Everything You Need to Know About Elmiron® Lawsuits: Part II

Elmiron®, a popular medicine used to treat bladder problems. Click here to read the first part.

In the first installment of this two-part article series, we explained what the Elmiron® lawsuit is and how it is presumed to treat interstitial cystitis. In this post, we explain how one small study led to the discovery of previously undisclosed, dangerous side effects of this drug. We will also show why Janssen Pharmaceuticals might be considered legally responsible for injuries caused by Elmiron® and what you can do if you feel you may have a valid legal claim against the drug’s manufacturer.

The Controversy Emerges

In 2018, a group of researchers from Emory Eye Center, a clinical eye care and research facility in Atlanta, Georgia, published a study presenting some evidence that long-term exposure to pentosan polysulfate sodium (the active ingredient in Elmiron®) may cause a dangerous eye condition affecting the retina and leading to a gradual loss of central vision. 

The researchers performed diagnostic tests on the eyes of six patients who had been regularly taking Elmiron® over the span of 15 years. They established that the patients all suffered from a condition known as unique pigmentary maculopathy. The term describes unusual, pathological changes to the macula, which is “the central part of the retina responsible for delivering clear, crisp, central vision.” The researchers found no other possible explanation of the abnormalities except for the long-term Elmiron® use. 

In 2019, the results of that initial research were further corroborated by another study conducted on a more representative sample of 91 patients. All participants had taken an average of 5,000 pills each over the course of 15 years. Nearly 25 percent of the patients tested showed clear signs of retinal abnormalities. Plus, the extent of damage to the retina rose with the amount of drug consumed by a given patient. These results are viewed as strong evidence to back up the researchers’ initial hypothesis that long-term exposure to pentosan polysulfate sodium may be correlated with abnormal changes to the retina.

Legal Ramifications of Elmiron®’s Side Effects Risk

Pharmaceutical companies are legally obliged to ensure that the medications they manufacture and distribute are reasonably safe for the consumers. As we mentioned in the first part of this article, there are no drugs that cause absolutely no side-effects. However, a drug manufacturer must exercise care and caution and make reasonable efforts to discover all adverse effects its product may have on a person’s health. In addition, it must also provide a clear and sufficient warning of all possible side-effects on the drug’s label so that any patient can make an informed decision whether or not they will use the medicine.

Under product liability law, a failure to exercise such care and caution may render a drug manufacturer legally responsible for any injuries a person may have sustained due to the use of a particular drug. For a pharmaceutical company to be found liable in a drug injury claim, the injured patient must prove that the company has acted negligently or recklessly. 

Here some of the ways which may constitute negligence or recklessness of a drug manufacturer:

• The manufacturer purposely concealed a dangerous side effect of a drug.
• The manufacturer did not know of a drug’s dangerous side effect that they reasonably should have known about.
• The manufacturer did not include a proper warning of a drug’s known side effect on the drug’s label.
• The manufacturer engaged in fraud or deceptive marketing practice.

Some of the legal principles mentioned above may well apply to Janssen Pharmaceuticals, the manufacturer of Elmiron®. People who used the drug for years had no way of knowing that pentosan polysulfate sodium may cause changes to the retina that might lead to some loss of vision. Therefore, in a potential lawsuit, it is possible that a jury might find Janssen Pharmaceuticals liable for the injuries resulting from the long-term use of the drug. In this case, a jury may award the victim of such an unjust injury financial compensation for the related financial losses.  

Drug injury lawyers across the country are now evaluating and accepting new cases related to Elmiron® eye damage. A person may qualify to file a personal injury claim against Janssen Pharmaceuticals if he or she has had prolonged exposure to pentosan polysulfate sodium. In other words, potential claimants will have used Elmiron® for a considerable time–in most cases, at least a year. 

Qualified claimants must also experience at least one of the following symptoms:

If you feel you may be eligible to file a claim against Janssen Pharmaceuticals in relation to your eye damage and injury from Elmiron®, you should contact an experienced drug injury lawyer. You may find more helpful information with regard to your legal rights and options on our dedicated Elmiron® lawsuits page.