Elmiron Eye Damage Lawsuits

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.

Why Choose Parker Waichman LLP For Your Elmiron Lawsuit?

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 LLP 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 Parker Waichman LLP‘s Experience With Suing For Damages From Use Of Elmiron?

Parker Waichman LLP has filed lawsuits in both federal court and state courts claiming serious and permanent physical damages to the retinas of its clients. Parker Waichman LLP has retained some of the world’s leading retinal specialists and others with extensive knowledge of Elmiron and its toxic effects on the retina.

Elmiron Medication Lawsuit: Criteria, Settlement and Other Questions Answered

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What is Elmiron ?

Elmiron, also known as Pentosan Polysulfate Sodium (PPS), is an oral heparinoid derived from beech tree bark. It was initially developed in the 1950’s to be used as a blood thinner – similar to Heparin.

Elmiron was the first – and remains the only – oral drug approved by the FDA specifically for the treatment of patients with interstitial cystitis (IC) aka bladder pain syndrome (BPS).

However, Elmiron is not the only treatment for Interstitial cystitis that is available to physicians and patients.

It is also not a first line treatment.

Who makes Elmiron?

Elmiron is manufactured by bene pharmaChem GmbH & Co., a German company

US marketing and sales entities (Elmiron makers):

• Baker Norton – then owned by Ivax – now both owned by Teva (Held NDA from date of approval to 1997)
• Alza Corporation – now owned by J&J (Held NDA from 98-02)
• Johnson & Johnson entities:
  • Alza Corporation
  • Janssen Research & Development LLC f/k/a Johnson & Johnson Research (Held NDA from 02-04)
• Janssen Pharmaceuticals, INC., f/k/a Ortho-McNeil-Janssen Pharmaceuticals, Inc. (Held NDA from 08-present)
• Janssen Ortho LLC (Packages Elmiron)
• Ortho-McNeil Pharmaceutical, L.L.C. (Held NDA from 04-present)
• Bayer entities:
  • Bayer Healthcare Pharmaceuticals, Inc f/k/a Bayer Pharmaceuticals Corporation (Entered into co-promotion agreement with J&J in 2005 to market to urologists in US)
  • Bayer Healthcare LLC;
  • Bayer US L.L.C;
  • Bayer Corporation

What is Elmiron used for?

Elmiron was approved by the FDA to treat interstitial cystitis (also known as “IC”) or “bladder pain syndrome” (also known as BPS)

Can Elmiron cause blindness?

Yes, Elmiron can cause blindness, potentially. Elmiron can cause serious and permanent damage to the retina which can result in a loss of vision.

Common Symptoms of Pentosan Polysulfate Sodium (PPS)-Associated Maculopathy:

• Blurred vision
• Difficulty reading
• Difficulty adjusting to dim lighting
• Problems with dark adaptation
• Glare
• Blind spots
• Muted, less vivid colors
• Night blindness
• Metamorphopsia
• Blindness

The misdiagnosis may be:

• AMD (age-related macular degeneration): While both forms of macular degeneration involve the retina and causes loss in the center of the field of vision, the injury caused by Elmiron is completely different and has a unique – almost “fingerprint-type” presentation on retinal imaging
• Macular Dystrophy
• Pattern Dystrophy
• Maculopathy
• Macular Disease
• Retinopathy
• Stargart’s Disease
• Severe Loss of Retinal Pigment Epithelium (RPE) with Photoreceptor Loss

Target Diagnosis:

• Pigmentary Maculopathy/Changes to the pigmentary layer of the retina
• Pentosan/Elmiron Toxicity
• Pentosan Polysulfate Sodium (PPS)/Elmiron toxicity
• Drug toxicity

Frequently Asked Questions About Elmiron Lawsuits

How can Pentosan Polysulfate Sodium (PPS)-Associated Maculopathy be diagnosed?

Pentosan Polysulfate Sodium (PPS)-Associated Maculopathy can be diagnosed using:

• Fundus autofluorescence (FAF) Imaging
• Optical Coherence Tomography (OCT), and/or
• Near-infrared fundus reflectance (NIR)

Does Elmiron cause macular degeneration?

No: Macular degeneration is a common misdiagnosis for the damage to the retina caused by Elmiron.

While both forms of macular degeneration involve the retina and cause loss in the center of the field of vision, in dry macular degeneration, the center of the retina deteriorates and with wet macular degeneration, leaky blood vessels grow under the retina. The injury caused by Elmiron is completely different and has a unique – almost “fingerprint-type” presentation on radiology.

I am having trouble reading. Is that enough to sue?

No – but that could be indicative of damage to your retina caused by Elmiron

The question is, have you ever taken Elmiron?

Note: The damage caused by Elmiron to your retina can occur long after you have stopped taking Elmiron

How does Elmiron cause damage to the retina?

Without getting into attorney confidential information, based on the published literature including the Elmiron updated label of June, 2020, many people who have reported Elmiron related damage to their retina:

• Have taken Elmiron for 3 years or longer though for some individuals, it was less
• It seems the cumulative dose of Elmiron taken appears to be a risk factor
• Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment

Should I get an eye exam? What kind of exam?

Yes, if:

• You have taken Elmiron, and
• You have any of the symptoms of Pentosan Polysulfate Sodium (PPS) toxicity

Then discuss with an ophthalmologist or retinal specialist, having your retina examined using at least one of the following technologies:

• Fundus autofluorescence (FAF) Imaging
• Optical Coherence Tomography (OCT), and/or
• Near-infrared fundus reflectance (NIR)

What is Parker Waichman LLP’s experience with suing for Damage from use of Elmiron?

• Parker Waichman LLP has filed lawsuits in federal and state courts claiming serious and permanent physical damages to the retinas of its clients.
• Parker Waichman LLP has retained some of the world’s leading retinal specialists and others with extensive knowledge of Elmiron and its effects on the retina

How do I know if I qualify for an Elmiron lawsuit? What is the criteria for a lawsuit?

Anyone who has ever taken Elmiron and is suffering from one or more of the following symptoms:

• Blurred vision
• Difficulty reading
• Difficulty adjusting to dim lighting
• Problems with dark adaptation
• Glare
• Metamorphopsia
• Blind spots
• Blindness

I you experience the above symptoms, you 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 commonly referred to now as a “fingerprint” injury – that is the damages to the retina caused by Elmiron has never been seen prior to its association to Elmiron

Why should someone choose the Parker Waichman LLP law firm for their Elmiron Lawsuit?

Parker Waichman LLP is a law firm that:

• Litigates their cases
• We don’t sit and hope the defendants will settle and then try to get in on the settlement
• From our almost 4 decades of pharmaceutical and medical device litigation experience, 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 litigated their cases
• In order litigate cases against giant corporations you need to be well financed. Parker Waichman LLP is well financed and has almost 4 decades of taking on the pharmaceutical and medical device manufacturers

What is your relevant experience?

The attorneys at Parker Waichman LLP has been involved in dozens of pharmaceutical and medical device litigations over the almost last 4 decades starting with diethylstilbestrol (DES), breast implants, Prozac suicidality cases, Fen-Phen, Zyprexa, Bausch & Lomb Renu with MoistureLoc contact lens solution, Zyprexa, Ortho Evra birth control patch, Yaz birth control medication, Medtronic’s InFuse spinal medical device, TDF drugs and so many more

Can I become part of an Elmiron class action lawsuit?

First, there’s no Elmiron class action lawsuit. A popular misconception in the United States is that these pharmaceutical and medical device cases brought against their respective manufacturers for serious personal injuries and death that they caused are class actions. They are not. With only a very few statutory exceptions there is no such thing in the United States as a class action involving personal injury or death.

Cases against pharmaceutical and medical device companies for serious personal injury or death are commonly referred to as mass torts. They are individually filed cases that are oftentimes consolidated by the court system into a single court to save time and effort by the court system and handling these cases. However, each case is individually filed and remains an individual case.

What could an Elmiron Lawsuit settlement amount be?

Elmiron Lawsuit settlement amount will depend on a variety of criteria and personal circumstances.

While everyone’s case is unique from so many different aspects – are you 20 years old or 90 years old, are you working or retired, is sharp vision important in your line of work, is it one eye that is damaged or both eyes, etc. – the loss of vision is a very substantial injury and must be appropriately compensated

How long will it take to get a settlement?

At Parker Waichman LLP, when we get involved in litigation, we never plan on a settlement. To do so is distracting and takes away our focus of learning everything we need to know about the science and about our clients.

It is from the power of strength and with the knowledge we gain through discovery and access to the defendants documents, that we can determine and assess the bad conduct of the defendants which factors into the amount of the recovery of our clients

How much will it cost me to sue the maker of Elmiron?

Parker Waichman LLP are taking Elmiron cases under a contingency fee agreement in which Parker Waichman LLP advance the out of pocket expenses of the litigation. These expenses can be very substantial. We only recover a fee if we are successful in obtaining recovery for you by way of settlement or judgment.

However, an advantage that the clients of Parker Waichman LLP have, is that Parker Waichman LLP represents a large number of clients who claim their loss of vision was caused by Elmiron.

What we are able to do many times with the oversight by the court, court appointed special masters or court approved settlement coordinators is that the “global” expenses incurred that benefit all clients, are spread among all the clients in an equitable fashion which greatly reduces the financial effect on all Parker Waichman LLP clients.

Of course, each client is ultimately responsible for the expenses that affect only their case i.e. filing fees, medical records, fees paid to the clients physician and other expenses that benefit only that one client.

Should I sue my doctor who prescribed it? Is this a medical malpractice suit?

At Parker Waichman LLP we generally do not believe the doctor has direct responsibility in cases such as this as they were not warned in any way by the defendants of the possibility of any injury to the eye

At Parker Waichman LLP we generally do not believe the doctor has direct responsibility in cases such as this we believe the doctor was duped just like you were and therefore, absent special circumstances, we will not sue the doctor

Should I talk to my doctor about my case?

You should definitely talk to your doctor about your injury – about your difficulty with your vision and your history of use of Elmiron; as there are non-invasive imaging tests that can easily be performed to diagnose whether your vision problems are caused by Elmiron.

You should not, however, talk to your doctor, of anyone other than your lawyers, about your lawsuit/case since those communications would likely be discoverable by the defendants in your case.

Will I have to testify or go to court? What else do I have to do?

While having to go to court is always a possibility, the % of clients who actually do is much less than 1% of our clients

Of cases that do go to trial, usually after several verdicts the parties get the feel of where the litigation is going and the litigation generally resolves, one way or the other

How can I pay my medical bills in the meantime?

Your medical bills should be payable by your healthcare insurance, Medicare or Medicaid

Has there been an Elmiron recall?

While there has not yet been a recall of Elmiron, in June, 2020 the label instructions for Elmiron was significantly changed to warn about the toxicity of Elmiron to the eye

What are long-term Elmiron side effects?

• Blurred vision
• Difficulty reading
• Difficulty adjusting to dim lighting
• Problems with dark adaptation
• Glare
• Blind spots
• Muted, less vivid colors
• Night blindness
• Metamorphopsia (i.e. a type of distorted vision in which a grid of straight lines appears wavy and parts of the grid may appear blank)
• Blindness

Is my lawsuit confidential?

Everything you tell us is confidential and protected by attorney/client privilege. However, in the event that a lawsuit is filed on your behalf, the lawsuit will be a matter of public record.

Elmiron Timeline (Pentosan Polysulfate Sodium)

• Aug. 7, 1985 – Elmiron was granted orphan drug status. An orphan drug is one intended to treat a rare disease; usually, it’s the only drug on the market for that disease. The company on the orphan drug designation was the Alza Corporation.
• 1986 – Elmiron was made available on a compassionate use basis. This means that it could be prescribed to seriously ill patients even though it had not yet been approved.
• Jan. 24, 1989 – The trademark for Elmiron was registered with the United States Patent and Trademark Office.
• July 31, 1989 – A patent for Elmiron was filed with the United States Patent and Trademark Office.
• June 11, 1991 – Baker Cummins Pharmaceuticals Inc. submitted a New Drug Application for Elmiron to the United States Food and Drug Administration (FDA).
• June 25, 1991 – FDA sent a letter to Baker Cummins Pharmaceuticals Inc. acknowledging receipt of the New Drug Application for Elmiron.
• Nov. 8, 1991 – A mathematical statistician with the FDA, James Gerbert, Ph.D., indicated that the “evidence of [the effectiveness] of Elmiron for the treatment of interstitial cystitis [was] very weak.”
• Nov. 15, 1991 – A review chemist with the FDA, Patricia Stewart, concluded that the New Drug Application for Elmiron was “not approvable from the standpoint of manufacturing and controls.”
• Dec. 20, 1991 – James E. Wilson, Ph.D., at the FDA concluded that the application was “approvable from the standpoint of pharmacology with changes in the labeling.”
• Jan. 27, 1992 – Daniel Gordin, Ph.D., with the Pharmacokinetics Evaluation Branch of the FDA noted a discrepancy in the chemistry.
• Feb. 18, 1992 – Acting Director of the FDA Wiley A. Chambers, M.D., concluded, “the application [was] not recommended for approval.” Chambers recommended that additional information be addressed if the application were to be resubmitted.
• Feb. 25, 1992 – Gordin stated that “the bio-data submitted in [the Elmiron] New Drug Application has not adequately described the bioavailability/pharmacokinetics of [Elmiron] and is not adequate to support its approval and its labeling.”
• Oct. 22, 1992 – Peter Vaccari at the FDA Office of Orphan Products Development sent a memorandum to FDA Acting Supervisory Consumer Safety Officer Jim Cheever regarding designating Elmiron as an orphan product and requesting to update their information management system to reflect the drug as an orphan product.
• Nov. 9, 1992 – Vice President of Regulatory Affairs at Baker Norton Pharmaceuticals Inc. Edward R. Gubish, Ph.D., sent a letter to FDA Director Wiley Chambers advising the FDA that Baker Cummins had undergone an administrative name change to Baker Norton Pharmaceuticals Inc.
• Dec. 10, 1992 – Baker Norton amended the New Drug Application.
• Dec. 18, 1992 – The FDA acknowledged receipt of the amended New Drug Application dated Dec. 10, 1992.
• Jan. 19, 1993 – A patent for Elmiron was granted by the United States Patent and Trademark Office.
• Jan. 27, 1993 – The FDA issued a not-approvable letter.
• March 19, 1993 – The FDA and Baker Norton Pharmaceuticals Inc. held a meeting to discuss the Jan. 27, 1993, not-approvable letter and requested that Baker Norton Pharmaceuticals study higher doses, specify the primary endpoints, and reanalyze clinical trial data.
• April 9, 1993 – FDA Chemist Kermit M. Floyd recommended non-approvability of the application.
• July 7, 1993 – Baker Norton amended the New Drug Application.
• July 9, 1993 – FDA Acting Division Director Patricia Love, M.D., prepared an internal memorandum to the FDA indicating that some of the responses in the July 7, 1993, amended NDA were adequate but there were still major deficiencies.
• July 20, 1993 – At the Pharmacokinetics Evaluation Branch of the FDA, Gordin indicated that the sponsor resubmitted information that was found to be inadequate.
• July 21, 1993 – The FDA acknowledged receipt of the amended New Drug Application dated July 7, 1993.
• Aug. 3, 1993 – Patricia Stewart, a review chemist with the FDA, concluded that the application was “not approvable from the standpoint of manufacturing and controls.”
• Sept. 8, 1993 – Stewart noted that the “application is not approvable as yet and awaiting response to deficiencies.”
• Sept. 30, 1993 – Elizabeth A. Turney, M.S., a biomedical statistician with the FDA, concluded that the applicant had failed to provide two independent, adequate, and well-controlled trials to support their claim that Elmiron was effective in the treatment of interstitial cystitis.
• Nov. 9, 1993 – A medical reviewer at the FDA, Paul Waymack, M.D., concluded that the sponsor’s comments failed to fully address the request made by the FDA in correspondence dated Jan. 27, 1993.
• Jan. 3, 1994 – Dr. Nancy Smith and Dr. Ralph Harkins, medical reviewers at the FDA, sent a memorandum to FDA Acting Division Director Patricia Love, M.D., in which they indicated that the sponsor was unwilling to perform a withdrawal study and an additional well-controlled trial should be required.
• Feb. 11, 1994 – An amended New Drug Application was submitted.
• Feb. 14, 1994 – Love recommended that the New Drug Application remain not approvable, as there were chemistry and environmental assessment deficiencies that should be added to the non-approval letter.
• Feb. 28, 1994 – The FDA acknowledged receipt of the amended New Drug Application dated Feb. 11, 1994.
• March 7, 1994 – Paul Waymack, M.D., a medical reviewer at the FDA, indicated that a full report would be required to determine if the study had truly documented safety at the dosages proposed for treating patients with interstitial cystitis.
• April 13, 1994 – Review chemist Stewart concluded that “there are still a few chemistry problems that should be resolved before final approval.”
• May 24, 1994 – Norman A. See, Ph.D., an FDA reviewing pharmacologist, had a call with a Dr. Kamul Abdul at Baker Norton about the fact that much of the existing data was old. It was agreed that Baker Norton should repeat its studies.
• Aug. 29, 1994 – Waymack sent a letter to Love indicating that the number of patients in each trial was insufficient to generate definitive proof of effectiveness.
• Aug. 31, 1994 – Baker Norton Vice President Jane Hsiac, Ph.D., sent a letter to Marlene Haffner, M.D., at the FDA regarding outstanding concerns about the effectiveness of Elmiron.
• Sept. 19, 1994 – FDA mathematical statistician Nancy D. Smith, Ph.D., recommends that Baker Norton be encouraged to do one large, multicenter study involving none of the investigators who participated in earlier studies.
• Oct. 28, 1994 – The FDA issued a second not-approvable letter.
• Feb. 16, 1995 – The FDA held a meeting with Baker Norton to discuss the October not-approvable letter.
• March 27, 1995 – Waymack indicated that the New Drug Application failed to provide adequate evidence from two well-controlled trials demonstrating that Elmiron was safe and effective in the treatment of the disease and noted that the two studies performed were flawed in that they had multiple investigators in both trials.
• March 30, 1995 – Cheever of the FDA spoke with Ed Mitchell of the regulatory affairs department at Baker Norton to request further information regarding existing data.
• June 29, 1995 – Love sent a letter to Mitchell regarding discrepancies noted in their meeting.
• Aug. 31, 1995 – The New Drug Application was amended.
• Sept. 12, 1995 – Stewart indicated that the “application was approvable from a chemistry standpoint.”
• Sept. 19, 1995 – The FDA acknowledged receipt of the amended New Drug Application dated Aug. 31, 1995.
• Oct. 12, 1995 – FDA Consumer Safety Officer Susan Cusack informed Baker Norton that the chemistry review of the amendment was complete.
• Oct. 23, 1995 – Cusack spoke with Steve Viti in the regulatory affairs department at Baker Norton to discuss that the labeling needed further revision.
• Nov. 30, 1995 – Cusack spoke with Viti to obtain authorization to discuss Elmiron with another individual.
• Dec. 5, 1995 – Stewart concluded that the “application may be approved from a chemistry standpoint.”
• Dec. 8, 1995 – Cusack spoke with Viti to ask questions about the Compassionate Use Study.
• Dec. 10, 1995 – The New Drug Application was amended.
• Jan. 19, 1996 – David J. Lee, Ph.D., a medical reviewer with the FDA, recommended that they not approve Elmiron from a biopharmaceutical perspective, as the bio-data submitted was not adequate to support its approval as well as support its labeling.
• Jan. 23, 1996 – Cusack spoke with Viti regarding a request for additional information.
• Feb. 12, 1996 – Stewart indicated that the amendment dated Dec. 10, 1995, did not specifically answer each question but the sponsor did present sufficient information to respond satisfactorily to the deficiencies.
• Feb. 23, 1996 – Love submitted an internal memorandum to the FDA indicating that Baker Norton had submitted sufficient safety and effectiveness data for Elmiron to be approvable.
• Feb. 29, 1996 – An Adverse Events Study looked at incidents associated with Elmiron.
• March 1, 1996 – Elmiron was finally approved by the FDA. Baker Norton was the sponsoring company on the FDA approval letter. Baker Norton was a subsidiary of the Ivax Corporation.
• April 10, 1996 – FDA statistician Ruthanna C. Davi showed adverse events being reported by Elmiron patients, including nervous system problems in 3.57% of females.
• June 13, 1996 – FDA acknowledged receipt of an amended New Drug Application dated April 10, 1996.
• Sept. 16, 1996 – Lee and FDA Deputy Director John Hunt commented that the amendment on April 10, 1996, did not adequately address the deficiencies previously indicated for Elmiron. The application was not acceptable from a clinical pharmacology/biopharmaceutical perspective.
• Sept. 20, 1996 – The FDA determined that pediatric studies were not needed for Elmiron.
• Sept. 23, 1996 – Division Director Brief Comment mentioned that the sponsor was asked to revise the labeling and submit additional safety data.
• Sept. 26, 1996 – The FDA approved the application for Elmiron and requested final printed labeling.
• Oct. 6, 1997 – Alza acquired the rights to Elmiron from Baker Norton.
• March 27, 2001 – Johnson & Johnson issued a news release that Johnson & Johnson was to merge with the Alza Corporation.
• June 22, 2001 – Johnson & Johnson acquired the Alza Corporation.
• Nov. 8, 2001 – An FDA letter to the Alza Corporation approved a New Drug Application for the removal of the cotton filler used to package Elmiron capsules.
• Sept. 26, 2003 – Elmiron’s orphan drug exclusivity expired.
• Aug. 24, 2004 – The FDA approved a package insert change.
• Jan. 26, 2006 – Teva issued a news release announcing that they had completed acquisition of Ivax.
• Feb. 1, 2006 – Ivax and Teva merged.
• Sept. 20, 2006 – The FDA approved a product labeling change.
• July 24, 2008 – The FDA approved a product labeling change.
• Dec. 12, 2008 – The FDA approved a product labeling change.
• Jan. 19, 2010 – The Elmiron patents expired. However, no generic was ever marketed in the United States.
• Jan. 15, 2015 – Orphan designation was granted by the European Commission to Dr. Ulrich Granzer in Germany for Elmiron for the treatment of interstitial cystitis.
• Nov. 4, 2017 – Elmiron was withdrawn in Europe from the list of designated orphan medicinal products on request of the sponsor.
• June 27, 2019 – The European Medicines Agency recommended an update for Elmiron to warn about the risk of pigmentary maculopathy, particularly in patients taking Elmiron long-term.
• June 16, 2020 – Janssen Pharmaceuticals makes a dramatic change to the Elmiron patient labeling on units sold within the United States. The newly revised patient label, approved by the FDA on June 16, 2020, now warns of “retinal pigmentary changes.” Retinal pigmentary changes could lead to severe and permanent eye injuries such as full or partial blindness, difficulty in adjusting to light changes, and difficulty reading. These eye problems do not improve should the patient discontinue taking Elmiron.

Contact an Experienced Defective Drug Attorney

If Elmiron has harmed you or a member of your family and you are interested in filing a lawsuit to recover monetary compensation, contact the defective drug attorneys at Parker Waichman LLP by calling 800-968-7529 for a free case review today.