Update: Elmiron Lawsuits Could Head to Trial in Early 2023
A lawsuit filed by Elmiron patients who allegedly developed potentially permanent vision damage / retinal damage and eye disease could head to trial in January 2023, 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 devices 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 2023, with subsequent clinical trials to follow,” Martinotti said in the order.
What is Elmiron?
Elmiron (generic: pentosan polysulfate sodium pps) is the only medicine approved by the U.S. Food and Drug Administration (FDA) to treat bladder pain or interstitial cystitis (IC), a retinal disease better known as “painful bladder syndrome.”
Pentosan polysulfate sodium is also used for the treatment of osteoarthritis in humans, horses and elderly dogs. Pentosan polysulfate works by forming a layer on the bladder wall and protecting it from harmful/irritating substances in the urine.
Janssen Pharmaceuticals, a division of Johnson and Johnson, is the drug's manufacturer. The drug was originally developed by Baker Norton Pharmaceuticals, Inc.
The FDA approved Elmiron in 1996 for IC. The drug manufacturer Alza Corporation obtained the rights in 1997 to sell Elmiron in the United States.
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. The only mention of potential vision problems with the drug are found in the Adverse Reactions section, and reference macular disease, nystagmus, conjunctivitis, optic neuritis, amblyopia, and retinal hemorrhage.
Chronic exposure to Elmiron may lead to the following serious side effects:
- Eye injury
- Eye damage
- Retinal damage
- Retinal maculopathy
- Pigmentary maculopathy
- Adult pattern macular dystrophy
- Retinal pigmentary endothelium injury (RPE)
- Vision loss
- Vision damage
- Permanent retinal injury
- Blurred vision
- Night blindness
- Alopecia (hair loss)
- Gastroesophageal reflux
- Skin rash
- Sleep disorders
- And more
Other Side Effects
In addition to being linked to eye problems, Elmiron may cause the following side effects:
- Skin rashes and/or bruising
- Hair loss (alopecia)
- Sleeping problems
- Gaining weight
- Liver problems
- Urinary tract infection
- Bloody stools
How Can Elmiron Cause Maculopathy?
There is substantial evidence from 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 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.
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 a 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 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 placebo for some IC complications. If this is true, it underscores that the risk of Elmiron is not worth the potential benefit.
Either way, the case comes down to whether side effects require warning based on the information that was available 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.
"Patient Zero" Files Lawsuit Over Side Effects
A woman whose case was documented as "Patient Zero" in a 2018 study conducted by physicians at the Emory Eye Center in Atlanta, Georgia, has filed a class action lawsuit with the help of lawyers seeking compensation for eye problems she allegedly suffered after taking Elmiron.
Plaintiff Valarie Hull of South Carolina claims she took Elmiron from 2001 to 2018, and as a result developed serious visual injuries including changes in eye color pigment, severe vision degradation, loss of night vision, and pigmentary maculopathy.
Hull was treated by Dr. Nieraj Jain, an ophthalmologist at Emory Eye Center. In 2018, Jain and other researchers published their findings, based on Hull and 5 other patients with the same eye problems who all took Elmiron.
The lawsuit accuses Janssen Pharmaceuticals, Teva Branded Pharmaceutical Products R&D, Teva Pharmaceuticals, and Teva Pharmaceutical Industries Ltd. of failing to warn of the risk of severe vision problems with Elmiron.
The complaint is: Hull vs. Janssen Pharmaceuticals Inc., et al., Case No. MIDL003646-20 .
Bladder Medication Linked to Eye Damage: AAO Study
A 2018 study published by the American Academy of Ophthalmology (AAO)  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 the course of 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 an 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."
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.
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 vision loss in the other.
When symptoms do present, they include:
- Difficulty reading
- Prolonged dark adaptation
- Image distortion, or metamorphopsia, where objects appear deformed or smaller than they actually are.
Anyone with these symptoms after being prescribed Elmiron should make an appointment with a vision care specialist.
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
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?
Elmiron is currently the only drug approved by the FDA to treat interstitial cystitis.
While there are no other approved medications for this condition, many doctors treat patients with a combination of other methods, which may include diet modification and pain relievers like ibuprofen.
Eye Care Tips
- Get a comprehensive dilated eye exam
- Find out if you’re at risk for eye diseases
- Take care of your health
- Protect your eyes
- Give your eyes a rest from reading/computer (take a break every 20 minutes and look at something about 20 feet away for 20 seconds)
- If you wear contacts, take steps to prevent eye infections (source: National Eye Institute) 
Can I File a Class Action Lawsuit?
Although Schmidt & Clark, LLP, 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 maximum the likelihood of successful Elmiron lawsuit criteria.
We file each lawsuit separately; however, most of the cases will eventually be consolidated into a 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 multidistrict litigation is:
- In re Elmiron (pentosan polysulfate sodium) Products Liability Litigation; MDL 2973 
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 for the damages caused by your injuries.
What are Elmiron Lawsuits Alleging?
The primary claim in an Elmiron lawsuit is that Janssen Pharmaceuticals failed to adequately warn the public and medical community about the dangerous side effects of the drug Elmiron.
The packaging and warning label did not list maculopathy as a potential risk before June 16, 2020.
Therefore, doctors were unaware of this complication of Elmiron use.
Had they known, they may not have prescribed it. And many patients may have chosen not to take it.
The warning label of Elmiron currently states:
Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.
The Food and Drug Administration also recommends that Elmiron users get eye exams that include auto-fluorescence imaging and optical coherence tomography.
Have There Been Any Elmiron Lawsuit Settlements?
No settlements have yet been reached in Elmiron lawsuits; however, plaintiffs’ personal injury attorneys are seeking large financial settlements.
The amount will vary according to a number of different factors in each case, including:
- The severity of the eye disorder you were diagnosed with
- How long you took the prescription drug Elmiron
- Any lost wages or income as a result of vision problems
No price can be placed on a person’s ability to see. Vision problems affect every aspect of a victim’s life.
Ultimately, attorneys are fighting for enough financial compensation to pay for:
- All past and future medical bills for vision loss (including mental health counseling)
- Lost wages (past and future)
- Pain and suffering
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 suffered vision problems after taking Elmiron.
Other Resources: Dangerous Pharmaceutical Lawsuits
Get a Free Elmiron Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group at our 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.