Botox Lawsuit Settlement Reached in Wrongful Death Claim

Allergan Inc. has reportedly agreed to settle a Botox wrongful death lawsuit filed by the family of a nurse who died after being injected with large amounts of Botox to combat shoulder pain. 

Sondra Bryant, 70, of Texas, died in 2008 after being injected with 100 units of Botox, about five times as much as one receives during plastic surgery. Her children sued the drug maker, saying that their mother would have never allowed herself to be injected with the substance if she’d known about the potential risk of life-threatening problems from Botox side effects. According to a report by The Orange County Register, a settlement was reached in the case last week.

The agreement comes shortly after Allergan reached a Botox settlement to resolve a claim brought by the U.S. Department of Justice (DOJ) in connection with a whistleblower lawsuit. As part of that settlement, Allergan admitted to being guilty of illegally marketing Botox for pain treatment and agreed to pay $600 million in criminal fines and civil settlements.

Botox has never been approved by the FDA for the treatment of pain, and although doctors can prescribe a drug for any purpose they wish, it is illegal for drug manufacturers to attempt to market a medication for an unapproved use.

Small quantities of the bacteria associated with the development of botulism poisoning are contained in Botox, which is approved for both cosmetic use to reduce the appearance of wrinkles in the skin and to treat medical conditions such as strabismus (crossed eyes), hyperhidrosis (excess sweating), cervical dystonia (involuntary contractions of the neck muscles) and blepharospasms (involuntary blinking of the eye). However, it also commonly used off-label at high doses to treat stiff and jerky movements associated with cerebral palsy in children.

A number of problems with Botox have been reported among users, where the medication can spread from the area of the injection to other parts of the body. This can result in symptoms of botulism poisoning, such as paralysis, difficulty swallowing, respiratory distress and other issues. These Botox reactions have most commonly been seen among children with cerebral palsy, where the typical Botox dose is substantially larger.

The details of the Bryant Botox lawsuit settlement were not disclosed.

In May, a Botox lawsuit over botulism poisoning filed by Sharla Helton, an Oklahoma City doctor, resulted in a $15 million jury award. Helton alleged that she suffered botulism after receiving injections to combat wrinkles in 2006.

Helton’s victory came about three months after an Orange County jury ruled in favor of Allergan in a wrongful death Botox lawsuit brought by Dee Spears, whose daughter, Kristen Spears, died in November 2007 after receiving injections of Botox to treat her cerebral palsy. Allergan attorneys argued that Spears’ daughter died of complications due to cerebral palsy, not as a result of problems with Botox.

In February 2008, the FDA issued a warning about the risks associated with use of Botox to treat cerebral palsy, after receiving a number of adverse event reports involving sudden death, breathing problems and other potentially life-threatening injuries. A “black box” warning was added to the medication in August 2009, about the risk of botulism-like side effects, such as swallowing and breathing difficulties, that can occur if the injection spreads to other areas of the body.

More than a dozen people have filed Botox lawsuits against Allergan, alleging that the company illegally promoted the medication for non-approved uses and failed to adequately warn about the risk of these severe and potentially life-threatening Botox injuries.