Lawsuit Claims Serious Injury and Death Due to Botox
By: Gerri L. Elder
A class action lawsuit has been filed against Allergan, the maker of the toxin-based injectable drug Botox, by people and families of people who have used the drug and either been injured by it or died as a result of its use. The lawsuit claims that Allergan failed to adequately warn users about the dangers associated with the use of Botox, according to a report by Consumer Affairs. The lawsuit was filed in California's Orange County Superior Court.
According to the complaint in the class action lawsuit, three people have died after being injected with Botox. One of the deaths was a 7-year-old girl who had cerebral palsy. She was injected with the drug in order to help control the spasticity in her limbs.
In February, the U.S. Food and Drug Administration said that Botox injections were being used at an alarming rate among children with limb spasticity due to cerebral palsy. The FDA noted at that time that the drugs Botox and Myobloc, a similar drug, are not approved for this use in the U.S. and that treatment with these two drugs has resulted in the deaths of children.
The FDA also said that it did not know of any deaths in adults resulting from the use of Botox. However, the class action lawsuit claims that a 69-year-old nurse from Texas who had received Botox injections for neck and shoulder pain died from the injections and a 71-year-old woman who received Botox injections at a mall clinic in Arizona for wrinkles around her mouth had trouble breathing and swallowing and died shortly afterward.
The U.S. Justice Department served Allergan with a subpoena in March seeking documents relating to the promotional practices for Botox. Allergan announced that it believed that the inquiry involves questions regarding the off-label promotion of Botox for the treatment of chronic headaches.
The deaths of the 7-year-old child and the two women resulted from uses of Botox that are not approved by the FDA.
The class action lawsuit also alleges that Botox injections also caused injury to at least a dozen other patients, leaving them with a wide range of disabilities. Some of these people were allegedly injured by the drug while having injections for approved uses, such as the smoothing of frown lines.
The drugs Botox and Myobloc are designed to block nerve impulses to certain muscles, causing a temporary paralysis or relaxation. Both drugs are approved to treat cervical dystonia, the uncontrolled muscle contractions of the neck and shoulder muscles. Botox is also approved by the FDA to treat wrinkles on the face between the eyebrows and also to control excessive perspiration of the underarms.
The active ingredient in Botox and Myobloc is a toxic derivative of botulism toxin Type A. It is one of the deadliest poisons known and can affect respiratory muscles and cause difficulty with swallowing. Both drugs carry warnings to doctors and consumers about this potentially deadly side effect.
In February, the FDA announced that it has recently discovered that the active ingredient in Botox - the deadly poison derivative - can spread from the site of the injection to other parts of the body. This means that children with cerebral palsy who receive Botox injections in their leg muscles could experience problems with breathing as the drug spreads through the body. It was previously believed that Botox only affected the local area to which it was injected.
The consumer group Public Citizen said in January that it has found 16 cases involving the use of Botox or Myobloc, dating from November 1997 through 2006, that resulted in death. The group filed a petition with the FDA requesting the agency's strictest black-box warning with regard to the potential for Botox side effects such as difficulty swallowing, pneumonia as a result of food getting into the lungs and, in rare instances, death from pneumonia.
The class action lawsuit filed in California alleges that several of the plaintiffs suffered injuries and side effects from the use of Botox that required hospitalization, and that these Botox patients now suffer from chronic and life-altering medical conditions and complications, including difficulty with swallowing.
Personal injury lawyers for the plaintiffs in the lawsuit say that thousands of people are being injected with Botox with no warnings as to the possibility of serious injuries or side effects. Allergan says that Botox is safe and that millions of people have received injections with no adverse side effects.