Discussion in 'FDA Regulations' started by skoony, Aug 18, 2016.
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I haven't read it yet.
[PROPOSED] ORDER Upon consideration of Defendants’ cross-motion for summary judgment, it is hereby ORDERED that the motion is GRANTED; and it is FURTHER ORDERED that Plaintiffs’ motions for summary judgment are DENIED; and it is FURTHER ORDERED that judgment is entered in favor of Defendants, and against Plaintiffs, on all claims raised in the complaints.
I'm just incredulous over the fact that on the very first page they instruct the court not to bother looking through the scientific evidence because they (the FDA) are the experts.
I got chuckles after reading only 10 pages. They are sticking to their guns about how dangerous and bad ecigs are and not admitting/recognizing any of the positive side...
They did acknowledge that cigs are the most dangerous product ever brought to market, but don't mention why they are allowing them to stay on the market...
Okay, I don't understand what that means. And has the judge signed off on it? If not, any idea when that might happen?
That is what the FDA is asking the court/judge to do and I don't know when we can expect a response.
I'm not surprised at this "answer" from the FDA. It's typical legal beagle stuff which happens in nearly all cases like this. The JUDGE makes the call and I would expect/guess that to happen in about one or two months.
Please note all the attorneys involved (SEVEN !!!!) for the FDA. Our tax dollars at work. /sigh
Those attorneys get paid whether they do anything or not. At least they had to do some work to write this garbage instead of chatting with co-workers all day.
The section on Judicial Deference seems to put a high bar in front of any lawsuit.
Based on this below, if the FDA looks at the evidence and comes to a conclusion, it seems like the Court is legally obliged to accept that conclusion. There are some exceptions under "arbitrary and capricious", but they look like they might be pretty hard to meet. I don't know how common it is for courts look past the Judicial Deference standard. If the plaintiffs are allowed to dispute the FDA's interpretation of research, introduce contrary research, and argue that the FDA cherry picked their sources of information, etc, maybe they have a shot. Maybe it just depends on the Judge.
# # #
Under the Administrative Procedure Act (“APA”), an agency’s decision must be upheld unless arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. See 5 U.S.C. § 706(2)(A). Under this deferential standard, the agency’s decision is presumed valid, and the Court considers only whether it “was based on a consideration of the relevant factors and whether there has been a clear error of judgment.” Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416 (1971). An agency decision may be deemed arbitrary and capricious only in circumstances where the agency “has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.” Motor Vehicle Mfrs. ...’n v. State Farm, 463 U.S. 29, 43 (1983). The Court may not “substitute its judgment for that of the agency.” Id.
This deference is heightened even further in cases like this one involving scientific or technical decisions. “We will give an extreme degree of deference to the agency when it is evaluating scientific data within its technical expertise,” West Virginia v. EPA, 362 F.3d 861, 871 (D.C. Cir. 2004), for “we cannot decide . . . whether technical evidence beyond our ken supports the proposition it is asserted to support,” Simpson v. Young, 854 F.2d 1429, 1434 (D.C. Cir. 1988). “When examining this kind of scientific determination . . . a reviewing court must generally be at its most deferential.” Baltimore Gas & Elec. Co. v. NRDC, 462 U.S. 87, 103 (1983). Indeed, “in the face of conflicting evidence at the frontiers of science, courts’ deference to expert determinations should be at its greatest.” Cellular Phone Task Force v. FCC, 205 F.2d 82, 90 (2d Cir. 2000).
CHECK: has relied on factors which Congress has not intended it to consider,
CHECK: entirely failed to consider an important aspect of the problem,
CHECK: offered an explanation for its decision that runs counter to the evidence before the agency,
CHECK: or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.
They qualify on all counts.
If only the judge could both grant the plaintiffs request AND add a lashing or something.
Their logic is so friggin twisted.
You can't complain about nicotine-free liquid being a tobacco product because we didn't say ALL nicotine-free liquid was a tobacco product. Yours might not be, so you can't complain. Yet. We only said nicotine-free liquid MIGHT be a tobacco product, even if it's not made from tobacco, if we think it might be used to mix with nicotine. And we haven't decided yet, we'll do that ON A WHIM, case-by-case, later - using our obvious expertise in such things to decide. Maybe then you can complain about it, but by then, you won't have enough money for another lawsuit, so good luck.
Yet they state
The above found here: Nicotine Replacement Therapy Labels May Change
They seriously cannot have it both ways!!! Holy they are blithering idiots!
The family tobacco act, or whatever it is called, was intended to protect existing tobacco products from competition including from lower risk alternatives. That ends up protecting taxes and the master settlement agreement money while it harms the public's health.
I'm avoiding the term "public health" because that refers to a bunch of people I don't trust or respect. From now on it's the "public's health" so I don't have to acknowledge those other people.
But remember, Robino1, the FDA is the hammer and vaping is the nails.
Welcome to the northernmost province of Nicaragua or the westernmost province of Turkey. Take your pick.
YT posted the PDF here yesterday:
Actually, I'm going to disagree with you here. Usually, when I read a lawsuit it is refreshingly logical, as opposed to emotional. I've sat thru many court trials and have never found the law and it's proceedings to be "illogical". I think that is the beauty of the law.
While I may not LIKE the outcome, the requirement of legal proceedings is the ability to use logic. You don't get to say things like "but water can be dangerous too!" and stuff like that. Basically, as I briefly read the pdf it just seems like they are sticking with Soterra and the job Congress gave the FDA to regulate stuff..... both of which already have been legally established. The long history of the tobacco industry of lying is not something the FDA is willing to go thru again and either is anyone else, so the burden of proving anything after BT debacle just naturally became more difficult.
Burden of proof and all that, it sounded to me that the arguments/reasonings surrounding non nicotine products used in conjunction with vaping haven't been well explained (yet) by the defendants at least not in a compelling way. There is more work to do, and yes, it does require a long string of go-arounds. That is always true when you are trying to prove an unjustified regulatory burden.
As with any lawsuit, it's not one thing, it's a number of things that get to be examined and decided on.
I doubt any defendants in the lawsuit thought it was going to be lickety-split. Now they have more to go on, more insight about how the FDA is seeing things, and how we should proceed from there.
It's a PROCESS.
I remember when big land development corporations would put their bulldozers atop all those nice sand dunes (nature's protection of the land beyond the sea) and started levelling them to build billion dollar condo projects. The local municpalities with their bare-bones legal staff would be trying to stop the bulldozers from raping the land while the development corps would bring their armies of Philadelphia lawyers........of course the municipalities ran out of resources and money and now we have no sand dunes to speak of.
Anybody bringing a lawsuit knows this ahead of time........i.e. that it will be expensive and time-consuming.
More legal battles ahead. Hopefully all the vendors are kicking in some monies to the various defendants? The same problems exist in horse racing as vaping industry..........no centralization, instead each racing venue and each state in the US has their own little commissions and sets of rules.........I can only say that NOTHING has gotten accomplished that way and I've been watching it for 20 years.
That's why I said 4 years ago that the vaping industry needed to band together under ONE large trade organization.
That never happened. That would have gone a long way toward resource sharing IMHO.
And "people" in 'control' are actually buying this ?!?!
This is the sorriest piece of I have seen yet.
I wonder why the defendants didn't bring this up in their preparations?
At any rate, knowing HOW this was accomplished is instructive.
Something to study for next course of arguments....
Fear Not Roino1.
I'm sure the FDA has a CDC Study that shows that Nicotine IS the most Addictive Substances known to Man when it is used in an Unregulated and Untaxed product that BT or BP did not produce.
All I want to hear from the judge is, "Plantiffs request is granted, we will reconvene for opening arguments on..."
Separate names with a comma.