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Elmiron Medication Lawsuit: Criteria, Settlement and Other Questions Answered

In this article: What is Elmiron? Who makes Elmiron? What is Elmiron used for? Can Elmiron cause blindness? How can Pentosan Polysulfate Sodium (PPS)-Associated Maculopathy be diagnosed? Does Elmiron cause macular degeneration? I am having trouble reading. Is that enough to sue? How does Elmiron cause damage to the retina? Should I get an eye […]

In this article:


Source: Elmiron Lawsuits Discussed by Personal Injury Attorney Jerry Parker, Partner @ Parker & Waichman LLP

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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

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’s experience with suing for Damage from use of Elmiron?

  • Parker Waichman has filed lawsuits in federal 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 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 law firm for their Elmiron Lawsuit?

Parker Waichman 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 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 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, 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 are taking Elmiron cases under a contingency fee agreement in which Parker Waichman 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 have, is that Parker Waichman 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 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 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 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.

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.

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