Elmiron Lawsuit Lawyer

Update: Elmiron Lawsuits Could Head to Trial in Early 2024

A lawsuit filed by Elmiron patients who allegedly developed potentially permanent vision damage, retinal damage, blurred vision, and eye disease could head to trial in January 2024, according to recent court documents.

Judge Brian R. Martinotti is currently overseeing about 240 federal Elmiron lawsuits in New Jersey.

In a Case Management Order issued on May 13, 2021, Martinotti directed lawyers to continue with general discovery and to present the Court with a plan to select medical device cases that will undergo additional discovery before trial.

“The Court contemplates that the first bellwether trial in this MDL will be held in or about January 2024, with subsequent clinical trials to follow,” Martinotti said in the order.

What are Elmiron Lawsuits Alleging?

Lawyers allege that the Elmiron drug maker did not include a warning about pigmentary maculopathy or any other form of eye disease / retinal damage.

Elmiron Side Effects

Elmiron (pentosan polysulfate sodium) has been linked to severe side effects such as retinal conditions, often progressing silently until significant damage occurs.

Understanding the timeline of vision loss, early symptoms, and essential medical evidence can help patients and healthcare providers detect and address issues early.

How Vision Damage Progresses Over Time

Elmiron’s impact on vision often develops gradually, making regular monitoring crucial:

• First Signs: Vision-related symptoms may start to appear as early as three years into treatment.
• Average Duration: Many affected individuals have used Elmiron for approximately 14.5 years, with symptoms intensifying over time.
• Post-Use Effects: Even after discontinuation, vision issues can persist for one to nine years, suggesting permanent retinal damage in some cases.

Warning Signs to Watch For

Patients using Elmiron should be alert to these early signs of potential retinal damage:

• Blurry Vision: Trouble focusing, especially on text or small objects.
• Difficulty in Low Light: Reduced ability to see clearly in dim or dark environments.
• Visual Distortions: Straight lines appearing curved or wavy (metamorphopsia).
• Color Changes: A noticeable decline in color perception or differentiation.
• Eye Discomfort: Persistent pain or irritation in the eyes, which should be promptly reported.

Additional Health Risks Linked to Elmiron

In addition to its impact on vision, Elmiron is associated with several other health risks:

Eye Conditions:

• Retinal damage, pigmentary maculopathy, and permanent retinal pigment epithelium (RPE) injury.
• Symptoms like blurred vision, metamorphopsia, and night blindness.

Other Complications:

• Gastrointestinal Issues: Nausea, diarrhea, reflux, and bloody stools.
• Skin and Hair Problems: Hair loss (alopecia), skin rashes, and bruising.
• Neurological Symptoms: Sleep disorders, dizziness, and headaches.
• Liver and Urinary Issues: Liver complications and persistent urinary tract infections.

Essential Medical Documentation for Claims

Patients filing claims for Elmiron-related eye damage should ensure they have the following medical evidence:

• Comprehensive Eye Exam Reports: Detailed assessments from an ophthalmologist, including visual acuity and retinal health evaluations.
• Optical Coherence Tomography (OCT): High-resolution images of the retina to detect structural damage indicative of maculopathy.
• Autofluorescence Imaging: Results showing alterations in retinal pigment, critical inproving Elmiron-related damage.
• Medication Usage Records: Documentation of Elmiron dosage, duration, and any symptoms reported over time.

Being aware of the timeline and symptoms of Elmiron-related vision damage empowers patients to seek timely medical intervention and strengthens their claims for compensation.

Regular eye exams, proactive communication with healthcare providers, and thorough documentation can make a significant difference in treatment and legal outcomes.

100+ Reports of Eye Damage in Elmiron Users: FDA Warning

At least 100 complaints involving “eye disorders” in patients treated with Elmiron were filed with the FDA Adverse Event Reporting System (FAERS) from 1997 to 2019. Eighty of the reports were classified as serious, and 22 listed maculopathy as the specific condition.

How Can Elmiron Cause Maculopathy?

There is substantial evidence from the medical literature that at least 6 months of the prescription medication Elmiron causes about 25% of users to develop pigmentary maculopathy. Macular injury can cause blurred vision, permanent vision loss, and total blindness.

In more mild cases, it can cause difficulty reading and other vision impairments. Studies have found that Elmiron causes maculopathy as a result of drug toxicity.

Maculopathy Symptoms

The eye disorder called maculopathy is a painless disease characterized by progressive loss of central vision that impairs eye function, according to MedicineNet. The condition may occur in patients who do not notice any eye problems, since a healthy eye may compensate for Elmiron vision loss in the other.

When symptoms do present, they include:

• Difficulty reading
• Prolonged dark adaptation
• Image distortion, or metamorphopsia, is where objects appear deformed or smaller than they are.

Anyone with these symptoms after being prescribed Elmiron should make an appointment with a vision care specialist.

Risk Factors

Factors that may increase your risk of macular degeneration include:

• Taking Elmiron
• Being 50 or older
• Having myopia
• Having one eye that has previously been affected by the disease
• Having other risk factors identified by a routine ophthalmologic exam

What is Interstitial Cystitis?

Interstitial cystitis is a chronic bladder condition that causes a range of bladder pressure, bladder pain, and pelvic pain.

The condition is part of a spectrum of diseases known as painful bladder syndrome.

The bladder is a hollow, muscular organ that stores urine. The organ expands until it’s full and then signals the brain through the pelvic nerves that it’s time to urinate.

This creates the urge to urinate for most people.

In patients with IC medical records, these signals get mixed up — you feel the need to urinate more often and with smaller volumes of urine than most people. IC most often affects women and can have a long-lasting impact on their quality of life.

Does Elmiron Cure IC?

Elmiron is not a cure for interstitial cystitis patients’ medical records. The drug helps to treat the symptoms of overactive bladder syndrome by preventing irritation and swelling of the walls of the bladder. Elmiron is thought to function as a synthetic mucus layer around the bladder to guard against irritation.

A lawyer will argue that the drug is not an efficacious treatment for IC. They point to studies suggesting that Elmiron performs no better than a placebo for some IC complications. If this is true, it underscores that the full risk of Elmiron is not worth the potential benefit.

Either way, the case comes down to whether side effects require a warning based on the available information that communicated the risk of vision problems.

Currently, palliative treatments may lessen or relieve some of the symptoms associated with bladder pain syndrome, but chronic exposure to medications alone will not eliminate the disorder.

Often, an IC patient may need to undergo several different therapies before identifying a combination that provides noticeable relief. For roughly half of all IC patients, symptoms may eventually go away naturally.

Valarie Hull: The First Elmiron Lawsuit and Its Impact

Valarie Hull, often referred to as “Patient Zero,” was the first person to file a lawsuit against Janssen Pharmaceuticals due to severe eye problems linked to long-term Elmiron use. Her case has become a landmark in exposing the risks of this medication and advocating for patient safety.

Timeline of Valarie Hull’s Symptoms and Diagnosis

• 2001: Hull begins taking Elmiron to treat interstitial cystitis.
• 2010: Subtle vision issues emerge, including difficulty reading and blurred vision.
• 2015: Vision problems escalate; Hull experiences significant night vision loss and changes in eye pigment.
• 2017: Seeking help from an ophthalmologist, Hull is referred to Dr. Nieraj Jain at Emory Eye Center due to worsening symptoms.
• 2018: Dr. Jain diagnoses Hull with pigmentary maculopathy and includes her case in a study linking Elmiron to retinal damage, drawing significant attention to the drug’s risks.
• September 2018: Hull files a lawsuit against Janssen Pharmaceuticals, accusing the company of negligence and failing to warn patients about the potential for vision-related side effects.

Medical Evidence Supporting Hull’s Case

• Initial Examination: Hull’s ophthalmologist conducts a comprehensive eye exam, identifying signs of retinal damage.
• Specialist Testing: At Emory Eye Center, she undergoes advanced tests, including Optical Coherence Tomography (OCT) and visual field assessments, confirming severe retinal damage.
• Legal Documentation: Hull’s legal team compiles her medical history, test results, and treatment records to strengthen her case.

Legal Progression and Case Details

Settlement and Compensation

As of January 2025, Hull’s settlement details remain undisclosed. However, MDL settlements

for similar cases have ranged from $100,000 to several million dollars, based on the severity of injuries. Potential compensation may cover medical costs, emotional suffering, diminished quality of life, and punitive damages for negligence.

Broader Impact of Hull’s Case

The complaint is Hull vs. Janssen Pharmaceuticals Inc., et al., Case No. MIDL003646-20 [2].

Bladder Medication Linked to Eye Damage: AAO Study

A 2018 study published by the American Academy of Ophthalmology (AAO) [3] described the cases of 6 female patients that took Elmiron for IC who had been diagnosed with retinal maculopathy, also known as pigmentary maculopathy or retinal pigmentary endothelium injury (RPE).

The American Academy of Ophthalmology report found Elmiron linked to problems with the retina, a thin layer of tissue at the back of the eye whose purpose is to convert light into neural signals which are then sent to the brain for visual recognition.

Kaiser Study Reveals Danger of Long-Term Elmiron Use

The AAO study led researchers at Kaiser Oakland to examine its database for Elmiron patients who had been prescribed Elmiron for painful bladder and had also suffered from eye damage.

The researchers found 140 patients in the system who had taken an average of 5,000 Elmiron pills each over 15 years.

Of the 140 patients, 91 agreed to undergo an eye exam during which researchers took detailed images of the backs of their eyes.

Twenty-two of the 91 participants had clear symptoms of eye disease or Elmiron toxicity.

The rate of toxicity rose with the dosage of Elmiron taken, from 11% of those taking 500 to 1,000 grams to 42% of those taking 1,500 grams or more.

The findings indicated that about 25% of patients who’d taken large doses of Elmiron had signs of eye damage and that complications caused by the drug could be mistaken for other retinal conditions, such as age-related macular degeneration or vision damage.

“It’s unfortunate,” said Dr. Robin Vora, lead author of the study. “You have a patient with a chronic condition like interstitial cystitis, for which there is no cure and no effective treatment. They get put on these medications because it’s thought to have few side effects and few risks, and no one thinks about it again. And year after year, the number of pills they’re taking goes up and up.”

Has Elmiron Been Recalled?

Janssen Pharmaceuticals has not issued a recall for Elmiron, and rheumatologists and urologists continue to prescribe it to unsuspecting patients across the U.S., despite the drug being linked to hundreds of reports of serious vision problems.

Is There an Alternative to Elmiron?

Expert-Recommended Tips to Protect and Enhance Your Vision

Can I File a Class Action Lawsuit?

Although Schmidt & Clark is a nationally recognized class action firm, our lawyers have decided against this type of litigation when it comes to Elmiron.

Our attorneys feel that if there is a successful resolution to these cases, individual suits, not class actions will be the best way to get the maximum likelihood of successful Elmiron lawsuit criteria.

We file each lawsuit separately; however, most of the cases will eventually be consolidated into multidistrict litigation (MDL), which will expedite the negotiation and settlement amounts.

Plaintiffs can include anyone who developed maculopathy, interstitial cystitis (IC), macular degeneration, or other eye damage after taking Elmiron. The Elmiron multidistrict litigation is:

• In re Elmiron (pentosan polysulfate sodium) Products Liability Litigation; MDL 2973 [5]

If you’ve suffered vision problems after taking Elmiron, we know you’ve suffered emotionally and economically, and want to work with you personally to obtain the maximum compensation settlement for the damages caused by your injuries.

Have There Been Any Elmiron Lawsuit Settlement Cases?

As of January 2025, no finalized settlements have been announced in Elmiron lawsuits. However, attorneys are actively pursuing significant compensation for plaintiffs who suffered vision damage linked to the drug. Below is an outline of factors influencing settlements, necessary documentation for claims, and expected timelines for resolution.

Factors Influencing Settlement Amounts

1. Severity of Vision Damage: Greater impairment, such as near-total vision loss or severe retinal damage, typically results in higher compensation.
2. Duration of Drug Use: Prolonged Elmiron use is often associated with more severe damage, strengthening claims.
3. Economic Impact: Plaintiffs may seek compensation for lost wages and diminished earning potential caused by their condition.
4. Medical Costs: Settlements factor in past and future expenses related to vision treatments and rehabilitation.
5. Emotional and Psychological Harm: Non-economic damages, including emotional distress and reduced quality of life, play a significant role in settlement determinations.

Required Documentation for Claims

Plaintiffs need comprehensive evidence to support their claims, tailored to the degree of impairment:

Severe Impairment (80%-100%): Potential settlement range $750,000–$1,000,000

• Full medical history and diagnostic results, including OCT scans and visual field tests.
• Documentation of lost earnings and future economic impact.
• Records of ongoing medical treatment and related expenses.

Significant Impairment (40%-80%): Potential settlement range $350,000–$700,000

• Detailed medical records of vision loss and treatment.
• Evidence of medical costs and partial loss of income.
• Records indicating reduced daily functionality or work performance.

Moderate Impairment (20%-40%): Potential settlement range $75,000–$200,000

• Proof of moderate vision impairment and relevant treatments.
• Documentation of symptoms affecting work or routine activities.
• Minimal evidence of economic or lifestyle disruptions.

Mild Impairment (<20%): Potential settlement range $25,000–$50,000

• Basic confirmation of diagnosis and medical consultations.
• Records of minor treatments with little disruption to life or work.

Settlement Timeline

• Initial Filings: Lawsuits began in 2020, with increasing momentum as more evidence of Elmiron’s risks emerged.
• Bellwether Trials: These initial cases are expected to set benchmarks for future settlements. Originally slated for March 2023, delays have pushed their timelines forward.
• Settlement Negotiations: Settlement discussions are expected to gain traction following the conclusion of bellwether trials.
• Projected Resolution: Experts anticipate a global settlement to be finalized by late 2023 or early 2024, contingent on the outcomes of initial trials.

Elmiron lawsuits represent a significant legal effort to hold manufacturers accountable for alleged vision damage caused by the drug. Settlements are expected to reflect the severity of injuries and the financial impact on affected individuals.

By compiling thorough documentation and consulting with legal professionals, plaintiffs can strengthen their claims and pursue the compensation they deserve.

How Long Do I Have to File a Claim?

The statute of limitations to file an Elmiron Lawsuit is short. In most states, it is only a year or two. This is why you should contact an attorney immediately if you suffer vision problems after taking Elmiron.

FAQs

1. How Do I Prove That Elmiron Caused My Vision Problems?

To prove that Elmiron caused your vision problems, you will need to provide evidence of your Elmiron usage and medical records documenting your diagnosis of an eye condition linked to the drug. Expert testimony from medical professionals who can connect your condition to Elmiron may also be necessary.

2. Do I Need a Lawyer To File an Elmiron Lawsuit?

While it is not mandatory to have a lawyer to file an Elmiron lawsuit, having an experienced attorney can significantly increase your chances of a successful outcome. A qualified Elmiron lawsuit lawyer can help navigate the complex legal process, gather necessary evidence, represent your interests in negotiations or court, and work to secure the maximum compensation for your case.

3. What Evidence Is Needed To Support an Elmiron Lawsuit?

To support an Elmiron lawsuit, you need evidence of Elmiron usage, medical records showing vision problems or a diagnosis linked to the drug, and expert testimony connecting your condition to Elmiron.

Get a Free Elmiron Lawsuit Evaluation With Our Lawyers

The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Elmiron lawsuits. We are handling individual litigation nationwide and currently accepting new Elmiron lawsuits in all 50 states.

Again, if you or a loved one suffered eye damage after taking Elmiron, you should contact our law firm immediately. You may be entitled to compensation by filing an Elmiron lawsuit and our lawyer can help.