Allergan was ordered by a federal court jury in Virginia to pay $212 million to a 67-year-old man who claimed he developed permanent brain damage after being injected with Botox to treat cramps and tremors in his hand in 2007. Douglas Ray was awarded $12 million in compensatory damages and $200 million in punitive damages, after convincing the jury Allergan failed to warn that injections could trigger an autoimmune reaction leading to brain damage.
For its part, Allergan denied a failure to warn or any connection between Botox and his illness. “The verdict reached today is inconsistent with Allergan’s past and current actions to properly warn physicians and patients about the potential risks of Botox,” a spokeswoman wrote Bloomberg News. "Every known and knowable risk associated with Botox treatment based on the scientific properties of the drug was in fact warned about.”
Ray, a Vietnam vet and retired AT&T engineer who owned a custom hat design business, but now requires 24-hour care, received Botox injections in 2007 for tremors and writer’s cramp in his right hand. “Botox can migrate outside the injected muscles and cause side effects including botulism and severe autoimmune reactions with resulting brain damage,” according to his lawsuit (read it here). The injections left him “frequently confused or disoriented” and unable to care for himself, he said.
His lawyer says Allergan was aware of this side effect, but failed to sufficiently warn doctors or patients to avoid losing sales. Last year, Botox sales reached $1.42 billion, or nearly a third of Allergan revenue. Meanwhile, the drugmaker maintains the $200 million in punitive damages will be capped at $350,000 under Virginia law. But Ray's attorney vows that if Allergan appeals the verdict, "we’ll attack the constitutionality of the cap."
Allergan has a checkered history when it comes to Botox marketing. Last year, an Oklahoma jury awarded $15 million in a negligent-damage verdict against Allergan in a lawsuit that was brought by Sharla Helton, a 48-year-old obstetrician and gynecologist, who suffered years of pain after getting Botox injections. Helton lost her job four years ago and blamed Botox for double vision, breathing difficulty and years of continual pains in her arms, hands and feet. A key issue was whether Allergan gave sufficient warning in the labeling about possible problems from Botox cosmetic use (read here).
Also last year, Allergan sought to recover $460,000 in legal costs from Dee Spears, who unsuccessfully sued the drugmaker over the death of her 7-year-old daughter, Kristen, after she was administered a series of therapeutic Botox shots. She sued for $60 million, accusing it of concealing info about the dangers of the drug, which was used to relax the girl’s clenched limbs; she suffered from cerebral palsy (look here).
To settle a probe by the US Department of Justice, Allergan last fall agreed to pay $$375 million and plead guilty to one misdemeanor count of misbranding in connection with off-label marketing of its Botox med for various unapproved uses - headache, pain, spasticity and juvenile cerebral palsy - between 2000 and 2005. Another $225 million was paid to in fines to cover civil claims asserted by the DOJ under the False Claims Act (back story).
photo thx to walknboston on flickr
5 Comments
ugh, I can NOT believe I have to defend Allergan (blech). They are pigs when it comes to off-label marketing but the focal dystonias like writer's cramp, plantar fascitis, etc. weren't their focus (heck, I'm not sure CD is much of a focus for them and they're approved for it) - the focus of their off-label use was more on HAs and spasticity (related to brain injury, CP, MS).
All drugs have the catchall warnings re allergic reaction and, as a biologic for which the FDA requested additional immunogenicity data, I find it hard to believe there weren't sufficient warnings about the possibility of a serious and severe allergic reaction. While it is known (I don't think that knowledge is hidden) that there can be some migration outside the muscle, the effects are usually proximal to the injection site (i.e., ptosis and visual accommodation are known potential AEs to use of BOTOX for crows feet, strabismus, bleph and, sometimes, glabellar lines) and I'm pretty sure they are listed in the PI.
Well put, Cranky, although I hope that Botox will not be approved for writers cramp, so that we can keep some of the bloviation on these boards to a tolerable minimum.
Strategic question: Allergan challenges based on the Virginia cap. Do they then try to negotiate a settlement with the plantiff or dig in their heels & risk the Virginia cap being declared unconstitutional, which would affect them & everyone else doing business in that state?
Has anyone heard of limb weakness after injection for cosmetic reasons in the face?
Perhaps the doctor injecting the Botox could experience weakness in the limbs after he realized he has accidentaslly injected the zygomatic branch of the facial nerve, causing paralysis of one half of the mouth.