A Trial Over Botox In Children With Cerebral Palsy
4 CommentsBy Ed Silverman // February 1st, 2010 // 10:09 am
A woman is suing Allergan, which makes Botox, because she believes the injectable cosmetic med led to the death of her seven-year-old daughter. Why? Botox was used to treat muscle spasms resulting from cerebral palsy, and Dee Spears charges Allergan wrongfully promoted untested and off-label uses, misrepresented Botox safety record, and failed to adequately warn health care providers of all the known risks of the product, according to court documents.
At issue is the safety of the drug, especially in higher doses used to treat kids with cerebral palsy. Kristen Spears died in 2007 of respiratory failure and pneumonia, according to The Los Angeles Times, which adds that experts hired by her mom say Botox weakened muscles that controlled her breathing and swallowing, leading to respiratory failure and pneumonia.
This is believed to be the first Botox case alleging a fatal reaction to reach trial, and is one of several pending suits related to cosmetic and non-cosmetic uses, the paper continues. The trial comes less than a year after the FDA required a black box warning about potentially serious reactions and documents indicate Allergan knew of serious problems as Botox as early as 2005, the paper adds.
Meanwhile, you may recall, Allergan last October filed an unprecedent lawsuit, alleging the FDA ban on off-label marketing violates its First Amendment rights to free speech (see background). The suit was filed a month after the FDA told Allergan to include a Risk Evaluation & Mitigation Strategies program to discuss some off-label prescribing guidelines with doctors. But to comply, Allergan argues it must tells docs about the latest Botox data, even if some info involves off-label use - and that could prompt the government to file a lawsuit for off-label marketing.
Allergone
I can’t speak to the current suit, but this is a company I don’t trust. They’ve been warned over Latisse at least once, and they’re constantly pushing the envelope. There are also potential whistleblowers inside, so, if I were them, I would watch my step.
Christopher
Botox has been used to treat muscular imbalances related to cerebral palsy for years. A quick search found a study conducted in 1993 on 27 patients for whom surgery was the only alternative. (No major side effects occurred.)
I saw a presentation from Allergan that described them pursuing multiple indications in medical as well as cosmetic use. I can’t recall if this was one of them.
It’s very sad that the young girl died, and I can’t help feeling that Allergan’s aggressive stance regarding off label discussions has done little to discourage such suits.
oh boy
let’s just say that it’s not only well know that Allergan’s actions in aggressively marketing off label (for this and other conditions) is not limited to this particular manufacturer of botulinum toxin. one of their competitors took Allergan’s activities and one upped them in a way that goes well beyond off-label marketing. . . let’s just say that quite a few published “case reports” and “research studies” weren’t exactly what they represented themselves to be
About Time
A tragic loss for everyone but the lawyers who took this case are the ones who should be sued by Allergan. They took this very questionable case on spec raising the hopes of this poor women and leaving her is desperate shape. I wonder if they have contributed anything to her care and are defending in the suit. Hopefully this case will teach them a lesson that chasing deep pockets pays off only for legitimate cases. This activity simply jacks up drug prices for all of us and fattens the pockets of the ambulance chasers.