In recent years, doctors found that a drug prescribed as a treatment for painful bladder disorders links to serious, and often permanent, vision impairment. If you take the drug Elmiron and suffer from a condition called maculopathy, you may be entitled to compensation against the manufacturer under product liability case law. Product liability cases result when manufacturers sell drugs to a trusting public. Manufacturers’ glowing promises to help patients turn sour when the drug proves hazardous to humans after ingestion.
What Is Elmiron?
Elmiron is the brand name for a drug called pentosan polysulfate sodium (also known as PPS). PPS is classified as a urinary analgesic, or a pain reliever, and is a mild or weak blood thinner. Doctors use PPS to treat painful bladder conditions. Because the drug is not available in a generic form, the manufacturers currently enjoy market dominance. Sales of the drug bring in about $150 million a year.
The Food and Drug Administration approved Elmiron in 1996. The drug manufacturer, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), put Elmiron on the market in the late 1990s. Elmiron is the only drug approved to treat pain associated with interstitial cystitis (also known as IC). Millions of Americans suffer from IC each year. IC affects both men and women, although doctors prescribe Elmiron to women two to three times more often than men.
Patients take Elmiron by mouth to treat bladder pain and pressure from chronic IC. Elmiron’s most common side effects are:
● hair loss (alopecia)
● abdominal pain
● abnormal liver function
● rectal bleeding, gum hemorrhage, and bruising (Elmiron is a mild blood thinner) and
● weight gain.
Elmiron is not an anti-inflammatory. Elmiron forms a barrier against substances that might irritate the bladder wall. That helps IC patients because of damage to their bladders’ protective lining. Elmiron does not cure IC but it does give patients some relief from painful IC symptoms. Symptoms include:
● urgent urination,
● burning sensation,
● pain, and
● tenderness in the lower abdomen and pelvic area.
Elmiron’s Vision Damage Claims
From 1996 until earlier this year, Elmiron’s medication instructions/alerts did not mention vision problems, eye damage, or eye disease. In 2018, the Journal of Urology reported that long-term use of the drug caused injury to the retina and to the retinal pigment epithelium. Recent studies indicate that pigmentary maculopathy damage seems unique to Elmiron patients.
In 2019, a report noted that PPS related maculopathy continued to worsen even after stopping the drug. Maculopathy is progressive and leads to loss of vision. The macula is the part of the retina that controls a person’s ability to read, see fine details, recognize faces, see colors, and focus.
The lawsuits filed against Elmiron include claims that plaintiffs suffered adverse events causing retina damage and symptoms of:
● blurry vision (often in center of visual field),
● retinopathy, and
● general vision impairment.
In October 2019, Health Canada published an Elmiron label update containing information about the potential for pigmentary maculopathy for long-term users. In December 2019, Kaiser Permanente researchers published a report in the American Journal of Ophthalmology Case Reports that a case originally misdiagnosed as Stargardt disease was later found to be PPS maculopathy.
It wasn’t until June 2020 that Janssen Pharmaceuticals revised the Elmiron label to include a warning about vision problems that may not stop after terminating drug use and may be irreversible.
What Qualifies as a Plaintiff for Elmiron Litigation?
You may qualify as a plaintiff in an Elmiron product liability case if you:
● took Elmiron for at least two years,
● have vision problems,
● still take the drug, or
● started having vision problems that persisted or worsened within one year of stopping treatment.
Some eye damage that appears in the lawsuits are:
● degenerative maculopathy,
● halo vision,
● macular retinopathy,
● pigmentary maculopathy,
● reduced night vision, and
● unilateral or bilateral blindness.
Your medical records will help an attorney confirm the diagnosis and tell the attorney what your doctor predicts for your condition going forward. Be prepared to discuss the emotional toll the condition takes on your life as well as how the condition affects day-to-day activities.
Doctors often prescribe Elmiron as a long-term regimen. That gives the drug the potential to inflict harm on hundreds of thousands of users. Product liability lawyers review potential plaintiffs for a growing number of lawsuits.
Attorneys filed the lawsuit Pelczar v. Teva Branded Pharmaceuticals R&D in the US District Court for the District of Connecticut on March 26, 2020. Janssen Pharmaceuticals is also one of the defendants.
On May 6, 2020, attorneys filed Allen v. Janssen Pharmaceuticals, Inc., et al. in the U.S. District Court for the Eastern District of Pennsylvania seeking class-action certification that would create a fund for medical monitoring of the vision status of Elmiron patients.
In May 2020, Tina Pisco filed a lawsuit against Janssen Pharmaceuticals claiming that Elmiron caused her to develop degenerative maculopathy in both eyes. Ms. Pisco started taking Elmiron in 2012 for IC. In 2019, she was diagnosed with permanent retinal damage to both eyes. Ms. Pisco’s complaint accuses Janssen Pharmaceuticals of “withholding material adverse events, including the causal link between Elmiron and maculopathy.” The label prior to June 2020 indicated that there were no warnings about the use of the product.
Valerie Hull was designated “patient zero” in Emory Eye Center’s 2018 study linking Elmiron to vision disorders. Ms. Hull’s complaint was filed on June 9, 2020, in Superior Court of New Jersey against defendants Janssen Pharmaceuticals and Reva Branded Pharmaceutical Products.
From its introduction into the market in 1996 until June 2020, Janssen Pharmaceuticals marketed Elmiron as a safe drug even though they knew there were significant risks associated with taking the drug. Researchers found that in an unmasked clinical trial in the 1990s reports indicated adverse vision and eye events. Those risks were never disclosed to physicians or patients in the medical community.
What Damage Awards Are Poss