Smoking Everywhere

[HKholer]

I think that the folk talking about filing an Amicus Brief are forgetting something.

I'm no lawyer, but it occurs to me that this appeal is about the FDA's right to continue to block our shipments. and that is ALL it is about.

IMHO you need to forget all your charts, graphs and studies and focus on the topic of the appeal.

We need to show how the FDA is unfairly treating the two companies involved. Use the Walnut thing. Just because one company mis-advertised (according to FDA) The FDA did NOT stop the selling or importation of all walnuts. And the Cheerioes, One company got a warning, NOT all breakfast cereals shut down.

Use things that the FDA has been chastised for to show that they are being unreasonable and that they should not be allowed to continue to be unreasonable.

Judge Leon has already indicated that he is leaning toward this being a tobacco product. Show that since Judge Leon has stated this, that the FDA has no right to continue to treat this product as a drug delivery device until it is determined on way or another by Judge Leon.

At this point I don't think (and I could be wrong) that the appeals court can even look at the facts of the rest of the case, only what is on the appeal.

Sun: Am I explaining myself clearly. I don't know a lot about the law but some people seem to want to go off the deep end in this 'brief' and I think it should be very narrow and stay on topic. Only the blockage should be addressed.

 

[the_antisheep]

This is probably true. The details involved with the safety of the product are likely not to be as high of an issue as the misrepresentation, as that is what is being attacked. For the FDA to make a sweeping judgment on all vendors, based on the actions of one, there is an issue of legal integrity that needs to be addressed. The FDA is not *supposed* to be in the business of regulating trade, but of addressing, and shutting down actual misrepresentation of products that could have damaging affects.

It could be an open and shut case, if like you said, the people defending will stay on a short and narrow path. The widened path of arguing actual statistics and numbers may lead to a bigger case that does not even need to be addressed with the FDA. If the push is to find a legal avenue to distribute the product, instead of fighting the FDA's claim of misrepresentation, vaping may have a higher chance for success in staying above the ban. It will take a HELL OF A LOT LONGER to get this thing passed through as a medical device then it will to get it through as a tobacco/recreational device.

There are thousands of drugs out there, sitting in the queue for years at the FDA that have far reaching medical advantages, then there are new products being non-nonchalantly passed through as recreational/tobacco devices.

Look at the recent caffeine inhaler! The professor released this thing, with no claims, and it's sitting in the open market with no repercussions or even interest by the FDA. I have heard several times on this board that people want this thing to get pushed through as a medical device, but I'm not sure you guys have a firm grip on the reality of what this really means.

Let the "misrepresentation" made by a few companies be their downfall (harsh, I know), so that we can continue to thrive as a "recreational" community.

In fighting a few misrepresentation cases, we may all be the facilitators of our own ban.

Remember this: the needs of the many, outweigh the needs of the few.

 

[Rosa]

The thing that bugs me the most is that I'd be willing to bet a hundred bucks that if e-cigarettes were originally marketed as "nicotine inhalers" and never had a light on the end of them people would be viewing them the same way we do, as a life saving device.

Perhaps if they looked like the "le whiff" thingy, people wouldn't be freaking out. So dumb.

 

[the_antisheep]

The thing that bugs me the most is that I'd be willing to bet a hundred bucks that if e-cigarettes were originally marketed as "nicotine inhalers" and never had a light on the end of them people would be viewing them the same way we do, as a life saving device.

Perhaps if they looked like the "le whiff" thingy, people wouldn't be freaking out. So dumb.

If they weren't marketed to have a medical purpose (safer alternative/cessation device), they wouldn't be in the limelight, or even a concern to the government. Once you place the medical tag on something, you have lengthy uphill battle with the government, that I don't believe this community has the money to fight (big Pharma does, but we aren't them).

 

[Windsage]

When you look at court cases like this you have to remember what they are actually about. The OP isn't thinking about is how and why this case started.

First, the FDA decided that ALL e-cigs should be seized and began sizing shipments from many vendors.

Then SE and later Njoy sued the FDA saying the FDA should not seize THEIR shipments.

So, really you have your analogy backwards. The FDA has already decided the fate of the entire industry. These two vendors just happen to be the only ones who have fought back. Even if these guys win this case, the FDA can still decide to seize shipments from other vendors.

In all reality, I would think that all of the other vendors should be helping them as much as possible.

 

[v1John]

Couldn't SE and Njoy aquire other small vendors, remodel and increase their product line size, and be able to defend the ecigs better too?

 

[Cuco3]

The argument of whether this is a drug or tobacco delivery thing is hilarious.

Did you know you can use a lightbulb to create a crack pipe?

I guess we should stop selling crack delivery devices, as well... I mean lightbulbs.

 

[the_antisheep]

The argument of whether this is a drug or tobacco delivery thing is hilarious.

Did you know you can use a lightbulb to create a crack pipe?

I guess we should stop selling crack delivery devices, as well... I mean lightbulbs.

When I was in college, I saw empty plastic coke bottles, every fruit on earth (apples, pineapples, mangos, etc..), and coffee cups used as "drug delivery devices." Everything and anything that can be semi-sealed is a drug delivery device to a stoner. They are the ultimate innovators of delivery devices.

Saying that, spending $100+ on one of these devices to deliver drugs is more money than most of these stoners would have. Typically they were trying to score $10 from someone to get their next hit, or buy a dime bag.

 

[HKholer]

Windsage:

You misunderstand me I think.
What I am saying is at the appeal, there is no sense briefing the judges ( and that is what we would be asking to do ) about the merits of the e-cig. The appeal is about Judge Leon telling the FDA they couldn't stop shipments anymore. And that is ALL it is about. Merits of the original case do not matter.

The whole question is: Can the FDA continue blocking shipments of SE and Njoy products while the other case is being heard.

Judge Leon said: NO.
FDA Appealed that decision.

Remember, the original case hasn't even started yet. This ruling was on a pre-trial motion to make the FDA let the shipments for these two companies thru.

So to file a brief for the court on ANYTHING except the FDA's right to block shipments is going to be ignored and if it is too, too much, the whole brief could be ignored as not being relevant to the appeal.

Again I believe that CASAA should look for examples of the FDA overreaching their authority and document their crappy attitude. ie. the walnut thing, the breast test thing, the cheerios debacle etc.

I'm no lawyer, but I believe anything else could seriously jeopardise the courts view of the brief.

Just my opinion.

 

[urbancowboy505]

I'd like to chime in on this one as I am a law student. If this case is up on appeal, the sole issue on appal should be the ban, not the classification of the devices. However, to say that an amicus brief should stick solely to the topic of The ban and not to the topic of health and safety is somewhat erroneous.

Depending on the standard of review, the court could consider other evidence in making its determination.

The biggest reason, however to include some off topic information In the amicus briefs is in hopes that the court would issue dicta. Dicta is essentially a non-binding part of an opinion that courts will often find incredibly persuasive. To get an appellate court judge to state in the record that the devices are harmless or much safer than cigarettes would create a powerful tool in the arsenal of other lawyers who may eventually need to defend e-cigs on other grounds.

Certainly, the briefs should be relevant to the appealed issue, but it is always possible for a lawyer to make some logical connection between two disparate issues so that the court has other information in front of it. So long as the briefs are not totally irrelevant to the issue they should not be ignored.

Also, as I have not been following the issue as closely as some since finals are here, I have a question for you guys. Has this case been certified to the supreme court and, if so, has the court taken the case? I'm a little lost as to why people are discussing amicus briefs. Generally, courts of appeals are limited in their review to the material in the trial court record as the appellate courts show deference to the trial courts in their findings of fact unless clearly erroneous. If this review has gone up de novo I understand the discussion.

Maybe someone could point me to a place where I can get more information and clarify.

I wonder if the trial opinions and pleadings are up on westlaw yet. Anybody know what the case name was? Were nJoy and the FDA the only parties?

 

[HKholer]

UrbanCowboy:

Go down to the Campaigning section of the Forum and snoop around there. ALL the data is there. The only reason this thread exists is because I don't have enough stupid posts to put it where it belongs.

So frustrating. I absolutely refuse to make 15 inane, idiot replys to thing just to gain 15 posts. Its ignorant.

 

[the_antisheep]

UrbanCowboy:

Go down to the Campaigning section of the Forum and snoop around there. ALL the data is there. The only reason this thread exists is because I don't have enough stupid posts to put it where it belongs.

So frustrating. I absolutely refuse to make 15 inane, idiot replys to thing just to gain 15 posts. Its ignorant.

Just say "hi" or "welcome" to 15 noobs. IMHO, the noob section is the most lively place on this board.

 

[urbancowboy505]

I actually found the memorandum opinion on westlaw. I'll be giving it a read later on but I'm a bit busy with finals at the moment. I am still searching for any other documents as well. Often I can find complaints and whatnot on westlaw as well.

One thing I did note, however, is that this was a motion for a preliminary injunction. The nature of such a motion requires an analysis of the merits of the case, which is probably why amicus briefs are being discussed. Amicus briefs about health concerns are probably not relevant though. It seems the issue in the case is whether the fda can consider e-cigs as a drug-device combination or whether it should properly be classified as a modified risk tobacco product. It seems that some of smoking everywhere's marketing material as well as some user submitted comments are leading the fda to believe e-cigs are being sold as smoking cessation devices, which would properly fall under the drug-device classification.