Thanks Julie.
Let us know when your coming and we'll all wear togas----can't wait to see Jerry in one!!!
*Sheesh* Next thing you know, you'll all be getting into a food fight!
SE, NJoy vs FDA -- Discussion
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*Sheesh* Next thing you know, you'll all be getting into a food fight!
Tapioca pudding and beer, all over the walls. It's hard to believe that at one time, the Veterans Forum was such a dignified place.
Updating DISTRICT Court njoy v. FDA: Full document attached, but here are the highlights:
"Defendants hereby move for an extension of time to respond to intervenors complaint.
Under this Courts Order of July 27, 2009, defendants answer to intervenors complaint is due
March 2, 2011 (20 days after the mandate was issued on February 10, 2011). Defendants seek an
extension of time to respond to the complaint until 30 days after final resolution of the appeal,
including the time for filing a petition for a writ of certiorari. The deadline for filing a petition
for a writ of certiorari is April 25, 2011. If such a petition is not filed, defendants will respond to
the complaint within 30 days, on or before May 25. If a petition is filed and denied, defendants
will respond to the complaint within 30 days of the denial. If a petition is filed and granted,
defendants will respond to the complaint within 30 days of the resolution of the matter before the
Supreme Court. The undersigned counsel for the government, Drake Cutini, has spoken with
counsel for intervenor, Phil Perry, and Mr. Perry stated that intervenor does not oppose this
motion."
Updating TW v. FDA: 02/28/2011 Set/Reset Deadlines: Defendants Report due by 3/2/2011. (kc ) (Entered: 02/28/2011)
"Defendants hereby move for an extension of time to respond to intervenors complaint.
Under this Courts Order of July 27, 2009, defendants answer to intervenors complaint is due
March 2, 2011 (20 days after the mandate was issued on February 10, 2011). Defendants seek an
extension of time to respond to the complaint until 30 days after final resolution of the appeal,
including the time for filing a petition for a writ of certiorari. The deadline for filing a petition
for a writ of certiorari is April 25, 2011. If such a petition is not filed, defendants will respond to
the complaint within 30 days, on or before May 25. If a petition is filed and denied, defendants
will respond to the complaint within 30 days of the denial. If a petition is filed and granted,
defendants will respond to the complaint within 30 days of the resolution of the matter before the
Supreme Court. The undersigned counsel for the government, Drake Cutini, has spoken with
counsel for intervenor, Phil Perry, and Mr. Perry stated that intervenor does not oppose this
motion."
Updating TW v. FDA: 02/28/2011 Set/Reset Deadlines: Defendants Report due by 3/2/2011. (kc ) (Entered: 02/28/2011)
Thanks Julie.
This case keeps getting dragged on and on and on by the Feds...which is making me wonder...
The ecig movement has gained so much ground with this case. What happens to it if the FDA reaches its goal of drowning njoy out of business as well? Does the precedence remain or is it gone? Does this just become another (later forgotten) case of Nicotine Water?
This case keeps getting dragged on and on and on by the Feds...which is making me wonder...
The ecig movement has gained so much ground with this case. What happens to it if the FDA reaches its goal of drowning njoy out of business as well? Does the precedence remain or is it gone? Does this just become another (later forgotten) case of Nicotine Water?
I don't think e-cigs will go the way of nicotine water as nicotine water was something that only a very limited number of people even knew about. E-cigs are becoming increasingly more known about due to all the recent press that they have garnered. We must continue to tell the general public about them, show them how they work and get the science needed to back up our claims of their safety over cigarettes or other smoked tobacco products. It's an uphill battle for sure, but it's one that can be won if we don't start doubting ourselves or letting others push the doubt on us.
I know for a fact that e-cigs and other modern smokeless alternatives are at least 95-99% safer than inhaling the toxic fumes from a burning cigarette, cigar or pipe. I watched my mother die from cancer in Oct of 2002, today would have been her 68th birthday, I refuse to let the FDA or any other anti-smoking/tobacco/nicotine group condemn me to that death when there are safer alternatives available. Now all we need to do is get the real truth out to all smoker's and their loved ones about how smokeless tobacco products are so much safer than smoking.
I had to look it up and thought it was worth sharing:
Definition: Certiorari, Petition for Writ of Certiorari.
Certiorari
Certiorari is a Latin word meaning "to be informed of, or to be made certain in regard to". It is also the name given to certain appellate proceedings for re-examination of actions of a trial court, or inferior appeals court. The U.S. Supreme Court still uses the term certiorari in the context of appeals.
Petition for Writ of Certiorari. (informally called "Cert Petition.") A document which a losing party files with the Supreme Court asking the Supreme Court to review the decision of a lower court. It includes a list of the parties, a statement of the facts of the case, the legal questions presented for review, and arguments as to why the Court should grant the writ.
Writ of Certiorari. A decision by the Supreme Court to hear an appeal from a lower court.
Cert. Denied. The abbreviation used in legal citations to indicate that the Supreme Court denied a Petition for Writ of Certiorari in the case being cited.
Someone with a legal claim files a lawsuit in a trial court, such as a U.S. District Court, which receives evidence, and decides the facts and law. Someone who is dissatisfied with a legal decision of the trial court can appeal. In the federal system, this appeal usually would be to the U.S. Court of Appeals, which is required to consider and rule on all properly presented appeals. The highest federal court in the U.S. is the Supreme Court. Someone who is dissatisfied with the ruling of the Court of Appeals can request the U.S. Supreme Court to review the decision of the Court of Appeals. This request is named a Petition for Writ of Certiorari. The Supreme Court can refuse to take the case. In fact, the Court receives thousands of "Cert Petitions" per year, and denies all but about one hundred. If the Court accepts the case, it grants a Writ of Certiorari.
"Review on writ of certiorari is not a matter of right, but a judicial discretion. A petition for writ of certiorari will be granted only for compelling reasons." Rule 10, Rules of the U.S. Supreme Court.
The U.S. Supreme Court's certiorari process is covered in Rules 10-16, Rules of the U.S. Supreme Court.
The effect of denial of certiorari by the U.S. Supreme Court is often debated. The decision of the Court of Appeals is unaffected. However, the decision does not necessarily reflect agreement with the decision of the lower court.
Definition: Certiorari, Petition for Writ of Certiorari.
Certiorari
Certiorari is a Latin word meaning "to be informed of, or to be made certain in regard to". It is also the name given to certain appellate proceedings for re-examination of actions of a trial court, or inferior appeals court. The U.S. Supreme Court still uses the term certiorari in the context of appeals.
Petition for Writ of Certiorari. (informally called "Cert Petition.") A document which a losing party files with the Supreme Court asking the Supreme Court to review the decision of a lower court. It includes a list of the parties, a statement of the facts of the case, the legal questions presented for review, and arguments as to why the Court should grant the writ.
Writ of Certiorari. A decision by the Supreme Court to hear an appeal from a lower court.
Cert. Denied. The abbreviation used in legal citations to indicate that the Supreme Court denied a Petition for Writ of Certiorari in the case being cited.
Someone with a legal claim files a lawsuit in a trial court, such as a U.S. District Court, which receives evidence, and decides the facts and law. Someone who is dissatisfied with a legal decision of the trial court can appeal. In the federal system, this appeal usually would be to the U.S. Court of Appeals, which is required to consider and rule on all properly presented appeals. The highest federal court in the U.S. is the Supreme Court. Someone who is dissatisfied with the ruling of the Court of Appeals can request the U.S. Supreme Court to review the decision of the Court of Appeals. This request is named a Petition for Writ of Certiorari. The Supreme Court can refuse to take the case. In fact, the Court receives thousands of "Cert Petitions" per year, and denies all but about one hundred. If the Court accepts the case, it grants a Writ of Certiorari.
"Review on writ of certiorari is not a matter of right, but a judicial discretion. A petition for writ of certiorari will be granted only for compelling reasons." Rule 10, Rules of the U.S. Supreme Court.
The U.S. Supreme Court's certiorari process is covered in Rules 10-16, Rules of the U.S. Supreme Court.
The effect of denial of certiorari by the U.S. Supreme Court is often debated. The decision of the Court of Appeals is unaffected. However, the decision does not necessarily reflect agreement with the decision of the lower court.
I don't speak legal very well...does this mean that the FDA is indeed going to take the injunction to the supreme court? The full case hasn't been heard, let alone ruled on, so the petition would only ask for a decision on the injunction telling them to desist seizing product?
I'm going to bore the old timers for a minute and give a bit of background for those who haven't been on this thread forever.
When SE filed the original lawsuit against the FDA, as I understand it, they knew that a trial would take a long time and cost a lot of money. Thus, SE asked for a temporary injunction, basically asking the court to tell the FDA that while the case was going on, the FDA couldn't continue to seize SE products as unapproved drugs. As everyone knows, that injunction is what we've been talking about for this entire time.
NJOY joined the lawsuit as an "intervenor." (SE dropped out of the case much later, leaving just NJOY at this point.)
Judge Leon granted the injunction, and FDA appealed that ruling. The Court of Appeals shot down the FDA, upholding Judge Leon's injunction. The FDA asked the Court of Appeals to reconsider (asking for a rehearing). The Court of Appeals refused.
So now the FDA has two choices. It can either appeal the injunction ruling to the Supreme Court, or it can not appeal and just set about litigating the case back before Judge Leon. (There is a third option, which I'll get to in a minute.) It still has some time to decide whether or not it's going to appeal to the Supreme Court, though. So basically, what the motion is saying is that when the injunction stuff is finally over, FDA will answer NJOY's complaint in district court. The injunction appeals will be "over" when (1) the time has elapsed where FDA can file with the Supreme Court (and doesn't file) OR (2) if the FDA does try to get the Supreme Court to hear the matter, when the Supreme Court issue is resolved (either the Supreme Court refuses to hear it, or, if it does agree to hear it, then when the Supreme Court issues its ruling).
Does this mean the FDA will ask the Supreme Court to hear the matter? Nope. It only means the FDA is trying to keep its options open, which is a reasonable thing to do. In any event, when the injunction litigation is "over" (whenever that is), the FDA is saying that within 30 days of that date, it will respond to NJOY's complaint in the case in chief pending before Judge Leon.
I said a minute ago that the FDA had two options--appeal to the Supreme Court or not. And then I said there was a third option that I'd get to in a minute . . . the third option is just to agree that e-cigarettes should be regulated as tobacco products (absent therapeutic claims) and reach a settlement with NJOY (and, of course, TW). That third option is what we've been seeing hints of for the past week or so--the FDA asking for a continuance in the TW case to talk about settlement options.
Hope that helps a bit, and I hope folks will forgive me for perhaps over simplifying a bit.
Nothing to report, and everybody is, as usual, welcome.
I notice Jerry is sporting a phoenix today . . . dare I ask?
I notice Jerry is sporting a phoenix today . . . dare I ask?
It's not for any special occasion, Julie, I have been using a phoenix as an avatar for a while now, but this one for only a couple of weeks. It has a special meaning to me.
Great synopsis Julie - one I can refer others to for getting the gist of the situation. Mahalos!!!
Thank you Julie, over simplified is what I need
I'm a simple person.
Nothing new on the NJOY v. FDA docket.
TW v. FDA, the status report was filed today and is attached. Here's the meat of it:
Hmmm... makes me wonder exactly what materials TW submitted.
Thank you Julie! And no, we wouldn't consider you simple, rather wonderfully intelligent for being able to take the jargon and put it in a nutshell for our benefit. It's the ones that can't speak anything but legalese that I worry about.
Thank you Julie! And no, we wouldn't consider you simple, rather wonderfully intelligent for being able to take the jargon and put it in a nutshell for our benefit.
It's the ones that can't speak anything but legalese that I worry about. If I'm wrong about this, somebody please explain...
It it starting to sound like TW is about to throw everyone under the bus.
In other words, they might be eager to come to a deal which exempts them.
So they will win their battle, set themselves up for future growth, and laugh at those left behind to fight the war.
It it starting to sound like TW is about to throw everyone under the bus.
In other words, they might be eager to come to a deal which exempts them.
So they will win their battle, set themselves up for future growth, and laugh at those left behind to fight the war.
By definition, TW is only fighting for itself. Remember--the legal theory that seems to have gained favor with the courts is that whether we are regulated as tobacco or pharma depends upon the nature of the advertising/marketing, which is specific to each vendor.
I suspect--although I have absolutely no first-hand (or even second- or third-hand) knowledge--that what is happening is TW is giving various documents to the FDA to show how it markets its e-cigarettes. I'm sure TW is giving safety and testing data as well.
So I guess what I'm saying is that, no, I don't think TW is throwing anyone under the bus.
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