Thank you for inviting me to share information with the members of the support group again. The recent reports of vision damage associated with long-term Elmiron use continue to grow and I know from talking with my clients how frightening that can be for both current and former Elmiron users. As we learn more about the science associated with the injuries, and the lawsuits across the country grow, I appreciate the opportunity to provide updated information to the members of the group and to answer some of the more common questions and concerns, which provide additional information to build on my last set of questions and answers.
What is the basis of the lawsuits?
Nearly every client we speak to takes filing a lawsuit very seriously. I frequently hear from clients that they have never sued anyone before and don’t want to file a baseless claim. Many clients wonder if a lawsuit is even possible if the company was not aware the drug might cause eye damage. At the outset, we believe the evidence will establish Janssen Pharmaceuticals was aware of the risk long before the label change. But, more important, the short answer to these questions is yes, we believe there is a basis for the lawsuit. One of the first questions we as lawyers evaluate at the beginning of any case is whether the company did anything wrong. In many cases our answer is no, there is not a legal basis to hold a company responsible for an injury. We are contacted by people injured by drugs all the time, but that alone does not answer the question of whether someone has a case. We must evaluate each claim individually before forming an opinion. In this case, our research led us to believe the company is liable under a number of different legal theories. The first is known as strict liability, which in essence is a claim that the drug is unreasonably dangerous for users to take it. In this instance, it was unreasonably dangerous to give IC patients a drug with minimal effectiveness for many patients when it may lead to permanent vision loss. Another theory is that the company failed to provide an adequate warning of the risks associated with the drug. While there were reports of an association of vision damage associated with the drug by 2018, the company did not add a warning to the drug label until June 2020. Finally, a third involves a claim that the drug was defectively designed and that the defective design caused the harm (in this case vision loss). Irrespective of the theory used, each presents persons injured by Elmiron with a potential pathway to recovery.
The company recently changed the Elmiron warnings? What does that mean for the lawsuits? What does that mean for patients?
On June 16, 2020, the FDA advised of significant changes to Elmiron’s label to disclose the risk of retinal pigmentary changes. Among other things, the “Warnings” section of the label, which was previously blank, now warns of irreversible vision changes that can progress even after patients stop taking Elmiron:
WARNINGS
Retinal Pigmentary Changes
Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor. Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON® . If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and auto-fluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment. If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.
This label change was an important first step to advise patients and their doctors about the risk of vision damage and the necessity of regular vision screening. The is confirmed because recent reports in the medical literature documents that less than half the people at risk for maculopathy due to Elmiron use received the necessary visual exams to monitor for vision damage. See Identification of Patients with Pentosan Polysulfate Sodium-Associated Maculopathy through Screening of the Electronic Medical Record at an Academic Center. Higgins K, Welch RJ, Bacorn C, Yiu G, Rothschild J, Park SS, Moshiri A. J Ophthalmol. 2020 Dec 17;2020:8866961. doi: 10.1155/2020/8866961. eCollection 2020. In addition, there are reports in the literature of a latency in developing vision damage even after stopping the drug. As a result, it is very important, even if you already stopped using the medication, to let your doctors know of your history and having regular vision screenings to monitor for eye damage.
What is the current status of the Elmiron lawsuits?
My Firm filed the first Elmiron lawsuit in the country nearly a year ago. Since that time, there were nearly 200 lawsuits filed in various state and federal courts across the country. In the federal court system, when there are cases with similar facts (such as these where women and men are alleging similar visual injuries against the same companies relating to the same drug), there is a mechanism to assign all the cases to one judge. There is a statute that allows for cases to be transferred to one federal district to allow one judge to oversee the cases. This process is referred to as Multidistrict Litigation. In this case, all the cases filed in federal court that allege an injury following use of Elmiron are being transferred to the District of New Jersey and Judge Brian Martinotti is overseeing the cases. Please note, the cases on federal court are not a class action. This means that your case is still your case and will be resolved individually on your behalf. In addition, Judge Martinotti appointed a group of Plaintiffs lawyers to head up the cases on behalf of all plaintiffs with filed lawsuits. I am honored to be a part of the group of lawyers appointed to the Plaintiffs’ Executive Committee. Judge Martinotti is putting together a plan for how all the cases in federal court will proceed.
While the vast amount of lawsuits are filed in federal court, there are also cases filed in a few state court venues. There are cases filed in both the New Jersey and Pennsylvania state court systems. At this time, there is no consolidation of cases in those systems, although both have mechanisms to consolidate cases similar to the federal system, so at some point the state cases may also be consolidated. At this time, I am not aware that a trial date has been set for any of the state or federal cases.
What is the difference between state and federal court?
When it comes time to file a lawsuit, there are several options to file a case in most instances. The United States is set up with two court systems – there are state courts and federal courts. In order to file a case in federal court, there are certain requirements a case must meet. For example, in most Elmiron cases the amount in controversy exceeds the statutory threshold of $75,000 and the parties are residents of different states which allows for filing in an appropriate federal district. However, no matter which federal court a case is filed, it is ultimately transferred to the MDL proceedings in New Jersey for pre-trial purposes. However, it is transferred back to the original district for trial. In some cases, cases must be filed in state court, for example, if the injured person is a resident of the same state as the manufacturer. In other cases, cases are filed in the state court of the home state of the manufacturer. Our firm makes a decision in each case based on the individual facts where we believe the case is best filed.
What kinds of people are filing lawsuits? What is required of me if I file a lawsuit?
Nearly 200 people, women and men, have already filed a lawsuit. These cases encompass a wide variety of ages and length of use. Our office represents women and men that are in their 30s through their 80s. The one requirement is that they all suffered vision damage after use of Elmiron. When you hire a lawyer, the law firm will collect your medical records to document your use of the drug and any vision damage. If it meets their criteria, they will let you know if they can proceed with a lawsuit. Once a complaint is filed, the discovery process begins. This is slightly different in state and federal courts, so there is no uniform answer to the next steps for any individual case. As an example, Judge Martinotti in the MDL for federal cases is planning to use a Plaintiff Fact Sheet which will require each person who files a lawsuit to complete a required form to provide information to the Defendants. This document is something our office will assist all of our clients in preparing. Judge Martinotti will issue more orders as time goes on as to what if any further work will be done in each induvial case.
I have used Elmiron for a long time, but don’t know if I have any injuries and don’t want to waste anybody’s time.
Every law firm has its own criteria in making a decision to undertake representation of a specific person. With respect to Elmiron users, our Firm is pursuing cases on behalf of people who are long-term users of Elmiron who have suffered visual injuries, including pigmentary retinopathy and damage to the macula. Please visit our Elmiron website (https://www.johnsonbecker.com/drug-injuries/elmiron-lawsuit/) or call us toll free by dialing (800) 279-6386 and we would be happy to discuss a potential case with you. In addition, we also created a brochure for our clients to discuss these injuries with their eye doctors if you wish to do that before contacting an attorney.
Do I need to hire a lawyer right away?
Our advice to clients is generally the sooner – the better. Every state has what is known as a statute of limitations to bring a claim against the manufacturer. The statute of limitations is different for every state. Some states allow only one year from the injury where others allow for as many as six years. In addition, the date that triggers the statute of limitations can be the date of diagnosis of the injury, whereas other states allow for the date when a person first learns of the link between the drug and their injury or symptoms. It is an individual analysis based upon the facts of your case. As a result, we always suggest contacting a lawyer as soon as possible to ensure you don’t miss lose an opportunity to pursue a claim to recover if you were injured.
I have heard lawyers take all the money and leave injured clients with very little. Is it worth my time to pursue a case?
Like every profession, there are good lawyers and lawyers that earn their poor reputation. My goal is always to look out for our clients’ best interest. After all, clients that hire our Firm were injured and we would never want an injured person to feel like they wasted their time and effort on a case where the only person who got anything out of it is the attorney. My firm pursues these cases on a contingency fee basis. That means we take a fee only if we are able to recover something for your injuries.
I hope this helps to provide additional information on the lawsuits associated with Elmiron. We know it can be intimidating and there are lots of questions. We are happy to answer questions anytime so if any of your members have additional questions that are not addressed here, they can visit my firm’s website at www.johnsonbecker.com/drug-injuries/elmiron-lawsuit/ which has additional information or a link to contact me or they can reach out by telephone to my firm at 1-800-279-6386.
