Case 1:21-cv-01080-JHR-KK Document 1-2 Filed 11/05/21 Page 1 of 60
`Case 1:21-cv-01080-JHR-KK Document1-2 Filed 11/05/21 Page 1 of 60
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`
`
`EXHIBIT A
`EXHIBIT A
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`
`
`
`

`

`Case 1:21-cv-01080-JHR-KK Document 1-2 Filed 11/05/21 Page 2 of 60
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`Defendants.
`
`Fourth Judicial District Court
`San Miguel County, New Mexico
`496 W. National Avenue
`Las Vegas, New Mexico 87701
`Court Telephone: (505) 425-7281
`
`CHRISTINE RAMIREZ,
`Plaintiff,
`
`vs.
`
`SAN MIGUEL HOSPITAL
`CORPORATION d/b/a ALTA VISTA
`REGIONAL HOSPITAL; ALTA VISTA
`REGIONAL HOSPITAL; QUORUM
`HEALTH RESOURCES, LLC; ELIN
`RITCHIE, MD; PFIZER, INC.; and
`GREENSTONE, LLC,
`
`SUMMONS
`
`Case Number: D-412-CV-2021-00268
`
`Assigned Judg@Sallegos, Flora
`
`Defendant:
`
`PFIZER,INC.
`
`c/o CT Corporation System,
`Registered Agent
`206 S. Coronado Avenue
`Espanola, New Mexico 87532
`
`
`
`TO THE ABOVE NAMED DEFENDANT(S): Take notice that
`A lawsuit has been filed against you. A copy of the lawsuit is attached. The Court issued
`1.
`this Summons.
`2.
`You must respondto this lawsuit in writing. You must file your written response with the
`Court no later than thirty (30) days from the date you are served with this Summons. (The date you
`are considered served with the Summons is determined by Rule 1-004 NMRA) The Court’s address
`is listed above.
`3.
`You mustfile (in person or by mail) your written response with the Court. When youfile
`your response, you must give or mail a copy to the person whosignedthe lawsuit.
`4.
`If you do not respond in writing, the Court may enter judgment against you as requested in
`the lawsuit.
`5.
`Youare entitled to a jury trial in most types of lawsuits. To ask for a jury trial, you must
`request one in writing and pay a jury fee.
`6.
`If you need an interpreter, you must ask for one in writing.
`7.
`You maywish to consult a lawyer. You may contact the State Bar of New Mexicofor help
`finding a lawyer at www.nmbar.org; 1-800-876-6657; or 1-505-797-6066.
`
`Dated at San Miguel County, New Mexico, this22nd day of September, 2021.
`
`
`
`

`

`
`
`Case 1:21-cv-01080-JHR-KK Document 1-2 Filed 11/05/21 Page 3 of 60
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`ROBERT S. DURAN
`CLERK OF DISTRICT COURT
`
`DURHAM,PITTARD & SPALDING,L.L.P.
`
`By:
`
`_/s/ Janis Baca
`Deputy
`
`Facsimile: (505) 986-0632
`
`/s/Justin R. Kaufman
`Signature of Attorney for Plaintiff
`Justin R. Kaufman
`505 Cerrillos Rd., Suite A209
`Santa Fe, NM 87501
`jkaufman@dpslawgroup.com
`Telephone No.: (505) 986-0600
`
`THIS SUMMONS IS [ISSUED PURSUANT TO RULE1-004 OF THE NEW MEXICO
`RULES OF CIVIL PROCEDURE FOR DISTRICT COURTS.
`
`
`
`
`
`

`

`
`
`Case 1:21-cv-01080-JHR-KK Document 1-2 Filed 11/05/21 Page 4 of 60
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`STATE OF NEW MEXICO
`COUNTY OF SAN MIGUEL
`FOURTH JUDICIAL DISTRICT COURT
`
`CHRISTINE RAMIREZ,
`
`No.
`
`vs.
`
`Plaintiff,
`
`SAN MIGUEL HOSPITAL CORPORATION
`d/b/a ALTA VISTA REGIONAL HOSPITAL;
`ALTA VISTA REGIONAL HOSPITAL;
`QUORUM HEALTH RESOURCES,LLC;
`ELIN RITCHIE, MD; PFIZER, INC; and
`GREENSTONE, LLC,
`
`Defendants.
`
`RETURN!
`
`) )
`
`)
`
`ss
`
`STATE OF
`
`COUNTY OF
`
`
`
`I, being duly sworn,onoath,state that I am overthe age of eighteen (18) years and nota party tothis
`lawsuit, and that I served this summonsin
`county on the
`day of
`’
`, by delivering a copy of this summons,with a copy ofcomplaintattached,
`in the following manner:
`
`(check one box andfill in appropriate blanks)
`
`(used when defendant accepts a copy ofsummons
`to the defendant
`[]
`and complaintor refuses to accept the summons and complaint)
`
`to the defendant by [mail] [courier service] as provided by Rule 1-004 NMRA (used when
`[]
`service is by mail or commercialcourier service).
`
`After attempting to serve the summonsand complaint on the defendant by personalservice or by
`mail or commercialcourier service, by delivering a copy ofthis summons,with a copy ofcomplaint
`attached, in the following manner:
`
`, aperson overfifteen (15) years ofage and residingat the
`to
`[]
`, (used whenthe defendant is notpresently at
`usual place ofabode ofdefendant
`place ofabode) and by mailing byfirst class mail to the defendant at
`(insert
`
`3
`
`
`
`

`

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`Case 1:21-cv-01080-JHR-KK Document1-2 Filed 11/05/21 Page 5 of 60
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`defendant's last known mailing address) a copy of the summonsand complaint.
`
`, the person apparently in charge at the actualplace of business
`to
`{J
`or employment of the defendant and by mailing by first class mail
`to the defendant at
`(insert defendant's business address) and by mailing the summonsand
`complaintby first class mail to the defendantat
`(insert defendant's last known
`mailing address).
`
`to
`[]
`defendant
`
`to
`[]
`defendant
`
`
`
`, an agent authorized to receive service of process for
`
`.___, [parent] [guardian] [custodian] [conservator] [guardian ad litem] of
`(used when defendant is a minor or an incompetentperson).
`
`
`
`’, (title
`(nameofperson),
`to
`[]
`of person authorized to receive service. Use this alternative when the defendant is a corporation or
`an association subject to a suit under a common name, a land grant boardoftrustees, the State of
`New Mexico or any political subdivision).
`
`
`
`Fees:
`
`Signature of person making service
`
`
`Title (ifany)
`
`Subscribed and sworn to before methis
`
`day of
`
`;
`
`My Commission Expires:
`
`Judge, notary or otherofficer
`authorized to administer oaths
`
`Official title
`
`USE NOTE
`
`Unless otherwise ordered by the court, this return is not to be filed with the court prior
`1.
`to service of the summonsand complaint on the defendant.
`2.
`If service is made bythe sheriff or a deputy sheriff of a New Mexico county, the
`signature of the sheriff or deputy sheriff need not be notarized.
`
`[Adopted effective August 1, 1988; as amended by Supreme Court Order 05-8300-01, effective
`March1, 2005; by Supreme Court Order 07-8300-16, effective August 1, 2007; by Supreme Court
`Order No. 12-8300-026,effective for all cases filed or pending on or after January 7, 2013.]
`
`4
`
`

`

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`FILED
`4th JUDICIAL DISTRICT COURT
`San Miguel County
`9/22/2021 9:52 AM
`CLERK OF THE COURT
`JNB
`
`No. D-412-CV-2021-00268
`Gallegos, Flora
`
`_
`STATE OF NEW MEXICO
`COUNTY OF SAN MIGUEL
`FOURTH JUDICIAL DISTRICT COURT
`CHRISTINE RAMIREZ,
`
`.
`Plaintiff,
`
`vs.
`
`SAN MIGUEL HOSPITAL CORPORATION
`d/b/a ALTA VISTA REGIONAL HOSPITAL;
`ALTA VISTA REGIONAL HOSPITAL;
`QUORUM HEALTH RESOURCES, LLC;
`ELIN RITCHIE, MD; PFIZER, INC; and
`GREENSTONE, LLC,
`
`Defendants.
`
`PLAINTIFF’S ORIGINAL COMPLAINT FOR PERSONAL INJURY
`
`AND PUNITIVE DAMAGES
`
`COMES NOWPlaintiff, Christine Ramirez, by and through her counsel of record, and
`states the following as her Original Complaint against Defendants San Miguel Hospital
`
`Corporation d/b/a Alta Vista Regional Hospital; Alta Vista Regional Hospital; Quorum Health
`
`Resources, LLC; Elin Ritchie,.M.D; Pfizer, Inc; and Greenstone, LLC (hereinafter referred to by
`
`name orcollectively as “Defendants”).
`
`I.
`
`INTRODUCTION
`
`1,
`
`In September of 2018, Plaintiff began taking the prescription drug Azulfidine
`
`(Sulfasalazine) manufactured, marketed, and controlled by Defendants Pfizer,
`
`Inc. and
`
`Greenstone, LLC. Plaintiff developed a commonly fatal condition as a reaction to taking the
`
`medication called Stevens Johnson Syndrome (“SJS”) with toxic epidermal necrolysis (“TEN”)
`
`overlap. She presented for medical care to address this serious condition before Defendants San
`Miguel Hospital Corporation d/b/a Alta Vista Regional Hospital, Alta Vista Regional Hospital,
`
`Quorum Health Resources, LLC, and Elin Ritchie, M.D., and was sent home. Plaintiff brings
`
`

`

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`failure to warn claims against Defendants Pfizer, Inc. and Greenstone, LLC for failing to warn
`
`Plaintiff and her medical providers of key safety information regarding increased risksrelating to
`
`SJS and TEN and medical malpractice claims against Defendants San Miguel Hospital
`
`Corporation d/b/a Alta Vista Regional Hospital, Alta Vista Regional Hospital, Quorum Health
`
`Resources, LLC, and Elin Ritchie, M.D. for failing to timely and properly diagnose andtreat
`
`Plaintiff's SJS/TENasset forth further herein.
`
`II.
`
`PARTIES
`
`2.
`
`Plaintiff Christine Ramirez is a citizen of the State of New Mexico and residesin
`
`San Miguel County, New Mexico.
`
`3.
`
`Defendant San Miguel Hospital Corporation d/b/a Alta Vista Regional Hospital is
`
`a domestic limited liability company authorized to do businessin the State of New Mexico. It may
`
`be served with citation by serving its registered agent for service, John Scott Mann, 665 E.
`
`University Ave, Suite C, Las Cruces, New Mexico 88001.
`
`4.
`
`Defendant Alta Vista Regional Hospital
`
`is an entity of unknown organization
`
`authorized to do business in the State of New Mexico.
`
`It may be served with citation by serving
`
`its registered agent for service, John Scott Mann, 665 E. University Ave, Suite C, Las Cruces, New
`
`Mexico 88001.
`
`5.
`
`Quorum Health Resources, LLC is a foreign limited liability company conducting
`
`business within the State of New Mexico.
`
`It may be served with citation by serving its registered
`
`agent for service, Mann Morrow, PLLC, 665 E. University Ave., Suite C, Las Cruces, New Mexico
`
`88001.
`
`6.
`
`Defendant Elin Ritchie, M.D.
`
`is a medical doctor residing in the State of New
`
`Mexico. She maybe served with citation at 7 Rabbit Run, El Prado, New Mexico 87529.
`
`

`

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`7.
`
`DefendantPfizer, Inc. is a foreign corporation conducting business within the State
`
`of New Mexico.
`
`It may be served with citation through its registered agent, CT Corporation
`
`System, 206 S. Coronado Avenue, Espanola, New Mexico 87532.
`
`8.
`
`Defendant Greenstone, LLC is a foreign limited liability company organized and
`
`existing under the laws of New Jersey. Atall times relevant hereto, Defendant Greenstone, LLC
`
`has conducted and is currently conducting business in the State of New Mexico but does not have
`
`a designated agent for service of process in New Mexico,andthis lawsuit arises from Defendant
`
`Greenstone, LLC’s business in New Mexico. Pursuant to NM Stat § 38-1-6 (2018), the New
`
`Mexico Secretary of State is the agent for service of process on Defendant Greenstone, LLC.
`
`Service may be obtained by serving the New Mexico Secretary of State, Business Division with
`
`two copies of the petition at New Mexico Secretary of State, Business Division, New Mexico
`
`Capitol Annex North, 325 Don Gaspar, Suite 300, Santa Fe, NM 87501 whoshall then forward it
`
`to Greenstone, LLCatits principal place of business 100 Route 206, North Peapack, New Jersey
`
`07977.
`
`7.
`
`Defendants acted by and throughtheir agents, partners, officers and employees and
`
`are responsible for their acts or omissions through the doctrines ofrespondeat superior or agency.
`
`Il.
`
`JURISDICTION, VENUE, AND JOINDER
`
`9.
`
`Jurisdiction over the parties and the subject matter herein is proper with this Court
`
`pursuantto Article VI of the New Mexico Constitution.
`
`10.|Venueis proper in this Court because Plaintiff Christine Ramirez resides in San
`
`Miguel County, State of New Mexico andthe events giving rise to this Complaint occurred in San
`
`Miguel County. NMSA 1978, § 38-3-I(A).
`
`IV.
`
`JOINT VENTURE/ENTERPRISE
`
`

`

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`A.
`
`Defendants San Miguel Hospital Corporation d/b/a Alta Vista Regional Hospital;
`Alta Vista Regional Hospital; Quorum Health Resources, LLC; Elin Ritchie, M.D.
`
`11.|Defendants San Miguel Hospital Corporation d/b/a Alta Vista Regional Hospital,
`
`
`
`Alta Vista Regional Hospital, Quorum Health Resources, LLC, and Elin Ritchie, M.D.
`
`(collectively “Medical Defendants”) were engaged in a joint venture/enterprise while providing
`
`medical care to Plaintiff.
`
`12.
`
`Each Medical Defendant had a shared communityinterest in the object and purpose
`
`of the undertaking of providing medical care to Plaintiff.
`
`13.
`
`Each Medical Defendant had an equal
`
`right
`
`to share in the control of the
`
`administration, management, operation, and provision of medical care provided to Plaintiff and
`
`any profits and losses stemming from medicalcare renderedto Plaintiff regardless of whether such
`
`right was exercised.
`
`14.
`
`The Medical Defendants controlled the administration, operation, planning,
`
`management, quality control, and provision of medical care to Plaintiff. The authority exercised
`
`by the Medical Defendants over the aforementioned areas including, but was notlimited to, control
`
`of marketing, human resources management, training, staffing, creation and implementation of
`
`policy and procedure manuals used in the provision of medical care, Medicare and/or Medicaid
`
`reimbursement, quality care assessment and compliance, compliance with state regulations,
`
`standard of care, licensure and certification, legal services, and/or financial, tax, and accounting
`
`control throughfiscal policies established by the Medical Defendants.
`
`15,
`
`The Medical Defendants operated as a joint venture/enterprise for the purpose of
`
`increasing profitability and furthering their similar business interests and collectively controlled
`
`one another.
`
`
`
`
`
`

`

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`16.
`
`Atall relevant times mentioned herein, the Medical Defendants owned, operated,
`
`administered, and/or controlled, either directly or through the agency of each other and/or other
`
`diverse subalterns, agents, subsidiaries, servants, or employeesin the provision of medicalcare to
`
`Plaintiff.
`
`17.
`
`Because the Medical Defendants namedherein and others were engagedin a joint
`
`venture/enterprise before and throughoutPlaintiff's medical care, the acts and omissions of each
`
`participantin the joint venture/enterprise are imputable toall other participants. The actionsof the
`
`Medical Defendantsand eachofits servants, agents, and employeesasset forth herein, are imputed
`
`to each the Medical Defendants jointly and severally.
`
`B.
`
`DefendantsPfizer, Inc. and Greenstone, LLC
`
`18.
`
`Defendants Pfizer,
`
`Inc.
`
`(“Pfizer”)
`
`and Greenstone, LLC (“Greenstone”)
`
`(collectively “Pharma Defendants”) were engaged in a joint venture/enterprise during the relevant
`
`time period complained ofherein.
`
`19.
`
`Pfizer has been the New Drug Application (“NDA”) holder for all Azulfidine
`
`(sulfasalazine) products marketed in the U.S. since 2003. Pfizer was the parent companyofits
`wholly owned subsidiary, Greenstone, which markets the generic version of Azulfidine
`
`(sulfasalazine) that Plaintiff ingested leading to her SJS-TEN overlap reaction during the relevant
`
`time period complained ofherein.
`
`20.
`
`Plaintiff specifically alleges that Pfizer controlled and/or had the right
`
`to
`
`unilaterally update the branded Azulfidine professional labeling pursuant to a “Changes Being
`
`Effected” labeling supplement under Food and Drug Administration (“FDA”) regulations for
`
`prescription drug products pursuantto 21 C.F.R. 314.70; and, therefore the parent company,Pfizer,
`
`exercised direct and indirect control over Greenstone with respect to the updating of Greenstone’s
`
`

`

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`generic drug labeling based on new safety information regarding the increased risks of SJS and
`
`TEN associated with Azulfidine and sulfasalazine prescription drugs sold in the U.S. Pfizer
`
`exercised control and managerial decision making over its wholly-owned subsidiary Greenstone
`
`with respect to pharmacovigilance and safety signal analysis of its wholly-owned subsidiary
`
`Greenstone; labeling and warnings relating to Greenstone products including Azulfidine and
`
`Sulfasalazine products; marketing initiatives
`
`and sales
`
`techniques
`
`for Azulfidine and
`
`Sulfasalazine; funding for marketing or sales, safety, developmentof the product; oversight of the
`
`safety data relating to Azulfidine and Sulfasalazine; and controls and/or unilaterally directs
`
`amendments and the content of the labeling of Azulfidine and Sulfasalazine products as well as
`
`warnings provided to the prescribing healthcare providers and to patients in the U.S. and in State
`
`of New Mexico,including Plaintiff's prescriber and Plaintiff.
`
`21.
`
`Pfizer was the parent company ofits wholly owned subsidiary, Greenstone during
`
`the relevant time period complained of herein. Plaintiff specifically alleges that Pfizer controlled
`and/orhadthe right to control Greenstone with respect to the safety initiatives of its wholly-owned
`
`subsidiary; labeling and warnings relating to Greenstone products including, but not limited to,
`
`Sulfasalazine; marketing initiatives and sales techniques for Sulfasalazine; funding for sales,
`
`safety, development of the product; oversight of the safety data relating to Sulfasalazine; and
`
`controls and/or unilaterally directs amendments and the content of the labeling of Sulfasalazine,
`
`as well was warnings provided to the medical and general populations.
`
`It is further alleged that
`
`Greenstone is the alter-ego of its parent company, Pfizer, and that with respect to safety and
`
`labeling initiatives, Pfizer and its officers are responsible for making decisions to update the
`
`Sulfasalazine label to warn ofthe risks at issue and that Pfizer maintains sufficient control to direct
`
`labeling changes for its wholly owned subsidiary, Greenstone.
`
`
`
`
`
`
`
`

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`22.|Greenstone also manufactured off-patented Pfizer products as generics and at the
`
`time of the incident giving rise to this suit said activities generated approximately $10 billion in
`
`revenuesfor Pfizer. Pfizer has turnedto its subsidiary Greenstone to respondto the disruption from
`
`genericsforits branded drug products including for Sulfasalazine. During the relevant time period,
`
`Greenstone waspart of Pfizer’s Established Products Business Unit, which marketed 380 branded
`
`and generic medicines, including Sulfasalazine.
`23.|Greenstone had the ability to leverage the brand recognition of Pfizer to marketits
`
`products in a way that would not be possible as an independent company. Pfizer marketed not
`
`only the branded drug Azulfidine (Sulfasalazine) for whichit still markets, but also holds the New
`
`Drug Applications for the branded Azulfidine (Sulfasalazine).
`
`Pfizer also simultaneously
`
`marketed the generic equivalent of Azulfidine (Sulfasalazine)
`
`through its wholly owned
`
`subsidiary, Greenstone. Pfizer received the ultimate profits from Greenstone sales and had access
`
`to and utilized the working capital of its subsidiary, Greenstone.
`
`24.
`
`Pfizer conducts pharmacovigilance! on the safety of both of their branded and their
`
`generic products (Azulfidine/Sulfasalazine) and caninitiate labeling changes (through the Pharma
`
`Defendants’ shared safety, labeling, and regulatory committees) for both products because the
`
`regulatory scheme allows for the branded drug company to changetheir label. Said changesin
`
`labeling by Pfizer’s branded drug Azulfidine would be simultaneously implemented for
`
`Pfizer/Greenstone’s own generic Sulfasalazine because the FDA regulations require that the
`
`generic labeling be the sameas the brandedlabeling.
`
`' The FDAdefinition of pharmacovigilance means“all scientific and data gatheringactivities relating to the detection,
`assessment, and understanding of adverse events. This includes the use of pharmacoepidemiologic studies. These
`activities are undertaken with the goal of identifying adverse events and understanding, to the extent possible, their
`nature, frequency, and potential risk factors.”
`(See FDA Guidance on Good Pharmacovigilance Practices and
`Pharmacoepidemiologic Assessment, March 2005)
`
`

`

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`25.
`
`Pfizer /Greenstone failed to implement such labeling changes that were warranted
`
`and outlined in this complaint, and in turn failed to comply with minimum FDAstandardsofcare
`
`regarding postmarketing safety surveillance and labeling changesforits’ Azulfidine/Sulfasalazine
`
`products.
`
`26.
`
`Pfizer advertised through its wholly owned subsidiary Greenstonethat it offered
`
`generic equivalents to the same quality of branded pharmaceuticals that were distributed under the
`
`manufacturer’s NDA identified as Pfizer Authorized Generics. Defendant Greenstonerelied upon
`Pfizer to monitor the safety ofAzulfidine and Sulfasalazine, to review the labeling for both branded
`
`and generic labeling for both branded and generic forms of Azulfidine and Sulfasalazine, and to
`
`undertake changes to revise the labeling to disclose new safety information and to make such
`
`changes using the CBE-0 process with the FDA.
`
`27.
`
`Pfizer, Inc. on behalfof its wholly owned subsidiary Greenstone and the Authorized
`
`Generics not only manufactured both the branded and generic versions of Azulfidine and
`
`Sulfasalazine, but Pfizer also monitors, collects, and reports and controls the safety information
`
`that Pfizer determines to communicate to prescribing physicians concerningtherisks entailed in
`the useofboth its’ branded and generic Azulfidine and Sulfasalazine products. Plaintiffcontends
`
`that Pfizer actually manufactured both the branded Azulfidine and generic versions of
`
`Sulfasalazine and used Greenstone to place a Pfizer’s label on the Pfizer authorized generic
`
`Sulfasalazine products.
`
`
`
`28.|Each Pharma Defendant had a shared communityinterest in the object and purpose
`
`
`
`.of the undertaking of providing accurate and complete warningsto Plaintiff and her prescribing
`
`physician ofthe risks associated with Azulfidine and Sulfasalazine.
`
`
`
`

`

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`29.
`Each Pharma Defendant has an equal
`right
`to share in the control of the
`administration, management, decision making, and controlof the information conveyed in the
`
`labeling and warnings regarding Sulfasalazine and anyprofits and losses stemming from thesale
`
`of Sulfasalazine regardless of whether such right wasactually exercised.
`
`30.
`
`The Pharma Defendants controlled the administration, management, decision
`
`making, and control of the information conveyed in the labeling and warnings regarding
`
`Sulfasalazine. The authority exercised by the Pharma Defendants over the aforementioned areas
`
`including, but was notlimited to, control of marketing, creation and implementation of policy and
`
`procedure manuals, quality assessment and compliance, compliance with state regulations,
`
`standard of care, compliance with FDA regulations, pharmacovigilance programs established by
`
`the Pharma Defendants.
`
`
`
`31.|The Pharma Defendants operated as a joint venture/enterprise for the purpose of
`
`
`
`increasing profitability and furthering their similar business interests and collectively controlled
`
`one another.
`
`32.
`
`Atall relevant times mentioned herein, the Pharma Defendants owned, operated,
`
`administered, and/or controlled, either directly or through the agency of each other and/or other
`
`diverse subalterns, agents, subsidiaries, servants, or employees in providing Sulfasalazine and
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`accurate and complete warningsto Plaintiff and her prescribing physician.
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`33.|Because the Pharma Defendants named herein and other were engagedin a joint
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`venture/enterprise before throughout the relevant time period, the acts and omissions of each
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`participant in the joint venture/enterprise are imputableto all other participants. The actions ofthe
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`Pharma Defendants and eachofits servants, agents, and employeesasset forth herein, are imputed
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`to each the Pharma Defendants, jointly and severally.
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`
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`

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`Case 1:21-cv-01080-JHR-KK Document 1-2 Filed 11/05/21 Page 15 of 60
`Case 1:21-cv-01080-JHR-KK Document 1-2 Filed 11/05/21 Page 15 of 60
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`Vv.|FACTUAL BACKGROUND
`
`A.
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`Plaintiff’s Medical Care
`
`34.
`
`On September 24, 2018, Dr. Lyle Amer prescribed Plaintiff the Pharma
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`Defendants’ Sulfasalazine product. On multiple occasions, and at the time he prescribed Plaintiff
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`the Sulfasalazine product, Dr. Amer relied upon the warnings and information provided by the
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`Pharma Defendants in their labeling and product
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`information materials while Dr. Amer was
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`located in Santa Fe, New Mexicoathis office.
`
`35.|On October8, 2018, Plaintiff presented to Alta Vista Regional Medical Center for
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`medical care. She complained of classic SJS symptoms including erythema, swelling of the face,
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`handsandfeet, pruritus, and swollen eyes and eyelids.
`
`36.
`
`Defendant Elin Ritchie, M.D. evaluated Plaintiff while at Alta Vista Regional,
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`prescribed Plaintiff prednisone and Benadryl and sent her home.
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`Plaintiff's SJS symptoms quickly escalatedto life threatening upon discharge from
`
`37.
`the hospital.
`
`38.
`
`Plaintiff presented to Christus St. Vincent Hospital on October 9, 2018. Her SJS
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`symptoms had progressed to mucosalandlip lesions as well as blister like lesions on the pharynx.
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`39.|Adiagnosis of SJS was madebyphysicians at Christus St. Vincent, prednisone was
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`discontinued, and Plaintiff was transported to University of New Mexico Hospital (“UNM”) for a
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`higherlevel of care given the seriousness of SJS.
`
`40.
`
`Plaintiff's eyes worsened while at UNM exhibiting swelling, discharge, redness,
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`and dryness. She also experienced severe SJS induced vaginal lesions and blistering as well as
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`peeling and blistering of her hands and feet. Her diagnosis was SJS-TEN overlap.
`
`41.
`
`Plaintiff remained at UNM until October 20, 2018.
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`

`

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`Case 1:21-cv-01080-JHR-KK Document 1-2 Filed 11/05/21 Page 16 of 60
`Case 1:21-cv-01080-JHR-KK Document 1-2 Filed 11/05/21 Page 16 of 60
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`42.
`
`Doctors
`
`at UNM determined that Pfizer
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`and Greenstone’s medication,
`
`Sulfasalazine, was the cause ofPlaintiff's SJS-TEN overlap, and related debilitating injuries.
`
`B.
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`Regulatory History of Azulfidine (Sulfasalazine) in the U.S.
`
`43.
`
`Azulfidine (sulfasalazine) was approved by the U.S. FDA on June 20, 1950 for the
`
`indication to treat ulcerative colitis submitted by Pharmacia & Upjohn (PNU). At somepointin
`
`1994, PNU submitted an SNDAto the FDA that was subsequently transferred to the Division of
`
`Anti-Inflammatory, Analgesic, and Ophthalmic Drug Products (HFD-SSO) who conditionally
`
`approved this new indication to treat rheumatoid arthritis on August 2, 1995 by an approvable
`
`letter. Following that initial approval, final approval for the RA indication was granted on October
`
`17, 1996.- In the August 2, 1995 approvable letter for the rheumatoid arthritis indication, the
`
`sponsor was requested to assess the safety and efficacy of sulfasalazine (SSZ) in patients with
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`juvenile rheumatoid arthritis (JRA) as a Phase 4 commitment.
`
`44,
`
`Various trade namesfor sulfasalazine are Azulfidine EN-tabs; Azulfidine; Azaline;
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`Sulfazine; Sulfazine EC; Apo-Sulfasalazine; PMS-Sulfasalazine; Salazopyrin En-Tabs;
`
`Salazopyrin; Azulfidina; Azulfin; Bomecon; Colo-Pleon; Disalazin; Falazine; Gastropyrin;
`
`Lazafin; Pyralin EN; Rosulfant; Salazine; Salazodin; Salazopirina; Salazopyrin Entabs;
`
`Salazopyrin-EN; Salazopyrina; Salazopyrine; Salivon; Salopyr; Salopyrine; Saridine-E; Sulcolon;
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`Sulfasalazin; Sulfitis; Ulcol; and Zopyrin.
`
`45.
`
`On October 18, 1999, Pharmacia & Upjohn (PNU) submitted their Type 6 NDA?
`
`for Azulfadine (NDA 7-073) for the indication to treat rheumatoid arthritis in adults submitted to
`
`? Porter RS, Kaplan JL (2013). The Merck manuals: Health care professionals. Whitehouse Station (NJ): Merck &
`Co., Inc. Available from: http://www.merckmanuals.com/professional/index.html,
`3 A Type 6 NDAwas used for an NDAreceived prior to July 27, 2009,5 for a drug productthat duplicates a drug
`product already approved or marketed in the United States by the same applicant, except thatit is intended for a new
`indication or claim (sameactive moiety or combination ofactive moieties, samesalt(s), ester(s), or other noncovalent
`derivative(s), same dosage form, and same formulation (including all ingredients used in the manufacturing process
`whetheror not they are presentin the final dosage form)).
`
`11
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`

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`Case 1:21-cv-01080-JHR-KK Document 1-2 Filed 11/05/21 Page 17 of 60
`Case 1:21-cv-01080-JHR-KK Document 1-2 Filed 11/05/21 Page 17 of 60
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`the Pilot Drug Evaluation Staff(HFD-007). Azulfidine wasoriginally approved on June 20, 1950,
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`providing for both Azulfidine (sulfasalazine) Tablets and Azulfidine EN-tabs Tablets for the
`
`treatment and maintenance of remission of ulcerative colitis. Azulfidine EN-tabs Tablets are also
`
`indicated in the treatment of patients with rheumatoid arthritis who have responded inadequately
`
`to salicylates or other nonsteroidal anti-inflammatory drugs (NSAIDS).
`
`46.
`
`PNUsubmitted an efficacy and safety supplementforthe indication oftreating JRA
`
`by searching for published literature and analyzing studies that reported on the efficacy and safety
`
`of Azulfidine in JRA patients. A total of 19 published papers were attached in support of the new
`
`indication totaling 499 JRA patients. Importantly, PNU submitted data from these studies showing
`
`an analysis of rashes that described an incidence of rashes as high as 9.6%. There were 48 reports
`
`of rashes from these 19 studies that were considered to be drug related out of the 499, and with
`
`43% (21 reports) were considered to be severe rashes leading to discontinuation of sulfasalazine.
`
`With a discontinuation rate of 43% that alone represented a safety signal (even though there had
`
`been published reports of SJS and TEN prior to this analysis) that PNU should have performed a
`
`safety signal analysis of severe cutaneous adverse reactions to sulfasalazine that led to labeling
`
`changes to warn about the risks of SJS and TEN at that time. PNU suggested that these rashes
`
`were morelike serum-sicknessreactions, although several of them were more characteristic of EM
`
`and SJS.
`
`47.
`
`By 2001, the Azulfidine label only noted that the incidence of rashes in RA patients
`
`wasat 13% andthat the rate of rashes amongulcerative colitis patients was approximately as high
`
`as | in every 30 patients. SJS and TEN were buried in the Adverse Reaction section without any
`
`reference to these life-threatening skin reactions in the WARNINGS or PRECAUTIONsections
`
`of the label.
`
`In the 2001 Azulfidine USPI, SJS and TEN was lumped with about 20 other
`
`

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`Case 1:21-cv-01080-JHR-KK Document 1-2 Filed 11/05/21 Page 18 of 60
`Case 1:21-cv-01080-JHR-KK Document 1-2 Filed 11/05/21 Page 18 of 60
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`hypersensitivity reactions of a more benign nature than these two potentially fatal reactions. There
`
`was in the AR section of the label one sentence about increased incidence of serum-sickness in
`
`JRA patients.
`
`48.
`
`In April of 2003, Pfizer completed its acquisition of Pharmacia and Upjohn and
`
`took control over the Azulfidine NDAs.
`
`Cc.
`
`Regulatory Action for Azulfidine/Sulfasalazine in Europe Regarding SJS and TEN
`
`49.
`
`In April 2010, the Registry of Severe Cutaneous Adverse Reactions (RegiSCAR)
`
`contacted
`
`the European Medicines Agency
`
`(EMEA) with
`
`information
`
`about
`
`their
`
`pharmacoepidemiologic analysis of newly acquired safety information about the increased risks
`
`of SJS and TENassociated with Sulfasalazine products that significantly altered the risk-benefit
`
`profile of Azulfidine and sulfasalazine products sufficient to update the labeling for these drug
`
`products.
`
`50.
`
`The EMEA’s Pharmacovigilance Working Party (PhVWP)received the new safety
`
`information and based on their review acknowledged the need to increase awareness amongst
`
`healthcare professionals and patients on medicines knownto carry higherrisks than previously
`
`known to cause Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), in order
`
`to allow earlier detection and treatmentof these potentially life-threatening adverse reactions.
`
`51.
`
`Therefore, the PhV WP agreed to develop key elements for the product information
`
`of 14 active substancesidentified by RegiSCAR as having a knownincreased risk of SJS or TEN
`
`to ensure that
`
`the product
`
`information contains newly acquired consistent and clear safety
`
`information.
`
`52.
`
`The active subst