Is There A Lawsuit Against Elmiron?
Yes. Hundreds of former users of the bladder drug are pursuing Elmiron class action lawsuits and individual injury claims against Johnson & Johnson and Jannsen Pharmaceuticals, over failure to warn about serious risks of losing eyesight.
The litigation emerged after a number of independent studies identified that users may be left with permanent eye damage from Elmiron, known as pigmentary maculopathy. However, the first information about a risk of retina disease was not added to the Elmiron FDA warning label until June 2020.
Reports have found that 20% of long-term users of Elmiron experience pigmentary maculopathy. It is a serious and dangerous side effect, involving a degenerative eye disease that causes progressive central vision loss and blindness.
Elmiron side effects
As a result of the failure to adequately warn about the Elmiron vision loss risks, lawsuits are being reviewed for individuals diagnosed with pigmentary maculopathy, macular degeneration or other retinal disease. These Elmiron side effects may cause types of vision impairment including:
- Blurry Vision
- Loss of Night Vision
- Distorted Vision
- Difficulty Reading
- Trouble Driving
- Dark Spots
- Central Vision Loss
- Depth Perception Problems
- Prolonged Adaption to Dim Light
Although there is mounting evidence that suggests the Elmiron vision risks were known by the drug makers for years before warnings were provided, Johnson & Johnson and its Janssen Pharmaceuticals subsidiary have refused to offer fair and reasonable Elmiron settlements for eye problems suffered by long-time users of their drug.
Johnson & Johnson and Janssen are global pharmaceutical companies, which have billions of dollars in resources that can be devoted to defending one of their top medications.
Our Elmiron injury attorneys can help you level the playing field!
June 2021 Elmiron Lawsuit Status Update:
All federal Elmiron eye injury lawsuits brought throughout the United States are centralized before U.S. District Judge Brian R. Martinotti, as part of a Multidistrict Litigation (MDL). As of summer 2021:
- More than 200 cases have been filed and Elmiron lawyers are investigating hundreds of additional claims for users nationwide. It is expected that several thousand eye damage lawsuits will ultimately be included in the Elmiron MDL;
- There have been no recalls of Elmiron, but new warnings about the risk of retinal injury were added in June 2020. Lawsuits allege that if earlier information had been provided, permanent eye damage from Elmiron could have been avoided;
- The first Elmiron jury trials are expected to begin in January 2023, which will serve as a “bellwether” or test case to determine how juries are likely to respond to certain evidence and testimony that will be repeated in claims filed throughout the U.S.
- The drug makers are currently refusing to offer individual Elmiron settlements, but our lawyers expect this will change as more trial dates are scheduled.
Free, no-obligation case evaluations are available to anyone concerned, and no fees or expenses are owed unless a recovery is obtained.
Allegations Raised in Elmiron Class Action Lawsuits
Many individuals who took Elmiron and experienced eye problems may have suffered needlessly for years. According to allegations raised in the litigation, drug manufacturers have:
- Failed to properly research the Elmiron retina side effects before introducing the drug;
- Failed to promptly follow up and investigate reports of macular degeneration, pigmentary maculopathy and other retina damage among Elmiron users;
- Withheld critical Elmiron warnings and information from consumers and the medical community;
- Knew or should have known that monitoring for signs of Elmiron vision changes with regular examinations may help users avoid serious eye problems;
- Failed to promptly issue an Elmiron recall or updated safety warnings as it became clear that long-term users face a high risk of vision loss, blindness and other eye problems;
Elmiron maculopathy may be misdiagnosed as other eye diseases
For decades, false and misleading information was provided to Elmiron users, urologists prescribing the bladder drug and ophthalmologists consulted after vision problems developed.
Due to the drug makers’ decision to withhold safety information from consumers and the medical community, many users who experienced symptoms of Elmiron vision loss were misdiagnosed with other eye diseases, such as
- Age-Related Macular Degeneration (AMD)
- Pattern Dystrophy
- Stargardt disease
- other Genetic Retina Deterioration
As a result of the failure to warn, users continued to take the drug, suffering further toxic side effects of Elmiron on their eyesight.
Our lawyers can help determine if you or a loved one may be entitled to an Elmiron lawsuit settlement. There are never any attorney fees or expenses unless a recovery is obtained!
Are there any costs to have an Elmiron attorney review my case?
There are absolutely no out-of-pocket costs to review your case or hire our Elmiron attorneys. Potential claims are evaluated for individuals throughout the United States, and all cases are handled on a contingency fee basis. Through the use of contingency attorney fees, individuals have access to the experience and resources of our national law firm for their Elmiron lawsuit settlement — regardless of their individual financial resources.
You pay nothing up front to hire our Elmiron vision loss lawyers, and we only receive an attorney fee or expenses out of the money that is obtained from the drug makers. Our law firm receives nothing unless we win your case!
When will I find out if I have an eligible case against Elmiron?
After requesting a free case evaluation, our lawyers are often able to determine whether we can move forward with your Elmiron case following a short initial consultation. However, in some circumstances it is necessary that additional details be obtained before we can confirm that a case is eligible.
If you decide to hire our law firm, you will be asked to sign a contingency fee agreement with our Elmiron attorneys, which confirms that there are no out-of-pocket costs associated with pursuing a case and that our lawyers are only paid if we are successful obtaining a recovery in your case.
Steps in an Elmiron vision loss case evaluation
Complete Our Case Evaluation Request Form. Providing contact information and some information about your elmiron vision loss case.
Get Contacted by Saiontz & Kirk, P.A. You will be contacted by our Elmiron law firm to help determine if financial compensation may be available for you and your family.
You Decide If You Want to Move Forward. If our lawyers determine that we can help with your Elmiron case then you decide whether to move forward and hire our us to pursue compensation.
After speaking with our Elmiron law firm to review what options may be available, it remains your decision whether to form an attorney-client relationship and pursue a claim against Elmiron.
As part of the Elmiron lawsuit evaluation, we will review the facts and circumstances surrounding your use of the drug, and any resulting eye damage and/or vision problems that you have experienced, to help determine whether you may have a successful case. If you decide to move forward with the full investigation of your claim, a medical authorization must be signed so that we can obtain records confirming the pigmentary maculopathy diagnosis or other retina damage that may have resulted from Elmiron exposure.
Throughout the process, you will have an opportunity to speak with our Elmiron attorneys to review any and all questions or concerns you may have.
Status of Elmiron Settlement Negotiations
Johnson & Johnson and Janssen Pharmaceuticals are currently refusing to negotiate fair and reasonable Elmiron settlements for individuals left with eye damage. However, based on the strength of the evidence and clear indication that the drug makers placed the desire profits before consumers safety, our Elmiron lawyers maintain that each individual client should receive substantial compensation and benefits, including:
- Coverage for Medical Expenses and Vision Treatments
- Compensation for Pain and Suffering
- Past and Future Lost Wages or Earning Capacity
- Other Benefits for Retina Damage Caused by Elmiron
How much money may I receive for an Elmiron vision loss settlement?
Ultimately, the amount of any out-of-court settlement paid for an Elmiron pigmentary maculopathy lawsuit will be based on the amount of damages a jury may award if that case goes to trial. Therefore, the money received by each client for settling their case will take into account the strength of the underlying evidence linking the bladder drug to each individual’s eye problems, as well as the impact that the Elmiron vision side effects have on their life.
The following are some of the common factors that a jury will consider at trial, which will influence the value of an Elmiron case during negotiations:
- The extent and duration of the retinal injuries from Elmiron;
- The effect that Elmiron maculopathy had on the overall physical and mental health or well-being of the patient;
- The pain and mental anguish suffered in the past and which will likely be suffered in the future as a result of Elmiron vision loss;
- The amount of any past or future medical expenses caused by Elmiron use, as well as lost income due to an inability to work as a result of the the eye damage;
Following settlement negotiations, each individual client will have the option to decide whether to accept the offer and settle their Elmiron case, or proceed through the court system.
How long will it take to settle my Elmiron case?
At this time, there are no global or mass Elmiron settlements being offered. Therefore, our lawyer can not predict how long it will take before each individual case resolves.
In the federal court system, a series of early test trials are expected to begin in early 2023, which may have a big influence on Elmiron settlement negotiations. While the outcome of these “bellwether” trials will not have a binding effect on other claims, they will provide information about how juries are likely to respond to certain evidence and testimony that will be repeated throughout the claims.
After the Elmiron warning label was updated in June 2020, it appears unlikely that the drug maker will consider settling cases for at least a few years. While the Elmiron statute of limitations for filing a case varies from state-to-state, and specific factors influence the deadline for each individual claim, Johnson & Johnson and Janssen Pharmaceuticals may start entering settlement negotiations after they have a better understanding about the total number of cases they will face.
While it will likely take several years to settle Elmiron vision loss claims, it is important that individuals who experienced eye damage take immediate steps to contact a lawyer and protect their legal interests. Every day you wait to review a case may result in insufficient time to properly investigate and document your claim!
To help determine the settlement amount that you or a loved one may be eligible to receive, request a no-obligation claim review.
Other Elmiron Lawyer Frequently Asked Questions
What is Elmiron?
Introduced by Janssen Pharmaceuticals in 1996, Elmiron (pentosan polysulfate sodium or PPS) is a prescription medication for individuals suffering from “interstitial cystitis” (IC), which involves severe bladder pressure, bladder pain and sometimes pelvic pain. Impacting more than one million people throughout the United States, “IC” is part of a spectrum of diseases known as “painful bladder syndrome” and is most common among women.
While it was sold as a safe and effective drug for bladder and pelvic pain caused by IC, growing research suggests that there is a link between side effects of Elmiron and macular degeneration, or other eye disease that results in irreversible retina damage, vision loss and blindness.
If earlier warnings and information had been provided about the potential risk of Elmiron eye damage, many individuals may have avoided these serious and life-changing vision problems, which may continue to worsen for years after last use of the interstitial cystitis drug.
How does Elmiron work?
Interstitial cystitis (IC) is often mistaken for a urinary tract infection (UTI), but is a chronic condition that has no known cure. As a result, most Elmiron users remain on the medication for years, if not decades.
The active pharmaceutical ingredient in Elmiron, pentosan polysulfate sodium or PPS, is a heparin-like compound that has anticoagulant and fibrinolytic effects. The exact mechanism of action for Elmiron treating interstitial cystitis is not known, even to the drug makers.
While the medication has been marketed as safe and effective, without adequate warnings that Elmiron may cause eye problems, users throughout the United States have been diagnosed with atypical retinal maculopathy and other eye disease that researchers have found is linked to long-term exposure.
Although there were more than a dozen published reports and papers involving vision problems or maculopathy from Elmiron side effects, the drug makers did not provide any information for users and doctors in the United States until June 2020, after thousands of long-term users had already been left with irreversible vision loss and retina damage.
How do you confirm Elmiron caused retina damage?
After discovering the link between Elmiron and retinal pigmentary changes, researchers are continuing to examine the risk and study the mechanism of action that allows Elmiron to cause eye damage.
Pigmentary maculopathy from Elmiron is a unique form of damage to the macula in the eye, which provides central vision. This retinal injury is typically diagnosed by an ophthalmologist, following multimodal imaging eye exam.
This optical testing involves the use of multiple different types of imaging scans conducted at the same time. By correlating the different types of information those imaging scans produce, eye doctors can get a clearer picture of what is occurring.
In February 2021, researchers with Northwestern University published a study that identified a “signature” for Elmiron maculopathy, involving a “distinct clinical constellation” of retinal damage caused by Elmiron.
Subsequent findings by researchers at the Stein Eye Institute at the University of California, Los Angeles indicate that 1-in-5 ling term users of Elmiron have evidence of the unique retina damage.
An ophthalmologist can easily diagnose this Elmiron eye injury through multimodal imaging scans that include fundus photography, fundus autofluorescence and ocular coherence tomography imaging all at once.
To learn more about how to get eye exams and speak with our Elmiron lawyers about the type of vision testing that may help diagnose whether you or a loved one are suffering from retina damage, request a free consultation.
History of Studies Linking Elmiron and Eye Damage
A retrospective case series was published in the medical journal Opthalmology, describing six Elmiron vision loss cases involving atypical maculpathy associated with long-term use.
Users were evaluated between May 2015 and October 2017, with ages ranging from 37 to 62 years old, and the length of Elmiron exposure ranging between 12 and 20 years. Primary symptoms included difficulty reading and prolonged dark adaption, with examinations revealing retinal pigmentary maculopathy.
Letter to the editor was published in The Journal of Urology, responding to a report published in the July 2018.
Researchers with the Emory University School of Medicine, Department of Ophthalmology wrote to alert readers to concerning new observations involving vision threatening retinal changes associated with Elmiron long-term exposure. Authors recommended any patient with Elmiron vision symptoms undergo comprehensive ophthalmic exams.
Findings were presented at the Annual Meeting of the American Urological Association in Chicago from a study involving 10 patients with vision threatening retinal degradation who had been treated for interstitial cytisis with Elmiron.
Researchers described a “unique form of pigmentary maculopathy”, and indicated that similar problems were not seen among 156 other patients treated for the same bladder condition who were not using Elmiron.
In a study published by the medical journal JAMA Ophthalmology, Canadian researchers described an eye condition as “pentosan polysulfate sodium (PPS)-associated maculopathy” or Elmiron maculopathy.
Researchers reviewed medical records of 35 long-term Elmiron users who exhibited characteristics of maculopathy, including women between the ages of 37 and 79 years old, who had received the drug between 3 years and 22 years. Leading symptoms of Elmiron vision problems included metamorphopsia, blurred vision and prolonged adjustment to dark light.
Health Canada announced an Eliron warning update that added information about the risk of pigmentary maculopathy reported among long-term users.
Updated warnings recommended that long-term Elmiron users have regular ophthalmic eye examinations for early detection of the retinal problems, and suggested that doctors should consider stopping treatment among users diagnosed with pigmentary maculopathy.
October 12, 2019
A new study was presented at the 2019 Annual Meeting of the American Academy of Ophthalmology, indicating that about 25% of patients with significant exposure to Elmiron shows retinal damage signals.
Three California ophthalmologists reviewed records from a database involving millions of patients, and found 140 patients who had taken an average of 4,000 Elmiron pills over a period of 15 years. 91 of the 140 patients agreed to come in for an eye exam, and about one-quarter (22) showed clear signs of drug toxicity. In the late stages, the retina toxicity can mimic age-related macular degeneration (AMD) and result in permanent vision loss.
November 6, 2019
A retrospective analysis of data from a large U.S. medical claims database was published by the British Journal of Ophthalmology, indicating that at a 7 year analysis, Elmiron users had significantly increased odds of having atypical maculopathy or a new diagnosis of macular disease.
Case report published by Harvard researchers in Ophthalmic Surgery, Lasers and Imaging Retina described a case of Elmiron maculopathy that continued to worsen over six years after stopping use of the drug.
The researchers indicated that after using 200mg of Elmiron for 18 years, a 62 year old woman stopped taking the drug after developing vision problems. However, over the next six years, she continued to suffer increasing vision damage.
In the American Journal of Ophthalmology Case Reports, researchers with Kaiser Permanente described a case of eye problems from Elmiron misdiagnosed as Stargardt disease, which is a genetic form of retina deterioration.
A 41 year old woman sought a second opinion after suffering darkening vision, progressive difficulty reading and loss of night vision. Genetic testing was negative and the woman was diagnosed with PPS maculopathy from Elmiron, highlighting the importance of doctors considering medications of those with retinal damage.
Researchers with the Emory School of Medicine published findings in the medical journal JAMA Ophthalmology, finding that users diagnosed with Elmiron maculopathy continued to experience worsening vision even 10 years after they stopped taking the drug.
Strong evidence of a cause-effect relationship between Elmiron and vision problems was outlined in a study published in the medical journal Retina, finding that those with the highest rates of exposure were twice as likely to report experiencing symptoms.
Study published in the medical journal Clinical Opthalmology identified a distinct signature of Elmiron-associated maculopathy, which can be detected through multimodal imaging by an ophthalmologist.
Researchers at University of California, Los Angeles published a study in the Canadian Journal of Opthalmology, finding that 20% (1 out of 5) long-term users had evidence of Elmiron retina damage.
Find Out If You or a Loved One Qualify for an Elmiron Settlement
The product liability lawyers at Saiontz & Kirk, P.A. provide free consultations and case evaluations to help individuals review the legal options that are available to them. After contacting our office toll free at 1-800-522-0102 or requesting a free case review on-line, the facts and circumstances surrounding your potential Elmiron lawsuit will be reviewed and evaluated by our lawyers.
If it is determined that you or a loved one may be eligible for financial compensation or a settlement, it is your decision whether to hire our law firm. All lawsuits are handled by our Elmiron attorneys under a contingency fee agreement, which means that there are never any fees or expenses paid unless we are successful in obtaining a settlement or other recovery in your case.
Start our two-minute survey to find out if you qualify for a settlement!