Smoking Everywhere V. FDA Daily Docket Sheet Update

[Sun Vaporer]

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 Smoking Everywhere V. FDA Daily OLD Posts depending on time constrants on a regular basis so that the thread stays clear. Please note this ---Sun

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

Richard J. Leon on 5/1/2009.(lcrjl1)

[Sun Vaporer]

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

[Sun Vaporer]

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,

FDA’s assertion ofjurisdiction over E-cigarettes, if left undisturbed, would doom the company. In FDA’s 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, FDA’s assertion ofjurisdiction over this product could have the practical effect of a death sentence for NJOY."


-------------Sun

[Sun Vaporer]

Status Update---Today there were no entries on the Docket sheet----Sun

[Sun Vaporer]

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

[Sun Vaporer]

The Docket sheet shows no movement again today. So we are still waiting--Sun

[Sun Vaporer]

Docket Sheet shows no movement again today. Sure is stalled for a Plaintiff seeking a Preliminary Injunction--Sun

[Sun Vaporer]

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 Vaporer]

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

[Sun Vaporer]

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