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SALT LAKE CITY — Carlos Chavez can't eat and drink normally due to the hole in his face.
Instead of going down his throat, food and water goes up his nose into his eye, causing excruciating headaches. He has undergone six surgeries the past four years, including removal of the bone around his nose, part of his jaw and seven teeth.
Chavez, of Salt Lake County, contends in a federal lawsuit that he developed a massive fungus infection in his face from taking a drug called CellCept that his doctor prescribed for him. He is suing the maker of the drug, Roche Laboratories Inc., of Nutley, N.J., for at least $500,000 in medical expenses and lost wages and an unspecified amount for general damages.
According to the lawsuit, Chavez has a disfigured face and suffers severe headaches and neurological and emotional pain. He needs another surgery to place barriers between his nose and mouth to keep food and water from going to his eye.
His face was peeled back in order to clean the fungus from his bones.
–- from the suit
The U.S. Food and Drug Administration approved CellCept in 1995. Doctors typically prescribe it as an anti-rejection medication for heart, liver and kidney transplant patients. But the drug also has been used to treat skin conditions and lupus nephritis, a kidney disorder, though the FDA has not approved it for those purposes.
CellCept can weaken the body's immune system leading to viral infections, a brain infection called progressive multifocal leukoencephlopathy and fungul infections, according to Roche Laboratories' medication guide approved by the FDA.
A doctor prescribed the drug for Chavez in June 2007, and after he began taking it, he had swelling and pain in his face, according to the lawsuit.
"His face was peeled back in order to clean the fungus from his bones," the suit says. He received daily serum injections for four months after the surgeries.
The suit does not explain why he went see a doctor or why he was prescribed CellCept. Repeated calls to Chavez's attorney Austin Johnson were not returned.
The suit claims CellCept is "defective and unreasonably dangerous in the way that it was designed, in the way that it was manufactured and in the way its users were warned."
Roche Laboratories spokesman Chris Vancheri said the company does not comment on pending litigation.
"Roche takes any and all information about our products seriously, and our sympathies remain with Carlos Chavez over his disease," he said.
In a response to the lawsuit filed in federal court, attorneys for Roche say the FDA recognizes CellCept as safe, effective and properly labeled. They suggest Chavez injuries might have been caused by an "idiosyncratic reaction" without any negligence on the part of the company or defect in the drug.
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