In 2019 it was discovered that prolonged use of the prescription drug Elmiron can cause a unique type of macular eye damage (pigmentary maculopathy), resulting in vision loss or impairment. This condition involves changes to the macula, the central part of the retina that is responsible for sharp, detailed vision. This led to a growing wave of Elmiron lawsuits by people who suffered vision loss from taking this drug.
The Elmiron lawsuits were consolidated into a class action MDL in federal court in New Jersey. In this post, we will look at how the Elmiron litigation has developed, the most recent events, and discuss what to expect in 2023 in this ongoing mass tort. We also discuss the widespread speculation that Janssen is going to start settling the pending Elmiron cases in large blocks.
But if you get nothing else out of this post, get this. Elmiron settlements may be close. If you have a case and you are sitting on the sidelines, get off the sidelines. Call us today at 800-553-8082. Or call another lawyer. But get off the sidelines or risk being left out or losing your rights to bring a claim.
Elmiron Linked to Macular Eye Damage
Elmiron (pentosan polysulfate sodium) is a prescription drug used for the treatment of a condition called interstitial cystitis (“IC”). Millions of people take Elmiron every day. Elmiron is manufactured and sold by Janssen Pharmaceutical Inc., a subsidiary of Johnson & Johnson.
Interstitial cystitis is a common bladder condition involving chronic pain and urinary frequency. Around 12 million people in the U.S. currently suffer from IC. Elmiron treats the symptoms of IC by preventing irritation and swelling of the bladder’s walls.
Elmiron works. Many patients say Elmiron is the only path to resolve their IC and live a normal life.
This is a big deal. Other treatments for interstitial cystitis such as subcutaneous and intravesical injection of heparin, intravesical injection of silver nitrate and bladder distension had been tried. But few patients were getting safe and effective symptomatic relief from IC.
Elmiron Comes to Market
The along came Elmiron. Janssen first released Elmiron back in 1996, and it has become the standard treatment option for IC. In fact, pontosan polysulfate sodium is the only FDA drug approved for the treatment of IC.
It often takes a long time to connect the dots from an injury to a drug. But after the FDA approved Elmiron, reports of serious eye injuries followed. Nearly 150 cases of eye disorders were reported to the FDA as adverse effects of Elmiron. The reports ranged from mildly blurred vision to maculopathy and blindness. Janssen also knew that users were also complaining of visual impairment, halo vision, and decreased visual acuity. Yet Janssen stayed quiet.
The medical community finally figured it out. In 2018, a group of eye doctors in Atlanta made a breakthrough discovery after noticing several patients with a unique type of macular eye damage:
“We wish to alert readers to a concerning new observation of vision threatening retinal changes associated with long-term exposure to [Elmiron]. We recently reported our findings of retinal pigmentary changes in six patients undergoing long-term therapy with [this drug]. These patients primarily described difficulty reading and/or trouble adjusting to dim lighting. Each patient had received a standard dosage of [Elmiron], ranting from 200 to 400 mg daily, for a median duration of 15.5 years. . . . After extensive investigations, which included molecular testing for hereditary retinal disease, we found these cases to resemble no other retinal disease.”
The doctors eventually discovered that the cause of this unique eye damage was prolonged use of Elmiron at high doses. The type of eye damage caused by chronic Elmiron use is now known as pigmentary maculopathy.
Elmiron Class Action Lawsuit
The discovery of the link between Elmiron and pigmentary maculopathy led to a growing wave of Elmiron product liability lawsuits against Janssen. The Elmiron lawsuits started getting filed in courts across the country in 2020.
By the spring of 2021, hundreds of Elmiron eye damage lawsuits were pending in federal and state courts across the country. This prompted the Judicial Panel on Multidistrict Litigation (JPML) to consolidate all Elmiron cases into a new class action MDL. The Elmiron class action MDL was assigned to Judge Brian Martinotti in the District of Jersey.
When the Elmiron class action MDL was created in 2021, it included about 100 pending cases from various federal districts. Following the creation of the MDL, the volume of new Elmiron injury lawsuits increased significantly. By the end of 2021, over 600 Elmiron eye damage cases were pending in the class action MDL in federal court and another 80 pending in state courts.
During the first half of 2022, the volume of new Elmiron lawsuits reached its peak, with an average of 200 new cases being filed and added to the MDL each month. Around 1,200 new Elmiron cases were transferred into the MDL in the first six months of 2022.
By the end of July 2022, however, the new case volume in the Elmiron class action suddenly stopped. Few than 100 cases were added to the Elmiron MDL in the last six months of 2022.
First Elmiron Bellwether Trial Set for March 2023
Judge Martinotti has been good about keeping the Elmiron MDL moving forward without undue delays. A bellwether trial program featuring 3 test trials was established early on. By May 2022, the three bellwether test cases had been selected and were started case-specific discovery.
The first bellwether test trial was initially set for January 2023 in the case of Maria Wyndham v. Janssen et al. (20-cv-14670). A second trial was set for March, and a third trial date was tentatively scheduled for May. The date for the first bellwether trial was later postponed from January to March 2023, and it is currently still set for March.
The bellwether trials will be critically important in getting a global settlement in these cases because they set expectations and help pressure the defendants into negotiating. The plaintiff in the first bellwether trial set for March is Maria Wyndham. Wyndham is a 67-year-old resident of Louisiana who claims that she suffered pigmentary maculopathy after a prolonged period of using Elmiron to treat her IC.
What Can We Expect in the Elmiron Litigation in 2023?
Our lawyers believe that the Elmiron class action lawsuit will be resolved in a settlement in 2023. That Elmiron settlement could happen right after the first bellwether test trial in March, assuming it results in a good outcome for the plaintiff. There is a real chance that a settlement could be announced before the first bellwether trial. Because Janssen would be foolish to let this litigation get out of hand when it can likely settle these cases for less than $1 billion right now.
We don’t think we will see a formal global settlement agreement approved by the Elmiron MDL Judge. Instead, we expect the Elmiron settlement to unfold the same way that the Roundup settlements happened, with the defendants confidentially large blocks of cases with individual law firms involved in the litigation. Each firm with many cases in the MDL would negotiate a separate but similar settlement deal for all its clients.
If this is how things play out – and we do not know for sure – there probably won’t be any formal settlement announcement. Instead, the bellwether trials will just get postponed (or the underlying bellwether case will settle and get dismissed), and the MDL will start to shrink as blocks of cases settle and get dismissed quietly.
Is it Too Late to File an Elmiron Lawsuit?
It is definitely not too late to file an Elmiron vision damage lawsuit as long as you were recently diagnosed with pigmentary maculopathy (the type of macular eye damage caused by Elmiron). In fact, Elmiron cases are currently still being filed in courts across the country and transferred into the MDL every month.
Estimated Elmiron Settlement Payouts
Our lawyers estimate that if a global settlement deal is hammered out this year, plaintiffs in the top settlement tier (those with the strongest claims and the most significant vision loss) could expect settlement payouts of around $375,000 to $500,000. Elmiron plaintiffs in the second settlement tier are probably looking at $250,000 to $350,000.
Teva R&D licensed Elmiron to Janssen, a subsidiary of J&J. This was a big deal for both Janssen and patients seeking relief from bladder pain and discomfort associated with interstitial cystitis. It was a groundbreaking drug and quickly gained popularity, with sales in the United States quickly totaling over $150 million each year. For many patients, they felt like it was the only option they had.
Road to FDA Approval
The journey to FDA approval for Elmiron was a long and complicated one. The original New Drug Application was submitted by a company called Baker Norton Pharmaceuticals, which was owned by Ivax Corporation. Ivax Corporation licensed Elmiron to Ortho-McNeil Pharmaceutical, which was later acquired by Janssen.
Challenges for Approval
The FDA initially designated Elmiron as an orphan drug product due to the rarity of interstitial cystitis. However, the road to FDA approval was not without its challenges. The sponsor submitted its first NDA for approval in 1991, which included data from two clinical trials. However, in 1993, the FDA issued its first non-approval letter due to problems with the clinical trial analyses and results. The FDA requested that the sponsor conduct another well-controlled clinical trial, but the sponsor declined and instead re-analyzed the data from the two pivotal studies already submitted.
In 1994, the FDA issued a second non-approval letter due to insufficient clinical trial evidence to establish efficacy. Janssen continued to decline to perform an additional clinical trial and instead proposed an analysis of the database from its Compassionate Use program. Ultimately, Janssen knew what a blockbbuster this would be and it kept pushing forward.
Third Time Is Charm
On its third resubmission of the NDA, the sponsor relied on two clinical studies. The first study was a blinded, randomized, placebo-controlled trial that evaluated only 151 patients for three months. The second clinical trial was an unblinded retrospective analysis of 2,499 patients in the Elimiron Compassionate Use program.
It was a stretch. But, maybe beating the odds, Elmiron was ultimately approved in 1996 based on just those these two studies. The FDA noted that, while the studies had flaws, the unique situation of interstitial cystitis and the apparent lack of significant clinical safety concerns based on these short-term studies resulted in a small risk/benefit ratio. The FDA required that the sponsor agree to an indication with a three-month initial treatment trial and continue to monitor the safety and efficacy of Elmiron (which they have to do anyway).
Unfortunately, following approval, multiple advverse events were submitted detailing injuries. The most notable? They including serious visual symptoms and/or retinal damage both in the United States and internationally.
Trouble from the Beginning
You have to remember, the link between Elmiron and pigmentary maculopathy is dose responsive. So the longer patients are on it, the more problems you will see.
The first report of this potential link came in the spring of 2018, when a team of researchers at Emory Eye Center published a letter to the editor of the Journal of Urology reporting their findings of unusual retinal pigmentary changes or maculopathy in six female patients who had been on long-term Elmiron treatment . The median use? 15.5 years. So a very small cohort but very long term use. None of the patients had a family history of retinal disease or any other pathogenic process that would predispose them to such a disease. Of the six patients, five had received 400mg daily of Elmiron (although two had later reduced their dose), and one received 300mg daily.
In May 2019, the same Emory team presented an update to their study at the American Urological Association annual meeting in Chicago. This study identified 10 patients with pigmentary maculopathy at the Emory Eye Center. The patients ranged in age from 38 to 68 and had a median treatment duration of 15.5 years (with the shortest duration of a little over two years). The authors of the study concluded that they had identified a potentially avoidable retinal degeneration phenomenon associated with chronic Elmiron exposure.
Later in 2019, researchers at other institutions also reported on the potential link between Elmiron and pigmentary maculopathy. A study conducted by a team at Kaiser Permanente in Oakland, CA found that out of 140 patients currently using Elmiron for an average of 15 years (and a minimum of five years), 24% had eye damage and/or retinal toxicity that increased with the total amount of Elmiron taken. The researchers then performed multimodal image screening on 117 patients exposed to Elmiron, of which 23% had definite indications of maculopathy and demonstrated a dose-response relationship. Specifically, approximately one quarter of patients with an intake of greater than 500g developed retinal changes consistent with Elmiron-associated maculopathy.
Okay, Let’s Finally Change the Warning
With all of that, the Elmiron label was not updated to include a warning about retinal pigmentary changes and the recommendation for periodic retinal screening until June 16, 2020.
Well, wait. Actually, the label was updated in 2019. But it was just for Elmiron in Canada and Europe. Those non-U.S. patients taking the drug for interstitial cystitis were able to have informed conversations with their doctors about the risk of retinal pigmentary changes caused Elmiron.
Example Elmiron Lawsuit
Let’s look at an example Elmiron maculopathy lawsuit that is now pending in the MDL class action. In Willaman v. Janssen Pharmaceuticals, Inc., Docket No. 2:20-cv-19998, Plaintiff was prescribed Elmiron by her physicians in 2008 to treat her painful bladder pain and/or interstitial cystitis. She took Elmiron continuously from 2008 to 2020, as directed by her physicians, until she began experiencing visual symptoms in early 2020. She was later diagnosed with vision-related injuries, including retinal maculopathy, in August 2020. Plaintiff first learned that Elmiron could have caused her vision-related injuries within two years of filing the complaint.
Plaintiff’s Elmiron lawsuit alleges Janssen ignored reports of Elmiron’s failure to perform as intended and injuries associated with long-term use, including the injuries suffered by Plaintiff and other patients. Instead of testing the drug to determine the cause of the injuries, Defendant continued to market Elmiron as safe and effective for interstitial cystitis. Defendant should have, the suit alleges, adequately inform the public or physicians of the adverse effects or defects associated with Elmiron or recommend regular eye exams for users.
Plaintiff’s lawsuit further claims that her physicians used Elmiron as directed by Defendant’s instructions which they would not have done if Janssen had not actively concealed the risks associated with the drug from them. As a result, Plaintiff suffered significant injuries, including serious visual injuries, physical pain, mental anguish, and economic loss due to medical expenses and lifestyle changes. The crux of her vision damage lawsuit is that injuries could have been avoided or less severe if the company had properly disclosed the risks associated with Elmiron use.
Contact Us to File an Elmiron Lawsuit
It is NOT too late to file your own Elmiron lawsuit. Call our Elmiron attorneys today at (800) 553-8082 to discuss your legal options if you believe your vision was lost or impaired because you used this drug. You can also get a free case evaluation online.