Botox trial - critical information withheld?

[Pea-n-Me]

It should be interesting. People all over the world will be following as it has legal implications everywhere botox [and presumably other like products] are used.

It is believed to be the first Botox case alleging a fatal reaction to reach trial, and is one of several pending suits related to the drug's cosmetic and non-cosmetic uses.

The trial comes less than a year after federal authorities mandated "black box" labels that warn of potentially serious reactions to Botox. And it opens a window on the Irvine-based drug maker's own records of reported ill effects, showing that the company knew of some serious problems linked to neurotoxins such as Botox as early as 2005.

Allergan declined to comment on the trial. In a court motion, Allergan says that Kristen died of a bacterial infection and that her mother cannot prove Botox killed her.

Kristen's death came more than a year before the U.S. Food and Drug Administration ordered the labels warning of the drug's potential to cause botulism symptoms, including "potentially life-threatening swallowing and breathing difficulties and even death."

At the same time, the agency required Allergan to notify physicians that the toxin could spread beyond the injection site and to prepare a patient guide saying that it was not known whether Botox was safe for children or for other patients whose conditions it had not been approved to treat.

In preparation for the trial, Allergan was required to produce safety assessments of Botox and other confidential internal reports. Portions of some documents were obtained by The Times after Orange County Superior Court Judge Ronald L. Bauer unsealed them.

The documents include a 2005 letter sent by a European health official that alerted Allergan of reports that botulinum toxin had spread beyond the injection site among patients who sought cosmetic treatment.

Entire article: http://www.latimes.com/news/local/la-me-botox27-2010jan27,0,1928030.story

 

[rie'smom]

Unless the doctor screwed up the way the Botox was injected, I don't see a case. Anyone with 2 brain cells knows that it's a poison and there are risks.

 

[Pea-n-Me]

Unless the doctor screwed up the way the Botox was injected, I don't see a case. Anyone with 2 brain cells knows that it's a poison and there are risks.

It is believed to be the first Botox case alleging a fatal reaction to reach trial

This suggests it's more complicated than that.

I'd love to hear from the Dis lawyers on this one.

 

[Geoff_M]

I have some thoughts from the business end of things.... there's almost zero chance of knowing how this trial will go. Juries can run all over the map. Even the screw up being largely the doctor's fault is not a safe assurance for a drug maker. In the 80's a doctor injected a steroidal product near a guy's eye in Chicago... even though it was not approved for use in such a manner. The drug then caused the loss of the man's eye. He sued the drug maker and won the largest jury personal injury verdict at that point in US history ($125M, though it was later reduced on appeal).

As for the EU regulatory reports on Botox from 2005, note that is said there were "reports" of Botox causing problems. That's not a confirmation of causation, only a suspicion. Some reports turn out to be false or flukes. More importantly will be what Allergan did after they received the reports. If they did nothing, then that'd be a red flag. However, if they investigated and didn't feel there was any linkage, that's another story. The LA Times doesn't give any details on this.

 

[NotUrsula]

The key to this one is the question of whether Allergan or the physician is at fault. In this case, you have a physician saying that he was told of the dosage by the drug mfr., and the mfr. says that they did no such thing, because technically they are prohibited by law from formally describing a dosage for an off-label use.

The discovery will tell the tale; if they can find written documentation of the doctor's claim, then Allergan is vulnerable; otherwise the doctor will take the fall. The plaintiff's attorneys want Allergan as the plaintiff because there is a much bigger potential payoff from the company than there is from the physician, and the physician's attorneys want it because it gets them off the hook for a big malpractice payout. (Though they are still almost certainly guaranteed to drop the poor schmuck anyway once the trial ends.)

 

[Pea-n-Me]

From today:

Dee Spears claims that the company wrongfully promoted off-label uses of the drug and failed to warn consumers of the risks involved with high doses of the injections.

Allergan spokesperson Crystal Muilenburg stated that “the evidence presented in this case will show that Botox did not play a role in this,” with an early court motion claiming that the girl died of a bacterial infection unrelated to Botox.

Earlier this week, an issue of Neurology, the medical journal of the American Academy of Neurology, published results of a study that found botulinum toxin type A to be “effective and generally safe” as a treatment for spasticity and muscle tightness associated with cerebral palsy, but with some risks involved.

Botox is currently not approved in the U.S. for the treatment of spasticity (spasms) in children with cerebral palsy, but it is widely prescribed by doctors as an off-label treatment for the condition. The drug is injected in large doses, up to 15 times the cosmetic dose, directly into muscles to reduce rigidity and allow patients to move and walk more easily.

http://www.drugwatch.com/news/2010/...ter’s-death-manufacturer-faces-first-lawsuit/