Elmiron Lawsuit: Everything You Need To Know

What is the Lawsuit Against Elmiron?

If you or a loved one took Elmiron, a bladder medication, and was diagnosed with vision damage as a result, you may be able to take legal action to recover compensation for your eye injury. If you are awarded monetary damages, you could cover your medical bills and other losses you suffered.

A consultation with a Elmiron lawsuit lawyer can determine if you are eligible to file an Elmiron lawsuit against the drugmaker. You can also review your legal options with an attorney who can explain your rights and represent you while fighting for your financial recovery. If you are interested in filing an Elmiron eye disease lawsuit, please fill out our contact form for help with your case.

Elmiron lawsuits allege bladder medication caused eye disorders

Elmiron (pentosan polysulfate sodium or PPS) is a prescription medication used to treat bladder pain and discomfort. The discomfort stems from the inflammation or irritation of the bladder, a condition known as interstitial cystitis (IC). In recent years, Elmiron has been linked to causing eye damage in longtime users. In addition, it has been alleged that the medication can cause serious retinal disorders and permanent vision loss.

As a result, plaintiffs have filed product liability lawsuits against Janssen Pharmaceuticals, the manufacturer of Elmiron. Janssen is a subsidiary of Johnson & Johnson. Plaintiffs allege that the drugmaker made a defective medication.

They also allege the drugmaker misrepresented the drug’s safety and failed to warn the public about its side effects, particularly those affecting vision. The medication’s label did not include warnings about possible eye damage linked to long-term use of Elmiron until June 2020.

Elmiron is the only FDA-approved drug to treat interstitial cystitis (IC)

Millions of people in the U.S. have interstitial cystitis and have been prescribed Elmiron to treat the condition. It is the only drug the U.S. Food and Drug Administration (FDA) has approved to treat IC; the medication was approved in 1996.

No warnings were available when the drug was approved and put on the market. There is no generic or over-the-counter version of this drug. If you do encounter a generic version of Elmiron, it is an illegal drug and could be counterfeit and unsafe for use, per Drugs.com.

IC is estimated to affect millions in the U.S. daily

Per the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), IC is a common condition affecting up to 8 million women and up to 4 million men in the U.S. It is also known as “painful bladder syndrome” and is marked by various symptoms, such as:

• Mild or chronic pain, pressure, or discomfort in the pelvic, bladder, or abdominal area
• Intense pain in the bladder
• Sudden urges to urinate
• Frequent urination
• Burning sensation or pain when urinating
• Awaking during the night to urinate

Interstitial cystitis is often mistaken for a urinary tract infection since both conditions share symptoms. Symptoms vary by person, but there is no cure for this chronic condition. Elmiron only treats the symptoms of IC.

Per Drugs.com, the recommended dosage of Elmiron is 300 mg a day. It can be taken as one 100 mg capsule by mouth three times a day. Patients can take the medication for at least three months before being reassessed. If cleared, they can take it for three additional months. This means patients may not see improved health until at least six months of treatment.

How does Elmiron work?

According to Janssen Pharmaceuticals’ Elmiron website, how the medication works after it is in the body is not fully understood. The pain linked to interstitial cystitis stems from a damaged bladder wall lining.

As Janssen explains, the medication attaches to the mucosal lining of the bladder wall to stop urine solutes from reaching it. The drug’s main ingredient, pentosan polysulfate sodium (PPS), is thought to be responsible for this. It acts as the buffer that controls cell permeability and keeps those irritating urine solutes from affecting the cells coated with it, according to PubChem.

Elmiron must be taken regularly for IC pain relief

PPS use is advised for adults and children who are at least 16 years old. The medication must be taken continuously for relief. It is taken regularly because it isn’t a pain medication, such as acetaminophen or aspirin. However, it should be taken exactly as a doctor prescribes. It should not be taken in larger or smaller amounts than recommended, and it should not be taken for longer periods than advised.

Patients are also urged to be careful with its use. It is a weak anticoagulant (blood thinner) and can increase bleeding. Anyone who experiences bleeding as a result of this medication is advised to receive immediate medical care.

Elmiron exposure led to eye disorders, studies find

Medical professionals have been monitoring Elmiron’s effects on patients in recent years. The American Academy of Ophthalmology (AAO) published a study in 2018 that highlighted the observations of Nieraj Jain, M.D., of Emory Eye Center in Atlanta. Jain treated six adult patients between May 2015 and October 2017.

Jain observed that several patients showed signs of pigmentary maculopathy, a retinal disease of the macula. The macula is part of the retina located at the back of the human eye. This area affects light sensitivity and helps us accurately process the images we see.

All of the patients were chronically exposed to pentosan polysulfate sodium (PPS) due to their treatment for interstitial cystitis. A follow-up study was published in 2019, and it, too, found that 10 more patients experienced vision problems after chronic PPS exposure. Per the study, the patients’ median age was 59, and the median time that had passed since their IC diagnosis was 19 years. According to the analysis, PPS exposure damaged the retina.

Additional findings

In addition to Jain’s study, three Kaiser Permanente ophthalmologists conducted an analysis and found eye abnormalities in patients who were exposed to PPS from Elmiron use. They also said many of the patients were likely wrongly diagnosed with age-related macular degeneration instead of PPS-related maculopathy.

In general, it is recommended that patients taking Elmiron have their vision examined at least once a year to monitor for retinal changes and other eye diseases.

Why are Elmiron lawsuits being filed?

Plaintiffs who have been injured after using defective drugs have the legal right to hold the liable parties accountable for their injuries and losses. Elmiron plaintiffs who are suing drug manufacturer Janssen Pharmaceuticals allege that the company failed to warn of the drug’s dangers, and that as a result, they suffered various eye injuries.

Warnings could have informed medical professionals about the medication’s side effects and given patients a choice on whether to take the medicine or not.

Common eye problems reported after chronic Elmiron or PPS exposure include:

• Reading difficulty
• Trouble with adapting to dim lighting
• Dealing with glare and blind spots
• Blurred or distorted vision
• Eye pain or eye strain
• Reduced night vision
• Difficulty with seeing objects up close
• Vision loss

Some people report experiencing halo vision or seeing dark spots in their vision. They may notice straight lines that bend in different shapes, becoming curvy or squiggly shaped (metamorphopsia). They may even notice a change in how they see colors, which can appear less vibrant. In its advanced stages, some people’s vision problems lead to them being declared legally blind.

Has the FDA recalled the drug Elmiron?

As of this writing, Elmiron is still being sold as a prescription medication in the United States. Despite the studies that have linked vision changes to Elmiron use, the drug continues to be available. In June 2020, the FDA approved the manufacturer’s decision to add a warning about eye-related complications to the drug’s packaging.

The medication’s label now warns about the retinal pigmentary changes that have been linked to long-term Elmiron use. It also says that while the cause of these changes is unclear, continued long-term dosages of the drug may be a risk factor. It also contains the following statement, “The consequences of these pigmentary changes in the retina are not fully understood.”

What to know about the updated Elmiron label warning

Janssen’s move to update Elmiron’s warning label on the medication does not mean it formally acknowledges study results that have linked eye damage to patients’ Elmiron use. It also does not indicate that it will conduct a voluntary recall of these medications due to concerns about the drug’s effects on eye health. Patients are urged to alert their doctors to any changes in their vision while taking Elmiron.

Drug recalls do not determine if consumers can still pursue legal action

A drug does not need to be recalled for consumers to file a defective drug lawsuit. It is important to note that a recall does not automatically mean a drug manufacturer is responsible for injuries that result from using the drug. It also does not automatically shield them from liability.

A mass tort lawsuit lawyer can establish a case for damages on their client’s behalf if they can prove the defective drug was dangerous when taken as intended and that their client suffered injuries as a result.

What is the status of Elmiron lawsuits?

Hundreds of separate lawsuits have been filed in connection with Elmiron use. It has been reported that the first Elmiron lawsuit was filed in May 2020 by Tina Pisco, who alleges she developed maculopathy after taking the drug for interstitial cystitis. She had been taking the medication since 2012.

In March 2019, she was diagnosed with permanent retinal injuries in both eyes, her lawsuit says. It also says her physicians would not have prescribed Elmiron had they known about the risks. Or, alternatively, if they were aware of the risks, they would have monitored her vision with routine eye exams if they had decided to prescribe it to her.

Elmiron MDL cases will go to trial in New Jersey

They all have been grouped into federal multidistrict litigation (MDL) and will be heard by Judge Brian R. Martinotti for the U.S. District Court for the District of New Jersey. MDLs help speed up the litigation process for multiple cases concerning the same matter. Even though cases are grouped together, plaintiffs will each collect a settlement based on their particular injuries.

A few sample cases from the group will be sent to trial to test the jury’s response. These cases could also determine if a settlement is possible, and if so, how much. These cases are called bellwether cases. It is too early to determine how much a potential Elmiron case settlement would be. However, the results of the bellwether cases could influence the outcome of other cases. The first Elmiron lawsuits could head to trial in early 2023, the Case Management Order No. 9 that was issued in May 2021.

You still have time to speak with an attorney who could help you prepare your Elmiron defective drug case and file it before the legal deadlines that apply to your situation.

Has an Elmiron lawsuit settlement been reached?

No, no settlement has been reached, and no trial has started for these cases. This means you might be able to join the MDL or a class action or file your own suit separately. Some personal injury law firms are accepting clients for Elmiron cases.

If you are considering filing legal action for eye injuries you suffered due to Elmiron use, you are encouraged to start as early as possible. Litigation is unpredictable, and it can take a long time. If you want a case review where you can go over your legal options, you can fill out the form to get help with your case.

Who can file an Elmiron lawsuit?

Anyone who has used Elmiron long-term and developed vision problems can seek legal action against the drug’s maker. You can file your lawsuit independently, which may be added to the MDL. You will have to present documentation that proves:

• You took Elmiron for interstitial cystitis. Your medical records or doctor’s prescription can satisfy this requirement. They will show when your treatment started and how long you have been taking Elmiron.
• You were diagnosed with macular degeneration or another eye disorder linked to Elmiron use. Medical records from your ophthalmologist or their testimony will help you in this area. You may be able to seek damages for a diagnosis of various kinds of maculopathy, macular degeneration, and other conditions.
• You experienced vision problems as a result of your exposure to pentosan polysulfate sodium (PPS), Elmiron’s main ingredient. You will have to document the vision problems you are having and how long you’ve had them. You can also document how your life has changed since your diagnosis via a written or video journal. You can also document your challenges with testimony from family members and friends or medical professionals.

A lawyer can advise you on what criteria you meet and if there are additional ones that apply. To learn more about your specific standing, you can fill out the contact form for help with your case.

Should you file an Elmiron lawsuit?

Considerable effort, time, and resources go into personal injury litigation, so it is understandable if you need time to think it over. An attorney can review your situation to determine if you are eligible to take legal action. They can also walk you through your options so that you can know what to expect going forward.

Speaking with an attorney can give you the tools you need to prove your case. They will review your evidence and investigate further to gather more proof showing how a defective drug harmed you. They can also show how the drug was defective by proving there was a problem in how it was manufactured, designed, or marketed.

Any of these can make a drug dangerous for consumers to use. It’s also possible for defective drug lawsuits to address more than one defect in a product. A lawyer will know what to look for when reviewing a client’s case.

Other ways an Elmiron attorney can help with your lawsuit

An attorney will take on your case from start to finish, looking out for your interests as they fight for your financial recovery. They will meet and manage communications with all parties, saving you time.

Having legal representation also ensures you meet important deadlines in your case, such as your state’s statute of limitations filing deadline. This is important because if you miss this state-imposed deadline, you won’t be able to move forward on your case.

Your attorney will also answer your questions and explain how state and federal laws apply.

Vision loss is a significant health problem to deal with

If you are weighing whether you should sue for your Elmiron-related eye injury, consider how your life will be affected now that you must live with this impairment. Your mobility may change, and your cost of living could increase because of the vision changes you are experiencing.

According to the U.S. Centers for Disease Control and Prevention (CDC), vision loss ranks among the top 10 causes of disability in the country. It also contributes a sizable burden when it comes to morbidity and one’s quality of life, the federal agency says. According to the CDC, “people with vision loss are more likely to report depression, diabetes, hearing impairment, stroke, falls, cognitive decline, and premature death.”

A decreased ability to see also leads to an inability to do other things, such as read, drive, monitor one’s accounts, or travel. This is something to consider as you weigh your legal options.

Possible recoverable damages in Elmiron lawsuits

Vision loss and eye damage can be devastating injuries to suffer. You may be able to recover economic and non-economic damages in your case.

Economic damages

These damages are your actual monetary losses, which could include:

• Past, ongoing, and future medical expenses to treat your eye injury
• Cost of any rehabilitative therapies you will need for your vision
• Lost income due to missing work or losing your job due to your eye injury
• Lost future income due to changes in your vision
• Reduced earning ability if your injury made you change job duties or jobs entirely due to your vision impairment
• Costs related to therapy or counseling you need as you deal with your vision loss and related changes
• Property damage related to your vision loss
• Other vision loss-related damages

You can prove the financial value of all these losses with documentation, such as medical records, invoices, receipts, time cards, pay stubs, and other written records.

Non-economic damages

Elmiron victims who suffered vision loss of any kind can show how this injury affected the quality of their life and well-being. These damages do not have a financial value assigned, but an injury lawyer can calculate and assign a value for you. These losses can include:

• Physical, mental, and emotional pain and suffering
• Emotional distress you experience due to your visual impairments
• Mental anguish
• Loss of enjoyment of life or reduced quality of life
• Total or partial disability, temporary or permanent

A lawyer will evaluate all your losses and determine what damages you could pursue with legal action. They can even uncover damages you may not know about.

A lawyer may be able to start on your case without an upfront payment

Many lawyers who work on defective drug cases do so on contingency. This means they provide legal representation upfront at no cost to you. If they secure a settlement for you, their payment will come from your award. Contingency fee arrangements keep risks and costs low for the client and allow lawyers to work on their case right away.

It could help you to have legal representation on your side when you go up against big pharmaceutical companies. They are coming to litigation with their team of lawyers and seemingly unlimited resources. Hiring an Elmiron lawsuit lawyer to represent your interests can give you a chance to recover the losses you endured because of another’s negligence.

Get immediate medical care for Elmiron-related eye concerns

It is important that you get medical care as soon as possible if you think your vision problems are related to your Elmiron use. The FDA recommends getting an eye examination at least once a year. An annual exam may be able to detect the early stages of an eye disorder. It is possible that Elmiron-related vision problems could mimic other conditions.

According to Healthline, a person with late-stage PPS toxicity may have Elmiron-related eye damage that looks similar to late-stage, age-related macular degeneration. Because of this, some patients exposed to the drug are misdiagnosed, believing their condition is unrelated to their Elmiron use. Late-stage macular degeneration can result in permanent vision loss.

When you see a doctor, tell them:

• How long you have been using Elmiron
• What dosage you are/were taking
• How long you have noticed a change in your eyesight
• If you took Elmiron with other medications
• If you have a history of eye disease in your family
• How long you have been experiencing side effects from Elmiron use

Side effects are possible with any medication. You can see a doctor about Elmiron side effects that you experienced. A few of the common ones are:

• Abdominal pain
• Abnormal liver function tests
• Blood in the stool
• Body aches
• Bruising
• Nausea
• Diarrhea
• Dizziness
• Headache
• Hair loss
• Rash
• Upset stomach

If you want to stop using Elmiron, speak with your doctor first before doing so. It is not safe to stop a drug abruptly after long-term use. Your body could go into withdrawal, and you could experience discomfort. Your doctor may recommend a tapering schedule to give the body time to adjust to the drug’s absence. You should also be aware that stopping Elmiron use means your interstitial cystitis symptoms could return. It might help to find other treatment options that can help you manage the condition.

Delayed treatment could affect the outcome of your case

Seeing a physician as soon as possible will help you document your efforts to seek immediate medical help. If you receive treatment for your eye health related to Elmiron use, you also must follow your doctor’s orders as directed.

If you delay getting the medical care you need or fail to follow your doctor’s orders, you may harm your case. Attorneys for the other side could argue that you worsened your condition when you delayed treatment or did not follow the treatment you were prescribed. They also could say your condition wasn’t as serious as you claimed it to be due to delayed treatment.

Start exploring your next steps in your Elmiron case today

It is important to act as quickly as possible once you have decided that filing an Elmiron lawsuit is right for you and your family. If your vision loss injuries occurred during or after using the drug, you can reach out to a law firm that can help you pursue the legal process.

Pharmaceutical lawsuits can be complex matters to understand and follow. Working with an attorney can help you simplify the process and give you peace of mind. A mass tort lawsuit lawyer who is familiar with litigation can make the process easier to understand. They will keep you up to date about any developments in your case.

Fill out our contact form for help with your case.