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Saturday, March 21, 2009

Lawsuits against Lynchburg company say laxative dose unsafe

Lynchburg company C.B. Fleet Co. Inc. faces four lawsuits each asking for more than $10 million.

A Roanoke law firm has leveled four $10 million lawsuits against a Lynchburg pharmaceutical company.

The lawsuits filed Friday claim C.B. Fleet Co. Inc. promoted doubling the dose of its Fleet Phospho-soda laxative knowing the higher dosage could cause kidney failure.

Each suit asks for $10 million in compensatory damages and $350,000 in punitive damages. The plaintiffs include two Roanoke residents, a Rocky Mount woman and a Martinsville man. The attorney who filed on their behalf, Tony Russell of Gentry Locke Rakes & Moore, declined to comment on the cases.

C.B. Fleet has been the target of numerous lawsuits from across the country since 2007, including one filed by Russell on behalf of a Roanoke County resident that ended with a confidential settlement earlier this year. A company spokeswoman could not be reached for comment late Friday afternoon.

Fleet first began selling its over-the-counter laxatives in 1893. According to the lawsuits, in 1985, the company began advocating the use of its product in a higher dosage as a way to cleanse the bowels before surgical procedures.

The suits claim that the company knew a dosage higher than 45 milliliters taken within 24 hours could be fatal but engaged in a marketing campaign that promoted using double doses of its product for bowel preparation.

The suits further claim the company continued this despite concerns raised by the Food and Drug Administration, which refused to approve the new dosage. The company also ignored studies warning that products such as Phospho-soda weren't safe for routine clinical use, the suits say.

The FDA warned that the people most at risk of kidney failure when using oral sodium phosphate products such as Phospho-soda include the elderly and those who have suffered heart failure.

In 2007, more than 50 lawsuits in 20 states were filed by a group of allied law firms, including the one in Roanoke County. The company stood by its product, saying it had been shown to be safe and effective when used properly.

On Dec. 11, the FDA issued a safety alert stating that products such as Phospho-soda should be available by prescription only and not sold over the counter. That same day, C.B. Fleet announced a recall of all its Phospho-soda products.

According to the lawsuits, all four people took a double dose of over-the-counter Phospho-soda in preparation for colonoscopies at the recommendation of their doctors. The suits assert that both the doctors and the patients were unaware of the health risks and based their judgments on the information Fleet provided.

Rocky Mount resident Mary F. McBride and Roanoke resident Susan E. Tabor both took Phospho-soda in June 2007, and both suffered permanent kidney failure, the suits assert.

Roanoke resident Irvin W. Vest took the dose in January 2008, then had to be rushed to a hospital and placed on dialysis after his kidneys failed, the suit states. Martinsville resident Eldridge C. Pickett Jr. did so in April 2008, developed chronic kidney failure and will likely require a kidney transplant, court papers say.

The suits claim that none of the four had any history of kidney problems prior to taking Phospho-soda.

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