Fleet® Phospho-Soda®
We are involved in the largest network of attorneys representing people injured from the use of Fleet®’s Phospho-Soda®. Phospho-Soda® has been given to patients many times in preparation for a colonoscopy. Since the early 1990’s, Fleet® had aggressively promoted the use of Phospho-Soda® as a safe bowel cleanser for colonoscopy and medical procedure preparation.
The Fleet® litigation began over four years ago when a courageous Holocaust survivor walked into the offices one of our partner firms in New York. That lawsuit, and the nearly 200 lawsuits that have followed it, have resulted in a numerous depositions, document productions and court proceedings.
Ultimately, after the many years of litigation and in the midst of a case we were handling in West Virginia, FDA finally issued an unequivocal statement in December, 2008, regarding the fact that the use of Phospho-Soda® can cause permanent kidney damage and a life threatening condition called nephrocalcinosis. Our client’s case settled shortly thereafter.
Many of the injured allege the same things; that they have suffered kidney failure, chronic kidney disease, end stage renal disease or nephrocalcinosis as a direct result of using Fleet® Phospho-Soda® in a dose recommended by Fleet® as "safe". Sadly, many of the injured are undergoing dialysis while awaiting a kidney transplant.
We have been active in developing the evidence about Fleet®’s knowledge about problems with its product and its failure to warn physicians and, most importantly, the public about what it knew. Some of the facts developed by the team of law firms in our network include the following:
- 1996: Fleet® was told by FDA that the Company had failed to demonstrate the safety of Phospho-Soda® as a bowel cleanser;
- 1997: Fleet® received reports of death in Australia following the use of Fleet Phospho-Soda® as a bowel preparation prior to surgery;
- 1998: FDA again warned that Fleet® had failed to demonstrate the safety of using the product in bowel preparation doses;
- 2001: the FDA issue a "Science Backgrounder" alerting consumers to safety issues with the product;
- 2002: J&J Merck Canada issued a “Dear Dr.” letter to Canadian healthcare professionals advising of the risks when using the Phospho-Soda®, in the dose recommended by Fleet®, as a bowel preparation prior to colonoscopy. Fleet® did not tell provide those in the United States with the same information. Fleet® instead sent its own “Dear Dr,” letter to U.S. healthcare professionals touting the safety of the product for bowel cleansing;
- Early 2003: Dr. Glen S. Markowitz, a renal pathologist from Columbia Presbyterian Hospital, identified cases of kidney failure associated with the use of Phospho-Soda® for bowel cleansing. Markowitz GS: Acute Phosphate Nephropathy and Renal Failure: N Engl J Med 349;10 September 4, 2003.
- 2004: Markowitz GS: Renal failure due to acute nephrocalcinosis following oral sodium phosphate bowel cleansing. Human Pathology, Volume 35 , Issue 6 , Pages 675 - 684.
- 2005: Glen S. Markowitz published the results of his expanded study examining oral sodium phosphate solutions, including Phospho-Soda® and Visicol® as under recognized causes of kidney and renal failure. Markowitz GS: Acute Phosphate Nephropaty following Oral Sodium Phosphate Bowel Purgative: An Underrecognized Cause of Chronic Renal Failure. J AM Soc Nephrol 16: Sept. 28, 2005. doi: 10.1681/ASN.2005050496
- May 5, 2006: FDA issued an "alert" regarding the occurrence of Acute Phosphate Nephropathy after the ingestion of sodium phosphates solution or tablets.
- October 31, 2007: Article published stating the incident rate of kidney failure due to the use of Oral Sodium Phosphate is approzimately to 1 in 100. Hurst FP: Association of Oral Sodium Phosphate Purgative Use with Acute Kidney Injury. JASN Express, October 31, 2007. doi: 10.1681/ASN.2007030349.
- December 11, 2008: the FDA issued an Alert stating that the use of Fleet® Phospho-Soda® could lead to kidney failure "in patients with no pre-existing health factors that would have put them at risk for developing kidney injury."
- December 15, 2008: Fleet® finally recalled Phospho-Soda® from the market.
Nearly 5 years after Dr. Markowitz’s articles, Fleet® persisted in its promotion of the Phospho-Soda® as a "safe" bowel preparation. If you or a loved one believe that you have been injured by Phospho-Soda®, call us for a free consultation.