SE, NJoy vs FDA -- court dockets / updates
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I'm sure this has been posted previously, but since the FDA's brief is due soon, I thought it might be helpful to repost the briefing schedule:
Appellants' Brief May 24, 2010
Appendix May 24, 2010
Appellees' Brief June 23, 2010
Amicus Curiae for Appellees' Brief July 8, 2010
Appellants' Reply Brief July 22, 2010
Appellant = FDA
Appellees = SE and njoy
Amicus Curiae for Appellees = Washington Legal Foundation
Appellants' Brief May 24, 2010
Appendix May 24, 2010
Appellees' Brief June 23, 2010
Amicus Curiae for Appellees' Brief July 8, 2010
Appellants' Reply Brief July 22, 2010
Appellant = FDA
Appellees = SE and njoy
Amicus Curiae for Appellees = Washington Legal Foundation
This Docket entry showing that the Judge is skipping right over SE's request for a TRO and moving right to a hearing on action of the Preliminary Injuction is very intersting. The Court has chosen to take the issue head on at the hearing. It speaks volumes to me. This thread will be cleared regularly to discuss events of the day and posts will be either deleted or moved here http://www.e-cigarette-forum.com/fo...verywhere-v-fda-daily-off-topic-posts-14.html depending on time constrants on a regular basis so that the thread stays clear. Please note this ---Sun
Richard J. Leon on 5/1/2009.(lcrjl1)
Filed & Entered:
05/01/2009Order on Motion for Order
Docket Text:
MINUTE ORDER. Based on a conference today with counsel for both
parties, the Court will treat plaintiff's [2] motion for a temporary restraining order as
a motion for a preliminary injunction. The following briefing schedule shall apply:
defendants' response to plaintiff's motion due by close of business 5/11/2009;
plaintiff's reply due by close of business 5/14/2009. A hearing on plaintiff's motion
is set for 5/15/2009 4:00 pm in Courtroom 18. Defendants' [8] motion to establish
briefing schedule for preliminary injunction is DENIED as moot. Signed by Judge
parties, the Court will treat plaintiff's [2] motion for a temporary restraining order as
a motion for a preliminary injunction. The following briefing schedule shall apply:
defendants' response to plaintiff's motion due by close of business 5/11/2009;
plaintiff's reply due by close of business 5/14/2009. A hearing on plaintiff's motion
is set for 5/15/2009 4:00 pm in Courtroom 18. Defendants' [8] motion to establish
briefing schedule for preliminary injunction is DENIED as moot. Signed by Judge
Richard J. Leon on 5/1/2009.(lcrjl1)
Last edited by a moderator:
The Court Docket shows that on the hearing held on May 15, 2008, the Honorable Judge Leon allowed NJOY's Motion to Intervene into the case and further heard all parties on the merits of the Motion for a Prelimnary Injunction. The Judge's ruling is now under advisement--all that can be done now is to wait for his decision-----Sun
On the Docket Sheet today, NJOY's Reply Brief was filed. In its Reply Motion NJOY argued that it would take 1 billion dollars and 8 years to comply with the requisite studies requied should the Court find that the FDA is correct in it's demand that the e-cig is in fact a new drug that needs to go though the application process----all Motions are now under advisement:
Here is an excerpt of the relevant part of NJOY's Brief--
"Finally,
Here is an excerpt of the relevant part of NJOY's Brief--
"Finally,
FDAs assertion ofjurisdiction over E-cigarettes, if left undisturbed, would doom the company. In FDAs view, E-cigarettes are drugs and/or medical devices within the meaning of the FDCA. 21 U.S.C. §~ 321(g)(1); 321(h). Presumably, FDA would require that NJOY submit and obtain FDA approval of a new drug application in order to market and distribute its product. See id. § 353(g)(1). But collection of the data necessary to support a new drug application and FDA review of such a submission takes, on average, over eight years and often requires the investment of sums approaching $1 billion. See Outlook 2009, Tufts Center for the Study of Drug Development, available at http://csdd.tufts.edullnfoServices/OutlookReports.asp
(last visited May 14, 2009). Thus, FDAs assertion ofjurisdiction over this product could have the practical effect of a death sentence for NJOY."
-------------Sun
-------------Sun
The Docket Sheet today advanced no ruling on the Motion for a Preliminary Injuntion, but did advance the Transcript of the hearing subject Redaction. I sense a ruling any day now as this is the normal procedure just prior to a ruling. The hold on releasing the Transcript to the public in no way stalls the release of the Judge's ruling-------Sun
TRANSCRIPT OF PROCEEDINGS before Judge Richard J. Leon of proceedings held on 5/15/09; Court Reporter/Transcriber
For the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purchased from the court reporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter. NOTICE RE REDACTION OF TRANSCRIPTS: The parties have twenty-one days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days.
Redaction Request due 7/6/2009. Redacted Transcript Deadline set for 7/16/2009. Release of Transcript Restriction set for 9/14/2009.(Gels, Patty) (Entered: 06/15/2009)
TRANSCRIPT OF PROCEEDINGS before Judge Richard J. Leon of proceedings held on 5/15/09; Court Reporter/Transcriber
For the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purchased from the court reporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter. NOTICE RE REDACTION OF TRANSCRIPTS: The parties have twenty-one days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days.
Redaction Request due 7/6/2009. Redacted Transcript Deadline set for 7/16/2009. Release of Transcript Restriction set for 9/14/2009.(Gels, Patty) (Entered: 06/15/2009)
Today, SE filed a supplemental brief in support of not rendering their case moot due to the newly signed legislation.
We will now await a reply from the FDA
-------------Sun
We will now await a reply from the FDA
-------------Sun
Today, Judge Leon granted SE's Request to file their Supplemental Motion and Brief in Support thereof and further ordered the FDA to file any Reply by July 6, 2009.
---------Sun
---------Sun
Today, SE filed it Brief supplementing the legal authority it cited in its original pleadings to the Court in light of the passage of the new Tobacco Control Act.
The FDA has until July 6, 2009 to respond. I would expect NJOY to also file supplements. After that the Court will issue a ruling.
Sun
The FDA has until July 6, 2009 to respond. I would expect NJOY to also file supplements. After that the Court will issue a ruling.
Sun
As expected, today NJOY (Sottera, Inc. As Invervenor) also filed a Supplemental Brief again arguing that this is a case of the FDA overstepping its jurisdiction even with the passage of the new legislation of the the Family Smoking Prevention and Tobacco Control Act of 2009
It will be very interesting to see the FDA's response that is due by July 6, 2009.
------------Sun
It will be very interesting to see the FDA's response that is due by July 6, 2009.
------------Sun
The MOTION for Leave to File Supplemental Brief in Support of Motion for Preliminary Injunction by SOTTERA, INC.( NJOY) was granted and it was further ordered that FDA's deadline to file their response, if any, to the supplemental briefs filed by SE and NJOY be extended to July 10, 2009 by Judge Leon.
Sun
Sun
The Docket Sheet today showed the AFFIDAVIT's filed by SE stating that they did indeed mail their submissions to Counsel for the FDA which again is simply another mandatory procedural filing with the Court. The FDA's Reply Brief to both SE's and NJOY's Supplemental Briefs must be filed by Friday......
Sun
Sun
Today the FDA did in fact file its Reply Brief to SE’s and NJOY’s Supplemental Briefs.
The FDA argued under the Federal Food, Drug, and Cosmetic Act ("FDCA"), the new law expands FDA’s jurisdiction by granting it the authority to regulate additional nicotine- and tobacco-containing products that previously were not within FDA’s jurisdiction.
It is now in the hands of Judge Leon for a ruling........................Sun
The FDA argued under the Federal Food, Drug, and Cosmetic Act ("FDCA"), the new law expands FDA’s jurisdiction by granting it the authority to regulate additional nicotine- and tobacco-containing products that previously were not within FDA’s jurisdiction.
It is now in the hands of Judge Leon for a ruling........................Sun
Today the Docket sheet showed that Judge Leon granted the appearance of two counsel for SOTTERA, INC (NJOY) to appear Pro Hac Vice (for this case and this case only as they are not admitted to practice law in this Federal Court). These again were a procedural entry and really has no bearing on the case. It is more of a "housekeeping" entry, as these Attorneys filed their motions with the Court back in May, but the Motions were never acted on.
It is interesting to note that in the FDA’s final Brief, they argue that the FDA's current position is that they are not, according to them, "banning" the e-cig, rather demanding that they go though the application and approval process before they "might" be put on the market.
This process can take years and a whole lot of money. That really constitutes a "defacto ban" in my book, due to the time and expense of the approval process on top of the fact that there is no guarantee that the FDA will ever approve it even after the application is submitted and the studies are done-----
Sun
It is interesting to note that in the FDA’s final Brief, they argue that the FDA's current position is that they are not, according to them, "banning" the e-cig, rather demanding that they go though the application and approval process before they "might" be put on the market.
This process can take years and a whole lot of money. That really constitutes a "defacto ban" in my book, due to the time and expense of the approval process on top of the fact that there is no guarantee that the FDA will ever approve it even after the application is submitted and the studies are done-----
Sun
Today, NJOY filed leave of the Court to reply to the FDA’s reply again arguing that the e-cig is a tobacco product that the FDA does not have jurisdiction to control.
Sun
Sun
Today the Docket sheet shows that Judge Leon, sua sponte, requested another hearing before ruling on SE's request for a Preliminary hearing.
Obvioulsy the Judge has questions and wants to hear from the parties in light of the FDA's findings. The hearing is set for August 17, 2009 at 3PM.
The Judge wants further to discuss the impact of Family Smoking Prevention and Tobacco Control Act with regards to the case.
Sun
Obvioulsy the Judge has questions and wants to hear from the parties in light of the FDA's findings. The hearing is set for August 17, 2009 at 3PM.
The Judge wants further to discuss the impact of Family Smoking Prevention and Tobacco Control Act with regards to the case.
Sun
Today the FDA moved for an extension of time to respond to SE's and NJOY's complaints. The FDA's answer to SE's and NJOY's complaint is due July 27, 2009. The FDA seeks an extension of time to respond to both complaints until 20 days after the Court resolves the preliminary injunction motions that are presently pending or, if this Courts decision on the preliminary injunction motions is appealed within 20 days, within 20 days after the Court of Appeals resolves the appeal.
Since this Motion is assented to by all the parties and is procedural, Judge Leon will most likey approve it.
Sun
Since this Motion is assented to by all the parties and is procedural, Judge Leon will most likey approve it.
Sun
Today the Judge ordered that the FDA's Motion for an Extension of Time to respond to SE and NJOY's complaints be GRANTED.The FDA's respons(s) to SE and NJOY's complaints are due 20 days after this Court resolves the pending preliminary injunction motions or, if this Court's decision on the preliminary injunction motions is appealed within 20 days, within 20 days after the Court of Appeals resolves the appeal.
Appears we are headed for an interlocatory appeal no matter which party prevails on the preliminary injunction.
Sun
Appears we are headed for an interlocatory appeal no matter which party prevails on the preliminary injunction.
Sun
And to think I was asking to much for the ECA to come into the case, I find that ASH is filing a Amicus Curiae Brief with the Court.
Sun
(I did not add the Red here or the font size--that is ASH)
BRIEF AMICUS CURIAE OF ACTION ON SMOKIING AND HEALTH (ASH)
IN SUPPORT OF THE F.D.A.'s JURISDICTION OVER E-CIGARETTES
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
____________________________________
SMOKING EVERYWHERE, INC. )
)
Plaintiff, )
)
and )
)
SOTTERA, INC. d/b/a/ NJOY, )
)
Intervenor-Plaintiff, )
)
v. )
)
U.S. FOOD AND DRUG )
ADMINISTRATION, et al., )
)
Defendants )
_____________________________________
Action on Smoking and Health (ASH) is a national scientific and educational tax-exempt antismoking organization which has been involved for more than thirty years with the legal issues of nicotine, FDA regulation of nicotine and nicotine-delivery devices, and related topics.
ASH seeks by this motion to file a brief amicus curiae (contained herein) to respectfully bring to the Court's attention important information about the potential consequences of any ruling to the effect that the FDA does not have jurisdiction over e-cigarettes (because they are either "tobacco products" or "modified risk tobacco products"), including new information which has just come to light. This information includes:
1. E-cigarettes are now being advertised for use in administering ...... (a prescription-only drug) to users. This indicates a new potential for abuse if the FDA cannot regulate such products.
2. News that e-cigarettes have been found to be "potentially lethal to children," a newly-recognized danger especially if there can be no FDA-imposed age-of-purchaser restrictions on selling the product - which comes in children-friendly fruit flavors - to minors.
3. The very strong concerns by the major national public health and antismoking organizations in this country about the known and potential health hazards of e-cigarettes, especially following the report by the FDA that several samples contained carcinogens and toxic chemicals; all of which are also directly relevant in connection with the factors which must be considered for granting injunctive relief.
Action on Smoking and Health (ASH), by this motion, respectfully seeks leave to file a very short amicus curiae brief, a brief which is included within this document. Unlike Sottera, Inc. d/b/a/ NJOY, to which this Court has granted intervenor status, ASH does not seek to intervene nor to necessarily present oral arguments.
Instead, by and through its included brief amicus curiae, ASH hopes to insure a more complete record for the Court's benefit, and to bring to the Court's attention information which may not now be before it, including new information which has just come to light.
See: Brief Amicus Curiae of ASH in Support of FDA's Jursidction Over E-Cigarettes
Sun
Sun
(I did not add the Red here or the font size--that is ASH)
BRIEF AMICUS CURIAE OF ACTION ON SMOKIING AND HEALTH (ASH)
IN SUPPORT OF THE F.D.A.'s JURISDICTION OVER E-CIGARETTES
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
____________________________________
SMOKING EVERYWHERE, INC. )
)
Plaintiff, )
)
and )
)
SOTTERA, INC. d/b/a/ NJOY, )
)
Intervenor-Plaintiff, )
)
v. )
)
U.S. FOOD AND DRUG )
ADMINISTRATION, et al., )
)
Defendants )
_____________________________________
COMBINED
MOTION FOR LEAVE TO SUBMIT A BRIEF AMICUS CURIAE,
AND BRIEF AMICUS CURIAE IN SUPPORT OF DEFENDANT F.D.A.,
BY ACTION ON SMOKING AND HEALTH (ASH)
MOTION FOR LEAVE TO SUBMIT A BRIEF AMICUS CURIAE,
AND BRIEF AMICUS CURIAE IN SUPPORT OF DEFENDANT F.D.A.,
BY ACTION ON SMOKING AND HEALTH (ASH)
Action on Smoking and Health (ASH) is a national scientific and educational tax-exempt antismoking organization which has been involved for more than thirty years with the legal issues of nicotine, FDA regulation of nicotine and nicotine-delivery devices, and related topics.
ASH seeks by this motion to file a brief amicus curiae (contained herein) to respectfully bring to the Court's attention important information about the potential consequences of any ruling to the effect that the FDA does not have jurisdiction over e-cigarettes (because they are either "tobacco products" or "modified risk tobacco products"), including new information which has just come to light. This information includes:
1. E-cigarettes are now being advertised for use in administering ...... (a prescription-only drug) to users. This indicates a new potential for abuse if the FDA cannot regulate such products.
2. News that e-cigarettes have been found to be "potentially lethal to children," a newly-recognized danger especially if there can be no FDA-imposed age-of-purchaser restrictions on selling the product - which comes in children-friendly fruit flavors - to minors.
3. The very strong concerns by the major national public health and antismoking organizations in this country about the known and potential health hazards of e-cigarettes, especially following the report by the FDA that several samples contained carcinogens and toxic chemicals; all of which are also directly relevant in connection with the factors which must be considered for granting injunctive relief.
MOTION FOR LEAVE TO FILE BRIEF AMICUS CURIAE
Action on Smoking and Health (ASH), by this motion, respectfully seeks leave to file a very short amicus curiae brief, a brief which is included within this document. Unlike Sottera, Inc. d/b/a/ NJOY, to which this Court has granted intervenor status, ASH does not seek to intervene nor to necessarily present oral arguments.
Instead, by and through its included brief amicus curiae, ASH hopes to insure a more complete record for the Court's benefit, and to bring to the Court's attention information which may not now be before it, including new information which has just come to light.
See: Brief Amicus Curiae of ASH in Support of FDA's Jursidction Over E-Cigarettes
Sun
Today the Docket Sheet shows that the MOTION for Leave to File a Brief of Amicus Curiae by JOHN F. BANZHAF (ASH) "Leave to file" was GRANTED by Judge Richard J. Leon and shall become part of the record as filed.
Sure wish there was a filing from us but that is not to be here.
Sun
Sure wish there was a filing from us but that is not to be here.
Sun
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