Fleet Phospho-Soda Laxative Recall, Injuries & Lawsuits: Attorney Answers FAQs

C.B. Fleet's phospho-soda laxatives, oral sodium phosphate (OSP) products which were primarily used in preparation for a colonoscopy, were recalled in December 2008. Our legal expert answered frequently asked questions (FAQs) about the recall, the injuries which have been reported, the pending lawsuits, the status of the MDL and provided advice to anyone who may have been injured.

Attorney Dan Thornburgh

Dan Thornburgh, a Florida attorney whose practice represents those injured by dangerous and defective products, provided the following answers to frequently asked questions in a recent interview:

Question: When did C.B. Fleet recall its laxative products?

Answer: The U.S. Food & Drug Administration (FDA) issued its first warning about Fleet Phospho-soda laxatives in May 2006. It continued to increase the severity of its warnings until December 2008, when a black box warning was issued.

In response to that warning, C.B. Fleet Company issued a voluntary recall of its products. However, the company is now considering re-releasing the under-fire laxatives to market. If it does return the products to the U.S. market, it must repackage the laxatives – in accordance FDA regulation – to properly highlight the risk of kidney damage.

Question: What injuries have been reported after using Fleet's laxative products?

Answer: Fleet failed to warn consumers that Fleet EZ Prep, Fleet Accu-Prep and Fleet Oral Sodium Phosphate were dangerous, defective and causing plaintiffs to suffer serious adverse reactions such as kidney failure, kidney transplant, and in some cases, even death. It didn't provide adequate warning to inform patients and their healthcare providers about the risks associated with the products. All of these violations, breaches, incidents and conduct of the defendants caused plaintiffs to suffer these very severe injuries.

Question: What are injured victims alleging in lawsuits against Fleet?

Answer: Patients who have been injured by these products have generally brought lawsuits for negligence which allege that the manufacturers owed them a duty to do appropriate product testing and to warn them about the risks associated with the products, but that the manufacturer breached those duties and caused them damage.

They've also brought negligence per se claims – which means that there is a statute that provides a specific protection to a class of people to which the plaintiffs belong and, as a result of the company’s violation of the statute, they were harmed.

Plaintiffs have also brought product liability lawsuits against the manufacturers alleging that the companies manufactured a product that was defective in some form or the other causing them injury.

Question: What is the status of the multi-district litigation (MDL) and are any cases set for trial?

Answer: The MDL, which is currently consolidated in the United States District Court of the Northern District of Ohio, is in the very early stages of litigation. There haven't been any bellwether trials set, but we are in the discovery phase of the litigation and that's moving along smoothly.

An MDL controls the litigation so that you don't have numerous lawsuits throughout the country with different results or conflicting orders or decisions from judges or juries. It also helps control the costs for plaintiffs. Instead of each plaintiff having to conduct generic discovery or find their own experts to give opinions about whether or not the Fleet product could cause an injury, this is all done on an aggregate basis to help save costs and help save judicial resources and time.

Question: What advice would you give to somebody who's been injured due to a Fleet product?

Answer: If you took a Fleet product and you developed and adverse effect from it, such as acute renal failure, you should seek the medical treatment you need. However, you should also find an experienced Oral Sodium Phosphate injury lawyer who does this type of litigation in order to protect your rights. It's important to do so promptly so that the statute of limitations in their state doesn't expire.

The foregoing article has been prepared by an attorney who is a regular contributor to FreeAdvice, and is now undergoing review by the site's editorial staff.