1. References

With the popularity and proliferation of botulinum toxin injections, a new form of botulism has been acknowledged by public health agencies around the world. In the United States, the Centers for Disease Control include iatrogenic botulism as a situation from an "overdose" of cosmetic or therapeutic BoNT treatment.^[1] In Canada, the Health Canada public health organization also recognizes iatrogenic botulism. ^[2]Iatrogenic botulism refers to botulism induced by a medical treatment of a botulinum toxin injection.

The medical literature found on Google Scholar reflects a growing recognition of iatrogenic botulism. As of February 2019, the search term "iatrogenic botulism" yielded a result of 352 publications on the subject.^[3]

In April of 2018, a pharmaceutical manufacturer of botulinum toxin injectables amended their Prescribing Information Guide to include a warning that their product could cause botulism.^[4] On page 38 of the 41 page document, the following paragraph conveys this information. Prior to this addition to the warning label, a pharmaceutical vice-president maintained that getting botulism was only "theoretic." The exact quote in the deposition video can be viewed at minute 6:10 of the Canadian documentary Worry Lines 16 x 9.^[5]

"Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body

away from the injection site and cause symptoms of a serious condition called botulism. The

symptoms of botulism include:

These symptoms can happen hours, days, to weeks after you receive an injection ....."

Other botulinum toxin manufacturers include similar disclaimers about their products possibly causing botulism; page 48 of a 49 page document provides a a botulism warning.^[6]

These recent disclaimers may be the result of several high-profile lawsuits accusing the manufacturers of producing products that allegedly caused iatrogenic botulism that resulted in permanent disabilities and even death. Lawsuits were brought by: Hollywood personality Irene Medavoy^[7] ; Jackson Wells age 3 ^[8] ; Joshua Drake age 7 ^[9]; and Sharla Helton, MD.^[10]

Among the dead: Sondra Bryant ^[11]; Douglas Ray ^[12] ;and two cerebral palsy patients Mandy Fortuna age 21 ^[13]; and Kristen Spears age 7 ^[14]. The only lawsuit to successful prevail - not be lost or settled out of court - was Sharla Helton's case brought in Oklahoma in 2010. Several pieces of evidence obtained during the discovery process became publicly available through the local TV station's website. ^[15] These include a one year 1991 monkey toxicity, strategic sales plans, a Confidential Special Analysis: Pediatric Fatal Outcomes, and marketing materials used to train pharmaceutical representatives.

With the black box warning labels disclosing the possibility of botulism from use of their products, the burden of informed consent shifts to the injector or physician, thus providing a legal shield to the manufacturers of botulinum toxin injectables.

References

• Lay Down the Law
• Lay Down the Law (Switches album)
• Lay Down Your Arms
• Lay Down Your Arms (Doron Levinson song)
• Lay Down Your Arms! (novel)
• Lay Down Your Guns
• Lay Down Your Weapons
• Lay Down Your Whip
• Lay-duce
• Lay-e Ahmad
• Laye Bid
• Lay-e Bid Bala
• Lay-e Bid-e Pa'in
• Lay-e Bid-e Pain
• Lay-e Bidun
• Lay Ecclesial Ministry
• Lay-e Farashahi
• La Yegros
• La Yeguada (corregimiento)
• Layeh
• La-ye Hana
• Layekan
• Lay-e Kareh
• Lay-e Khorrami
• La-ye Khorrami