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Lawsuits filed against drug makers

By Mary Jo Melone
12/23/2009 © Health News Florida
Floridians Wanda Hubbard and Arthur Schlichting have a few things in common. They both had colonoscopies. Both suffer from kidney disease. And both have filed lawsuits against the makers of the drugs they took to cleanse their bowels before the tests.

Hubbard and Schlichting took products that contained sodium phosphate, a substance so powerful that some doctors call it a “killer of kidneys.” Hubbard took prescription OsmoPrep pills prior to her colonoscopy in January 2008. Schlichting took the over-the-counter liquid Fleet Phospho-soda in May 2007. Their lawyer, Jeffrey De Carlo of Miami, argues that the drugs caused their kidney damage.

Hubbard, a 63-year-old retired court clerk from Seminole, suffered kidney failure. She is on dialysis and needs a kidney transplant. She has been forced to move back home to Tennessee so her daughter can take care of her. She declined to discuss her case.

Schlichting, 80, a retired airline pilot from Punta Gorda, doesn’t need dialysis -- yet. But he’s had to give up the pleasures of his active life, including sailing and camping. He couldn’t be reached for comment.

OsmoPrep now carries the most severe warning the FDA can issue -- about the possible link between sodium phosphate products and kidney damage. As a result of the FDA warning, its maker took Fleet Phospho-soda off the market. However, the FDA didn’t issue its warning until December 2008, long after both Hubbard and Schlichting had taken the drugs. Now the agency says people who use sodium phosphate preparations have a one in 1,000 chance of kidney damage.

Sodium phosphate is dangerous for a wide range of people, according to the FDA: people over 55; people who have impaired kidney function, bowel obstruction, colitis or congestive heart failure, are dehydrated or take diuretics, some heart medicines and possibly some anti-inflammatory drugs. The lawsuits list other risk factors as well, including people with hypertension, hypothyroidism, or diabetes.

That gives Hubbard and Schlichting plenty of company. The FDA has reported 20 cases of kidney failure associated with these medications, but De Carlo has filed 40 cases in Florida since January 2008 against the maker of Fleet Phospho-soda, C.B. Fleet Company, and now, another against Salix Pharmaceuticals, the maker of OsmoPrep.

Lawsuits over kidney failure associated with these drugs are a cottage industry. According to court records, 120 suits nationwide against Fleet alone have been resolved. De Carlo declined to say how many of his cases have been settled.

Hubbard’s suit against Salix, filed early this month in Pinellas County, charges that the company knew that OsmoPrep could cause kidney damage even before 2008, but did nothing about it. Today, the company touts OsmoPrep as a “reliable, tolerable” product, even as its website carries the FDA warning. Charles Hurd, a lawyer for Salix, said the company was “sympathetic to Mrs. Hubbard’s medical problems,” but would fight the allegations in court.

Schlichting’s suit against Fleet Phospho-soda was filed in September in Charlotte County. The product is well known. Single doses have long been used as a safe laxative. Fleet allegedly recommended a double dose of the product for bowel cleansing without FDA approval, beginning in 1992, when colonoscopies became a common procedure. “They knew they could capitalize on it,” De Carlo said.

Later, according to Schlichting’s suit, the FDA warned that the dose used for colonoscopy was not proven to be safe. Dr. Glen Markowitz, a pathologist from Columbia-Presbyterian Hospital in New York, contacted the company in 2003 after he began seeing cases of kidney failure.

Fleet allegedly said one thing about the drug in the United States and another overseas. Australian authorities sought a warning in 1997 after a few renal failures and one death, De Carlo said. But in the U.S., the company was silent, “to avoid a reduction in sales of the product and a reduction of its profits,” according to the suit. The product is still sold overseas, the lawsuit said.

Fleet has denied all wrongdoing. In its reply to Schlichting’s suit, the company said his kidney damage was the result of “operations of nature or idiosyncratic or allergic reactions over which Fleet had no control.”

Publix, where Schlichting bought the product, was also named in the suit and did not return a call for comment.