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Elmiron Legal Update

Elmiron, Elmiron update, mass tort elmiron

Elmiron litigation is moving along with a fast-paced judge in a fast-paced MDL (#2973).  The Judicial Panel on Multi-District Litigation (JPMDL) issued the order creating the Elmiron MDL on December 15, 2020, and centralized it in the District of New Jersey.  The JPMDL assigned the Hon. Brian R. Martinotti as the presiding judge.  The magistrate is the Hon. Edward S. Kiel.

The MDL is just about three months old and Judge Martinotti already held three status conferences (Jan. 8, 2021; February 10, 2021; and March 10, 2021).  He intends to continue to hold status conferences ever 30-45 days.  Current orders are published on the MDL’s page on the District of New Jersey web page (  Before the MDL officially started, 45 Elmiron cases were winding their way through the court, and Judge Martinotti adopted all of the CMOs pertinent to those cases into the MDL as well.

Today we’ll review the major claims, the defendants, and progress in the MDL so far.

The Primary Tort Claims Against Elmiron

The primary claims in this litigation are traditional pharmaceutical tort claims:

         1.   Failure to Warn

         2.   Negligent Testing

         3.   Fraudulent Concealment

         4.   Design Defect

The first three claims were bolstered by a 2018 Emory University study concluding that the vision injuries caused by Elmiron showed up in clinical trials, but were never warned about or revealed.[1]  Other studies published since them have confirmed Emory’s initial results. Sadly, a July 2020 JAMA Ophthalmology study showed that the damage doesn’t go away when clients stop taking the medication, meaning that the injuries might be permanent and irreversible.[2]  We already know that Elmiron-related injuries are severe; if they are also irreversible, then the damage to clients is even greater.

The design defect claim stems from the way the Elmiron medication (pentosan polysulfate sodium) is absorbed in ocular tissues, which leads to maculopathy and other documented injuries.

The Defendants

The “Janssen Defendants” consist of a group of entities, including parent company Johnson & Johnson:

               1.   Janssen Pharmaceuticals, Inc.,

               2.   Ortho- McNeil Pharmaceuticals,

               3.   Janssen Pharmaceutica, Inc.,

               4.   Janssen Research and Development, LLC (f/k/a Johnson & Johnson Pharmaceutical Research and Development),

               5.   Janssen Ortho LLC, and

               6.   Johnson & Johnson

Baker Norton Pharmaceuticals is a named defendant, as the company which held the New Drug Application (NDA) for Elmiron, and Alza Corp. later bought Elmiron from Norton.

Various Bayer pharmaceutical entities were initially named as well, but in a pre-MDL order Judge Martinotti dismissed them all on the grounds that Janssen indemnified them from any claims and took judicial notice that “none of the Named Bayer Defendants (including, but not limited to, any corporate parent, subsidiary or affiliate), were involved in developing, designing, or testing ELMIRON®, and none of the Named Bayer Defendants (including, but not limited to, any corporate parent, subsidiary or affiliate), has ever held the ELMIRON New Drug Application (“NDA”) since the product was approved by the FDA in 1996.”  (Pre-2973 MDL Case Management Order #5 at 2.)

On January 15, 2021 the court noted that almost all parties agreed to dismiss Teva Pharmaceuticals USA, Inc.  Discussions are ongoing about dismissing the other Teva defendant, Teva Branded Pharmaceutical Products R&D, Inc. (holder of the trademark).

Progress in the MDL

Judge Marinotti hit the ground running.  Less than three months into the MDL he’s appointed defense and plaintiff leadership teams (CMO #2 and CMO #3), established the status conference calendar through the end of 2021, and noted that counsel are making progress in developing the Plaintiffs’ Fact Sheets.

Defendants’ Lead Counsel are Kristen Fournier and Bruce Hurley of King & Spalding. (CMO #2 at 2).  Plaintiffs’ lead Counsel are Virginia E. Anello of Douglas & London, P.C.; Parvin Aminolroaya of Seeger Weiss, LLP; and Paul Pennock of Morgan & Morgan, P.A. (CMO#3 at 2).  Numerous other counsel round out the positions for liaison and discovery counsel, as well as the Plaintiffs’ Executive and Plaintiffs’ Steering Committees.

mass tort case, Elmiron, Elmiron update

This is not a large docket, given the nature of the number of people taking Elmiron for interstitial cystitis, but the injuries are severe, so each case is seen as significant.  The Court noted after recent status conferences that as of January 8, 2021 there were 169 filed and served Elmiron cases (CMO#2 at 1).  By February 10, 2021, the total number grew to 177 (CMO #4 at 1).  Most are filed in the MDL, but around just under 25 cases are filed in state courts in New Jersey and Pennsylvania.

We are a long way from bellwether trials, but the MDL is moving.  On January 15, Judge Martinotti lifted all discovery stays (CMO#2 at 4), so we will see movement very soon in obtaining written and electronic discovery, and deposition scheduling will follow.

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Written by Donna J. Blevins

[1]        “Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium.”  William A. Pearce, Ruoi Chen, Nieraj Jain.  Ophthalmology. 2018 Nov; 125(11):1793-1802.doi: 10.1016/j.ophtha.2018.04.026.Epub 2018 May 22.

[2]        “Disease Course in Patients with Pentosan Polysulfate Sodium-Associated Maculopathy after Drug Cessaton”; Rachel Shah MD; Joseph M. Simonett MD; Riley J. Lyons, BA; et al., JAMA Ophthalmol. 2020;138(8):894-900. doi:10.1001/jamaophthalmol.2020.2349.) 


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