Botulinum toxin type A is the active component in BOTOX® and BOTOX® Cosmetic. BOTOX® was FDA approved in 1989 for medical therapeutic use. The FDA approved BOTOX® Cosmetic in 2002 for the treatment of wrinkles known as the glabellar lines. Since being FDA approved, BOTOX® has been used for more and more medical conditions. In spite of the tens of thousands reports of adverse events after botulinum toxin injections, BOTOX® use is growing. Below is a report of some the lawsuits that have been filed regarding Botox:
In 2002, there was a case brought against Allergan from a woman who claimed that after a BOTOX® treatment for a then off-label use for migraines she developed unbearable migraine, fatigue, neck weakness and difficulties breathing and swallowing for four months. She lost her case against Allergan, but the company admitted that the product insert stated that BOTOX® had unknown risks as an anti-wrinkle treatment in doses higher than 20 units and acknowledged that the drug could spread to other areas of the body.
Allergan’s clinical studies had shown a potential link to headaches, pain, flu-like symptoms and respiratory problems. In 2005 a case of a death after a treatment with a BOTOX® -lidocaine mixture was reported for a woman being injected for chronic neck and back pain. It was felt at the time that she had an anaphylactic reaction to the lidocaine.
In 2006 there was a report of 4 adults who developed botulism after cosmetic injections. However, the botulinum preparation used reportedly was an unlicensed, highly concentrated mixture, and the patients received doses much higher than what is typically given.
In 2008, 15 BOTOX® users and their relatives sued Allergan claiming that the company failed to warn of the drug’s dangers. There were four deaths which included two children and two adults involving off-label use of the drug. The children received very high doses for limb spasticity related to cerebral palsy. One adult died from complications from injections for neck and shoulder pain, and one died from treatment for excessive salivation. Of the remaining eleven plaintiffs, the complaints were for droopy eyelids, numbness, headaches and swallowing and breathing difficulties. Three in this group had been treated for cosmetic reasons.
Later in 2008, a Consumer group called Public Citizen reported linking 16 deaths to use of botulinum toxin between 1997 and 2006. They also reported finding 180 adverse effects reported. This lead the FDA to do a Safety Review of BOTOX®, BOTOX® Cosmetic ( both botulinum toxin type A) and Myobloc® (botulinum toxin type B). The conclusion of the FDA Safety Review was reported in April 2009. It stated that the manufactures of botulinum toxin products must add a boxed warning about the risk of adverse events that may occur when the effects of the toxin spread beyond the injection site.
The FDA had received reports of systemic adverse reactions suggestive of botulism that would occur if the toxin spread beyond the injection site, including respiratory compromise and death, after use of these products for both approved and unapproved uses. The deaths in children occurred when treating limb spasticity associated with cerebral palsy. The adult cases had been also treated for spasticity and cervical dystonia. However, the adult cases of death could not be attributed to botulinum toxin, claiming “pre-existing conditions”. There had been reports of symptoms after cosmetic use, but the FDA claimed there were no definitive serious adverse event had been found with on-label use of BOTOX® Cosmetic.
In February 2010, a lawsuit was filed by a woman in Virginia who claimed that after being treated for head tremors with BOTOX® in 2008 she suffered brain injuries, movement disorders and dementia. She stated that she developed autoimmune encephalitis movement disorder. She alleged that Allergan failed to warn consumers that a side effect of BOTOX® can cause serious autoimmune responses, brain injury and botulism. The FDA “black box” warning about potential spread beyond the site of injection had been added in 2009. Her case settled out of court in October 2011.
In March 2010, Allergan was found not liable in the death of a 7 year old who died after being treated with BOTOX® for limb spasms caused by severe cerebral palsy.
In May 2010, a physician in Oklahoma sued Allergan stating that she suffered botulism poisoning after using 50 units of BOTOX® to treat wrinkles. Allergan was found negligent because the 2006 product labeling did not have adequate information about side effects. Another point made in that trial was the fact that Allergan had known about potential botulism dangers but had denied the connection in promotional materials to doctors and patients. An independent study commissioned by Allergan in 2007 found 207 adverse events being due to the spread of the toxin, including this plaintiff’s case. It was reported that Allergan had the study revised to show only 26 adverse event cases, eliminating any incident that had a plausible explanation other than an effect from BOTOX®.
In September 2010, Allergan settled a BOTOX® wrongful death lawsuit on behalf of a woman who died in 2008 after receiving 100 units to treat pain in her shoulder. The family claimed that the patient was never informed about the potential side effects before she was injected.
In April 2011, Allergan was sued by a Virginia man who claimed he developed brain damage after being treated with BOTOX® in 2007 for cramps and tremors in his hand. He claimed that Allergan failed to warn him that injections could trigger an autoimmune reaction leading to brain damage. Allergan claimed that the injuries weren’t caused by BOTOX® but by a pre-existing genetic stroke condition. During the trial, it came to light that in 2007 Allergan had sent European regulators a letter that contained warnings about BOTOX®, but had failed to do so in the U.S. market.
In 2013 an abstract was published by Dr. Anna Hristova titled “Neurological complications to botulinum toxin A therapy” published by the International Congress on Bacteriology & Infectious Diseaese. She suggests that there is evidence that the toxin can spread and cause clinical illness. She postulates that there can be CNS damage resulting in autoimmune encephalitis and persistent fatigue and lack of endurance, peripheral nervous system damage resulting in an autoimmune reaction such as Guillaine-Barre and small fiber polyneuropathy, and autonomic nervous system damage such as heart arrhythmias. She makes her claim based on personal experience, personal observation and a review of the literature. She also acknowledged that currently there are unfortunately no tools or methods to prove the causality of death or damage due to botulinum toxin type A.
In September 2011, Allergan settled a case of a San Francisco woman who had cosmetic injections and claimed to have developed systemic problems including weakness and fatigue.
In May 2012, a Missouri man settled a $60.5 million lawsuit with Allergan. He claimed he was diagnosed with Guillain-Barre Syndrome after having BOTOX® injections for back pain in 2008. Guillian-Barre Syndrome is a paralyzing condition that can occur after a viral illness. Allergan denied any awareness of the condition being caused by BOTOX®.
In April 2014, a physician who injected a patient for TMJ and migraines as well as cosmetic enhancements was sued for failing to adequately inform her of known serious and debilitating side effects of BOTOX®. She was injected with 75 units of BOTOX®. It was reported that she developed an acute severe immune reaction to BOTOX®, and that reaction resulted in permanent devastating injury to her. She gradually became worse and died. Allergan was not a party to the lawsuit.
In November 2014, two parents sued Allergan after their 7 year old son developed life-altering damage after BOTOX® injections in 2010 for leg spasms secondary to cerebral palsy. It was claimed that the boy suffered an allergic reaction leading to development of seizures. Though BOTOX® is not approved by the FDA for pediatric spasticity, the parents argued that Allergan did not properly warn the public of potential dangers of using the product. The family was awarded $6.75 million.
A literature review of peer-reviewed articles from 1988 until 2008 published in the Journal of Cutaneous and Aesthetic Surgery by HM Omprakash and SC Rajendran found two classes of adverse events reported: transient benign events and potentially serious events. Transient benign events, associated with smaller doses used for cosmetic treatments, included hematoma, injection site pain, intractable headache, ptosis, diplopia and hyperactivity of the local antagonistic muscle. The serious events suggestive of botulism-like symptoms were dry and red eye, accommodation difficulty, dry mouth, gastrointestinal disturbances, dysphagia, hoarseness and breathing difficulties.