A widely used rubella vaccine gives one in 20 women painful, long-term joint ailments and one in 500 are permanently disabled, researchers and attorneys contend.
Among the women is 38-year-old Kay Ann Fox of Rose Lake, whose lawsuit against the maker of Meruvax II is the lead case of about a dozen nationwide.The U.S. Food and Drug Administration and the vaccine's maker, Pennsylvania-based drug giant Merck Sharp & Dohme, say there is no controversy. They contend Meruvax II is a safe German measles vaccine for women, and the National Centers for Disease Control promotes its use.
But two attorneys contend Merck has treated women "like garbage" by failing to warn them and their doctors of allegedly severe and lasting side effects from the vaccine.
Dr. Janet Chantler, a physician and virologist at a University of British Columbia laboratory where the side effects are being studied, calls Meruvax II a "totally inappropriate vaccine for adult women."
All agree that rubella vaccinations have nearly eradicated the tragic phenomenon of congenital rubella syndrome, which causes serious birth defects in babies born to mothers who contract German measles during pregnancy.
But the price for that eradication has been too many women like Fox, say her attorneys, Allen McDowell of Chicago and Mike Verbillis of Coeur d'Alene.
Fox, a nurse, got the Meruvax II shot five years ago at a Coeur d'Alene hospital after she started work. She has been sick and unable to drive a car or perform routine household chores since.
She has been diagnosed with symptoms of systemic lupus, immune complex disorder, chronic arthritis, and what she describes as "a permanent case of the flu."
She was healthy with no history of those illnesses when she got the shot. But within a few days, Fox said she had broken out in a rash accompanied by painful and swollen joints. Those symptoms persist.
Fox said physicians she initially sought treatment from were told by Merck the reaction could not have come from the vaccine. But convinced the vaccine was the culprit, she sued Merck in 1985.
Two other women had similar reactions out of the 50 who were vaccinated at the hospital, according to court documents.
"I wouldn't even call it the tip of the iceberg," McDowell said. "There've got to be hundreds of women who've had serious adverse reactions to the vaccine and didn't know it at the time because their doctors didn't realize it was a reaction to the vaccine."
McDowell contends Merck's literature for doctors on Meruvax II does not indicate it can cause problems six to eight weeks after vaccination, and that the problems can be permanent.
"Physicians aren't even looking for it. They don't even associate reactions with the shot, because they are not aware of it," he said.
"Doctors would have been flooded with reaction reports, if Merck had told them what was going on," McDowell said. "They've treated adult women like garbage. That's what's got me angry."
Fox's suit was to have gone to a jury in October, but was postponed until next April pending an Idaho Supreme Court ruling on whether Merck should provide her with the vaccine's formula and manufacturing process.
In the literature, Merck provides physicians through its product insert and the Physicians' Desk Reference, long-term injuries from Meruvax II are described as "rare."
"I don't consider these kinds of serious injuries in one out of 20 women `rare,' particularly in light of their clinical trials on the vaccine," Verbillis said.
He and McDowell contend Merck has been aware of a greater frequency and severity of side effects since the vaccine was introduced, but has made no effort to warn physicians or patients, or to develop a safer product for women.
"The reality is, Merck never intended this shot for adult women," Verbillis said.
Tony Fiskett, senior director of corporate affairs for Merck in West Point, Pa., declined to answer specific questions about vaccine reactions and clinical testing because of the lawsuits.
However, Fiskett said, Merck is "absolutely confident in the integrity of the vaccine."
"We take the safety of all our products very seriously," he said, adding that any risk from the shot is far outweighed by the societal benefit of eliminating congenital rubella syndrome.
Merck is the largest drug maker in the United States and the largest vaccine maker in the world. It has been cited twice this decade by Fortune magazine as America's most-admired company.
Meruvax II is the only rubella vaccine now made or marketed in the U.S. It netted Merck $30 million last year, McDowell said.
Hospitals routinely give the shot to women while they are recuperating from childbirth, in accordance with Centers for Disease Control policy. Children usually get the shot in school, in combination with a mumps vaccine. Most states require rubella vaccination for marriage licenses.
The live virus vaccine, grown in cells from aborted human fetuses, was introduced in 1979, replacing a vaccine cultured in duck eggs.
Live virus vaccines are intended to stimulate the body's immune responses by giving the recipient a mild form of the disease. Having done its job, the virus is supposed to be killed off and eliminated from the body.
Hormonal changes at puberty, and again at menopause, apparently make women more susceptible to the phenomenon than men or children, Chantler said.