Janssen Pharmaceuticals Sued For Product Liability Due to Orphan Drug Elmiron

In what appears to be an accelerating wave of product liability lawsuits, Janssen Pharmaceuticals has been sued multiple times by patients who have taken the drug pentosyn polysulfate sodium, popularly known as Elmiron. The cases are currently at the complaint stage, but have been filed in the Eastern District of Pennsylvania as well as the District of New Jersey.

Elmiron is currently designated as an “orphan drug” under Title 21 of the United States Code. This status permits a drug that is intended to treat a disease or medical condition that does not have a current mainstream effective treatment to bypass certain testing protocols and efficacy requirements. This permits people suffering from these conditions to have access to the drug while either further studies or newer innovations are pursued. However, the relaxation of these requirements does not mean that the pharmaceutical company is exempt from the requirements to provide drug interaction and warnings as a part of the packaging materials and educational materials provided to prescribing physicians.

The plaintiffs in these suits were prescribed varying doses of Elmiron in the 1980s, 1990s, 2000s, and 2020s. While each suit is specific to the facts for that particular plaintiff, the suits hold the common thread that each of the plaintiffs was prescribed a long term, large dose of the drug. The facts of the suit point to multiple studies indicating an increased likelihood of atypical pigmentary maculopathy, which leads to reduced vision and blindness. However, none of these studies were widely disclosed and there were no warning indicators officially submitted as required by the Food and Drug Administration under Title 26.

The plaintiffs are suing under theories of strict liability and negligence, stating that Janssen and its subsidiaries manufactured and distributed the drug without adequate testing, concealed clinical data regarding side effects, failure to warn as to efficacy of the product, failure to warn as to toxicity, failure to disclose alternative treatments and other negligent acts. 

The plaintiffs are represented by Johnson Becker, PLLC, and Anapol Weiss. Janssen, along with Johnson & Johnson and Teva Pharmaceuticals, have been sued repeatedly in recent months under claims arising from the same drug. A motion to transfer to the Judicial Panel on Multidistrict Litigation is pending.