Failure to Warn

March 2, 2021

Manufacturer of bladder drug Elmiron fails to warn of reactions signaling significant eye damage

Photograph of Close Look at Retina of the Eye Medications are meant to bring relief and peace of mind, but when your treatment begins to attack unrelated areas of your body, that peace of mind can be compromised. In June 2020, the Food and Drug Administration (‘FDA’) issued a Labeling Change related to the prescription drug Elmiron used for a bladder condition. This label change gave warning that Elmiron can cause issues with eyesight. Although there has been no recall, users were advised to get regular eye exams and stop using it if they notice problems with their vision.

Elmiron is used to treat pain and discomfort from interstitial cystitis (‘IC’), a painful (and common) bladder condition which is difficult to treat and often mistaken for urinary tract infections. Elmiron is believed to help with the pain from this condition by attaching to the bladder wall and creating a barrier to prevent more damage. Elmiron has been prescribed to treat this condition for decades and is the only drug approved by the FDA to do so.

After a troubling study at Emory University in 2018, researchers wrote a letter to the Journal of Urology stating they found that long term use of Elmiron can cause serious damage to the retina. This “pigmentary maculopathy” comes from injury to the outer layer of the retina. Physicians at Kaiser Permanente took this warning seriously and reviewed medical records of over four million of their patients and were able to actually study 91 of them who had been taking Elmiron over a long period of time. Around one-quarter of the patients examined were found to have significant damage to the retina which had previously—and unfortunately—been attributed to other diseases that affect the eyes.

February 27, 2020

PJ the Wrong Way Part I: Product Liability and Hot Coffee. “It’s outrageous, egregious, preposterous.”

by Neumann Law Group

“Yeah, that’s going to be a problem. That’s going to be a problem for them.”

In so few words, Jackie Chiles, legendary consumer rights warrior, issued a battle cry, distilling public safety litigation into its most primal essence. Dangerous products impose a cost upon the consumer. Product liability lawsuits reallocate the cost w Chiles-Top-of-Blog here it belongs: the manufacturer. A dangerous product is a problem, but this time, it will be a problem for them.

This article is the first installment in a series that explores the evolution of personal jurisdiction as it relates to product liability litigation, concluding with a discussion of two personal jurisdiction cases pending before the Supreme Court. In those consolidated cases, Ford Motor Company is asking the Court to severely limit the number of courts that can hear a case against a company that serves a regional or national market.

August 16, 2017

Michigan Appeals Court Holds Plaintiffs Failed to Establish Design Defect and Failure to Warn in Boating Accident Case

by Neumann Law Group

The Michigan Appeals Court recently affirmed the lower court’s grant of summary disposition to a defendant in a Michigan boating accident case. Specifically, the appeals court held that the plaintiffs failed to demonstrate a genuine dispute of material fact regarding defective design and failure to warn.The plaintiff was injured while pontoon boating in June 2013. Before the accident, her husband purchased a boat hoist and a canopy frame manufactured and sold by defendant NuCraft. He also purchased a vinyl canopy from the defendant. He testified that, at some point before the night of the accident, he spoke with NuCraft’s vice president about how to best install the canopy. He planned to use the hoist and the canopy assembly for a boat that he kept at his mother’s cottage on Lake Margrethe.