OSP Kidney Failure Lawsuits Still Coming

Washington, DCSometimes it's difficult to talk about the nether regions of the human body, but the fact remains that the public must be notified: a preparation used to cleanse the bowel prior to colonoscopy is suspected of having the potential to trigger such dire consequences as OSP kidney damage. OSP is shorthand for oral sodium phosphate. One product—Phospho-soda and manufactured by Fleet—has been flagged by the US Food and Drug Administration (FDA).

Fleet's Visicol and OsmoPrep, both prescription medications, now carry a black box warning for acute phosphate nephropathy (APN). Fleet Phospho-soda, however, gets tagged by the FDA against the indication for bowel cleansing. In the FDA's eyes, Phospho-soda is only appropriate as a laxative.

Fleet quickly pulled the products off the market anyway, but the damage is done. AboutLawsuits.com reported in late summer that about 550 claims had been made to C.B. Fleet Co. with regard to the intent to litigate over allegations that the over-the-counter (OTC) Phospho-soda when used as a bowel cleanser caused severe kidney damage.

APN, the kidney issue tied to the use of Phospho-soda as a bowel cleanser, is a serious condition that could lead to kidney failure, the need for dialysis and eventual kidney transplant—or even death.

"In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury," says C.B. Fleet in a statement posted on their web site. "We cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSPs or they did not drink sufficient fluids after ingesting OSP."

Fleet had indicated at the time of the FDA alert that in its view Phospho-soda, when used as directed, was safe. Part of the requirement for safe use was to ensure proper ongoing hydration prior to use, together with the ingestion of the recommended amounts of liquids in concert with the medication.

No matter. C.B. Fleet recalled Phospho-soda. And now come the lawsuits. As of late summer there were more than 100 Phospho-soda lawsuits pending throughout the nation, together with indications that more will be coming through the pipeline.

Most of the cases were consolidated in Multidistrict litigation (MDL) in June before US District Court Judge Ann Aldrich in US District Court for the Northern District of Ohio.

According to AboutLawsuits.com there were about 120 cases that were resolved in negotiation with the manufacturer prior to the MDL. Phospho-soda litigation actually goes back to 2004 when the first lawsuit was filed. Since that time only one Phospho-soda case has gone to trail, coming to conclusion after just three days in California state court.