Get Your Elmiron Lawsuit Reviewed for Free by Skilled Defective Drug Attorneys
Parker Waichman LLP is reviewing cases involving severe side effects affecting vision, such as blindness and vision loss, suffered by patients who have been prescribed Elmiron (pentosan polysulfate sodium) who are now interested in filing lawsuits to recover monetary compensation for Elmiron eye damage.
If you or a loved one have been prescribed Elmiron and suffered eye damage such as blindness or vision loss, protect your legal rights by contacting Parker Waichman by calling 1-800-YOUR-LAWYER (1-800-968-7529) for a free case review today. We won’t charge you for anything unless you receive a settlement from your Elmiron lawsuit.
Why Choose Parker Waichman for Your Elmiron Lawsuit?
Image source: Elmiron Vision Loss & Blindness Lawsuit Lawyers
What Is Parker Waichman’s Experience With Suing for Damages From Use of Elmiron?
Parker Waichman has filed lawsuits in both federal court and state courts claiming serious and permanent physical damages to the retinas of its clients. Parker Waichman has retained some of the world’s leading retinal specialists and others with extensive knowledge of Elmiron and its toxic effects on the retina.
Why Should Someone Choose Parker Waichman for Their Elmiron Lawsuit?
Parker Waichman represents clients in pharmaceutical or medical device cases in all 50 states. We are a national firm; we’re a litigation firm.
We don’t collect cases and let other law firms do the work. We don’t get cases and then refer them out. We litigate our cases. We don’t sit around and hope the defendants will try to settle and then try to get in on a settlement. From our almost four decades of pharmaceutical and medical device litigation experience, we have found that the clients of the law firms that actually litigate their cases are more appropriately compensated than the clients of law firms that sit and hope to piggyback onto a settlement arrived at by others who actually did litigate the cases.
In order to litigate cases against giant corporations like we have here, you may be wondering, “How do you do such a thing?
“How do you take on some of the largest corporations in the world? It must be very expensive.”
It is. It costs millions, tens of millions of dollars that we advance to the litigation. It takes an army of lawyers and paralegals. We have the army.
Parker Waichman is well-financed and has almost four decades of taking on the pharmaceutical and medical device manufacturers. And we know from firsthand experience that when you actually do the work, when you take the depositions, when you do the discovery, when it comes time for case resolution, our clients are going to benefit from that work.
What Is Your Relevant Experience?
The attorneys at Parker Waichman have been involved in dozens of pharmaceutical and medical device litigations over the last four decades, starting with diethylstilbestrol (more commonly known as DES), breast implants, Prozac suicidality cases, Bausch & Lomb Renu with MoistureLoc contact lens solution (which involved damage to the cornea, not the retina) … . In the Renu case, a lot of our clients had their cornea replaced — but unfortunately, you can’t get your retina replaced.
So that speaks to the damages. Zyprexa, Ortho Evra birth control patch, Yaz birth control medication, Medtronic’s InFuse spinal medical device, TDF drugs of many types, and so many other pharmaceutical medical device cases — defibrillators, pacemakers … it’s quite a list.
Is My Lawsuit Confidential?
Everything that you tell Parker Waichman and that we tell you is confidential, highly confidential, and protected by the attorney-client privilege.
That’s why when you talk to your doctor, you talk to your doctor about medical things: You talk to him about problems with your vision, talk to him about the time you took Elmiron, the period of time you took Elmiron, whether you need to go see a retinal specialist, whether you need the retinal imaging that is able to diagnose if you have Elmiron-related toxicity to your retina.
But you never talk to your doctor about the litigation: You never talk to your doctor about things that we talk about. Because if you do that, you could be deemed to have waived the attorney-client privilege once you start talking about the privileged things, and we don’t want that to happen.
Another very important thing is that we ask defendants for discovery: We ask them for their emails, their clinical trials, adverse event data, pharmacological data, all kinds of information. But they also ask us for information from you. They want us to look at your emails. They want us to look at your Facebook page. They want us to find any information that you’ve posted that would be relevant to this litigation.
So I plead with you to keep everything to yourself having to do with this litigation. Don’t post anything on Facebook. Don’t be emailing your friends or relatives about your problems with your vision or litigation. This will be information that they will want, and this is gonna be information that they are going to get. And they’re going to use it against you as effectively as they can.
So don’t give them that opportunity. Keep everything to yourself having to do with your problems with your eyes. Keep it off the social media. Keep it out of your emails.
How Do I Know if I Qualify for an Elmiron Lawsuit? What Are the Criteria for a Lawsuit?
Anyone who has ever taken Elmiron and is suffering from one or more of the following — blurred vision, difficulty reading, difficulty adjusting to dim lighting, problems with dark adaptation, glare, metamorphopsia, blind spots, blindness — should see a retinal specialist who has the radiological tools to confirm whether there is damage to the retina and if it was caused by Elmiron.
The damage to the retina caused by Elmiron is what I would refer to as a “fingerprint” injury. That is, the damage to the retina caused by Elmiron had never been seen before Elmiron was available for sale.
What Is Elmiron?
Elmiron is a commonly prescribed weak blood thinner (anticoagulant). Elmiron is used to treat bladder pain or discomfort caused by cystitis of the bladder. Elmiron contains the active ingredient pentosan polysulfate sodium (PPS). According to ICHelp.org, Elmiron is the only medication approved by the U.S. Food and Drug Administration for interstitial cystitis (also known as bladder pain syndrome or IC/BPS).
What Is Interstitial Cystitis (Bladder Pain Syndrome or IC/BPS)?
Interstitial cystitis is a debilitating, chronic, and rare urogenital disease that presents symptoms such as bladder pressure; pain in the lower back, lower abdomen, or pelvic area; Hunner’s lesions or glomerulations in adults feeling moderate to severe pain; urinary urgency; and increased micturition frequency. In patients suffering from interstitial cystitis, the patient’s pelvic nerve sends a signal to the brain that creates an urgency to urinate. However, in severe IC cases, the patient may attempt to urinate 40 to 60 times a day in very small amounts. IC is commonly mistaken for a bladder infection, but IC is not an infection. It is estimated that IC affects 2.7% to 6.53% of older women in the United States. Patients suffering from irritable bowel syndrome (INS), fibromyalgia or allergies are more likely to experience IC.
Contributing Factors That Lead to Interstitial Cystitis
According to a MarketWatch.com press release, the known contributing factors that may cause interstitial cystitis are:
- A defect of the epithelium layer of the bladder, which allows toxins in urin to irritate the bladder
- An autoimmune reaction
- An allergy
Diagnosing Interstitial Cystitis
Interstitial cystitis is commonly diagnosed by performing a bladder ultrasound, cystoscopy, urine analysis, bladder stretching, a biopsy of the bladder and urethra, and a culture on the patient’s prostate fluid. There are many treatment options that provide relief for the symptoms of interstitial cystitis, but there is no cure for it.
Market for Interstitial Cystitis Expected to Generate Greater Revenue Share Between 2017 and 2025
Interstitial cystitis (IC), commonly referred to as “painful bladder syndrome,” could be a ripe opportunity for drug manufacturers, according to an article appearing on The Business Wire, because existing treatments are few and their effectiveness can be questionable.
Physicians typically prescribe five stages of therapy to relieve a patient’s symptoms. The first stage is physical therapy. Next, the patient will take oral medications like amitriptyline, which helps reduce bladder spasms, and Elmiron (pentosan polysulfate sodium) to reconstruct the wall lining the patient’s bladder. Doctors may prescribe additional medications, too, like steroids to reduce inflammation and hydroxyzine or dimethyl sulfoxide to help block pain in the most severe cases.
If the primary course of medicinal treatments proves unsuccessful, then doctors will prescribe neurostimulation as the third stage of treatment. Neurostimulation includes therapies like transcutaneous electrical stimulation and sacral nerve stimulation.
The fourth phase of IC treatment involves a course of cyclosporine. Cyclosporine is a medication designed to change the bladder’s immune response. Finally, the fifth stage — and most invasive — is a surgical intervention or bladder detention.
Problems developing new medicines to combat IC persist. Drug companies have experienced pushback when developing new IC treatments because of the limited efficacy of the drugs now available. People facing IC do so with a lack of greater awareness of the need to develop new medications, and companies do not fully understand the growing need for new drugs to reach the market to help people with IC. Consequently, drug makers could find entry into the space to be a tremendous opportunity if they could develop a safe drug that works.
Does Elmiron Cause Pigmentary Maculopathy?
Recent medical research has linked being prescribed Elmiron with an increased risk of developing an eye disease known as maculopathy. The specific Elmiron eye disease cited is called pigmentary maculopathy, which affects the retina of the eye. However, Elmiron has not yet been recalled by the Food and Drug Administration (FDA).
If you or a loved one is suffering from pigmentary maculopathy and has been prescribed Elmiron, contact Parker Waichman at 1-800-YOUR-LAWYER for a free personal injury case review.
Startling New Elmiron Drug Label Warns of “Retinal Pigmentary Changes” Risk Factor
On June 16, 2020, the FDA approved a surprising Elmiron label change: Drug manufacturer Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, admitted that a cumulative dose of Elmiron “appears to be a risk factor” for side effects such as “retinal pigmentary changes.”
Patient labeling for Elmiron that is sold within the United States never listed serious warnings or health risks under the “Warnings” section of its patient labeling, but now, it carries a warning about the risk of retinal changes such as pigmentary maculopathy. The only warnings included in the patient labeling prior to this change included such benign side effects as diarrhea, nausea, hair loss, and headaches.
Health Canada required similar warnings for Elmiron starting in October 2019. In June 2019, the European Medicines Agency demanded that Janssen Pharmaceuticals list a similar health warning on all Elmiron patient labeling. Janssen now warns that these retinal changes have been observed with short-term use as well.
If you or a loved one have been prescribed Elmiron and suffered harm, contact Parker Waichman today to receive a free case review. We have been at the forefront of litigation involving defective drugs, products, and medical devices that harm the public. Our firm has successfully represented clients who have sustained severe and permanent eye injuries for more than a decade. There is no obligation when you discuss your case with one of the experienced and caring attorneys at our nationally recognized law firm, and since we represent clients in Elmiron lawsuits on a contingency-fee basis, there will be no fee for our firm’s services unless you receive compensation from your Elmiron lawsuit. Call us today at 1-800-YOUR-LAWYER (1-800-968-7529) to discuss your case and learn how you could recover monetary compensation for your Elmiron eye injury.
Elmiron, Blindness, and Other Symptoms: Links Between Elmiron and Eye Disease
Maculopathy is a disease that affects the macula. The macula is the part of the retina that is responsible for producing accurate and highly sensitive vision. The symptoms of the Elmiron eye disease, pigmentary maculopathy, may be mild or severe depending on the amount of retinal damage that has occurred. Common signs and symptoms of maculopathy include:
- Difficulty reading
- Difficulty acclimating to dim lighting
- Symptoms that mimic pigmentary pattern dystrophy
- Partial or full loss of vision
- Retinal toxicity
- Other vision-related dysfunction
The link between Elmiron and eye problems like maculopathy was first reported back in 2018. Researchers at the Emory Eye Center at the Emory School of Medicine in Atlanta, Georgia, published an alert alleging Elmiron’s link to retinal injury (maculopathy). The alert followed a study conducted by Emory researchers who found the retinal disease in young adults who were diagnosed with interstitial cystitis, also known as bladder pain syndrome (BPS). Bladder pain syndrome is chronic pain that affects the bladder.
Maculopathy is a disease that typically presents itself in elderly patients. However, the study found that patients in their 20s who were taking daily doses of Elmiron began having difficulty reading and developed near-vision problems by age 30.
Parker Waichman Suing on Behalf of Client Who Suffered Permanent and Irreversible Vision Loss After Taking Elmiron
In July 2020, Parker Waichman sued Bayer Healthcare Pharmaceuticals Inc., Johnson & Johnson, Janssen Pharmaceuticals, Ortho-McNeil Pharmaceuticals, and a host of other drug companies on behalf of a woman from San Diego who took Elmiron for a long time and now has permanent vision loss, among other eye problems. The plaintiff alleges that Elmiron damaged her retinas, caused pigmentary maculopathy, and resulted in permanent vision loss. With the help of Parker Waichman, she is seeking compensation for damages including pain and suffering, mental anguish, lost wages, lost earning capacity, and medical expenses.
According to the plaintiff and our knowledgeable defective drug lawyers, the defendant drug companies caused her injuries by failing or refusing to develop, manufacture, and sell a safe prescription drug. Additionally, the plaintiff alleges in her lawsuit that the defendants knew about the potential vision loss and eye injuries caused by Elmiron but still failed to warn, educate, advise, and alert physicians, the FDA, and patients about the possible side effects that could render a patient blind.
The depth of the defendant drug companies’ deceit runs deep. Our investigation revealed that the studies the defendant drug makers used to convince regulators that Elmiron was safe and effective do not support the companies’ assertions. Instead, the studies merely indicate that Elmiron is an effective treatment for interstitial cystitis. However, subsequent clinical trials determined that Elmiron was about as effective as a placebo for treating interstitial cystitis.
The complaint was filed in the United States District Court for the Southern District of California, and the docket number is 20CV1266 JM BLM, according to APNews.com.
All Pending National Elmiron® Retinal Damage Lawsuits Transferred to the District of New Jersey
December 16, 2020 – PRNewswire – Plaintiffs successfully persuaded the United States Judicial Panel on Multidistrict Litigation, in the matter of Elmiron (pentosan polysulfate sodium) Products Liability Litigation, under 28 USC § 1407, to centralize all pending national Elmiron retinal injury lawsuits in the District of New Jersey. On December 15, 2020, the United States Judicial Panel on Multidistrict Litigation (Case MDL No. 2973) issued a Transfer Order (Case MDL No. 2973; Document 158) moves all federally-filed Elmiron injury lawsuits to the District of New Jersey. In addition, the Transfer Order assigned the Honorable Brian R. Martinotti to head up the consolidation and coordinate the trial proceedings.
The Multidistrict Litigation Panel recognized that several of the witnesses, defendants, and litigation documents are in New Jersey, and by centralizing the Elmiron lawsuit would avoid inconsistent pretrial rulings, eliminate duplicative discovery; and would conserve the resources of the judiciary, the parties, and their counsel. The Multidistrict Litigation Panel also ruled that the Honorable Brian R. Martinotti has the experience needed to handle the complexities of multidistrict litigation, and he has begun the action required to organize litigation, which is predicted to grow by hundreds of cases.
The lawsuits assert the prescription drug Elmiron causes severe and permanent retinal damage, notably atypical or pigmentary maculopathy. Pigmentary maculopathy symptoms include permanent blindness, difficulty reading, difficulty adjusting to changes in lighting, blurred vision, and other vision problems.
Health Canada Upgrades Warning to Healthcare Professionals Regarding Elmiron® Pigmentary Maculopathy Risks
North America – December 17, 2020 – Health Canada, Canada’s government agency in charge of developing the country’s health policies, published an “Important Safety Information” letter (RA-74549) informing healthcare providers of Elmiron (pentosan polysulfate sodium) Pigmentary Maculopathy risks. Health Canada stated that the agency implemented updates to its “Canadian Product Monograph” for Elmiron. The updates contain a new patient contraindication and additional warnings about the increased risk of Elmiron-induced pigmentary maculopathy.
The “Important Safety Information” letter was distributed to all healthcare professionals, including urogynecologists, urologists, optometrists, ophthalmologists, pharmacists, and family physicians.
The letter includes the following key messages:
- Long-term Elmiron usage has been linked to pigmentary maculopathy.
- Patients who have a history of macular pathology should not start Elmiron therapy.
- Healthcare professionals are asked to:
- Weight the benefits and risks prior to starting patients on Elmiron and consider the assessment frequently.
- Obtain the patient’s comprehensive ophthalmologic medical history before starting Elmiron therapy.
- Obtain a baseline retinal examination and perform ongoing retinal examinations to catch any early signs of pathology.
- Direct your patients to contact you if they experienced any vision changes, including difficulty reading, slow adjustment to low or reduced light, wavy vision near or in the center of their field of vision, or blurred vision.
- Health Canada also applied these warns to a new Canadian Product Monograph for Elmiron.
Elmiron (pentosan polysulfate sodium) is used to treat the symptoms of interstitial cystitis.
Health Canada is the first government agency to announce how the long-term use of Elmiron increases the risk of developing atypical or pigmentary maculopathy. The symptoms of atypical or pigmentary maculopathy are not reversible and do not improve when the patient stops taking Elmiron.
Health Canada has now declared Elmiron a contraindication for patients with a medical history of macular pathologies. In addition, the Canadian Product Monograph for Elmiron will be updated to contain the new contraindication, and the risk of pigmentary maculopathy will be added to the “Consumer Information” section and the “Serious Warnings and Precautions Box.”
Persistence of Deficits in Pentosan Polysulfate-Associated Maculopathy Beyond Drug Discontinuation
Pentosan polysulfate (“PPS”), marketed as Elmiron by Janssen Pharmaceuticals, is a heparin-like macromolecule used to treat interstitial cystitis. It has been linked to a unique form of maculopathy (often referred to as “PPS Maculopathy”). To date, studies have provided limited information about the prolonged progression of PPS maculopathy following the cessation of drug use.
PPS Maculopathy Risk Factors Associated with Elmiron
The risk of developing PPS maculopathy stems from prolonged exposure to PPS. Multiple studies have indicated that there is a dose-response relationship between this distinct maculopathy and the amount of PPS exposure. For instance, one study observed prevalence rates of PPS maculopathy at 12.7%, 30%, and 41.7% among groups with cumulative exposures of 500—999 g, 1000-1500 g, and >1500 g, respectively. As screening programs become more widespread, it is likely that cases of early PPS maculopathy will be identified at even lower exposures.
In addition, a comprehensive study examining medical comorbidities and medications among patients with interstitial cystitis (IC) revealed that, apart from PPS exposure, no other factors were associated with the presence of the characteristic maculopathy. While PPS is metabolized and excreted by the liver, spleen, and kidneys, there have been no established connections to hepatic, renal, or splenic dysfunction. Furthermore, genetic analyses exploring genes linked to retinal disease have not uncovered any associations thus far.
The Pathophysiology of PPS Maculopathy
The underlying mechanisms of PPS maculopathy are still not fully understood. However, there are several speculative hypotheses regarding how PPS contributes to maculopathy. One theory suggests that PPS disrupts the homeostasis between retinal pigment epithelium (RPE) and photoreceptors, leading to aberrant processing of photoreceptor outer segments. The interphotoreceptor matrix, which is composed of glycosaminoglycans, plays a crucial role in supporting the interface between photoreceptors and RPE. Due to its similar structure, PPS could potentially interfere with the integrity of this matrix. Alternatively, some researchers propose that long-term inhibition of fibroblast growth factor (FGF) signaling may be responsible for PPS maculopathy. In vitro studies have shown that PPS inhibits FGFs, which are vital for maintaining retinal health. Finally, OCT angiography studies indicate early injury to the choriocapillaris, suggesting the involvement of other mechanisms in the development of PPS maculopathy.
Regardless of the exact mechanism behind it, the existing literature consistently reports a dose-dependent relationship between PPS exposure and the progressive development of maculopathy, which persists even after discontinuing the drug.
How Do I Know if I Qualify for an Elmiron Lawsuit?
Call the defective drug attorneys at Parker Waichman at 1-800-YOUR-LAWYER and we’ll review your potential case for free. We have been litigating eye damage cases involving defective medical devices and pharmaceuticals for more than a decade, and we can help you determine if you should pursue a legal claim over the harmful Elmiron side effects you’ve experienced.
Why Choose Parker Waichman
for Your Elmiron Lawsuit?
When you choose to work with us for your defective drug lawsuit, lawyers with vast experience litigating and winning these types of cases will go to work for you. We have the litigation resources and expertise to effectively represent victims of defective pharmaceuticals that caused eye damage in their fight against large drug manufacturers. Our law firm strives to provide our clients with exemplary legal services based on tenacious advocacy in the pursuit of the fullest recovery possible.
The reputation of Parker Waichman as an industry leader is evinced by a wide array of accolades and awards, which include:
- Martindale-Hubbell’s highest peer-review rating, “AV Preeminent”
- Lawdragon’s highest ranking of “5 Dragons”
- Rating of 9.8 out of 10 by AVVO
- Inclusion in Best Lawyers, an honor based on extensive peer review
Founding partner Jerrold S. Parker’s list of honors is also extensive:
- Award for outstanding service in New York City and the community at the New York Families for Autistic Children’s Awards Ceremony
- Proclamation from the New York City Council, which gave him a Citation of Honor
- Proclamation from the U.S. House of Representatives, signed by Congress
- Congressional Achievement Award in recognition of his outstanding and invaluable service to the community from the U.S. House of Representatives, signed by Congressman Gregory W. Meeks
- Citation from the New York State Assembly, signed by Assemblywoman Audrey I. Pheffer
- Proclamation from the New York State Senate, signed by state Sen. Serphin R. Maltese, for his outstanding service to the community
These acknowledgments and awards are just a few of the prestigious honors that have been bestowed on Parker Waichman attorneys and staff, solidifying our reputation not only as one of the most outstanding personal injury law firms in the United States but as a law firm that cares about others.
Don’t Delay: File Your Defective Drug Injury Claim Against the Makers of Elmiron
The time you have to recover compensation for Elmiron eye damage is limited by law, so it’s important to act quickly. You can count on Parker Waichman to handle your case promptly and professionally: We’re a nationally recognized defective drug and medical device litigation law firm with vast experience representing individuals harmed by defective medications. Parker Waichman has helped clients to collect more than $2 billion in compensation, and our attorneys will fight hard for you or your loved one. Our product liability litigators have the experience to take on the big pharmaceutical companies on your behalf and are prepared to fight for compensation for those who have had experience with Elmiron and eye issues.
If Elmiron has harmed you or a member of your family and you are interested in filing a lawsuit to recover monetary compensation, contact Parker Waichman by calling 1-800-YOUR-LAWYER (1-800-968-7529) for a free case review today.
- FDA-Approved Drugs
- ELMIRON®-100 mg
- Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium
Elmiron News & Articles
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation