MTN will continue our discussions related to State Court Consolidation filing strategies in the Zantac/Ranitidine litigation following the MDL Court’s recent preemption rulings (and why your firm should continue marketing for these cases). The MDL is not “dead” by any means, and concurrent State Court Consolidations simply make sense, especially while the MDL PSC works out the “bumps in the road,” for which they are not to blame, but must deal with, nonetheless.
While many of you may have been taking time off for Christmas and New Year’s, The Judicial Panel on Multidistrict Litigation granted a petition to Transfer and Consolidate cases involving the drug Elmiron to the District of New Jersey, forming MDL 2973.
HIGH POINTS ON ELMIRON
Elmiron is the only drug approved by the FDA to treat Interstitial Cystitis. The primary symptoms of Interstitial Cystitis are chronic pain in the bladder and pelvic area.
The primary adverse event in the Elmiron litigation is Pigmentary Maculopathy. Pigmentary Maculopathy induced by Elmiron is latent (important to SOL), progressive, and irreversible. If diagnosed early, treatment may slow the progression of the disease; however, there is no cure. Pigmentary Maculopathy often leads to complete blindness, or near blindness, over time.
WHAT YOUR FIRM SHOULD DO TODAY
If your firm, (or lead generation company) was involved in the Transvaginal Mesh Litigation, have your staff begin compiling a list of every woman that contacted your organization (without regard to whether they qualified for retention as a TVM client). After attending the January 20, 2021 Whiteboard Wednesday session (and receiving our Elmiron Litigation Package with the suggested qualifying criteria), you will want to reach out to all TVM plaintiffs (including those you rejected) and ask if they were prescribed Elmiron. If they answer is yes, you should then proceed to asking the qualifying questions relevant to Elmiron (see recent label changes at the end of this article).
If you have attended the MTN Four Days to Mass Tort Success Course, you already know that “past clients” (including those that contacted your firm, but were not retained) are your best, first source of new clients in any mass tort litigation.
You are very likely to find that many of the women who contacted your firm about a potential Transvaginal Mesh Litigation, were also prescribed Elmiron, before, during, or after their TVM surgeries.
Given the extremely high rate of progressive maculopathy apparently associated with long term consumption of Elmiron, you are likely to find a significant number of Elmiron potential plaintiffs, in your firms TVM files. Do you really want another firm to sign a client that your firm has already contacted or represented, simply because you did not take the time to reach out to the one group of people your firm can initiate direct contact with?
As a primer, the relevant changes to the Elimiron label are below. Keep in mind, this adverse event is latent, progressive, and irreversible. Do not assume that the 06/16/2020 label change date will have begun the SOL running on the majority of potential plaintiff cases.
06/16/2020 (SUPPL-14)
5 Warnings and Precautions
Retinal Pigmentary Changes
(Newly added subsection)
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.
6 Adverse Reactions
Post-Marketing Experience
(Newly added information)
The following adverse reactions have been identified during post approval use of pentosan polysulfate sodium; because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
- pigmentary changes in the retina (see WARNINGS).
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Patient Information
(Newly added information)
Patients should be informed that changes in vision should be reported and evaluated. Retinal examinations including optical coherence tomography (OCT) and auto-fluorescence imaging are suggested for all patients within six months of starting ELMIRON® and periodically during long-term treatment (see WARNINGS).
Other
Patient Leaflet
(Extensive changes; please refer to label)
