01

What is Elmiron?

Elmiron is the brand name for pentosan polysulfate sodium, a prescription drug that treats the painful bladder condition, interstitial cystitis. Elmiron is the only oral drug available for the millions of Americans who suffer from interstitial cystitis. Most interstitial cystitis patients are women, many of whom are long-term Elmiron users.

Janssen Pharmaceuticals—a subsidiary of the behemoth healthcare company, Johnson & Johnson—has manufactured and distributed Elmiron in the U.S. since its 1996 FDA approval. Janssen licensed the rights to produce the drug from its original developer, Teva Pharmaceuticals. Janssen earns an estimated $150 million in Elmiron sales every year.

02

How Does Elmiron Work?

Elmiron is a treatment, but not a cure, for interstitial cystitis. Elmiron’s primary action is as an anticoagulant. Though the exact mechanical function is not clear, it is believed Elmiron use may help restore thinned or damaged areas of the bladder’s surface where leakage has occurred. The bladder’s surface is made up of glycosaminoglycans (GAG layer), a coating of protective mucus. The job of the mucus is to protect the bladder wall from bacteria and irritating substances found in urine. The general assumption is that treatment with Elmiron provides a synthetic GAG layer for the damaged bladder surfaces associated with interstitial cystitis.

Officially categorized under the spectrum of diseases called painful bladder syndrome, the precise cause of interstitial cystitis is unknown. Interstitial cystitis is a painful condition where urinary bladder inflammation leads to pelvic pain and abnormally frequent urination. Sufferers of this chronic condition experience bladder pressure and pain that can range from mild discomfort to severely painful levels. Interstitial cystitis also disrupts the communication signals between the bladder and the brain that regulate the need to urinate. Interstitial cystitis patients typically feel the urge to urinate frequently and produce smaller amounts of urine. Doctors have been prescribing Elmiron for interstitial cystitis patients for almost 20 years.

03

Elmiron Side Effects

Indications of adverse side effects from Elmiron date back to the drug’s clinical trials in the 1990s. These initial trials, administered by researchers at the Emory Eye Center, first found that a number of Elmiron patients experienced vision loss, macular degeneration, and other eye-related problems. Additional side effects included optic neuritis and retinal hemorrhage. Despite these results, Elmiron was still approved by the FDA.

But it wasn’t until 2018 that true alarm bells were sounded for Elmiron’s risks to vision health— particularly a degenerative eye disease called maculopathy. Doctors from the Emory Eye Center—the very same site as the drug’s clinical trials—observed unusual macula changes in six patients who had used Elmiron for about 15 years. Doctor Nieraj Jain, M.D., reported that these patients exhibited “injury to the retinal pigment epithelium, a layer of cells that nourishes the retina.” With no other medical history or diagnostic explanation for the subtle pattern of abnormalities in their macula, the doctors went public with the theory that chronic Elmiron use may damage the retina.

The next year, The Journal of Urology published another study from the Emory Eye Center that found that “patients with a history of interstitial cystitis who did not take pentosan polysulfate sodium did not have the unique form of pigmented maculopathy present in patients who took the drug.” The authors recommended that patients experiencing vision problems should stop taking Elmiron. They also recommended that any asymptomatic patients seek an ophthalmic examination and retinal imaging.

04

Dangers Associated with Elmiron Use: 2019 Research

Three scientific findings in the fall of 2019 heightened concern for Elmiron usage within the ophthalmology community—particularly for the degenerative eye disease, maculopathy. This progressive affliction impacts the macula which sits behind the eye retina. Sufferers can lose their central vision, which controls the crisp, clear details or color of an object. Someone with maculopathy might see everything around an object or a person they’re looking at, but not be able to crisply discern pieces or parts of what they’re looking at. It’s like there are patches obscuring their field of vision. Elmiron has also been associated with pigmentary maculopathy, a specific type of maculopathy that causes pigment changes in retina cells, leading to eye dysfunction and vision loss.

Kaiser Permanente Research

Kaiser Permanente ophthalmology researchers found that 24% of 91 Elmiron users had pigmentary damage and retinal maculopathy after approximately 15 years of using the drug. The changes to the macula were just like those experienced by the users in the Emory Eye Center study. The Kaiser study also showed that the patients that took 1,500 grams or more of Elmiron had 42% higher toxicity rates.

Emory Eye Center Followup

In another study from the Emory Eye Center, Doctor Neiraj Jain and his colleagues determined that Elmiron patients developed significantly higher odds of macular degeneration and vision loss after seven years of usage. The research team analyzed data from a large database of U.S. medical claims spanning from 2002–2016. Two groups of Elmiron users were assessed—one group at five years and another group at seven years. The research indicated alarming Elmiron long term side effects. The team found that users had significantly increased odds of macular degeneration after seven years.

Dr. Jain and team also studied 219 interstitial cystitis patients, 80 of whom had Elmiron exposure.  The team identified the “characteristic pentosan polysulfate maculopathy” in 14 of the 80 patients. Conversely, none of the 139 interstitial cystitis patients without Elmiron use developed the eye condition. Dr. Jain also issued a warning to ophthalmologists that the retinal damage linked to Elmiron can masquerade as age-related macular degeneration (AMD). He cautioned against this misdiagnosis paired with overlooking this clear connection to Elmiron.

Harvard University Research

A study of Elmiron patients conducted by Harvard University researchers, Drs. Rachel M. Huckfeldt and Demetrios G. Vavvas Thisey revealed the presence of progressively severe pentosan-associated maculopathy, even in users who stopped taking Elmiron. These findings were published in Ophthalmic Surgery, Lasers and Imaging Retina.

Expert insights have never been more important.

05

The FDA’s Response to Elmiron Dangers

Despite the growing body of scientific research linking Elmiron to eye diseases over nearly 30 years, the FDA has not issued a recall of the drug. Instead, on June 16, 2020, the FDA posted a new warning label for Elmiron. The warning states that retinal pigmentary changes in the retina have been identified among long-term users of the drug. The FDA recommends a retinal exam and imaging within six months of starting Elmiron, and periodically thereafter.

06

Active Class Action Lawsuits Against Elmiron Makers

There are a few early Elmiron class action lawsuits that have been filed so far. With hundreds of thousands of Elmiron users, many more lawsuits are expected to materialize. Here is a sampling of these early Elmiron lawsuits.

Pelczar v. Teva Branded Pharmaceutical Products R&D, Teva Pharmaceuticals USA, Inc., Janssen Pharmaceuticals, Inc., and Johnson & Johnson, Inc.

Plaintiff Kimberly Pelczar filed the first Elmiron product liability class action lawsuit, claiming the drug had caused her to suffer retinal macular dystrophy and permanent vision loss. The complaint, filed in the U.S. District Court for the District of Connecticut on March 26, 2020, asserts that the defendants misled Elmiron users and the medical community by failing to disclose that long term use of the drug was linked to retinal damage. Janssen, Johnson & Johnson, and Teva Branded Pharmaceutical are all named as defendants.

The plaintiff began using Elmiron to treat her interstitial cystitis and painful bladder condition in 2015. In the same year, the plaintiff alleges she also began to experience visual symptoms. She was medically evaluated for her symptoms multiple times from 2016–2019. The complaint states she was diagnosed “with permanent retinal injury and vision loss due to Elmiron toxicity in approximately 2019.” The plaintiff is seeking damages related to her vision loss injuries. This case is in the early stages of the Connecticut court procedures.

English v. Janssen Pharmaceuticals, Inc., and Johnson & Johnson

On May 24, 2020, Barbara English sued Janssen and Johnson & Johnson in the U.S. District Court for the Eastern District of Pennsylvania. This personal injury case asserts that “The defendants failed to exercise ordinary care in the manufacture, sale, labeling, and marketing Elmiron in that defendants know or should have known that Elmiron created a high risk of unreasonable harm to plaintiff and others.” The plaintiff started taking Elmiron for painful bladder symptoms in 2001. She experienced visual symptoms in 2017, and was diagnosed on April 11, 2019, with “permanent retinal injury and vision loss associated with Elmiron use.” She seeks the same damages as Pelczar.

Pisco v. Janssen Pharmaceuticals, Inc., and Johnson & Johnson

The same law firm representing English filed a lawsuit on behalf of Tina Pisco on May 24, 2020, in the same Pennsylvania district court. This lawsuit is a similar personal injury case alleging the defendants’ negligence caused Ms. Pisco’s various injuries and vision loss. The plaintiff began taking Elmiron in 2012 for bladder pain and in 2018, she was diagnosed with “permanent retinal injury and vision loss associated with Elmiron use.” The plaintiff seeks the same damages as in the other cases.

07

What Attorneys Should Know About Pursuing Elmiron Cases

Attorneys considering taking Elmiron lawsuit clients will want to follow these early cases and pay special attention to how the two legal theories—product liability and negligence—play out. This can inform your strategy for any future lawsuits you pursue related to Elmiron usage.

Attorneys will also want to carefully determine if Elmiron may have been the cause of potential client vision injuries. This is true even when the patient was diagnosed with something else. Experts have warned that the Elmiron macular degeneration can look like AMD and lead to misdiagnosis. AMD look-alike problems are not the only source of missed Elmiron toxicity diagnosis. At least one diagnosis of Stargardt disease was subsequently re-diagnosed as pentosan polysulfate maculopathy.

The best way to confirm whether a prospective client may have been misdiagnosed with AMD is to consult with an ophthalmology expert to trace symptoms of any visual impairment. With early expert collaboration, you can quickly identify those cases with strong standing for Elmiron liability claims.

Your client’s Elmiron usage timelines will also be important in these cases. As indicated in the research, patients have used Elmiron for at least two years before experiencing vision issues. Since this research became especially robust after 2018, any claims from this time onward will be particularly strong.

08

The Best Expert Witnesses for Elmiron Mass Torts

Attorneys building Elmiron cases will want support from highly qualified expert witnesses. The focus of damages in Elmiron suits—the ocular system—is a complex sensory organ and its functionality will be at the heart of every case. Attorneys will need to enlist the help of ophthalmology experts, especially those with a specialization in retinal disease, to solidify strong damages arguments. An ophthalmology expert’s skilled review of medical records will be crucial for collecting evidence on your client’s eye injuries and vision condition. Their expertise will also be critical at trial and during settlement negotiations. Retinal images may also be submitted as evidence and you will need retinal medical experts skilled in explaining complicated medical terms, vision conditions, and diagnostic images to the jury.

In preparation for Elmiron litigation, attorneys will also require pharmacologists who can help explain the clinical trial data and subsequent studies on Elmiron toxicity. Understanding the drug’s chemical properties and processes within the body will also aid in preparing an effective argument. As your case progresses, you may also need the same expert to take a deposition or testify at trial, so getting an assessment of how they perform before juries will be essential.

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