Jan, I'm no legal expert, but since it appears that the FDA has no solid ground for a reconsideration, I would think that the court will quickly deny their request for both the stay and reconsideration.
SE, NJoy vs FDA -- Discussion
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unbelievable! they just won't swallow the pill of defeat...
so what are the chances of them getting a rehearing? seems like the judges won't take kindly to "you're wrong on interpretation"...
and can njoy submit a motion to deny the hearing? anyone?
so what are the chances of them getting a rehearing? seems like the judges won't take kindly to "you're wrong on interpretation"...
and can njoy submit a motion to deny the hearing? anyone?
LOL. I keep posting the citation to the Rules, but I may as well put them right here:
Rule 35. En Banc Determination
(a) When Hearing or Rehearing En Banc May Be Ordered.
A majority of the circuit judges who are in regular active service and who are not disqualified may order that an appeal or other proceeding be heard or reheard by the court of appeals en banc. An en banc hearing or rehearing is not favored and ordinarily will not be ordered unless:
(1) en banc consideration is necessary to secure or maintain uniformity of the courts decisions; or
(2) the proceeding involves a question of exceptional importance.
(b) Petition for Hearing or Rehearing En Banc.
A party may petition for a hearing or rehearing en banc
(1) The petition must begin with a statement that either:
(A) the panel decision conflicts with a decision of the United States Supreme Court or of the court to which the petition is addressed (with citation to the conflicting case or cases) and consideration by the full court is therefore necessary to secure and maintain uniformity of the courts decisions; or
(B) the proceeding involves one or more questions of exceptional importance, each of which must be concisely stated; for example, a petition may assert that a proceeding presents a question of exceptional importance if it involves an issue on which the panel decision conflicts with the authoritative decisions of other United States Courts of Appeals that have addressed the issue.
(2) Except by the courts permission, a petition for an en banc hearing or rehearing must not exceed 15 pages, excluding material not counted under Rule 32.
(3) For purposes of the page limit in Rule 35(b)(2), if a party files both a petition for panel rehearing and a petition for rehearing en banc, they are considered a single document even if they are filed separately, unless separate filing is required by local rule.
(c) Time for Petition for Hearing or Rehearing En Banc.
A petition that an appeal be heard initially en banc must be filed by the date when the appellees brief is due. A petition for a rehearing en banc must be filed within the time prescribed by Rule 40 for filing a petition for rehearing.
(d) Number of Copies.
The number of copies to be filed must be prescribed by local rule and may be altered by order in a particular case.
(e) Response.
No response may be filed to a petition for an en banc consideration unless the court orders a response.
(f) Call for a Vote.
A vote need not be taken to determine whether the case will be heard or reheard en banc unless a judge calls for a vote.
**************
Rule 40. Petition for Panel Rehearing
(a) Time to File; Contents; Answer; Action by the Court if Granted.
(1) Time.
Unless the time is shortened or extended by order or local rule, a petition for panel rehearing may be filed within 14 days after entry of judgment. But in a civil case, if the United States or its officer or agency is a party, the time within which any party may seek rehearing is 45 days after entry of judgment, unless an order shortens or extends the time.
(2) Contents.
The petition must state with particularity each point of law or fact that the petitioner believes the court has overlooked or misapprehended and must argue in support of the petition. Oral argument is not permitted.
(3) Answer.
Unless the court requests, no answer to a petition for panel rehearing is permitted. But ordinarily rehearing will not be granted in the absence of such a request.
(4) Action by the Court.
If a petition for panel rehearing is granted, the court may do any of the following:
(A) make a final disposition of the case without reargument;
(B) restore the case to the calendar for reargument or resubmission; or
(C) issue any other appropriate order.
(b) Form of Petition; Length.
The petition must comply in form with Rule 32. Copies must be served and filed as Rule 31 prescribes. Unless the court permits or a local rule provides otherwise, a petition for panel rehearing must not exceed 15pages.
Petitions for panel rehearings are actually very rarely granted; rehearings en banc, as you can see above in red, are "not favored" and granted even more rarely.
thanks for that - i missed your previous reply...
so long story short...it looks like it will slant in our favor...
just when i was able to relax at night...the FDA has me doubling up on sleeping pills again!
so long story short...it looks like it will slant in our favor...
just when i was able to relax at night...the FDA has me doubling up on sleeping pills again!
If the court asks for an answer, it is: "As already made plain by the opinion of Judge Garland, even outside Brown & Williamson, "products made or derived from tobacco and accessories" are very clearly defined as "tobacco products" under the Tobacco Act. FDA's attempt shoehorn "isolated nicotine products" into FDCA represents a refusal to follow the directive of Congress. In their petition, FDA intentionally and maliciously re-interprets the provisions of FSPTCA for modified risk tobacco products under drug and device provisions (p.17)."
Instead of submitting garbage like this, why isn't the FDA actually IMPLEMENTING the Tobacco Act?!? The FDA has not shown a single regulatory concern over e-cigarettes that would not be addressed by regulation under the Tobacco Act, yet they simply refuse to follow the mandate of Congress. If I remember correctly, FDA was supposed to promulgate regulations for tobacco products in place over a year ago with a fast track for Modified Risk Tobacco Products...which they don't seem to have even BEGUN.
Instead of submitting garbage like this, why isn't the FDA actually IMPLEMENTING the Tobacco Act?!? The FDA has not shown a single regulatory concern over e-cigarettes that would not be addressed by regulation under the Tobacco Act, yet they simply refuse to follow the mandate of Congress. If I remember correctly, FDA was supposed to promulgate regulations for tobacco products in place over a year ago with a fast track for Modified Risk Tobacco Products...which they don't seem to have even BEGUN.
Are not such motions either accepted or denied very quickly ? as in by the end of the week ?
How long has it been since their hearing on menthol and what exactly have they decided? That's an indication of the FDA's desire to meet congress's mandates. The FDA is too busy trying to ban PVs and take control of our food (and possibly water?} supply to worry about promulgating modified risk regulation. I could work those regs out easy for them. A modified risk product is any already FDA approved "safe and effective" NRT product that the manufacturer, in this case BP, would like to market for long term use rather than a 12 week program. Promulgation complete..........
At the FDA hearing on Long Term Use of NRTs, attorney Scott Ballin suggested that very idea. He submitted written testimony. http://www.casaa.org/files/Ballin-Comments-NRT.pdf
wow these fda are a pain
with no exceptional importance, cant see the judges wanting to be proved wrong
if this appeal gets turned down what are the next steps for the fda??
does go to the supreme court or back down to judge leons court?
ive read here these rehearing en bance appeals are not usually accepted. what are your opinions??
is this a procedural step that the fda is proceeding to go to the supreme court?
do you think the njoy attorneys knew this fda appeal was going to take place and do you think they are confident of never being granted by the federal court judges?
ty
with no exceptional importance, cant see the judges wanting to be proved wrong
if this appeal gets turned down what are the next steps for the fda??
does go to the supreme court or back down to judge leons court?
ive read here these rehearing en bance appeals are not usually accepted. what are your opinions??
is this a procedural step that the fda is proceeding to go to the supreme court?
do you think the njoy attorneys knew this fda appeal was going to take place and do you think they are confident of never being granted by the federal court judges?
ty
My my that FDA is a pesky group. Maybe someone just needs to wish them some good cheer!
Merry Christmas FDA!
Wiz!
Merry Christmas FDA!
Wiz!
Looks like it. After all, it isn't their money they are spending on attorneys and court costs. It's YOUR money and MY money. Meanwhile, they are boo-hooing that the products are ungregulated. Just like a teenager who refuses to lift a finger around the house complaining that there are no clean dishes in the cupboard.
Folks:
The FDA was dealt a serious blow to its authority and it is acting in desperation to try and save a few careers. Tactically they played into a huge trap and now they are stuck. By classifying this as a tobacco product and arguing along the Brown and Williamson case line we put FDA into a very difficult position legally. I expected that they would not try and agree that this is a tobacco product but would rather fight to the end that it is a drug/device which would walk them into the same logic path in Brown and Williamson. Brown and Williamson really does not make sense if you really dig into the logic but it is the law. If a burning cigarette is not a drug/device that delivers nicotine neither can a battery powered one be a drug/device - changing the mode of action from combustion to electronic thermal gradient increase to get nicotine out of a tobacco product doesn't change the ultimate nature of the "device". Now that the e-cigarette is effectively linked to conventional cigarettes the only real way to undo this is to re-write Brown and Williamson which will impact the tobacco industry - not likely. Filing for re-hearing and taking as many cuts at the apple as possible gives FDA political cover and that is what the bureaucrats seek right now. Enjoy the moment and the fact that the more attention and debate this gets the more difficult it is to deny the simple truth that in the end, an electronic cigarette is a less harmful way to "enjoy" the primary desired component of tobacco - nicotine. Once you get the argument to the real issue - whether humans can use nicotine as a recreational product - you will have many allies in the tobacco industry.
The FDA was dealt a serious blow to its authority and it is acting in desperation to try and save a few careers. Tactically they played into a huge trap and now they are stuck. By classifying this as a tobacco product and arguing along the Brown and Williamson case line we put FDA into a very difficult position legally. I expected that they would not try and agree that this is a tobacco product but would rather fight to the end that it is a drug/device which would walk them into the same logic path in Brown and Williamson. Brown and Williamson really does not make sense if you really dig into the logic but it is the law. If a burning cigarette is not a drug/device that delivers nicotine neither can a battery powered one be a drug/device - changing the mode of action from combustion to electronic thermal gradient increase to get nicotine out of a tobacco product doesn't change the ultimate nature of the "device". Now that the e-cigarette is effectively linked to conventional cigarettes the only real way to undo this is to re-write Brown and Williamson which will impact the tobacco industry - not likely. Filing for re-hearing and taking as many cuts at the apple as possible gives FDA political cover and that is what the bureaucrats seek right now. Enjoy the moment and the fact that the more attention and debate this gets the more difficult it is to deny the simple truth that in the end, an electronic cigarette is a less harmful way to "enjoy" the primary desired component of tobacco - nicotine. Once you get the argument to the real issue - whether humans can use nicotine as a recreational product - you will have many allies in the tobacco industry.
fda is crying its unregulated but the courts are stating simply to regulate it as a tobacca product.
its getting very obvious that fda is following BT and BP orders. its getting outright corrupt.
funny how BT spent millions $$$ to get the tobbacca act passed in the supreme court is going to bite their asse this time around.
its all about the $$$$
fda is going to mud in their faces
its getting very obvious that fda is following BT and BP orders. its getting outright corrupt.
funny how BT spent millions $$$ to get the tobbacca act passed in the supreme court is going to bite their asse this time around.
its all about the $$$$
fda is going to mud in their faces
Thank you so much for your great explaination! I hope and keep my fingers cxrossed that you & your firm will get paid for all the hard work you put in!
Merry Christmas.
Karen
Thanks Legal One. Personally, I think that the FDA is arrogant, so I will enjoy watching them squirm.
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Thanks Legal One - that its what I thougt was happening, although I am not an attorney so I really didn't know. While I agree with your observation of "seeking political cover" it does bring up two questions: one, what is this 'political cover your a**' actually costing the American Taxpayers and two, won't this inevitably work against them over time in the eyes of the court - arguing the same "losing" arguments, while not doing anything (as Thulium mentioned) to regulate the product under their existing jurisdiction - does this not expose a significant degree of disingenuiness in terms of their stated goal which they indicate is " we are acting on behalf of public health." ?
No news on the docket.
Here's some information from The Handbook of Practice and Internal Procedures for the D.C. Court of Appeals:
B. RECONSIDERATION
1. Rehearing by the Panel
(See Fed. R. App. P. 32, 35, 40; D.C. Cir. Rule 35.)
Very few petitions for rehearing are granted. Sanctions may be imposed as a penalty for filing a petition for rehearing found to be wholly without merit.
A party seeking rehearing must file a petition within 30 days after entry of the judgment if the United States or an agency or officer thereof is not a party to the case, and within 45 days if the United States or an agency or officer thereof is a party. These time limits will not be extended except for good cause shown.
The petition must state with particularity the errors that the panel is claimed to have made. An original and 4 copies must be filed. A copy of the panel's opinion, a Rule 28(a)(1)(A) certificate of parties and amici, and any disclosure statement required by Circuit Rule 26.1 must be attached as an addendum to the petition. See D.C. Cir. Rule 35(c). The form of a petition for rehearing is governed by Federal Rule of Appellate Procedure 32, and the petition may not exceed 15 pages. See Fed. R. App. P. 35(b)(2), 40(b); D.C. Cir. Rule 35(b). Motions to exceed this page limitation are viewed with disfavor and will be granted only for extraordinarily compelling reasons.
A response to the petition is not permitted unless the panel requests one. A petition for rehearing,
however, will not ordinarily be granted, nor will an opinion or judgment be modified in any significant respect, in the absence of a request by the Court for a response.
The Clerk does not send the mandate to the district court or agency until a timely petition for rehearing has been decided, unless the Court expressly so orders. The Clerk also will delay issuing the mandate when a party moves for an extension of the time within which to petition for rehearing or rehearing en banc. A timely petition for rehearing or rehearing en banc extends the time for petitioning the United States Supreme Court for a writ of certiorari.
The Clerk’s Office transmits the petition to the panel members via an electronic vote sheet. When
voting is complete, the Clerk enters an appropriate order for the Court. If a petition for rehearing en banc also has been filed, the Clerk will withhold entry of an order denying rehearing by the panel until the en banc question has been resolved. If rehearing en banc is granted, the panel's judgment, but ordinarily not its opinion, is vacated, but the panel may act on the petition for rehearing without waiting for final termination of the en banc proceeding. On termination of the en banc proceeding (including when the en banc Court divides evenly), a new judgment will be issued.
2. Rehearing En Banc
(See Fed. R. App. P. 35; D.C. Cir. Rule 35.)
Like petitions for rehearing by a panel, petitions for rehearing en banc are frequently filed but rarely granted. Federal Rule of Appellate Procedure 35(a) expressly states that en banc hearings are not favored and ordinarily will not be ordered except to secure or maintain uniformity of decisions among the panels of the Court, or to decide questions of exceptional importance.
The formal requirements for a petition for rehearing en banc partly duplicate, and partly differ from,
those for a petition for rehearing by the panel. The petition must be filed within 30 days after entry of the judgment if the United States or an agency or officer thereof is not a party, and within 45 days if the United States or an agency or officer thereof is a party. It must begin with a section that sets forth why the case is of exceptional importance or cites the decisions with which the panel judgment is claimed to be in conflict.
An original and 19 copies must be filed. As with panel rehearing petitions, a copy of the panel opinion, a Rule 28(a)(1)(A) certificate of parties and amici, and any disclosure statement required by Circuit Rule 26.1 must be attached as an addendum to the petition. See D.C. Cir. Rule 35(c). The petition may not exceed 15 pages in length. Motions to exceed this limitation are viewed with disfavor and will be granted only for extraordinarily compelling reasons.
If a party is submitting both a petition for rehearing by the panel and a petition for rehearing en banc, the two should be combined in the same document, in which event an original and 19 copies must be filed, and the page limit for the combined pleading is 15. If the two pleadings are filed separately, they may not, combined, exceed this page limit.
As in the case of petitions for panel rehearing, the rules do not provide for a response to a petition for rehearing en banc, except by request of the Court. If any member of the Court wishes a response, the Clerk will enter an order to that effect. There is no oral argument on the question whether rehearing en banc should be granted.
The Clerk’s Office transmits a vote sheet and the petition for rehearing en banc electronically to all
members of the original panel, including a senior judge of this Court, and to all other active judges of this Court. A vote may be requested by an active judge of the Court, or by any member of the panel. If no judge asks for a vote within a specified time, and none requests more time to consider the matter, the Clerk will enter an order denying the petition.
If a judge calls for a vote on the petition for rehearing en banc, the Clerk’s Office transmits
electronically to the full Court a new vote sheet, along with any response to the petition ordered by the Court. The question now is whether there should be a rehearing en banc. On this question only active judges of the Court may vote, and a majority of all active judges who are not recused must approve rehearing en banc in order for it to be granted.
When rehearing en banc is granted, the Clerk enters an order granting the rehearing en banc and
vacating the judgment by the original panel, either in whole or in part, as circumstances warrant. This order is posted on the Court’s web site and is published in the federal reporter system. An order granting rehearing en banc does not indicate the names of the judges who voted against rehearing, but an order denying rehearing en banc does indicate the names of the judges who voted to grant rehearing en banc, if they wish.
The Court has followed a variety of procedures in conducting rehearing en banc. On occasion, only the original briefs have been considered; in other cases, the Court has requested supplemental briefs. The Court almost always hears oral argument in considering a case en banc.
The Court sitting en banc consists of all active judges, plus any senior judges of the Court who were members of the original panel and wish to participate. When the Court sits en banc with an even number of judges, and the result is an evenly divided vote, the Court will enter a judgment affirming the order or judgment under review, and it may publish the en banc Court's divided views.
In the absence of a request from a party, any active judge of the Court, or member of the panel, may suggest that a case be reheard en banc. If a majority of the active judges who are not recused agree, the Court orders rehearing en banc.
In addition, a party may move for en banc consideration prior to a panel decision. Such a petition must include a concise statement of the issue and its importance and conform to the other requirements of Federal Rule of Appellate Procedure 35(c). If a party wishes a case to be heard initially en banc, counsel ideally should file the petition within the first 30 days after docketing, but in no event later than the date on which the appellee's or the respondent's brief is due. A judge also may suggest en banc consideration prior to the panel decision; on occasion this has been done by the panel itself.
********************
http://www.cadc.uscourts.gov/internet/home.nsf/Content/VL%20-%20RPP%20-%20Handbook%202006%20Rev%202007/$FILE/handbook20091201rev20091106.pdf
I'm sorry the link stinks . . . never was good with that. But if you copy the whole thing, and then paste into a browser window, it should work.
Here's some information from The Handbook of Practice and Internal Procedures for the D.C. Court of Appeals:
B. RECONSIDERATION
1. Rehearing by the Panel
(See Fed. R. App. P. 32, 35, 40; D.C. Cir. Rule 35.)
Very few petitions for rehearing are granted. Sanctions may be imposed as a penalty for filing a petition for rehearing found to be wholly without merit.
A party seeking rehearing must file a petition within 30 days after entry of the judgment if the United States or an agency or officer thereof is not a party to the case, and within 45 days if the United States or an agency or officer thereof is a party. These time limits will not be extended except for good cause shown.
The petition must state with particularity the errors that the panel is claimed to have made. An original and 4 copies must be filed. A copy of the panel's opinion, a Rule 28(a)(1)(A) certificate of parties and amici, and any disclosure statement required by Circuit Rule 26.1 must be attached as an addendum to the petition. See D.C. Cir. Rule 35(c). The form of a petition for rehearing is governed by Federal Rule of Appellate Procedure 32, and the petition may not exceed 15 pages. See Fed. R. App. P. 35(b)(2), 40(b); D.C. Cir. Rule 35(b). Motions to exceed this page limitation are viewed with disfavor and will be granted only for extraordinarily compelling reasons.
A response to the petition is not permitted unless the panel requests one. A petition for rehearing,
however, will not ordinarily be granted, nor will an opinion or judgment be modified in any significant respect, in the absence of a request by the Court for a response.
The Clerk does not send the mandate to the district court or agency until a timely petition for rehearing has been decided, unless the Court expressly so orders. The Clerk also will delay issuing the mandate when a party moves for an extension of the time within which to petition for rehearing or rehearing en banc. A timely petition for rehearing or rehearing en banc extends the time for petitioning the United States Supreme Court for a writ of certiorari.
The Clerk’s Office transmits the petition to the panel members via an electronic vote sheet. When
voting is complete, the Clerk enters an appropriate order for the Court. If a petition for rehearing en banc also has been filed, the Clerk will withhold entry of an order denying rehearing by the panel until the en banc question has been resolved. If rehearing en banc is granted, the panel's judgment, but ordinarily not its opinion, is vacated, but the panel may act on the petition for rehearing without waiting for final termination of the en banc proceeding. On termination of the en banc proceeding (including when the en banc Court divides evenly), a new judgment will be issued.
2. Rehearing En Banc
(See Fed. R. App. P. 35; D.C. Cir. Rule 35.)
Like petitions for rehearing by a panel, petitions for rehearing en banc are frequently filed but rarely granted. Federal Rule of Appellate Procedure 35(a) expressly states that en banc hearings are not favored and ordinarily will not be ordered except to secure or maintain uniformity of decisions among the panels of the Court, or to decide questions of exceptional importance.
The formal requirements for a petition for rehearing en banc partly duplicate, and partly differ from,
those for a petition for rehearing by the panel. The petition must be filed within 30 days after entry of the judgment if the United States or an agency or officer thereof is not a party, and within 45 days if the United States or an agency or officer thereof is a party. It must begin with a section that sets forth why the case is of exceptional importance or cites the decisions with which the panel judgment is claimed to be in conflict.
An original and 19 copies must be filed. As with panel rehearing petitions, a copy of the panel opinion, a Rule 28(a)(1)(A) certificate of parties and amici, and any disclosure statement required by Circuit Rule 26.1 must be attached as an addendum to the petition. See D.C. Cir. Rule 35(c). The petition may not exceed 15 pages in length. Motions to exceed this limitation are viewed with disfavor and will be granted only for extraordinarily compelling reasons.
If a party is submitting both a petition for rehearing by the panel and a petition for rehearing en banc, the two should be combined in the same document, in which event an original and 19 copies must be filed, and the page limit for the combined pleading is 15. If the two pleadings are filed separately, they may not, combined, exceed this page limit.
As in the case of petitions for panel rehearing, the rules do not provide for a response to a petition for rehearing en banc, except by request of the Court. If any member of the Court wishes a response, the Clerk will enter an order to that effect. There is no oral argument on the question whether rehearing en banc should be granted.
The Clerk’s Office transmits a vote sheet and the petition for rehearing en banc electronically to all
members of the original panel, including a senior judge of this Court, and to all other active judges of this Court. A vote may be requested by an active judge of the Court, or by any member of the panel. If no judge asks for a vote within a specified time, and none requests more time to consider the matter, the Clerk will enter an order denying the petition.
If a judge calls for a vote on the petition for rehearing en banc, the Clerk’s Office transmits
electronically to the full Court a new vote sheet, along with any response to the petition ordered by the Court. The question now is whether there should be a rehearing en banc. On this question only active judges of the Court may vote, and a majority of all active judges who are not recused must approve rehearing en banc in order for it to be granted.
When rehearing en banc is granted, the Clerk enters an order granting the rehearing en banc and
vacating the judgment by the original panel, either in whole or in part, as circumstances warrant. This order is posted on the Court’s web site and is published in the federal reporter system. An order granting rehearing en banc does not indicate the names of the judges who voted against rehearing, but an order denying rehearing en banc does indicate the names of the judges who voted to grant rehearing en banc, if they wish.
The Court has followed a variety of procedures in conducting rehearing en banc. On occasion, only the original briefs have been considered; in other cases, the Court has requested supplemental briefs. The Court almost always hears oral argument in considering a case en banc.
The Court sitting en banc consists of all active judges, plus any senior judges of the Court who were members of the original panel and wish to participate. When the Court sits en banc with an even number of judges, and the result is an evenly divided vote, the Court will enter a judgment affirming the order or judgment under review, and it may publish the en banc Court's divided views.
In the absence of a request from a party, any active judge of the Court, or member of the panel, may suggest that a case be reheard en banc. If a majority of the active judges who are not recused agree, the Court orders rehearing en banc.
In addition, a party may move for en banc consideration prior to a panel decision. Such a petition must include a concise statement of the issue and its importance and conform to the other requirements of Federal Rule of Appellate Procedure 35(c). If a party wishes a case to be heard initially en banc, counsel ideally should file the petition within the first 30 days after docketing, but in no event later than the date on which the appellee's or the respondent's brief is due. A judge also may suggest en banc consideration prior to the panel decision; on occasion this has been done by the panel itself.
********************
http://www.cadc.uscourts.gov/internet/home.nsf/Content/VL%20-%20RPP%20-%20Handbook%202006%20Rev%202007/$FILE/handbook20091201rev20091106.pdf
I'm sorry the link stinks . . . never was good with that. But if you copy the whole thing, and then paste into a browser window, it should work.
It seems from the opinions expressed by the Judicial Branch during the course of this case that they know this quite well.
In fact, I suspect this is a pissing contest that the FDA is purposely putting them through at this point.
They have to know they are going to lose, and they don't seem to care.
In other words, I think the court already has a pretty low opinion of the FDA and what they keep trying to do.
But because of that I don't think this will necessarily change things much.
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