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Elmiron Litigation Continues: What they still aren’t telling you…

The Product – Elmiron

Elmiron, also known as pentosan polysulfate sodium (PPS), is used to treat interstitial cystitis. Interstitial cystis is an ailment of the urinary tract system that may cause pain in the abdomen, pelvic and genital regions. Although Elmiron is not a cure to interstitial cystitis (IC), it aids in relieving some of the symptoms associated with bladder pain syndrome.

Recent Emiron Cases

 

Tina Prisco

Tina Pisco filed an Elmiron complaint on May 4, 2020. The complaint alleges that Elmiron caused Pisco to develop maculopathy. Pisco began taking Elmiron in 2012, and over the course of six years, her vision depleted. Then, in March 1019, Pisco was diagnosed with permanent retinal injury in both eyes.

Pisco filed a suit against Johnson & Johnson Pharmaceuticals and Janssen Pharmaceuticals, one of its subsidiaries, alleging the “dangerously defective prescription drug was designed, marketed, and distributed…while knowing significant risks that were never disclosed to the medical and healthcare community.”

Further, in her complaint, Prisco claims Janssen Pharmaceuticals “withheld material adverse events” and “failed to disclose the serious link between Elmiron use and significant visual damage, including pigmentary maculopathy.”

Janssen only described conjunctivitis, optic neuritis, amblyopia, and retinal hemorrhage as visual side effects to Elmiron, and these side effects fell in the “less than 1% category.” Additionally, Elmiron’s official website, prescription guide, and patient leaflet fail to mention permanent vision loss or maculopathy.

No official statements have been made by Johnson & Johnson or its subsidiary, Janssen Pharmaceuticals, but it is likely that both companies will deny the allegations.

Valerie Hull

As of June 8, 2020, Valerie Hull has filed a personal injury lawsuit against manufacturers of Elmiron.

Hull consistently took Elmiron throughout 2001-2018. As a result, Ms. Hull suffers from severe visual injuries, including changes in eye color pigment, severe vision loss, loss of night vision, and pigmentary maculopathy.

Ms. Hull and five others, who participated in the same study, displayed the same eye injuries but only shared one common medication which was Elmiron. Researchers and physicians have since associated the use of Elmiron with an increased risk of visual complications.

Approximately hundreds of thousands of patients have used Elmiron, yet the drug continues to be sold with little to no warning of potential vision complications. Up to 24% of Elmiron users, in some studies, have been found to have eye damage linked to the drug.

Kimberly Pelczar

Kimberly Pelczar filed a lawsuit on March 26, 2020, against Teva Pharmaceuticals USA Inc. and Janssen Pharmaceuticals because of vision loss she claims to be linked to Elmiron.

Pelczar began taking Elmiron in 2005. Then, in 2015, she began to suffer eye problems, and from 2015 to 2019, she saw multiple medical providers for her visual symptoms. In 2019, Pelczar was diagnosed with permanent retinal injury and vision loss which she claims to be a result of Elmiron toxicity.

The complaint alleges that drug makers failed to properly warn physicians and the public about the vision problems Elmiron could cause and further claims that drug makers actively tried to hide these side effects from the public.

Common Side Effects of Elmiron

As with most drugs, there are common side effects. With Elmiron, common side effects include nausea, diarrhea, abdominal pain, headaches, hair loss, bleeding, bruising, and changes in mental state.

Not so Common Side Effects of Elmiron

One significant complication is retinal maculopathy, an eye disorder. Researchers concluded a connection exists between chronic exposure to PPS and retinal maculopathy. Patients are encouraged to be screened regularly by an ophthalmologist if they experience unusual vision symptoms and to immediately stop using Elmiron if diagnosed with an eye disease.

In extreme cases, patients have suffered permanent vision loss. However, the most common symptoms of patients taking pentosan (Elmiron) include:

  • Image / Vision Distortion (e.g. when objects appear smaller or deformed)

  • Blind spot where patients are unable to see

  • Difficulty with adjusting to changes in lighting

  • Loss of vision

  • Trouble with focusing

Recommendations:

If you are taking Elmiron or have taken Elmiron, you should undergo a full eye examination even if you are not currently experiencing symptoms. This includes people who have not taken Elmiron over long periods of time as patients have demonstrated symptoms of eye disease as early as the age of 30. The eye damage is likely irreversible therefore patients on Elmiron should speak with prescribers as soon as possible.

To help the Food and Drug Administration (FDA) track issues with Elmiron, the FDA encourages both health professionals and patients to report any side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Please submit any relevant information through one of these outlets:

The MedWatch Online Voluntary Reporting Form

Contacting the FDA at 855-543-DRUG (3784) and pressing 4, or at druginfo@fda.hhs.gov.

Downloading the form, or calling 1-800-332-1088 to request a reporting form, then submitting the completed form by fax to 1-800-FDA-0178 or on the listed return address.

Are you entitled to compensation in the Elmiron lawsuits?

  1.  Were you prescribed Elmiron?

  2. Did you develop maculopathy symptoms, eye disorders, or other vision problems while taking the drug?

Note: Symptoms and injuries include but are not limited to maculopathy (macular degeneration), vision impairment or loss, unilateral or bilateral blindness, reduced nighttime and dark light vision, macular dystrophy, and retinopathy.

COPYRIGHT © 2020, STARK & STARKNational Law Review, Volume X, Number 203
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About this Author

Martin P. Schrama, Stark Law, Intellectual Property and Litigation Law Attorney
Shareholder

Martin P. Schrama is a Shareholder in Stark & Stark's Commercial Litigation, Mass Tort, Intellectual Property and Green Litigation Groups. Mr. Schrama has extensive experience litigating on both the trial and appellate levels of the federal and state courts of New Jersey and New York, as well as numerous other jurisdictions throughout the nation in a pro hac vice capacity. This experience also extends to regular practice before AAA, JAMS and various other alternate dispute resolution fora.

The primary focus of Mr. Schrama’s practice is...

609-895-7334
Stefanie Colella Walsh, Pharmaceutical Litigation Attorney, Stark Law Firm
Shareholder

Stefanie Colella-Walsh is a Shareholder and member of Stark & Stark’s Litigation, Insurance Coverage & Liability, Intellectual Property and Mass Torts Groups where she concentrates her practice in complex litigation with a focus in mass tort and pharmaceutical litigation. She also handles litigation related to nursing home negligence and abuse claims, elder abuse, and assisted living facility litigation.

Recently, Ms. Colella-Walsh was a member of the national trial team involved the first trial in the country of a TVT-Secur transvaginal...

609-219-7416
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