Lack of Spanish-language Warning Results in Tragedy for Modesto Family

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In 1994, Jorge Ramirez was 8 years old. Blind, quadriplegic and severely mentally impaired, he required 24-hour care. His large, loving family provided that care in a small white stucco house in the outskirts of Modesto, an agricultural town in the San Joaquin Valley. The street that Jorge's family lived on was not marked on a map, because it was in an unincorporated area. There were few sidewalks, and the rutted and unpaved streets were, at intervals, home to abandoned cars and piles of old mattresses and battered furniture.

The residents of this neighborhood were mainly poor Latinos who worked as agricultural laborers or in the low-paying service sector. The area was neglected by the City Council and lacked many municipal services. Yet the Ramirez house, like many on the street, was a haven, with a green lawn lined with red and yellow rose bushes.

Sin Aviso (Nor Warning)

It was a haven inside, too, for young Jorge. In 1986, when he was four months old and ill with the flu, his mother Rosa gave him St. Joseph Aspirin for Children. Rosa, who spoke no English, had seen ads in Spanish for the aspirin and as a religious woman was attracted and comforted by the name "St. Joseph's." But she was unable to read the English language label that carried a warning for babies and children with the flu. Shortly after taking the medicine, Jorge had a seizure. He was diagnosed with Reye's syndrome, a potentially fatal neurological disorder first linked to aspirin in young children by a 1981 series of studies by the federal Centers for Disease Control.

Plough, the multinational drug corporation that produced St. Joseph Aspirin for Children, sold and advertised its product aggressively in areas with large Spanish-speaking populations. Its invocation of the saint's name had a familiar appeal to the largely Catholic population.

However, Plough printed solely in English the crucial warning on the container: "Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin." The warning had been mandated to be on every aspirin bottle since 1986.

Effects of Reyes Syndrome

Eight years after being given the aspirin, young Jorge was still confined to a crib when alone in a room. Blind, and unable to use his limbs, a family member needed to help him dress, eat and wash.

"Jorge really can't do anything by himself," his mother lamented in Spanish, holding the smiling, wriggling 8-year-old in her lap. "He is blind. He can't walk. He cannot really function at all.

"It's hard for me because I work at MacDonald's six hours a day, and my husband cannot work because he has to spend most of his time taking care of Jorge."

Plough Resists Warning Labels

Other non-English speaking parents who were targeted by Plough's Spanish-language advertisements for baby aspirin were also unaware of the potentially devastating side effects of giving the medicine to their children under certain conditions.

In the 1980s, when several studies showed an association between aspirin and the onset of the Reye's syndrome in children and teenagers, health advocates called on the federal government to require this information on warning labels on aspirin. Plough was one of the companies that lobbied against the requirement. In December 1985, the Food and Drug Administration (FDA) requested that aspirin manufacturers voluntarily place a label on aspirin products warning consumers of the possible association between aspirin and Reye's syndrome. The warning became mandatory in 1986.

Preventable Deaths

Dr. Sidney Wolfe, Director of Public Citizen's Health Research Group in Washington, D.C. decried the delay in labeling due to pressure from the pharmaceutical giants. "Hundreds of American children whose parents can read English are dead and hundreds more are severely brain-damaged because of aspirin-caused Reye's syndrome. They would be healthy today if warning labels had started in 1982, instead of 1986. But for Spanish-only parents like the Ramirez family, the slaughter may still be continuing," Dr. Wolfe said.

In a desperate attempt to seek help in Jorge's demanding care, his family brought a lawsuit against the pharmaceutical corporation, seeking damages for the harm its drug had done to Jorge. His family needed money to pay for the continuing medical and home care that Jorge required, demands that would increase as he grew older.

Lawyers for Plough asked the court to categorically exempt drug manufacturers from any liability from failure to issue warning labels in any language other than English. It would, the company argued, be "unduly burdensome" to hold the company potentially liable for failing to warn consumers of dangerous side effects in a language other than English, even if the product is targeted for a non-English speaking market.

A Stanislaus County Superior Court judge agreed with the company and declared that Plough had no duty to warn consumers in Spanish; the Court of Appeal reversed that ruling.

High Stakes

When the case, Ramirez v. Plough, came to the California Supreme Court, the stakes were very high. Esteban Lizardo, director of the Languages Rights Project of MALDEF said, "If the California Supreme Court reverses the appellate court's ruling, it will have relegated the many Spanish-speaking citizens of this state to second class status by denying them the protection against dangerous products that all people have the right to receive."

In 1993, the California Supreme Court sided with the pharmaceutical company and declared that drug manufacturers have no obligation to print warnings in any language other than English.

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