Well, the devil never takes a holiday . . . the alphabet soup group of "charities" filed its amicus brief today as well (attached).
SE, NJoy vs FDA -- court dockets / updates
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Well, looks like we won't have easy access to the Appendix . . . since it's more than 500 pages, it was filed in paper form (and not electronically). The attached is the notice filed by the FDA to that effect.
Well, in a somewhat surprising turn of events, SE filed for a voluntary dismissal from the case. Apparently, it filed in the district court last week, and I missed it because it never occurred to me that anything exciting would happen in the district court while the matter is on appeal. Today, SE filed notice of the dismissal in the Court of Appeals (document attached).
No, this is not good news. On the other hand, it's not devastating. njoy is still very much in the game, and it will be filing its brief tomorrow.
And, yes, I will check the docket a couple of times during the day and post the brief as soon as it becomes available.
No, this is not good news. On the other hand, it's not devastating. njoy is still very much in the game, and it will be filing its brief tomorrow.
And, yes, I will check the docket a couple of times during the day and post the brief as soon as it becomes available.
24-hour filing is probably great for the lawyers . . . but not so great for the docket-watchers. 
njoy's brief still hasn't hit the PACER system yet, but I'll check again later this evening.
However, the Court of Appeals did announce the date for oral arguments: September 23rd, 2010.
njoy's brief still hasn't hit the PACER system yet, but I'll check again later this evening.However, the Court of Appeals did announce the date for oral arguments: September 23rd, 2010.
njoy's brief filed today, and it's a good one. It was too large to upload here, so I uploaded it to scribd:
http://www.scribd.com/doc/33475929/NJOY-Brief-Ct-app
It was too large to upload here, so I uploaded it to scribd:http://www.scribd.com/doc/33475929/NJOY-Brief-Ct-app
Excitement! Happiness! Joy!
One expected and one a bit of a surprise . . . and all wonderful.
One expected and one a bit of a surprise . . . and all wonderful.
I got all excited reviewing the docket today because something was filed. But it turned out to be nothing interesting . . . just a corrected brief and motion (Smokefree amicus petition). Looks like some non-substantive certification was left off the brief, so they took care of the error.
But I'm attaching the documents anyway in case folks are interested in reviewing them.
Tomorrow should bring a bit of excitement with the filing of the FDA's brief.
But I'm attaching the documents anyway in case folks are interested in reviewing them.
Tomorrow should bring a bit of excitement with the filing of the FDA's brief.
FDA Reply Brief is attached.
No, I haven't read it, but I will read it this evening.
No, I haven't read it, but I will read it this evening.
No, not a docket update, but an interesting read: The Rest of the Story: Tobacco News Analysis and Commentary: FDA Reply Brief in NJOY Electronic Cigarette Case is Not Compelling Because It Ignores FDA Tobacco Law
Good news . . . the Court of Appeals has accepted the Smokefree amicus brief (filed by Smokefree Pennsylvania, American Council on Science and Health, CASAA, National Vapers Club, Midwest Vapers Group, Michael Siegel, and Joel Nitzkin).
(As a reminder, Washington Legal Foundation had previously been granted approval to participate as amicus curiae due to its timely filing of its notice.)
(As a reminder, Washington Legal Foundation had previously been granted approval to participate as amicus curiae due to its timely filing of its notice.)
It's not a hearing; it's an oral argument. In the US Court of Appeals for the DC Circuit. Appeals in the federal courts of appeal are assigned to a panel of three judges. The order calendaring this case for argument spells out the panel to hear it, as follows:
"It is ORDERED, on the court's own motion, that this case be scheduled for oral argument on September 23, 2010, at 9:30 A.M., before Circuit Judges Garland and Kavanaugh and Senior Circuit Judge Williams."
Here's the September Calendar: http://www.cadc.uscourts.gov/bin/calendar/60day.html
You can read short bios of the judges here: U.S. Court of Appeals - D.C. Circuit - Judges
But you won't really get a sense of how they might lean without researching their opinions in prior cases (or asking someone who is familiar with the decisions coming out of their court). Not practicing either in federal courts in general nor in the DC circuit specifically, I confess total ignorance on them.
It should, of course, come as a shock to no one that there was no movement on the docket today.
But I do not come empty-handed. While not specifically regarding the SE/NJOY v. FDA case, this article does have a quote or two from Ray Story, who as many know, is one of the owners of Smoking Everywhere, and the article makes mention of how he is in litigation with another owner, Taieb.
The Associated Press: E-cigarette maker agrees to halt sales in Oregon
Oh, yes . . . and, as always, you're very welcome, Jerry.
But I do not come empty-handed.
While not specifically regarding the SE/NJOY v. FDA case, this article does have a quote or two from Ray Story, who as many know, is one of the owners of Smoking Everywhere, and the article makes mention of how he is in litigation with another owner, Taieb.The Associated Press: E-cigarette maker agrees to halt sales in Oregon
Oh, yes . . . and, as always, you're very welcome, Jerry.
No movement per se, but there were some filings.
First, a letter to the clerk of the court from the FDA providing notification that it sent 5 warning letters to e-cigarette companies as well as to the ECA. (Document attached.)
Second, a court order regarding the oral argument schedule, giving 15 minutes to each side to argue, as well as identifying the panel of judges: Circuit Judges Garland and Kavanaugh, and Senior Circuit Judge Williams. (Document attached.)
Also, attorneys who are making the arguments filed their Form 72s today (not available through Pacer). Attorneys identified are Alisa B. Klein, on behalf of Appellants FDA, Margaret Hamburg, Kathleen Sebelius and HHS; and Gregory G. Garre, on behalf of Appellee Sottera, Inc.
First, a letter to the clerk of the court from the FDA providing notification that it sent 5 warning letters to e-cigarette companies as well as to the ECA. (Document attached.)
Second, a court order regarding the oral argument schedule, giving 15 minutes to each side to argue, as well as identifying the panel of judges: Circuit Judges Garland and Kavanaugh, and Senior Circuit Judge Williams. (Document attached.)
Also, attorneys who are making the arguments filed their Form 72s today (not available through Pacer). Attorneys identified are Alisa B. Klein, on behalf of Appellants FDA, Margaret Hamburg, Kathleen Sebelius and HHS; and Gregory G. Garre, on behalf of Appellee Sottera, Inc.
Oral Arguments were heard today in the U.S. District Court of Appeals for the District of Columbia
Judges Garland, Kavanaugh and Williams (Links to their profiles below)
U.S. Court of Appeals - D.C. Circuit - Merrick B. Garland (202) 216-7460
U.S. Court of Appeals - D.C. Circuit - Brett M. Kavanaugh (202) 216-7180
U.S. Court of Appeals - D.C. Circuit - Stephen F. Williams (202) 216-7210
Case # 10-5032 Sottera, Inc. v. FDA 15 min per side
Appearing for NJOY, Gregory G. Garre, Latham & Watkins, LLP. Latham & Watkins LLP - Attorney Biography
Appearing for FDA, Alisa B. Klein, U.S. Department of Justice Georgetown Law - J.D. Adjunct Faculty
The first person I recognized waiting outside the courtroom was everyone's favorite law professor, John Banzhaf, Executive Director of Action on Smoking and Health (ASH). I saw him go over to speak the DOJ attorney representing the FDA. He asked her about the content of her argument, but she demurred, telling him that he should read the brief and that she did not want to "mischaracterize" their position. Next I overheard him making a phone call presumably to his office. He sounded a bit concerned. He told the person on the other end that they needed to get ahold of Michelle because he (Banzhaf) had gotten the time wrong. He thought the arguments started at 10:30 but they actually were starting this case at 9:30. He also said something about a press release.
Lucky him, he got to hang on to his cell phone. Mine was confiscated at the security station when I entered the building because I am not an attorney. They did return my phone when I left. It's possible they might have let me hang on to it, had it not been for the fact that it has a camera. No recording devices, visual or audio are permitted in the courtroom, and all electronic devices that the attorneys were permitted to take into the courtroom had to be turned off, including IPods and IPads.
The courtroom isn't huge, but there were 4 wooden pews on each side and these were pretty much filled by the time the judges entered the room. There was a lot of meet and greet going on in the audience before the case got started, and I had the impression that I was one of the few people in the room lacking a law degree.
The DOJ attorney Alisa Klein spoke first. She had not been speaking for more than a few moments when the Judges began interrupting and asking questions. She began by stating that the District Court held that the electronic cigarette is exempt from regulation under the Food, Drug and Cosmetics Act (FDCA) because it is not intended for therapeutic use. The plaintiff's contention that electronic cigarettes should be treated like real cigarettes which, under FDA v. Brown & Williamson, are exempt from regulation under the FDA is a misunderstanding of that case, she argued.
Judge Kavanaugh then asked whether it had been the FDA's long-held position that the Agency did not have the authority to regulate tobacco products. Klein responded that as the term was used by FDA, these are products that have tobacco in them. She further argued that Brown & Williamson was limited to cigarettes and smokeless tobacco products. Judge Williams commented that the Favor smokeless cigarette was not discussed in Brown & Williamson and that this is "not a good move for an interpretation of Brown & Williamson."
There was then some back and forth among the judges and Klein regarding the interpretation of "tobacco product." The judges thought it reasonable to use the concept of whether a product is marketed with a theraputic claim to determine which of the two Statutes (FDCA or the "Tobacco Act") gave the FDA regulatory authority over a product. Klein disagreed. She cited the example of the nicotine lollipop that FDA chose to regulate under FDCA and stated that the product would have been totally unregulated otherwise. She said that the Supreme Court relied on the FDA's interpretation.
Judge Kavenaugh asked whether the FDA felt that it could ban electronic cigarettes but not (tobacco) cigarettes. Klein commented, "If it could be shown that electronic cigarettes are a safe method of nicotine maintenance, that could be supported." In the new legislation there was a mandate for the FDA to encourage the development of more and better nicotine replacement products. She mentioned that the FDA had written to the Electronic Cigarette Merchant's (sic) Association, encouraging companies to come to the FDA to work with it.
I found it strange that after discussing a section of the Tobacco Act that FDA claimed to be supporting via its correspondence to the ECA, Klein asserted that since the Tobacco Act had not been passed when the original case was filed, it should not apply to this case.
Judge Williams asked about cigars not being covered in the 1996 rule, but that they are specifically covered in the Tobacco Act. The position of the judges appeared to be that even though Brown & Wiilamson did not specify all current and future tobacco products, that it applied a rule of "tobacco products as customarily marketed." Brown & Williamson left a regulatory gap that Congress came and filled in (by passing the Tobacco Act.) Judge Williams reiterated that the presence of absence of therapeutic claims seemed like a good way to determine whether a product shyould be regulated under FDCA. Klein continued to disagree. She said that "There is no reason to think that you could sell a nicotine lollipop and nobody could regulate it.
Judge Garland pointed out that the FDA's order of detention was the only piece of paper the court has that explains the FDA's position. The order detained the products based on the idea that they were intended for therapeutic use. He asked whether the FDA has an administrative record documenting that NJOY made therapeutic claims. He said that the lower court ruling left the door open for the FDA to come forward with evidence that the products are marketed with claims of therapeutic use. He asked Klein whether the FDA is asking the court for an advisory opinion on what the FDA is limited to. "No, no, no," said Klein. "We don't regard the Tobacco Control Act as ambiguous."
The Judge asked about a "Chevron deference."
ASIDE: I had to look this up when I got home. This is what I found:
Klein stated that the law provided delegation of authority to the Agency. FDA gets to deem what is or is not a tobacco product. "If all we had were FDCA and the Tobacco Act, FDA would win," she stated. She said that invoking the Brown & Williamson case was the cause of confusion.
Judge Garland noted that the passage of the Tobacco Act has granted the FDA unquestionable authority to regulate tobacco products. He asked whether the FDA's purpose in regulating electronic cigarettes under FDCA was so that it could ban the products.
At this point, Attorney Garre took over the podium, representing the Plaintiff, NJOY. One of the judges asked whether John Banzhaf has, indeed, changed sides and now is one of the plaintiffs against FDA. This brought a chuckle from the courtroom. Garre said that he highly doubted that and that including Banzhaf's name as a co-plaintiff was probably a clerical error.
Garre began by stating that the FDA's position is just wrong, in the same way that FDA sought to regulate all tobacco products in Brown & Williamson. The debate is centered on the interpretation of "tobacco products." He commentd that the FDA gets no deference in interpreting Supreme Court decisions. He said that in passing the Tobacco Act, Congress ratified a line that the FDA advanced in Brown & Williamson. Congress in 2009 saw the need to give the FDA jurisdiction to regulate tobacco products, which it defined as anything derived from tobacco.
One of the judges asked whether this law would apply to street drugs, and Garre responded that it is limited to tobacco products.
There was some discussion of modified risk tobacco products, and how they might differ from tobacco dependence products which would be classified as smoking cessation drugs and devices that would still be regulated under FDCA.
DISCLAIMER:
I apologize to attorneys and the judges if I have misquoted or mischaracterized anything they said. I had to rely on my hand-scratched notes to interpret and report on what I heard.
My feelings about the arguments: Given the hard questions the judges were throwing at the DOJ attorney representing the FDA, I got the impression they are leaning toward the plaintiff's side of the case. But they did pin down NJOY's lawyer with some hard questions as well. Anything can happen, but given what I know and what I understood today, I would say the odds are that the Appeals Court will uphold the injunction. No guarantees, you understand.
AFTERWORD: I happened to run into everyone's favorite law professor upstairs in the Clerk of Courts office where I went to request a transcript of the arguments. I told him that I had been glad to see that he was finally supporting the rights of those of us who would rather use an electronic cigarette than smoke, but was disappointed that he had chosen to go back to the "dark side." He looked quizzical, but he did smile.
Judges Garland, Kavanaugh and Williams (Links to their profiles below)
U.S. Court of Appeals - D.C. Circuit - Merrick B. Garland (202) 216-7460
U.S. Court of Appeals - D.C. Circuit - Brett M. Kavanaugh (202) 216-7180
U.S. Court of Appeals - D.C. Circuit - Stephen F. Williams (202) 216-7210
Case # 10-5032 Sottera, Inc. v. FDA 15 min per side
Appearing for NJOY, Gregory G. Garre, Latham & Watkins, LLP. Latham & Watkins LLP - Attorney Biography
Appearing for FDA, Alisa B. Klein, U.S. Department of Justice Georgetown Law - J.D. Adjunct Faculty
The first person I recognized waiting outside the courtroom was everyone's favorite law professor, John Banzhaf, Executive Director of Action on Smoking and Health (ASH). I saw him go over to speak the DOJ attorney representing the FDA. He asked her about the content of her argument, but she demurred, telling him that he should read the brief and that she did not want to "mischaracterize" their position. Next I overheard him making a phone call presumably to his office. He sounded a bit concerned. He told the person on the other end that they needed to get ahold of Michelle because he (Banzhaf) had gotten the time wrong. He thought the arguments started at 10:30 but they actually were starting this case at 9:30. He also said something about a press release.
Lucky him, he got to hang on to his cell phone. Mine was confiscated at the security station when I entered the building because I am not an attorney. They did return my phone when I left. It's possible they might have let me hang on to it, had it not been for the fact that it has a camera. No recording devices, visual or audio are permitted in the courtroom, and all electronic devices that the attorneys were permitted to take into the courtroom had to be turned off, including IPods and IPads.
The courtroom isn't huge, but there were 4 wooden pews on each side and these were pretty much filled by the time the judges entered the room. There was a lot of meet and greet going on in the audience before the case got started, and I had the impression that I was one of the few people in the room lacking a law degree.
The DOJ attorney Alisa Klein spoke first. She had not been speaking for more than a few moments when the Judges began interrupting and asking questions. She began by stating that the District Court held that the electronic cigarette is exempt from regulation under the Food, Drug and Cosmetics Act (FDCA) because it is not intended for therapeutic use. The plaintiff's contention that electronic cigarettes should be treated like real cigarettes which, under FDA v. Brown & Williamson, are exempt from regulation under the FDA is a misunderstanding of that case, she argued.
Judge Kavanaugh then asked whether it had been the FDA's long-held position that the Agency did not have the authority to regulate tobacco products. Klein responded that as the term was used by FDA, these are products that have tobacco in them. She further argued that Brown & Williamson was limited to cigarettes and smokeless tobacco products. Judge Williams commented that the Favor smokeless cigarette was not discussed in Brown & Williamson and that this is "not a good move for an interpretation of Brown & Williamson."
There was then some back and forth among the judges and Klein regarding the interpretation of "tobacco product." The judges thought it reasonable to use the concept of whether a product is marketed with a theraputic claim to determine which of the two Statutes (FDCA or the "Tobacco Act") gave the FDA regulatory authority over a product. Klein disagreed. She cited the example of the nicotine lollipop that FDA chose to regulate under FDCA and stated that the product would have been totally unregulated otherwise. She said that the Supreme Court relied on the FDA's interpretation.
Judge Kavenaugh asked whether the FDA felt that it could ban electronic cigarettes but not (tobacco) cigarettes. Klein commented, "If it could be shown that electronic cigarettes are a safe method of nicotine maintenance, that could be supported." In the new legislation there was a mandate for the FDA to encourage the development of more and better nicotine replacement products. She mentioned that the FDA had written to the Electronic Cigarette Merchant's (sic) Association, encouraging companies to come to the FDA to work with it.
I found it strange that after discussing a section of the Tobacco Act that FDA claimed to be supporting via its correspondence to the ECA, Klein asserted that since the Tobacco Act had not been passed when the original case was filed, it should not apply to this case.
Judge Williams asked about cigars not being covered in the 1996 rule, but that they are specifically covered in the Tobacco Act. The position of the judges appeared to be that even though Brown & Wiilamson did not specify all current and future tobacco products, that it applied a rule of "tobacco products as customarily marketed." Brown & Williamson left a regulatory gap that Congress came and filled in (by passing the Tobacco Act.) Judge Williams reiterated that the presence of absence of therapeutic claims seemed like a good way to determine whether a product shyould be regulated under FDCA. Klein continued to disagree. She said that "There is no reason to think that you could sell a nicotine lollipop and nobody could regulate it.
Judge Garland pointed out that the FDA's order of detention was the only piece of paper the court has that explains the FDA's position. The order detained the products based on the idea that they were intended for therapeutic use. He asked whether the FDA has an administrative record documenting that NJOY made therapeutic claims. He said that the lower court ruling left the door open for the FDA to come forward with evidence that the products are marketed with claims of therapeutic use. He asked Klein whether the FDA is asking the court for an advisory opinion on what the FDA is limited to. "No, no, no," said Klein. "We don't regard the Tobacco Control Act as ambiguous."
The Judge asked about a "Chevron deference."
ASIDE: I had to look this up when I got home. This is what I found:
http://en.wikipedia.org/wiki/Chevron_U.S.A.,_Inc._v._Natural_Resources_Defense_Council,_Inc.
Klein stated that the law provided delegation of authority to the Agency. FDA gets to deem what is or is not a tobacco product. "If all we had were FDCA and the Tobacco Act, FDA would win," she stated. She said that invoking the Brown & Williamson case was the cause of confusion.
Judge Garland noted that the passage of the Tobacco Act has granted the FDA unquestionable authority to regulate tobacco products. He asked whether the FDA's purpose in regulating electronic cigarettes under FDCA was so that it could ban the products.
At this point, Attorney Garre took over the podium, representing the Plaintiff, NJOY. One of the judges asked whether John Banzhaf has, indeed, changed sides and now is one of the plaintiffs against FDA. This brought a chuckle from the courtroom. Garre said that he highly doubted that and that including Banzhaf's name as a co-plaintiff was probably a clerical error.
Garre began by stating that the FDA's position is just wrong, in the same way that FDA sought to regulate all tobacco products in Brown & Williamson. The debate is centered on the interpretation of "tobacco products." He commentd that the FDA gets no deference in interpreting Supreme Court decisions. He said that in passing the Tobacco Act, Congress ratified a line that the FDA advanced in Brown & Williamson. Congress in 2009 saw the need to give the FDA jurisdiction to regulate tobacco products, which it defined as anything derived from tobacco.
One of the judges asked whether this law would apply to street drugs, and Garre responded that it is limited to tobacco products.
There was some discussion of modified risk tobacco products, and how they might differ from tobacco dependence products which would be classified as smoking cessation drugs and devices that would still be regulated under FDCA.
DISCLAIMER:
I apologize to attorneys and the judges if I have misquoted or mischaracterized anything they said. I had to rely on my hand-scratched notes to interpret and report on what I heard.
My feelings about the arguments: Given the hard questions the judges were throwing at the DOJ attorney representing the FDA, I got the impression they are leaning toward the plaintiff's side of the case. But they did pin down NJOY's lawyer with some hard questions as well. Anything can happen, but given what I know and what I understood today, I would say the odds are that the Appeals Court will uphold the injunction. No guarantees, you understand.
AFTERWORD: I happened to run into everyone's favorite law professor upstairs in the Clerk of Courts office where I went to request a transcript of the arguments. I told him that I had been glad to see that he was finally supporting the rights of those of us who would rather use an electronic cigarette than smoke, but was disappointed that he had chosen to go back to the "dark side." He looked quizzical, but he did smile.
LOL. Hot off the presses, with thanks for the head's up from Bill Godshall.
WOO-HOO! It is a clear victory with a nice, long opinion.
WOO-HOO! It is a clear victory with a nice, long opinion.
The Court of Appeals dissolved its March 31st stay of Judge Leon's injunction. In English, Judge Leon (District Court) issued an preliminary injunction against the FDA, telling it that it could no longer seize NJOY and SE's shipments while the case was being heard.
The FDA appealed Judge Leon's grant of the preliminary injunction to the Court of Appeals. The Court of Appeals said that until it actually had time to fully consider the issues, Judge Leon's injunction would be stayed (put on hold).
The Court of Appeals has now dissolved that stay, effectively making Judge Leon's preliminary injunction once again in full force and effect.
Happy days for NJOY.
The FDA appealed Judge Leon's grant of the preliminary injunction to the Court of Appeals. The Court of Appeals said that until it actually had time to fully consider the issues, Judge Leon's injunction would be stayed (put on hold).
The Court of Appeals has now dissolved that stay, effectively making Judge Leon's preliminary injunction once again in full force and effect.
Happy days for NJOY.
FDA has asked for a rehearing and rehearing en banc and also filed a motion asking that the stay be reinstated pending a rehearing.
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