Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY
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Today there was no movement on the Docket Sheet again. We are still waiting for a the FDA to respond to the SE's Sup. Brief which is due by July 6, 2009
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)
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
Status Update--No update on the Docket Sheet again today, May 28. 2009---Maybe tommorrow there will be a decision. I am being to wonder if the Judge does not see any harm here --I hope that is not the case as the Motion really should have been acted on by now. Judge Leon's lack of a timely decision may indicate that he just does not see a substantial threat of irreparable damage or injuryif the injunction is not granted. But lets just wait--hopefully there will be a decision tommorrow-------Sun
Docket Sheet shows no movement again today. Sure is stalled for a Plaintiff seeking a Preliminary Injunction--Sun
Again, there is no movement on the docket today. Really thinking three weeks out from the date of the hearing, that Judge Leon does not see any harm to SE of NJOY in holding up their supplies and not granting a Perliminary Injunction quickly. ----------
-----Sun
-----Sun
Other then a procedural entry about a Certificate of Service, Again there was no movement on the Docket Sheet today. Either this is very difficult or very easy to understand depending on how you view it-------Sun
Again today going into the weekend, there is no movement on the Docket Sheet. Looks like we are into next week for any decision. For a Preliminary Injuction Motion to not be acted on after 3 full weeks is really out of the norm by any standards------I will keep posting updates till a decision comes down---------Sun
Today the Docket Sheet again shows no movement at the time the Clerk's Office closed------Sun
The Docket Sheet today again shows no movement today. I expect now that the Senate has passed the bill and it is about to become law soon that the FDA has jurisdiction over tobaccco, that we will see a ruling on SE and NJOY's Motion as the issue is moot.
The SE and NJOY argued that the FDA did not have jurisdiction as the e-cig is a "tobacco" product and the FDA had no jusridiction over them. IMO, with the new bill almost ready to be signed into law giving the FDA full jurisdiction over tobacco products, Judge Leon really does not have many options here but to render the jurisdiction question moot.------------Sun
The SE and NJOY argued that the FDA did not have jurisdiction as the e-cig is a "tobacco" product and the FDA had no jusridiction over them. IMO, with the new bill almost ready to be signed into law giving the FDA full jurisdiction over tobacco products, Judge Leon really does not have many options here but to render the jurisdiction question moot.------------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)
The Docket Sheet today shows no movement on the Judge's decision. From what I understand, the decision is coming very soon.----
Sun
Sun
The Docket Sheet today again showed no movement in the case. Time is running--------Sun
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