evaluation and Research, Dr. FP Janet Woodcock, issued a statement that some ranitidine medicines;may contain NDMA. AH 64. On September 24, 2019, generic manufacturer Sandoz Inc. voluntarily recalled all of WD its ranitidine-containing products due to concerns of a “nitrosamine impurity, N- ND nitrosodimethylamine (NDMA), which was found in the recalled medicine.” Oo 65. On September 26, 2019, Walgreens, Walmart, and Rite-Aid and Apotex Corp.— ODO makers of generic OTC ranitidine—voluntarily recalled all ranitidine-containing products and DOD removed the products from the shelves.* Apotex issued a statement, noting that “Apotex has learned KF& from the U.S. Food and Drug Administration and other Global regulators that some ranitidine NY WO BR UH ndma-zantac-ranitidine; https://www.ema.europa.eu/en/news/ema-review-ranitidine-medicines- following-detection-ndma. OBO 7 https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-sandoz- ranitidine-capsules-following-detection-impunty. nN 8 https://www.fda.gov/drugs/drug-safety-and-availabilit /fda-updates-and-press-announcements- ao ndma-zantac-ranitidine. 15 FIRST AMENDED COMPLAINT medicines including brand and generic formulations of ranitidine régardless of the manufacturer, FY contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA)[.]”? NY 66. On September 28, 2019, CVS Health Corp. stated that it would stop selling Zantac and WD its own generic ranitidine-containing products out of concern that it might contain a carcinogen. BP 67. On October 2, 2019, the FDA ordered testing on Zantac and specified a protocol to be wD used that did not involve the use of heat.'° | BDH 68. On October 8, 2019, GSK voluntarily recalled all Zantac and ranitidine-containing NY products internationally.'! As part of the recall, GSK publicly acknowledged that unacceptable levels co of NDMA were discovered in Zantac and noted that “GSK is continuing with investigations into the Oo potential source of the NDMA.”? | | OO 69. On October 23, 2019, Dr. Reddy’s Laboratories Ltd'and Sanofi voluntarily recalled all | of their ranitidine-containing products. NY 70. On October 28, 2019, Perrigo Company ple, Novitium Pharma LLC, and Lannet WY Company Inc., voluntarily recalled all their ranitidine-containing products from the market.'* Fe 71. | On November 1, 2019, the FDA announced the results of recent testing, finding nH “unacceptable levels” of NDMA in ranitidine-containing products, and requested that drug makers DH begin to voluntarily recall their ranitidine-containing products.!° | ON 72. Between November 1, 2019 and February 27, 2020, the following ranitidine makers recalled their products from the market, citing NDMA concerns: Aurobindo Pharma USA, Amneal OO OD ° https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-volunt KF nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes-and. NY 10 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements- ndma-zantac-ranitidine WwW "| https://www.gov.uk/government/news/zantac-mhra-drug-alert-issued-as-glaxosmithkline-recalls- all-unexpired-stock BR !2 Justin George Varghese, GSK recalls popular heartburn drug Zantac globally after cancer scare, Reuters (Oct. 8, 2019), available at https://www.reuters.com/article/us-gsk-heartburn-zantac/gsk- NAN recalls-popular-heartburn-drug-zantac-globally-after-cancer-scare-id USK BNIWNISL. 13 hetps://www fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements- ndma-zantac-ranitidine. on 14 Iq. 15 https://www.fda.gov/drugs/drug-safety-and-availability/laboratory-tests-ranitidine. 16 FIRST AMENDED COMPLAINT Pharmaceuticals, LLC, American Health Packaging, Golden State Medical Supply, Precision Dose Inc., Glenmark Pharmaceutical Inc., Appco Pharma LLC, and Northwind Pharmaceuticals. !° YY 73. On January 2, 2020, research laboratory, Emery Pharma, submitted a Citizen Petition WD to the FDA, showing that NDMA accumulates in ranitidine at unsafe rates when exposed to heat Fe levels that would occur during transport and storage. AWN 74. _Emery’s Citizen Petition outlined its substantial concern that Ranitidine is a time- and DH temperature-sensitive pharmaceutical product that develops a known carcinogen, NDMA, when aI exposed to heat, a common occurrence during shipping, handling, and storage. In addition to Oo warning about this condition, Emery requested agency directives to manufacturers and distributors to oO ship Ranitidine-Containing Products in temperature-controlled vehicles. SG 75. Inresponse,'’ on April 1, 2020, the FDA recounted that a recall is an “effective FSF methods [sic.] of removing or correcting defective FDA-regulated products . . . particularly when NY those products present a danger to health.”!® The FDA sought the voluntary consent of Ww manufacturers to accept the recall “to protect the public health from products that present a risk of FF injury.”!? The FDA found that the recall of all Ranitidine-Containing Products and public warning of DH the recall was necessary because the “product being recalled presents a serious health risk.”?° The DH FDA therefore sent Information Requests to all applicants and pending applicants of Ranitidine- ND Containing Products “requesting a market withdrawal.””! DOD 76. The FDA found its stability testing raised concerns that NDMA levels in some O6O ranitidine products stored at room temperature can increase with time to unacceptable levels. Other DOD testing conducted by FDA revealed a correlation between NDMA levels and expiration date. The K& NY WO ress-announcements- ndma-zantac-ranitidine. F&F '7 Letter of Janet Woodcock, Docket No. FDA-2020-P-0042 (April 1, 2020), available at nA https://emerypharma.com/wp-content/uploads/2020/04/FDA-2020-P-0042-CP-Response-4-1- 2020.pdf. DWN 18 Tq, citing 21 CFR 7.40(a). 19 Td. on 20 Td. 1 7q., fn. 43. 17 FIRST AMENDED COMPLAINT FDA’s testing eroded the agency’s confidence that any ranitidine product could remain stable through its labeled expiration date. Consequently, the FDA was compelled to order the products off the NY market. The FDA’s decision to ban the dmg rendered moot Emery’s request for temperature- W controlled sales conditions. BP 77. The FDA therefore issued