Elmiron® Lawsuit

Elmiron® has been linked to serious side effects such as eye/vision damage. 

Elmiron® linked to serious eye damage

The use of the drug Elmiron® has been linked to serious eye damage. If you have ever taken prescription Elmiron® (aka. pentosan polysulfate sodium, or PPS), you are at risk of developing a unique form of progressive eye disease. This eye damage can be (mis)diagnosed by ophthalmologists as retinal pigmentary maculopathy, pattern dystrophy, or age-related macular degeneration.

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Some of the common symptoms for patients experiencing this Elmiron® associated eye damage are:

• Blurred vision (often in the patient's central field of vision)
• Difficulty reading
• Dark spots in center of vision
• Straight lines that appear curved
• Muted, less vivid colors and
• Difficulty adapting to dim lighting

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This disease is so similar in appearance to ‘ordinary’ macular degeneration that many Elmiron® patients may not even know they have this macular disorder, and instead just assume their vision is degrading. However, if you have taken Elmiron and have problems in both eyes, you may have the unique retinal injury caused by Elmiron®. In fact, a significant percentage of Elmiron® users in several studies showed Elmiron® associated retinal maculopathy and pigmentary damage. These patients had significant damage to their retina and they reported significant eye and vision problems as a result.

What is most alarming about Elmiron eye damage is that eye damage in patients can develop even after the patient has stopped taking Elmiron®. Often when a prescription drug is found to be causing a side effect, discontinuing use can reverse, or at least stop, the progression of that side effect. But in the case of Elmiron® that may not be true. It is highly recommended that if you ever took Elmiron®, you should see an ophthalmologist and have your eyes examined on a regular and on-going basis.

If you are experiencing any of the aforementioned side effects after using Elmiron, contact TheLawFirm.com today for a Free Consultation. You may be entitled to financial compensation.

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Do you qualify for a Elmiron® lawsuit?

It is important to make sure that your ophthalmologist is aware of the current developments surrounding Elmiron. Seeing an ophthalmologist regularly will allow you to establish a baseline of the health of your retinas. This will allow you to monitor any progression of eye disease that may occur later on. This will be important for your eye health as well as to establish evidence in a lawsuit, should you choose to file one. Such a lawsuit will likely allege that Janssen Pharmaceuticals® (the maker of Elmiron®) failed to properly warn patients of known eye related injury risks. TheLawFirm.com is currently accepting cases nationally from all 50 states. Call us for a free consultation and we will help you determine if you are eligible to pursue financial compensation. It is important to act quickly because each State has a statute of limitations and the time window for pursuing a case is getting shorter each day. Our law firm works strictly on a contingency basis. This means that clients we represent only pay out of their recovery if they win their case.

Source

pubmed.ncbi.nlm.nih.gov

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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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Do you qualify for a Elmiron® lawsuit?

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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.