throbber
JS 44 (Rev. 02/19)
`
`Case 2:20-cv-05344-WB Document 1 Filed 10/27/20 Page 1 of 21
`CIVIL COVER SHEET
`The JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except as
`provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the
`purpose of initiating the civil docket sheet. (SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.)
`I. (a) PLAINTIFFS
`DEFENDANTS
`
`(b) County of Residence of First Listed Plaintiff
`(EXCEPT IN U.S. PLAINTIFF CASES)
`
`County of Residence of First Listed Defendant
`(IN U.S. PLAINTIFF CASES ONLY)
`IN LAND CONDEMNATION CASES, USE THE LOCATION OF
`THE TRACT OF LAND INVOLVED.
`
`NOTE:
`
`(c) Attorneys (Firm Name, Address, and Telephone Number)
`
` Attorneys (If Known)
`
`II. BASIS OF JURISDICTION (Place an “X” in One Box Only)
`
`’ 1 U.S. Government
`Plaintiff
`
`’ 3 Federal Question
`(U.S. Government Not a Party)
`
`III. CITIZENSHIP OF PRINCIPAL PARTIES (Place an “X” in One Box for Plaintiff
`(For Diversity Cases Only)
`and One Box for Defendant)
`PTF DEF
`PTF
` DEF
`’ 1
`’ 1
`’ 4
`’ 4
`
`Citizen of This State
`
`Incorporated or Principal Place
` of Business In This State
`
`’ 2 U.S. Government
`Defendant
`
`’ 4 Diversity
`(Indicate Citizenship of Parties in Item III)
`
`Citizen of Another State
`
`’ 2
`
`’ 2
`
`Incorporated and Principal Place
`of Business In Another State
`
`’ 5
`
`’ 5
`
`’ 6
`
`’ 6
`
`Citizen or Subject of a
` Foreign Country
`
`’ 3
`
`’ 3
`
`Foreign Nation
`
`Click here for: Nature of Suit Code Descriptions.
`BANKRUPTCY
`OTHER STATUTES
`FORFEITURE/PENALTY
`’ 422 Appeal 28 USC 158
`’ 375 False Claims Act
`’ 625 Drug Related Seizure
` of Property 21 USC 881 ’ 423 Withdrawal
`’ 376 Qui Tam (31 USC
`’ 690 Other
` 28 USC 157
` 3729(a))
`’ 400 State Reapportionment
`PROPERTY RIGHTS
`’ 410 Antitrust
`’ 430 Banks and Banking
`’ 820 Copyrights
`’ 450 Commerce
`’ 830 Patent
`’ 460 Deportation
`’ 835 Patent - Abbreviated
`’ 470 Racketeer Influenced and
` New Drug Application
` Corrupt Organizations
`’ 840 Trademark
`SOCIAL SECURITY
`’ 480 Consumer Credit
`’ 485 Telephone Consumer
`’ 861 HIA (1395ff)
` Protection Act
`’ 862 Black Lung (923)
`’ 863 DIWC/DIWW (405(g)) ’ 490 Cable/Sat TV
`’ 864 SSID Title XVI
`’ 850 Securities/Commodities/
`’ 865 RSI (405(g))
` Exchange
`’ 890 Other Statutory Actions
`’ 891 Agricultural Acts
`’ 893 Environmental Matters
`’ 895 Freedom of Information
` Act
`’ 896 Arbitration
`’ 899 Administrative Procedure
` Act/Review or Appeal of
` Agency Decision
`’ 950 Constitutionality of
` State Statutes
`
`FEDERAL TAX SUITS
`’ 870 Taxes (U.S. Plaintiff
` or Defendant)
`’ 871 IRS—Third Party
` 26 USC 7609
`
`IMMIGRATION
`’ 462 Naturalization Application
`’ 465 Other Immigration
` Actions
`
`IV. NATURE OF SUIT (Place an “X” in One Box Only)
`CONTRACT
`TORTS
` PERSONAL INJURY
` PERSONAL INJURY
`’ 110 Insurance
`’ 120 Marine
`’ 310 Airplane
`’ 365 Personal Injury -
`’ 130 Miller Act
`’ 315 Airplane Product
` Product Liability
`’ 140 Negotiable Instrument
` Liability
`’ 367 Health Care/
`’ 150 Recovery of Overpayment ’ 320 Assault, Libel &
` Pharmaceutical
` & Enforcement of Judgment
` Slander
` Personal Injury
`’ 151 Medicare Act
`’ 330 Federal Employers’
` Product Liability
`’ 152 Recovery of Defaulted
` Liability
`’ 368 Asbestos Personal
` Student Loans
`’ 340 Marine
` Injury Product
` (Excludes Veterans)
`’ 345 Marine Product
` Liability
` PERSONAL PROPERTY
`LABOR
`’ 153 Recovery of Overpayment
` Liability
`’ 710 Fair Labor Standards
` of Veteran’s Benefits
`’ 350 Motor Vehicle
`’ 370 Other Fraud
` Act
`’ 160 Stockholders’ Suits
`’ 355 Motor Vehicle
`’ 371 Truth in Lending
`’ 720 Labor/Management
`’ 190 Other Contract
` Product Liability
`’ 380 Other Personal
` Relations
`’ 195 Contract Product Liability ’ 360 Other Personal
` Property Damage
`’ 740 Railway Labor Act
`’ 196 Franchise
` Injury
`’ 385 Property Damage
`’ 751 Family and Medical
`’ 362 Personal Injury -
` Product Liability
` Leave Act
` Medical Malpractice
` PRISONER PETITIONS ’ 790 Other Labor Litigation
` CIVIL RIGHTS
`Habeas Corpus:
`’ 791 Employee Retirement
`’ 440 Other Civil Rights
`’ 463 Alien Detainee
` Income Security Act
`’ 441 Voting
`’ 510 Motions to Vacate
`’ 442 Employment
` Sentence
`’ 443 Housing/
`’ 530 General
` Accommodations
`’ 445 Amer. w/Disabilities - ’ 535 Death Penalty
`Other:
` Employment
`’ 446 Amer. w/Disabilities - ’ 540 Mandamus & Other
` Other
`’ 550 Civil Rights
`’ 448 Education
`’ 555 Prison Condition
`’ 560 Civil Detainee -
` Conditions of
` Confinement
`
` REAL PROPERTY
`’ 210 Land Condemnation
`’ 220 Foreclosure
`’ 230 Rent Lease & Ejectment
`’ 240 Torts to Land
`’ 245 Tort Product Liability
`’ 290 All Other Real Property
`
`V. ORIGIN (Place an “X” in One Box Only)
`’ 1 Original
`’ 2 Removed from
`Proceeding
`State Court
`
`’ 3 Remanded from
`Appellate Court
`
`’ 4 Reinstated or
`Reopened
`
`’ 5 Transferred from
`Another District
`(specify)
`Cite the U.S. Civil Statute under which you are filing (Do not cite jurisdictional statutes unless diversity):
`
`’ 6 Multidistrict
`Litigation -
`Transfer
`
`’ 8 Multidistrict
` Litigation -
` Direct File
`
`VI. CAUSE OF ACTION
`
`Brief description of cause:
`
`VII. REQUESTED IN
`COMPLAINT:
`VIII. RELATED CASE(S)
`IF ANY
`
`DATE
`
`FOR OFFICE USE ONLY
`
`’ CHECK IF THIS IS A CLASS ACTION
`UNDER RULE 23, F.R.Cv.P.
`
`DEMAND $
`
`CHECK YES only if demanded in complaint:
`’ Yes
`’ No
`JURY DEMAND:
`
`(See instructions):
`
`JUDGE
`SIGNATURE OF ATTORNEY OF RECORD
`
`DOCKET NUMBER
`
`RECEIPT #
`
`AMOUNT
`
`APPLYING IFP
`
`JUDGE
`
`MAG. JUDGE
`
`

`

`JS 44 Reverse (Rev. 02/19)
`
`Case 2:20-cv-05344-WB Document 1 Filed 10/27/20 Page 2 of 21
`
`INSTRUCTIONS FOR ATTORNEYS COMPLETING CIVIL COVER SHEET FORM JS 44
`Authority For Civil Cover Sheet
`
`The JS 44 civil cover sheet and the information contained herein neither replaces nor supplements the filings and service of pleading or other papers as
`required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is
`required for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. Consequently, a civil cover sheet is submitted to the Clerk of
`Court for each civil complaint filed. The attorney filing a case should complete the form as follows:
`
`I.(a) Plaintiffs-Defendants. Enter names (last, first, middle initial) of plaintiff and defendant. If the plaintiff or defendant is a government agency, use
`only the full name or standard abbreviations. If the plaintiff or defendant is an official within a government agency, identify first the agency and
`then the official, giving both name and title.
`(b) County of Residence. For each civil case filed, except U.S. plaintiff cases, enter the name of the county where the first listed plaintiff resides at the
`time of filing. In U.S. plaintiff cases, enter the name of the county in which the first listed defendant resides at the time of filing. (NOTE: In land
`condemnation cases, the county of residence of the "defendant" is the location of the tract of land involved.)
`(c) Attorneys. Enter the firm name, address, telephone number, and attorney of record. If there are several attorneys, list them on an attachment, noting
`in this section "(see attachment)".
`
`II.
`
`III.
`
`IV.
`
`V.
`
`Jurisdiction. The basis of jurisdiction is set forth under Rule 8(a), F.R.Cv.P., which requires that jurisdictions be shown in pleadings. Place an "X"
`in one of the boxes. If there is more than one basis of jurisdiction, precedence is given in the order shown below.
`United States plaintiff. (1) Jurisdiction based on 28 U.S.C. 1345 and 1348. Suits by agencies and officers of the United States are included here.
`United States defendant. (2) When the plaintiff is suing the United States, its officers or agencies, place an "X" in this box.
`Federal question. (3) This refers to suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution of the United States, an amendment
`to the Constitution, an act of Congress or a treaty of the United States. In cases where the U.S. is a party, the U.S. plaintiff or defendant code takes
`precedence, and box 1 or 2 should be marked.
`Diversity of citizenship. (4) This refers to suits under 28 U.S.C. 1332, where parties are citizens of different states. When Box 4 is checked, the
`citizenship of the different parties must be checked. (See Section III below; NOTE: federal question actions take precedence over diversity
`cases.)
`
`Residence (citizenship) of Principal Parties. This section of the JS 44 is to be completed if diversity of citizenship was indicated above. Mark this
`section for each principal party.
`
`Nature of Suit. Place an "X" in the appropriate box. If there are multiple nature of suit codes associated with the case, pick the nature of suit code
`that is most applicable. Click here for: Nature of Suit Code Descriptions.
`
`Origin. Place an "X" in one of the seven boxes.
`Original Proceedings. (1) Cases which originate in the United States district courts.
`Removed from State Court. (2) Proceedings initiated in state courts may be removed to the district courts under Title 28 U.S.C., Section 1441.
`Remanded from Appellate Court. (3) Check this box for cases remanded to the district court for further action. Use the date of remand as the filing
`date.
`Reinstated or Reopened. (4) Check this box for cases reinstated or reopened in the district court. Use the reopening date as the filing date.
`Transferred from Another District. (5) For cases transferred under Title 28 U.S.C. Section 1404(a). Do not use this for within district transfers or
`multidistrict litigation transfers.
`Multidistrict Litigation – Transfer. (6) Check this box when a multidistrict case is transferred into the district under authority of Title 28 U.S.C.
`Section 1407.
`Multidistrict Litigation – Direct File. (8) Check this box when a multidistrict case is filed in the same district as the Master MDL docket. PLEASE
`NOTE THAT THERE IS NOT AN ORIGIN CODE 7. Origin Code 7 was used for historical records and is no longer relevant due to changes in
`statue.
`
`VI.
`
`Cause of Action. Report the civil statute directly related to the cause of action and give a brief description of the cause. Do not cite jurisdictional
`statutes unless diversity. Example: U.S. Civil Statute: 47 USC 553 Brief Description: Unauthorized reception of cable service
`
`VII. Requested in Complaint. Class Action. Place an "X" in this box if you are filing a class action under Rule 23, F.R.Cv.P.
`Demand. In this space enter the actual dollar amount being demanded or indicate other demand, such as a preliminary injunction.
`Jury Demand. Check the appropriate box to indicate whether or not a jury is being demanded.
`
`VIII. Related Cases. This section of the JS 44 is used to reference related pending cases, if any. If there are related pending cases, insert the docket
`numbers and the corresponding judge names for such cases.
`
`Date and Attorney Signature. Date and sign the civil cover sheet.
`
`

`

`Case 2:20-cv-05344-WB Document 1 Filed 10/27/20 Page 3 of 21
`
`UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF PENNSYLVANIA
`__________________________________________
`
`JEAN C. SHARPE
`
`
`
`v.
`
`JANSSEN PHARMACEUTICALS,
`INC.
`
`__________________________________________
`
`)
`)
`)
`)
`)
`)
`)
`)
`
`CIVIL ACTION NO.
`
`COMPLAINT
`
`COMES NOW THE PLAINTIFF, Jean C. Sharpe (“Plaintiff”), and by and for her Complaint
`
`against Defendant, states and alleges upon information and belief and based upon the investigation
`
`of counsel, as follows:
`
`INTRODUCTION
`
`This is a personal injury action for damages arising from Plaintiff’s use of Defendant’s
`
`dangerously defective prescription drug, Elmiron (pentosyn polysulfate sodium), prescribed for
`
`the treatment of interstitial cystitis and bladder pain. Defendant designed, marketed, and
`
`distributed Elmiron in the United States, all the while knowing significant risks that were never
`
`disclosed to the medical and healthcare community, including Plaintiff’s prescribing doctor,
`
`Food and Drug Administration (hereinafter referred to as "FDA''), to Plaintiff, and/or the public
`
`in general. Further, Defendant failed to provide adequate warnings to patients and the medical
`
`community, including Plaintiff’s prescribing physician, of the risks associated with using the
`
`drug.
`
`

`

`Case 2:20-cv-05344-WB Document 1 Filed 10/27/20 Page 4 of 21
`
`Throughout the time Defendant marketed Elmiron, Defendant withheld material adverse
`
`events from the public, medical community and FDA. Defendant failed to disclose the serious
`
`link between Elmiron use and significant visual damage, including pigmentary maculopathy.
`
`Ultimately, tens of thousands of patients, including Plaintiff, were placed at risk and harmed as
`
`a result of this misleading conduct.
`
`PARTIES
`
`1.
`
`At all times relevant hereto, Plaintiff Jean C. Sharpe was a citizen and resident
`
`of Mecklenburg County, in the State of North Carolina.
`
`2.
`
`Upon information and belief, Plaintiff consumed and regularly used Defendant’s
`
`Elmiron (pentosyn polysulfate sodium) product. As a result of her use of Defendant’s Elmiron
`
`product, Plaintiff suffered from severe physical and emotional injuries, including but not
`
`limited to loss of vision, including a diagnosis of macular degeneration. Based on information
`
`and belief, Plaintiff's ingestion of Elmiron caused her injuries.
`
`3.
`
`Defendant Janssen Pharmaceuticals, Inc, is a Pennsylvania corporation with a
`
`principal place of business located at 800 Ridgeview Drive, Horsham, Pennsylvania 19044.
`
`4.
`
`Defendant directly or through their agents or employees designed,
`
`manufactured, marketed, and sold Elmiron in the United States which is used to manage
`
`symptoms of interstitial cystitis and painful bladder syndrome.
`
`JURISDICTION AND VENUE
`
`5.
`
`This Court has diversity jurisdiction over this action pursuant to 28 U.S.C. §1332,
`
`because the amount in controversy exceeds $75,000.00 and the Parties are citizens of different
`
`states.
`
`

`

`Case 2:20-cv-05344-WB Document 1 Filed 10/27/20 Page 5 of 21
`
`6.
`
`This Court has supplemental jurisdiction over the remaining common law and state
`
`claims pursuant to 28 U.S.C. §1367.
`
`7.
`
`Venue is proper in this Court pursuant to 28 U.S.C. §1391 because Defendant
`
`Janssen Pharmaceuticals is a Pennsylvania Corporation.
`
`8.
`
`Defendant currently transacts business in within this District by selling their
`
`products within this District and throughout the United States.
`
`GENERAL ALLEGATIONS
`
`A. Interstitial Cystitis
`
`9.
`
`Interstitial cystitis is a medical condition in the bladder that causes bladder pressure,
`
`bladder pain, and sometimes pelvic pain. There is no known cause of interstitial cystitis. The
`
`symptoms can range from mild to debilitating. The disease is known to affect women more often
`
`than men. There is no known cure for interstitial cystitis or painful bladder syndrome.
`
`10.
`
`The American Urological Association has established guidelines to provide a
`
`clinical framework for the diagnosis and treatment of interstitial cystitis. These guidelines were
`
`created by a comprehensive review of the literature. The guidelines include principles for the
`
`diagnosis of interstitial cystitis. The AUA guidelines further state that initial treatment type and
`
`level should depend on symptom severity, clinician judgment, and patient preferences. Treatments
`
`that may be offered are divided into first-, second-, third-, fourth-, fifth-, and sixth-line groups
`
`based on the balance between potential benefits to the patient, potential severity of adverse events
`
`(AEs) and the reversibility of the treatment. Second-line treatment of interstitial cystitis includes
`
`multi-modal pain management approaches including manual therapy and pharmacological options
`
`including amitriptyline, cimetidine, hydroxyzine, or pentosyn polysulfate.
`
`

`

`Case 2:20-cv-05344-WB Document 1 Filed 10/27/20 Page 6 of 21
`
`B. Elmiron
`
`11.
`
`Elmiron (pentosyn polysulfate sodium) was approved in 1996 to be used as a
`
`treatment for interstitial cystitis and painful bladder symptoms.
`
`12.
`
`Upon information and belief, Elmiron was granted an Orphan Drug
`
`designation in 1995. The original NDA was submitted in 1991 which was deemed non-approvable
`
`in 1993. A second non-approvable letter was sent in 1994 over concerns about the lack of data on
`
`efficacy of the drug. Elmiron was originally submitted to by Baker Norton Pharmaceuticals, a
`
`division of Ivax Pharmaceuticals that has since been purchased by Teva Pharmaceuticals, Inc.
`
`13.
`
`Elmiron (Pentosan polysulfate sodium) is a low molecular weight heparin-like
`
`compound. It has anticoagulant and fibrinolytic effects, but the mechanism of action of pentosan
`
`polysulfate sodium in interstitial cystitis is not known.
`
`14.
`
`Upon information and belief, Elmiron was first approved by FDA in September,
`
`1996 for painful bladder symptoms at which time Baker Norton Pharmaceuticals was the sponsor
`
`of the New Drug Application.
`
`15.
`
`Upon information and belief, in 1997 Elmiron was purchased from Baker Norton
`
`Pharmaceuticals and Ivax by Alza Pharmaceuticals.
`
`16.
`
`Upon information and belief, in 2002, Alza Corporation was acquired by Ortho-
`
`McNeil Pharmaceuticals, Inc, a subsidiary of Janssen Pharmaceuticals. Janssen Pharmaceuticals
`
`has been the sponsor of the NDA since that time.
`
`17.
`
`The label and prescribing information that accompany Elmiron when prescribed to
`
`patients contains the following: “Warnings: None.”
`
`18.
`
`According to the Drugs@FDA website, the label for Elmiron has been updated on
`
`approximately five occasions, at no time has it contained any information about vision loss,
`
`

`

`Case 2:20-cv-05344-WB Document 1 Filed 10/27/20 Page 7 of 21
`
`including pigmentary maculopathy, in any section of the label. The only mention in the label of
`
`any visual adverse events is a disclosure in the Adverse Reactions section that reveals clinical trial
`
`patients reported conjunctivitis, optic neuritis, amblyopia, and retinal hemorrhage. However, none
`
`of these adverse events are related to pigmentary maculopathy.
`
`19.
`
`Elmiron is known to take long time to exert an effect and patients who are prescribed
`
`Elmiron are advised to take the drug for at least six months in order to determine if there is an
`
`effect. For those patients who take the drug, the drug is known to be used for long-term use and in
`
`many patients, use is expected to last years, if not decades.
`
`C. Drug-Induced Retinal Toxicity
`
`20.
`
`The administration of drugs that are physiologically foreign to the body can lead to
`
`adverse side effects or toxicity with significant consequences. The retina is especially susceptible
`
`to the effects of systemic drugs. It has an extensive dual blood supply from the retina and is one of
`
`the most metabolically active tissues in the body. The retina has minimal ability to regenerate and
`
`is therefore at high risk of drug toxicity. Thus, it is critical that eye care professionals are aware
`
`and monitor for adverse drug effects, especially those affecting the retina.
`
`21.
`
`For example, the anti-malarial drug Plaquenil (hydroxychloroquine) is known to be
`
`associated with retinal toxicity. The label that accompanies that drug contains explicit instructions
`
`of the risk of injury and monitoring for signs of toxicity.
`
`Irreversible retinal damage has been observed in some patients who had received
`hydroxychloroquine sulfate. Significant risk factors for retinal damage include
`daily doses of hydroxychloroquine sulfate greater than 6.5 mg/kg (5 mg/kg base)
`of actual body weight, durations of use greater than five years, subnormal
`glomerular filtration, use of some concomitant drug products such as tamoxifen
`citrate and concurrent macular disease.
`
`A baseline ocular examination is recommended within the first year of starting
`PLAQUENIL. The baseline exam should include: best corrected distance visual
`acuity (BCVA), an automated threshold visual field (VF) of the central 10 degrees
`
`

`

`Case 2:20-cv-05344-WB Document 1 Filed 10/27/20 Page 8 of 21
`
`(with retesting if an abnormality is noted), and spectral domain ocular coherence
`tomography (SD-OCT).
`
`For individuals with significant risk factors (daily dose of hydroxychloroquine
`sulfate greater than 5.0 mg/kg base of actual body weight, subnormal glomerular
`filtration, use of tamoxifen citrate or concurrent macular disease) monitoring
`should include annual examinations which include BCVA, VF and SD-OCT. For
`individuals without significant risk factors, annual exams can usually be deferred
`until five years of treatment.
`
`In individuals of Asian descent, retinal toxicity may first be noticed outside the
`macula. In patients of Asian descent, it is recommended that visual field testing be
`performed in the central 24 degrees instead of the central 10 degrees.
`
`It is recommended that hydroxychloroquine be discontinued if ocular toxicity is
`suspected and the patient should be closely observed given that retinal changes (and
`visual disturbances) may progress even after cessation of therapy.
`
`D. Elmiron-Induced Macular Toxicity
`
`22.
`
`In November, 2018, Pearce, et al, reported a case series of patients known to be
`
`long term users of Elmiron that presented with an atypical maculopathy that resulted in significant
`
`vision loss.
`
`23.
`
`A follow-up study by the same authors (Hanif, et al.) included a retrospective review
`
`of 219 patients seen at Emory and evaluated vision loss as additional support for the association
`
`between Elmiron use and vision loss.
`
`24.
`
`In Jain et al., the authors reported a large, administrative, U.S. database was used to
`
`examine the association of PPS use and a diagnosis of a macular disorder. Their exposure cohort
`
`(PPS users) was matched 1:5 with an unexposed cohort of patients (not necessarily IC/BPS
`
`patients). The primary outcome was any new diagnosis of a hereditary or secondary pigmentary
`
`retinopathy or any new diagnosis of dry age-related macular degeneration (AMD) or drusen in
`
`addition to the previously described retinopathy. At seven years, there was a statistically significant
`
`

`

`Case 2:20-cv-05344-WB Document 1 Filed 10/27/20 Page 9 of 21
`
`increase in the exposed group in multivariate analysis (odds ratio [OR] 1.41; 95% confidence
`
`interval [CI] 1.09–1.83; p=0.009].
`
`25.
`
`At a recent meeting of the American Academy of Ophthalmologists in San
`
`Francisco, Vora et al., presented their findings using data from Kaiser Permanente and identified
`
`140 patients (from the database of 4.3 million) who had taken an average of 5000 pills over a 15-
`
`year period. Of the 140 exposed patients, 91 agreed to an examination and of those, 22 patients
`
`showed clear evidence of this specific maculopathy, which authors believe was associated with
`
`PPS exposure. This work has since been published in the journal, Opthamology in January 2020.
`
`According to Dr. Vora,
`
`You have a patient with a chronic condition like interstitial cystitis, for which there is no
`cure and no effective treatment. They get put on these medications because it’s thought to
`have few side effects and few risks, and no one thinks about it again. And year after year,
`the number of pills they’re taking goes up and up.
`
`Because it’s unclear how much medication is too much, Dr. Vora is reported to recommend
`
`patients who show no signs of toxicity be screened for retina damage at least once a year. For
`
`those who do show some signs of damage, he recommends they speak with their urologist or
`
`OB/GYN about discontinuing the medication.
`
`26.
`
`Greenlee et al. postulated that the mechanism of toxicity of pentosyn polysulfate
`
`may relate to the antagonist properties of pentosyn polysulfate towards the fibroblast growth factors
`
`1, 2, and 4. The authors of that publication reported that several known FGF antagonists are
`
`associated with significant ocular side effects.
`
`27.
`
`In Lyons, et al., published in Obstetrics and Gynecology in 2020, the authors made
`
`the following screening and follow-up recommendations:
`
`a. Providers discuss the risks associated with pentosan polysulfate with their patients
`and prescribe the lowest necessary dose and duration of pentosan polysulfate
`
`

`

`Case 2:20-cv-05344-WB Document 1 Filed 10/27/20 Page 10 of 21
`
`for patients who require long-term treatment. Providers may discuss alternative
`treatments for interstitial cystitis at their discretion.
`b. A baseline examination with fundus photography, optical coherence tomography,
`and fundus autofluorescence imaging.
`c. Testing is repeated within 5 years after pentosan polysulfate initiation and
`annually, thereafter. Some patients may be at higher risk for developing
`pentosan polysulfate maculopathy and may benefit from either more
`frequent screening examinations or drug avoidance.
`d. We recommend that patients diagnosed with pentosan polysulfate maculopathy
`stop taking the drug and discuss alternative interstitial cystitis management
`options with their treating physician
`
`28.
`
`Since the original report, there have been more than a dozen papers published in the
`
`medical literature regarding the atypical maculopathy associated with Elmiron use. Despite these
`
`publications, Defendant has made no change to the label in the United States or taken any steps to
`
`warn the medical community and users of the drug regarding these effects.
`
`29. More troubling, Defendant made label changes in other countries to warn users of
`
`these injuries. For example, in September, 2019, Defendant changed the label of Elmiron in
`
`Canada to reflect the following warning:
`
`Ophthalmologic
`
`Post-market cases of pigmentary maculopathy have been reported with chronic use of
`pentosan polysulfate sodium (PPS). Visual symptoms in these cases included difficulty
`reading and prolonged dark adaptation. All patients should have regular ophthalmic
`examinations for early detection of pigmentary maculopathy, particularly those with long-
`term use of PPS. If pigmentary maculopathy is confirmed, treatment discontinuation should
`be considered.
`
`PLAINTIFF SPECIFIC FACTS
`
`30.
`
`Upon information and belief, in or about 2000, Plaintiff's treating medical
`
`physician prescribed Elmiron to Plaintiff due to Plaintiff’s medically diagnosed painful bladder
`
`and/or interstitial cystitis. Defendant represented Elmiron to be an appropriate and suitable product
`
`for such purposes.
`
`

`

`Case 2:20-cv-05344-WB Document 1 Filed 10/27/20 Page 11 of 21
`
`31.
`
`In or about 2020, Plaintiff began to experience visual symptoms, and on June
`
`24, 2020, was diagnosed with Macular Degeneration associated with Elmiron use.
`
`32.
`
`As a result of Defendant’s actions and inactions, Plaintiff was injured due to
`
`Elmiron which caused Plaintiff various injuries and damages due to her vision loss. Plaintiff
`
`accordingly seeks damages associated with these injuries.
`
`33.
`
`Defendant ignored reports from patients and health care providers throughout
`
`the United States of Elmiron’s failure to perform as intended, and injuries associated with long
`
`term use which led to the severe and debilitating injuries suffered by Plaintiff, and numerous
`
`other patients. Rather than doing adequate testing to determine the cause of these injuries or
`
`rule out Elmiron’s design as the cause of the injuries, Defendant continued to market Elmiron
`
`as a safe and effective prescription drug for interstitial cystitis.
`
`34.
`
`Defendant did not timely or adequately apprise the public and physicians,
`
`including Plaintiff’s physicians, of the adverse effect or defects in Elmiron despite Defendant’s
`
`knowledge that it was associated with visual effects following use. Defendant did not timely or
`
`adequately apprise the public and physicians, including Plaintiff’s physicians, to monitor
`
`Elmiron users’ vision and eyes with regular examination.
`
`35.
`
`Defendant’s' Elmiron was at all times utilized and prescribed in a manner
`
`foreseeable to Defendant, as Defendant generated the instructions for use for Plaintiff to take
`
`Elmiron.
`
`36.
`
`Plaintiff and Plaintiff’s physicians foreseeably used the Defendant’s Elmiron,
`
`and did not misuse, or alter the Elmiron in an unforeseeable manner.
`
`

`

`Case 2:20-cv-05344-WB Document 1 Filed 10/27/20 Page 12 of 21
`
`37.
`
`Through their affirmative misrepresentations and omissions, Defendant actively
`
`concealed from Plaintiff and his/her physicians the true and significant risks associated with
`
`Elmiron consumption.
`
`38.
`
`As a result of Defendant’s actions, Plaintiff and her physicians were unaware,
`
`and could not have reasonably known or have learned through reasonable diligence that Plaintiff
`
`would be exposed to the risks identified in this Complaint and that those risks were the direct
`
`and proximate result of Defendant’s conduct.
`
`39.
`
`As a direct result of being prescribed and consuming Elmiron, Plainitff has been
`
`permanently and severely injured, having suffered serious consequences.
`
`40.
`
`Plaintiff, as a direct and proximate result of Elmiron, suffered severe mental
`
`and physical pain and suffering and has sustained permanent injuries and emotional distress,
`
`along with economic loss due to medical expenses and living-related expenses due to her new
`
`lifestyle.
`
`41.
`
`Plaintiff’s physicians would not have prescribed Elmiron had Defendant properly
`
`disclosed the risks associated with its use or in the alternative, would have actively monitored
`
`her vision with regular eye exams.
`
`EQUITABLE TOLLING OF STATUTE OF LIMITATIONS
`
`42.
`
`Defendant failed to disclose a known defect and affirmatively misrepresented that
`
`Elmiron was safe for its intended use. Further, Defendant actively concealed the true risks
`
`associated with the use of Elmiron. Neither Plaintiff nor the prescribing physician had
`
`knowledge that Defendant was engaged in the wrongdoing alleged herein.
`
`43.
`
`Because of Defendant's concealment of and misrepresentations regarding the true
`
`risks associated with Elmiron, Plaintiff could not have reasonably discovered Defendant’s
`
`

`

`Case 2:20-cv-05344-WB Document 1 Filed 10/27/20 Page 13 of 21
`
`wrongdoing at any time prior to the commencement of this action.
`
`44.
`
`Thus, because Defendant fraudulently concealed the defective nature of Elmiron
`
`and the risks associated with its use, the running of any statute of limitations has been tolled.
`
`Likewise, Defendant is estopped from relying on any statute of limitations.
`
`45.
`
`Additionally, and alternatively, Plaintiff files this lawsuit within the applicable
`
`limitations period of first suspecting that Elmiron caused the appreciable harm sustained by
`
`Plaintiff. Plaintiff did not have actual or constructive knowledge of acts indicating to a
`
`reasonable person that Plaintiff was the victim of a tort. Plaintiff was unaware of the facts upon
`
`which a cause of action rests until less than the applicable limitations period prior to the filing
`
`of this action. Plaintiff’s lack of knowledge was not willful, negligent, or unreasonable.
`
`COUNT 1
`STRICT LIABILITY
`
`46.
`
`Plaintiff incorporates by referenced each and every preceding paragraph as though
`
`fully set forth herein.
`
`47.
`
`At all times relevant hereto, Defendant manufactured, designed, distributed, and/or
`
`sold Elmiron.
`
`48.
`
`At all times relevant hereto, the dangerous propensities of Elmiron were known
`
`to Defendant, or reasonably and scientifically knowable to them, through appropriate research and
`
`testing by known methods, at the time they distributed, supplied, or sold their respective products,
`
`and not known to ordinary physicians who would be expected to prescribe the drug to their
`
`patients.
`
`49.
`
`The Elmiron product as distributed by Defendant was a defective and unreasonably
`
`dangerous product, as Defendant failed to provide appropriate and adequate warnings and
`
`

`

`Case 2:20-cv-05344-WB Document 1 Filed 10/27/20 Page 14 of 21
`
`instructions to render the products reasonably safe for its ordinary, intended, and reasonably
`
`foreseeable uses; in particular the common, foreseeable and intended use of Elmiron to treat
`
`painful bladder syndrome and interstitial cystitis.
`
`50.
`
`Defendant failed to properly and adequately warn and instruct Plaintiff and
`
`Plaintiff’s treating physician that Defendant’s Elmiron product was designed and/or manufactured
`
`in a way that could cause injuries and damages, including lasting and permanent visual i

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket