The Oklahoma Court of Appeals has upheld a $15 million jury verdict in favor of a medical doctor in her case against Allergan Inc. The plaintiff, Sharla Helton, an obstetrician and gynecologist, suffered debilitating side effects after receiving an injection of Botox.
The court said that plaintiff met her burden of proof at trial to show that Botox caused her injuries. The appeals panel said that Dr. Helton provided adequate evidence to the jury to show that an injection of Allergan’s Botox product caused her to develop botulism poisoning.
The lawsuit alleges that Dr. Helton, an obstetrician and gynecologist, received Botox injections four times between 2004-2006 without any problems. Following an injection in July 2006, however, she started experiencing unusual side effects, such as joint and muscle pain, breathing problems and double vision, which eventually became so debilitating, she was forced to resign as medical director at an Oklahoma women’s hospital.
She was later diagnosed with botulism poisoning, according to court documents. Botulism is a serious illness, caused by a nerve toxic, Clostridium botulinum, which can enter the body through food, a cut in the skin, or from accidental overdose. It causes paralysis of the nerve.
Many people use Botox injections for cosmetic purposes to reduce wrinkles. The toxin prevents contraction of muscles beneath the skin and is also used for the temporary treatment of certain medical conditions such as eyelid spasms, severe underarm sweating (hyperhidrosis), as well as other conditions.
Dr. Helton sued Allergan in 2009 for negligence and product liability, stating that Botox’s product labels were inadequate. She also claimed that Allergan fraudulently encouraged physicians to use their Botox “off label” for purposes and doses not approved by the U.S. Food and Drug Administration (FDA).
The complaint included claims based both on product liability and negligence.
The appellate court’s decision upheld the verdict in its entirety, with no reduction.
The jury trial lasted just over two weeks, and returned a verdict in favor of Dr. Helton on the negligence claim, but found in favor of Allergan on the product liability claim.
On appeal, Allergan argued Dr. Helton failed to establish that Botox caused her injuries. The panel did not agree, pointing to the testimony of one of Helton’s treating physicians, Dr. Brent Beson, who testified that it was indeed the Botox injection did, in fact, cause Dr. Helton’s condition.
After the jury came back with the $15 million verdict, Allergan claimed the court erred by allowing Dr. Helton, as well as her anesthesiologist husband and other physicians to testify regarding their observations and opinions about the cause of her illness. Allergan claimed that none of them were qualified as expert witnesses in toxicology, nor had they ever treated a patient with botulism. The appeals court said those witnesses appropriately represented their relationship to Dr. Helton and based their testimony on their general knowledge of medicine rather than any expertise in treating botulism.
Another lawsuit involving Allergan in Virginia found in favor of the plaintiff as well, awarding $212 million to a man who suffered brain damage after receiving Botox injections. The victim in this lawsuit claims that he was unaware, due to inadequate warning labels, that Botox could cause autoimmune reactions and, potentially, brain damage.
After the victim received the Botox in has hand to treat tremors and cramps, the Botox traveled away from the injection site, causing severe side effects such as botulism and an autoimmune reaction. The victim claims that Allergan failed to warn physicians and patients of these risks, along with other symptoms he suffered such as frequent confusion and disorientation.
Botox sales exceeded $1.5 billion in 2010, and is Allergan’s best-selling drug. Initially, the FDA approved Botox to treat muscle stiffness in the fingers, hands, and arms, as well as spasms of the upper limbs. It also was recently approved to treat migraine headaches.
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