Elmiron Lawsuit Update and Settlement Report (2024)

Janssen Pharmaceuticals has settled hundreds of outstanding Elmiron lawsuits. Learn more about these settlements and the ongoing litigation.

Reviewed By Adam Ramirez, J.D.

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Elmiron Lawsuit Update and Settlement Report (2024)

This article will explore the details of the Elmiron lawsuits and discuss the latest updates about what's happening in court. We will review the facts of these cases and help individuals affected by Elmiron better understand the current legal situation.

Curious about other health-related lawsuits? See Ozempic lawsuit

What Is Elmiron?

Elmiron is a prescription drug developed and manufactured by Jannsen Pharmaceuticals (a subsidiary of Johnson & Johnson). The FDA has approved it in 1996 to treat interstitial cystitis, a chronic condition that causes bladder inflammation and pelvic pain. Elmiron is not a cure but can help patients reduce discomfort and manage their condition.

What Are the Side Effects of Elmiron?

In the early 2000s, clinicians began to notice an unusually high correlation between patients taking Elmiron and a rare eye condition called pigmentary maculopathy. This disorder involves damage to the tissue at the back of the eye (the retina). Because patients take Elmiron for a bladder condition, it took many years for doctors and researchers to connect the increase in pigmentary maculopathy with the drug.

A study published in 2018 in the journal Ophthalmology analyzed various instances where patients developed pigmentary maculopathy following prolonged use of Elmiron. Subsequent research bolstered the evidence of a direct connection between the medication and the disorder. In 2020, the FDA issued a cautionary advisory regarding potential vision hazards linked to the extended use of Elmiron.

Since then, research has reinforced the association between Elmiron and many different vision problems. These include loss of central vision, impaired depth perception, blurry or distorted vision, loss of color vision, loss of night vision, maculopathy, retinopathy and vision impairment. They can be severe and permanent.

Janssen added a "black box" warning about these risks to the packaging and literature of Elmiron in June 2020. Equipped with this information, physicians can more effectively assess whether to recommend the medication or consider alternative therapies for interstitial cystitis. Additionally, they are better prepared to recognize the initial indicators of eye issues associated with the drug.

Why Are There Elmiron Lawsuits?

While the FDA warning and the updated package disclosures helped prevent injuries after 2020, thousands of patients had already suffered harmful effects from years of Elmiron use. Many of these patients have filed lawsuits against Janssen Pharmaceuticals.

Individuals who have been injured by dangerous or defective products, including pharmaceutical products, may have grounds for a product liability. Manufacturers and distributors can be liable for a design flaw or manufacturing defect that makes the product unreasonably dangerous.

Manufacturers are also obligated to disclose any hazardous side effects or risks linked to the usage of a specific product, including prescription medications. Failing to warn consumers about potential safety hazards can render a manufacturer liable in a product liability lawsuit.

It's usually not necessary to prove that a defendant acted negligently or intentionally in a product liability case. However, some lawsuits also include allegations that Janssen knew of and deliberately downplayed the risks, engaged in deceptive marketing practices or engaged in other unethical conduct that prioritized profits over patients.

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Is There an Elmiron Class Action Lawsuit?

Thousands of product liability cases are filed in the U.S. every year. When many cases are filed about a particular drug or product, there are a few different ways the courts can help them move more quickly and efficiently toward resolution.

One of these tools is a class action lawsuit, where a single individual or a small group of plaintiffs sue on behalf of a larger class of people with similar damages. This leads to a judgment or settlement that will bind all class members, even if they aren't named (or even aware) of the case.

A judge must approve plaintiffs' request to certify a case as a class action, and there are many procedural rules. In November 2020, a Pennsylvania federal court judge issued a ruling that prevented a nationwide Elmiron class action lawsuit. It held that patients must file Elmiron-related claims individually against Janssen to recover damages.

Federal courts often use a "multidistrict litigation" (MDL) system to streamline the process of resolving similar claims. MDL allows a single judge to oversee common questions of fact, procedural issues and the discovery process (gathering documentary evidence and testimony) before the cases go to trial individually.

Many state courts have similar programs allowing plaintiffs to consolidate their lawsuits for discovery and pre-trial matters. The strongest cases are designated "bellwether" cases and scheduled first for trial. The outcome of these often determines the fate of the remaining cases.

Where Are the Elmiron Lawsuits?

Since 2020, thousands of plaintiffs have filed Elmiron lawsuits. Some of these have been dismissed, while others have been settled. Most of the nearly 2,000 federal cases were grouped into multidistrict litigation (MDL 2973) in the U.S. District Court of New Jersey. (The headquarters of Janssen's parent company, Johnson & Johnson, are located in New Jersey.) As of May 2024, there are 1,829 active cases remaining in the New Jersey MDL.

Other state court cases were also filed in Pennsylvania, where Jansson is incorporated and headquartered. In response to the flood of state court cases, the state developed and implemented a new system to manage complex litigation like the Elmiron claims. The Elmiron mass tort program, which operates similarly to MDL, began collectively overseeing nearly 150 state court cases in September 2022.

What Is the Latest on the Elmiron Lawsuits?

The first bellwether trial in the Pennsylvania Elmiron mass tort cases was scheduled to begin in March 2024. It did not proceed. Instead, Janssen settled most of the state court cases privately with confidential settlement agreements. While a handful remain unresolved, no bellwether cases will go to trial.

Janssen has also confidentially settled more than 100 of the New Jersey MDL cases and continues to engage in active settlement negotiations. The court has been actively facilitating this process to encourage the resolution of plaintiffs' claims. Previously scheduled trial dates for the MDL bellwether cases have been canceled and suspended indefinitely.

Elmiron Lawsuit Settlement Amounts

Janssen has used confidential settlement agreements to resolve the Elmiron lawsuits. This means that the nature and amount of the settlement payments are unknown. Most confidential settlement agreements prohibit plaintiffs from discussing these terms with anyone except their spouse, attorney and financial professionals.

Determining the value of an Elmiron claim depends on many factors, including the nature and severity of a plaintiff's injuries. Individuals with complete vision loss or significant impairment will likely recover much more than plaintiffs with less severe injuries. Encouragingly, awards and settlements in other toxic tort cases (like asbestos-related claims and RoundUp lawsuits) have been steadily rising over the last few decades.

How to Join Elmiron Lawsuit

If you have taken Elmiron and experienced problems with your vision, consult with a pharmaceutical litigation attorney as soon as possible. An experienced Elmiron lawyer can help you determine whether you are eligible to pursue a claim for compensation.

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Jamie Pfeiffer, J.D.

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She writes accessible, engaging content to demystify everyday legal issues for all readers and is passionate about food, wine, and travel.

Frequently Asked Questions

  • Every Elmiron claim is different. Because liability is fairly well established, patients who took the drug before 2020 and experienced vision problems will likely recover compensation for their medical expenses and other economic damages. How much additional compensation they recover for pain, suffering and other non-economic damages generally correlates with the severity and permanence of their injuries.

  • If you took Elmiron before 2020, you may be able to recover compensation even if you don't currently have vision problems. Vision problems due to Elmiron can develop after patients stop taking the drug. You may need to visit your eye doctor more frequently to monitor for any changes. You should consult with an Elmiron attorney to discuss whether you may be able to seek compensation for additional medical expenses and other damages.

  • The FDA has never issued a recall for Elmiron, although it issued a cautionary advisory in 2020 connecting extended usage of Elmiron with an increased risk of developing pigmentary maculopathy and other vision problems.

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