Elmiron Injury Lawsuits

Have you or a member of your family experienced vision or eye problems after taking Elmiron? After taking Elmiron, have you or a family member been diagnosed with Maculopathy?

Elmiron: What is it?

Elmiron, manufactured by Janssen Pharmaceuticals, is used to treat Interstitial Cystitis, a disorder of the urinary tract that causes abdominal and pelvic pain. The pain may be intermittent or persistent, and the condition is frequently accompanied by frequent urination. Interstitial Cystitis is also known as Bladder Pain Syndrome on occasion. The condition affects millions of women and a much smaller number of men in the United States.

Elmiron functions by attaching to the bladder wall and acting as a barrier between irritating substances and the bladder. It has been on the market since the late 1990s and is the only drug FDA-approved to treat Interstitial Cystitis-related pain.

Elmiron: Possible Side Effects and Irreversible Injuries

Recent studies have revealed that Elmiron-prescribed and -used patients have developed maculopathy, an eye disorder that can lead to blindness. Medical experts now recommend that Elmiron patients undergo ophthalmic examinations for the early detection of maculopathy.

The manufacturer of Elmiron did not adequately test the drug prior to its release or warn patients of the risks associated with its use.

Elmiron is specifically associated with pigmentary maculopathy. The macula is a highly sensitive and crucial portion of the eye for accurate vision. Maculopathy is usually referred to as macular degeneration. This condition has been linked to the gradual loss of central vision that has been associated with Elmiron use.

  • impaired vision
  • Reading difficulties Difficulty adjusting the eyes to darkness
  • Having difficulty seeing nearby objects
  • Vision deteriorates
  • Lost area of vision in the visual field
  • Metamorphosia (visual defect that causes linear objects to appear curved or rounded) (visual defect that causes linear objects to appear curved or rounded)

Vision issues and retinal damage brought on by Elmiron may manifest in a variety of ways, depending on the patient’s prescribed dose and duration of treatment.

  • Total vision loss
  • Partial vision loss
  • impaired vision
  • diminished night vision
  • Pigmentary maculopathy
  • Degenerative macular disease
  • Halo vision
  • Macular retinal disease
  • Pattern/macular dystrophy
  • Maculopathy
  • Metamorphopsia
  • Atrophy of the retinal pigment epithelium
  • Retinopathy
  • Scotoma
  • Blindness unilateral or bilateral
  • Vision impairment

Janssen Pharmaceuticals did not mention the risks of vision problems or Maculopathy in their prescribing information and warning labels for many years, despite the fact that studies have documented irreversible vision problems associated with the long-term use of Elmiron since 2018.

In addition, the manufacturer filed with the FDA over 100 reports of eye-related injuries (including maculopathy) between 1997 and 2019, the majority of which were classified as “serious.”

In June 2020, Janssen Pharmaceuticals updated its prescribing information in the United States to include the following: “Pigment changes in the retina of the eye (also known as pigmentary maculopathy in medical journal articles) have been reported with long-term use of Elmiron. While the cause of pigmentary changes is unknown, long-term administration of ELMIRON® may be a risk factor…”

Despite receiving over 100 reports of vision problems over a 20-year period, Janssen Pharmaceuticals did not warn doctors or patients about the potential risk of vision impairment associated with Elmiron. Responsible drug manufacturers typically include warnings on their package inserts after receiving fewer reports of serious side effects.

They are obligated to provide this information so that patients and their physicians can decide whether to use Elmiron based on the best available data. Janssen Pharmaceuticals decided to withhold information about the connection between Elmiron and Maculopathy despite complaints of these adverse events. To date, Janssen Pharmaceuticals has not conclusively linked Elmiron’s long-term use with the occurrence of serious adverse effects.

Case Study Suggests Maculopathy Can Develop Years After Stopping Elmiron

According to doctors from the Emory University School of Medicine in Atlanta, Georgia, a 44-year-old woman complained of vision problems three years after she stopped taking Elmiron. Examining her, doctors determined that she had “pentosan polysulfate maculopathy” or “Elmiron-induced maculopathy.”

Before discontinuing Elmiron, the woman displayed no symptoms of this condition, indicating that it developed well after she stopped taking the medication. The case suggested that new-onset maculopathy may develop years after a person discontinues use of a harmful drug.

This study suggests that you may still have a case if your symptoms return years after you stopped taking Elmiron. You will meet with AbramsLaw Group, P.C. to discuss your case and legal options.

Do I have an Elmiron Injury Lawsuit?

The only way to determine if you have a valid legal claim against Janssen Pharmaceuticals is to discuss the specifics of your case with an experienced New York City mass tort injury attorney. Consider scheduling a free consultation with AbramsLaw Group, P.C. if any of the following apply:

  • You or a member of your family used Elmiron and are experiencing vision issues; or You or a member of your family used Elmiron and are experiencing early symptoms of Maculopathy; or You or a member of your family used Elmiron and have been diagnosed with Maculopathy.

The knowledge that you or a family member have suffered a severe injury and/or death due to a dangerous drug can be traumatic for both the individual and the family. Using such a dangerous drug could result in significant problems in the future due to your injuries, leaving you liable for medical bills, pain and suffering, and lost wages, which could have a devastating effect on your finances.

There is no downside to discussing your case and learning about your legal options with an attorney. Your initial consultation with one of our personal injury attorneys in New York City is free of charge.

How much is my Elmiron case worth?

Every case is unique. The value of each case will ultimately depend on a number of variables, including:

  • Your or your family’s current and future medical costs
  • The severity of injuries/ultimate cause of death
  • What your prognosis or that of a loved one is and what the road to recovery will look like.
  • The emotional and psychological impact of your injury or death on you or your family

In general, plaintiffs in Elmiron personal injury lawsuits will be able to recover both economic (monetary) and non-economic (intangible) damages. This may include medical expenses, lost wages and income, emotional distress, mental anguish, and pain and suffering.

AbramsLaw Group, P.C. can assist you during this challenging time. Call our law office today to discuss your legal rights.

Pharmaceutical Companies, Dangerous Drugs, and New York Product Liability Laws

Even though drugs like Elmiron must undergo rigorous testing to receive FDA approval, dangerous medications can still make their way onto the market and into the hands of patients. Unfortunately, the agency cannot be expected to monitor everything and ensure the safety of all products, especially after they have been approved and released onto the market.

To compensate for this, states such as New York have enacted product liability laws to ensure that businesses have an incentive to sell only safe products.

Pharmaceutical companies can be held strictly liable under New York’s product liability laws if the drugs they design, manufacture, or market are dangerous and cause harm.

Strict liability means that Elmiron users who sustain injuries do not need to prove negligence. Regardless of the company’s level of care in creating or selling the drug, it bears financial and legal responsibility.

Keep in mind that New York has a time limit for filing a product liability lawsuit against a pharmaceutical company. The statute of limitations is typically three years from the date of injury (or discovering that injury).

Schedule a Free Consultation to discuss your Elmiron Injury Lawsuit

You or a family member were prescribed Elmiron for the treatment of interstitial cystitis or painful bladder syndrome, and you or they subsequently developed poor eyesight, vision loss, or even blindness. If so, you may be able to file a lawsuit against Janssen Pharmaceuticals, the manufacturer of the harmful drug.

The New York City mass tort injury attorneys at AbramsLaw Group, P.C. are able to guide you through the process and maximise your financial recovery.

Contact Our Personal Injury Law Firm

Contact Abrams Law Group for a free consultation if you’ve been hurt in an accident and require legal assistance.

Abrams Law Group
104-70 Queens Boulevard, Suite 502
Forest Hills, NY 11375
(718) 997-9797

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