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Elmiron Lawsuits Allege Drug Companies Knowingly Withheld Risks
August 25, 2020: Two women filed lawsuits against manufacturers of Elmiron, the only oral medication approved by the U.S. Food and Drug Administration to treat interstitial cystitis, also known as painful bladder syndrome.
The Elmiron lawsuits against Johnson & Johnson, Bayer, and Teva, allege that the drug manufacturers knowingly withheld information about harm caused by long-term use of Elmiron such as blurred and distorted vision and retinal damage. Pigmentary maculopathy, also known as pentosan polysulfate sodium maculopathy, is a unique type of retinal damage associated with long-term use of Elmiron according to a 2018 case study of six patients and a larger 2019 study of 219 patients.
The women are seeking compensation for pain and suffering, mental anguish, anxiety, physical impairment, and medical expenses.
Each of the manufacturers is accused of multiple civil wrongs including failure to warn consumers of Elmiron’s risk, negligence, designing Elmiron in a way that makes the drug defective and hazardous to health, and fraudulent misrepresentation of the risks associated with Elmiron.
Elmiron, or pentosan polysulfate sodium (PPS), is a medication prescribed to treat pain and discomfort associated with the chronic bladder condition known as interstitial cystitis (IC). While the drug has been prescribed for decades, new studies and reports have tied long-term Elmiron use to possible retinal damage, vision loss, and blindness. Patients who took Elmiron showed unusual changes to their macula, the center of the retina responsible for clear, focused vision. Hundreds of thousands of Americans who took Elmiron could be at risk of developing maculopathy, a disease that can cause permanent vision damage. If you or a loved one took Elmiron to treat pain and discomfort associated with IC and subsequently developed vision problems, you may be eligible to participate in an Elmiron lawsuit. Contact an Elmiron vision loss lawyer from TorHoerman Law to learn how you may be eligible for compensation for your injuries.
Read on to learn more about Elmiron and Elmiron maculopathy lawsuits.
Patients who were prescribed Elmiron and developed maculopathy and vision problems have accused Janssen Pharmaceuticals, the drug’s manufacturer, of failing to warn the public about the risks of ocular toxicity and potentially permanent vision damage or loss. In 2019, American Academy of Ophthalmology researchers presented findings that showed links between PPS use and vision-threatening eye conditions and changes in the macula. If you were prescribed Elmiron and developed changes in your vision, you could be eligible for a Elmiron vision loss and blindness lawsuit. Contact a Elmiron vision loss lawyer to learn more.
Elmiron is an FDA-approved daily oral medication that is prescribed to treat bladder discomfort and pain associated with interstitial cystitis (IC). The medication, also known as pentosan polysulfate sodium (PPS), is thought to create a thin layer in the wall of the bladder to protect it against irritating and potentially harmful substances found in the urine. Elmiron is prescribed for both women and men suffering from IC, but IC is more commonly prescribed for women.
Elmiron is used to treat pain and discomfort associated with interstitial cystitis, a chronic, painful bladder syndrome.
Elmiron is classified as a urinary analgesic (pain reliever) and weak anticoagulant (blood thinner).
Janssen Pharmaceuticals lists common Elmiron side effects as:
Janssen did not issue warnings about potential vision damage or loss. The American Academy of Ophthalmology report noted patients might also experience additional symptoms. These symptoms could include:
A study presented at the 2019 American Academy of Ophthalmology linked Elmiron to maculopathy, an eye disease that affects the central part of the retina. Investigators from Kaiser Permanente in Northern California found that Elmiron use led to retinal damage in close to 25 percent of patients. Maculopathy causes progressive loss of central vision (often bilateral) and is one of the most common causes for blindness in the western world. However, maculopathy rarely causes complete blindness as bilateral vision is usually preserved.
To help the Food and Drug Administration (FDA) track Elmiron safety issues, the agency encourages both health professionals and patients to report any adverse reactions and side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Information can be submitted through:
The MedWatch Online Voluntary Reporting Form
Contacting the FDA at 855-543-DRUG (3784) and pressing 4, or at firstname.lastname@example.org.
Downloading the form, or calling 1-800-332-1088 to request a reporting form, then submitting the completed form by fax to 1-800-FDA-0178 or on the listed return address.
Research presented at the 2019 American Academy of Ophthalmology linked Elmiron use to the development of maculopathy, a vision-threatening eye condition. Maculopathy, also known as macular degeneration, is a disease that affects the macula, the central part of the eye’s retina. Maculopathy is characterized by a gradual loss of central vision and vision distortion.
In the research, investigators from Kaiser Permanente in Northern California found that taking Elmiron (pentosan polysulfate sodium) led to retinal damage in nearly 25 percent of patients. The findings came after a 2018 study reported similar conclusions. An M.D. at Emory Eye center in Atlanta found that six patients who had been taking Elmiron for close to 15 years developed uncommon changes in the macula. The Kaiser Permanente research also found that Elmiron patients showed clear signs of drug toxicity, and that higher rates of toxicity correlated with higher doses of Elmiron.
Maculopathy (macular degeneration) is often painless, and patients might have trouble detecting symptoms early on. Maculopathy symptoms include:
United States attorneys are currently accepting Elmiron lawsuits. If you were prescribed Elmiron for at least two years and developed maculopathy symptoms, eye disorders, or other vision problems while taking the drug, you could qualify for an Elmiron lawsuit. Symptoms and injuries include, but are not limited to: maculopathy (macular degeneration), vision impairment or loss, unilateral or bilateral blindness, reduced nighttime and dark light vision, macular dystrophy, and retinopathy.
If you were prescribed Elmiron and developed any of these injuries, contact an Elmiron vision loss lawyer right away to discuss your legal options, including filing an Elmiron lawsuit.
If you were prescribed Elmiron (pentosan polysulfate sodium) and experienced maculopathy, reduced vision, retinal injury, other adverse side effects, you could be eligible for an Elmiron lawsuit. If you took Elmiron and were diagnosed with any of the above symptoms, we will work to seek the following damages for you:
If you believe that you qualify for an Elmiron lawsuit, contact an Elmiron vision loss lawyer.
You should also do everything in your power to mitigate injury – seek medical attention right away, follow your doctor’s orders, and discuss substituting or discontinuing your Elmiron prescription if you are still taking the drug.
The first step to filing an Elmiron lawsuit is familiarizing yourself with the process of a civil lawsuit so that you are aware of the steps of an Elmiron lawsuit. You will need to hire a personal injury lawyer to represent you as your Elmiron vision loss lawyer.
Your Elmiron vision loss lawyer will help you to gather evidence to support your Elmiron lawsuit claims. They will also help determine liability, which will likely fall on the manufacturer. In many product liability lawsuits, the injured party will make a claim for both punitive damages and compensatory damages for the injuries suffered.
Your Elmiron vision loss lawyer will work to gain compensation for your losses through a Elmiron lawsuit settlement or verdict.
Your state’s statute of limitations bars the amount of time you have to take legal action after your injuries are first developed or discovered, so do not hesitate to reach out to an Elmiron vision loss lawyer right away.
Hiring an experienced bad drug lawyer is critical for earning full compensation for you or your loved one’s damages and suffering. At TorHoerman Law, we have a team of experienced bad drug attorneys with a proven track record of success. We will work with you to hold Janssen Pharmaceuticals accountable and successfully pursue your drug injury lawsuit. Our law firm offers free, no-obligation case consultations for all potential Elmiron vision loss and blindness lawsuit clients. Contact TorHoerman Law today to learn more about your potential Elmiron case and legal options.
July 29, 2020 - Plaintiffs have filed a proposed Elmiron class action lawsuit against the drug manufacturer in Canadian courts.
The proposed action alleges that the long-term use of Elmiron is linked to vision issues, specifically a novel and progressive eye disorder impacting the part of the retina that allows for highly sensitive, accurate vision. The actions allege that the makers of Elmiron failed to adequately warn users and their health care providers that the use of Elmiron increases the risk of vision loss.
“Elmiron is used by hundreds of thousands of Canadians, the majority whom are women, in the management of interstitial cystitis,” said Jill McCartney, a partner practicing Health Law Litigation with Siskinds LLP. “Elmiron, which is often used long-term, has been linked to permanent vision loss. These vision impairments significantly impact the quality of life for the Canadians that have suffered these injuries.”
Legal pressures continue to mount against Elmiron in the US.
If you or a loved one has suffered vision loss or other injuries due to Elmiron, you may qualify for an Elmiron Lawsuit.
July 9, 2020: After heavy criticism from the scientific community, Janssen Pharmaceuticals updated its label for its interstitial cystitis drug, Elmiron, to include the risk of vision loss. The company had already made this change in Canada and Europe but failed to warn U.S. consumers until now.
In 2018, several studies showed a correlation between long-term use of Elmiron and pigmentary maculopathy. This began when Dr. Neiraj Jain wrote a letter to the editor of the Journal of Urology alerting readers to the new condition they were noticing among their patients.
Several of the doctor’s patients had difficulty reading and adapting to areas of dim light. Furthermore, the medical professionals found that these patients had subtle spots on the retina of their eyes.
Dr. Jain published a second case series with 10 patients with a median age of 59 years who were currently using Elmiron or had used it in the past. All the patients showed similar symptoms of retinal damage.
Despite these studies, Janssen Pharmaceuticals refused to change the product’s warning label to address these concerns. In 2019 the European Medicines Agency demanded that Elmiron warning label be updated to warn consumers of the risk. Janssen adhered to the request but still did not change the label in the U.S.
Finally, in June 2020, the company added the new warning about eye disease to its Elmiron label. The new label says that pigmentary changes in the retina “have been identified with long-term use of Elmiron.”
Elmiron users may be eligible for financial compensation through an Elmiron lawsuit. More claims are being filed every month.
May 18, 2020 – Tina Pisco filed an Elmiron lawsuit claiming that the drug caused her to develop maculopathy – a degenerative disease of the retina. According to the complaint, Pisco started taking the drug in 2012 as a treatment for interstitial cystitis. Approximately six years later, her vision rapidly deteriorated.
After being diagnosed with permanent retinal injury in both eyes, Pisco filed a suit against Johnson & Johnson Pharmaceuticals.
The lawsuit alleges the “dangerously defective prescription drug was “designed, marketed, and distributed…while knowing significant risks that were never disclosed to the medical and healthcare community,” Pisco’s complaint also adds that “Janssen Pharmaceuticals withheld material adverse events and failed to disclose the serious link between Elmiron use and significant visual damage, including pigmentary maculopathy.”
The plaintiff attorney notes that the “label and prescribing information that accompanies Elmiron when prescribed to patients contains the following: ‘Warnings: None.’”No mention of permanent vision loss or maculopathy is present on either Elmiron’s official website, prescription guide, or patient leaflet.
Neither Johnson & Johnson nor its subsidiary, Janssen Pharmaceuticals, have made any official statements regarding the case, but it is expected the company will deny wrongdoing.
June 8, 2020 - Valerie Hull has filed a personal injury lawsuit against the manufacturers of the prescription drug Elmiron. Elmiron is typically prescribed for the treatment of bladder pain and is also prescribed – albeit less frequently, for osteoarthritis.
Hull began taking Elmiron continuously from 2001-2018. Consequentially, Mrs. Hull suffers from severe visual injuries, including changes in eye color pigment, severe vision loss, loss of night vision, and pigmentary maculopathy.
Dr. Nieraj Jain, an ophthalmologist in Atlanta, performed a study based on Mrs. Hull and five others who displayed the same eye injuries but only shared one common medication: Elmiron. Since the study, researchers and physicians have concluded there is an association between Elmiron use and an increased risk of visual complications.
It is estimated that hundreds of thousands of patients have used Elmiron. The drug continues to be sold without any warning label regarding potential vision complications. In some studies, up to 24% of Elmiron users have been found to have unique eye damage caused by the drug.
If you or a loved have been prescribed Elmiron and have experienced any visual complications, you should contact a personal injury lawyer immediately.
May 22, 2020 - A woman is taking legal action after suffering an eye injury that she claims was caused by a bladder drug. The drug, Elmiron, is made and sold by a subsidiary of Johnson & Johnson.
Elmiron is the only FDA-approved medication for treating cystitis, a bladder condition that causes lower abdominal pain and a frequent need to urinate. It’s also known as painful bladder syndrome and bladder pain syndrome.
The woman filing suit says that her vision started to decline about six years after she started taking the drug. Doctors diagnosed her with maculopathy, a retinal disease that can lead to blindness.
Warnings on Elmiron bottles outline the possible side effects and rare visual complications from using the drug, but they don't mention maculopathy. The plaintiff Johnson & Johnson Elmiron lawsuit says that this misinformation makes J&J liable for the woman’s injuries.
Janssen Pharmaceuticals, the maker of the bladder medication, has sold the drug for more than two decades. Despite thousands of other lawsuits Johnson & Johnson has faced over the years, this is the first time Elmiron has been the subject of legal injury claims.
Preliminary investigations have found that at least 100 other Elmiron consumers have lost their vision as a result of taking the drug. The manufacturers have not declared vision loss as a side effect of Elmiron, nor have they made a statement about the incoming lawsuits.
The Johnson & Johnson Elmiron lawsuit alleges that the company had knowledge of the serious health risks but chose not to disclose them. If you or someone you know has suffered a visual problem after taking Elmiron, contact TorHoerman Law to see if you’re eligible for a Johnson & Johnson Elmiron lawsuit.
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Last Modified: October 1st, 2020 @ 12:15 pm
Elmiron, or pentosan polysulfate sodium (PPS), is a medication prescribed to treat pain and discomfort associated with the chronic bladder condition known as interstitial cystitis. While the drug has been prescribed for decades, new studies have tied long-term Elmiron use to possible retinal damage, vision loss, and blindness. Hundreds of thousands of Elmiron users could be at risk of developing maculopathy, a disease that can cause permanent vision damage. An Elmiron lawsuit is being filed against manufacturer Janssen Pharmaceutical on behalf of individuals who took Elmiron and were subsequently diagnosed with vision damage.
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