Suits allege laxative caused kidney failure

StarTribune.com

Suits allege laxative caused kidney failure

At least 13 Minnesotans are among those suing C.B. Fleet alleging they suffered permanent damage from a colonoscopy prep.

By Chao Xiong and Mary Lynn Smith, Star Tribune staff writers
Last update: August 15, 2007 – 11:59 PM

Kathy Sevcik's colonoscopy was supposed to be routine, "no big deal."

But the 55-year-old Minnetonka woman said the over-the-counter laxative she used to prep for the procedure made her light-headed, caused her to vomit and left her with one thought: "I'm going to die."

Now she is among dozens of people across the country and 13 Minnesotans who have filed lawsuits against the manufacturer, C.B. Fleet Holding Co. Inc., alleging irreparable damage to their kidneys -- and their lives.

"I trusted the [doctor's] recommendation" to ingest Fleet Phospho-soda, Sevcik said Wednesday. "I would like to have known [kidney damage] was a potential."

The laxative, used since the late 1800s, allegedly has caused permanent kidney damage in patients across the country, including Minnesotans who filed nine lawsuits in federal court this week against C.B. Fleet, said their attorneys.

The company began promoting Phospho-soda as a bowel cleanser in the 1990s as more people became aware of colon cancer risks and underwent colonoscopies. But it doubled the historically small, safe dosage to two 45-milliliter doses 10 hours apart, leading to kidney failure and "kidney death" in many patients who took the laxative at their doctors' urging, said Stephen Foley, a Minneapolis attorney representing local patients who have sued the Lynchburg, Va., company.

In a 2001 letter to the Food and Drug Administration, C.B. Fleet representatives said Phospho-soda is "safe and effective for use as laxatives and for bowel cleansing when used as directed." Company attorneys could not be reached for comment Wednesday.

Although there are prescription and over-the-counter alternatives, Phospho- soda, the product at question in suits in at least 20 states, is popular because it requires patients to drink far less water -- a few glasses vs. a gallon -- than many other products, Foley said.

A coalition of six law firms across the country is pursuing litigation against the company in state and federal court on behalf of clients they said have suffered through dialysis, waited on organ-donor lists and been forced to quit their jobs because of health problems. Other law firms independent of the effort have done the same.

Attorneys said the first suits surfaced about three years ago, about the time doctors began publishing papers connecting the dots between Phospho- soda and kidney failure. This year a Virginia law firm filed a $10 million suit against C.B. Fleet. Minnesota attorneys expect to file at least nine more suits.

'I threw up for months'

Sevcik initially attributed her reaction to Phospho-soda to her diabetes and directions not to eat or take insulin before her colonoscopy. "I threw up for months" and was in and out of the hospital for most of the summer, she said. She suffered kidney failure and underwent dialysis for two weeks.

"I had absolutely no energy," said Sevcik, whose colonoscopy showed no problems. "No one knew what was wrong with me."

Last year, she received a transplanted kidney from her brother and returned to work full time as an accountant for the first time in 10 months.

"Fleet ... has refused to recognize that there's a hazard," said Foley, the attorney. "It's profit over people."

In a 2006 letter to the FDA, company representatives said they issued a "Dear Doctor" letter to physicians about health concerns and made label changes; the letter did not specify what those changes were. Attorneys pursuing litigation against C.B. Fleet said the company removed "bowel cleanser" from its packaging but continues to recommend the double dosage.

The laxative is not aggressively regulated by the FDA because it's sold over the counter, Foley said, adding that the company did nothing illegal in recommending a double dosage.

FDA spokeswoman Susan Cruzan said no one at the administration was available for comment Wednesday. She referred to a May 2006 alert issued by the FDA warning that sodium phosphates taken orally for bowel cleansing had been linked to kidney failure. The alert, which cautioned doctors to carefully choose bowel cleansers, named Phospho-soda and Visicol tablets as examples of such medications, but did not point to a particular product as the main cause of 21 documented cases of kidney failure.

The alert warns that the bowel cleansers involve a large load of phosphate (a salt of phosphoric acid) and large shifts in fluid. In layman's terms, Foley said, the drugs cause patients to become dehydrated and to excrete calcium, which accumulates in and damages the kidneys.

New York City attorney Bernard Daskal, whose firm has handled 19 cases against C.B. Fleet since 2004, said the FDA issued a similar statement in 2001, which prompted the Canadian government to do the same a year later.

Foley said the company has been aware of the side effects for years but failed to rectify the problem and aggressively pushed Phospho-soda. "I think it's been nothing short of malicious," he said.

A 'flagship product'

Spectrum Science Communications says on its website that it worked for C.B. Fleet promoting its "flagship product" in a campaign that included the Colon Cancer Alliance as a corporate partner. It got gastroenterologists and colorectal surgeons to speak with the media about Phospho-soda and created EneMan, "a superhero in the fight against colon cancer." Rosie O'Donnell featured EneMan in a song on her TV show, and Jay Leno mentioned him on "The Tonight Show," the communications company said on its website.

In nearly identical suits filed this week by Foley's firm, Minnesota plaintiffs alleged that C.B. Fleet continued to market its product although the company "knew or should have known" about health risks "which many users would be unable to remedy by any means," did not include warnings about possible kidney damage and other side effects and was negligent in manufacturing, selling and testing its product.

For reasons that are still unclear, attorneys said that white women over 60 are most vulnerable. They also note that some patients have taken the product with no long-term damage. Daskal said some of his clients from New York and New Jersey have osteoporosis but can't undergo certain treatments for the bone disease because their kidneys can't take the calcium load.

Kidney failure can lead to a host of other health problems, he said, including anemia and coronary artery disease.

Attorneys said they have no plans to pursue a class-action suit because their clients' health problems, although mostly similar and all stemming from kidney failure, are specific to each individual. Foley said class-action suits are easier to pursue when the damage to all clients is identical.

As for Sevcik, she will take anti-rejection drugs four times a day, every day, for the rest of her life. She is also at higher risk for skin cancer because of the drugs she takes, she said.

"Almost without exception, these clients' lives have been irrevocably changed for the worst," Foley said.

"These are ordinary people who were vibrant, active people who are taxed by ordinary chores. Going to the grocery store can tire them out and put an end to their day."

cxiong@startribune.com • 612-673-4391 mlsmith@startribune.com 612-673-4788

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