Thread by @AkivaMCohen

OK, fine, fine, #LitigationDisasterTourists, I did promise you a rundown on that antivax lolsuit.

So, today's episode of litigation nutbaggery is brought to you by "Children's Health Defense" - the RFK Jr. group who brought you such antivax hits as "VAXXED (2016)" and "VAXXED II (2019)". These aren't just covid vaccine mandate fighters. They are general purpose antivaxxers

But CHD isn't the only plaintiff here, and the caption tells the story - they wanted to be in the Western District of Texas, so they found a local plaintiff or two to anchor the case there

As is now de rigueur for a political Lolsuit, Barnes - stellar attorney that he is - opens his complaint with a random political stump speech.

And, I just ... what even is this shit?

You're opening your complaint with an un-numbered bold-underlined rant about government power? Why?

Also, "the greatest threat to a government is often itself" is some serious 2:30am post-many-bong-rips freshman poli-sci dorm crap, right?

Aside from everything else, why are you, the plaintiffs suing the government, concerned about what is or isn't a threat *to the government*? Why should the court be concerned about it on your behalf? This is an idiot's idea of profundity

Also also, this next highlighted part? This is a problem for you. Because if what you're complaining about is a mandate, you should be suing the folks who imposed the mandate. "The FDA did something and downstream someone else did something that harmed us" is not a claim

This is a pretty basic standing problem, btw. None of these plaintiffs - frankly, no plaintiff I can think of, except maybe a competitor - was harmed by the FDA granting emergency use authorization for the Covid vaccines. Even if the rest of the complaint was valid (it ain't)...

the grant of an EUA can never be the relevant cause of an individual plaintiff's injury. An EUA just says that doctors are legally allowed to offer a drug to their patients. It's the doctor's and patient's choice whether to take the drug. So no injury can flow from the EUA itself

So what are these antivaxidiots whining about? Well, apparently they think that the grant of an EUA is subject to notice-and-comment procedures, that an emergency can't exist for any length of time, and that come on, Covid in kids really doesn't matter

Oh, and of course the insanely, galactically stupid "it's not a vaccine" take beloved of Alex Berenson stans everywhere

Oh, really?

Hey, did you know that the FDA is really a labelling and marketing agency with no real say in questions like "should a drug be approved"?

No? You're in good company, then.

Complaint is here, for anyone wondering drive.google.com/file/d/1q3dyn7…

Also, RFK Jr. can go fuck himself sideways with a rusty hanger for the continued Holocaust comparisons, and yes, @barnes_law can join him in that endeavor for bringing the fucking Nuremberg Code in to an antivax complaint.

Side note: I'm not going to be screenshotting every paragraph of antivax lunacy that Barnes vomited into this complaint; it doesn't need to be spread any wider. So this thread will proceed a little slower than usual as I try to figure out which paragraphs are relevant & which are

just RFK and Barnes taking advantage of their soapbox

I don't even know which joke to make here.

Like ... just LOOK at this

Is it the Gotye-ian "didn't have to stoop so LAW"?

The fact that Barnes is so out of touch that he still thinks Big Bird is the kids' favorite Sesame Street character?

That he appears to be complaining about the fact that the Food and DRUG Administration is, by law, the agency that regulates drugs in this country?

The fact that he's spending the first paragraphs of his complaint driving home that his clients are "injured" not by the FDA approval, but by downstream actors? The comically bad writing? TOO MANY CHOICES

Oh my God, they're going Klownhandler on us, @questauthority. Never go full Klownhandler!

So ... a brief "Previously, in #LitigationDisasterTourism ..." recap.

Last year, Howard Kleinhendler filed a suit against MLB for moving the All-Star Game out of Georgia on behalf of a business network that, among other things, advocates against policies it opposes

One of the arguments for injury to that network he made was "well, when MLB did this, JCN had to spend money on a billboard in Times Square to advocate against moving the ASG

To say that the judge was not ... amused by this argument would be a vast understatement. The oral argument went something like "Look, idiot, if part of your client's reason for being is to advocate against policies they oppose, they can't be 'injured' by spending money on that"

Apparently, Robert Barnes watched that argument go down in Hindenbergian flames and went

"Your Honor, CHD was founded to be a group of plague-spreading village idiots about diseases generally, but now the FDA is forcing us to spend money on being plague-spreading village idiots about Covid specifically! It's not fair!"

Also - and I recognize that logical thinking isn't Barnes's or RFKJR's forte - but nobody forced you to spend a dime on this. You could have just let this one go and, y'know, NOT been a plague-spreading village idiot this one time. Nobody went into your wallet

Also also, as some folks have already pointed out in the replies, NONE of that goes in the "Parties" section of your complaint.

You just put in a description of who your client is and where their HQ/home is located. Not

Next we come to the individual plaintiffs and ... oh boy.

1) You're not doing much of a job of anonymizing the children's names when you plead their parents' names in the clear. I wonder what the "D." and "E." stand for?

2) Again, none of this harm is FROM the EUA

3)...

3) again, none of these substantive allegations about the harm belong in the "parties" section

4) It sure seems like the *actually* injured parties (in the fantasy world where anyone is) would be the kids, not the parents, but the kids aren't plaintiffs here

5)

"We feel pressured [by people other than the FDA] to take the vaccine so we can sue the FDA for authorizing it" is not a thing! It's not the next door neighbor of a thing!

You cannot SEE a thing from there, even with binoculars. It is a NONthing!

I feel like Chris Tucker talking to Jackie Chan

Like, how can a presumably literate human being quote the words "responsible for assuring the safety, effectiveness, quality, and security" of drugs and take away from that "this is primarily a labeling and marketing agency"

Yes, yes, it's labeling and marketing that determines drug effectiveness

ALSO WHY ARE THERE NO DRUG COMMERCIAL GIFS ON THIS WEBSITE? I DEMAND SOMEONE WITH HIGH BLOOD PRESSURE JOGGING WITH A PUPPY!

Now we get to the part of the complaint where they start setting out their claims, so let's take a look at the emergency use section they're saying was violated

Did you catch that? The HHS Secretary has the authority to declare an emergency situation on the basis of their assessment that there's a public health emergency or the potential for one.

And that lasts until the Secretary says it doesn't

That is SUPER wide discretion that Congress gave the HHS secretary:

The HHS Secretary has discretion to determine when an emergency that would justify an EUA exists

The HHS Secretary has discretion in such circumstances to authorize the use of otherwise unapproved drugs

Given that exceptionally wide statutory discretion, anyone arguing that the Secretary's decision was wrong will effectively need to show that it was "arbitrary and capricious" - in other words, that no reasonable person could have come to that conclusion from the evidence

They also seem to want to make claims under the APA, which ... hooo boy, wow.

OK. I'm not a regulatory lawyer, so any of my followers who are and want to chime in - to correct my understanding or support it - PLEASE feel free. But basically, the APA sets out the procedure by which federal agencies can engage in rule making.

And the APA defines those terms. A "Rule" is: "an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency"

"Rule making", in turn, is "agency process for formulating, amending, or repealing a rule"

Anyway, the APA provides that any agency rulemaking must include notice published in the federal register, a public comment period, and a right to petition to repeal any agency rule

But all of this applies to RULES and RULE making. In what ass-backwards universe would "approving or not approving a drug" (much less "issuing an emergency use authorization") be "Rule making"? (again, regulator[y lawyer]s:

Is drug approval "designed to implement, interpret, or prescribe law or policy"?

No. So is it rule making? Not as far as I can tell.

So does there need to be a notice-and-comment period? Not as far as I can tell

Again ... not my area. Maybe I'm way out over my skis here. Someone who works in this area please confirm if there's some precedent that makes these sections of the USC mean something different. But absent that, and after some quick research, that's my working assumption

This is good to see. I figured as much, but ... one of the tough things about doing these is I am very much NOT an expert in every area of law and I'm trying to educate, not misinform. That means calling out when I'm uncertain or out of my area. So thanks.

https://twitter.com/silbersd/status/1486908777513328641

Oh come on, no!

Like, Bobby, we talked about this. If anyone is injured by "marketing to children" it's the children, especially for medications that have to be prescribed by a doctor and consented to by a parent. That Big Bird was OK getting vaccinated doesn't harm the parents!

This is just unhinged whining. "I want robust debate and meaningful public participation in the EUA process"

I mean, that's nice, but you don't have any right to that. Congress chose not to require it.

And oh, btw, that makes sense! An EUA is, by definition, issued in a situation that is at least on some level time-sensitive. You can't have an emergency provision that requires potentially years of notice-and-comment rulemaking.

You complete, absolute, slimy motherfuckers.

Do you know what these cockroaches have the balls to argue?

They're very worried about how this will impact "vaccine confidence" among the general public

THESE fucking plague rats are concerned about "vaccine confidence"

Seriously, these people need to fuck off into the sun

That aside, "we think the FDA got the science wrong" is just not a cause of action that private citizens (or organizational CHUDs like CHD) can bring. There's no citizen review board on whether a drug shouldn't have been approved by the FDA.

If a drug is approved and ends up being dangerous, your remedy is to sue the manufacturer. And the FDA may eventually withdraw approval if the data warrants it. But you can't sue to force them to do it

I'm not going to screenshot the next few paragraphs of antivax "data" "analysis" and claims that the vaccine is itself dangerous. Because not only is it dangerously wrong, but it doesn't matter. "We think the FDA got it wrong" doesn't get them anywhere.

So, slight problem here. That "1-5" thing? The statute doesn't say anything at all about "5"

No, seriously, where did they get the "right to decline treatment is protected by informed consent" portion? You might think that would be a nice condition to impose, but it's very much not in the statute. They just made it up!

There's so much wrong with the complaint that something this otherwise obvious feels like nitpicking, but do these pangalactic corncobs not understand the direction in which time flows? Why are these paragraphs in THIS order?

I mean "describe events in chronological order, especially where the first event in time leads to the second event you're describing" isn't exactly a recently discovered rule of writing. How do you manage to fuck THAT up? Even Paul fucking Davis didn't screw that up!

I ... what??

No, seriously. What on God's green Earth does the *press release* and *who signed it* have to do with anything?

Also, you're suing over an EUA issued by the Secretary of Health & Human Services. Why are you naming the acting head of the FDA??

1) Not going to quote all the nutbaggery

2) More "we think the FDA got it wrong"

3) More time running backwards in its tracks. Why are we jumping from an October EUA for kids (what your suit is about) to the December EUA for 16+ (which you're NOT suing over)??

Ohhh, that's why you're mentioning Woodcock and the press release - because she's quoted in it supporting the decision you hate, and you're bigmad at her.

Guys. That doesn't make her an appropriate defendant even in the bizarro universe where a claim against the EUA had merit

Like ... what the fuck? Robert Barnes is nominally a lawyer, and has represented plaintiffs in the past. "Identifying the defendants you have claims against" is plaintiff's lawyer 101. How can he screw it up this badly?

"You aren't doing what we want" is not a cause of action

See, and I'D argue that nothing destroys public confidence in vaccines more than a bunch of conspiracy theorists peddling long-debunked nonsense theories to ill-informed or partisan marks, but hey, tomato tomahto, right?

BTW, there absolutely is a "Citizen Petition" process that required the FDA to consider and respond to the petition within 180 days. Which the FDA did. And while RFK and his merry band of plague rats called it "dismissive & unsatisfactory" it was thorough as hell.

I mean, it was 50 pages of "Fuck You, No". Any medical twitter followers out there want to do a breakdown on it?

Anyway, let's break here for the night, and we can pick up with "we don't have the first fucking clue what the word vaccine means" tomorrow

Update: if you want an informed breakdown of the FDA's response to the plague rat petition, start here

https://twitter.com/DMV_Makoto/status/1486963512651878404?s=20&t=PSLPDGSvlcLtdk4QB3a9jQ

Folks, Professor Reiss (who absolutely IS a subject matter expert in the area of agency regulation generally and vaccine law specifically) has been responding with comments (and where appropriate corrections). I encourage everyone interested to read them

https://twitter.com/doritmi/status/1487060639205838849

Programming note: It's Friday. As long-time followers know, that means (1) today's continued tour will be broken up by cooking for shabbos as well as work (2) will end relatively early in the day and (3) something crazy will probably happen at 5pm EST or later. Fair warning

On we go. Next, our local disease enthusiasts go down the "it's not a vaccine!" road, apparently unencumbered by minor skills like "reading comprehension", "research ability", or "knowledge of the law"

They're arguing it's not a vaccine because it's mRNA, not "attenuated or killed micro-organisms", and citing to "The Free Dictionary". The Free Dictionary, while useful, is not a source of law. There's actually a law defining what "vaccine" means! (h/t

https://twitter.com/travofoz/status/1487060256870047744

)

Also, that quote from the CDC about what a vaccine is? Says nothing about formulations. It's "a preparation that is used to stimulate the body’s immune response against diseases." Full stop.

What do you think the Covid vaccine does, geniuses?

But Akiva, does that mean Congress and the CDC are arguing with <dun dun dun> the dictionary?!

1) They actually get to do that if they want to; if Congress wants to write a statute that says "no sneakers in schools" and define "sneakers" for purposes of the law as "open toed"

But also ... no. No they're not. Here are a couple of other dictionary definitions listed on that specific Free Dictionary webpage

Bottom line: if it's a preparation administered to help a patient develop an immunological response to a disease, it's a vaccine: legally, medically, and as a matter of dictionary definitions

Again, these disease enthusiasts absolutely got an A+ in their "fail to understand domain-specific language" classes in remedial school.

"Immunity" doesn't mean "you can never get a disease". It means "you have an immune system response to the disease"

Also, what exactly do they think the difference is between a "product" and a "preparation"?

Anyway, since these guys love online dictionaries ...

Sorry, brief break to try and settle a case #LitigatorProblems

Leaving out a whole bunch more antivax nonsense about how this is "really" 'gene therapy' which leads up to this idiocy here.

You don't get to allege "on information and belief we think that regulations weren't followed"

Again, this goes back to basic Twiqbal probability requirements. You can't just wave your hands and say "we think". You need to point to specific facts that would make that conclusion a reasonable one to draw.

Also, you don't have standing to complain about the absence of an "environmental assessment" since you aren't claiming an "environmental" injury. (Note: FDA environmental assessments for gene therapies are "if this gets into the wild, how will this impact the environment" not ...

"the vaccine makes me shed virus" the way these goons love to argue)

Everything about this paragraph is wrong.

(As others have pointed out, the Secretary has issued regulations providing that in an EUA context there should be a way to ensure patients are informed of the status, risk, and right to decline the drug; that's not in the statute!)

There's no "First Amendment Right" for Bob Plague Enthusiast from Topeka to be involved in the FDA's drug authorization process. The APA has exactly ZERO to say about what drugs the FDA can approve; it's a procedure statute, not a substantive one.

These goobers really seem to think that a "right to Petition" means "a right to have your Petition granted even if it's written in crayon by a submitter obviously in advanced stages of mad cow disease"

Oh, for fuck's sake, now they're going to spend time yelling about VAERS. I'm not screenshotting this nonsense

Anyway, this next bit is just a variation on the "we think the FDA got it wrong" theme and the court is not the FDA's substantive supervisor. (Bonus points to any non-lawyer who understands the pic below)

Just pages and pages of "look at our badly misunderstood or distorted data that supports our belief that the FDA got this wrong" and guys

Like, yes, your data and conclusions are shit and easily debunked by people who know what they're talking about. But from a legal perspective: Even if every last bit of it were true, you STILL couldn't get the relief you're asking for, because you don't have standing and because

courts don't get to second-guess the FDA's scientific decisions if there's any basis at all for the FDA to have made the decisions they made. "We'd have done something different" is not a cause of action

Man, it's almost like parents have the right to make these decisions. Crazy.

Uh, guys, are you OK? Because it's almost like neither the FDA nor the CDC have anything to do with that

And we're back to Twiqbal-useless conspiracy theorizing.

"We think it's all about the money and everyone is going to lie" doesn't get you through the courthouse doors

Yeah, this is very much not a thing. Even accepting their batshit premises "if you grant authorization there's going to be coercion and coercion is unethical and bad" doesn't mean "so you can't grant authorization"; it would mean "so get an injunction against coercion"

Yeah, no.

First: Texas has a literal ban on vaccine mandates. They can't happen there.

Second, if vaccine requirements are legally problematic (they're not), your remedy is to sue the entity imposing them, not the FDA for authorizing the drug for people who want to take it!

And look, we've been laughing at how bad this complaint is. But as @questauthority keeps saying, the heart of what they're trying to do isn't funny at all.

They're not arguing "don't make me or my kids get vaccinated"

They're arguing "don't let ANYONE get vaccinated"

It's a direct assault on the rights of every parent and child in the country who don't share these plague enthusiasts' views.

Luckily "I'm suing you because you bought the car that was used to drive the person to the place where he kicked the rock that caused the avalanche that made a deer flee through my garden and eat my azaleas" is not a viable claim

No, seriously: for want of a nail is a terrific proverb. But none of the folks who die in that battle can sue the ostler for not properly shoeing the horse

Oh God, @estockbridge, I've reached paragraph 133

I'm just gonna leave this side-by-side

And you definitely want to write about the Constitutional right to not have to be vaccinated without discussing Jacobson, the case in which the Supreme Court expressly held that states could require people to be vaccinated

Oh wait, they mention Jacobson in the next paragraph, as akin to Japanese internment (Korematsu) and forced sterilization for eugenics

We travel from here back through Nuremberg and Tuskegee and the plague enthusiasts' greatest hits and no I'm not helping spread that nonsense. They then move on to "other treatments are effective" and we're back in "this isn't a cause of action, dudes" land

On to the causes of action. Again, they don't seem capable of reading or understanding English; this isn't a "rule"

They move on (apparently still under the APA claim) to "Covid isn't an emergency" which ... good luck, and also, the statute just requires a declaration of emergency (which was made and not challenged)

More fun with "not reading the statute" - remember, Congress gave a specific statutory structure for when the HHS Secretary's health emergency powers terminate, and it's not "as provided under the NEA"

No need to quote the repetition of "yes, you reviewed and responded to our petition, but not granting our petition is a first amendment violation"

Same for "you redefined vaccine!!!11!!1!"

This is fun, though - what evidence of harm have you provided?

Oh

"People keep telling me I'm being an idiot and trying to persuade me to not be an idiot" IS NOT A FUCKING CAUSE OF ACTION

Wait, how did we get from that to this? Did MC Escher design this Complaint?

The rest of this is just variations on the "NO, THE FDA IS WRONG" theme

But again, they're asking a federal judge to order that nobody in the country can have their kids vaccinated. It's not going to work, but fuck them very much for trying

/fin