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Elmiron Lawsuits

Elmiron lawsuits are legal claims that people who took Elmiron and later developed maculopathy or other serious vision problems have filed. Elmiron lawsuits allege Janssen Pharmaceuticals knew about the risk of eye damage but failed to adequately warn the public.

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If you developed maculopathy or other serious vision problems after using Elmiron, you may be entitled to compensation. Get a free case review today.

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Last Modified: November 7, 2022
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Drugwatch writers gather lawsuit information by studying court records, watching lawsuit proceedings and speaking with experienced attorneys.

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Why Are Elmiron Lawsuits Being Filed?

Elmiron lawsuits are being filed against Janssen Pharmaceuticals by plaintiffs who suffered vision problems that could lead to blindness, including maculopathy.

Plaintiffs claim Elmiron, a medication used to treat interstitial cystitis, caused their vision damage and that it is a dangerously defective drug. According to lawsuits, Janssen withheld adverse event reports from the public, medical community and the U.S. Food and Drug Administration.

People who filed lawsuits are demanding that Janssen pay compensation for permanent vision injuries.

Elmiron Patients File Suit

People began filing lawsuits against Janssen in 2020. Three of these early lawsuits belonged to Jeanette Milburn, Valarie Hull and Kimberly Pelczar.

The three women claimed long-term Elmiron use caused them to develop loss of night vision, pigmentary maculopathy, vision degradation, retinal injury and retinal hemorrhage. They claimed Elmiron was defective and that Janssen failed to warn them and their doctors of the risk of permanent vision damage.

In the latest Elmiron lawsuit 2022 court update, Janssen is facing 1,774 cases in federal court as of Sept. 15, 2022.

Status of Elmiron Lawsuits

So far there have been no Elmiron lawsuit 2022 trials, but the first bellwether trial in the Elmiron multidistrict litigation in New Jersey is tentatively scheduled for January 2023.

Bellwether trials are important because they set the stage for how all other cases are valued and how soon a global settlement can be reached in all cases in the multidistrict litigation, or MDL.

An MDL is when judges consolidate a large group of cases that have similar facts and injuries against a defendant. It helps save money and time in litigating a large number of cases.

Recent Elmiron status highlights include:
  • September 2022
    There are now 1,774 cases pending in the Elmiron MDL. The judge has scheduled the first bellwether trial in the Elmiron MDL for January 2023. A second trial will be in March 2023 and a third will follow in March 2023 unless the cases settle before then.
  • July 13, 2022:
    Judge Brian Martinotti approved 14 plaintiff’s attorneys for the Plaintiff’s Steering Committee — a group of attorneys that oversee and coordinate the litigation for the plaintiffs in the MDL.
  • June 29, 2022:
    Judge Martinotti ruled Maria Windham’s case will remain the first bellwether case and the trial will be in January 2023. The next case management conference is July 13, 2022. Parties submitted Science Day recordings to present the science of Elmiron and vision loss for the court. A date to view the presentations has yet to be decided.
  • June 15, 2022:
    As of June 15, there are now 1,360 pending cases in New Jersey federal court.

The first studies linking Elmiron to pigmentary maculopathy were published in 2018. In 2020, Janssen updated the label to include a warning for “changes in the retina of the eye (pigmentary maculopathy).”

In 2020, shortly after the warning was added to the label, the first Elmiron lawsuits were filed.

Elmiron Lawsuit 2022 Settlement Amounts

So far, there haven’t been any Elmiron lawsuit 2022 settlements. Because there have been no trials, jury verdicts or global Elmiron settlement offers, it’s difficult to determine what Elmiron lawsuit settlement amounts will be. Verdicts from bellwether trials typically provide a benchmark for case value, and the first Elmiron bellwether will be in January 2023.

If juries award high verdict amounts to plaintiffs, it could also encourage a global settlement. If Janssen offers a settlement, factors such as severity of injuries and financial damages will determine what each individual plaintiff’s settlement amount will be.

Complex Elmiron litigation may take a few years to resolve. Even after a settlement is reached, disbursing settlement funds to hundreds of people will take time.

Am I Eligible to File an Elmiron Lawsuit?

If you have a confirmed diagnosis of eye issues after taking Elmiron for at least two years, you may be eligible to file an Elmiron lawsuit. Lawyers have additional criteria that could affect your chances of qualifying.

You may qualify to file an Elmiron lawsuit if you:
  • Took Elmiron for at least two years
  • Sought medical treatment for vision issues
  • Were diagnosed with vision problems, such as pigmentary maculopathy, retinal maculopathy or macular degeneration, after taking Elmiron
  • Suffered vision changes such as blurred vision, difficulty reading, distorted vision, eye pain, issues adjusting to darkness, vision disturbances, or vision loss after taking Elmiron
  • Were diagnosed with vision problems or started having vision problems while taking the medication or within one year of stopping the medication
  • Started having vision problems on or after Jan. 1, 2010

Only a lawyer can tell you for sure if you qualify to file an Elmiron lawsuit. If you aren’t sure if you fit the criteria above, make sure to contact an Elmiron lawyer. With just a few questions they can tell you if you qualify, and the consultation is free.

Elmiron Linked to Maculopathy

Several studies have linked Elmiron, the brand name of pentosan polysulfate sodium (PPS), to a unique type of maculopathy called pigmentary maculopathy.

Researchers have said this type of maculopathy only occurs in Elmiron users. Maculopathy is a progressive disease that could lead to blindness, and there is no cure.

“In 2018, eye physicians published the first report of retinal damage associated with Elmiron use,” Elmiron lawyer Trent B. Miracle told Drugwatch. “Since then, the medical literature regarding eye damage and vision loss associated with Elmiron continues to grow.”

Anatomy of an Eye
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Elmiron may damage a part of the retina called the macula, causing vision problems.

The most common visual symptoms reported in studies were difficulty reading and difficulty adapting to dim lighting. Researchers found that PPS users who took more of the drug over a longer period of time had the worst eye damage and that damage could continue progressing even after a patient stopped taking the medicine.

In a study from April 2022 published in Asia-Pacific Journal of Ophthalmology, researchers said Elmiron maculopathy is often misdiagnosed as another eye problem. According to a March 2022 study, people who used Elmiron for more than three years had a 9.5-fold greater risk of maculopathy.

Have you suffered vision damage related to Elmiron usage?

Why File an Elmiron Lawsuit?

Filing an Elmiron lawsuit may help those suffering permanent vision problems get compensation for medical bills, pain and suffering, lost wages, loss of quality of life and future care.

Studies have linked Elmiron to permanent vision damage for years, and yet Jannsen didn’t warn the public of the risk until many years later. Some people may file lawsuits to bring awareness to Elmiron’s side effects and prevent others from suffering permanent vision loss.

Elmiron lawsuits may hold Janssen accountable for negligence. When people injured by Elmiron go to trial, they may be awarded punitive damages. Juries award punitive damages to punish defendants for grossly negligent or malicious behavior and to discourage further negligent behavior.

Will There Be an Elmiron Recall?

Elmiron has not been recalled despite studies linking long-term use of the interstitial cystitis drug to potentially permanent vision damage.

The drug has been on the market since 1996 and is still the only oral treatment available for the condition. Janssen didn’t warn about the risk of retinal pigmentary maculopathy until June 2020.

The FDA published the new label with the maculopathy warning but has not issued a statement or safety communication about it. So far, the agency hasn’t asked Janssen to recall the drug and the drugmaker hasn’t said it plans to issue a recall.

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Learn more about Elmiron and how to take legal action if you developed vision problems after taking the drug.

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Questions Your Elmiron Lawyer May Ask

When you contact a lawyer about your potential Elmiron vision damage case, they may ask you questions about your experience with the drug. Make sure you answer questions with as much detail as possible.

What injuries have you experienced?

People filing Elmiron lawsuits have typically been diagnosed with maculopathy or macular degeneration. Your medical records will help your attorney confirm the diagnosis.

When did your vision problems begin?

Knowing when you first started experiencing vision problems may help your lawyer accurately draw the connection between your vision problems and your Elmiron use. Generally, individuals seeking compensation for their injuries were diagnosed with vision problems either while they were taking Elmiron or within one year of stopping the medication.

Do your vision problems affect your day-to-day activities?

Be open with your attorney about how your vision problems have impacted your ability to do certain daily activities. He or she will also want to know about the emotional toll these vision problems have taken on you.

How long did you take Elmiron?

Vision problems have been linked to long-term exposure to the drug. The majority of individuals filing Elmiron lawsuits had taken it for at least two years prior to experiencing vision problems.

Do you or your family have a history of eye problems?

Your Elmiron lawyer will ask about your medical history to determine whether you may be prone to vision problems. Have copies of your medical records on hand.

What treatment did your medical provider recommend for your vision problems?

Bring any medications you’re currently taking for your vision problems. Your Elmiron attorney will want to know if your vision problems have improved as a result of this treatment.

What prognosis did your medical provider give you?

Be prepared to discuss what your medical provider told you about the chances of regaining your vision and if symptoms would improve over time.

There may be a time limit to file your case, so you should contact an Elmiron attorney as soon as you can. There is no charge to contact a lawyer about a potential Elmiron vision damage case.

Please seek the advice of a medical professional before making health care decisions.