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Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 1 of 34
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF FLORIDA
`MIAMI DIVISION
`
`
` CASE NO.:
`
`
`EVELYN CRAYNE,
`
` Plaintiff,
`
`v.
`
`JOHNSON & JOHNSON,
`JANSSEN PHARMACEUTICALS, INC.,
`ORTHO-MCNEIL
`PHARMACEUTICAL, LLC,
`JANSSEN RESEARCH &
`DEVELOPMENT, LLC,
`JANSSEN ORTHO, LLC,
`TEVA PHARMACEUTICAL
`INDUSTRIES LTD.,
`TEVA PHARMACEUTICALS USA, INC.,
`and TEVA BRANDED PHARMACEUTICAL
`PRODUCTS R&D, INC.,
`
` Defendants.
` /
`COMPLAINT
`
`Plaintiff Evelyn Crayne (“Plaintiff”), by and through her undersigned counsel,
`
`herein brings this action against Defendants Johnson & Johnson, Janssen Pharmaceuticals,
`
`Inc., Ortho-McNeil Pharmaceutical, LLC, Janssen Research & Development, LLC,
`
`Janssen Ortho, LLC, Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA,
`
`Inc., and Teva Branded Pharmaceutical Products R&D, Inc. (collectively, “Defendants”),
`
`

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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 2 of 34
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`and states and alleges upon information and belief and based upon the investigation of
`
`counsel, as follows:
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`INTRODUCTION
`
`1.
`
`This is a personal injury action for damages arising from Plaintiff’s use of
`
`Elmiron®, a prescription drug manufactured and sold by Defendants.
`
`2.
`
`Defendants designed, marketed, and distributed Elmiron® in the United
`
`States, all the while knowing of significant risks that the drug poses to users, which were
`
`never disclosed to the medical and healthcare community, including Plaintiff’s prescribing
`
`doctor, to Plaintiff, the Food and Drug Administration (“FDA”), and/or the public in
`
`general.
`
`3.
`
`Defendants also failed to provide adequate warnings of the risks associated
`
`with using Elmiron® to patients and the medical community, including Plaintiff’s
`
`prescribing physician.
`
`4.
`
`Defendants also marketed Elmiron® while, at the same time, withholding
`
`material adverse events from the public, the medical community, and FDA. Specifically,
`
`Defendants failed to disclose the known link between using Elmiron® and the risk of harm
`
`to vision, including, but not limited to, pigmentary maculopathy.
`
`5.
`
`Defendants’ misleading conduct placed Plaintiff at risk of harm, caused harm
`
`to Plaintiff, and did the same for countless other patients who were prescribed Elmiron®.
`
`
`
`2
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`

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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 3 of 34
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`PARTIES
`
`6.
`
`At all times relevant hereto, Plaintiff Evelyn Crayne was a citizen and
`
`resident of Miami, Miami-Dade County, Florida.
`
`The Johnson & Johnson Family of Defendants
`
`7.
`
`Defendant Johnson & Johnson (“J&J”) is a New Jersey corporation with a
`
`principal place of business located at 1 Johnson and Johnson Plaza, New Brunswick, New
`
`Jersey 08933.
`
`8.
`
`Defendant Janssen Pharmaceuticals, Inc. (“Janssen Pharmaceuticals”) is,
`
`upon information and belief, a wholly-owned subsidiary of Defendant J&J and a New
`
`Jersey corporation with a principal place of business located at 1125 Trenton-Harbourton
`
`Road, Titusville, New Jersey 08560.
`
`9.
`
`Defendant Ortho-McNeil Pharmaceutical, LLC (“Ortho Pharma”) is, upon
`
`information and belief, a wholly-owned subsidiary of Defendant J&J and a Delaware
`
`corporation with a principal place of business located at 1000 US Highway 202, Raritan,
`
`New Jersey 08869.
`
`10. Defendant, Janssen Research & Development, LLC, (“Janssen R&D”) is,
`
`upon information and belief, a wholly-owned subsidiary of Defendant J&J and a New
`
`Jersey limited liability company with a principal place of business located at One Johnson
`
`& Johnson Plaza, New Brunswick, Middlesex County, New Jersey 08933.
`
`
`
`3
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`

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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 4 of 34
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`11. Defendant Janssen Ortho, LLC (“Janssen Ortho”) is, upon information and
`
`belief, a wholly-owned subsidiary of Defendant J&J and a Delaware limited liability
`
`company with a principal place of business located in Gurabo 00777, Puerto Rico.
`
`12. Defendant Janssen Ortho’s sole member is OMJ PR Holdings, a corporation
`
`incorporated in Ireland with a principal place of business in Puerto Rico.
`
`13. At all relevant times, Defendants Janssen Pharmaceuticals, Ortho Pharma,
`
`Janssen R&D, and Janssen Ortho have been wholly-owned subsidiaries of Defendant J&J,
`
`with the profits of each inuring to Defendant J&J's benefit.
`
`14.
`
`The Johnson & Johnson Family of Defendants—Defendant J&J and its
`
`subsidiaries, Janssen Pharmaceuticals, Ortho Pharma, Janssen R&D, Janssen Ortho— are
`
`involved in the research, development, sale, and/or marketing of pharmaceutical products,
`
`including Elmiron® in the United States and in the State of Florida.
`
`15. Defendant J&J made consequential decisions and/or took significant actions
`
`concerning, inter alia, the design, labeling, marketing, advertising, promotion, and/or
`
`regulatory approval of Elmiron®.
`
`16.
`
`The Johnson & Johnson Family of Defendants’ decisions and/or actions with
`
`respect to Elmiron® impacted, inter alia, the design, testing, labeling, packaging,
`
`marketing, advertising, distribution, sale, promotion, and/or FDA-approval of Elmiron® in
`
`the United States.
`
`
`
`4
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`

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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 5 of 34
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`17.
`
`The Johnson & Johnson Family of Defendants, directly or through their
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`agents or employees, designed, manufactured, marketed, and sold Elmiron® in the United
`
`States to manage symptoms of interstitial cystitis.
`
`The Teva Family of Defendants
`
`18. Defendant Teva Pharmaceutical Industries Ltd. is, upon information and
`
`belief, an American-Israeli company with dual headquarters located at 5 Basel Street,
`
`Petach Tikva 49131, Israel, and 400 Interpace Parkway, #3, Parsippany, New Jersey 07054.
`
`19. Defendant Teva Pharmaceuticals USA, Inc. is, upon information and belief,
`
`a wholly-owned subsidiary of Defendant Teva Pharmaceutical Industries Ltd. and a
`
`Delaware corporation with a principal place of business located at 1090 Horsham Road,
`
`North Wales, Pennsylvania, 19454.
`
`20. Defendant Teva Branded Pharmaceutical Products R&D, Inc. is, upon
`
`information and belief, a wholly-owned subsidiary of Defendant Teva Pharmaceutical
`
`Industries Ltd. and a Delaware corporation with a principal place of business located at 41
`
`Moores Rd., Frazer, PA 19355.
`
`21.
`
`The Teva Family of Defendants— Teva Pharmaceutical Industries Ltd., and
`
`its subsidiaries Teva Pharmaceuticals USA, Inc. and Teva Branded Pharmaceutical
`
`Products R&D, Inc.—made consequential decisions and/or took significant actions
`
`concerning, inter alia, the design, testing, labeling, packaging, marketing, advertising,
`
`distribution, sale, promotion, and/or regulatory approval of Elmiron® in the United States.
`
`
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`5
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`

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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 6 of 34
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`JURISDICTION AND VENUE
`
`22.
`
`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.
`
`23. Venue is proper in this Court pursuant to 28 U.S.C. §1391 because a
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`substantial part of the events or omissions giving rise to the claim occurred in this District.
`
`24.
`
`The Court has personal jurisdiction over Defendants. Defendants currently
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`transact business within this District by selling their products, including Elmiron®, within
`
`this District and throughout the United States.
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`GENERAL ALLEGATIONS
`
`Interstitial Cystitis
`
`Interstitial cystitis is a chronic medical condition in the bladder that causes,
`
`A.
`
`25.
`
`among other things, bladder pressure and pain. There is no known cause of interstitial
`
`cystitis and no known cure. The symptoms can range from mild to debilitating.
`
`26.
`
`The American Urological Association (“AUA”) has established guidelines
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`for the diagnosis and treatment of interstitial cystitis. The AUA guidelines further state that
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`a given patient’s initial treatment type and level should depend on symptom severity,
`
`clinician judgment, and patient preferences.
`
`27.
`
`Treatments that may be offered are divided into first-, second-, third-,
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`fourth-, fifth-, and sixth-line groups based on the balance between the potential benefits to
`
`the patient, the potential severity of adverse events (“AEs”), and the reversibility of the
`
`
`
`6
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`

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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 7 of 34
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`treatment. Second-line treatment of interstitial cystitis includes multi-modal pain
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`management approaches, including manual therapy and pharmacological options, such as
`
`amitriptyline, cimetidine, hydroxyzine, or pentosan polysulfate sodium (Elmiron®).
`
`B.
`
`28.
`
`Elmiron® and FDA Approval.
`
`In 1991, Baker Norton Pharmaceuticals (“Baker Norton”) submitted a New
`
`Drug Application (“NDA”) for pentosan polysulfate sodium (Elmiron®). At the time,
`
`Baker Norton was a division of Ivax Pharmaceuticals.
`
`29.
`
`The FDA deemed the original NDA non-approvable in approximately 1993.
`
`30. Baker Norton responded by submitting additional materials in support of its
`
`NDA for FDA review.
`
`31.
`
`The FDA deemed the supplemented NDA non-approvable in approximately
`
`1994.
`
`32.
`
`Elmiron® was granted an Orphan Drug designation in 1995, and Baker
`
`Norton subsequently submitted additional materials in support of its NDA for further FDA
`
`review.
`
`33.
`
`The FDA finally approved Elmiron® as a treatment for the pain or
`
`discomfort of interstitial cystitis in 1996.
`
`34.
`
`Elmiron® is intended for long-term patient use. Patients who are prescribed
`
`Elmiron® are advised to take the drug for at least six months in order to determine whether
`
`they benefit from its use. For those patients who take the drug, the time of use is indefinite,
`
`and patients could take the drug for several years or even for life.
`
`
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`7
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`

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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 8 of 34
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`35. Defendants are aware that physicians prescribe Elmiron® for long-term use
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`and, in fact, encourage and recommend long-term use of Elmiron®. According to
`
`Defendants’ Elmiron® patient leaflet, the drug “must be taken continuously for relief…”
`
`C.
`
`36.
`
`Elmiron® Is Licensed.
`
`From approximately 1996, when
`
`the NDA was approved, until
`
`approximately 1997, Baker Norton owned the trademark for Elmiron®.
`
`37.
`
`In approximately 1997, Baker Norton was purchased by Teva
`
`Pharmaceutical Industries, Ltd., and/or Teva Pharmaceuticals, Inc.
`
`38.
`
`In connection with the purchase of Baker Norton, Teva Pharmaceutical
`
`Industries, Ltd. and/or Teva Pharmaceuticals, Inc. acquired all rights to Elmiron®,
`
`including trademark rights.
`
`39.
`
`Elmiron® is a registered trademark of Teva Branded Pharmaceutical
`
`Products R&D, Inc., Teva Pharmaceuticals USA, Inc. and/or Teva Pharmaceutical
`
`Industries Ltd., under license to Defendant Janssen Pharma.
`
`40.
`
`From approximately August 2002 until August 2004, Defendant Janssen
`
`R&D held the NDA for Elmiron®.
`
`41.
`
`From July 2004 until August 2008, Defendant Ortho Pharma held the NDA
`
`for Elmiron®.
`
`42.
`
`Since August 2008, Defendant Janssen Pharma has held the NDA for
`
`Elmiron® and continues to manufacture and/or distribute Elmiron® throughout the United
`
`States.
`
`
`
`8
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`

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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 9 of 34
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`43.
`
`There is no FDA-approved generic form of Elmiron® sold in the United
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`States.
`
`D.
`
`44.
`
`Drug-Induced Retinal Toxicity
`
`The retina is one of the most metabolically active tissues in the human body
`
`and, thus, is especially susceptible to the effects of systemic drugs.
`
`45.
`
`The retina has minimal ability to regenerate and is at high risk of drug
`
`toxicity. Thus, it is critical that physicians, especially eyecare professionals, are aware of
`
`adverse drug effects impacting the retina.
`
`46.
`
`For example, the anti-malarial drug Plaquenil (hydroxychloroquine), which
`
`is also prescribed for the treatment of lupus and rheumatoid arthritis, is known to be
`
`associated with retinal toxicity in patients taking it for these two illnesses. Accordingly,
`
`the FDA label for Plaquenil contains explicit warnings regarding the risk of injury for
`
`patients with lupus and rheumatoid arthritis, and stresses the importance of monitoring for
`
`signs of retinal toxicity.
`
`47. Until June 2020, Elmiron®’s FDA label contained no warning of the risk of
`
`retinal toxicity or instructions relating to the risk of injury and monitoring for signs of
`
`toxicity.
`
`48.
`
`In fact, from 1996, when Elmiron® was first approved by the FDA, until
`
`June of 2020, neither Elmiron®’s Package Insert nor its Medication Guide contained any
`
`warnings or information regarding the risk of serious visual complications, including, but
`
`not limited to, maculopathy.
`
`
`
`9
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`

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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 10 of 34
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`E.
`
`49.
`
`The Link Between Elmiron® Use and Retinal Maculopathy.
`
`Elmiron® is the “only game in town” to treat discomfort or bladder pain
`
`associated with interstitial cystitis, and has been regularly prescribed for long-term use to
`
`treat these conditions.
`
`50.
`
`In recent years, an increasing number of independent studies have found a
`
`link between damage to the retina and exposure to pentosan polysulfate sodium (PPS), or
`
`Elmiron®.
`
`51.
`
`For example, from 2015 to 2018, Emory Eye Center began observing a new
`
`eye disease in patients called “retinal maculopathy,” a unique presentation that does not
`
`resemble any other hereditary or acquired maculopathy, where the pigment cells within the
`
`eye’s retina changes color. This change in color causes significant vision loss and eye
`
`dysfunction.
`
`52.
`
`In 2018, scientists at Emory Eye Center published a study documenting a
`
`link between Elmiron® use and retinal maculopathy. Pearce WA, Chen R, Jain N.,
`
`Pigmentary Maculopathy Associated with Chronic Exposure To Pentosan Polysulfate
`
`Sodium. Ophthalmology 2018. The authors suggest that the retinal cells may be
`
`accumulating PPS over time and warn that “[c]linicians should be aware of this condition
`
`because it can be mistaken for other well-known macular disorders, such as pattern
`
`dystrophy and age-related macular degeneration.”
`
`53.
`
`In letters to the editor, the study authors also stated that “[a]fter extensive
`
`investigations, which included molecular testing for hereditary retinal disease, we found
`
`
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`10
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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 11 of 34
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`these cases to resemble no other retinal disease,” and “[w]e encourage drug cessation in
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`affected patients.”
`
`54.
`
`In 2019, an Emory Eye Center team submitted a second study further
`
`documenting a link between Elmiron® use and this unique change to the retina. Foote, et
`
`al. Chronic Exposure To Pentosan Polysulfate Sodium Is Associated With Retinal
`
`Pigmentary Changes And Vision Loss. AUA 2019 Abstract MP47-03. The authors of this
`
`study conclude that structural changes of the retina are occurring and that it is unclear
`
`whether stopping Elmiron® will alter the course of this new retinal disease. The authors
`
`recommend that affected patients should discontinue the use of Elmiron® and undergo
`
`comprehensive ophthalmic examinations.
`
`55.
`
`In 2019, researchers using data from Kaiser Permanente reported that 24%
`
`of the Elmiron® users had the exact same Elmiron®-associated retinal pigmentary
`
`maculopathy and vision symptoms that were presented by the Emory Eye Center study,
`
`and that patients reported significant eye and vision problems. American Academy of
`
`Ophthalmology. The findings were presented at a meeting of the American Academy of
`
`Ophthalmologists in San Francisco. See More evidence linking common bladder
`
`medication to a vision threatening eye condition: New study shows about a quarter of
`
`patients with significant exposure to the drug show signs of retinal damage. ScienceDaily,
`
`12 October 2019.
`
`56. An additional 2019 study by Emory Eye Center found a statistically
`
`significant increase in the atypical retinal maculopathy in people who had taken Elmiron®
`
`
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`11
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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 12 of 34
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`(PPS) for 7 years. Jain N, Li AL, Yu Y, et al. Association Of Macular Disease With Long-
`
`Term Use Of Pentosan Polysulfate Sodium: Findings From A U.S. Cohort. Br J
`
`Ophthalmology Nov. 6, 2019.
`
`57.
`
`In January 2020, a UCLA study also suggested a “significant risk” of
`
`maculopathy in Elmiron®-treated patients. Derrick Wang, Adrian Au, Frederic
`
`Gunnemann. Pentosan-Associated Maculopathy: Prevalence, Screening Guidelines, And
`
`Spectrum Of Findings Based On Prospective Multimodal Analysis, Canadian Journal of
`
`Ophthalmology, January 2020,
`
`58. Also, in January 2020, a study using the Kaiser Permanente database of
`
`patients with interstitial cystitis who had taken Elmiron® over the past 20 years reported
`
`that 23.1% showed signs of “definite” Elmiron®-associated maculopathy. Vora RA, Patel
`
`AP, Melles R, Prevalence of Maculopathy Associated with Long Term Pentosan
`
`Polysulfate Therapy Ophthalmology (2020).
`
`59. When researchers at Emory Eye Center looked more closely at the
`
`Defendants’ early clinical trials for Elmiron®, they found evidence of reported retinal eye
`
`damage that was never followed up on, never warned about or otherwise disclosed. Instead,
`
`Defendants chose to ignore it.
`
`60.
`
`Specifically, the Emory Eye Center researchers found that in Defendant
`
`Janssen’s own clinical trial of patients who took Elmiron® for up to four years, both vision
`
`and eye-related adverse events were reported, including optic neuritis and retinal
`
`hemorrhage.
`
`
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`12
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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 13 of 34
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`61. Defendant Janssen performed no further tests or research to explore the
`
`connection, and none of these risks were disclosed on the Elmiron® warning label.
`
`62.
`
`Further, the Adverse Event Reports concerning Elmiron® that Defendants
`
`received included serious visual complications believed to be associated with Elmiron®
`
`use, ranging from retinal hemorrhage to macular degeneration and unilateral blindness.
`
`63. Reports of serious visual complications associated with Elmiron® use were
`
`not unique to the United States. Upon information and belief, serious visual complications
`
`were reported to Defendants and recorded in other adverse event reports databases
`
`maintained in other countries and continents around the world where Elmiron® is sold,
`
`including EudraVigilance—the European Medicines Agency’s adverse event database.
`
`64.
`
`It is widely recognized and accepted in the pharmaceutical industry that
`
`Adverse Event Reports represent only a small fraction of the total number of adverse events
`
`associated with and/or caused by a particular drug.
`
`65. Moreover, beginning in approximately 2019, Defendants took steps to warn
`
`consumers and physicians outside of the United States of the risk of serious visual
`
`complications, including pigmentary maculopathy, associated with the extended use of
`
`Elmiron®.
`
`66.
`
`In approximately September 2019, Defendants revised the Elmiron® label in
`
`Canada to warn of the risk of serious visual complications, including pigmentary
`
`
`
`
`
`
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`13
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`

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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 14 of 34
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`maculopathy, associated with the extended use of Elmiron®, as follows:
`
`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 longterm use of PPS. If
`pigmentary maculopathy is confirmed, treatment discontinuation should be
`considered.
`
`67.
`
`Likewise, in approximately 2019, Defendants “agreed” with a European
`
`Medicines Agency’s Committee recommendation that the Elmiron® label be changed to
`
`warn of the risk of serious visual complications, including pigmentary maculopathy,
`
`associated with long-term use of Elmiron®.
`
`68.
`
`The Elmiron® label in European Medicines Agency countries now warns:
`
`All patients should have an ophthalmologic examination after 6 months of
`use of PPS for early detection of pigmentary maculopathy, and, if there are
`no pathologic findings, regularly after 5 years of use (or earlier, in case of
`visual complaints). However, in case of relevant ophthalmologic findings, a
`yearly examination should be conducted. In such situations, treatment
`cessation should be considered.
`
`69.
`
`The Elmiron® label used in European Medicines Agency countries further
`
`admits that “eye disorders” like pigmentary maculopathy are “uncommon” undesirable
`
`effects of the medication.
`
`70.
`
`In approving these changes to the Elmiron® label, the European Medicines
`
`Agency Committee for Medicinal Products for Human Use (“CHMP”) created a report,
`
`which Defendants are believed to have received. This report specifically noted that such a
`
`
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`14
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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 15 of 34
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`warning regarding ophthalmological side effects of Elmiron® was needed, in part, because
`
`pigmentary maculopathy “might not be easily recognized by the urology community.”
`
`71. Notwithstanding Defendants’ duty to ensure that the warning label for
`
`Elmiron® sold in the United States was adequate, and even though Defendants had a
`
`continuing responsibility to conduct post-marketing surveillance and to study the safety
`
`and efficacy of Elmiron®, Defendants did nothing to ensure that the Elmiron® label in the
`
`United States included a warning similar to the one introduced in Europe, or a warning of
`
`any type for that matter.
`
`72.
`
`The Elmiron® patient leaflet did not disclose any ophthalmological side
`
`effects. Rather, Defendants limited the disclosed side effects to “hair loss, diarrhea, nausea,
`
`blood in the stool, headache, rash, upset stomach, abnormal liver function tests, dizziness
`
`and bruising.”
`
`73.
`
`It was not until June 16, 2020 that Defendants revised the Elmiron® label in
`
`the United States to include a warning of “Retinal Pigmentary Changes.”
`
`74.
`
`Prior to that date, Defendants did not warn, and made no effort to warn,
`
`healthcare professionals or patients in the United States of the risk of harm, including, but
`
`not limited to, pigmentary maculopathy associated with long-term Elmiron® use.
`
`75. Defendants continue to sell Elmiron® and, upon information and belief,
`
`continue to market Elmiron® as safe and efficacious for the long-term treatment of
`
`discomfort or bladder pain associated with interstitial cystitis.
`
`
`
`15
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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 16 of 34
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`F.
`
`76.
`
`Plaintiff Crayne’s Use of Elmiron®
`
`Plaintiff was diagnosed with interstitial cystitis in or around September 2016
`
`and was prescribed Elmiron® shortly thereafter. Plaintiff took Elmiron as prescribed from
`
`approximately September 2016 to mid-2019.
`
`77.
`
`In May 2017, Plaintiff began experiencing vision issues, including problems
`
`with night vision, and was subsequently diagnosed with a macular condition related to her
`
`use of Elmiron®.
`
`78. Due to the absence of any warning by Defendants of the risks posed by
`
`Elmiron®, Plaintiff was unaware that use of Elmiron® could result in retina damage and
`
`vision impairment. This danger was also unknown to Plaintiff’s healthcare providers or
`
`the general public due to Defendants’ failure to warn.
`
`79. Due to the absence of any instructions regarding how to identify and/or
`
`monitor Elmiron® patients for potential vision-related complications, Plaintiff was
`
`unaware that Elmiron® could result in retina damage and vision impairment. This danger
`
`was also unknown to Plaintiff’s healthcare providers or the general public due to
`
`Defendants’ failure to provide any such instructions.
`
`G. Tolling and Estoppel of Statute of Limitations
`
`80. Defendants have had actual knowledge for years that Elmiron® is unsafe for
`
`its intended use and that it failed to warn or otherwise disclose to patients, including
`
`Plaintiff, that testing of the drug established that it can cause – and, indeed, has caused –
`
`
`
`16
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`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 17 of 34
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`significant ophthalmological side effects, including pigmentary maculopathy and other eye
`
`and vision problems.
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`Discovery Rule Tolling
`
`81. During the period of any applicable statutes of limitation, Plaintiff could not
`
`have discovered, through the exercise of reasonable diligence, that Elmiron® is unsafe for
`
`its intended use and capable of causing significant ophthalmological side effects.
`
`82.
`
`Plaintiff did not discover, and did not have knowledge of, facts that would
`
`cause a reasonable person to suspect that Elmiron® is unsafe for its intended use and
`
`capable of causing significant ophthalmological side effects.
`
`83. Until recently, only Defendants had knowledge of the fact that Elmiron® is
`
`unsafe for its intended use and capable of causing significant ophthalmological side effects.
`
`Indeed, Defendants only revised the Elmiron® label to include a warning of
`
`ophthalmological side effects on June 16, 2020.
`
`84.
`
`Plaintiff could not have reasonably discovered the true extent of Defendants’
`
`illegal conduct in connection with the health and safety risks posed by Elmiron® as
`
`Defendants never disclosed it while marketing and selling it to Plaintiff.
`
`85.
`
`For the foregoing reasons, all applicable statutes of limitation have been
`
`tolled by operation of the discovery rule.
`
`
`
`
`
`
`
`
`
`17
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`

`

`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 18 of 34
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`Fraudulent Concealment Tolling
`
`86. All applicable statutes of limitation have also been tolled by way of
`
`Defendants’ fraudulent concealment of Elmiron® test results and their knowledge of
`
`significant ophthalmological side effects the through the relevant time period.
`
`87. Rather than disclose to Plaintiff that test results indicate a connection
`
`between Elmiron® and significant ophthalmological side effects, Defendants continued to
`
`manufacture, market, and sell the drug for several years without disclosing this
`
`information.
`
`Estoppel
`
`88. At all times relevant to this action, Defendants had a duty to disclose to
`
`Plaintiff, prescribing physicians, the medical community, and the general public, the
`
`serious risks posed to Elmiron® users. Defendants knowingly, affirmatively, and actively
`
`concealed or recklessly disregarded the aforementioned serious risks and persisted with the
`
`manufacturing, marketing, promoting, distributing, and selling of Elmiron®.
`
`89.
`
`For the foregoing reasons, Defendants are estopped from relying on any
`
`statutes of limitations in defense of the allegations raised in this Complaint.
`
`CLAIMS FOR RELIEF
`
`COUNT I
`Fraudulent Concealment
`
`90.
`
`Plaintiff hereby realleges and incorporates by reference all allegations raised
`
`
`
`in the preceding paragraphs as if fully stated herein.
`
`
`
`18
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`

`

`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 19 of 34
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`91. Defendants have a duty to disclose the truth regarding Elmiron® and the
`
`ophthalmological side effects that can result, and have resulted, from taking the drug,
`
`including pigmentary maculopathy. Defendants also have a duty to advise patients of the
`
`importance of regular ophthalmologic examinations for early detection of pigmentary
`
`maculopathy.
`
`92. Defendants made material misrepresentations and/or omissions to Plaintiff,
`
`Plaintiff’s prescribing physician, the medical community, and the general public regarding
`
`the safety (or lack thereof) of taking Elmiron®.
`
`93.
`
`Plaintiff reasonably relied on Defendants’ material misrepresentations and/or
`
`omissions regarding the safety of Elmiron®.
`
`94. Defendants’ failure to disclose that taking Elmiron® can result, and has
`
`resulted, in certain ophthalmological side effects was intentional. Defendants were aware
`
`of the health risks inherent in Elmiron®, but intentionally chose not to disclose this material
`
`fact to patients, including Plaintiff, as well as Plaintiff’s prescribing physician, the medical
`
`community, and the general public.
`
`95. As described above, the packaging and labeling of Elmiron® did not include
`
`any warning regarding ophthalmological side effects.
`
`96. Defendants’ fraudulent concealment of material facts regarding the safety of
`
`Elmiron®, coupled with its deceptive marketing, packaging, labeling, and representations,
`
`induced Plaintiff’s prescribing physician to prescribe Plaintiff Elmiron®, and induced
`
`
`
`19
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`

`

`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 20 of 34
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`Plaintiff to take the drug. Plaintiff would not have taken Elmiron® if the truth had been
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`disclosed to her regarding the safety (or lack thereof) of the drug.
`
`97.
`
`Plaintiff had a reasonable expectation that Elmiron® was safe to take as
`
`prescribed. Defendants should have reasonably anticipated and intended that Plaintiff
`
`purchased and took Elmiron®, in part, based upon such expectations and assumptions, and,
`
`indeed, Defendants intended her to do so.
`
`98. Defendants’ failure to disclose and omission of material facts regarding the
`
`safety risks inherent in Elmiron® occurred uniformly and consistently in connection with
`
`Defendants’ trade or business, was capable of deceiving and, indeed, did deceive a
`
`substantial portion of patients to a serious health risk.
`
`99. Defendants’ failure to disclose the health risks of Elmiron® had the direct
`
`result of concealing material facts from and breaching Defendants’ duty to disclose to
`
`Plaintiff.
`
`100. Beyond failing to disclose the aforementioned information, Defendants
`
`chose to actively conceal this material information regarding the health risks posed by
`
`Elmiron®.
`
`101. As a direct and proximate result of Defendants’ concealment and suppression
`
`of material facts regarding the safety (or lack thereof) of Elmiron®, Plaintiff has suffered
`
`and will continue to suffer actual damages.
`
`
`
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`
`
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`20
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`

`

`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 21 of 34
`
`COUNT II
`Negligence – Failure to Warn
`
`102. Plaintiff hereby realleges and incorporates by reference all allegations raised
`
`
`
`in the preceding paragraphs as if fully stated herein.
`
`103. At all times material hereto, Defendants designed and manufactured
`
`Elmiron®.
`
`104. Defendants had a duty to Plaintiff to design and manufacture a drug that was
`
`free of defects, which would not cause ophthalmological side effects, including pigmentary
`
`maculopathy and other significant eye and vision problems.
`
`105. Defendants had a duty to Plaintiff to test Elmiron® to ensure that patients,
`
`including Plaintiff, would not suffer ophthalmological side effects, and to ensure that the
`
`drug would not cause other significant eye and vision problems.
`
`106.
`
`In the event that such tests confirmed to Defendants that Elmiron® could and
`
`would cause ophthalmological side effects in patients, as is the case here, Defendants had
`
`a duty to Plaintiff to disclose this fact.
`
`107. Defendants had a duty to Plaintiff to ensure that Elmiron® complied with
`
`industry standards, testing, and safety guidelines.
`
`108. Defendants had a duty to Plaintiff, prescribing physicians, the medical
`
`community, and the general public to forewarn regarding the known risk of
`
`ophthalmological side effects.
`
`109. Defendants failed to exercise ordinary and reasonable care in the design of
`
`Elmiron® and the omission of any warning to patients that the drug it designed,
`21
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`
`
`

`

`Case 1:20-cv-23500-RNS Document 1 Entered on FLSD Docket 08/21/2020 Page 22 of 34
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`manufactured, marketed, sold, and continues to sell, contains a defect that would injure
`
`patients and cause ophthalmological side effects.
`
`110. Defendants failed to exercise ordinary and reasonable care in the design of
`
`Elmiron® an

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