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Oklahoma Jury Awards Botox User $15 Million

Posted by Jane Akre
Thursday, May 13, 2010 4:29 PM EST
Category: Major Medical
Tags: Botox, Allergan, Dermatology, Women's Health

Allergan Was Negligent Jury Ruled


IMAGE SOURCE: The Oklahoman Web site/ image of Dr. Sharla Helton in 2006

A jury on Tuesday, May 11, awarded $15 million to an Oklahoma City doctor who said Botox Cosmetic ruined her life and career.

The jury found 9-2 that Dr. Sharla Helton suffered actual damages and that Allergan, the maker of Botox, was negligent.

At least nine jurors must agree in civil cases. The jury did not award any punitive damages.

“Hopefully, now people will wake up to the real dangers,” said Helton, 48.

Allergan plans an appeal. “Botox does not cause botulism” said a company spokeswoman Caroline Van Hove to The Oklahoman.

In the Hester case, her attorney Ray Chester of Austin, Texas argued that many people have been hurt by Botox. Dr. Hester claimed that after receiving injections of 50 units of Botox Cosmetic on July 14, 2006, that she experienced many side effects including those from botulism.

Botox Cosmetic is made from botulinum toxin.

Dr. Hester claimed that pain and weakness forced her to sell her medical practice and resign as medical director of Lakeside Women’s Hospital in Oklahoma City.

An attorney for Allegan said the drug does not cause botulism.

Whether consumers receive fair warning about that possibility was the key to the trial.

In 2006, the label did not include a botulism warning though it did include a warning about the possibility of death.

One juror told The Oklahoman that the label in 2006 did not have adequate information about side effects. Jurors compared the 2009 label to the 2006 label to come to that conclusion. Botox Cosmetic was approved by the Food and Drug Administration in 1989. Millions have used it since then.

Side effects on the warning label today say that botulinum toxin may affect areas outside of the injection site and include serious symptoms such as: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing, among other side effects.

Off-Label Use

Botox has also been used off-label, or outside of the uses for which it’s been approved, to treat the spasms of cerebral palsy.

In a March trial, A California jury found that Allergan was not responsible for the 2007 death of Kristen Spears, 7, who had a series of seven injections of therapeutic strength Botox, a stronger cousin to Botox Cosmetic.

The girl died of pneumonia and respiratory failure. Allergan argued that Kristen died from the natural progression of her disease.

In an aggressive move, Allergen announced it would file to recover the $460,000 in legal costs from Kristen’s mother, Dee Spears, a nurse who cares for disabled children.

Her attorney, Ray Chester, who also represented Dr. Hester said “I’ve been a lawyer for 25 years, and I’ve never seen anything more outrageous than a corporation pursuing this lady for $460,000.” #

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