More on Allergan Botox Suits

Updated 3/2017 -- all links removed as many no longer active. and it was easier than checking each one.

A year ago the FDA required Allergan to add a black box warning Botox and a Risk Evaluation and Mitigation Strategy (REMS)  to it’s safety labels for all botulinum toxin products.  The agency took the action because of two main reasons. 

In February, I wrote about the lawsuit in Orange County, California by a mother who alleges that the Botox treatments used to decrease muscle spasms weakened her daughters respiratory muscles, therefore causing her death.

Kristen Spears’ mother has sued Allergan alleging that her daughter died from a fatal reaction to the Botox treatments Kristen received for treatment for cerebral palsy. In March, Orange County Registar ran this article by Colin Stewart:  Allergan wins Botox death trial.

Yesterday Katherine Hobson, WSJ Blog, wrote an article:  Allergan Now Batting .500 in Botox Lawsuits

Yesterday an Oklahoma jury awarded $15 million to a woman who claimed she experienced pain and other problems after receiving the shots, reports the Orange County Register. (The O.C. is Allergan’s home base.) Though the jury ruled for Allergan on a product liability claim, it found the company was negligent in its off-label promotion of the drug, plaintiff’s attorney Ray Chester tells the Health Blog.

The Orange County Register article by Colin Stewart:  Jury blames Botox

An Oklahoma jury Tuesday reached a $15 million negligent-damage verdict against the maker of Botox in the case of a 47-year-old woman who suffered years of pain after getting the wrinkle-smoothing injections.

The suit was filed against Irvine-based Allergan by Dr. Sharla Helton, an obstetrician and gynecologist in Oklahoma who fell ill and eventually lost her job after getting the injections in 2006.

She blamed Botox for double vision, breathing difficulty and years of continual pains in her arms, hands and feet.

The article states “wrinkle-smoothing injections” were done, doesn’t specifically tell us why Dr Helton had Botox injections, but leaves us to assume it was facial expression lines.  Botox can be used safely, but should be done by a trained physician.  I would not recommend the DIY trend.

Related posts:
Excess Sweating  (April 20, 2009)
BOTOX -- Black Box Warning (May 7, 2009)
Neurotoxins: Dysport and Botox (January 6, 2010)
Black Market Botox  (January 27, 2010)
Botox Gets Bad Press (February 10, 2010)
Botox for Upper Extremity Spasticity 9March 17, 2010)

$250,000 for Loss of Consortium?

Updated 3/2017 -- all links (except to my own posts) removed as many no longer active. and it was easier than checking each one.

Why should the husband of  a woman who was disfigured by her facelift get $250,000 for pain and suffering?  Actually, his is for “loss of consortium.”

President Barak Obama is scheduled to sign the new healthcare bill into law today.  No tort reform was included.

According to the Georgia Supreme Court ruling

In January 2006, Harvey P. Cole, M.D., of Atlanta Oculoplastic Surgery, d/b/a Oculus, performed CO2 laser resurfacing and a full facelift on appellee Betty Nestlehutt.  In the weeks after the surgery, complications arose, resulting in Nestlehutt’s permanent disfigurement. Nestlehutt, along with her husband, sued Oculus for medical malpractice. The case proceeded to trial, ending in a mistrial. On retrial, the jury returned a verdict of $1,265,000, comprised of $115,000 for past and future medical expenses; $900,000 in noneconomic damages for Ms. Nestlehutt’s pain and suffering; and $250,000 for Mr.
Nestlehutt’s loss of consortium.

The Georgia Supreme Court ruled the 2005 Tort Reform Act was unconstitutional and that the state legislature may not limit the amount of money that juries award to victims of medical malpractice.   So the above amounts stand rather than being reduced to $115,000 for medical expenses and $350,000 for noneconomic damages.

The 2005 Tort Reform Act was part of a legislative package that capped jury awards at $350,000 for the “noneconomic damages” of malpractice victims.  The Georgia Supreme Court has ruled that the cap improperly removes a jury’s fundamental role to determine the damages in a civil case.

Chief Justice Carol W. Hunstein wrote in the decision,“The very existence of the caps, in any amount, is violative of the right to trial by jury.”

The current healthcare bill to be signed into law today by President Obama fails to address tort reform.

Botox Gets Bad Press

Updated 3/2017-- all links (except to my own posts) removed as many no longer active. and it was easier than checking each one.

BOTOX has been getting a lot of bad press recently. First, the potential use of black market Botox in terroristic activity. Now it is the focus of a lawsuit in Orange County, California by a mother who alleges that the Botox treatments used to decrease muscle spasms weakened her daughters respiratory muscles, therefore causing her death.

Kristen Spears’ mother has sued Allergan alleging that her daughter died from a fatal reaction to the Botox treatments Kristen received for treatment for cerebral palsy. The trial began two weeks ago. I have looked for updates, but found none.  [update below]

BOTOX is most commonly known for it’s cosmetic uses in wrinkle reduction, but is approved by the FDA for treatment of cervical dystonia, strabismus, blepharospasm, primary axillary hyperhidrosis, and glabellar wrinkles. It is also used "off label" for a variety of more prevalent conditions that include migraine headache, chronic low back pain, stroke, traumatic brain injury, cerebral palsy, achalasia, and various dystonias.

The treatments in cerebral palsy are used to decrease muscle spasms. A multidisciplinary panel systematically reviewed relevant literature from 1966 to July 2008 and published their recommendations in the Journal Neurology:

For localized/segmental spasticity, botulinum toxin type A is established as an effective treatment to reduce spasticity in the upper and lower extremities. There is conflicting evidence regarding functional improvement. Botulinum toxin type A was found to be generally safe in children with cerebral palsy; however, the Food and Drug Administration is presently investigating isolated cases of generalized weakness resulting in poor outcomes.

Recommendations: For localized/segmental spasticity that warrants treatment, botulinum toxin type A should be offered as an effective and generally safe treatment (Level A).

Botox, manufactured by Allergan Inc., contains extremely minute quantities of Botulinum Toxin A, which causes temporary muscle paralysis. A Botox “black box” warning was ordered by the FDA in May 2009 due to reports that the effects of the toxin may spread from the area of injection to other areas of the body causing serious adverse problems. This label requirement is required on Botox and Botox Cosmetic (botulinum toxin type A); Myobloc (botulinum toxin type B); and a new FDA-approved product, Dysport (abobotulinumtoxinA).

When the botulinum toxin spreads beyond the area injected the toxin can cause symptoms similar to those of botulism. These symptoms include unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids

According to AboutLawSuits.com Allergan Inc. currently faces at least 15 Botox lawsuits that claim that the company hid the risks associated with the drug.

 

REFERENCES

LA Times

Practice Parameter: Pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review); NEUROLOGY 2010;74:336-343

 

***March 3, 2010 Update

Yesterday, Orange County Registar ran this article by Colin Stewart:  Allergan wins Botox death trial. 

By a 10-2 vote, jurors decided Tuesday that Botox-maker Allergan was not responsible for the death of a young cerebral palsy patient who died in 2007 after Botox injections.