SE, NJoy vs FDA -- court dockets / updates

[JustJulie]

njoy has filed "Opposition to Motion for Stay Pending Disposition of Petition for Rehearing and Rehearing En Banc."

Note that njoy is not responding to the FDA's request for a rehearing/hearing en banc (which njoy is not permitted to do absent the Court of Appeals asking for a response). Rather, NJOY is arguing about the FDA's request that the stay of Judge Leon's injunction be reinstated until the Court of Appeals disposes of the FDA's request for a rehearing/hearing en banc.

Basically, NJOY is arguing that regardless of what the Court of Appeals does in terms of the FDA's request for a rehearing/hearing en banc, Judge Leon's injunction against the FDA should stand.

Clear as mud?

Oh, and thank you for the birthday wishes, Jerry.

 

[JustJulie]

The alphabet soup group has filed an amicus brief in support of the FDA's request for a rehearing/rehearing en banc.

Once again, I am stunned that some of these people are able to sleep at night.

 

[JustJulie]

No news on the docket.

But I do not come completely empty-handed. As many already know, FDA Deputy Commissioner Sharfstein is resigning. Bill Godshall believes that Sharfstein is the one pushing much of the nicotine/e-cigarette prohibitionist agenda of the FDA. If Bill is correct, then maybe we'll get luckier with the next appointee.

http://online.wsj.com/article/SB10001424052748704723104576061692596851936.html

 

[JustJulie]

Woots!!!!!!



Now every body get back to making some phone calls and faxes for New York. We're on a roll . . . I really, really believe that we can stop this latest New York mess before it gets before the entire Assembly. And then we'll do the same with the NY Senate.

But to make it work, we need some help . . . phone calls and faxes by tomorrow noon EST.

CASAA.org

 

[JustJulie]

Well, a tiny bit of movement today:

02/07/2011 MANDATE ISSUED to Clerk, District Court [10-5032]

I believe this means that the stay the Court of Appeals first placed on Judge Leon's grant of a preliminary injunction has now been officially lifted. Confusing, I know--but Judge Leon issued a preliminary injunction against the FDA, basically telling the FDA it could not seize NJOY's products (and also SE, which is no longer a party in the case) while the case in chief was pending. The FDA appealed that preliminary injunction, and the Court of Appeals stayed Judge Leon's grant of the preliminary injunction. In English, the Court of Appeals said that until it could hear the appeal, Judge Leon's decision was basically on hold.

It is my understanding that the issuance of the mandate means that the stay has been lifted . . . meaning that the FDA officially cannot seize NJOY's products.

More importantly, Yolanda is thinking that this means the case is officially back with Judge Leon.

 

[JustJulie]

Thanks Julie.

Mid morning Saturday here. Beautiful morning...not too hot & good wind for the sails later.

Cheers.

Well, I'm going to forgive your good weather, Clark, because we're having a nice spell here in the Midwest for a change. It's sunny and nearly 50 degrees, which is downright balmy for this time of year.

But the reason why I'm popping in over the weekend when there's clearly no docket update to be offered is because the word is that Totally Wicked is filing a lawsuit against the FDA: Totally Wicked: "UNITED STATES DISTRICT COURT<br/>FOR ..." « Deck.ly

It seems to me that since the legal theories have been fairly well developed (and apparently well-received by the courts), vendors who have a bone to pick with the FDA wouldn't be taking too much of a risk to file a lawsuit. With any luck, Totally Wicked's law suit will be the start of a movement among vendors to put some pressure on the FDA with lawsuits.

 

[JustJulie]

No movement on the NJOY docket (either District Court or Court of Appeals).

That being said, a little birdie tweeted to let me know that TW has indeed filed its lawsuit.

I am having difficulty uploading the Complaint on ECF, so I uploaded it to Scribd: Totally Wicked v. FDA complaint filed 2/15/2011

I was able to attach the Motion for Temporary Restraining Order and Preliminary Injunction and the Memorandum in Support of Motion for Temporary Restraining Order and Preliminary Injunction. I am also attaching the Unopposed Motion for Briefing Schedule. According to that, "Counsel for plaintiff and defendants have agreed that defendants will file a response to the motion for temporary
restraining order and preliminary injunction on Wednesday, February 23, 2011."

Thanks to my friend, Jan, for tweeting me.

 

[JustJulie]

Nothing on the NJOY v. FDA docket (District Court or Court of Appeals).

FDA's response to TW's motion for temporary restraining order and preliminary injunction was due today. Parties filed an unopposed motion for an extension of time today, noting:

The parties are discussing whether this matter can be resolved without further litigation, and defendants hereby request a further extension of time to respond to plaintiff’s motion.

See also Placebo Effects thread on FDA's position: http://www.e-cigarette-forum.com/fo...oduct-classifcation-paducah-sun-kentucky.html

 

[JustJulie]

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 intervenor’s complaint.
Under this Court’s Order of July 27, 2009, defendants’ answer to intervenor’s 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)

 

[JustJulie]

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.

 

[JustJulie]

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:

Plaintiff filed the instant case on February 15, 2011, challenging an FDA decision regarding the detention of a product plaintiff seeks to import. Along with the complaint, plaintiff filed a motion for a temporary restraining order and preliminary injunction. Counsel for plaintiff and defendants agreed last week that defendants would report to the Court on or before Wednesday, March 2, informing the Court of the status of the discussions or with a schedule for resolution of plaintiff’s motion.

The parties are attempting to resolve this matter without further litigation and believe that their discussions will be completed soon. Yesterday, plaintiff submitted a significant amount of material to FDA for review and expects to submit additional materials by March 8. FDA is reviewing the materials that have been submitted to date and will review the forthcoming materials upon receipt.

The parties will submit a report to the Court on or before Wednesday, March 16, informing the Court of the status of the discussions or with a schedule for resolution of plaintiff’s motion.

 

[JustJulie]

I come bearing gifts this evening . . .

Smoke Anywhere (not to be confused with Smoking Everywhere) has filed a motion to intervene in the NJOY v. FDA case currently pending before Judge Leon.

I've attached the motion, the complaint, and the Rule 7.1 certificate. I didn't bother to attach the motions pro hac vice (attorneys not admitted to practice in this particular court asking for permission to do so for this particular case).

This isn't an automatic in . . . Judge Leon will need to rule on the motion.

Game on.

My computer thanks each and every one of you.

 

[JustJulie]

Sorry so late . . . been swamped today.

A status report was filed in the TW v. FDA case saying that the parties are in discussions, and a report is expected by be filed on or before May 13.

I expect the FDA is reviewing documentation provided by TW to determine whether or not TW is making therapeutic claims.

 

[JustJulie]

NJOY v. FDA seems to be truly over. I've attached a copy of the Stipulation and Order of Final Judgment filed today whereby the parties agree that the case has been resolved. Of course, Judge Leon will have to agree, but I can't imagine why he wouldn't. Looks like the FDA isn't going to be arguing that NJOY is making therapeutic claims.

TW v. FDA is still ongoing.

 

[JustJulie]

Hey, guys . . . hope everyone had a great Mother's Day.

Final Order signed by Judge Leon, which disposes of NJOY v. FDA.

TW v. FDA still ongoing.

And everyone is welcome.

 

[JustJulie]

TW has voluntarily dismissed (without prejudice so it can refile if necessary).

I'm attaching the TW voluntary dismissal. Apparently, the FDA felt that TW's marketing material contained some therapeutic claims, and TW, while certainly not agreeing with that assessment, nonetheless made changes requested by the FDA. There's no mention of what those changes were.

And with that, the docket watch is finally done.

I'm sure that eventually, we'll wind up with a thread where we follow the FDA as it proposes regulations . . .