Federal OSP Lawsuits Consolidated to Northern Ohio

Lynchburg, VAWhile a multidistrict order has been issued for 38 oral sodium phosphate (OSP) lawsuits for centralization to Northern Ohio, the manufacturer of phospho soda that has been linked to osp kidney damage in the context of colonoscopy maintains its product is safe.

According to a report in the News & Advance based in Lynchburg, Virginia C.B. Fleet asserts that its laxative products are safe when used as directed.

Two C.B. Fleet products—Phospho-soda and Phospho-soda E-Z Prep Bowel Cleansing System—are routinely used prior to a colonoscopy. Fleet Phospho-soda is a laxative, while E-Z Prep Bowel Cleansing System is a double dose of the laxative and is used to clear the intestine.

C.B. Fleet says that the products at issue have been made using the same formula for more than a hundred years. Both products were classed as oral sodium phosphates (OSP) and were available over the counter (OTC) without need for prescription.

However, in December the US Food and Drug Administration (FDA) issued a warning that OSPs had been linked to some cases of acute phosphate nephropathy—an acute kidney injury involving a buildup of calcium-phosphate crystals—when used in doses large enough for bowel cleansing.

While acknowledging that the product overall had a long history of safe use, the FDA submitted that OTC formulas were not to be used for bowel cleansing.

It should be noted that concern predates the FDA's December warning. According to a lawyer representing a plaintiff currently embroiled in a lawsuit against C.B Fleet, the company's Phospho-soda products have been linked to kidney damage since the 1990's.

Following the FDA warning the manufacturer issued a voluntary recall of its Phospho-soda products. According to Chris McDaniel, the chief scientific officer for C.B. Fleet, the company is in negotiations with the FDA to allow Phospho-soda as a prescription-only product.

"At this point we're considering our options and considering their input," McDaniel said in comments published in the June 29th, 2009 edition of the News & Advance. "No formal decision has been made about how we're going to go forward with this."

In the meantime, lawsuits continue. A total of 38 actions at the federal level have recently been consolidated into the Northern District of Ohio, while others will proceed in state court.

Federal oral sodium phosphate lawsuits will be consolidated to the Honorable Ann Aldrich. A lawyer representing one of the phospho soda plaintiffs at the federal level together with several others at the state level told the News & Advance he expects ops kidney damage plaintiffs to seek about $10 million each in damages.