Elmiron Lawsuit Update: Elmiron MDL Nears First Bellwether Trial
December 28, 2022
Author: Daniel Gala
Multidistrict litigation (MDL) over the bladder drug Elmiron has reached a crucial phase, with the first bellwether trial scheduled to commence on January 30, 2023, court documents show.
The massive federal MDL has centralized nearly 2,000 cases filed by plaintiffs alleging that they have suffered serious damage to their vision as a result of taking Elmiron, the brand name for the drug pentosan polysulfate sodium, or PPS.
The first bellwether case is slated to feature plaintiff Maria Windham, a Louisiana woman who claims that she developed “retinal pigmentary changes, including macular degeneration” only a couple of years after she started taking Elmiron in 2012, according to her lawsuit.
“As a result of the defective nature of Elmiron, persons who were prescribed and ingested Elmiron, including Plaintiff, have suffered and may continue to suffer severe and permanent personal injuries, including but not limited to pigmentary changes, vision changes, and potentially irreversible vision damage,” claims Windham’s lawsuit, originally filed in October 2020.
Elmiron typically is prescribed for the treatment of interstitial cystitis, a chronic condition of the bladder. However, the connection between Elmiron (PPS) and vision damage is so well established that the condition has a name: PPS maculopathy. Perhaps worst of all, for reasons that have yet to be explained, many patients’ vision continues to deteriorate even after they have stopped taking Elmiron.
The trial dates for the second and third Elmiron bellwether trials have not yet been scheduled, though the court instructed the parties to “continue to meet-and-confer” regarding the timelines for later cases.
During an MDL, bellwether trials are intended to test the merits of the plaintiffs’ claims in front of a live jury. A bellwether trial does not only resolve the case in question, the verdict and the amount of damages, if any, help inform settlement negotiations for the remaining cases.
If you or a loved one has suffered vision problems after taking Elmiron, contact TheLawFirm.com for a free consultation!
Sources:
United States District Court District of New Jersey. (1 November 2022). MDL Case Management Order No. 31. Case 2:20-md-02973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation.
United States Judicial Panel on Multidistrict Litigation (JPML). MDL Statistics Report – Distribution of Pending MDL Dockets by Actions Pending.
United States District Court District of New Jersey. (19 October 2020). Complaint and Demand for Jury Trial. Case 2:20-cv-14670.
Elmiron Lawsuit Update: Elmiron MDL Approaches 1800 Cases
October 24, 2022
Author: Daniel Gala
As multidistrict litigation (MDL) over the bladder drug Elmiron makes its way toward its first bellwether trial in early 2023, the fast-growing MDL is nearing 1,800 total cases, court records show.
Elmiron is the brand name for pentosan polysulfate sodium, also known as PPS. First approved by the US Food and Drug Administration (FDA) in 1996, Elmiron is used in the treatment of interstitial cystitis, or IC, an ailment the Mayo Clinic describes as “a chronic condition causing bladder pressure, bladder pain and sometimes pelvic pain.”
The Elmiron MDL has centralized federal lawsuits filed by plaintiffs alleging, based on a significant and ever-growing body of medical evidence, that Elmiron and generic PPS cause damage to the eyes’ retinas, resulting in irreversibly deteriorating vision. The symptoms of PPS maculopathy, as the condition is now known, include difficulty reading and a diminished ability for vision to adjust to low-light settings.
Most concerning, the symptoms of PPS maculopathy continue to progress even after patients have discontinued taking Elmiron or generic PPS. The mechanisms behind this troubling phenomenon are not yet well understood.
The parties to the Elmiron MDL presently are engaged in a lengthy but commonplace back-and-forth over expert witnesses, with opposition briefs on so-called Daubert motions due October 27, according to a case management order issued in September.
The MDL’s first bellwether trial presently is slated to commence January 30, 2023.
The Windham Case
The case selected as the first Elmiron bellwether is that of Maria Windham, a 68-year-old resident of Metairie, Louisiana who began taking Elmiron in 2012 and started to experience vision damage in September 2014. According to her original complaint filed in October 2020, Windham suffered from “retinal pigmentary changes, including macular degeneration.”
“Plaintiff has incurred and will continue to require and incur medical and related expenses in connection with these injuries, which were caused by Defendants’ ELMIRON, and their unlawful conduct with respect to ELMIRON’s design, manufacture, marketing, distribution, and sale,” Windham’s lawsuit alleges.
The named defendants in Windham’s case include Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, which also is named. Other defendants include generic drugmaker Teva Pharmaceuticals, as well as other Janssen and J&J affiliated entities.
If you or a loved one has experienced deteriorating vision after taking Elmiron, contact TheLawFirm.com today for a free legal consultation!
Sources:
United States Judicial Panel on Multidistrict Litigation (JPML). (14 October 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District.
Mayo Clinic. (Accessed 21 October 2022). Interstitial Cystitis.
United States District Court District of New Jersey. (27 September 2022). CMO 17 – Seconded Amended. Case No. 2:20-md-02973. MDL No. 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation.
Elmiron Lawsuit Update: Elmiron MDL Court Sets Pretrial Schedule for First Bellwether Trial
October 3, 2022
Author: Daniel Gala
On September 27, the presiding judge in multidistrict litigation (MDL) over allegations that the bladder drug Elmiron causes permanent eye damage issued an order outlining the pretrial schedule leading up the MDL’s first bellwether trial, which now is slated to begin January 30, 2023.
As of September 15, the Elmiron MDL had centralized 1,774 active cases, according to the Judicial Panel on Multidistrict Litigation (JPML). The lawsuits are based on a growing body of medical evidence showing that Elmiron—the brand name for pentosan polysulfate sodium, or PPS—causes damage to the eyes’ retinas, which results in diminished vision, including difficulty reading and adjusting to low-light settings. The condition—known as PPS maculopathy—does not appear to be reversable, and, more troubling still, patients’ vision continues to deteriorate even after they have stopped taking Elmiron.
The first bellwether case will be that of plaintiff Maria Windham, a Louisiana resident who began taking Elmiron in 2012 and started experiencing vision problems two years later. Under the recently released schedule, motions over expert witnesses and their responses are to be filed throughout October and November, with witness lists for both fact and expert witnesses due by December 2. Exhibit lists also are to be submitted by that date.
By January 6, 2023, the parties must file any objections to exhibit lists, and, by January 9, each party must file proposed jury instructions as well as its proposal for the jury selection process, including a questionnaire, if the proposed process will involve one. From January 9 through 13, the court will conduct hearings on motions in limine and deposition designations, and a pre-trial conference will be held the week of January 23. The first bellwether is scheduled to begin January 30.
In her lawsuit, the first bellwether plaintiff Windham alleges that the “Defendants intentionally made material misrepresentations to the FDA and the public in general, including the medical profession, and Plaintiff, regarding the safety of ELMIRON, specifically but not limited to ELMIRON being a safe means of treatment for the relief of bladder pain or discomfort associated with interstitial cystitis.”
The defendants in the Elmiron MDL include Janssen Pharmaceuticals, the maker of brand name Elmiron, and its parent company Johnson & Johnson, as well as generic drugmaker Teva Pharmaceuticals.
If you or a loved one has experienced deteriorating eyesight while taking Elmiron or generic PPS, contact TheLawFirm.com today for a free legal consultation!
Source:
United States District Court District of New Jersey. (27 September 2022). CMO 17 – Seconded Amended. Case No. 2:20-md-02973. MDL No. 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation.
Elmiron Lawsuit Update: Judge Cancels Case Management Conference in Elmiron MDL
September 7, 2022
Author: Daniel Gala
A case management conference previously scheduled to take place August 10 was abruptly cancelled. without explanation in multidistrict litigation (MDL) over the bladder drug Elmiron, and no further entries have been made to the case docket since, court records show.
The matters scheduled to be discussed at the case management conference included the parties’ proposed schedule for the events leading up to the MDL’s first bellwether trial and other discovery issues. However, on August 8, the conference was called off with just a text order entered directly into the docket, which stated only, “The Case Management Conference scheduled for Wednesday, August 8, 2022 is cancelled.” The order offered no further explanation or information as to when the conference might be rescheduled.
As of the end of the court day on Tuesday, September 6, the text order cancelling the status conference remained the last entry into the MDL’s docket, marking the longest stretch the court has gone in some time without a docket entry. Such long periods of activity are rare but not unheard of, with the court previously having gone from April 18 to May 9 without an entry earlier this year.
The Elmiron MDL centralized federal lawsuits filed by plaintiffs alleging that the bladder drug—which is used primarily in the treatment of interstitial cystitis—caused serious, permanent damage to their eyesight, including difficulty adjusting to lowlight settings and trouble reading. The condition is so closely associated with Elmiron (the brand name for pentosan polysulfate sodium, or PPS) that it has been labeled “PPS maculopathy” in the medical literature.
The Elmiron MDL has been growing at a rapid clip throughout the spring and summer, with the litigation including 1,740 active cases as of August 15.
If you or a loved one has experienced deteriorating vision after taking Elmiron or generic pentosan polysulfate sodium, contact TheLawFirm.com for a free legal consultation!
Sources:
United States District Court District of New Jersey. (8 August 2022). Civil Docket for Case #: 2-20-md-02973-BRM-ESK. Case No. 2-20-md-02973. MDL No. 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation.
United States Judicial Panel on Multidistrict Litigation (JPML). (6 September 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District.
Elmiron Lawsuit Update: Elmiron MDL Cases Surge, Topping 1700
August 2, 2022
Author: Daniel Gala
The number of active cases in multidistrict litigation (MDL) over the bladder drug Elmiron (pentosan polysulfate sodium) has surged by roughly 70% in the past two months, increasing from just over 1,000 in mid-May to more than 1,700 as of July 15, according to statistics from the Judicial Panel on Multidistrict Litigation (JPML).
Located in US District Court for the District of New Jersey, the MDL has centralized lawsuits filed by individuals alleging that taking Elmiron or generic pentosan polysulfate sodium has caused them to develop PPS maculopathy, a serious eye-condition that results in permanently diminished vision, including difficulty reading and problems adjusting to low-light settings.
Elmiron, the brand name for pentosan polysulfate sodium, or PPS, is used in the treatment of interstitial cystitis (IC), a bladder condition.
Defendants in the Elmiron MDL include the makers of brand-name Elmiron—Janssen and its parent company Johnson & Johnson—as well as makers of generic PPS such as Teva Pharmaceuticals.
Plaintiffs already have been selected for the first three bellwether trials, which currently are scheduled to begin in January, March, and May 2023.
In addition to the federal Elmiron MDL, dozens of cases have been filed at the state-court level, as well, with more than 100 such state actions currently in progress, according to an order issued by the MDL judge.
If you or a loved one has been diagnosed with PPS maculopathy or a similar condition after taking Elmiron or generic PPS, contact TheLawFirm.com for a free legal consultation!
Sources:
United States Judicial Panel on Multidistrict Litigation (JPML). (29 July 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District.
United States Judicial Panel on Multidistrict Litigation (JPML). (16 May 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District.
United States District Court District of New Jersey. (11 May 2022). CMO 17 – Amended. Case No. 2:20-md-02973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation. MDL No. 2973.
United States District Court District of New Jersey. (30 June 2022). MDL Case Management Order No. 29. Case No. 2:20-md-02973. MDL 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation.
Elmiron Lawsuit Update: Elmiron MDL Court Names Presumptive First Bellwether Case
June 15, 2022
Author: Daniel Gala
The court in multidistrict litigation (MDL) over the bladder drug Elmiron has named the presumptive first bellwether case, clearing the way for preparations to begin in earnest for the MDL’s first trial. The court also issued an amended case management order containing an updated trial schedule, which calls for the first bellwether to commence in January 2023.
The MDL has centralized more than 1,030 federal lawsuits alleging that Elmiron (Pentosan Polysulfate Sodium, or PPS) caused severe damage to the plaintiffs’ eyesight. For years, researchers have documented a strong causal connection between PPS and a condition known in the medical literature as PPS maculopathy, which is characterized by damage to the retinas that results in difficulty reading and a diminished ability to adjust the eyes to low-light settings. Since 1996, Elmiron has been approved by the US Food and Drug Administration (FDA) for the treatment of interstitial cystitis and bladder pain.
In a study published in the January 2020 issue of the journal Ophthalmology, Dr. Robin A. Vora, MD, and her colleagues identified 140 patients who over a 15-year period had each taken an average of 5,000 Elmiron pills. When contacted by researchers, 91 of those patients agreed to undergo an examination, and 22 (24%) showed clear evidence of PPS maculopathy.
“You have a patient with a chronic condition like interstitial cystitis, for which there is no cure and no effective treatment,” Dr. Vora explained.
“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.”
Despite all of the available evidence, including adverse incident reports, Janssen did nothing to warn doctors, patients, or regulators of the risk until June 2020, when the FDA advised that Elmiron’s warning label should be updated to include the risk of irreversible damage to one’s vision.
In a June 1 hearing order, United States District Judge Brian R. Martinotti named Maria Windham v. Janssen Pharmaceuticals as the presumptive first bellwether trial case. This case was selected for the bellwether pool by the defendants. Accordingly, a case selected by the plaintiffs will be either the MDL’s second or third bellwether trial, the order states. The defendants also will have the chance to select an additional case, meaning that two of the first three cases will have been cases selected by the defendants.
The Presumptive First Bellwether Trial Case
The presumptive first bellwether trial case was filed by plaintiff Maria Windham in October 2020. Windham, a resident of Metairie, Louisiana, started taking Elmiron in 2012 and began to experience “retinal pigmentary changes, including macular degeneration, in or about September 2014,” according to her lawsuit.
Windham alleges that the defendant drug companies failed to adequately warn about known risks related to Elmiron and generic PPS.
“Defendants intentionally made material misrepresentations to the FDA and the public in general, including the medical profession, and Plaintiff, regarding the safety of ELMIRON, specifically but not limited to ELMIRON being a safe means of treatment for the relief of bladder pain or discomfort associated with interstitial cystitis,” Windham’s lawsuits claims.
The Plaintiff-Selected Bellwether Trial Case
The case selected by plaintiffs to be among the first three bellwether trials was brought by husband-and-wife plaintiffs Julia Manning and Brian Manning, who filed their lawsuit in May 2021 after Julia suffered injuries to both of her eyes, allegedly from taking Elmiron.
“Plaintiff took Elmiron as prescribed by her physician from approximately 2008 through 2014,” the lawsuit says. “At all relevant times, Plaintiff was given no warning and had no knowledge of the serious risk of eye injury posed by Elmiron.”
In addition to Elmiron-seller Janssen and its parent company Johnson & Johnson, the Mannings also sued makers of generic pentosan polysulfate sodium, including Teva Pharmaceuticals.
Where Things Go From Here
An amended case management order issued May 11 outlines the pretrial schedule for the three bellwether cases. By June 30, defendants must serve expert reports for all three cases, with expert witness depositions and motions expected to last the remainder of the summer and into the fall. The first bellwether trial is slated to commence in January 2023, with the second to follow in March 2023, and the third in May 2023.
If you or a loved one has been diagnosed with macular degeneration after taking Elmiron, contact TheLawFirm.com for a free legal consultation!
Source:
United States District Court District of New Jersey. (1 June 2022). CMO 17 – Amended. Case No. 2:20-md-02973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation. MDL No. 2973
United States District Court District of New Jersey. (11 May 2022). CMO 17 – Amended. Case No. 2:20-md-02973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation. MDL No. 2973
United States Judicial Panel on Multidistrict Litigation (JPML). (16 May 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District.
Vora, Robin. (17 January 2020). Prevalence of maculopathy associate with long-term pentosan polysulfate therapy. Ophthalmology
United States District Court District of New Jersey. (19 October 2020). Complaint. Case No. 2:20-cv-14670. Maria Windham v. Janssen Pharmaceuticals et al
United States District Court District of New Jersey. (28 May 2021). Complaint. Case No. 2:21-cv-11942. Julia Manning and Brian Manning v. Teva Branded Pharmaceutical Products, et al
Elmiron Lawsuit Update: Three Bellwether Cases Selected in Elmiron MDL
June 1, 2022
Author: Daniel Gala
What once was 20 cases chosen as potential bellwethers has been whittled down to just three in multidistrict litigation (MDL) over the bladder drug Elmiron. Those cases will now undergo further discovery in preparation for the MDL’s first trial.
The MDL has centralized more than 800 federal lawsuits alleging that Elmiron has caused damage to the plaintiffs’ vision. Elmiron is the brand-name for pentosan polysulfate sodium, or PPS, which is used in the treatment of interstitial cystitis, a type of bladder pain syndrome. There is a well-documented connection between PPS and a type of maculopathy for which the symptoms include difficulty reading and adjusting to low light levels. This connection is so well established that the condition is known as PPS maculopathy in the medical literature. Tragically, the deteriorating vision caused by PPS maculopathy continues to worsen even after one has stopped taking Elmiron.
In a case management order issued May 25, the court provided an update on the status of the litigation. In addition to confirming that the bellwether cases had been narrowed down to just three, the order also announced that the parties had submitted their proposed schedules for “certain bellwether deadlines” and that the court “shall review the proposed order for entry.”
Further, the MDL’s oft-delayed Science Day—the day during which the parties educate the court on the scientific and technical aspects of the litigation—now is being held via “pre-recorded Science Day presentations, which shall be submitted to the Court.”
The order also stated that, as of May 11, there were a total of 933 products liability lawsuits involving Elmiron filed in the United States, including 823 federal cases and 110 state court cases, which are being conducted in coordination with the federal MDL.
“The parties shall continue to coordinate discovery and deadlines between the state court cases and the MDL, and shall report regarding status at the next case management conference,” the order signed by US District Judge Brian Martinotti said.
The next case management conference is scheduled for June 8.
If you suffered deteriorating vision after taking Elmiron, contact TheLawFirm.com for a free legal consultation!
Sources:
United States District Court District of New Jersey. (25 May 2022). Case Management Order No. 28. Case No. 2:20-md-02973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation. MDL No. 2973
Elmiron Lawsuit Update: Elmiron MDL Judge Delays Science Day and Cancels April Case Management Conference Amid Hectic Discovery Schedules
April 25, 2022
Author: Daniel Gala
So-called Science Day, a day when the parties educate the court on relevant technical and scientific matters, has been delayed yet again in multidistrict litigation (MDL) over the bladder drug Elmiron (Pentosan Polysulfate Sodium, or PPS). Additionally, with the parties deeply embroiled in discovery for prospective bellwether cases, a case management conference scheduled for April 13 was cancelled. https://ecf.njd.uscourts.gov/doc1/119118579724 Meanwhile, the parties sparred over the release of personnel documents for an employee of defendant Janssen.
As of April 15, the Elmiron MDL had centralized 899 active cases alleging, based on significant scientific evidence, that Elmiron risks causing serious damage to patient’s vision, a condition dubbed PPS Maculopathy. Elmiron typically is prescribed for the treatment of interstitial cystitis (IC), a type of bladder pain syndrome, but it has been found to damage the eyes’ retinas in ways that diminish patients’ ability to read or to adjust to low-light settings. Worse yet, for reasons not yet fully understood, the condition continues to worsen even after Elmiron use has stopped.
The April 13 case management conference was cancelled at the request of the parties, citing already overloaded schedules.
“As Your Honor is aware, the parties have been engaged in fact discovery for the twenty (20) bellwether discovery cases,” read a letter to the court submitted by the MDL defense liaison counsel. “That process has included not only depositions for each plaintiff and certain family members, but also nearly seventy (70) depositions of treaters and prescribers, as well as written discovery in the cases, on a compressed schedule.”
On April 5, the same day that the MDL court approved the parties’ request to cancel the April 13 conference, the court also issued a text order relating to a challenge by defendant Janssen to a decision by the MDL’s special master. On March 29, following an in-camera review, the court-appointed special master issued a recommendation that certain portions of the personnel file of a witness for and employee of defendant Janssen be released to plaintiffs. The portions of the personnel file that the special master found to be relevant to the case were those that specifically referenced the drug Elmiron.
However, despite that seemingly narrow ruling, Janssen shot back, writing the court to appeal the special master’s recommendation.
“Given the important privacy and policy interests at stake, courts in the Third Circuit and across the country have repeatedly recognized that personnel files should be protected from discovery, especially where, as here, all the potentially relevant information contained in the file has been produced from other sources,” asserts Janssen’s letter to the court challenging the special master’s conclusions.
Janssen’s letter prompted the court to issue its April 5 text order giving plaintiffs until April 18 to file a response, after which the defendants would have five days to file an additional response.
On April 11, plaintiffs rejected the defendants characterization, arguing that the special master had taken into the account the heightened level of scrutiny a personnel file warranted by conducting the in-camera review in the first place, and that “based on that review, [the special master] confirmed that the specific documents within Ms. Giacchi’s personnel file that he ordered disclosed met the heightened standard of relevance, and were unavailable from other sources, as required by case law in this Circuit and his earlier ruling.”
Finally, on April 18, defendant Janssen issued its response to plaintiffs’ response, reiterating that plaintiffs had not met the standard necessary for production of a personnel file, including by failing to demonstrate that the information requested was not available from any other source.
As of the close of business on Friday, April 22, the court had not yet issued its ruling on the matter.
If you or a loved one has been diagnosed with PPS Maculopathy or has suffered from deteriorating vision after taking Elmiron, contact TheLawFirm.com today for a free legal consultation!
Sources:
United States District Court District of New Jersey. (21 March 2022). MDL Case Management Order No. 27. Case No. 2:20-md-02973. MDL No. 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
United States Judicial Panel on Multidistrict Litigation (JPML). (15 April 2022). MDL Statistics Report – Distributions of Pending MDL Dockets by District
United States District Court District of New Jersey. (5 April 2022). Order granting Letter requesting that the 4/13/2022 Case Management Conference be cancelled
United States District Court District of New Jersey. (29 March 2022). Special Master Recommendation Regarding In Camera Review of Jenna Giacchi’s Personnel File. Case No. 2:20-md-02973. MDL 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
United States District Court District of New Jersey. (5 April 2022). Letter from Janssen to Magistrate Judge Edward S. Kiel Appealing Special Master March 29, 2022 Recommendation. Case No. 2:20-md-02973. MDL 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
United States District Court District of New Jersey. (5 April 2022). Docket. Case No. 2:20-md-02973. MDL 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
United States District Court District of New Jersey. (11 April 2022). Response. Case No. 2:20-md-02973. MDL 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
United States District Court District of New Jersey. (18 April 2022). Response. Case No. 2:20-md-02973. MDL 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
Elmiron Lawsuit Update: Elmiron MDL: Bellwether Fact Discovery Wraps Up as Case Selection Nears
March 14, 2022
Author: Daniel Gala
Mass tort litigation over allegations that the bladder drug Elmiron causes vision problems is nearing another milestone in the pretrial process, with bellwether fact discovery scheduled to conclude March 31 and bellwether selection slated to take place April 8, according to a recently issued case management order. These represent important steps as the multidistrict litigation (MDL) continues its march toward its first bellwether trial.
In another significant development, the MDL court also will conduct Science Day on March 25. Science Day is a non-adversarial proceeding that essentially functions as a one-day crash course during which the parties educate the court on the scientific evidence involved in the cases. As pandemic-related public-health measures are rolled back across the country, Science Day will be conducted via a combination of in-person and telephonic appearances.
Elmiron (pentosan polysulfate sodium) is prescribed primarily for the treatment of interstitial cystitis (IC). A form of bladder pain syndrome, IC causes symptoms such as pain during sexual intercourse and frequent urination. However, over the years, a growing body of scientific evidence has demonstrated a connection between Elmiron and damage to the eyes’ retinas, resulting in significantly diminished vision. PPS maculopathy—as it has come to be called—damages the eye in such a way as to decrease one’s ability to see in low-light settings and to make reading more difficult. Tragically, the condition appears irreversible and seems to worsen even after one has stopped taking Elmiron.
Originally formed in December 2020, as of February 15, 2022, the Elmiron MDL included a total of 736 total cases. Additionally, a further 81 cases were pending at the state-court level.
Unlike a class-action lawsuit, which includes many similarly situated plaintiffs within a single case, multidistrict litigation (MDL) centralizes many different cases—sometimes several thousand—for the purposes of conducted consolidated pretrial proceedings. This not only ensures greater consistency of rulings across many different cases, it also conserves judicial resources, as well as those of the parties.
In addition to centralized pretrial proceedings, an MDL court also will conduct bellwether trials, which are intended not only to resolve the individual case but also to act as a sort of test case that hopefully will inform settlement negotiations across the MDL’s other cases. In the event that a case involved in an MDL is not selected for a bellwether trial and does not settle before the MDL winds down, it will be sent back to its home district for further proceedings.
If you or a loved one has experienced deteriorating vision after taking Elmiron, contact TheLawFirm.com for a free legal consultation!
Sources:
United States District Court District of New Jersey. (7 March 2020). MDL Case Management Order No. 25. Case 2:20-md-02973. MDL 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
United States Judicial Panel on Multidistrict Litigation (JPML). (15 February 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District
Elmiron Lawsuit Update: What Is PPS Maculopathy, the Eye Condition Behind Elmiron Litigation?
February 16, 2022
Author: Daniel Gala
As of mid-February 2022, more than 730 active cases had joined multidistrict litigation over the bladder drug Elmiron, also known by its chemical name pentosan polysulfate sodium, or PPS. Originally approved by the US Food and Drug Administration (FDA) in 1996, Elmiron is prescribed, in the words of the original FDA approval letter, “for the relief of pain and discomfort associated with interstitial cystitis,” or IC, a type of bladder pain syndromeA. To date, Elmiron is the only FDA-approved oral treatment for IC.
However, over the years, a growing body of evidence has demonstrated a troubling connection between Elmiron and damage to the eyes’ retinas, specifically a part of the retina known as the macula, which can result in significantly diminished eyesight. The problem first came to light with a small study published in 2018 that followed six adult patients from May 2015 to October 2017, all of whom were taking Elmiron.
“We describe a novel and possibly avoidable maculopathy associated with chronic exposure to PPS,” the study’s authors concluded. “Patients reported symptoms of difficulty reading and prolonged dark adaptation despite generally intact visual acuity.”
Colleagues have attributed the original discovery of the connection between Elmiron exposure and this new eye condition to the insights of a single researcher.
“The discovery of pentosan toxicity was a very astute observation by one of our former fellows, Nieraj Jain,” Dr. Mark E. Pennesi, MD, PhD, of the Casey Eye Institute in Portland, Oregon told EyeNet Magazine for a piece published in March 2020. “Dr. Jain noticed a cluster of patients with a curious pattern dystrophy who also happened to be on pentosan polysulfate [Elmiron].”
As any good researcher would, Dr. Jain investigated the connection and discovered more patients who were both taking Elmiron and suffering from the same mysterious problems with their vision. One of the confounding aspects of the condition, according to Dr. Jain, was that patients could be experiencing relatively normal visual acuity as good as 20/20, and yet their eyesight would be diminishing due to other factors.
“[P]atients tend to suffer from significant subjective visual problems, such as trouble reading or adjusting to dim lighting, glare, and blind spots,” Dr. Jain told EyeNet Magazine, a publication of the American Academy of Ophthalmology. “In advanced stages, the condition can lead to profound disability with some patients meeting the criteria for legal blindness.”
What are the risk factors for PPS Maculopathy?
According to Dr. Jain, who is credited with originally identifying the correlation between Elmiron and the condition that would become known as PPS maculopathy or pentosan polysulfate maculopathy, the biggest risk factors involve the amount of exposure the patient had to Elmiron, namely, dosage and duration.
“Long-term exposure seems to have the strongest correlation so far,” according to Dr. Pennesi of the Casey Eye Institute. “This makes sense since most toxicities are related to dosage or duration.”
So how long does one need to be exposed to Elmiron before developing PPS maculopathy? Not as long as one might think, according to Dr. Jain, who has noted that the mean duration of Elmiron use among the subjects of his research was less than one year. In a retrospective study that examined reports of macular disease in those who had been taking Elmiron for seven years, Dr. Jain and his team found a strong correlation.
However, other factors do appear at play, as some patients have taken a large dosage of Elmiron for many years and reported only minimal symptoms while others have taken a smaller quantity of the drug for a much shorter period of time but have developed severe vision problems. As of now, however, researchers still are at a loss as to what those other factors might be, with Dr. Jain’s team having looked into correlations with other potential risk factors, including race, history of smoking, other medications, and problems with organs such as the spleen, liver, and kidney, but have yet to identify a connection.
If I stop taking Elmiron, will my vision recover?
Unfortunately, research does not indicate that patients’ vision will recover if they stop taking Elmiron when they start to experience PPS maculopathy.
“In fact, the majority of patients [who stopped taking Elmiron due to vision problems] reported that their visual symptoms continued to worsen,” Dr. Jain reported.
Researchers suspect that this could be due either to a “reservoir” of Elmiron being built up in the body over time, meaning that the exposure continues even after the patient has stopped taking Elmiron, or to a cascading cycle of cell damage and death that, once started, continues even without further Elmiron exposure.
What are my legal rights if I am suffering from maculopathy after taking Elmiron?
If you have been diagnosed with PPS maculopathy after having taken Elmiron, contact TheLawFirm.com for a free legal consultation. In order to determine whether or not you have a valid claim, you will need to have certain information available, such as the duration of your Elmiron exposure and the dosage, as well as the dates of any doctor visits and diagnoses.
Sources:
United States Judicial Panel on Multidistrict Litigation (JPML). (15 February 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District
United States Food and Drug Administration (FDA). (26 September 1996). Letter from Acting Director Paula Botstein, M.D. to Baker Norton Pharmaceuticals, Inc. re: Elmiron. Drugs@FDA
Jain, Nieraj et al. (Updated 21 December 2021). Pentosan Polysulfate Maculopathy. EyeWiki. American Academy of Ophthalmology
Pearce, William A. et al. (1 November 2018). Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium. Ophthalmology
Stuart, Annie. (March 2020). Pentosan Polysulfate Maculopathy: An Elusive Masquerader. EyeNet Magazine. American Academy of Ophthalmology
Elmiron Lawsuit Update: Elmiron MDL Court Issues Ground Rules For Depositions
January 25, 2022
Author: Daniel Gala
Multidistrict litigation (MDL) over allegations that the bladder drug Elmiron damaged the plaintiffs’ eyesight continues to make its way through the pretrial discovery process, with the court issuing on January 13 its ground rules for how the parties are to conduct depositions.
The Elmiron MDL is based on a well-established and still-growing body of medical evidence showing that Elmiron—the brand name for Pentosan Polysulfate Sodium, or PPS—can cause serious and lasting damage to the eye’s retina, resulting in significantly diminished vision. Specifically, those suffering from PPS maculopathy, as the condition is known, experience problems adjusting their vision to low-light settings as well as difficulty reading.
Elmiron is used in the treatment of interstitial cystitis (IC), a type of bladder pain syndrome (BPS) characterized by frequent urination and pain during sexual intercourse.
One of the issues facing the parties and the court in establishing the Elmiron MDL’s deposition protocol was whether depositions would be held remotely or in-person in light of the ongoing COVID-19 pandemic. The court’s order calls for all depositions to be held in-person by default but allows for depositions to be conducted remotely for witnesses “unwilling to participate in in-person depositions for their own personal health reasons.”
In terms of costs associated with the taking of depositions, the order calls for the party noticing the deposition to pay for the deposition to be recorded by a stenographer and videotaped, but the parties must bear their own costs for transcripts and videotaped copies of the deposition. When the deponent is a physician, the noticing party again must pay that individual for his or her time.
However, when it comes to the location of in-person depositions, it is the responsibility of the defending party to secure an appropriate venue—which must contain a deposition room, a separate breakout room, and ample space to allow for adequate social distancing—and the defending party must bear the costs associated with its chosen venue.
As of January 19, the Elmiron MDL included a total of 714 cases, according to the Judicial Panel on Multidistrict Litigation (JPML), an increase of nearly 90 cases since mid-November.
Sources:
United States District Court District of New Jersey. (13 January 2022). Case Management Order #22 (Deposition Protocol). Case No. 2:20-md-02973. MDL No. 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Litigation
United States Judicial Panel on Multidistrict Litigation (JPML). (19 January 2022). MDL Statistics Report – Distribution of Pending MDL Dockets by District
United States Judicial Panel on Multidistrict Litigation (JPML). (15 November 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by District
Elmiron Lawsuit Update: Elmiron MDL Passes 600 Cases
December 2, 2021
Author: Daniel Gala
Multidistrict litigation (MDL) over the bladder drug Elmiron continues to grow, passing 600 cases as of mid-November, court records show. Additionally, several dozen cases also have been filed in state courts across the country.
The litigation arises from allegations that Elmiron (pentosan polysulfate sodium)—commonly used in the treatment of interstitial cystitis (IC)—can cause serious damage to the eye’s retina, thereby resulting in diminished vision.
As of November 15, the federal Elmiron MDL contained a total of 628 total cases, according to the Judicial Panel on Multidistrict Litigation (JPML). Additionally, the MDL court reported that there were 77 Elmiron state court actions as of November 10.
The MDL is early in the discovery phase, with a December 1 case management order instructing the parties to continue to meet over discovery issues related to the defendants Janssen and Teva. The first three bellwether trials remain more than a year off at least, having been scheduled to take place in the first half of 2023.
A growing body of medical research has documented that exposure to Elmiron—the brand name for pentosan polysulfate sodium, or PPS—can cause serious damage to the retinas. The connection between PPS and damaged retinas is so well established that the resulting condition is named for the drug believed to cause it: PPS maculopathy. The symptoms of PPS maculopathy include difficulty reading and a reduced ability to adjust to low-light settings.
Though more than a full calendar year remains before the scheduled start date of the first bellwether trial, the Elmiron MDL is expected to continue to grow in the meantime, perhaps into the thousands of cases.
Sources:
United States District Court District of New Jersey. (1 December 2021). Case Management Order No. 20 (Bellwether Selection and Scheduling Order). Case 2:20-md-02973. MDL 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
United States Judicial Panel on Multidistrict Litigation (JPML). MDL Statistics Report – Distribution of Pending MDL Dockets by District
United States District Court District of New Jersey. (6 October 2021). Case Management Order No. 17 (Bellwether Selection and Scheduling Order). Case 2:20-md-02973. MDL 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
Elmiron Lawsuit Update: Elmiron MDL dates set
October 22, 2021
Author: Daniel Gala
The first three bellwether trials in multidistrict litigation (MDL) over the bladder drug Elmiron will take place in the first half of 2023, according to a court order issued October 6.
The case management order signed by US District Judge Brian R. Martinotti for the District of New Jersey lays out a detailed schedule for the selection of bellwether cases, pretrial discovery, and the commencement of the trials themselves. The order calls for the first bellwether trial to begin sometime in January 2023, for the second bellwether to follow in March, and for the third to be held in May of that year.
While such schedules are highly susceptible to change—particularly with even the first trial date well over a year away—the order does provide a rough guideline for when participants to and observers of the litigation can expect the first trials to take place. And, while the trial dates might be postponed for any number of reasons, it is a near certainty that the trial dates will not be moved up any earlier than the dates stated in the order.
Elmiron is the brand name for pentosan polysulfate sodium, or PPS, which is typically prescribed for the treatment of interstitial cystitis (IC), a chronic—and oftentimes painful—bladder condition.
The Elmiron MDL stems from medical research showing that patients taking Elmiron (PPS) have suffered serious damage to their eyes’ retinas, resulting in diminished vision. The condition has been so well documented in the medical literature that it has acquired its own name: PPS maculopathy, a condition characterized by difficulty reading and a diminished ability of the eyes to adjust to low-light environments.
As of October 15, the Elmiron MDL contained a total of 580 active cases, nearly double the figure from just two months prior.
What Cases Are Eligible To Be Selected As Bellwethers?
The October 6 order also lists three criteria that a case within the MDL must satisfy in order to be eligible for selection as a potential bellwether. First, the plaintiff must have “ingested Elmiron” and “provided proof of prescription on or before November 7, 2021”. Second, the plaintiff must have “developed pigmentary maculopathy and/or exacerbation of [an] underlying retinal disorder subsequent to Elmiron use”. Finally, the plaintiff must have properly submitted a plaintiff fact sheet (PFS) on or before September 24, 2021.
Sources:
United States District Court District of New Jersey. (6 October 2021). Case Management Order No. 17 (Bellwether Selection and Scheduling Order). Case 2:20-md-02973. MDL 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
United States Judicial Panel on Multidistrict Litigation (JPML). (15 October 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by District
United States District Court District of New Jersey. (11 August 2021). Amended MDL Case Management Order No. 12. MDL No. 2973. Case No. 2:20-md-02973-BRM-ESK. In Re: Elmiron(Pentosan Polysulfate Sodium) Products Liability Litigation
Elmiron Lawsuit Update: Fast-Growing Elmiron MDL Passes 500 Cases
September 20, 2021
Author: Daniel Gala
Multidistrict litigation (MDL) over the bladder drug Elmiron (pentosan polysulfate sodium / PPS) has passed 500 active cases and continues to grow, court data shows.
According to the Judicial Panel on Multidistrict Litigation (JPML), the Elmiron MDL included a total of 527 cases as of September 15. With the court having reported a total of recorded 310 cases as of August 11, the updated figures show an increase of over 200 cases, or 70%, in just five weeks.
As of September 16, a further 58 Elmiron lawsuits had been filed at the state court level, as well.
The fast-growing litigation is based on medical research showing that Elmiron—a bladder medication used in the treatment of interstitial cystitis, or IC—can cause serious damage to the retinas, resulting in deteriorating vision. Specifically, those suffering from so-called PPS maculopathy report difficulty reading as well as a diminished ability to adjust to low-light settings.
Defendants in the case include Janssen Pharmaceuticals, its parent company Johnson & Johnson, as well as generic drugmaker Teva Pharmaceuticals. Also named are Alza Corporation, Centocor Research & Development, and Ortho-McNeil Pharmaceuticals.
Established in December 2020, the Elmiron MDL is making its way through the early stages of pretrial proceedings. According to a September 16 case management order, the parties continue to meet and confer on a number of matters, including “bellwether and trial process issues” as well as defendants’ “discovery items, deposition issues, and document production.”
That the parties still are hashing out such fundamental matters reveals how early in the process the MDL remains. Additionally, the proceedings continue to be affected by the ongoing COVID pandemic, with the court also announcing that the MDL’s “Science Day” will be conducted virtually. In multidistrict litigation, Science Day is when the parties present their scientific evidence to the court in order to educate the judge on the scientific principles underlying the matters at issue. The event is scheduled for September 30.
If you have suffered from deteriorating vision after taken Elmiron or generic PPS, contact TheLawFirm.com for a free legal consultation!
Sources:
United States Judicial Panel on Multidistrict Litigation. (15 September 2021). MDL Statistics Report – Distribution of Pending MDL Dockets by District
United States District Court District of New Jersey. (11 August 2021). Amended MDL Case Management Order No. 12. MDL No. 2973. Case No. 2:20-md-02973-BRM-ESK. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
United States District Court District of New Jersey. (16 September 2021). Amended MDL Case Management Order No. 16. MDL No. 2973. Case No. 2:20-md-02973-BRM-ESK. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
Elmiron Lawsuit Update: Elmiron MDL: Parties Meet and Confer Re: Bellwether Cases and Trials
August 16, 2021
Author: Daniel Gala
As multidistrict litigation (MDL) over the bladder drug Elmiron continues to grow in the District of New Jersey, the parties have been meeting and conferring regarding potential bellwether cases and trials, court records show.
As of an August 11 case management order, however, no bellwether cases had been selected or trial dates established.
The relatively young Elmiron MDL was established in December 2020 to centralize federal lawsuits involving claims that the bladder medication—typically used in the treatment of interstitial cystitis, or IC—can cause damage to the eye’s retinas, resulting in impaired vision.
Elmiron is the brand name for pentosan polysulfate sodium, also known by its acronym PPS. Deteriorating eyesight caused by Elmiron / PPS has become prevalent enough to garner its own name in the medical literature: PPS maculopathy. The condition is characterized by difficulty reading as well as a reduced ability of the eyes to adjust to low-light environments.
As of August 11, the Elmiron MDL included 310 federal cases, with an additional 51 Elmiron-based claims having been filed in state courts in New Jersey and Pennsylvania, according to the case management order . A case management conference also was held August 11.
Defendants in the case include Janssen Pharmaceuticals, its parent company Johnson & Johnson, as well as generic drugmaker Teva Pharmaceuticals. Also named are Alza Corporation, Centocor Research & Development, and Ortho-McNeil Pharmaceuticals.
For their part, the defendants deny any wrongdoing, arguing that the plaintiffs lack an adequate factual and legal basis for filing their claims and, additionally, that the plaintiffs’ claims are preempted by what the defendants say is their full compliance with applicable regulations.
Among other claims, plaintiffs have accused defendants of failing to warn patients about what plaintiffs argue was the known risk of PPS maculopathy associated with Elmiron / PPS. As pharmaceutical companies have argued in other cases, the Elmiron MDL defendants also have asserted that their hands were tied with regards to unilaterally altering the drugs’ warning labels.
“Plaintiffs’ claims are pre-empted by the manufacturer’s compliance with applicable governmental regulations and requirements and industry standards and further because the manufacturer was prohibited from changing its label,” defendant Teva Pharmaceutical asserted in its answer to the plaintiffs’ complaint, filed June 15.
Sources:
United States District Court District of New Jersey. (11 August 2021). Amended MDL Case Management Order No. 12. MDL No. 2973. Case No. 2:20-md-02973-BRM-ESK. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
United States District Court District of New Jersey. (15 June 2021). Master Answer of Defendant Teva Branded Pharmaceuticals R&D, Inc. to Plaintiff’s Complaints. MDL No. 2973. Case No. 2:20-md-02973-BRM-ESK. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
Elmiron Lawsuit Update: Elmiron MDL Passes 300 Cases; Court Schedules ‘Science Day’
July 20, 2021
Author: Daniel Gala
In a pair of case management orders issued July 16, the court presiding over multidistrict litigation (MDL) involving the bladder drug Elmiron took significant steps toward moving along the fast-growing legal action, establishing a number of dates and deadlines for important pretrial proceedings.
Meanwhile, the MDL—brought by plaintiffs alleging that Elmiron caused serious damage to their retinas, resulting in diminished eyesight—continues to add dozens of cases by the week, reaching 310 as of July 7, according to court documents. An additional 51 Elmiron lawsuits have been filed in New Jersey and Pennsylvania state court.
Elmiron is the brand name for pentosan polysulfate sodium (PPS), a prescription medication approved by the US FDA to alleviate bladder pain associated with interstitial cystitis, also known as IC. However, at least as early as 2018, researchers began to identify a correlation between patients taking Elmiron and damage to their eyes’ retinas. The condition became so widely recognized that it got its own name in the medical literature: PPS maculopathy.
The symptoms of PPS maculopathy include difficulty reading and the inability for the eyes to adapt to low-light settings. The condition often goes undetected by traditional testing techniques, meaning that there is a high likelihood that it has been significantly underdiagnosed.
As awareness of the connection between Elmiron and damaged eyesight grows, the number of lawsuits is expected to grow, as well.
In the meantime, the relatively young Elmiron MDL proceeds apace, with the court establishing in one of the July 16 orders a “Science Day” at which the parties will present to the court in a non-adversarial manner certain science-related factual matters at the core of the plaintiffs’ claims. These topics include basic facts about both Elmiron and IC, as well as the injuries alleged and the tools used to diagnose them. Science Day is to be held September 30, 2021.
The other July 16 case management order provided an update on the status of the litigation, including several discovery matters on which the court reported that the parties will continue to meet and confer. Additionally, that order set the date for the MDL’s next case management conference for August 11.
Sources:
United States District Court District of New Jersey. (16 July 2021). Case Management Order No. 13 (Science Day). MDL No. 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation. Case No. 2:20-md-02973
United States District Court District of New Jersey. (16 July 2021). Case Management Order No. 12. MDL No. 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation. Case No. 2:20-md-02973
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Elmiron Lawsuit Update: Elmiron MDL Continues to Grow as Parties Confer on Deadlines, Procedures
June 22, 2021
Author: Daniel Gala
Multidistrict litigation (MDL) over the bladder drug Elmiron continues to add cases by the week, reaching 237 cases as of June 9, according to court documents. Meanwhile, the parties continue to meet and confer over numerous items including discovery deadlines, a case management order issued June 22 reported.
Formed in December 2020, the relatively new MDL has centralized federal lawsuits alleging that Elmiron, the brand name for pentosan polysulfate sodium (PPS), caused damage to the plaintiffs’ retinas. Elmiron is approved for the alleviation of pain and discomfort in the bladder, particularly that associated with interstitial cystitis (IC).
The June 22 case management order provided an update on the status of the litigation, revealing how early in pretrial proceedings the MDL is. For instance, the parties have yet to set up a process by which they will select the first bellwether cases, or to establish a discovery schedule.
However, the litigation continues to make progress and continues to add cases. In addition to the 237 federal MDL cases, 43 cases have been filed in the state courts of New Jersey and Pennsylvania, bringing the total number of Elmiron cases in the United States to 280, according to the June 22 order.
The defendants in the case include Janssen Research & Development, LLC—formerly known as Johnson & Johnson Pharmaceuticals Research & Development—along with Johnson & Johnson itself and generic drugmaker Teva Pharmaceuticals.
The connection between Elmiron / PPS and damage to the retinas of the human eye first was identified in a 2018 study published in the journal Ophthalmology. The study involved six adult patients who had received PPS following a diagnosis of IC. Though the sample size was small, the results were disturbing enough to generate concern.
“We describe a novel and possibly avoidable maculopathy associated with chronic exposure to PPS,” the study concluded. “Patients reported symptoms of difficulty reading and prolonged dark adaptation despite generally intact visual acuity.”
In the medical literature, this has become known as “PPS maculopathy,” and further research has supported the findings of the initial study. However, one of the difficulties in identifying PPS maculopathy both as a condition in its own right and as a diagnosis in individual patients is that the visual problems identified by sufferers are not easily captured on traditional visual acuity tests.
“Individuals with pentosan polysulfate sodium (PPS) maculopathy commonly report symptoms of prolonged dark adaptation and difficulty reading,” wrote the authors of a 2020 study on the subject. “We hypothesize that PPS maculopathy causes degradation of the visual function not fully captured with visual acuity testing.”
Despite these limitations, that study did identify significant structural problems resulting in a loss of visual acuity.
“Eyes with advanced disease based on retinal structure had significantly worse retinal function for several testing modalities,” reported the authors of the 2020 study.
The United States Food and Drug Administration (FDA) now requires Elmiron’s drug label to include a warning about retina damage.
“Although most of these cases [of PPS maculopathy] occurred after 3 years of use or longer, cases have been seen with a shorter duration of use,” the FDA warning reads in part. “Visual symptoms in the reported cases included difficulty reading, slow adjustment to low reduced light environments, and blurred vision.”
Given that both the science and the litigation remain in their relative infancy, the number of cases involved in the Elmiron MDL is expected to continue to grow.
The next case management conference is scheduled for July 7.
If you have experienced deteriorating vision after being prescribed Elmiron, contact TheLawFirm.com today for a free legal consultation!
Sources:
United States District Court District of New Jersey. (22 June 2021). MDL Case Management Order No. 11. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation. Case No. 2:20-md-02973. MDL No. 2973
Pearce, William A. et al. Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium. Ophthalmology. (November 2018)
Lyons, Riley et al. (2 November 2020). Visual Function in Pentosan Polysulfate Sodium Maculopathy. Investigative Ophthalmology & Visual Science
United States Food and Drug Administration (FDA). (16 June 2020). Elmiron – 100 MG (Pentosan Polysulfate Sodium) Capsules Prescribing Information
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Elmiron Lawsuit Update: Elmiron MDL Judge Sets Discovery Rules, Dates in Pair of Orders
May 26, 2021
Author: Daniel Gala
On May 13 and 20, the judge presiding over multidistrict litigation (MDL) involving the drug Elmiron issued a pair of case management orders establishing discovery rules and other guidelines aimed at pushing the litigation further toward the as-yet-unscheduled first bellwether trials.
As of mid-May, the Elmiron MDL includes roughly 200 federal products liability lawsuits filed by plaintiffs alleging that taking Elmiron—the brand name for pentosan polysulfate sodium (PPS)—caused them to experience damage to their retinas, resulting in diminished vision. Elmiron is prescribed to alleviate bladder pain and discomfort, specifically that associated with interstitial cystitis (IC).
In the May 13 order, US District Judge Brian Martinotti established a discovery plan aimed at streamlining the pretrial discovery process by limiting case-specific discovery to the standardized forms known as the Plaintiff Fact Sheet and Defendant Fact Sheet. This requirement will stand until further order of the court.
Similarly, Judge Martinotti limited the scope of general discovery, as well, allowing only general discovery issued by the attorneys previously named as Plaintiffs' Co-Leads, until further notice.
While these orders limit the ability of individual plaintiffs to pursue discovery on their own, at least for the time being, they are aimed at making the immense amount of discovery necessary in complex litigation such as the Elmiron MDL more manageable on the parties and the court.
The pretrial process was further moved along by the May 20 order, which provided an update on the status of the growing litigation, established additional guidelines, and scheduled several important dates.
According to a status update provided by Judge Martinotti, as of May 12, 2021, a total of 225 combined state and federal products liability lawsuits had been filed relating to Elmiron.
The May 20 order instructs the parties to continue to meet and confer on discovery issues. It also schedules a court "Science Day" for September 21 and the next case management conference for June 9.
The number of state and federal Elmiron cases is expected to continue to grow in the aftermath of a landmark 2018 study that revealed a connection between exposure to Elmiron/PPS and damage to the retina.
"Patients reported symptoms of difficulty reading and prolonged dark adaptation despite generally intact visual acuity," the 2018 study found.
Though the Elmiron MDL continues to make progress, complex litigation can last years, even decades, so this MDL is still in its relative infancy. With parties still focused exclusively on discovery issues by direction of the court, it will be some time before bellwether cases are selected and even longer before bellwether trials are scheduled.
Sources:
United States District Court District of New Jersey. (13 May 2021). Case Management Order No. 9 (Preliminary Discovery Plan, Procedures & Schedule). Case No. 2:20-md-02973. MDL No. 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
United States District Court District of New Jersey. (20 May 2021). Case Management Order No. 10. Case No. 2:20-md-02973. MDL No. 2973. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation
Pearce, William A. et al. Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium. Ophthalmology. (November 2018)
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Elmiron Lawsuit Update
May 11, 2021
Author: Daniel Gala
Elmiron MDL Court Allows Direct Filing as Cases Exceed 200
As multidistrict litigation (MDL) over the drug Elmiron continues to get underway in the District of New Jersey, the court has issued several orders that will streamline the filing of additional cases, including an order allowing plaintiffs to file their lawsuits directly with the MDL court, rather than filing their claim with a separate court first. Together, the orders should accelerate the growth of the nascent litigation, which recently surpassed 200 total cases, according to court documents.
In an order dated April 26, 2021, US District Judge Brian R. Martinotti wrote that, in order to "eliminate delays associated with transfer of cases filed in or removed from other federal district courts to this Court, and to promote judicial efficiency, any plaintiff whose case would be subject to transfer to MDL No. 2973 may file his or her case directly into MDL No. 2973 by filing in the District of New Jersey pursuant to this order."
By allowing direct filing—a standard move in multidistrict litigation—the court will make it faster and easier for new plaintiffs and their attorneys to file lawsuits that will become part of the MDL. As of May 10, the Elmiron MDL has 223 cases, court records show.
In a subsequent order issued May 5, the court initiated another important development with the release of the MDL's plaintiff and defendant fact sheets. These standardized forms allow plaintiffs and defendants to submit relevant facts to the court and opposing party in an organized, streamlined way.
The fact sheets also give a key glimpse of the evidence at issue in the fast-growing Elmiron litigation, with questions on the plaintiff fact sheet asking for information about the duration and dosage of Elmiron use, and whether or not the plaintiff ever was warned of any side effects related to taken Elmiron.
Elmiron is the brand name for pentosan polysulfate sodium (PPS), a drug used to alleviate bladder pain and discomfort, especially that caused by interstitial cystitis, also known as IC.
However, a landmark study published in 2018 revealed a connection between exposure to PPS and damage to the retina, resulting in vision problems.
"Patients reported symptoms of difficulty reading and prolonged dark adaptation despite generally intact visual acuity," the 2018 study said.
Elmiron now is forced to carry a warning regarding the potential for damage to the retina.
"Visual symptoms that have been reported include: difficulty reading, slow adjustment to low or reduced light environments, and blurred vision," the official Elmiron website warns.
With the Elmiron MDL only having been established in December 2020, the litigation still is in its very early stages. However, these recent developments are laying important foundations for later proceedings and are likely to accelerate the filing of new cases.
Stay tuned to TheLawFirm.com for the latest developments in Elmiron litigation, and if you have developed vision problems after being prescribed Elmiron for an extended period of time, contact TheLawFirm.com for a free legal consultation!
Sources:
United States District Court District of New Jersey. (Accessed 10 May 2021). Member Cases. Civil Docket For Case #: 2:20-md-02973-BRM-ESK. Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation. MDL No. 2973
United States District Court District of New Jersey. (26 April 2021). Amended Case Management Order No. # 6 (Direct Filing — Stipulated). In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation. Case No. 2:20-md-02973 (BRM)(ESK). MDL No. 2973
United States District Court District of New Jersey. (5 May 2021). Amended Case Management Order No. # 8 (Plaintiff Fact Sheets and Defendants' Fact Sheets. In Re: Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation. Case No. 2:20-md-02973 (BRM)(ESK). MDL No. 2973
Pearce, William A. et al. Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium. Ophthalmology. (November 2018).
Janssen Pharmaceuticals, Inc. (2020). Elmiron (pentosan polysulfate sodium) Official Website
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Legal Disclaimer: The information in this article is not intended to be used as medical information or diagnosis. The sources of the information presented in the article have been researched and are linked within the article. Please seek out medical advice from a licensed medical professional if you are experiencing a problem with any of the drugs or devices mentioned in this article.
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