The Judicial Panel on Multidistrict Litigation (JPML) sent suits alleging Johnson and Johnson’s pharmaceutical unit concealed a harmful side effect of bladder cyst medicine that results in serious eye damage to New Jersey federal court, where a judge has already taken steps to organize the litigation.
The panel’s order sends 42 suits to New Jersey and the litigation is expected to increase to several hundred suits.
The patients took Elmiron to treat interstitial cystitis, also known as painful bladder syndrome, according to one of the lawsuits. They claim that since 1997 Janssen has received reports from doctors about Elmiron patients having visual complications such as retinal hemorrhage, macular degeneration and light perception.
Janssen last year began taking steps to warn consumers and physicians in other countries about Elmiron’s risk of serious visual complications, such as adding a warning to the medicine’s label in Canada, according to the lawsuit.
Janssen has said that “nothing is more important to us than the health and safety of our patients who take our medicines and we are confident in the overall safety profile of Elmiron.”
“As the MDL process moves forward, we will continue to defend against the allegations made in these lawsuits. Elmiron is the only FDA-approved oral prescription medicine that has been helping patients with bladder pain or discomfort associated with interstitial cystitis for more than two decades,” the company said.
A group of patients and Johnson & Johnson’s pharmaceutical unit told the Judicial Panel on Multidistrict Litigation that suits alleging that it concealed a harmful side effect of bladder cyst medicine Elmiron should be heard in New Jersey federal court because the judge there has already been treating the litigation as a mass tort.
Michael London of Douglas London PC said that from day one, U.S. District Judge Brian Martinotti has treated the cases as a mass tort: Instead of setting individual trials and discovery plans, he implemented procedures and processes to advance the suits as a whole. The parties agreed that the suits alleging Janssen Pharmaceuticals Inc. of failing to warn consumers that Elmiron can cause serious eye damage should be consolidated, at issue in the hearing was where.
“Judge Martinotti has had monthly status conferences almost every three weeks, he’s become very Zoom friendly, almost too much,” London said. “Judge Martinotti clearly fits this bill.”
Another factor in favor of New Jersey is that it is where Janssen is headquartered and where all the witnesses and documents are, a representative for Janssen said.
The patients took Elmiron to treat interstitial cystitis, also known as painful bladder syndrome, according to one of the lawsuits. They claim that Janssen has received reports from doctors about Elmiron patients having visual complications such as retinal hemorrhage, macular denegration and light perception blindness.
Janssen began taking steps last year to warn consumers and physicians in other countries about Elmiron’s risk of serious visual complications, such as adding a warning to the medicine’s label in Canada, according to the lawsuit.
But it was only a few months ago, after the U.S suits were filed, that the company revised Elmiron’s U.S. label, the patients say.
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.
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.
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.
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.