#WAOpioidTrial Day 24 is now starting at this link. State will continue to assert their case - after some housekeeping measures to be discussed. !
#WAOpioidTrial Lots of housekeeping measures discussed. I don't think there were any rulings?
Regardless, state resumes questions with Dr. Cutler, starting with neonatal abstinence syndrome. When babies are born with addictive substances in their system. NAS for short.
#WAOpioidTrial Dr. Cutler is discussing the financial impact for caring with babies with NAS, later issues with potential foster care placement, treatment for the mother, etc.
So far zero differentiation between licit or illicit use trends. Because I don't think we have it.?
#WAOpioidTrial The state continues to collapse ALL opioid use and, in many cases, ALL illicit drug use of any kind into one big bucket - and is attempting to lay the blame (and all of the costs) at the feet of LEGAL, DEA-registered and overseen pharmaceutical distributors. 🤷🏽♀️
#WAOpioidTrial And once again, Dr. Cutler is associating "more opioid shipments with more NAS rates".
"more pills = more harms". Less pills also = more harms, to the latter groups.
#WAOpioidTrial I sincerely hope the defense asks Dr. Cutler IF, in fact, he accounted for legitimate pain care needs in his blanket 'more pills = more harms" statements which he's made repeatedly.
Hey if I'm wrong, let's hear it. But. I don't think I'm wrong. 😬
#WAOpioidTrial Dr. Cutler is now talking about "Deaths of Despair", one of the newer identified descriptors for early mortality. Here's a good layperson-friendly article about it. Princeton University economists Anne Case and Angus Deaton coined it.
#WAOpioidTrial Interestingly, Dr. Cutler says it's not about despair (despite ... extensive studies/coverage by Case and Deaton).
He's showing a chart showing a big spike in ANY opioid overdoses. Not RX ones.
MOST opioid overdoses are not RX. And hardly ever were. Ask any ME.🤷🏽♀️
#WAOpioidTrial Also - his chart (and he) clearly said: suicides did NOT increase in states with 'high shipments' of opioids?
But "Deaths of despair defined as “mortality resulting from suicide, drug overdose, and alcohol-related liver disease” So .. drug overdose IS despair?!
#WAOpioidTrial We're back to this spiffy chart from yesterday. In which Dr. Cutler says that these 3 actors (Dispensers, Distributors, Manufacturers) are responsible for . .. HOLD ON A MINUTE
#WAOpioidTrial State just had Dr. Cutler read aloud from this report. Specifically:
"On the supply side, weak governmental oversight combined with actions in the 1990s and 2000s by the pharmaceutical industry <..>, pain control advocacy groups (often funded by pharmaceutical companies), and physicians . .. "
!!!🤬
#WAOpioidTrial Once again an expert asserts that PATIENT ADVOCACY GROUPS are funded by pharma companies.
You know, we are ALL paid shills. Not speaking on behalf of our own needs, and the needs of the DISABLED and CHRONIC PAIN COMMUNITIES. (I have never met a paid advocate)
"With encouragement from pain control advocacy groups and pharmaceutical companies, physicians and other health care providers significantly increased their opioid prescribing."
Yes. How dare those pain advocacy groups want pain control. 🤦🏽♀️🤬🤯
#WAOpioidTrial State tenders the witness. McKesson's counsel is now beginning cross.
McK starts with 'how much of Dr. Ciccarone's testimony did you hear' because . . . Dr. C said shipments increased because prescribing increased, right?
#WAOpioidTrial There's some weird language nuance here. McK asks Cutler if prescribing drives shipments and he says "it's one of the factors". Restated: pharmacies order what they'll need to fill prescriptions. Cutler restates: They order what they expect to dispense. ???
#WAOpioidTrial I don't understand the nuance there. But whatever.
Oh now we're getting into a weird area here.
#WAOpioidTrial McK counsel gets to: "you say more pills = more harms, but in reality it's like more prescriptions = more shipments, more shipments more pills, yes? So more prescriptions = more harms?
Cutler says: I wouldn't say it that way because dosage, MMG, yadda yadda . ??
#WAOpioidTrial Defense points out that the chart of shipments of opioids that Dr. Cutler shared yesterday included distributors who are NOT part of the defense - so 25% of those shipments were NOT from the defense.
#WAOpioidTrial Defense also points out that prescribers in WA includes ARNPs and also Dentists, who prescribed MOST opioids in WA for younger people. It was a big uptick.
(As a person with a lengthy dental surgery history - hallelujah for appropriate pain relief because OW.)
#WAOpioidTrial Defense enters a document citing "rapid increases in opioid prescribing activity" - to illustrate that it's PRESCRIPTIONS which drive shipments which drive pills which drive harms, according to Cutler. He agrees.
#WAOpioidTrial Defense also gets Dr. Cutler to repeat an earlier statement: "Doctors are the ULTIMATE gatekeeper for writing opioid prescribing", etc.
Defense is doing well here to repeatedly get the doctor to state: no shipments without prescribing.
#WAOpioidTrial Defense is asking Dr. Cutler about his earlier testimony, where apparently Dr. Cutler characterized RX opioids as 'drugs of abuse', patients misusing the RX as prescribed, etc. etc.
Aaand we're in the mid AM break. NOTE: The are restarting the stream link!
#WAOpioidTrial NEW LINK for the rest of the AM session. Judge is opining on admissibility of some stuff. <Lawyer input welcome>
#WAOpioidTrial McK: Opioids can be prescribed for legitimate medical need, and any leftovers can be diverted, yes?
Cutler: Yes.
McK: And many who misuse say they get it from friends or family?
Cutler: Yes.
#WAOpioidTrial McK shows a slide of NSDUH data which indicates that like 70% or more people surveyed say they acquired RX opioids for free from friends/family or bought from friend, relative, or dealer.
Cutler concurs.
#WAOpioidTrial Dr. Cutler: "I'm not making a determination of what would be the RIGHT level of prescribing for legitimate medical need. I'm not a medical doctor."
And yet he's happy to state . .well, all the earlier stuff about costs. With no mention of legitimate medical need.
#WAOpioidTrial Aha. Dr. Cutler relied on Ms. Keller's earlier data to reach some of his conclusion.
Ms. Keller ... was assigned very specific work. By the state of Washington.
There you go. Dr. Cutler - a smart guy - was using her analysis, right or wrong. Aha.
#WAOpioidTrial McKesson confirms: "You are not a medical doctor. You are not a pain doctor. You don't have opinions on appropriate levels of opiate prescribing in WA?"
Cutler says: There are too many shipments in WA which resulted in harm. But as to specific medical opinion..
#WAOpioidTrial McK: You don't have an opinion about the APPROPRIATE level of shipments?
Cutler: <paraphrasing> Nope, but there were too many and it caused harms.
???
#WAOpioidTrial McK: You have not weighed in on the harms vs the BENEFITS of opioids treating pain?
Cutler: Nope.
McK: And you are not an epidemiologist?
Cutler: Nope.
#WAOpioidTrial McK asks if he's a law and economics expert, and Cutler gives a wiggly answer about 'sort of'.
McK pulls up an earlier transcript where Cutler had said, specifically: "I'm not a law and economics expert, but ... "
#WAOpioidTrial McKesson brings up this paper, co-authored by Dr. Cutler. Talking about regional differences in standard medical treatment decisions.
#WAOpioidTrial McKesson: Investigators look for causalities. Getting data. Using computers. Resources, etc. But that doesn't necessarily give you causality, correct?
Cutler: Correct.
McK: So Compass Lexicon . . those graphs .. that gave to you TOOLS, not causality? Yep.
Cutler: Yes. Thankfully, computers have not replaced economists just yet.
McKesson: They also haven't replaced lawyers yet, thankfully.
(Ha, nice joke there folks)
#WAOpioidTrial Basically: computers/automated analysis are good at EXCLUDING causality, not at determining it.
It takes judgment by humans to determine causality. Using some assumptions .. ?
I think McK is aiming at subconscious (or conscious?) bias here? Let's see.
#WAOpioidTrial McKesson points out that the 'assignment" for Dr. Cutler from state of WA - his initial report did NOT include 'misconduct of the defendants', which it didn't.
And Cutler focused solely on SHIPMENT of opioids and not (at all?!) on PRESCRIPTIONS of opioids. Hmm
#WAOpioidTrial Oh my. Dr. Cutler is doubling down: the best way for economists to measure things is 'prime age white male employment to population ratio'.
McKesson is asking about women. Black people. LatinX.
Cutler says: "If we know about white males we can derive the rest."
#WAOpioidTrial This is regarding his slide on "Cutler's Control Variables for Deaths of Despair" in which it includes, among others:
The Change in:
- The prime age male employment to population ratio
- Median household income
- Share of population that is white
🤦🏽♀️👀
#WAOpioidTrial Well, I don't know if those derivations hold up because maths and economists and all .. but the optics are TERRIBLE.
Cutler also didn't include divorced people?!
So only married, white, men were used to derive things?
#WAOpioidTrial Woh. McKesson pulls up the "Deaths of Despair Mortality Rate" in WA state chart and points out that while Cutler dismissed alcohol and suicide earlier in his conclusions . . . those were much higher rates in WA than overdose from 1993-2018? Like every year?
#WAOpioidTrial Cutler concurs, but believes that overdose numbers are higher post-2018.
Hmm. Earlier he portrayed this data as inconsequential when compared to 'more pills = more harms'.
#WAOpioidTrial McKesson brings back up Cutler's chart and points out MANY players are missing. Like *mainly* illicit drug cartels/distributors. "There's important people missing from this chart, right? Doctors? The ultimate gatekeepers? Also ARNPs? Dentists?"
Cutler: Yup.
#WAOpioidTrial McKesson is trying to ask the witness if he is aware that heroin metabolizes to morphine in the human body, which means death records reflecting morphine (historically) would report heroin deaths as morphine. Inaccurately.
Cutler is aware.
#WAOpioidTrial And the longer it takes the crime lab to get a sample to the lab, the more likely it is that heroin will test as morphine (inaccurately). Meaning tons of older records - we'll never know if it was heroin or RX morphine. Crime labs NOW can tell the difference.
#WAOpioidTrial McKesson is pointing out that CDC data on overdose data are from the states. And the states get their data from counties and cities. And that data is from an assortment of medical examiners, coroners, city officials - tons of variance on quality/accuracy.
#WAOpioidTrial Sidebar: It's also true that smaller counties/cities often don't have budget for toxicology for EVERY death they have - they have to budget their investigations. Some people die w/o toxicology when it could be helpful ... so yeah. Data quality varies.
#WAOpioidTrial We're on the lunch break now until 1:30PM PT (when we will have a new link).
But I want to circle back to the "we derived stuff from the white, male population" for a second. I scribbled some notes as we went.
#WAOpioidTrial McKesson's defense counsel asks Harvard Economist Dr. Cutler:
"and these controls (from his state-level report) completely ignored half of the state, correct?
Cutler: I'm not sure what you mean by that?
McK: Women?
Cutler: Oh no that's not true.
#WAOpioidTrial Cutler: 'So what economists have concluded in recent years is that the best measure of - an extremely good measure of how the economy is doing is for people who are traditionally in the labor force, how many are not in the labor force?'
Soo ...white men. Is what.
#WAOpioidTrial Cutler: 'Women's labor force participation still varies a lot for various other characteristics, so the male labor force participation is generally taken. Like it's reported a lot and it's taken as a measure of how strong the economy is.'
Hmm.
#WAOpioidTrial McKesson continued: 'would it be fair to say that with respect to two of the variables that you controlled for, you have not accounted for Blacks, Hispanics and Native Americans that live in the state of Washington?'
Cutler's answer was no - and lengthy.
#WAOpioidTrial Cutler: "the best measure of the economy would be that one: to share the population that's white. Of course once you've included that you know about the share of the population that's non-white so that's really just a demographic split that I'm picking up.'
#WAOpioidTrial To clarify: I'm almost certain there is a sciencey reason to derive population information based off of . . . well, white men, I guess?
But the optics are TERRIBLE. Later it came up that he did not control for unmarried and divorced men, either.
🤦🏽♀️
#WAOpioidTrial HEY economists! Maybe find some other method to derive population information which keys off of all genders, marital status, races, ethnicities . .. ?
Yeah yeah I'm sure it's more complicated than I realize. But ...this looks BAD.
Anyway. Back after lunch.
Helpful chart provided by a friend. Um. Women's labor participation rates seem to have . . .well, prior to pandemic (whole other set of issues, don't get me started) STABILIZED.
Let's count ALL the genders, shall we?
#WAOpioidTrial Coming back from lunch - here's the afternoon link.
Defense continues it's cross-examination of Harvard Economist Dr. Cutler.
#WAOpioidTrial McKesson is asking about the earlier testimony of the "Economic Cost of the Opioid Epidemic in Washington State" in which - those calculations were based on a "statistical life" not actual costs spent.
Also: No differentiation between RX and illicit opioids.
#WAOpioidTrial So earlier Dr.Cutler testified that the 'costs' to WA state in 2016 were $9.19 billion. But that's not what the state actually spent. It was based on a hypothetical analysis of a representative statistical (apparently a married white male, I'm guessing) life. Hmm.
#WAOpioidTrial McKesson: Your mortality calcualtions would include people who never had a prescription for opioids, correct?
Cutler: Yes.
McK: Including those who used heroin and NEVER had a prescription?
Cutler: I was talking about the impact of the SHIPMENTS. (Whut?)
#WAOpioidTrial McKesson: I think the answer to my question was yes?
Cutler: Yes. It would include those who never had a prescription and who used heroin.
#WAOpioidTrial McKesson is now asking about the National Academies report - the one which keeps saying that patient advocates 'often' took money from opioid manufacturers and 'encouraged' opioid prescribing. Not that I have feels about it.
#WAOpioidTrial It's a 600 page report, btw. The report came out in 2021. By which time ... Dr. Cutler had already served as an expert witness in opioid litigation for 'several years'. Hmm.
(So says McKesson during the lead up to his questioning, which Cutler confirms)
#WAOpioidTrial OH HOLY COW. I had not noticed. The citation for the comment about 'pain management advocacy groups many of which were funded by the pharmaceutical industry" - was ANDREW KOLODNY.
#WAOpioidTrial Well. I'd tag Kolodny but he's blocked me ages ago for daring to ask him to cite a source for some other bullshit she said.
So. That's . . . interesting. By which I mean horrifying.
#WAOpioidTrial The line of questioning is that the statements read earlier were specific to pharmaceutical manufacturers of opioids, NOT the distributors.
The earlier quotes sounded damning. But the were not at all about the defendants. So yeah. Good catch, McKesson.
#WAOpioidTrial So the National Academic of Sciences report has a lot of things to say about misconduct . .. but in looking at the details, it's all about the manufacturers. Somewhat about prescribers, I'd guess.
But the companies shipping the stuff? Not mentioned so far.
#WAOpioidTrial I spoke too soon - they did eventually mention the distributors on the list of ... let's see: "other major culprits".
From a scientific consensus report. I now have some serious questions about the level of bias which survived the editorial pass in this report.
#WAOpioidTrial The scientific consensus report quoted this article (among others) as a source for the 'culprit list'. The article lists allegations and complaints in pending lawsuits. Not .. proven facts.
#WAOpioidTrial Once again Dr. Cutler states that his analysis and opinions are based that the data provided to him by Ms. Keller. That data was produced because the state defined the parameters and gave her the assignment. So Cutler only got what the state wanted him to see.
#WAOpioidTrial Here's what I think about what Dr. Cutler has testified. He's almost certainly correct about his analysis. But this is a drawing which represents the fact he's talked about.
State cherry-packed SOME data. Got a qualified expert to talk about it. Here we are.
#WAOpioidTrial Wouldn't it be great if someone could identify just the costs/impacts of diverted or misused RX opioids which would be the most relevant thing in this trial? But that can't be done and no one knows. So let's ignore polypharma, ignore heroin metabolism . .
#WAOpioidTrial Let's just collapse all the drug overdose causes IN THE WORLD into a big bucket (including all of the illicitly sourced and manufactured ones) aaand figure out how to charge the distributors of legal, DEA-sanctioned and overseen medications for the costs. WTAF.
#WAOpioidTrial State on redirect - asks Dr. Cutler about standard of pain care for the rest of the world, chart showing Canada, UK, Germany, France.
McKesson tries to object, but judge overrules.
OUD deaths are lower in those countries, by a lot. Here's the thing.
#WAOpioidTrial ALL of those counties have universal health care. So when someone is in pain, or needs a surgery, or some kind of care: they can afford to get it. Without hesitation.
Here in the states? We struggle along, self-treating, self-medicating. A LOT.
I'm not at all surprised to learn that the USA is worse that countries which ALL have universal healthcare.
I would imagine we have worse healthcare numbers in EVERY area, mapped against those countries.
#WAOpioidTrial Washington state gets rated "very good" in reporting death data to the CDC. Yay us.
By which I mean: that's pretty great. People don't think funding studies on how and when people die is important, but it's VERY important to learn about causes of mortality.
#WAOpioidTrial Re-cross by McKesson. There's been a recent spike in WA in opioid deaths, you said? Because of FENTANYL, not heroin, and not RX opioids, correct?
Cutler: That is correct.
Taking 15 min afternoon break before we hear a deposition next. BRB!
#WAOpioidTrial We're back. State calls (via recorded deposition): a Cardinal employee who had some kind of responsibility for regulatory oversight as it related to diversion. Let's see where it goes.
#WAOpioidTrial This guy looks annoyed AF and I love how he is pushing back on vague questions.
Q: Did you request historical sales information from pharmacies?
A: Depends on what you mean by "Sales". 😉
#WAOpioidTrial If this line of questioning is at all similar to other depos of defendants' employees, they will be asking "DID YOU EVER MAKE A MISTAKE AND IF SO HOW CAN YOU DEFEND IT."
Plaintiff will have reviewed millions of pages looking for ANY little question or concern.
#WAOpioidTrial Over the many decades of millions of orders of probably billions of pills being ordered nationwide - to fulfill the medical needs of real human people - there will almost certainly be a problem here or there. It happens. Despite best efforts.
#WAOpioidTrial This was a complex and evolving regulatory space, in which the DEA failed to provide guidance or examples for ANY of the distributors over time. They all most likely did the best that they could. No one is perfect.
Just ... this is not compelling testimony.
#WAOpioidTrial I am reminded of an Olympic figure skating commentator who once remarked about a skater in mid-skate: "All she has to do now is NOT MAKE ANY MISTAKES."
No corporation ANYWHERE is flawless. They ALL have mistakes made and try to do better. 🤷🏽♀️
#WAOpioidTrial And the ongoing mantra of this trial: NOT ONE RX OPIOID was dispensed in WA or in ANY state without a prescription from a DEA-licensed provider from a DEA-registered pharmacy. NO distributor shipped pills to the public, EVER.
HOW are the distributors on trial?
#WAOpioidTrial Interestingly, the defense is objecting to tons of questions in this deposition. The Judge is mostly sustaining them. Not all, but most.
#WAOpioidTrial "In your 9 years at Cardinal Health, did you ever see a shipment go out that you believed would be diverted?"
Answer: No.
That guy was great. Very contained rage while on the surface answering ... politely if reluctantly? And we're on to the next witness.
#WAOpioidTrial Next up: State calls (via recorded deposition) a former (and local) McKesson employee. He worked there for 39 years! Dang.
He is now retired. This depo was filmed in May of 2021. Questions being asked by the plaintiff's lawyer.
#WAOpioidTrial State: "Can you please describe your role at McKesson?"
Witness: "To herd the cats."
I love this guy already.
#WAOpioidTrial State: "Would you be eligible for a bonus each year?"
Witness: No.
State: <dammit>
Also: Do you mean that a company with sales incentives would sometimes pay annual bonuses??? HOW DARE THEY. Those bastards. </sarcasm>
#WAOpioidTrial State asks witness to read an email he wrote in which he reminds some of sales people that they are overdue in getting updated pharmacy data to him.
Not that something was diverted. Not that the pharmacy had done something inappropriate. Just needed updates. 🙄
#WAOpioidTrial So now we're not even alleging that the distributor made a mistake. A manager was APPROPRIATELY reminding sales people to update their paperwork on customers.
That's it. We just spent 5 minutes of trial time on that.
Sigh.
#WAOpioidTrial And there wasn't much more of that deposition. With the last ten minutes of trial time today, state calls a live witness! It is: Dr. Nancy Kathryn Young, a social worker in 'macro practice', or policy administration? Or something?
#WAOpioidTrial She has apparently testified in previous trials as well. She is co-founder and executive director of Children and Family Futures. Here's an article on the WV trial.
#WAOpioidTrial Can I make a prediction? She's going to tell us some harrowing and awful things about children families throughout the overdose crisis. Brutal.
And she will not be able to illustrate the differences of impacts from prescribed medications and illicit use. At all.🤷🏽♀️
Court is adjourned; all links to courtroom streaming are now offline.
Court resumes tomorrow, which will be the last day of trial this week. Trial is held Mon-Thurs, 9-12, 1:30-4 PT. (with 15 min breaks AM & PM, each). Ciao!
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Here's the AM link. Also it is snowing here this morning, WTF??
#WAOpioidTrial IANAL here but it seems like the state just got admonished a bit for trying to pull some exhibit back OFF the record after defense went to the expense of reviewing; state doubles down and says they are SURE it will be in; then tried to pull it. Judge said nope.
#WAOpioidTrial And now we resume McKesson's counsel cross-examining Dr. Daniel Ciccarone, MD, MPH. He's a widely respected harms reduction expert (among many other things). He's been testifying about the uptick in heroin/fentanyl use, generally.
#WAOpioidTrial Day 22 is now starting; WA state vs. McKesson, et al can be watched here for the morning session (then the link disappears at the lunch break).
We resume with the depo from a Cardinal employee being played; most of which we saw last Thurs.
#WAOpioidTrial Once again the questions are about how the pharmaceutical distributors offered marketing/ad opportunities to the manufacturers.
Which somehow makes the distributors liable for the 'opioid crisis' which is almost exclusively polypharma heroin/fentanyl/meth. M'kay.
#WAOpioidTrial The rules of evidence remain ... elusive.
Somewhat lengthy technical discussion about whether the witness in the depo could refer to 'notes' about facts about a doc she had not seen.
Cardinal's objection is sustained! (I have no idea about why, but okay!)
#WAOpioidTrial Day 21 is now starting. Here is this morning's link, good only as long as the court is in this morning's session. It will disappear at around noon when the court adjourns for lunch.
Will the 'not-an-expert-witness' shenanigans continue? 🤔
#WAOpioidTrial Oh that is interesting - Dr. Banta-Green just closed that the attorney I assumed was 'his' is actually representing the University of Washington .. . from the WA State Attorney General's office.
Um. It's the AG who is the plaintiff. Well. That's curious.
#WAOpioidTrial McKesson's counsel is cross-examining Dr. Banta-Green. Showing this site from ADAI. Specifically THIS chart. Showing hospitalization rates ... by substance. Most of which . . . are not RX opioids.
#WAOpioidTrial Day 20 is about to begin; here's the AM link for today.
SEVERAL big issues to be decided upon this morning by the Judge; who will have reviewed a few briefs from counsel this morning before court adjourns. WHAT will happen?? Stay tuned.
#WAOpioidTrial The first big question: Will the Judge allow these subjective surveys to be admitted - dancing around whether Dr. Banta-Green is a fact witness (which means the surveys COULD be hearsay) or if he's a dang expert (which he clearly is, but not for this trial?)
#WAOpioidTrial The judge - sort of bemused about how state keeps referring to Dr. Banta-Green as a 'fact witness' - has asked both parties for BRIEF oral arguments about admitting the surveys.
Hopefully defense brings up that it was a teeny survey of one county by syringe users.
#WAOpioidTrial resumed earlier this morning - I'm feeling bleah so I'm late on the updates. We finally, finally wrapped up testimony/cross/re-everything with Ruth Carter with only three things which stood out. Also here's the AM link until lunch.
1st: Counsel inquired about various things Ms. Carter had missed or excluded or got wrong in specific documents. There were quite a few things in various redirect/cross where that happened ... all of which painted the defense negatively. Hmm
#WAOpioidTrial Second: When Ms. Carter was asked about a benzo in a document, she replied: "Yes but that's not an opioid, it's a benzodiazepine, and those are also widely sought after by DRUG ABUSERS."
She has continually called people who use RX or illicit substances this.
#WAOpioidTrial Day 18 has begun this morning! As suspected the unscheduled trial break was because one of the key players got COVID. It was the judge!😳 He's back now.
State has resumed their redirect of their witness, former DEA Ruth Carter.
AM link:
#WAOpioidTrial We're spending a ton of time looking at distributor reports from 2008 (and such) about percentage of controlled substances ordered by specific pharmacies. With zero context about the population(s) those locations served, proximity to cancer centers, surgery, etc.
It's not possible to call something a "red flag" w/o having that context. State's argument is distributors should've flagged all kinds of things w/o guidance, regulatory requirements etc.