Elmiron is a prescription brand name for pentosan polysulfate sodium. It has been approved by the FDA since 1996 as a treatment for the symptoms of interstitial cystitis, a chronic condition causing bladder inflammation and pelvic pain. Although there is no cure for interstitial cystitis, taking Elmiron can help patients manage their discomfort and minimize the impact on their lives.
Thousands of people who used Elmiron have filed individual lawsuits or joined class action claims against its manufacturer, Janssen Pharmaceuticals.
The manufacturer has settled many of these claims out of court, and others may go to trial in 2024. Because these settlements have been confidential, we don’t know how much plaintiffs received. This article explains the Elmiron lawsuits and discusses how much a product liability settlement or jury verdict could be in these or similar cases.
What Are The Claims In The Elmiron Lawsuits?
The FDA first approved Elmiron in 1996 to treat the symptoms of interstitial cystitis, including bladder pain and inflammation. Over time, clinical reports began to link Elmiron use to a rare eye condition called pigmentary maculopathy. This condition involves damage to the retina (the tissue at the back of the eye), leading to vision problems and even blindness.
Researchers began investigating the potential link between Elmiron and vision problems as more cases surfaced. In 2018, a study published in the journal Ophthalmology reviewed several cases of patients who developed pigmentary maculopathy after long-term use of Elmiron. Subsequent additional studies and published research supported a causal link between the drug and the disorder. In 2020, the FDA warned about potential vision risks associated with long-term use of Elmiron.
Since then, additional research has reinforced the association between Elmiron and vision problems, including loss of central vision, blurry or distorted vision, loss of color vision, or impaired depth perception. In June 2020, Janssen added a warning about these risks to Elmiron’s packaging and literature. The risk of severe side effects has prompted healthcare providers to reconsider its use and explore alternative treatments for interstitial cystitis.
Consumers harmed by dangerous or defective products may pursue product liability claims against their manufacturers and distributors. Generally, plaintiffs in product liability cases do not need to prove that the defendant acted negligently or intentionally. A defendant can be liable for a design or manufacturing defect that makes the product unreasonably dangerous to use.
Manufacturers also have a legal duty to disclose dangerous side effects or risks associated with using a particular product, including prescription drugs. Failing to warn consumers of potential safety dangers is considered a type of “marketing defect” that can expose a manufacturer to liability in a product liability lawsuit.
In the Elmiron lawsuits, it is clear that Janssen did not include any warning about the risk of vision damage associated with the drug until 2020. Plaintiffs who took Elmiron before that time have a good chance of succeeding in a product liability lawsuit if they establish that they used the drug as intended and suffered compensable injury or harm. Patients who used the drug after 2020 may still be able to recover but should discuss their situations with an experienced attorney.
How Much Money Can I Get From The Elmiron Lawsuit?
Every settlement is unique. Valuing each Elmiron claim depends on many things, including:
- The nature and severity of each plaintiff’s injuries.
- Any contributory fault by the plaintiff—such as taking the medication improperly.
- The evidence that can be proven against the defendant.
No federal law governs product liability claims, so the compensation available to plaintiffs depends on where they filed their case.
Plaintiffs may be able to recover compensation for medical expenses, pain and suffering, lost wages, emotional distress and other losses related to their use of the drug. In some states, plaintiffs may ask the jury to award punitive damages if they find Janssen engaged in intentionally deceptive marketing practices related to Elmiron or covered up known risks.
As of March 2024, 1,865 Elmiron cases are pending in the multidistrict litigation (MDL) in the U.S. District Court of New Jersey. Janssen has settled more than 100 MDL cases in private, confidential settlement agreements, making it difficult to estimate what others may be worth. Previously scheduled trial dates in the “bellwether” cases have been canceled, and the cases remain on hold while settlement negotiations are ongoing.
In cases like the Elmiron lawsuits, which affect thousands of injured plaintiffs, corporations often negotiate “global” settlement packages that resolve many cases simultaneously. This can help streamline the recovery process for each claim so that each plaintiff doesn’t have to go to trial separately.
The Elmiron plaintiffs will likely work to negotiate such a settlement to resolve the ongoing claims. Although the total settlement amount may be millions or billions of dollars, the amount recovered by each plaintiff will depend on the case’s unique circumstances. Janssen may also establish a settlement fund to pay future claims related to Elmiron.
Consult An Attorney For An Elmiron Injury Claim
If you have suffered adverse effects or injuries, such as vision issues, after using Elmiron, it’s vital to consult an attorney with experience handling pharmaceutical litigation. Acting promptly is essential. Time limits, known as statutes of limitations, can affect your ability to file a lawsuit. The progress of the existing litigation and settlement negotiations may also affect where and how you can pursue a claim.
A proficient legal team can help you determine whether you have a valid claim for an Elmiron injury lawsuit and, if so, work with you to pursue the compensation you deserve.
