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Elmiron Eye Damage Lawsuit

The first of what will be hundreds of Elmiron lawsuits have been filed.

Elmiron (pentosan polysulfate sodium) is a popular prescription drug used for the treatment of bladder inflammation in people with interstitial cystitis. Elmiron has been around since the mid-90s and was thought to be completely safe. In October 2019, however, a new study was released which found that Elmiron causes retinal damage to the eyes. The study confirmed that Elmiron can cause a serious eye disease called maculopathy which can result in blindness in potentially one-fourth of the patients who took this drug.  This is a pretty staggering number, right?  Our lawyers rarely see mass torts with a risk of injury as high as we are seeing with Elmiron.  

Anyone who used the drug Elmiron and has been diagnosed with maculopathy or other eye conditions may be entitled to financial compensation from the drug manufacturer. Our law firm is currently accepting new cases from anyone who used this prescription medication and has been diagnosed with pigmentary maculopathy, macular degeneration or other conditions.

What Is Elmiron?

Elmiron is the popular brand name of a drug called pentosan polysulfate sodium. Pentosan polysulfate belongs to a family of anticoagulant drugs known as low molecular weight herapins. Most drugs in this category are used as blood thinners, but Elmiron is used for the treatment of a condition called interstitial cystitis.

Interstitial cystitis (“IC”) is a bladder condition that causes chronic and pain and discomfort as well as urinary frequency. Over 12 million people in the U.S. currently suffer from IC. Elmiron helps to treat the symptoms of IC by preventing irritation and swelling of the walls of the bladder. The drug is thought to function as a synthetic mucus layer around the bladder to guard against irritation.

Elmiron was developed and manufactured by Janssen Pharmaceuticals Inc., which is a corporate subsidiary of Johnson & Johnson. Elmiron was first approved by the FDA back in 1996 and since then it has become the standard treatment option for individuals suffering from cystitis. In fact, Elmiron is still the only drug currently approved by the FDA for treatment of IC related bladder pain. Millions of people take it every day. Elmiron is also sometimes used to treat bladder pain associated with urinary tract infections.

Evidence Links Elmiron to Serious Eye Damage

There is strong evidence that Elmiron causes an eye disorder called retinal maculopathy. Long-term exposure appears to increase the risks.

Since its initial release back in 1996, Elmiron has always been viewed as relatively safe drug with few significant risks or serious side effects. All that has changed very drastically in the last 6 months. The discovery of Elmiron’s toxicity began in 2018 when doctors from the Emory Eye Center in Atlanta, Georgia started noticing a strange trend. They had 6 patients with abnormal damage to the macula region of their eyes and were diagnosed with pigmentary maculopathy. The doctors eventually realized that all of these patients were long-term users of the drug Elmiron. This led the Emory Eye Center to publish a preliminary report which suggested that Elmiron may be toxic to retinal tissue in the human eye.

This warning call immediately prompted a more detailed study into the safety of Elmiron and its potential toxicity to the eyes. This was done by a team of ophthalmologists in Northern California based on thousands of patient records. The alarming results of this research were presented at the annual meeting of the American Academy of Ophthalmology in October 2019.

The study results showed very conclusively that Elmiron was in fact very toxic to the sensitive retina tissue in the back of the eyes. About 25% of patients who used Elmiron displayed signs of maculopathy or significant eye damage. Many of these victims already have partial or total loss of their vision. When these individuals were examined and tested, doctors found clear signs of drug toxicity related to their prolonged use of Elmiron.

What Type of Eye Condition Does Elmiron Cause?

The recent studies have linked prolonged use of Elmiron to maculopathy, which is also known as macular retinopathy. Maculopathy is a broad term for any disease or pathologic condition affecting the macula – the central region of the retina in the eye. The type of maculopathy directly associated with Elmiron is called pigmentary maculopathy. However, macular damage from Elmiron can easily be misdiagnosed as age-related macular degeneration. Maculopathy can result in impairment or even loss of vision.

Elmiron Lawsuits

Hundreds of thousands of people have been exposed to Elmiron: the drug is still on the market.

The recent evidence showing that Elmiron causes serious eye damage is going to lead to a wave of lawsuits against the drug’s manufacturer. If you took Elmiron and were subsequently diagnosed with eye problems involving the retina such as maculopathy the drug maker can be held liable for your injuries.

There is already sufficient evidence establishing a link between Elmiron and retinal damage to support a product liability lawsuit. Hundreds and possibly thousands of Elmiron lawsuits are expected to be filed against Janssen Pharmaceutical.

We Are Accepting New Elmiron Eye Damage Cases

Our law firm is now actively seeking new Elmiron product liability cases. We are looking for individuals who meet the following basic criteria:

  1. You took Elmiron on a daily basis for a period of 6-months or longer; and
  2. After using Elmiron you experienced vision problems and were diagnosed with any of the following conditions:
    1. Maculopathy / macular retinopathy
    2. Age-related macular degeneration
    3. Retinal dystrophy
    4. Other retinal conditions

If you or a family member meet these criteria, contact our law office today for a free consultation to find out if you qualify for an Elmiron lawsuit.

Will There Be an MDL Class Action for the Elmiron Lawsuits?

At this point, we are still in the very earliest stage of the Elmiron eye damage litigation. The first few lawsuits against Janssen Pharmaceutical are just starting to get filed around the country. Everyone is fully expecting several thousands of individual Elmiron eye damage lawsuits to get filed eventually.

At some point in the next few months, all the Elmiron cases in the federal court system will likely be consolidated into an MDL class action. An MDL is similar to a class action lawsuit. All pending cases from around the country involving a single defective drug or product are consolidated under a single federal judge for pretrial discovery.

Claim details and basic information is gathered and compiled for all of the plaintiffs. Then a few individual “test” cases will be selected for trial and the results of those trials are used to negotiate a global settlement of all the remaining cases. Usually, the settlement has tiers or levels of payments to plaintiffs based on the severity of their injuries.

Potential Settlement Amounts for Elmiron Lawsuits

Right now the first Elmiron eye damage lawsuits are just getting filed, so we have no way of knowing for sure what the settlement value of these cases may end up being. However, we can estimate the value of the Elmiron cases by comparing them to the settlement value of prior cases involving similar injuries. Please keep in mind we are making a lot of assumptions here based on very little information. It is too early to accurately predict expected settlement values of these cases.

The victims in the Elmiron lawsuits are going to have the same basic injuries - vision impairment or loss of vision. We can look at the settlement value vision loss or vision impairment injuries in other tort cases to get an idea of what the settlement value of those injuries will be in the Elmiron litigation. Based on this data, we anticipate that Elmiron cases in which the plaintiff suffered total vision loss will have a settlement value of $1,000,000 or more.

Elmiron cases involving only vision impairment will likely be grouped into tiers based on the level of impairment to the plaintiff’s vision. The most serious injuries will involve permanent vision loss. Plaintiffs with the most extensive impairment to their vision (maybe 75%-80% impairment) will be in the top settlement tier (“tier 1). Plaintiffs with less impairment (40%-75%) will be in the next tier (“tier 2”) and there will likely be 2 or more lower tiers after that.

Based on average case values in other vision impairment lawsuits, we guess/believe that Elmiron impairment cases in tier 1 may have settlement value in the range of $300,000 to $600,000. Cases in tier 2 may have a settlement range somewhere between $75,000 and $250,000. Keep in mind that these are very general estimates that only account for the level of vision impairment.

Example Elmiron Lawsuits 

Below are two recently filed Elmiron lawsuits.

  • Worden v Janssen Pharmaceuticals, et al. (New Jersey): The plaintiff is a aintiff, in this case, was middle-aged woman living in upstate New York who took Elmiron for IC daily basis for 17 years. In 2020 the plaintiff was diagnosed with maculopathy and retinal damage that has permanently impaired her vision. The complaint brings claims for Strict Liability; Breach of Warranty; Breach of Implied Warranty; Negligence; Negligence Per Se; and Negligent Misrepresentation. Named defendants included Janssen Pharmaceuticals Inc. (and 2 Janssen subsidiaries); Johnson & Johnson; and Ortho-McNeil Pharmaceuticals, Inc. The Complaint was filed in May 2020 in the U.S. District Court for New Jersey. 
  • Allen v Janssen Pharmaceuticals, et al. (Pennsylvania): This putative class action was filed by a middle-aged female from Illinois who took Elmiron regularly from 2009 to 2020 for the treatment of her interstitial cystitis condition. The plaintiff here has actually not been diagnosed with maculopathy or suffered any vision damage or impairment. Rather, the plaintiff is alleging that her use of Elmiron has placed her (and others in the proposed class) at increased risk of severe visual injuries associated with Elmiron. This complaint seeks to force the defendants to establish a fund to pay for the plaintiff and other Elmiron users to have regular eye exams and diagnostic testing. This is called a medical monitoring lawsuit.  The complaint was filed in the U.S. District Court in Philadelphia.   

More Elmiron Eye Injury Medical Literature
  • 2020: Doiron, RC, et. al:  Possible drug-induced, vision-threatening maculopathy secondary to chronic pentosan polysulfate sodium (Elmiron®) exposure, Can Urol Assoc J. 2020 Feb; 14(2): 10–11, doi: 10.5489/cuaj.6401. This 2020 article, which came out after the Elmiron litigation, summarizes the literature and underscores the risks of newly understood risks of the drug.  
  • 2019: Jain N, et. al: Association of macular disease with long-term use of pentosan polysulfate sodium: Findings from a U.S. cohort. Br J Ophthalmol. 2019 Nov 6; doi: 10.1136/bjophthalmol-2019-314765
  • 2018: Pearce, WA, et. al: Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium, 2018 Nov;125(11):1793-1802. doi: 10.1016.  This study found unique pigmentary maculopathy in six patients taking pentosan polysulfate sodium. This is the article that set off alarms in the medical and scientific community we talked about above. 
Contact Us About Elmiron Eye Damage Lawsuits

If you believe your vision was lost or impaired because you used the drug Elmiron, call our product liability attorneys today at 800-553-8082 to discuss your legal options. You can also get a free case evaluation online.

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