The suit, in the Los Angeles Superior Court, pits Irena Medavoy against Arnold Klein, 59, a dermatologist who has earned the sobriquet Dr Botox thanks to a client list that includes celebrities such as Cher, Dolly Parton and Carrie Fisher.
At stake, however, is more than just the £50m in damages that Medavoy is demanding from Klein for the migraines she suffered after Botox treatment which, she says, deprived her husband Mike, 63, of her “companionship, intimacy and services”.
Victory for the Russian-born actress and former model in the case — believed to be the first of its kind against the drug — could also deal a blow to the £1 billion a year industry that has grown up around the toxic jab since it was authorised for cosmetic use two years ago.
More than half a million Americans regularly pay £300 a session to have a distilled form of the botulism food-poison toxin injected into their nerves to block the release of acetylcholine, a chemical that activates muscles.
Even before talk of Medavoy’s trial, however, there were signs of a backlash against the treatment which can create a frozen look that lasts up to three months. Martin Scorsese, the film director, has complained that it erases “character lines” from his actors.
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Encouraged by a website set up by Medavoy to harvest complaints, patients’ groups are suggesting that there may be hitherto unknown side effects associated with Botox, ranging from impaired swallowing to “burning” leg muscles.
The US Food and Drug Administration has admonished Allergan, the pharmaceutical company which makes the drug, for not fully informing patients that up to 44% of users suffer some kind of adverse reaction.
The Los Angeles company has dismissed such claims and points out that only one person has died after taking Botox. It says that most side effects are mild. It has agreed, however, to ask doctors to brief their patients in more detail.
In her suit, Medavoy accuses Klein of injecting her with too high a dose of Botox and failing to warn her of the risks. After treatment in March 2002, involving 86 shots to the temples, the base of her skull and between her brows, she says she suffered ailments including “severe and unrelenting migraines”, shortness of breath and fatigue, which undermined her relationship with her husband and her work with a medical charity. After tests she was advised that her problems were connected to the Botox.
The actress, who began her career 20 years ago in the soap opera Dallas, says her motivation for bringing the case is not financial — her husband produced hit films such as Platoon and Sleepless in Seattle — but rather to warn people about the “dangers” of Botox.
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Allergan says the serum cannot leave the muscle and enter the bloodstream, but Medavoy’s doctor, Andrew Charles, a neurologist at the University of California Los Angeles, said he did not necessarily accept that. “Some toxins may move along the nerve into the brain or spinal cord. The potential consequences of such a spread are not known,” he said.
The case has also focused attention on Klein’s alleged links with the pharmaceutical industry, including receiving payments of £13,000 every three months from Allergan as a consultant while bound by his medical oath to offer unbiased advice. He insists the payments do not affect his judgment.
Charles Inlander, of a pressure group called the People’s Medical Society, said Botox was lucrative for doctors. “Once you start talking about side effects, you risk losing business,” he said.
Allergan dismisses Medavoy’s case as frivolous, but dermatologists are preparing alternative treatments for youth-obsessed clients. Inamed Corp, another American company, is taming a strain of botulism which it wants to sell under the name Dysport. Even old- fashioned make-up may return: on the horizon is a Japanese synthetic wrinkle-filler claimed to last longer than Botox.