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.
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Learn MoreWithin 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.
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11 Comments
LindaOctober 4, 2010 at 7:43 pm
i have stage 3 kidney disease from drinking this fleet drink.
C.T.April 4, 2010 at 11:56 pm
I AM A 29 YEAR OLD MOTHER, OF THREE SMALL BOYS. I AM 6 YEARS POST MENOPAUSE DUE TO SURGICAL HYSTERRECTOMY. .I TOOK FLEET BEFORE A SURGERY IN FEB 2008 .SHORTLY AFTER I WAS VERY SICK. NAUSEA, AND PAIN UNDER MY LEFT RIB ,BACK PAIN, SHARP SHOOTING PAIN IN MY LEGS THAT WOULD WAKE ME UP IN THE MIDDLE OF MY SLEEP.I WAS LOOSEING WEIGHT BECAUSE I WAS SO SICK. I HAD SWELLING IN MY FACE, FEET ,AND HANDS SO[Show More]I AM A 29 YEAR OLD MOTHER, OF THREE SMALL BOYS. I AM 6 YEARS POST MENOPAUSE DUE TO SURGICAL HYSTERRECTOMY. .I TOOK FLEET BEFORE A SURGERY IN FEB 2008 .SHORTLY AFTER I WAS VERY SICK. NAUSEA, AND PAIN UNDER MY LEFT RIB ,BACK PAIN, SHARP SHOOTING PAIN IN MY LEGS THAT WOULD WAKE ME UP IN THE MIDDLE OF MY SLEEP.I WAS LOOSEING WEIGHT BECAUSE I WAS SO SICK. I HAD SWELLING IN MY FACE, FEET ,AND HANDS SOME MORNING I COULD NOT EVEN SEE TO GO TO SCHOOL BECUSE MY EYES WERE ALMOST SWOLLEN SHUT.IT WAS HARD TO BREATH I WAS LOOSING RBC,RENAL CELLS,PROTIEN I ALSO HAS RECTAL SORES THAT WOULD BLEED.THE MORE I WIPED THE WORST THEY GOT THAT WOULD BE PAINFUL LEADING TO ECOLI INFECTION .I WOULD URINATE OUT BLOOD FOR DAYS FINALY I MEDICALY HAD TO WITHDRAWL FROM COLLAGE I KNOW FLEET IS RESPONSBLE MY NEPHROLOGIST HAS RAN MANY TEST. ELMINATING DISEASES THAT YOUR OWN BODY CAN CAUSE TO INJURY YOUR KIDNEYS .IT AFTER MY SURGERY IN FEB 2008 I WENT TO GO AND SEE MY DOCTOR 10 DAYS LATER COMPLAINING I WAS IN PAIN SHE CHECKED ME AND SAID IT WAS NOT A BLOOD CLOT I LEFT IN PAIN WITH NO ANSWERS NOT SUSPECTING A FLEET MEDICINE .I MEAN HOW CAN THEY GET AWAY WITH ALL THESE YEARS MAKING US ILL AND SUFFER I FEEL LIKE MY LIFE IS EXHASTED.I AM NOT EVEN 30 I HAVE BEEN VERY SICK FOR 2 YEARS MY KIDS ARE SUFFERING.I WISH I WOULD HAVE NEVER TOOK THIS MEDICINE AND NEVER RECOVERED SINCE ONLY FEELING LIKE I AM SLOWLY DYING AND MY DREAMS HAVE BEEN STOLDEN. I WAS GOING TO SCHOOL TO BECOMING A NUSE AND ENDED UP NEEDING ONE IN THE END .I HAVE FILED SUIT AGAINST C.B. FLEET IT IS BEING HELD IN THE OHIO FEDERAL COURT NORTHERN DISTRICT THE JUDGE ANN ALDRICH
suebFebruary 1, 2010 at 11:45 pm
wow. I am petrified to return for my fourth colonoscopy. I am 44 year old female. My lab tests have been horrible regarding creantine levels and protein in kidneys. I'm raising a son on my own as his father died. The last thing I need is to find out those products did this. My sister also had the colonoscopy products (fleet) and is in very bad condition. How does one even know if this is part o[Show More]wow. I am petrified to return for my fourth colonoscopy. I am 44 year old female. My lab tests have been horrible regarding creantine levels and protein in kidneys. I'm raising a son on my own as his father died. The last thing I need is to find out those products did this. My sister also had the colonoscopy products (fleet) and is in very bad condition. How does one even know if this is part of the problem. I didnt get severely ill though after using these products. Does this mean I'm not affected? I just keep getting sent to kidney and bladder specialist and no one can tell what is going on. why were the doctors offices allowed to recommend these items to patients. I know it was "fleet" and would have to check with my pharmacy and past records.
MaryNovember 11, 2009 at 6:32 am
i experienced kidney stones which i never had before and now i'm having some problems with my kidneys,i did not know by using fleet you can have problems later own and if the doctors don't put 2 to 2 together they would not know that a over the counter product can cause so many problemsi hate that i had 2 colonoscopies,using fleet prep because i have so many problems with my kidneys.
BettySeptember 23, 2009 at 4:00 am
I was traumatized after my colonoscopy in 12/2001. I was so ill afterwards, thought I had been poisoned for 7 weeks afterward. From absolutely perfect health, problems started, first being bedfast for a year with lower back, both feet in pain, extremely high cholesterol, etc. My life has been taken from me. I still have the [empty] bottle of phoso-pho. Did not drink the whole bottle at first. Dran[Show More]I was traumatized after my colonoscopy in 12/2001. I was so ill afterwards, thought I had been poisoned for 7 weeks afterward. From absolutely perfect health, problems started, first being bedfast for a year with lower back, both feet in pain, extremely high cholesterol, etc. My life has been taken from me. I still have the [empty] bottle of phoso-pho. Did not drink the whole bottle at first. Drank some latter 2007 for cleansing [smaller amount] and by January 2008, I was tiredest I had been in the past few years, could barely put one foot in front of the other. Such weakness kept me bedfast most days for several hours.Have not been able to work for 1-1/2 years and about to lose everything. No medical insurance. Get very tired even being away for a couple hours or so. In mid 2008, I was finally told my kidneys were failing. GSR was 49 at that time, diagnosed with chronic renal insufficiency. Sonogram showed damage. Sent summary letter to Fleet and now sending docs to their attorneys, but too tired to get a lot done. Living on faith and social security check, but barely living. Can't go to a specialist, have no funds. State of AZ states my social security check is more than the approximately $860 income limit for getting on medical insurance. I'm definitely stuck in a corner!
shondaAugust 19, 2009 at 6:31 pm
I have been suffering from several kidney inf. I have been in the hospital for one of these inf. and I have to see a urologist in sept. I am just wondering if this has anything to do with it . i have took the phospha soda about 10 times in the last 6 years.
SusanAugust 1, 2009 at 11:21 pm
Never, ever had a renal issue in my life. Took phosphosoda after discussion with a pharmacist who told me the prep was used by most people because it was economical . It was also on the list of preps at the gasteroenterologist's office. I took the prep, had the worst headache imaginable Post-procedure I started having abnormal labs with estimated GFRs <60. I'm now seeing a nephrologist as I[Show More]Never, ever had a renal issue in my life. Took phosphosoda after discussion with a pharmacist who told me the prep was used by most people because it was economical . It was also on the list of preps at the gasteroenterologist's office. I took the prep, had the worst headache imaginable Post-procedure I started having abnormal labs with estimated GFRs <60. I'm now seeing a nephrologist as I have to watch every med I take (definitely aspirin, watchful eye to antibiotics, etc), diet and other concerns due to kidney damage. The colon screening was normal, but I will never have another one in this lifetime--you can't trust anything about healthcare right now. Just ask the 4,700 exposed to Hepatitis C in Denver due to a surgical tech exchanging her dirty needles for clean ones "unbeknownst" to anyone. How many health care dollars are being eaten up by mistakes by the very system meant to help? I DO NOT APPRECIATE HAVING A RENAL ISSUE TO DEAL WITH THAT WAS NEVER PRESENT BEFORE! AND I SURE DON'T WANT TO BE TETHERED TO A BLASTED DIALYSIS MACHINE!
maryJuly 24, 2009 at 5:37 pm
I ingested the two prescribed fleet phospho soda prior to colonoscopy and was so ill I could barely move from the bathroom for 12 hours. Within two weeksI was taken by ambulance in great pain to emergency care passing kidney stones (phsician referred to them as the boxcars). I still have problems and seek specialized care out of the area.
mikeJuly 17, 2009 at 5:46 pm
after taking visicol the night before my colonoscopy I was informed during my pre procedure check up that I was in A fib . Never had any problems before that. Any connection ?
VicMarch 12, 2009 at 3:49 pm
I used (per my doctor's instructions) the two-dose Fleet phospho-soda ten years ago in preparation for my colonoscopy. This is when I turned 60. Subsequent annual lab tests revealed my B.U.N. and creatine levels were "out-of-range". (Prior labwork showed normal numbers.) I saw a nephrologist about 3 years ago and he could find no other root causes (e.g. diabetis or high blood pressure, etc.) Thjis[Show More]I used (per my doctor's instructions) the two-dose Fleet phospho-soda ten years ago in preparation for my colonoscopy. This is when I turned 60. Subsequent annual lab tests revealed my B.U.N. and creatine levels were "out-of-range". (Prior labwork showed normal numbers.) I saw a nephrologist about 3 years ago and he could find no other root causes (e.g. diabetis or high blood pressure, etc.) Thjis FDA announcement in December 2007 is the first I heard of the problem. I sent a copy of the FDA report to my nephrologist in February but have not heard back from him.
KathrynMarch 5, 2009 at 10:44 pm
This is interesting. I had an allergic reaction to this product when doing a prep for a colonoscopy. I broke out in a rash from head to toe in about fifteen minutes after taking the sodium-phosphate.