Our lawyers are reviewing Elmiron lawsuits for victims who have suffered vision loss, pigmentary maculopathy, toxic maculopathy, or other eye conditions due to the use of Elmiron for interstitial cystitis or bladder pain.
The purpose of this page is to provide:
- an update on the current status in March 2023 of the Elmiron lawsuits in the MDL class action and Pennsylvania and New Jersey state court
- information on eye injuries with Elmiron and the connection between this medication and macular degeneration
- what our lawyers expect for an average individual settlement amount in the Elmiron class action lawsuit
- the plan for how the Elmiron lawsuit will proceed in the MDL class action and state court
The Elmiron MDL (In Re: Elmiron (Pentosan Polysulfate Sodium) Prod. Liab. Litigation, MDL 2973) was established in the U.S. District Court for New Jersey under Judge Brian Martinotti. Judge Martinotti is a seasoned class action judge. These eye injury and blindness claims have been proceeding in pre-trial discovery.
Our attorneys believe there will be Elmiron settlements in 2023, maybe in the next few months. But there are deadlines to bring an Elmiron lawsuit. Call our lawyers today at (800) 553-8082 to discuss your legal options if you used Elmiron and your vision was lost or impaired. You can also get a free case review online.
Elmiron Litigation Updates
Before we break down the Elmiron litigation, let us give you the most recent news and updates:
March 24, 2023 – More Cases Added to the MDL
Five new Elmiron vision damage lawsuits were transferred into the class action MDL over the last 30 days. This brings the current number of pending cases in the MDL up to 1,879. The opening bellwether trial is scheduled to start in less than two weeks, although it Janssen could elect to settle that case to avoid the trial.
March 8, 2023 – Elmiron Defendants
Many Elmiron lawsuit just name Janssen as a defendant. In addition to Janssen, other defendants in this litigation could include Teva, Bayer, Alza, Centocor, Ortho-McNeil, and IVAX. But the Elmiron class action lawsuit is about Janssen and we think the settlement amounts that will be offered on many in the near future will be offered by Janssen alone.
February 20, 2023 – Elmiron Class Action Continues to Grow
Another 31 new Elmiron vision loss cases were filed or transferred into in the class action MDL over the last month. There are now 1,872 total pending cases in the Elmiron MDL. The first bellwether test trial is set to begin in 3 months and there is widespread speculation that Janssen might start to settle large blocks of these cases very soon.
February 16, 2023 – What Is FAF Testing and How Does It Impact the Elmiron Lawsuits?
Fundus autofluorescence (FAF) testing is a diagnostic tool used in ophthalmology to evaluate the health of the retina, the light-sensitive tissue at the back of the eye. FAF testing uses a special camera to capture the natural fluorescence emitted by the retina in response to light. This allows doctors to assess the health of the retina, identify abnormalities, and monitor the progression of certain eye conditions.
FAF testing has been used to confirm visual disturbances and retinal damage caused by Elmiron. As a result, ophthalmologists have used FAF testing to evaluate the extent of this damage and monitor the progression of any related eye conditions from the drug. In turn, Elmiron lawyers are looking to this test to show that Elmiron caused the patients injury as opposed to some other cause.
Specifically, FAF testing has revealed that some patients who have taken Elmiron exhibit patterns of retinal damage that are consistent with toxic maculopathy, a condition that affects the central part of the retina and can cause vision loss. While the exact mechanism by which Elmiron causes this damage is not fully understood, FAF testing has proven to be a useful tool in identifying and monitoring these types of retinal abnormalities in patients taking Elmiron.
February 13, 2023 – New Elmiron Eye Injury Lawsuit
An example of an Elmiron lawsuit that was recently transferred into the MDL is Padelford v. Janssen Pharmaceuticals Inc., et al. (2:23-cv-265) which was filed directly in the Elmiron MDL on January 18, 2023.
This suit is typical. The plaintiff, a resident of Izard County, Arkansas, took Elmiron daily for IC condition from 2001 to 2008. Her legal complaint alleges that neither she or her doctor had any warning about the risk of potential eye injury from Elmiron. Padelford claims that as a result of her long-term use of Elmiron, she suffered serious damage to her eyes resulting impaired vision. The Complaint sets forth six separate causes of action, but the primary claim is- as it is for all of these lawsuits – is failure to warn.
February 1, 2023 – Elmiron Settlement Math
Last week, we reported 1,841 Elmiron lawsuits in the MDL. We do not have the most recent tally of state court suits. But the best guess is around 175.
With a trial Janssen does not want to try on deck in March, it is hard to avoid the temptation to do back-of-the-napkin settlement calculations on this, right? Let’s say that the average Elmiron settlement is $400,000. That would be just over $800 million. In relative terms, that is not a significant number for Janssen/J&J, who likely projected many more plaintiffs.
January 29, 2023 – Elmiron Trial Set to Go
The first bellwether trial in the Elmiron class action MDL is scheduled to begin in two months in the cases of Windham v. Janssen Pharmaceuticals, et al. (20-cv-14670). The defendants filed a number of pretrial motions over the last few months, including a motion for summary judgment and a motion to exclude certain expert testimony. The plaintiff also filed her own motion attacking some of the defense experts. All of these motions have been fully briefed and Judge Martinotti will probably rule on them together sometime in the next few weeks.
So this trial is ready to go. Will this case go to trial? Probably not. Janssen is likely too smart to let this case go to a jury and risk a large verdict that will increase awareness of the connection between Elmiron and vision-related injuries.
January 17, 2023 – Litigation Update
Over the last month, only three new Elmiron vision damage lawsuits were filed or transferred into the class action MDL bringing the current total case count to 1,841.
This marks the lowest monthly volume of new cases since the MDL was created over two years ago and could indicate that the Elmiron litigation is moving into a new phase in which we only see a small handful of new cases each month. The first bellwether trial is just over two months away. (Our prediction? This case never goes to trial. Janssen would be foolish to let one of these lawsuits go to a jury.)
Certainly, Elmiron lawyers want a greater volume of claims. Many people with solid claims do not know they have strong claims, which is an injustice. But… if you have an existing Elmiron lawsuit, the small number of cases is a blessing. Because the smaller number of cases makes it easier for Janssen to pay top settlement dollar without putting too much of a burden on shareholders. So the low volume of lawsuits might lead to faster Elmiron settlements and larger payouts.
January 11, 2023 – Updated Medical Records
If you are our client, we want your most up-to-date information. So if you have recently seen your ophthalmologist or retina specialist, that is something we want to know so your Plaintiff Fact Sheet can be updated.
January 8, 2023 – New Elmiron Lawsuit
Although the volume of Elmiron vision damage lawsuits slowed down significantly throughout 2022, new cases continue to get filed. One of the most recent Elmiron lawsuits is Keys v. Janssen Pharmaceuticals, Inc., et al. (2:22-cv-07487).
The case was filed by Shirley Keys, an Arkansas woman who took Elmiron for “many years” to treat her bladder condition. According to her Elmiron vision loss lawsuit, Keys subsequently developed pigmentary maculopathy (the unique eye disease caused by Elmiron) and now suffers from blurred and distorted vision.
The Keys suit was filed directly in the Elmiron class action MDL in the District of New Jersey.
January 2, 2023 — Elmiron Lawsuits Continue to Advance
The Elmiron class action MDL continued its trend as one of the least active mass torts in the second half of 2022. Only 55 new cases were transferred into the MDL over the last month, bringing the currently pending cases to 1,839.
At the start of the year, 200 new Elmiron cases were being added every month, and we seemed to be on pace to reach the 2000 mark before the end of summer. The MDL class action docket has also been remarkably quiet. There was only one docket entry for December, and it was a notice canceling the monthly status conference.
December 30, 2022 — Trial Date Still Set for March 2023
You get used to serial postponements in mass tort cases. The first Elmiron trial has already been pushed back two months. But the March 27, 2020 trial date is still set.
December 20, 2022 – California Plaintiffs Move to Stay in California State Court
Three California plaintiffs have filed a motion requesting that the Court remand the case back to the Superior Court of California County of San Diego where it was initially filed. Defendants argue that diversity jurisdiction exists under the Class Action Fairness Act (CAFA), but Plaintiffs contest this argument, asserting that Defendants have not satisfied the elements required to confer jurisdiction on the Court.
Their argument is that according to CAFA, removal to federal court is only appropriate if the amount in controversy for the class-action claim(s) exceeds $5 million. Defendants have failed to present any evidence to support their position, whereas Plaintiffs have presented evidence that the amount in controversy is likely less than $5 million.
Plaintiffs also argue that the local controversy exception would apply since all class members are California citizens and they have also sued a doctor, who is a California citizen. So there is no diversity. What is the claim against the doctor? Plaintiffs’ lawsuit claims that the doctor that prescribed Elmiron was “fully aware of the of the safety risks of Elmiron dating back
to their original clinical trials.”
November 17, 2022 – Elmiron Class Action Update
Earlier this year, the Elmiron class action lawsuit was sizzling with an average of over 200 new Elmiron vision damage cases being transferred into the MDL each month. During the first six months of 2022, the Elmiron class action MDL doubled from 700 to 1,700 pending cases.
Since about July, the incoming flow of new Elmiron lawsuits has slowed almost to a trickle. Only ten new cases were added to the MDL over the last month, bringing the current total to 1,784. This means only 59 new Elmiron lawsuits have been filed since July.
November 7, 2022 – First Elmiron Trial Pushed Back
The first bellwether test trial in the Elmiron class action lawsuit was set to begin in January 2023. The outcome of this trial is expected to have a significant impact on moving these cases forward toward a global settlement.
Unfortunately, however, we will have to wait a little longer for this trial to take place. On Monday, the Elmiron MDL judge issued an Order postponing the bellwether trial to March 27, 2023. There was no explanation for the postponement in the Order. Two more test Elmiron bellwether trials are set to follow.
October 23, 2022 – Elmiron Class Action Lawsuit Growing
Only ten new Elmiron lawsuits were added to the MDL over the last month, bringing the total number of pending cases up to 1,784. This marks the third month in a row of slow growth after this MDL was seeing 100 new cases each month earlier this year. This is not a large class action but this may lead to higher average settlement payouts. Our lawyers believe the average Elmiron settlement may be north of $500,000.
October 19, 2022 – California Lawsuits Put on Hold
A federal judge has granted a motion to stay proceedings in a putative class action lawsuit involving plaintiffs Melissa Morrison, Kellie Valencia, and Karie Kuehl against Teva Branded Pharmaceutical Products R&D, Teva Pharmaceuticals USA, Alza Corporation, Janssen Research & Development, Ortho-McNeil Pharmaceutical, Janssen Pharmaceuticals, Janssen Ortho, Johnson & Johnson, and Dr. C. Lowell Parsons. The plaintiffs allege that Elmiron, a prescription drug marketed to treat Interstitial Cystitis and manufactured by some of the named defendants, caused them severe physical and emotional injuries, as well as severe symptoms including blurred vision, difficulty adapting to dim lighting or darkness, difficulty seeing at night, and sensitivity to light. The defendants requested a stay pending a decision by the Judicial Panel on Multidistrict Litigation on transfer to an MDL court, and the judge granted the motion, vacating the hearing scheduled for October 21, 2022, and the hearing on Plaintiffs’ Motion to Remand, currently scheduled for December 2, 2022.
October 14, 2022 – Elmiron Lawsuit Case Count
As of October 12, 2022, 1,926 Elmiron lawsuits have been filed, 1680 in the MDL and 169 in state courts.
It is hard to avoid the temptation to do back of the napkin math on this, right?
October 12, 2022 – Windham Bellwether Trial Set for January 2023
The first bellwether test trial in the Elmiron MDL (Windham v. Jansen, et al. – 2:20-MD-2973) is only three months away.
Recently, the Elmiron class action judge issued CMO 17. This order finalized the upcoming pre-trial deadlines in the Windham case.
Briefing on Daubert motions challenging the admissibility of expert opinions will conclude on November 10th. Witness and exhibit lists for both sides are due on December 2nd and objections to those lists as due by January 6th. A hearing on pre-trial motions will be held on January 16th, and the trial will commence on January 30th.
September 16, 2022 Elmiron Lawsuit Update
A few months ago, the Elmiron class action MDL was red hot with 150 to 200 new lawsuits being added to the MDL each month.
It has now officially cooled off. From August 15th to September 15th, only 34 new Elmiron vision loss cases were added to the MDL. The total number of cases pending in the Elmiron MDL is now 1,774. The first bellwether test trial in the Elmiron MDL is still set to go forward in January, followed by a second trial in March and a third test trial in May.
Our Elmiron lawyers believe there are many more eye damage cases out there. But many victims still have not made the connection between their eye injury and Elmiron use.September 2, 2022: Following the last monthly status conference in the Elmiron MDL, Judge Martinotti confirmed that the Windham case will serve as the first bellwether test trial and the Manning case will be the 3rd bellwether case to go to trial.
A new bellwether case selected by the defense will go second. Only 15 new Elmiron lawsuits were added to the MDL over the last month, after an average of 60 per month since March. There are 1,740 claims in the class action lawsuit with another 169 Elmiron lawsuits pending in New Jersey state courts.
August 11, 2022 – Slow Elmiron Summer
July has been a very slow month for the Elmiron MDL docket. This is primarily a function of Elmiron lawyers on vacation and not filing lawsuits and the courts slowing down over the summer. The number of new being transferred into the MDL has slowed to a crawl after four months of record highs.
No new lawsuits have been transferred into the MDL since July 7. Judge Martinotti held a status conference on July 13, 2022, and appointed new attorneys to the Plaintiffs’ Steering Committee. But, otherwise, the docket has been empty. Ultimately, the Elmiron lawsuit is small litigation. Smaller cases are easier to resolve and settlement compensation payments in those cases are often higher.
July 25, 2022 – Elmiron Class Action Lawsuit Update
The sometimes sleepy Elmiron vision damage litigation has seen some action this summer. Over the last 30-day period (June 15 to July 15) a total of 365 new plaintiffs with Elmiron vision damage lawsuits were transferred into the Elmiron MDL, bringing the current total of pending plaintiffs up to 1,725. This was the most significant increase in new cases since the start of the Elmiron MDL and it was the largest percentage increase for any mass tort during the same period. This trend will likely continue over the next five months until the bellwether trials begin in January.
June 7, 2022 – Picking First Elmiron Eye Damage Lawsuit for Trial
We now know the first Elmiron will go to trial in seven months. Judge Martinotti ruled last week that Maria Windham’s will be the first trial in January 2023. (Update: this has since been pushed back to March 2023.)
Windham was picked by the defense lawyers to go to trial. Usually, that means it is a strong case for the defendants. But our Elmiron lawyers believe this is a very winnable case.
In this litigation, every Elmiron lawsuit can be won at trial. Our attorneys believe the Elmiron claims are very strong cases. Defense attorneys will always be drawn to a lawsuit that will be tried under Louisiana law because that state’s law is not typically favorable to victims. But this Elmiron eye injury lawsuit can be won at trial.
June 3, 2022 – Elmiron Lawsuit Update
After selecting the first three bellwether IC medication trials, the judge in the Elmiron MDL issued a new Case Management Order establishing revising scheduling deadlines for pretrial discovery and motions in the test cases.
In all three Elmiron lawsuits going to trial, pre-trial discovery will conclude by September 9, 2022, and dispositive motions are due by September 20, 2022. Bellwether Elmiron trial No. 1 will be held in January 2023. Bellwether trial No. 2 will commence in March, and the 3rd trial will be in May 2023.
May 10, 2022 – Facts of Bellwether Lawsuits
The Elmiron class action judge recently announced his selections for the three Elmiron bellwether trial cases: Manning (21-cv-11942), Broussard (21-cv-2028), and Windham (20-cv-14670).
Julia Manning (a case picked by the plaintiffs) is a resident of Georgia who took Elmiron from 2008 to 2014 and suffered damage to both eyes. The defense team selected Opal Broussard, a Louisiana resident who claims she used Elmiron and suffered “a loss of vision and a diagnosis of macular degeneration.”
The third plaintiff, Maria Windham, was selected by the MDL Judge, but it was also a case nominated by the defense. Windham is a 67-year-old Louisiana resident claiming she suffered pigmentary maculopathy after taking Elmiron for just two years. In most class action lawsuits, any case the defendant picks is likely to lead to a defense verdict. But the cases in this litigation are strong enough that Elmiron lawyers think there is a chance of winning in any case that goes to trial.
May 5, 2022 – Class Action Growing
Over 900 victims have joined the Elmiron lawsuit in federal court in New Jersey. This 16-month-old class action has grown slower than many Elmiron lawyers expected. Why? Not enough Elmiron patients and prescribing doctors are connecting Elmiron to their vision loss. In class action lawsuits, often television commercials increase awareness. But there are not enough potential claims for Elmiron attorneys to make a strong investment marketing for vision loss lawsuits on television.
This is unfortunate because many worthy plaintiffs will never know they have a claim for which they might be eligible for settlement compensation. There is, however, a flip side to this coin for patients who have brought a claim. Elmiron lawsuit settlement amounts will be higher per person in a mass tort with fewer plaintiffs. It makes it easier for the defendants to resolve the lawsuit without burdening shareholders, which pushes the settlement payout higher.
April 14, 2022 – Status Conference
: The monthly status conference will be held next in the Elmiron MDL-2973. The agenda will likely include a new date for the elusive science day – it keeps getting scheduled and rescheduled – and address various other housekeeping issues related to the Elmiron class action lawsuit bellwether selection process.
April 1, 2022 – How Many Elmiron Lawsuits?
At the Monthly Status Conference for March, the judge in the Elmiron class action issued another Case Management Order (CMO No.27). CMO 27 updated the status of the litigation, noting that a total of 803 Elmiron product liability lawsuits have been filed (712 in federal courts, 91 in New Jersey state courts, and an unknown number in Pennsylvania state court). The judge also agreed to reschedule the upcoming Science Day for, incredibly, the third time.
March 17, 2022 – New Case Management Order
In the first week of March, the judge in the Elmiron MDL issued a series of Case Management Orders which addressed various housekeeping issues and set the table for the litigation moving forward this year.
At the next monthly status conference, Judge Martinotti will finalize the protocol for how the first bellwether cases will be selected. Fact discovery on the pool of bellwether candidate cases will conclude at the end of the month. The first group of bellwether trial cases will be selected by April 8, 2022. A new mandatory Case & Claim Data Form (“CCDF”) was approved.
February 22, 2022 – New Jersey State Court Class Action
The New Jersey Supreme Court ordered the consolidation of all Elmiron vision loss lawsuits pending in New Jersey state courts before a single judge in Bergen County. This is the New Jersey state court equivalent of an MDL. There are already over 800 Elmiron lawsuits in federal courts consolidated in the Elmiron MDL-2973.
January 13, 2022- Science Day
The next case management conference in the Elmiron class action lawsuit was held yesterday. There were no significant developments. The Science Day to educate the judge on the issues in the litigation with expert witnesses was reset for March 23, 2022.
January 7, 2022 – How Many Elmiron Lawsuits in 2022?
: There are now 679 Elmiron class action lawsuits, up from 622 eye damage class action lawsuits in November and 580 in October. There are another 80 Elmiron lawsuits that have been filed in state court in New Jersey and Pennsylvania. So this macular degeneration litigation continues to grow. Our Elmiron lawyers believe there will be over 1,000 vision side effects lawsuits in 2022 as awareness of the connection between Elmiron and vision side effects grows.
December 14, 2021 – Science Day for Elmiron
Judge Brian Martinotti (District of New Jersey) held a case management conference in the Elmiron MDL class action lawsuit last week. The conference addressed housekeeping issues including proposed dates for rescheduling the Elmiron “Science Day,” and logistics of document discovery from Janssen Pharmaceuticals.
December 5, 2021 – Elmiron Class Action Lawsuit – The Judicial Panel on Multidistrict Litigation created a new MDL class action for the consolidated handling of all Elmiron lawsuits in federal courts. Three trial dates have now been set. The Elmiron litigation is proceeding, mostly with discovery against Janssen and Teva as lawyers prepare for the first bellwether trial. Judge Martinotti ordered the parties to prepare a bellwether test trial plan with the first Elmiron bellwether trial to be held in January 2023.
Yes, the trial of the first eye injury case is still 11 months away. But getting a trial date – three trial dates as we discuss below – is a big deal. Our Elmiron lawsuit attorneys’ prediction – and it is just a prediction – is an Elmiron global settlement will occur before a single Elmiron lawsuit goes to trial. Our lawyers believe these are very strong cases for the plaintiffs.
November 1, 2021 – Manufacturing Defect Argument
Judge Martinotti denied the defendants’ lawyers’ effort to amend Case Management Order #1 to file a motion to dismiss plaintiffs’ Elmiron lawsuits that allege a manufacturing defect with Elmiron. The defense lawyers are correct that the focus of these lawsuits. So this motion might eventually be granted. But the court ruled that at this stage of the Elmiron class action, this motion is premature.
October 22, 2021 – Science Day
Judge Martinotti was supposed to have a “Science Day” last month to allow Elmiron lawyers on both sides to educate the judge by providing an overview of the key medical and scientific issues pertinent to Elmiron and the plaintiffs’ allegations of eye injuries and blindness. But Science Day was postponed to an undetermined date in the future.
October 1, 2021 – Elmiron Study
Sometimes in lawsuits like these Elmiron claims, the scientific literature looks promising but turns in favor of the defendants. The medical literature in this case that is now coming out continues to support the arguments plaintiffs’ Elmiron class action lawyers are making. A Northwestern University study looked at the presence of Elmiron-related maculopathy. Researchers examined the medical records of 131 Elmiron patients. Forty underwent imaging and 91 underwent fundus examinations.
August 11, 2021 – Elmiron Lawsuit Update
A new Elmiron lawyer has been added to the steering committee. There are now 310 federal eye damage claims in federal court and 51 in New Jersey and Pennsylvania state courts.
Elmiron is a a low molecular weight prescription medication that was approved by the FDA in 1996 to treat interstitial cystitis. IC isa painful bladder condition that affects an estimated 1 million people in the United States, mostly women.Elmiron. The drug was originally submitted by Baker Norton Pharmaceuticals, a division of Ivax Pharmaceuticals. The drug has since been acquired by Teva Pharmaceuticals and then Janssen.
The active ingredient in Elmiron is pentosan polysulfate sodium, which is believed to work by restoring the bladder’s protective mucous layer and reducing inflammation. Elmiron has anticoagulant and fibrinolytic effects, but its mechanism of action in treating IC is not yet understood. No one is exactly sure how and why it works.
For many years, Elmiron was the only FDA-approved drug for interstitial cystitis, and was considered a safe and effective treatment option. However, in recent years, concerns have arisen about the potential for Elmiron to cause serious eye damage, including maculopathy, a degenerative disease of the retina that can lead to vision loss.
As a result of these concerns, thousands of people who have taken Elmiron and developed vision problems have filed lawsuits against the drug’s manufacturer, Janssen Pharmaceuticals, alleging that the company failed to warn them about the risk of eye damage. In 2023, Elmiron lawsuits are consolidated into a multidistrict litigation (MDL) in federal court, as we explain further below.
What Is Interstitial Cystitis?
Elmiron is used for the treatment of a condition called interstitial cystitis (“IC”). Millions of people take it every day. Janssen continues to make a fortune from this IC drug.
Interstitial cystitis is a bladder condition that causes chronic pain and discomfort as well as urinary frequency. As many as 12 million people in the U.S. currently suffer from IC. Interstitial cystitis is a chronic disease of the bladder. The condition most commonly affects women between 30 and 70. It is debilitating. It involves a multitude of urinary and psychiatric complaints such as suprapubic pain on bladder filling, urinary frequency, malaise, anxiety, dysuria, and malaise, among others. Not surprisingly, it can lead to depression and anxiety.
Elmiron and IC
Elmiron is the popular brand name of a drug called pentosan polysulfate sodium. Pentosan polysulfate belongs to a family of anticoagulant drugs known as low molecular-weight herapins. Most drugs in this category are used as blood thinners. Elmiron is not.
Elmiron was developed and manufactured by Janssen Pharmaceuticals Inc., which is a corporate subsidiary of Johnson & Johnson. Elmiron was first approved by the FDA back in 1996 and since then it has become the standard treatment option for individuals suffering from interstitial cystitis. Elmiron is also sometimes used to treat bladder pain associated with urinary tract infections.
There are few Americans diagnosed with interstitial cystitis that do not know what Elmiron is. Elmiron treats the symptoms of IC by preventing irritation and swelling of the walls of the bladder. The medication is thought to function as a synthetic mucus layer around the bladder to guard against irritation.
How Elmiron Work
How does Elmiron work to control IC? Again, the mechanism of action of pentosan polysulfate sodium and IC is not fully understood. But, with the caveats expressed below, it does seem to work well for that purpose. Our lawyers do know people (including a lawyer in our office, in fact) who know of the risk of blindness the Elmiron lawsuits have helped uncover and still take the medication because they simply don’t have another path. Elmiron is still the only drug currently approved by the FDA for the treatment of IC-related bladder pain. IC is awful for many people. (It is hard to know this and support an Elmiron recall instead of just an honest warning. More on that shortly.)
Elmiron and Eye Damage and Vision Loss
Studies suggest that Elmiron causes retinal damage to the eyes. One study confirmed that Elmiron can cause a serious eye disease called maculopathy that can result in blindness in potentially one-fourth of the patients who took this drug.
This is a pretty staggering number, right? Our class action lawyers rarely see mass torts with a risk of injury as high as it is with Elmiron. Let’s say this number is off by half. That would still be a tragic number of victims.
Anyone who used the drug Elmiron and has been diagnosed with maculopathy or other eye conditions may be entitled to financial compensation from the drug manufacturer. Our law firm is currently accepting new cases from anyone who used this prescription medication and has been diagnosed with pigmentary maculopathy, macular degeneration, or other conditions.
These lawsuits are growing quickly. The quirky thing about this litigation is that Elmiron users will often not link their vision issues to the drug. The cause of these vision loss injuries will often be misdiagnosed — they have already been told by a doctor there was some other cause for the eye injury.
But when awareness of the side effects of Elmiron increases, the number of victims lawyers will see will increase accordingly.
Elmiron Patients Did Not Know of Elmiron Side Effects
But the question that will be the focus of this litigation is when did Janssen first learn of all the risks and side effects of Elmiron? Janssen may be arguing at trial that it was the last to know. This will be a hard argument to sell, right?
The suits filed in the Elmiron class action allege Janssen did know about the risk of some serious visual complications. And we’re not talking about just a blurry vision or some dry eyes, we’re talking retinal hemorrhages, macular degeneration, and even unilateral blindness. Come on now, that’s not something you just sweep under the rug. But alas, the defendant failed to state this risk to their patients, leaving them in the dark and potentially endangering their precious sight. Not cool, defendant, not cool at all.
Elmiron lawsuits have been filed as of March 2023 in state court and in the federal class action. An Elmiron class action MDL was created to rope off these lawsuits 16 months ago. There are many more Elmiron eye injury lawsuits coming in the months ahead.
You should act now if you have an eye injury claim because there are deadlines to sue because of the statute of limitations. But that does not mean you cannot bring an Elmiron lawsuit if your injury occurred some time ago. Most states have a discovery rule which means the statute of limitations does not begin to run until you know or have reason to know how you were injured. Until recently, no one connected the dots between eye injuries and Elmiron.
Elmiron May Be Less Effective Than Originally Believed
There is also, parenthetically, some argument from some Elmiron lawyers that this drug is not an efficacious treatment for IC. They point to studies suggesting that Elmiron performs no better than a placebo for some IC complications.
This needs to be flushed out. The argument against an Elmiron recall is that this medication is the only path to resolve IC for some patients. But if this argument that Elmiron is not a game-changing treatment for IC patients carries water, the risk is hardly worth the benefits and maybe the FDA should consider an Elmiron recall. (Note: this is probably not the case but we are basing that conclusion on what Elmiron patients are telling us, not medical research.)
Either way, these lawsuits come down to whether Elmiron’s side effects require a warning based on the information that was available that communicated the risk of a vision-related injury.
Evidence Links Elmiron to Serious Eye Damage
Since its initial release back in 1996, Elmiron has always been viewed as a relatively safe drug with few significant risks or serious side effects. All that has changed very drastically in the last year.
There is strong evidence that Elmiron causes an eye disorder called retinal maculopathy. Long-term exposure appears to increase the risks.
The world began to develop a concern about Elmiron’s side effects in 2018 when doctors from the Emory Eye Center in Atlanta, Georgia noticed a strange trend. They had six patients with abnormal damage to the macula region of their eyes and were diagnosed with pigmentary maculopathy.
The doctors eventually realized that all of these patients were long-term users of the drug Elmiron. This led the Emory Eye Center to publish a preliminary report which suggested that Elmiron may be toxic to retinal tissue in the human eye.
Further Research Leads to Greater Concern About Elmiron
This warning call immediately prompted a more detailed study into the safety of Elmiron and its potential toxicity to the eyes. This was done by a team of ophthalmologists in Northern California based on thousands of patient records. The alarming results of this research were presented at the annual meeting of the American Academy of Ophthalmology in October 2019.
The study results showed very conclusively that Elmiron was very toxic to the sensitive retina tissue in the back of the eyes. About 25% of patients who used Elmiron displayed signs of maculopathy or significant eye damage.
Many of these victims already have partial or total loss of their vision. When these individuals were examined and tested, doctors found clear signs of drug toxicity related to their prolonged use of Elmiron.
The researchers’ data revealed 10 patients with Elmiron-related maculopathy signs. Half of them underwent imaging. The other half underwent fundus examinations. They also found that these 10 patients took Elmiron for an average of 4.2 years with an average cumulative dose of 380g.
The researchers inferred that imaging could detect Elmiron-related maculopathy. Which tells you… Elmiron can cause maculopathy.
What Type of Eye Condition Does Elmiron Cause?
Recent studies have linked prolonged use of Elmiron to maculopathy, which is also known as macular retinopathy. Maculopathy is a broad term for any disease or pathologic condition affecting the macula – the central region of the retina in the eye. The type of maculopathy directly associated with Elmiron is called pigmentary maculopathy.
However, macular damage from Elmiron can easily be misdiagnosed as age-related macular degeneration. Maculopathy can result in impairment or even loss of vision.
Elmiron Lawsuits for Vision Loss Maculopathy
Hundreds of thousands of people have been exposed to Elmiron: the drug is still on the market.
The recent evidence showing that Elmiron causes serious eye damage is going to lead to a wave of lawsuits against the drug’s manufacturer. If you took Elmiron and were subsequently diagnosed with eye problems involving the retina such as maculopathy the drug maker can be held liable for your injuries.
There is already sufficient evidence establishing a link between Elmiron medication and retinal damage to support a product liability lawsuit. Hundreds and possibly thousands of Elmiron vision loss lawsuits are expected to be filed against Janssen Pharmaceutical.
Our Lawyers Are Accepting New Elmiron Eye Damage Lawsuits
Our Elmiron lawyers are taking new Elmiron class action lawsuit cases for victims seeking compensation. We are looking for individuals suffering from side effects who meet the following basic criteria:
- You took Elmiron on a daily for 6 months or longer; and
- After using Elmiron you experienced vision problems and were diagnosed with any of the following conditions:
- Maculopathy/macular retinopathy
- Age-related macular degeneration
- Retinal dystrophy
- Other retinal conditions
If you or a family member meet these criteria, contact our law office today for a free consultation to find out if you qualify for an Elmiron eye injury lawsuit.
Is There an MDL Class Action for the Elmiron Lawsuits?
The Elmiron multidistrict litigation (MDL) class action lawsuit was established on December 15, 2020, when the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal lawsuits involving Elmiron into one court in the U.S. District Court for the District of New Jersey.
An MDL is similar to a class action lawsuit. All pending cases from around the country involving a single defective drug or product are consolidated for litigation under a single federal judge for pretrial discovery. So if you file an Elmiron vision loss lawsuit is filed in federal court in California, Texas, New York, Illinois, or any other state, your claim will be transferred to federal court in New Jersey.
The plaintiffs’ lawyers are in the discovery phase of the Elmiron eye damage litigation. The first Elmiron trial is set for March 2023. In most class action lawsuits, there area few individual “test” cases will be selected for trial and the results of those trials are used to negotiate a global settlement of all the remaining cases. But few lawyers believe Janseen would be foolish enough to let this case go to trial. We believe Janssen plans to settle these lawsuits in 2023 before the first case goes to trial.
Claim details and basic information are gathered and compiled for all plaintiffs for many lawyers in anticipation of settlement. Usually, the settlement has tiers or levels of payments to plaintiffs based on the severity of their injuries.
There were few Elmiron lawsuits than our lawyers expected? Why? This is a good question and the answer is important. People are just starting to connect Elmiron to their vision-related injuries. So our attorneys are expecting more individual Elmiron eye damage lawsuits to get filed eventually. Whether that comes to pass will remain to be seen.
Potential Elmiron Lawsuit Settlement Compensation
It is early in the Elmiron litigation. Our lawyers cannot predict with accuracy what the Elmiron settlement amounts will be. But we can estimate the Elmiron settlement amounts by comparing them to the settlement amounts of similar cases involving similar injuries.
The victims in the Elmiron lawsuits will have the same basic injuries – vision impairment, macular degeneration, and loss of vision. The settlement compensation of vision loss or vision impairment injuries in other cases is a lens to the settlement values in the Elmiron litigation.
Potential Elmiron Lawsuit Jury Payouts
Based on this data combined with our take on this litigation, our Elmiron lawyers anticipate that cases in which the plaintiff suffered total vision loss may see settlement amounts that approach or exceed $1,000,000. The average jury payout in a blindness lawsuit is expected to be much higher, possibly in the $10 million neighborhood.
What Are Expected Elmiron Settlement Amounts?
Based on average case values in other vision impairment lawsuits, our Elmiron attorneys guess/believe that an Elmiron eye damage lawsuit in Tier 1 may have settlement values in the range of $300,000 to $800,000 per person. Cases in Tier 2 may have a settlement amount range somewhere between $75,000 and $250,000 per person.
Settlement tiers are just a way of grouping plaintiffs for settlement. In an Elmiron settlement, there will likely be a points system that rewards the severity of the injury, length of usage, age of the plaintiff, and so forth. Plaintiffs with the most extensive impairment to their vision (maybe 75%-80% impairment) will be in the top settlement payout tier. Plaintiffs with less impairment (40%-75%) will be in Tier 2 and there will likely be two or more lower settlement compensation tiers after that.
Putting Projected Elmiron Settlement Amounts in Context
Are these numbers realistic? Our law firm is particularly bullish on the individual average settlement amounts for a meritorious Elmiron lawsuit. We also believe there is a legitimate hope that the defendants offer reasonable settlement amounts in this ballpark in 2023.
Is Elmiron settlement talk pure speculation? Of course. Our attorneys keep beating this drum – anything can happen in litigation, but it is still very early. But you do not need to be a class action lawyer for 25 years to understand that losing your vision is an awful injury that deserves a great deal of compensation if the defendants are culpable.
Elmiron cases involving only vision impairment will likely be grouped into tiers based on the level of impairment to the plaintiff’s vision. The most serious injuries will involve blindness and other permanent vision loss.
Please keep in mind we are making a lot of assumptions here based on very little information. It is too early to accurately predict the expected settlement amounts of these vision loss lawsuits. But people want to know what the settlement compensation payout could be so we give our unvarnished opinion.
Selection of Bellwether Cases in Elmiron Litigation
Millions of Americans take the prescription drug Elmiron (pentosan polysulfate sodium) to treat chronic bladder inflammation and related conditions. In 2018, however, it was discovered that prolonged use of Elmiron can cause vision loss and blindness from a unique type of damage to the retina in the eye.
Since this discovery, over 900 Elmiron lawsuits have been filed in federal court by users of the drug who experienced blindness and vision loss or damage. The Elmiron lawsuits in federal courts have been consolidated into a class-action MDL in New Jersey. The first bellwether test trials in the Elmiron MDL will start in January 2023. At least our attorneys hope so.
Let’s review the Case Management Order in the Elmiron MDL (CMO No. 17). This CMO lays out the process for the selection of bellwether cases and establishes all of the major discovery and procedural deadlines moving forward.
Protocol for Selection of Bellwether Cases
Section III of CMO 17 sets forth detailed protocols and rules for how the parties will go about selecting cases for the bellwether trials set for January 2023. First, the order identifies very simple criteria for what cases are eligible to be bellwether cases. These include standard requirements such as a completed Plaintiff Fact Sheet and documented proof of an Elmiron prescription.
Under CMO 17, an initial pool of 20 cases will be selected as “Bellwether Discovery Cases.” 10 of these cases will be selected by the Plaintiffs Executive Committee (“PEC”) and ten will be picked by Lead Counsel for Defendants. CMO 17 requires the parties to notify the judge of their case selections by 11/22/21, so this has presumably already happened.
Once the 20 cases are selected, CMO 17 directs the parties to begin conducting “fact discovery” in the 20 bellwether cases immediately. This means that lawyers in the 20 bellwether cases can conduct normal civil discovery (depositions, requests for documents, etc.) under the federal rules.
To streamline that discovery process, however, CMO 17 imposes certain obligations that each side must comply with. For example, by 12/8/21 each bellwether plaintiff must provide two available deposition dates in January 2022. A similar obligation is imposed on defense counsel for their witnesses. CMO 17 further obligates lawyers for both sides to work out a plan for deposing all prescribing and treating doctors in February and March 2022.
Fact discovery in the 20 bellwether cases must be completed by March 31, 2022. Once factual discovery is completed, CMO 17 provides that 3 of the 20 cases will be selected as the Bellwether Trial Cases. One case will be selected by the PEC. Defendants’ Lead Counsel will choose one case and the Court will select the third case.
Once the three Bellwether Trial Cases are selected, the partican to conduct expert witness discovery in those cases. CMO 17 lays out clear deadlines for the completion of expert discovery, which will last until September 2022.
- An even newer eye injury mass tort is brewing as Beovu lawsuits are now alleging vision loss
- Taxotere watery eye lawsuits also have a class action MDL in 2023
Schedule and Deadlines for Bellwether Cases
Section IV of CMO 17 lays out a schedule of deadlines for selecting the Bellwether Discovery Cases, completing fact discovery in those cases, and then accomplishing expert discovery in the 3 Bellwether Trial Cases. A list of those deadlines is below:
|11-22-2021||Selection of 20 Bellwether Discovery Cases reported to MDL Judge and Fact Discovery begins in these cases.|
|12-2-2021||Bellwether plaintiffs must provide retinal imaging and ophthalmology treatment records.|
|3-31-2022||Completion of all Fact Discovery.|
|4-8-2022||Selection of 3 initial Bellwether Trial Cases and Expert Discovery begins immediately.|
|5-10-2022||Deadline for Plaintiffs’ expert reports in Trial Cases.|
|6-17-2022||Deadline for Defendants’ expert reports in Trial Cases.|
|6-27-2022||Deadline for Plaintiff rebuttal expert reports in Trial Cases.|
|9-9-2022||Expert deposition deadline in Trial Cases|
|9-13-2022||Dispositive motions deadline|
|9-30-2022||Daubert motions deadline|
|3-27-2023||1st Bellwether Trial|
|TBD||2nd Bellwether Trial|
|TBD||3rd Bellwether Trial|
More Elmiron Eye Injury Medical Literature
- 2021: Kalbag NS, et. al: Maculopathy Secondary to Pentosan Polysulfate Use: A Single-Center Experience. Clin Ophthalmol. 2021;15:513-519
- 2020: Doiron, RC, et. al: Possible drug-induced, vision-threatening maculopathy secondary to chronic pentosan polysulfate sodium (Elmiron®) exposure, Can Urol Assoc J. 2020 Feb; 14(2): 10–11, doi: 10.5489/cuaj.6401. This 2020 article, which came out after the Elmiron litigation, summarizes the literature and underscores the risks of newly understood risks of the drug.
- 2019: Jain N, et. al: Association of macular disease with long-term use of pentosan polysulfate sodium: Findings from a U.S. cohort. Br J Ophthalmol. 2019 Nov 6; doi: 10.1136/bjophthalmol-2019-314765
- 2018: Pearce, WA, et. al: Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium, 2018 Nov;125(11):1793-1802. doi: 10.1016. This study found unique pigmentary maculopathy in six patients taking pentosan polysulfate sodium. This is the article that set off alarms in the medical and scientific community we talked about above.
Elmiron NJ State Court Lawsuits
Most Elmiron lawsuits have been filed in (or removed to) federal court and consolidated into the Elmiron MDL.
Recently, a growing number of Elmiron cases are being brought in the state courts in New Jersey. The maker of Elmiron, Janssen Pharmaceuticals, is based in New Jersey so these cases cannot be removed to federal court based on diversity jurisdiction.
This fall, lawyers for 20 Elmiron plaintiffs filed a petition to consolidate all Elmiron cases in NJ state courts in a new Multicounty Litigation (MCL). In February 2022, these claims were consolidated under one judge.
This is the state court equivalent of an MDL class. So we will see consolidated pretrial proceedings before a single judge.
FAQs: Elmiron Lawsuits
Below are answers to commonly asked questions about the Elmiron eye damage lawsuits.
Can Elmiron Cause Blindness?
The use of Elmiron can cause blindness in certain patients. It was recently discovered that extended use of Elmiron can cause a unique type of eye condition called pigmentary maculopathy that can cause vision impairment and complete blindness.
Do I Qualify for an Elmiron Lawsuit?
We spell out the Elmiron lawsuit criteria above. Anyone diagnosed with pigmentary maculopathy after taking the prescription injection drug Elmiron is eligible to bring an Elmiron injury lawsuit. Even if you have not been diagnosed with this specific condition you may still qualify if you took Elmiron and subsequently suffered vision impairment or blindness.
What Is the Status of the Elmiron Lawsuit in March 2023?
All pending Elmiron suits in federal courts have been consolidated into an MDL, both in federal court and in New Jersey. The first Elmiron lawsuit to go to trial will be in March 2023. Many believe this lawsuit will not go to trial because Janssen is intent on settling these suits before getting a verdict,
How Much of a Settlement Compensation Payout Can Elmiron Victims Expect?
Elmiron lawsuits could have a very high settlement value because of the severe nature of the injuries. Elmiron plaintiffs with total vision loss could see settlement amounts worth close to $1,000,000. Our lawyers are bullish on these claims. As we discuss above, the amounts will be less for less serious eye damage injuries. Our guess for the average Elmiron settlement? Between $350,000 and $400,000.
No-Risk in Joining Elmiron Class Action Lawsuit
Again, there are already over 700 Elmiron lawsuits filed in the MDL against Janssen Pharmaceuticals for failing to warn doctors and patients of possible vision damage and blindness when using Elmiron for IC. Most lawyers will handle an Elmiron lawsuit on a contingency fee. This means you only pay the costs of fees if you receive a settlement compensation payout or a verdict.
Contact Our Law Firm About Elmiron Eye Damage Lawsuits
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.