Elmiron

Janssen Pharmaceuticals is facing lawsuits over the link between Elmiron (pentosan polysulfate sodium), a drug used to treat Interstitial Cystitis (also known as Painful Bladder Syndrome) and a dangerous eye condition known as Retinal Maculopathy.

Janssen Pharmaceuticals—a Belgium-based division of the global conglomerate Johnson & Johnson—is facing a pile of potential legal claims over the safety of its Interstitial Cystitis drug Elmiron. Although evidence has come to light linking Elmiron with a serious eye disease, the company has yet to address these concerns or document this condition as a potential side effect on warning labels and drug documentation. 

In 2015, doctors at Atlanta’s Emory Eye Center discovered a link between Elmiron and a form of Retinal Maculopathy, a condition that causes vision impairment and may eventually result in blindness. 

If you or a loved one took Elmiron and were diagnosed with maculopathy, you may be eligible for compensation. Our attorneys have the skills and resources to fight for the justice you deserve. Lawsuits on behalf of the injured have already begun. Contact us today for a free case evaluation.

PLAINTIFFS FILE LAWSUITS AGAINST MANUFACTURER

Some patients who took Elmiron and were then diagnosed with vision impairment are taking legal action against Janssen Pharmaceuticals. Lawsuits were filed in state and federal courts across the United States, claiming that Janssen Pharmaceuticals knew or should have known that Elmiron had a risk of vision damage, and, therefore, warned customers.

All of the Elmiron lawsuits that were filed federally have now been consolidated into a Multi-District Litigation (MDL), which is a judicial procedure designed to speed up the process of litigating a large number of similar cases. The MDL centralizes these Elmiron lawsuits before a single federal judge—Judge Brian R. Martinotti—in the District of New Jersey. 

Morgan & Morgan attorney Paul Pennock, who is revered as one of the most experienced MDL litigators in the country, was appointed co-lead counsel of the Plaintiffs’ Steering Committee. Pennock has a proven track record of resolving mass tort litigations in product liability and pharmaceuticals. 

NEW STUDY LINKS LONG TERM USE TO INCREASED RISK

A new study, published in the scientific journal Retina, finds that long-term exposure to Elmiron could increase one’s risk for vision problems.

Researchers examined 912 respondents with a median age of 55, analyzing for use of Elmiron, their visual function, and prior diagnoses of maculopathy.

According to the results of the study, the respondents with the highest exposure to Elmiron were more likely to report difficulty reading small print and to have a diagnosis of macular degeneration and/or pigmentary maculopathy. 

A TRACK RECORD OF SAFETY UPENDED 

Elmiron has been prescribed to millions of people around the world since 1996. It is often the only available treatment for patients suffering with Interstitial Cystitis/Painful Bladder Syndrome, a debilitating condition that causes chronic bladder pain and pressure, and the frequent urge to urinate. 

The normal side effects of Elmiron include:

  • Diarrhea
  • Hair loss
  • Nausea
  • Headache
  • Stomach upset or pain
  • Abdominal pain
  • Dizziness
  • Depressed mood
  • Itching or skin rash

These are relatively low-impact, and because of this, Elmiron has been widely and freely prescribed. 

Patients taking Elmiron have done so believing that it was a low-risk option for relief of a serious and potentially debilitating condition, but new research suggests that doctors may have been wrong to prescribe and up the doses so easily. 

As reported by ScienceDaily and the American Association of Ophthalmology, a 2019 study by Kaiser Oakland found that about one quarter of the patients surveyed who were taking Elmiron showed signs of retinal damage. The study concluded that Elmiron may be toxic to the retinas, and that the toxic damage increased as the dose prescribed increased. 

These links to such a serious eye condition call Elmiron’s long-established status as a safely prescribed drug into question. Despite all this, Janssen Pharmaceuticals continues to manufacture and distribute Elmiron without listing eye damage as a possible side effect. 

ELMIRON-LINKED EYE DISEASE EMERGES 

In 2015, six patients at the Emory Eye Center in Atlanta came in with symptoms that the doctors had trouble understanding. They all had vision impairment and damage to the eye that put it into the category of Maculopathy: damage to the Macula—the center of the retina. But it did not fit precisely into any of the forms of the disease that they had encountered previously, or seen discussed in the medical literature. It was in fact, a new and previously undiscovered condition. 

After thorough investigation over the next few years, the doctors found that the only commonality between the patients with this new eye disease was that they all were taking or had taken Elmiron to treat their Interstitial Cystitis. The suspicion is that this condition has been hiding in plain sight due to its surface similarity to other forms of Maculopathy. 

When this finding was published in 2018, it found ready corroboration in the clinical experience of Dr. Rachel Huckfeldt MD PhD, of the Harvard Medical School Dept of Ophthalmology, who soon after published a study showing the progression of these symptoms in her patients even after the patient had stopped taking Elmiron. 

This may indicate that the damage done by Elmiron may continue and escalate even long after the use of Elmiron had been stopped. 

The symptoms associated with this eye condition include:

  • A change in the color of the retina itself
  • Dark spots in visions 
  • Straight lines turned curved or squiggly
  • Muted, less vivid colors
  • Trouble reading
  • Blurred vision, including in the center of the field of view
  • A hard time adjusting to dimmer lighting 

Patients currently taking Elmiron should consult their doctor about the best future course of action. 

ELMIRON USERS SEEK COMPENSATION  

Many people who take Elmiron and are now suffering from vision impairment have begun filing lawsuits against the manufacturer, demanding accountability and compensation. Reports that Janssen Pharmaceuticals knew that Elmiron had the potential to cause serious eye conditions have only added fuel to the fire. 

If you or a loved one is now suffering from vision impairment or blindness after taking Elmiron for any period of time, you can access a free case review with our legal team at any time to help you consider your options. 

We have recovered more than $7 billion for our clients to date, and as the largest personal injury firm in the country we are one of the few with the resources to take on Janssen Pharmaceuticals—a division of Johnson & Johnson, one of the largest multinational conglomerates on the planet 

There are never any upfront costs with us, and you don’t pay anything unless we win a jury award or settlement for you. Contact us today for a free, no-obligation legal consultation.