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Off-Label Botox Death Brings 60 Million Court Case

Off-Label Botox Use Could Cost Allergan $60 Million

Botox manufacturer Allergan may lose a lot of money — up to $60 million, to be precise — and be forced to re-evalute its stance on the drug's safety if an Orange County court case goes against them. The company stands accused of indirectly causing the death of 7-year-old Kristen Spears, whose doctor had administered Botox injections as a means of easing leg spasms caused by cerebral palsy. While the story is tragic no matter how the jury decides, the larger discussion surrounding the case concerns the safety of off-label Botox use and what Allergan knows about it. To hear more about what Allergan's accused of doing, just keep reading.

Lawyers for Spears's family argue that Allergan is hiding risks associated with Botox, citing a previously confidential internal document as evidence. They say the company was aware that an injection of eight units per kilogram of body weight is the maximum safe ratio at which Botox can be administered, but its training sessions have routinely encouraged doctors to use 15 units per kilogram — which could endanger the health of off-label users who receive much larger doses than the minuscule amount used to smooth wrinkles. The company also allegedly tweaked a report on serious complications and deaths possibly associated with Botox, paring it from 207 cases to just 25.

For its part, Allergan argues that Kristen's fatal respiratory failure was due to her cerebral palsy, not to being treated with Botox. "Sadly," said its attorney Vaughn Crawford, "that is the natural progression of the disease in severely challenged children." Allergan has said that it has released little about the effects of off-label Botox use because it doesn't want to be seen as promoting the practice, but it remains to be seen whether that will help them in court. The jury's deliberations began yesterday and continue today.

Do you know anyone who's ever used Botox for something besides its express purpose? And do you think Allergan should be responsible for health complications and deaths that occur from off-label use?

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Ellenora Ellenora 5 years
Bella--I've heard the same thing too concerning palsies and Botox. Palsies are known for tremors or really, really tight or loose muscle tone. I have mainly spastic Cerebral Palsy along with a whole bunch of other disorders (Asthma, Epilepsy, Autism). Botox basically allows the muscle to relax so there's less spasming and it allows easier stretching (or so they say), but it's still more dangerous over stretching the muscle using traditional therapies to work out spasms and tight muscle tone, surgeries or castings. I was casted twice from the balls of my feet to my the bottom of my knees (no crutches) followed by orthotic braces on my legs. I have a list of exercises I do given by a physical therapist when I saw one when I'm in pain from C.P. I'm not going to go to my doctor and tell her, "I'm at my wits' end. Inject me with Botox in my hamstring and Achilles tendon" to relieve the sometimes excruciating and debilitating pain. It hurts to do those exercises when you're in that much pain and can barely crawl (much less walk), but it works a lot better than any pain pills I've tried. Regardless of what happens and what the whole case is (whether she died due to her previous respiratory problems or Botox), Allergan really needs to think about doing some rigorous testing Botox for those off-label uses. I think this is the second time or third time Allergan has gotten in trouble for Botox being used for off-label uses. I know there was the one case where two Epileptic children died from misplaced Botox before this one.
Ellenora Ellenora 5 years
Bella--I've heard the same thing too concerning palsies and Botox. Palsies are known for tremors or really, really tight or loose muscle tone. I have mainly spastic Cerebral Palsy along with a whole bunch of other disorders (Asthma, Epilepsy, Autism). Botox basically allows the muscle to relax so there's less spasming and it allows easier stretching (or so they say), but it's still more dangerous over stretching the muscle using traditional therapies to work out spasms and tight muscle tone, surgeries or castings. I was casted twice from the balls of my feet to my the bottom of my knees (no crutches) followed by orthotic braces on my legs. I have a list of exercises I do given by a physical therapist when I saw one when I'm in pain from C.P. I'm not going to go to my doctor and tell her, "I'm at my wits' end. Inject me with Botox in my hamstring and Achilles tendon" to relieve the sometimes excruciating and debilitating pain. It hurts to do those exercises when you're in that much pain and can barely crawl (much less walk), but it works a lot better than any pain pills I've tried.Regardless of what happens and what the whole case is (whether she died due to her previous respiratory problems or Botox), Allergan really needs to think about doing some rigorous testing Botox for those off-label uses. I think this is the second time or third time Allergan has gotten in trouble for Botox being used for off-label uses. I know there was the one case where two Epileptic children died from misplaced Botox before this one.
Merlin713 Merlin713 5 years
Eh... I don't like reporting on stories like this especially when a lawsuit is being discussed. It's easy to manipulate the facts [nonfacts] to get a snazzy headline. That being said, it's always your best bet to wait until the full case write up is available in order to get the full picture. Very sad case though. :-(
Merlin713 Merlin713 5 years
Eh... I don't like reporting on stories like this especially when a lawsuit is being discussed. It's easy to manipulate the facts [nonfacts] to get a snazzy headline. That being said, it's always your best bet to wait until the full case write up is available in order to get the full picture. Very sad case though. :-(
Beauty Beauty 5 years
The original story was a bit murky, but I tracked down a video news report. Apparently, the girl had respiratory problems beginning at birth, so that's being blamed for her death. I do know that many doctors have praised Botox for its ability to treat various palsies, so it'll be interesting to see how the lawsuit pans out.
Ellenora Ellenora 5 years
Death from Cerebral Palsy?! I don't think so. That's the most ridiculous and bullsh** statement I've ever heard. It's incredibly difficult to die from Cerebral Palsy. It's sad that a company blames a neurological disorder that, while debilitating and traumatizing, is not known to be fatal. I have C.P. and while I've never used Botox for a treatment option, I'd be suing the doctor over the company. It's up to the doctor to decide the dosage.
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