Allergan To Pay $15M In Botox Verdict
16 CommentsBy Ed Silverman // May 14th, 2010 // 8:39 am
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.
The verdict is the “first step in making sure the public is aware of the actual risks of Botox. It’s a steppingstone to protect the public from what the company is hiding,” Helton tells The Orange County Register. “Hopefully, now people will wake up to the real dangers.” The jury, which did not award punitive damages, also found that Botox was not defective. Allergan plans to appeal.
A key issue was whether Allergan gave sufficient warning in the labeling about possible problems from Botox cosmetic use. The labeling in 2006 did not include botulism. One juror told The Oklahoman that the jury found negligence because the 2006 labeling did not have adequate info about side effects. The juror said the jury reached that conclusion after comparing a 2006 label with the 2009 label.
Interestingly, Helton’s attorney, Ray Chester, maintains crucial testimony included an Allergan sales rep who admitted to providing off-label dosing guidelines to Botox clients in a sealed envelope, which Allergan disputes. Chestery, by the way, also represented Dee Spears, the first person to sue Allergan over problems allegedly caused by Botox.
Spears claimed Botox was responsible for the death of her seven-yea-old daughter, who suffered from cerebral palsy patient and died three years ago after receiving injections to relax clenched muscles. Allergan is seeking $460,000 in legal costs from Spears (background here and here).
photo thx to The Oklahoman
patrons99
“…an Allergan sales rep who admitted to providing off-label dosing guidelines to Botox clients in a sealed envelope.”
Sounds like just another lone, rogue sales rep doesn’t it! NOT!!!
“…to Botox clients”. No doubt that illegal off-label applies here. I wonder if a “learned intermediary” was involved. If a learned intermediary was not involved, would this case not actually represent an example of illegal off-label marketing which is DTC? Sounds like a “clear and present danger” to me. It sounds to me like it’s more than just an “imminent lawless action”. It sounds like a completed crime to me.
patrons99
Here are two recent links to articles titled, “Free Speech, Off-label marketing, and the learned intermediary doctrine” and “Off-label drug marketing threatens patients. It could soon be legal.” on April 15, 2010.
http://www.tortdeform.com/archives/2010/04/free_speech_offlabel_marketing.html
http://www.stltoday.com/stltoday/news/stories.nsf/editorialcommentary/story/7242B8EDE96A2A79862577050082F594?OpenDocument
“The contradiction between how drugs are marketed and how they are prescribed creates a gray area that opened the door for the allergan case”.
Perhaps, the best solution to this legal quandry is for Congress to simply ban all drug promotions - including “any type of promotional media” and “drug promotion - period”.
If Allergan wins its suit, and pharma is allowed to market off-label drug uses, why would we need an FDA at all? For that matter, why would we need “learned intermediaries” at all? Wouldn’t pharma have effectively supplanted and replaced both the FDA and physicians?
I may find myself actually supporting Elena Kagan’s view of the First Amendment.
http://www.washingtonexaminer.com/opinion/blogs/beltway-confidential/Kagan-Speech-is-free-if-government-decides-it-has–93309159.html#ixzz0nex6tCbS
“Whether a given category of speech enjoys First Amendment protection depends upon a categorical balancing of the value of the speech against its societal costs.”
Biotruth
I agree with B. Martin MD at her Pathophilia blog post (see http://bmartinmd.com/2010/05/allergan-will-appeal.html ) - that it is hard to believe Sharla Helton’s multitude of symptoms arose solely from cosmetic doses (20 units, FDA approved treatment) of Botox. Her complaints began after she received her FIFTH round of Botox injections, reportedly at 50 units, in her upper face (per Oklahoman’s NewsOK article at http://newsok.com/article/3460693 ). It has never been made clear to me whether Helton was given these injections by another physician or if she actually self-administered these injections - it would be interesting to know.
In my opinion, Helton was an ob/gyn MD, a women highly educated and trained in the medical field - what part of “toxin” and “vision problems” did she not understand from the start? When are women (and increasingly, men) going to wake up to the fact that there are noted side effects, some of which are quite unpleasant? These people commit to a long-term regimen of injections for vanity because treatment results only last for a few months. I am over 40, will never “Botox”, and I live happily and at peace with my inevitable sneaky crows feet and wrinkles. So the story sums up as: a 3-week trial, $13 million award, sold her medical practice. One report wrote “Helton said she is still debilitated by weakness but hopes to get back to practicing medicine again in some way.” By takin’ it on the road with a new high-fee medical-oriented speaking career, perhaps?
And no, I have never worked for Allergan.
Justice in MI
Based on Ed’s summary, it sounds like the Allergan/Botox story goes way beyond the merits of this or that particular case.
As is also clear, the issue is not whether “all drugs have dangers” (how tired that is…). It’s whether the company, Allergan in this case, made known to docs and pts what it itself knew. Per above:
“A key issue was whether Allergan gave sufficient warning in the labeling about possible problems from Botox cosmetic use. The labeling in 2006 did not include botulism. One juror told The Oklahoman that the jury found negligence because the 2006 labeling did not have adequate info about side effects. The juror said the jury reached that conclusion after comparing a 2006 label with the 2009 label.”
patrons99
JiM - with reference to your comment above, which is worse an “error” of omission (simple negligence - a “weak” package insert) or an “error” of commision (illegal off-label promotion)? I would argue that the latter is potentially much more damaging to the public health, i.e., have greater “societal costs”. Now, I’m not a lawyer, but doesn’t the latter type of “error” actually represent criminal misconduct? There is mens rea. The latter type of misconduct is criminal, while the former type (negligence) is generally civil.
http://en.wikipedia.org/wiki/Mens_rea
So while “sufficient warning” may have been “a key issue” in this particular case, I wonder how “crucial” the Allergan sales rep’s testimony was in the jury’s verdict?
Generally speaking, would a state Attorney General have a cause of action in a scenario similar to this one?
John
“One juror told The Oklahoman that the jury found negligence because the 2006 labeling did not have adequate info about side effects. The juror said the jury reached that conclusion after comparing a 2006 label with the 2009 label.”
This reasoning assumes that all possible negative outcomes, no matter how rare, are forseeable without the benefit of experience.
Public Citizen’s 2008 press release calling for a black box warning on Botox cited 16 deaths and 87 hospitalizations associated with Botox injections. Working backwards from Allergan’s sales figures and an AWP of $250, this comes to about one death and five hospitalizations for every one million injections. The information about these rare adverse effects accumulated over several years and was for the most part not available in 2006.
Yes, people have been injured by Botox and some have died. But if you run the numbers, for the average patient about 25% of the risk of having a Botox injection comes from driving to and from the appointment (40K deaths/year divided by 300M Americans divided by 365 days per year = 1 death / 2.7M driver days).
At some point it seems that as an MD, Dr Helton had to be aware of and assume risk for the fact that any medical treatment can have rare and unanticipated side effects.
patrons99
Who are Allergan’s Botox “clients”?
http://www.botoxcosmetic.com/How_To_Get_Started.aspx
http://inyourface.freedomblogging.com/2008/07/10/botox-led-to-four-deaths-says-lawsuit-against-allergan/
http://inyourface.freedomblogging.com/2010/05/11/jury-awards-15-million-for-botox-damages/17361/
http://inyourface.freedomblogging.com/category/non-surgical-treatments/botox/
“As an example of Allergan’s alleged cover-ups, Chester described a company document recommending how doctors should talk to patients about Botox:
Call it a protein. Don’t call it a toxin. Well, that’s fine except it is a toxin. People ought to know that if they’re going to get injected.
Next, call it a purified protein. Don’t call it a poison. Well, that’s fine except that it is a poison. …
My favorite one – Call it …”temporary.” Don’t call it “deadly,” even though it is a deadly neurotoxin.”
This is a perfect example for why Congress should simply ban all drug promotions - including “any type of promotional media” and “drug promotion - period”. The societal cost of this particular type of commercial free speech is too high.
Just imagine for a moment the nightmare for public health that will take place if off-label marketing is made legal. It will certainly represent a game-changing event…a pharma marketer’s ultimate “wet dream”. Market-based medicine will have become the status quo. No real need for an FDA. No real need for doctors. FDA and doctors will have just become “tools” for pharma.
John
“Poison”, and “deadly neurotoxin” are strong words, but to understand the issue you have to look at it quantitatively. Using Public Citizen’s own numbers, the risk of this “deadly toxin” is pretty low when used according to its label.
Numbers are very helpful in understanding these issues, because unlike non-quantitative adjectives, they provide insight into the extent of a problem. As an example, table salt is “toxic” as judged by its effects in large acute doses or when used excessively over long periods of time. But simply calling salt a “poison” does not provide any real insights into how it should be used and regulated. You need numbers for that.
patrons99
John -
Why should dissemination of off-label dosing guidelines for a “deadly neurotoxin” pose any risk to public health and safety? Hmmm. Let me count the ways.
Doesn’t our government have a substantial interest in protecting the public health?
With regard to drug promotion, which has more “value” to government, commercial free speech or the “societal costs” of a few unintended deaths?
ohn
I guess my issue is that your rationale here seems to simply be that botox is “deadly”, but I see no justification in your remarks for this adjective other than that someone else has described it in this way.Nutritional supplements have killed quite a few people too.
patrons99
John - to avoid redundancy, I refer you to this comment:
http://www.pharmalot.com/2010/05/bio-locks-out-media-from-keynote-speeches/#comment-500247
patrons99
If I were to hazard a guess, Pharma might be willing to forgo DTC advertising. On the other hand, it will probably require either an act of Congress or a Supreme Court ruling to cause Pharma to forgo the off-label drug promotion “safe harbor”. Moreover, Pharma wants to expand off-label drug promotions, notwithstanding the “societal costs” of a few unintended deaths.
See an article titled “Is it time to back off DTC advertising?” by Tracy Staton on November 6, 2009.
http://www.fiercepharma.com/story/it-time-back-dtc-advertising/2009-11-06
See an article titled “How Drug Advertising Restrictions Could Benefit the Industry” by Jim Edwards on November 5, 2009.
http://industry.bnet.com/pharma/10005144/how-drug-advertising-restrictions-could-benefit-the-industry/?tag=shell;content
See an article titled “NYT Poll: Everyone Hates Drug Advertising” by Jim Edwards on August 11, 2009.
http://industry.bnet.com/advertising/10003433/nyt-poll-everyone-hates-drug-advertising/?tag=content;selector-perfector
patrons99
“Interestingly, Helton’s attorney, Ray Chester, maintains crucial testimony included an Allergan sales rep who admitted to providing off-label dosing guidelines to Botox clients in a sealed envelope, which Allergan disputes.”
Earlier in this thread, I made a prejudgment and drew an inappropriate conclusion, with respect to Allergan. I inferred that Allergan had somehow gone astray from the off-label marketing “safe harbor”.
As far as I know, this reps admission has not been examined and ruled on by any court of law or other impartial body. Nor was there any allegation of impropriety, that I know of.
John, in another pharmalot thread, makes some good points. “…a good role model with regard to prejudgment and when it is appropriate to draw conclusions.”
http://www.pharmalot.com/2010/05/roche-pressured-reps-to-push-tamiflu-illegally/#comment-502769
Becky
If reading the information about the drug you are taking prevents you from using the it- no one would be taking any medications! i.e. digitalis etc. Medicine utilizes many harmful and dangerous drugs to our benefit. I myself have been told “it’s only in small amounts and won’t harm you”.
patrons99
Whoa, Becky - I would be careful here. An overdose of digitalis can be fatal.
You may have inadvertently identified the problem with off-label marketing of Botox very succinctly.
“I myself have been told “it’s only in small amounts and won’t harm you”
Who told you that? A drug rep? I can’t believe that any physician would have told you that.
Let me give you my opinion on this subject:
“it’s only in small amounts” - the wrong dose for either the labeled indication or for a particular off-label indication could be fatal.
“it won’t harm you” - I don’t think that anyone can say that with certainty, given that toxicity is often dose-dependent, and a dose may not have been properly specified for a particular off-label use.
Harm is relative and can range from something as severe as death, if overdosed, to something as mild as, for example, droopy eyelids, muscle weakness, and difficulty swallowing. Some toxicity with all medications is idiosyncratic, e.g. anaphylaxis.
Before I dabbled in Botox use, I would certainly seek the advice and supervision of a licensed physician. I would not depend on direct to consumer ads for Botox. This is just my opinion and is not intended to be medical advice.
patrons99
Hi Becky -
Just a little more opinion about your comment.
How can a patient possibly know where to find accurate, trustworthy information about this product? From television, e.g. “Nip/Tuck”, “Extreme Makeover”? From an Allergan drug rep?
What about the route of admininstration? Here’s the link to an article titled “Incorrect route of drug administration in the use of Botox in real world”.
http://www.ehealthme.com/ds/botox/incorrect+route+of+drug+administration
Here’s another link to an article titled “Botox side effects in real world”.
http://www.ehealthme.com/q/botox-side-effects-drug-interactions
Here’s another link to Botox from drugs.com.
http://www.drugs.com/pro/botox.html
This last link has a particularly interesting section titled “Spread of Toxin Effect”.
Here’s a link to an article from Reuters titled “Group seeks Botox warning after 16 death reports”.
http://www.reuters.com/article
/idUSN2422612920080125
Here’s a link to an article titled “Death by Botox? The Hidden Toll of the Quest for Beauty” by Stephanie Brail on February 25, 2008.
http://www.naturalnews.com/022720.html
Disclaimer: No representations are made as to the accuracy, completeness, or timeliness of the information in this comment. The information presented here is not to be construed as medical advice. If you have a medical problem, you need the help of a trained medical professional.