This Spring, four federal lawsuits were filed on behalf of IC patients who are struggling with pigmentary maculopathy, a new retinal disease associated with the long-term use of Elmiron. Each case alleges that Janssen Pharmaceuticals, part of the Johnson & Johnson umbrella of companies, failed to provide adequate warnings to patients and the medical community of the risks associated with the drug and may have withheld information about the linkage between Elmiron use and retinal disease.

Labelling is a central issue with each case referring to another med- ication known for causing retinal damage. The Plaquenil label provides explicit information on the risk of injury and encourages users to actively monitor their vision for signs of toxicity. It also suggests that a baseline ocular examination be per- formed in the first year of Plaquenil use so that changes can be monitored over time. The Elmiron label in the USA provides no education about potential vision changes nor instruction to have annual eye exams. This becomes all the more compelling when we learned that the Elmiron label in Canada was changed in September 2019 to include the following warning:

Post-market cases of pigmentary maculopathy have been reported with chronic use of pentosan polysulfate sodium (PPS). Visual symptoms in these cases included difficulty reading and prolonged dark adaptation. All patients should have regular ophthalmic examinations for early detection of pigmentary maculopathy, particularly those with long-term use of PPS. If pigmentary maculopathy is confirmed, treatment discontinuation should be considered.

So why are USA customers of Elmiron not being warned of this risk? That is one of several questions that will be asked and answered in future court proceedings. The latest case, Allen v. Janssen Pharamceuticals, Inc. et al., takes the litigation one step further by seeking class certification to establish a fund to be used for medical monitoring of patients using Elmiron to monitor the status of their vision. This was filed in the United States District Court for the Eastern District of Pennsylvania on May 6, 2020

The counsel of record for all four cases are Timothy J. Becker and Stacy K. Hauer of Johnson // Becker, a firm that specializes in drug and medical device injuries located in St. Paul, Minnesota. Ms. Hauer graciously agreed to take questions about the case for our readers.

1. What is the lawsuit about?

In 2018, eye doctors first published research linking long-term use of Elmiron to a unique injury to the retina or macula. Since that time, many additional papers were published linking long-term use of the drug to eye damage. We recently filed the first lawsuits in the country against Janssen Pharmaceuticals and Johnson & Johnson, the manufactur- ers of Elmiron. Our lawsuits include different legal theories. The first is known as strict liability, which is a claim that the drug is unreasonably dangerous for users to take it. Another theory is that the company failed to provide an adequate warning of the risks associated with the drug. At the end of the day, the claim is that had they told you of the risk of vision damage, or the need to monitor your vision, you would have acted differently and either not taken the drug or you would have gotten regular eye exams to monitor for damage to your eye.

2. What should I look for in a law firm and what experience do you personally possess?

We at Johnson Becker believe that expertise and experience matters. The attorneys at Johnson Becker col- lectively possess nearly 100 years of experience pursuing cases to hold pharmaceutical companies account- able for their actions. In addition to helping injured persons, I have always possessed an interest in medi- cine. Specifically, I received a Master’s Degree from the College of Pharmacy at the University of Minnesota before I went to law school. For the past two decades, I’ve focused my practice exclusively on cases involving injuries due to defective drugs.

If you decide to contact a law firm, make sure you ask questions about the lawyers working on your case and the firm’s experience in these types of cases. In many cases, the firm you talk to may not be the firm pursuing the case, but is simply working in partnership with another firm. Make sure to find out the name of the firm and attorney who will be primarily responsibility for your case. And, if you have questions, you should ask to set up a time to talk to an attorney about your potential claim.

Johnson Becker was the first firm in the nation to file a lawsuit on behalf of a woman who is now legally blind following her Elmiron use. We represent many current and former users across the country who were injured by Elmiron. We plan to vigorously prosecute our clients’ claims in order to obtain the best possible recovery.

3. Who qualifies? What does a law firm look for as far in order to represent someone?

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.

4. How long do lawsuits like this take?

Cases involving pharmaceutical products are complex and take more time than an average lawsuit. For example, if you are injured in a car accident, the case usually only involves the two drivers and potentially a passenger or eyewitness. Those cases are usually done in less than two years. In the case of a drug lawsuit, there are often hundreds, if not thousands, of people bringing claims. In addition, there are lots of employees at the drug companies involved in the drug development, marketing, and interacting with FDA. There are a variety of factors that go into the length of time, but generally speaking, the average lifespan of a pharmaceutical case is 3-5 years. Each case is different and could take less or more time. Depending on if and when cases are consolidated, the plan a judge overseeing a consolidation puts into place, the outcome of the jury verdict(s) in the first trial(s), defendants could decide to discuss settlement, or they could decide to try more cases. At this point in the litigation, it is too early to determine how long the process will take.

5. Is my individual injury case part of a class action?

No. First, and this is critical, if you took Elmiron and were injured by the product, your case is your own and is NOT part of a class action. The United States Supreme Court has ruled that cases involving injuries cannot be consolidated into a class action. This is because when people are injured, there is often a spectrum of damages that is not easily resolved through a class action. As such, every injured person we represent is an individual with their own individual lawsuit. That said, given the number of people impacted by the drug, all the cases may ultimately be consolidated for pretrial purposes through a variety of mechanisms. If that occurs, your individual case remains your own and we will continue to work to maximize your individual recovery.

6. What if I am NOT injured, but am concerned about my continued Elmiron use?

If you continue to use Elmiron, are asymptomatic and concerned about future vision loss, recent rec- ommendations and the drug labels in other countries suggests you should have regular eye exams. You should discuss this with your eye doctor. In addition, you may have a claim for medical monitoring. The medical literature suggests that the earlier doctors identify eye damage stemming from Elmiron use, the more likely they are to limit any vision loss or disruption. If you are an Elmiron user who is concerned about your on-going use, you may – in certain states – ask the Court to ensure you receive periodic eye examinations and testing that is paid for by the manufacturer. This case is called a “medical monitoring class action.” Put another way, the plaintiff asks the Court to provide monitoring to all persons potentially impacted by a future harm associated with the product’s use (in this case, potential vision loss). We represent an Elmiron user from Illinois who filed the first case in the nation seeking medical monitoring for all Elmiron users.

7. What type of medical records do you need to file my claim?

You do not need to go out and get any records for us to evaluate your claim. We do need the name and facility information for every doctor you saw related to your Elmiron use and injuries from Elmiron. Examples include: Primary doctor, urologist, eye doctor, and retinal specialists. We will also need to know every location where you filled a prescription for Elmiron. Without appropri- ate records, we cannot pursue a case. For example, we need proof from your medical records that you used Elmiron which can be either in phar- macy records or medical records.

With the information our clients provide to us, we request all of the necessary records. In some cases, we have trouble finding records and then contact our clients if we need further information to obtain additional records, or in some cases, ask for help in obtaining the medical records. For example, many pharmacies destroy records after seven years, but if we cannot locate pharmacy records we can often locate medical records from the prescribing doctor that document consistent use of the drug. In the case of Elmiron, since it has been on the market for over 20 years, and many of our clients have taken the drug for long periods of time, this may be an issue. However, we faced it many times in the past and generally are able to locate the records we need to proceed with a case.

8. Is there a time limit to hire a lawyer?

Every state has what is known as a statue 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 is 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.

9. How much will it cost?

Most firms pursue these cases on a contingency fee basis. A contingency fee is an agreement where the law firm advances the out of pocket costs for the lawsuit so nothing comes out of the injured person’s pocket as the cases moves forward. In the event there is a recovery for the injured person through a verdict or settlement, the attorneys’ fees are paid out of the recovery along with reimbursing the costs. If there is no recovery, then there are no fees to the client.

For additional information, please visit their website at: www.johnson-becker.com/drug-injuries/elmiron- lawsuit/ which has additional information or a link to contact me. Or, you can contact Stacey Hauer directly at 1-800-279-6386.

Source:

• Elmiron Lawsuit Filed Over Eye Damage and Vision Side Effects
https://www.johnsonbecker.com/firm-news/elmiron-lawsuit-eye-damage-vision-side-effects/

• Johnson // Becker, PLLC Files Elmiron Lawsuits Against Janssen Pharmaceutical For Elmiron Associated Retinal Maculopathy – https://www.johnsonbecker.com/firm-news/elmiron-lawsuits-for-elmiron-retinal-maculopathy/

• Elmiron Class Action Lawsuit Filed Against Janssen Pharmaceuticals For Medical Monitoring by Johnson // Becker, PLLC – https://www.johnsonbecker.com /firm-news/elmiron-class-action-lawsuit/

The Cases:

• Pelczar v. Teva Branded Pharmaceutical Products R&D et al. (Connecticut) https://dockets.justia.com/docket/connecticut/ctdce/3:2020cv00406/1 38690

• English v. Janssen Pharmaceuticals, Inc. et al. https://www.johnsonbecker.com/wp-content/uploads/2020/05/Elmiron_ Lawsuit_English_v_Janssen_Pharamceuticals__Inc_et_al.pdf

• Pisco v. Janssen Pharmaceuticals, Inc. et al., https://www.johnsonbecker.com/wp-content/uploads/2020/05/Elmiron_Lawsuit_Pisco_v_Janssen_Pharmaceuticals__Inc_et_al.pdf

• Allen v. Janssen Pharmaceuticals, Inc. et al. https://www.johnsonbecker.com/wp-content/uploads/2020/05/Elmiron-Class-Action-Lawsuit-Medical-Monitoring-Stamped-Complaint.pdf