Emerging Mass Tort: Women Sue After the Bladder Pain Drug Elmiron Causes Eye Damage

Litigation is building against three major drug companies that make Elmiron, which treats painful bladder syndrome. Studies show it damages the retina in the eye and causes severe vision loss, particularly in women.

Shockingly, the drug label contains no warning about eye damage.

A major study released on October 12, 2019, found that about 25 percent of patients taking the drug show signs of retinal damage. As a result, plaintiffs have filed vision loss lawsuits against Janssen Pharmaceuticals, Teva Branded Pharmaceuticals, and Ortho-McNeil Pharmaceuticals. The lawsuits focus only on brand-name drugs and charge that the manufacturers failed to warn the public about the risk of vision problems properly.

For many years, pentosan polysulfate, known by its brand name Elmiron, is the most commonly prescribed drugs for patients suffering from interstitial cystitis (IC), a rare and extremely painful bladder condition. Currently, it’s the only oral drug approved to treat bladder pain and discomfort associated with IC, and it’s not available in generic.

Elmiron causes pigmentary maculopathy, or macular degeneration, affecting the retina, resulting in:

● Blurry Vision
● Night blindness
● Difficulty Reading
● Dark Spots in Vision
● Loss of Detailed Vision
● Blurred vision
● Seeing dark spots
● Color blindness
● A change in eye color
● Blindness

Elmiron was approved in 1996 by the FDA to treat IC, a chronic, progressive, and debilitating urinary bladder disease. The sickness causes severe bladder and pelvic pain and the urge to urinate constantly. According to the Mayo Clinic, IC can cause complications, including reduced bladder capacity, lower quality of life, sexual intimacy problems, and emotional troubles.

Toxic to retina

Research presented in October 2019 to the American Academy of Ophthalmology linked Elmiron to retinal damage. Researchers concluded that Elmiron “appears to be toxic to the retina,” which is a thin layer of tissue at the back of the eye that receives light and allows us to see. The study, conducted by three ophthalmologists at Kaiser Permanente in California, reviewed 140 patients who had taken an average of 5,000 pills each for 15 years. They found that the rate of toxicity rose with the amount of drug consumed.

The first to raise the alarm about Elmiron eye damage was Dr. Nieraj Jain of the Emory Eye Center in Atlanta, GA. In 2018, he reported that six patients who had been taking Elmiron for about 15 years had developed unusual changes in their macula, the central part of the retina responsible for delivering clear, crisp, central vision. Because nothing in the patients’ medical history or diagnostic tests explained the subtle, but striking pattern of abnormalities, Dr. Jain and his colleagues raised a warning flag that long-term use of Elmiron may damage the retina

Health Canada announced in October 2019 that that pigmentary maculopathy would be added to the warnings and precautions on the drug label. However, the FDA did not add this change to the label.

Multiple lawsuits

Plaintiff demographics involve mostly women between the ages of 37 to 79 years. Common presenting symptoms include blurred vision, prolonged dark adaptation, and metamorphopsia (which is a type of distorted vision in which a grid of straight lines appears wavy and parts of the grid may appear blank).

Levy Konigsberg LLP and Napoli Shkolnik PLLC filed a product liability lawsuit against the manufacturers for failing to warn plaintiff Valerie Hull of the serious eye and vision injuries. Plaintiff Valerie Hull, a South Carolina resident, was documented as “patient zero” in the 2018 study by Emory Eye Center. The complaint, case No. MID-L-003646-20, was filed on June 9, 2020, in the Superior Court of New Jersey, Middlesex County, naming Janssen Pharmaceuticals and Teva Branded Pharmaceutical Products R&D as defendants.

Johnson // Becker, PLLC filed Pelczar v. Teva Branded Pharmaceuticals R&D, et al. was filed in the United States District Court for the District of Connecticut on March 26, 2020. Defendants include Teva Branded Pharmaceuticals and Janssen Pharmaceuticals.

The firm also filed the case Allen v. Janssen Pharmaceuticals, Inc. et al. in the US District Court for the Eastern District of Pennsylvania on May 6, 2020. It seeks class certification to establish a fund to be used for medical monitoring of patients using Elmiron to monitor the status of their vision.

Plaintiff Tina Pisco filed an Elmiron lawsuit on May 4, 2020, against Janssen and Johnson & Johnson, charging the medication caused her to develop maculopathy. Pisco started taking Elmiron in 2012 to treat interstitial cystitis. In 2018 she noticed that her vision was rapidly deteriorating. By March 2019, she was diagnosed with permanent retinal injury in both eyes, according to her lawsuit.

Pisco claims that the “dangerously defective prescription drug” was “designed, marketed, and distributed . . . while knowing significant risks that were never disclosed to the medical and healthcare community.” Pisco alleges that Janssen “withheld material adverse events” and “failed to disclose the serious link between Elmiron use and significant visual damage, including pigmentary maculopathy.”

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