OsmoPrep Black Box Lawsuit

by admin on March 22nd, 2010

Fleet Bowel Prep Recall

CB Fleet Company, Inc., has recalled its Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System as over-the-counter products. In addition, an Osmoprep black box warning was announced due to concerns of kidney damage. These were products used as bowel prep products to prepare for a colonoscopy. The Fleets Phospho Soda recall was issued in December 2008. Patients who have suffered kidney damage have looked at their legal options including filing a Fleet, Visicol and Osmoprep lawsuit.

Kidney Problems and FDA Warnings

Some people who took an Osmoprep, Visicol or Fleet bowel prep product suffered a severe injury to their kidneys within days or weeks following the bowel cleansing. In 2008, the FDA warned about Fleet kidney damage after several people suffered from kidney problems called acute phosphate nephropathy (renal failure). In cases of acute phosphate nephropathy, calcium phosphate crystals deposit in the renal tubules causing kidney failure, which can be permanent. Because of the risk of kidney failure, the FDA decided that the Fleet bowel prep products should not be used, and CB Fleet Company issued its Fleet bowel prep recall.

Were the Fleet Bowel Prep Drugs Necessary?

Prior to a colonoscopy, patients must take a bowel cleansing solution that clears the bowel. Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System were such products. The Osmoprep black box warning was also issued in response to concerns of serious kidney side effects. Bowel cleansing is necessary because during a colonoscopy, the doctor inserts a camera to take pictures of the inside of the large intestine, which the doctor can view on a monitor during the exam. This camera cannot take accurate pictures if the bowel is not clear. While the Fleet bowel prep drugs did their job in most cases, they caused severe kidney damage in other cases.

Who was vulnerable to kidney damage?

People with known kidney problems were especially vulnerable to kidney failure from using a Fleet bowel prep product. What is so frustrating is that Fleet advertised their bowel prep products for use at very high dosage rates without adequate warnings about the risk of kidney failure for years prior to the recall. People with known kidney disorders could have avoided the life-threatening kidney problems if there had been proper warnings.

What Complications were caused by a Fleet product?

When kidneys are not functioning properly, the damage can be severe, including tiredness, shortness of breath, decreased urine output, leg swelling, confusion, seizures, and comas. Some kidney problems can be reversed, but at advanced stages, kidneys may be permanently damaged and may not return to their full functionality.

What are my rights?

It is unknown exactly how many people have suffered from Fleet kidney failure. If you have taken Fleet Phospho-Soda or Fleet Phospho-soda EZ-Prep Bowel Cleansing System, Visicol or OsmoPrep and sustained kidney damage, you have a right to hold the manufacturer responsible for the side effects it caused, and should contact an experienced OsmoPrep lawsuit Attorney as soon as possible.