Elmiron, or pentosan polysulfate sodium, is the only oral medication approved by the U.S. Food and Drug Administration to treat interstitial cystitis. IC is a chronic condition that causes bladder pain and pressure. About three to eight million women and one to four million men in the United States have IC, according to the National Institute of Diabetes and Digestive and Kidney Diseases.

After studies began linking Elmiron to vision problems — specifically a unique condition called retinal pigmentary maculopathy — people started suing Johnson & Johnson’s subsidiary Janssen Pharmaceuticals. The lawsuits claim the drugmaker failed to warn the public about the risk of vision problems, including permanent vision loss. 

In this Q&A, mass torts and product liability attorney Trent B. Miracle explains why people are filing Elmiron lawsuits, the status of Elmiron litigation and who qualifies to file a claim.

Q: What is Elmiron, and why are people suing Janssen Pharmaceuticals and Johnson & Johnson? 

A: Elmiron is a drug used to treat the pain and discomfort of interstitial cystitis. It works like a mild anticoagulant. Recent studies have linked longer term usage of Elmiron to certain vision disturbance disorders, most significantly retinal pigmentary maculopathy.

Q: In pharmaceutical and medical device injury litigation, failure to warn is one of the most common claims. Can you explain what failure to warn means in the Elmiron litigation?  

A: The long and short of a failure to warn claim is where a drug causes certain injuries (such as retinal pigmentary maculopathy) but doesn’t include a warning about it in the label or package inserts.  This particular drug has been on the market for a very long time without any such warnings. Only as recently as June 16, 2020, did Janssen change the label to include a warning for people using Elmiron for three years or longer possibly being afflicted with pigmentary maculopathy. This is the first such warning for this product.  

Q: Elmiron is the only oral drug approved to treat bladder pain and discomfort associated with IC, a condition that mostly affects women. How many people do you estimate may be affected by the vision-related side effects of this drug?  

A: Potentially tens of thousands. It remains to be seen how many women diagnosed with some of the conditions [associated with Elmiron use] have either on their own or through their physicians connected their use of Elmiron to these conditions. Now Janssen has changed the warning for Elmiron to include pigmentary maculopathy in people using the drug for three years or longer.

Q: What are some of the injuries claimed in lawsuits?

A: Specifically, some of the injuries being named in these suits include retinal pigmentary maculopathy and macular degeneration.  

Generally, we are screening potential cases where clients are experiencing symptoms such as:

  • Blurred or distorted vision
  • Difficulty reading
  • Eye pain
  • Loss of vision
  • Macular degeneration
  • Pigmentary maculopathy
  • Retinal maculopathy
  • Trouble adjusting to darkness
  • Vision disturbances

Q: Recently, several studies surfaced potentially linking Elmiron to permanent vision problems. What does the science say about Elmiron and eye damage?

A: In 2018, eye physicians published the first report of retinal damage associated with Elmiron use. Since then, the medical literature regarding eye damage and vision loss associated with Elmiron continues to grow. A recent study found that approximately one quarter of patients using Elmiron for extended periods of time had retinal damage and visual symptoms. 

Q: What is the status of the Elmiron vision problems litigation, and how big do you think this litigation will be?

A: There are approximately 50 cases filed in federal and state courts across the country, with about half of those in the Eastern District of Pennsylvania. Those federal cases are pending before Judge Wendy Beetlestone, who is known as an aggressive and experienced jurist. The parties expect that Judge Beetlestone will oversee the majority of cases nationally, and that she will allow plaintiffs to press forward with meaningful discovery over the next 12 months. Given the universe of patients on Elmiron and the relatively unique nature of the injuries here, plaintiffs expect that the universe of cases will ultimately increase to approximately 1,000 cases.  

Q: If people believe they were injured by Elmiron, how do they know if they qualify for a lawsuit?

A: The hallmark diagnosis here is pigmentary maculopathy diagnosed after patients have imaging done with an eye doctor. These cases tend to be progressive in nature and subject to misdiagnoses. Accordingly, many patients will have to revisit their conditions with their physicians to receive appropriate testing to ascertain proper diagnoses. 

Q: What can people who contact an Elmiron trial attorney expect?

A: Folks interested in talking to experienced pharmaceutical injury attorneys about their potential cases can reasonably expect a few phone calls with members of those law firms to discuss their case. Those phone calls discuss their background information, what doctors they see, what medications they have taken, and things like that. 

Once basic information is gathered, the attorneys will email or mail a contract to these prospective clients for them to review and sign. In pharmaceutical cases, those contracts will provide that the attorneys will cover all of the legal expenses during the litigation. Only if the attorneys recover money for their clients will they collect a certain percentage of the recovery in the case.