Botox Use Lawsuit History

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.

About Soloist

Single woman who was very physically active, outgoing, healthy person with lots of friends and interests prior to receiving injections. Within 3 days of the my injections of Dysport, I started having trouble breathing; ended up in the ER. Stress test, chest Xray done and were normal....after 24 hours of monitoring was okay and sent home. Five days later, I started having extreme head pressure, dry mouth, felt tingling down the sides of my cheeks, got chills/sweats, and felt horribly sick. Back to the ER…..more blood work/CT scan…and again, all normal. I had told the ER physicians about my injections and they really didn’t know what to do...a more test and sent home. A few days later……my symptoms continued to get worse. I developed EXTREME dry mouth, chest tightness, my throat started closing up, the nerves all over my body started shaking, eyes became blurred, started with extreme ear pressure, shoulders became tight…my forearms and shins became weak. My heart would start racing so fast and so hard I thought it was going to pop out of my chest. I had incontinence…I also had weakening in my colon and couldn’t go to the bathroom. All of these seemed to move around my body. When my neck would tighten…..my arms/legs would be fine. When my legs/arms would become weak…my neck would be fine. None of what was happening to me made any sense, although most of my symptoms correlated with the warnings on the Dysport website and label, neither of which I knew about prior to receiving the injections. My body became very sensitive to medications...and after trying several as prescribed.....they only make the symptoms worse. My headache pain/pressure then became so completely intolerable….I went again to the ER and was admitted for 2 days. I had an MRI in the hospital….and again nothing structurally was found wrong. It became difficult to talk as my jaw would become tight….and had a hard time eating as I wasn’t producing any saliva. I had already lost 12 pounds in 3 weeks. I could only manage to drink liquids to maintain what little strength that I had. A few days later……I became EXTREMELY sensitive to light, sound, and movement. I couldn’t go outside as the street noise would cause nerve reactions. I could only sit in a dark room for the same reason. I couldn’t watch TV or be on the computer because the light would bother my eyes. I obviously couldn’t drive……and couldn’t even sit in a car without staring at the floor as the movement of objects whizzing by would cause the nerve reactions. Nerve sensations would shoot down the back of my neck and cause my arm and chest muscles to contract and become stiff. I was homebound except for my trips to the doctors……which I scheduled one per day. Each minute felt like and hour. I chad no idea if I was going to live or die. My internist was just monitoring me. Taking notes, watching what was happening…..checking my vitals……and put me on a heart monitor for a month. By this time I couldn’t take care of myself…..nor could I be alone. The symptoms would vary in intensity. The waves would be so bad that I needed someone with me to help me through them. A friend moved in with me to help me through the worst of it. I of course had to take leave from work around Week 3...and didn’t return until Week 16. I eventually had to leave my home and move in temporarily with family. From an alternative treatment standpoint……I could not try anti-toxin programs as my body was in such a weakened state that any other stressors would not be tolerable. Acupuncture, massage....only made things worse. Blood tests were taken to measure my nutritional levels of vitamins, etc in my system, and was placed on a nutritional supplement program to help my body heal. The symptoms became less intense and less frequent over time through months 4-8 post-injection. I did not have a day where I was symptom-free……but I learned how to live with them enough to be able to get through the days. I would have setbacks and waves of severe symptoms on occasion, but the waves would not last as long as they did in the beginning. At 8 months post injection……symptoms would come and go....not really following any pattern or reasons for doing so. I was still having head pressure, ear pressure, ears ringing, dizziness, tingling in my cheeks, and muscle weakness. I couldn’t exercise yet due to the muscle weakness. Was still having occasional heart “racing” and nerve shakes. Some days were worse than others. But.....by one year post-injection...I thought I was really through the worst of it. By June/July 2011....I went two months of being symptom-free....and I thought I was in the clear. I was starting to run again....starting to feel fairly normal again. But unfortunately...the nightmare was not over. At 17+ months post-injection.....the symptoms begain to return. They started all over like they did in the beginning....starting gradually with head sensations, labored breathing, tingling in the arms and legs. I would feel a little "something" more with each passing week....and within 30 days of the first feeling of the return of the symptoms....I was full-blown symptomatic again....this time even WORSE than in the beginning. I had to leave work, again, and had to move in with family, again.,,,,.I became so weak....I had to be hospitalized, again. More MRIs, blood work, tests and more tests. There was nothing "else" found that can explain these symptoms. I was on complete medical leave for 4 months....and then part time for 8 months. While I have managed to return to work, I have not been able to resume any other part of my life. I have a caretaker with me that assists with all other daily tasks. Long term symptoms have been muscle severe cramping and tightness, convulsions, seizures, unrelenting naseau, tightness in my brain, can’t think straight, parathesia, extreme extreme extreme anxiety, shooting nerve sensations down my spine and all over my body, extreme weakness, pain in my eyes, dry eyes, heart racing, tremors, joint pain, numbness in hands, feet, legs, headaches, among other things....unrelenting fatigue. I no longer lead a normal life and I do wonder if I will ever be well again.

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