Elmiron Lawsuit | Vision Loss, Eye Damage & Blindness Claims
In the latest legal blow to Johnson & Johnson* and its subsidiary Janssen, the company has been sued for eye damage caused by Elmiron. Elmiron is medication to treat bladder pain and discomfort. Elmiron medication is alleged to cause retinal injuries and vision loss. The eye problems caused by Emiron are both severe and irreversible. The initial Elmiron lawsuits were filed earlier this year. Observers are now expecting a large number of Elmiron vision loss lawsuits to be filed against Johnson & Johnson. The company is already facing lawsuits for its other product such as talc powder, Risperidone and its opioid painkillers.
Elmiron is a prescription medication prescribed by physicians to treat cystitis occurring in the bladder. Cystitis is a an extremely painful syndrome of the bladder. The vast majority of people taking Elmiron are women- usually women who are perimenopausal. “The drug Elmiron, which treats interstitial cystitis, bladder pain and osteoarthritis, is being linked to permanent eyesight damage, including macular degeneration and pigmentary and retinal maculopathy. A number of studies dating to 2018 have revealed risks associated with long-term use of Elmiron. Mass tort law firms are looking for claimants now. Elmiron was developed by Janssen Pharmaceuticals (a Johnson & Johnson subsidiary).” Versus
Update-11/09/2020- “As attorneys across the country fight over whether to consolidate litigation over the bladder infection medication Elmiron into a single federal court, a district judge in Pennsylvania has decided that claims seeking medical monitoring over the medication can’t be litigated as a national class action.” Law
9/3/2020- “The second plaintiff is from California and filed her case in the District of New Jersey. Like the first plaintiff, she claims that she was diagnosed with IC and was prescribed Elmiron, which she took for about four years from 2013 through 2017. During that time, she received no warnings about any risk of retinal damage or vision loss. Now, she suffers from toxic maculopathy, retinal damage, blurred vision, distorted vision, and other visual symptoms. She blames these issues on her ingestion of Elmiron and seeks damages from the drugmaker.” New York Legal Examiner
6-9-2020- A prominent law firm “filed a products liability lawsuit against the manufacturers of a prescription drug Elmiron (pentosan polysulfate sodium) for, among other things, failing to warn plaintiff Valerie Hull of the potential risk of developing serious eye and vision-related injuries. The complaint was filed on behalf of Valerie Hull, a South Carolina resident, whose case was documented as “patient zero” in a published 2018 study conducted by Emory Eye Center in Atlanta, Georgia.” The lawsuit “names Janssen Pharmaceuticals, and several other Johnson & Johnson entities as well as Teva Branded Pharmaceutical Products R&D, Teva Pharmaceuticals, and Teva Pharmaceutical Industries Ltd., as the defendants who manufactured, marketed, and distributed Elmiron. The case is Hull vs. Janssen Pharmaceuticals Inc., et al., Case No. MIDL003646-20.” PR NEWSwire
8/12/2020- “On Aug. 12 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 were filed by Clara Johns and Shirley Ruth Levy in the U.S. District Court for the District of New Jersey against units of Johson & Johnson, Bayer and Teva, as reported by Law360. Johns and Levy 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, and failed to alert physicians or patients of these risks.” Med truth
Vision Loss, Eye Damage & Blindness Claims
If you have taken Elmiron and have experienced any problems with your eyes and vision, you may be entitled to significant financial compensation. You should contact a Elmiron eye damage lawyer immediately to learn more about how you can file your own Elmiron vision loss lawsuit.
What Is Elmiron?
- Elmiron is used to treat interstitial cystitis and painful bladder syndrome.
- There are numerous side effects of this condition.
- Those who suffer from this suffer from frequent urination, the urge to constantly urinate and pain during sex.
- There is no cure for this condition, but it may be managed with medication.
- In addition, Elmiron is also prescribed to treat osteoporosis.
- Elmiron is the name brand for a class of drugs called Pentosan polysulfate.
- The medication is intended to strengthen the bladder wall by providing a coating. This is supposed to reduce the urge to urinate.
- The medication is similar to a blood thinner. In fact, it is billed as a heparin-like substance, However, the exact way that the drug works is not known.
Elmiron blindness lawsuit
- Patients do not take Elmiron for a short period of time.
- In fact, it takes months for the drug to begin working at all.
- The drug is intended to be a long-term medication that patients take for years.
- Patients will be on the drug for a minimum of six months.
- The drug was developed by Teva Pharmaceuticals. Teva then licensed the product to Janssen Pharmaceuticals, which is a subsidiary of Johnson & Johnson. This is why all three of these parties appear on the Elmiron vision loss lawsuits.
Elmiron in Europe and the UK
Elmiron has been on the market since it was approved by the FDA in 1996. European regulators only recently approved it. There have been concerns raised about the benefits of the drug versus the steep cost. In Europe, cost matters when it comes to approving the drug for use. The U.K. distributor was forced to make price concessions before it was approved for use in the U.K. In the U.S., the drug does between $150-$250 million in sales annually. Given the expensive cost of the drug, this means that roughly one million people in the U.S. take the medication.
Are there any warnings on the Elmiron’s Label?
- Elmiron was originally sold to the public with no warnings on its label.
- A drug company is under the obligation to update its warning label when it learns of any type of side effects that can cause a danger to patients.
- Johnson & Johnson updated the warning label on the drug several times.
- However, at no time did the company warn patients specifically about any danger to their eyesight.
- “In fact, from 1996, when Elmiron® was first approved by the FDA, until June of 2020, neither Elmiron®’s Package Insert nor its Medication Guide contained any warnings or information regarding the risk of serious visual complications, including, but not limited to, maculopathy.” TOMME ECHERD Elmiron lawsuit complaint
- In June 2020, Elmiron’s manufacturer, issued a major change to Elmiron’s label in the United States. Previous Elmiron labels had nothing listed as a potential risk risks pigmentary maculopathy under the “Warnings” area. The new label was given the green light by an FDA approval on June 16, 2020. The warning was entitled, “WARNINGS Retinal Pigmentary Changes.”
- The warning states, “Pigment changes in the retina of the eye (also referred to as pigmentary maculopathy in medical journal articles) have been reported with long-term use of ELMIRON® . While the cause of the pigmentary changes is unclear, continued long term dosing with ELMIRON® may be a risk factor. Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use” Elmiron warning
- In this warning Janssen Pharmaceuticals notable does not warn consumers of vision loss or blindness. Janssen Pharmaceuticals conceded that the drug could cause “Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision.” id.
- “Pigmentary maculopathy is a unique type of maculopathy linked to the interstitial cystitis drug, Elmiron (pentosan polysulfate sodium). Some people who used the drug long-term for treating IC and bladder pain developed pigmented deposits that resemble little specks in the macula, according to a 2018 study by Drs. William A Pearce, Rui Chen and Nieraj Jain in Ophthalmology.” Drug Watch
Canadian Elmiron medication warnings:
Authorities in Canada mandated similar Elmiron warnings in October 2019. The Canadian government stated on it’s website, “The risk of pigmentary maculopathy has been included in the Warnings and Precautions, Post-Market Adverse Drug Reactions, and Consumer Information sections of the Canadian product monograph for Elmiron. The Canadian health authorities even provided a “Key messages for healthcare professionals:
- In the post-market setting, pigmentary maculopathy has been reported with chronic use of Elmiron. Visual symptoms included difficulty reading and prolonged dark adaptation.
- Patients, particularly those with chronic use of Elmiron, should have regular ophthalmic examinations for early detection of pigmentary maculopathy.
- If pigmentary maculopathy is confirmed, Elmiron treatment discontinuation should be considered.” Canada Elmiron warnings
Emory Eye Center study:
- “For example, from 2015 to 2018, Emory Eye Center began observing a new eye disease in patients called “retinal maculopathy,” a unique presentation that does not resemble any other hereditary or acquired maculopathy, where the pigment cells within the eye’s retina changes color. This change in color causes significant vision loss and eye dysfunction.” Elmiron complaint
- “In 2018, scientists at Emory Eye Center published a study documenting a link between Elmiron® use and retinal maculopathy. Pearce WA, Chen R, Jain N., Pigmentary Maculopathy Associated with Chronic Exposure To Pentosan Polysulfate Sodium. Ophthalmology 2018. The authors suggest that the retinal cells may be accumulating PPS over time and warn that “[c]linicians should be aware of this condition because it can be mistaken for other well-known macular disorders, such as pattern dystrophy and age-related macular degeneration.” Id.
- “In letters to the editor, the study authors also stated that “[a]fter extensive investigations, which included molecular testing for hereditary retinal disease, we found these cases to resemble no other retinal disease,” and “[w]e encourage drug cessation in affected patients.” Id.
- “In 2019, an Emory Eye Center team submitted a second study further documenting a link between Elmiron® use and this unique change to the retina. Foote, et al. Chronic Exposure To Pentosan Polysulfate Sodium Is Associated With Retinal Pigmentary Changes And Vision Loss. AUA 2019 Abstract MP47-03. The authors of this study conclude that structural changes of the retina are occurring and that it is unclear whether stopping Elmiron® will alter the course of this new retinal disease. The authors recommend that affected patients should discontinue the use of Elmiron® and undergo comprehensive ophthalmic examinations.” Id.
- “An additional 2019 study by Emory Eye Center found a statistically significant increase in the atypical retinal maculopathy in people who had taken Elmiron® (PPS) for 7 years. Jain N, Li AL, Yu Y, et al. Association Of Macular Disease With Long Term Use Of Pentosan Polysulfate Sodium: Findings From A U.S. Cohort. Br J Ophthalmology Nov. 6, 2019.” Id.
- “When researchers at Emory Eye Center looked more closely at the Defendants’ early clinical trials for Elmiron®, they found evidence of reported retinal eye
damage that was never followed up on, never warned about or otherwise disclosed. Instead, Defendants chose to ignore it. Specifically, the Emory Eye Center researchers found that in Defendant Janssen’s own clinical trial of patients who took Elmiron® for up to four years, both vision and eye-related adverse events were reported, including optic neuritis and retinal
- Authorities in Europe mandated a label warning in June 2019.
- “Likewise, in approximately 2019, Defendants “agreed” with a European Medicines Agency’s Committee recommendation that the Elmiron® label be changed to warn of the risk of serious visual complications, including pigmentary maculopathy, associated with long-term use of Elmiron®.” Complaint
- “The Elmiron® label in European Medicines Agency countries now warns: All patients should have an ophthalmologic examination after 6 months of use of PPS for early detection of pigmentary maculopathy, and, if there are no pathologic findings, regularly after 5 years of use (or earlier, in case of visual complaints). However, in case of relevant ophthalmologic findings, a yearly examination should be conducted. In such situations, treatment cessation should be considered.” Id.
- “The Elmiron® label used in European Medicines Agency countries further admits that “eye disorders” like pigmentary maculopathy are “uncommon” undesirable effects of the medication.” Id.
- “In approving these changes to the Elmiron® label, the European Medicines Agency Committee for Medicinal Products for Human Use (“CHMP”) created a report, which Defendants are believed to have received. This report specifically noted that such a warning regarding ophthalmological side effects of Elmiron® was needed, in part, because pigmentary maculopathy “might not be easily recognized by the urology community.” Id.
Valerie Hull lawsuit allegations:
- “Specifically, Mrs. Hull suffered various injuries, serious physical pain and suffering, medical, and hospital expenses as a direct result of her use of Elmiron.” Complaint
- “At all relevant times, all Defendants were in the business of and, indeed, did design, research, manufacture, test, advertise, promote, market, sell and/or distribute Elmiron for
the treatment of the bladder pain and/or discomfort associated with interstitial cystitis.” Id.
Issues Begin to Be Discovered By Researchers in 2018
The first issues with Elmiron began to be noted by researchers at the end of 2018. A research paper noted that long-term users of the drug experienced atypical maculopathy at a higher rate than usual. This makes sense because the retina may be one of the first areas of the body to suffer when a patient is exposed to medicine toxicity. This occurs in other drugs that are known to be possibly toxic such as malaria drugs. The researchers did a follow-up study the next year. They looked at 219 patients who took Elmiron for the long term. Their results supported their initial conclusion that there may be a connection with Elmiron and vision loss.
Johnson & Johnson made no changes to the warning label
Researchers studied 140 people who have been known to have taken over 5,000 pills of Elmiron. They were able to examine 91 people. Of this group, 22 exhibited symptoms of vision loss. This is an alarming ratio that shows that nearly one-quarter of the sample group who were long-term users suffered damage to their eye. After the initial studies, multiple researchers launched their own studies and reached the same conclusions. However, even after the study results were released to the public, Johnson & Johnson made no changes to the warning label. One lawsuit notes that the company made changes to warning labels in foreign countries to warn patients of the exact same side effects of which they failed to warn U.S. patients.
Plaintiffs File Elmiron Lawsuits
After the initial research findings were published, plaintiffs began to step forward with their claims of vision loss and damage to their eyes. One particular plaintiff filed a lawsuit in Connecticut in March 2020. She claimed that she took Elmiron for nearly 15 years. Believing the drug to be without major side effects, her doctors progressively prescribed more to her and increased her dosage. However, in 2019, she was examined and found to have suffered significant vision loss.
This plaintiff is one of many that are now filing Elmiron vision loss lawsuits. Many are alleging the following grounds of product liability in their lawsuits:
- Johnson & Johnson should be strictly liable for the damage caused by Elmiron because there was a design defect and a manufacturing defect.
- The defendants were negligent in their design and manufacture of the product since they failed to exercise the due care that a drugmaker owes the patients who take the medication.
- The company knew of the fact that Elmiron can cause vision loss yet took no steps to either make the product safer or warn the public.
- The defendants marketed Elmiron as safe when they knew that there were dangerous side effects.
Each Elmiron vision loss lawsuit that has been filed has variations of the same allegations.
Where the Elmiron Lawsuits Stand Today
The Elmiron eye damage lawsuits have just recently been filed in different federal courts. Since the lawsuits are just in their infancy, discovery and motions have not yet happened. In many cases, the defendants have just filed their answers to the allegations. Plaintiffs are just beginning to come forward as the initial lawsuits have been filed. It is possible that the Elmiron lawsuits will be rolled into a multi-district lawsuit so all cases can proceed with common discovery. Right now, cases are still being filed across the country.
What Should I Do if I Have Taken Elmiron?
The first thing that you should do is to see a doctor to have your vision checked. You may be taking risks with the statute of limitations if you wait to have your vision examined. Make sure that you get extensive documentation from the eye doctor of any condition that you have along with their medical opinion of what caused it. You should continue to get annual checkups so you can track your vision.
Even before you go see an eye doctor, you should consult with a product liability lawyer. The attorney will tell you what documentation you need and will help you assemble what you need in order to file your lawsuit. Then, the Elmiron attorney will draft your complaint and represent you as you seek to hold Johnson & Johnson and Teva responsible for any damage to your eyes. You may be entitled to substantial financial compensation for your Elmiron-induced vision loss if you act now.
*ELMIRON® is a Registered Trademark of Teva Branded Pharmaceutical Products R&D, Inc. under license to Janssen Pharmaceuticals, Inc.