The American Academy of Ophthalmology in a 2018 study, made the connection between Elmiron use and vision problems. The study was done on six patients who had used Elmiron for a long time, revealing similar damage to their vision.  

The link between Elmiron and vision damage has led to a lawsuit where patients are holding Janssen Pharmaceuticals accountable for negligently failing to warn of the potential harm their bladder medication causes to vision. 

You may qualify to join an Elmiron lawsuit if you or a loved one has taken Elmiron for interstitial cystitis or related bladder pain and developed serious side effects that caused eye damage. 

Elmiron Overview 

Elmiron (pentosan polysulfate sodium) is an oral medication approved by the FDA for the treatment of interstitial cystitis. Interstitial cystitis is a chronic condition that causes bladder pressure and pain. More than 12 million suffer from the condition in the US, with the majority being women. 

Elmiron works as a mild anticoagulant thus helping in the management of the pain and discomfort from IC. Elmiron is currently the only FDA-approved oral drug for the treatment of IC-related bladder pain and discomfort. 

IC is a chronic condition usually accompanied by pain in the bladder. The disease does not have a cure; therefore, patients have to manage their condition for the rest of their lives. 

Some of the symptoms accompanying IC include:

  • Constant urine urgency throughout the day
  • Waking several times at night to urinate
  • A burning sensation
  • Frequent urination
  • Pain that only reduces when you empty the bladder
  • Pain or discomfort during or after intercourse

Researchers believe that Elmiron works by creating a barrier between the bladder and urine, thus preventing irritants in the urine from reaching the bladder walls. Manufacturers tested the effectiveness of Elmiron through two clinical trials with 2627 participants, a majority being women. The results of the second trial indicated that most patients experienced pain relief after several months of treatment. However, another smaller study by G.R. Sant found that oral PPS did not provide significant benefits to most IC patients.   

IC is a condition that affects more than 12 million people in the U.S. alone, and since its introduction, Elmiron has been the standard medication for IC. Considering that a patient needs three capsules per day, Elmiron is estimated to generate annual revenue of at least $150 million in the US alone. 

The manufacturer has marketed Elmiron as a safe medication for managing the pain and discomfort arising from IC. For years since its introduction, the company indicated that Elmiron expressly indicated that Elmiron had no warnings leading physicians to recommend the drug as a relatively safe medication with few significant side effects. 

Later on, the manufacturer added some vision-related problems related to the medication, including conjunctivitis, amblyopia, retinal hemorrhage, and optic neuritis with potential side effects affecting less than 1% of the users. 

The Studies

Doctors from the Emory Eye Center noticed that six of its patients developed damage to their macula without a known source. The common thing about these patients was their long-term use of Elmiron. All six patients were diagnosed with pigmentary maculopathy, a condition causing severe vision problems and could result in permanent vision loss. The doctors at the Emory Eye Center published these results suggesting the link between the eye problem and the use of Elmiron.  

In 2019, doctors from the Emory Eye Center conducted a case study with ten patients with pigmentary maculopathy due to the long-term use of Elmiron. The study published in The Journal of Urology indicated the dosage and duration for these patients. The study further added that another 156 patients suffering from IC (who did not use Elmiron) did not show any signs of pigmentary maculopathy. 

Additional studies from researchers at Kaiser Permanente found a higher level of toxicity in patients who took Elmiron for longer.

These studies prompted the American Academy of Ophthalmology to conduct a deeper study into the correlation between pigmentary maculopathy and Elmiron use. The research indicated clear signs of toxicity from patients using Elmiron with 25% of these patients showing signs of serious eye damage and maculopathy. Another follow-up study in January 2020 supported earlier results that Elmiron led to the development of toxic maculopathy. The study also showed that if caught early and Elmiron use ceased, the retinal damage may cease. Prolonged use of the medication could result in permanent blindness. 

Elmiron Lawsuits

The growing body of research linking vision problems to Elmiron toxicity has increased since 2018, and prompted the current litigation. The first lawsuit against Janssen was filed in 2020, and since then, people who suffered damages from taking the drug are joining. Most of the plaintiffs are mostly women aged between 37 and 79 years. 

Plaintiffs in the Elmiron lawsuit are primarily claiming that the manufacturer, Jonson & Johnson a subsidiary of Janssen Pharmaceuticals failed to warn doctors and patients of the potential side effects of the medication including vision problems and possible blindness. 

According to the plaintiffs, Janssen “withheld material adverse events” resulting from the use of Elmiron and failed to disclose the serious link between Elmiron and visual damage. 

The manufacturer failed to list maculopathy in their packaging and warning label as a risk of taking the medication. Without this warning, doctors were unaware of the potential of patients developing maculopathy from taking the medication. Had doctors known of the potential impact, they might not have prescribed the medication, and patients might have chosen not to take the medication. The manufacturer started listing vision-related complications (pigmentary maculopathy) in June 2020.

Previously, the only side effects listed included hair loss, diarrhea, nausea, stomach pain, upset stomach, headache, rash, abnormal liver function tests, and dizziness.

At least 100 cases identified as eye disorders were identified in Elmiron users between 1997 and 2019 filed by patients through the FDA’s Adverse Event Reporting System. However, before 2018, no studies had established the link between these eye problems with Elmiron use.

Recent studies support the claim that Elmiron use exposes patients to the risk of retinal damage with at least 6 months of use. The condition, which results from injury to the macula (the central part of the retina) could result in permanent vision loss and blindness in severe cases. Patients who develop mild vision damage could have difficulty reading and vision impairment.

The common symptoms of pigmentary maculopathy include:

  • Hyperpigmentation of the retina
  • Dark spots
  • Abnormal blood vessels and capillaries
  • Blurred vision
  • Distorted vision
  • Difficulty reading
  • Loss of vision
  • Eye pain
  • Macular degeneration
  • Vision disturbances
  • Retinal maculopathy
  • Difficulties adjusting to low light conditions
  • Pigmentary pattern dystrophy
  • Permanent vision loss

Some of the side effects you are likely to experience from using Elmiron include:

  • Skin rashes or bruising
  • Alopecia
  • Sleeping problems
  • Weight gain
  • Swelling
  • Dizziness
  • Diarrhea
  • Liver problems
  • Bloody stools
  • Reflux

As of March 10, 2021, 196 cases had been filed alleging product liability claims following the use of Elmiron in New Jersey federal court and Pennsylvania state courts. 

Joining an Elmiron Lawsuit

You are eligible to file or join an Elmiron lawsuit if you experienced serious side effects, including eye damage after taking Elmiron for bladder pain and discomfort associated with IC. 

The Elmiron lawsuit is still in its early stages and has been consolidated into multidistrict litigation for the federal cases to be tried in the District of New Jersey. 

You are eligible to join the lawsuit if you were diagnosed with vision problems after taking Elmiron for more than two years. These vision problems must have occurred on or after January 1, 2010. Other factors that qualify you or a loved one to join an Elmiron lawsuit include:

  • You have been diagnosed with retinal maculopathy, pigmentary maculopathy, or macular degeneration.
  • You were diagnosed with one of the conditions within one year of stopping Elmiron treatment.
  • You experienced symptoms like blurred vision, problems reading, difficulties adjusting to dim or low light environments, vision disturbances, or vision loss.
  • You have sought treatment for vision issues.

If you are concerned about your eligibility to join an Elmiron lawsuit, talk to a product liability attorney. An attorney will help you evaluate your case and determine whether you meet the eligibility criteria. Besides, the attorney has the skill and knowledge to prove that the defendant was negligent and that you suffered damages from the defendant’s negligence.

Some of the questions your attorney might ask to determine your eligibility for the Elmiron lawsuit include:

  • What condition were you diagnosed with? Plaintiffs in the Elmiron lawsuit should have a diagnosis of vision problems.
  • When did your vision problems start? Most of the plaintiffs in Elmiron lawsuits started.
  • You experienced vision problems two years after they began using Elmiron or one year after stopping its use.
  • How have these vision problems affected your life? Determining the impact of the vision problems helps your attorney represent you. You should explain how these problems have affected you physically, emotionally, psychologically, and financially. Openness and honesty will help your attorney get fair compensation on your behalf.
  • Have you experienced eye problems before? If you did, what problems were they? Did the use of Elmiron worsen your condition?
  • What treatment have you used for the resulting eye problems?
  • What is your prognosis? Discuss with the attorney what the doctor said about your outlook on the condition you have. Will it worsen, or do you have a chance for improvement?

You should have well-organized medical records that support your IC diagnosis, prescriptions, and diagnosis for the resulting eye conditions. 

The information you provide your attorney and the investigation he or she conducts will help him or her prove that:

  • The defendant manufactured Elmiron,
  • The product had risks that the manufacturer knew or should have known,
  • The risks presented a substantial danger even when used in the intended or foreseeable manner,
  • Regular consumers could not have reasonably recognized the potential risks from the medication,
  • The manufacturer failed to warn adequately of the potential risks of taking the drug
  • The plaintiff suffered harm due to the absence of warning about the potential risks of the medication

Note that, you must take action sooner if you want a chance at recovering the damages you suffer from taking Elmiron. The statute of limitations for defective products in California is two years since the discovery of the eye condition. In Massachusetts, Rhode Island, and New Hampshire the statute of limitations for filing a case against a manufacturer is three years. 

Has Elmiron Been Recalled 

Although evidence continues to show the risk of permanent eye damage from the use of Elmiron, Janssen has yet to announce an Elmiron recall. The FDA has also not requested a recall or provided safety information about the risk associated with the use of Elmiron. 

This might leave most patients wondering whether to continue or discontinue their use of Elmiron. Dr. Robin A. Vora recommends patients without vision changes continue their use of Elmiron but have their vision evaluated every year. The doctor also recommends those with symptoms speak with their doctors about discontinuing the use of Elmiron.  

Elmiron is the only oral medication approved for the treatment of IC. However, you can manage the discomfort arising from the condition through:

  • Dietary changes
  • Exercise
  • Bowel training
  • Bladder training
  • Physical therapy
  • Pain relievers
  • Direct injection of dimethyl sulfoxide into the bladder using a catheter or a syringe

Damages You Can Recover in an Elmiron Lawsuit 

Elmiron lawsuits are an example of product liability lawsuits. The lawsuit is currently consolidated into multi-district litigation. Each lawsuit is different, and the plaintiffs will receive compensation based on the injuries and damages they suffered. 

The case is still in its early stages, but if settled in favor of the plaintiffs, you could recover compensatory damages, including: 

  • Medical expenses including hospital bills, doctor’s bills, and future medical costs associated with the injuries you suffer. You should include the costs for the diagnosis and treatment of the vision problems you developed.
  • Pain and suffering arising from the vision impairment you suffered
  • Wage losses, including loss of an income, profits, bonuses, and other benefits that you could have received were it not for your injuries. You will also be compensated for lost potential income.
  • Punitive damages (these are usually awarded if the court determines that the defendant’s actions were grossly negligent.)

Vision loss is a serious problem that will affect many areas of your life. Therefore, if you qualify for the Elmiron lawsuit, you should contact your physician and attorney as soon as possible so you do not miss the statute of limitations in your state. 

Litigation Process

The Elmiron lawsuit has been consolidated into multidistrict litigation, meaning that the cases will be dealt with as one, but each plaintiff will be compensated based on the damages they suffered. These types of lawsuits follow a different process than a one-plaintiff case would follow. Some of the steps to expect include:

  • Discovery: at this stage, the attorney will identify and establish consistency in damages by examining claims from different claimants. The attorney also evaluates the medical records of these claimants to ensure they meet the criteria.
  • The attorney categorizes cases based on the similarities to determine the appropriate compensation for each plaintiff.
  • A Bellwether trial involves the selection of a small group of lawsuits from the larger whole. The selected group acts as a representative of other plaintiffs claiming against the same defendant. The results of the bellwether trial are usually an attempt to predict the outcome of future litigation. When a bellwether trial results in a settlement for the defendant, the remaining cases are also likely to settle even for higher amounts. An unsuccessful bellwether trial, however, could drastically reduce the compensation for subsequent cases in the MDL.
  • Settlement: the defendant and plaintiffs begin negotiations, which might lead to an out-of-court settlement or proceed to trial. If the plaintiff and defendant cannot settle, the case proceeds to trial.

The litigation process for a mass tort typically takes longer due to the large number of plaintiffs involved. These cases also include several formalities, including motions, state conferences, bellwether trials, and case management. Factors such as the following could also contribute to a longer case:

  • Consultations with expert witnesses who are often busy and hard to reach
  • Investigations and evidence collection take time, especially where an attorney is dealing with more than one plaintiff

The Elmiron MDL is currently in its early stages and could take years before its conclusion. However, if you suffered any injuries, you should file a claim as soon as possible before the statute of limitations expires. You can also follow the lawsuit progress on the official site www.njed.uscourts.gov MDL number is 2973. 

Join an Elmiron Attorney To File A Lawsuit

Drug manufacturers are required by law to provide sufficient information about the risks, side effects, and warnings for using the drugs they produce. Failure to warn consumers and medical professions of the potential or known risks of using certain drugs could result in a lawsuit, such as the currently ongoing Elmiron lawsuit.

You can join the Elmiron lawsuit if you developed vision problems after taking Elmiron for the management of bladder pain and discomfort due to IC. Consumer Alert Now helps patients who suffer injuries from Elmiron to find the best counsel to represent them when seeking damages for their injuries.  Call our attorneys at 800-511-0747 to discuss your eligibility for an Elmiron lawsuit.