Fleet Phospho-Soda Lawsuit Filed By Women Who Suffered Kidney Injury

A product liability lawsuit has been filed in the US District Court for the Middle District of Florida on behalf of three different women who developed acute phosphate nephropathy, a rare but serious form of kidney damage, after using Fleet Phospho-soda as part of their colonoscopy prep.

The Fleet Phospho-soda lawsuit was filed on February 17, 2009, on behalf of Sara Hancock, Mary Lou Abrams and Ruth Hite, who purchased the over-the-counter oral sodium phosphate laxative to use at high doses to clear out their bowels before a colonoscopy.

According to the complaint, Hancock purchased two 1.5 fluid ounce bottles of Fleet Phospho-soda on July 16, 2007 at a Walmart in Volusia County, Florida, and drank the solution the next day in accordance with instructions promoted by Fleet to consumers and the medical community.

Within a few days, Hancock was hospitalized with kidney failure and subsequently had a kidney biopsy done which led to a diagnosis of phosphate nephropathy. She now is in Stage IV renal disease and is waiting on the kidney transplant list at Mayo Clinic in Jacksonville, Florida.

The factual allegations made by Abrams and Hite are similar, indicating that they each purchased two bottles of Fleet Phospho-soda at their local Walmart and Publix, respectively. In the days after their colonoscopy, they also fell ill as a result of problems with their kidneys, and are now being treated by a nephrologist.

Acute phosphate nephropathy is a form of kidney insufficiency which is caused by the use of oral sodium phosphate products like Fleet Phospho-soda. It is rare, but can develop in some people within a few hours to a few weeks after the colonoscopy or other medical procedure. The kidney damage is permanent, and in many cases it results in the need for dialysis treatment, a kidney transplant or could ultimately be fatal.

In December 2008, the FDA issued a colonoscopy prep warning, indicating that the two prescription oral sodium phosphate products used for bowel prep, Visicol and OsmoPrep, will have new “black box” warnings added to their label about the risk of acute phosphate nephropathy.

At that time, the FDA also indicated that they were equally concerned about the use of over-the-counter oral sodium phosphate solutions like Fleet Phospho-soda, which can cause kidney damage when used at higher doses for bowel cleansing.

The FDA recommended that the other-the-counter laxative not be used for bowel cleansing, and the same day a recall of Fleet Phospho-soda was issued by C.B. Fleet.

The lawsuit filed on behalf of Hancock, Abrams and Hite alleges that Fleet was negligent in the production and marketing of Phospho-soda. They indicate Fleet knew or should have known about the risk of kidney injury involved with use of their product as a bowel cleanser and failed to adequately test the product or warn about the kidney problems.

Fleet’s recommended dose of two 1.5 oz bottles of Phospho-soda for bowel prep was never approved by the FDA or demonstrated to be safe.

Since 2004, C.B. Fleet has faced over 150 Phospho-soda lawsuits filed in state and federal courts throughout the country. While they initially settled a number of cases involving double-dose use, they have recently been fighting the claims and face mounting litigation over the now recalled product.