A federal judge has blocked the class action lawsuit proposed in Almond v. Janssen Pharmaceuticals, wherein the plaintiff had not yet suffered injury from the defendant’s drug, but rather demanded compensation for medical monitoring to check for signs of damage from the medication.
In rendering her decision, U.S. District Judge Wendy Beetlestone of the Eastern District of Pennsylvania took issue with Pennsylvania’s handling of “no-injury” medical monitoring claims with no regard for residency. She further explained that Almond v. Janssen Pharmaceuticals did not warrant a class action because the lawsuits that would fold into the class lacked sufficient cohesion.
Judge Beetlestone’s decision does not affect the viability of class action lawsuits stemming from plaintiffs who have already suffered injury from Janssen’s Elmiron drug.
The drug at issue, Elmiron (pentosan polysulfate sodium), is an oral prescription drug used to treat discomfort or pain that accompanies interstitial cystitis, or IC, a chronic condition that causes bladder pain and pressure. It is the only FDA-approved drug for treating IC.
Lawsuits related to Elmiron commenced following publication and increasing awareness of studies conducted by the American Academy of Opthalmology (2018) and The British Journal of Ophthalmology (2019). These studies revealed that patients who received Elmiron therapy for their IC showed a prevalence of a distinctive type of retinal damage called pigmentary maculopathy. According to the researchers, hundreds of thousands of patients had likely suffered exposure to Elmiron’s injurious effects, thereby risking the following hazardous side effects of the drug:
- Distorted vision
- Vision loss
- Difficulty adjusting to changes in lighting
- Trouble focusing
- Blind spots
- Blindness (rare)
Janssen’s response to date has been to update the Elmiron label that appears as a package insert with a warning regarding the risk of pigmentary maculopathy, along with directions for patient care and screening. The pharma company took this action in June 2020.
More than 80 lawsuits have been filed with regard to the drug, with plaintiffs alleging that the drugmaker knew of the risks associated with long-term use of Elmiron and knowingly withheld those risks from the public. The lawsuits further accuse drug makers of negligence in their design of the drug.