Thread by @funchefchick

#WAOpioidTrial Day 14 has begun; this morning's link below.

We resume with former DEA unit chief Ruth Carter, state's witness, still on the stand IRL discussing various alleged issues with the 3 defendants' diversion control issues over the years.

Oh for . . . 'Cardinal stepped up reporting suspicious orders (undefined) to DEA in 2012; but if a pharmacy's order was held bc it they'd reached their order threshold, but then the threshold reset because time passed - THEY WOULD STILL SHIP NEW ORDERS.' Right. Because ....

The only reason that order was suspicious/held was because it exceeded their previously-determined order limit. Not because it was "suspicious". Then when that pharmacy needed to fill scripts PER USUAL, they placed their usual order. DEA wanted patients to suffer/go without? 🤯

I'm surmising that state needs to scrutinize every possible flaw in every C2 order ever filled in order to lay the foundation for this 'public nuisance' case but - this is just nonsense. The OD/drug poisoning crisis was caused by many complex factors, but primarily illicit drugs.

State's DEA witness: "It should have concerned Cardinal that X% of their orders were this particular drug/dosage. OF COURSE, THERE COULD BE A PERFECTLY REASONABLE EXPLANATION."

Yes. Yes there could. Like it was the most commonly RX'd drug/dosage for surgical pain, trauma etc

DEA: "This form shows someone checked "yes" that there's not a concern here, so that's fine UNLESS THE ANSWER IS NOT ACCURATE, then it would be a problem."

Um- Defense? Hello? Can I get an objection?

DEA: They just used a checklist to review diversion checks at pharmacies. How dare they.

You mean ... defendant came up with a list of most common diversion concerns, made a form, had their people fill out that form each time and write down if any concerned were identified..?

State shows an email where someone at ABDC (AmeriSourceBergen) was sending most, if not all orders to the diversion control team for review instead of assessing them himself. Basically: a dude was (allegedly) NOT doing his job, and causing problems by blocking all orders.

As a person who had to train people on how to comply with a consent decree: THIS IS A PERSONNEL THING. They needed someone who COULD determine when an order should be flagged, and when not. DEA sees this as evidence of ..something. It looks like a dude not doing the job well.🤷‍♀️

Witness literally just contradicted herself. "If someone makes an error placing an order and it's caught in review, it does not need to be reported to DEA. BUT IF they catch an order in review and decide not to ship it (because an error?) THEN IT SHOULD BE REPORTED TO DEA." Um?

Okay so we spent a minute on Walgreen's #3840 in Burien, WA and that it dispensed a lot more of a particular dosage than 'average' for ABDC customers. I wonder why that could have been. Let's look. Here's the city of Burien, WA border:

It's south of downtown Seattle, and close to SEA-TAC airport. And if we zoom in a little there's the Walgreen's in question on the upper left. And .. at least 2 full hospitals and 4 outpatient surgical centers RIGHT THERE close to it. You can orient on HWY 509 and SR 518.

Do I know that nothing suspicious was happening at that one pharmacy? Clearly no. But can I see a reasonably plausible explanation for why they might have higher than average dispensing than say, a more rural pharmacy customer, or even average customers NOT near surgical centers?

Oh for . .. ABDC local rep emails a pharmacy in 2017 and asks them to complete a 'tell us about your pharmacy and assess diversion risk form' as was NOW required due to DEA ... and state/DEA witness introduces as "evidence they were lax". Um. Seriously?

Defendants will be in trouble if they do NOT do diversion controls, the level of oversight/controls increased over time, and when they implemented NEW controls .. . that's now evidence of wrongdoing? Somehow?? I just . .. defendants could not win for losing. Per the DEA.

We are back from the mid-morning break, state continues w/DEA witness.

Multiple senior DEA witnesses have testified that it was NOT DEA's fault that DEA-registered distributors shipped C2 substances to DEA-licensed pharmacies who dispensed meds to patients via DEA-licensed MDs.

DEA has literally pointed the finger at literally everyone one else: manufacturers, distributors, pharmacies, and medical providers. Oh! And patients, of course. Very consistent.

Anyone and everyone EXCEPT the DEA. And the drug cartels/drug dealers, of course. Derp.

Ugh. I just can't. We're now focusing on a pharmacy in Aberdeen. On their forms they indicated they were dispensing lots of opioid 'because doctors in the area' - INCLUDING a pain mgmt doctor they listed. Guess what else is in the city of Aberdeen nearby?

If you guessed a hospital & an orthopedic surgical center, you'd be correct. There's a whole cluster of ortho surgeons within a stone's throw of the pharmacy. Again was there something hinky with this pharmacy? WE DO NOT KNOW. DEA found them suspicious bc they dispensed C2s.

For those unaware - DEA finds it 'suspicious' if a pharmacy dispenses above a certain ratio of controlled substances compared to non-controlled. IN FACT - they won't let them dispense them beyond a certain ratio. EVEN WHEN REAL PEOPLE HAVE REAL SCRIPTS FOR REAL PAIN. DEA: 🤷‍♀️

So now - DEA dictates the annual quota for how many C2 medications CAN BE PRODUCED every year - and they've lowered that number six years in a row now even during a pandemic.🤦‍♀️

DEA also dictates what ratio pharmacies can dispense them. HOW IS THAT WAR ON DRUGS GOING?!

And now the state is showing - AGAIN - the distasteful internal emails from that one jerk from 2012 as 'evidence the company culture didn't care about diversion'.

Sigh. There's always going to be that one jerk sending terribly inappropriate emails.

Also - WE SAW THESE ALREADY.

Oh dear lord. State is using stickers to indicate 'in which time periods the defendant's actions did not constitute effective diversion controls'.

STICKERS. Seriously. These are my tax dollars at work, people. I just. 🤦‍♀️😬

"The DEA has not said that distributors should second-guess the doctors who are prescribing."

REALLY.

But to be clear - the DEA is 100% ABSOLUTELY saying the distributors should second-guess each and every pharmacy who is dispensing. .. THE PRESCRIPTIONS WRITTEN BY THOSE VERY SAME DOCTORS.

Clear as mud.

Exhibits, exhibits . .. letters, emails, reports over the years. "DEA will not approve or endorse a particular diversion control program". Because it was the distributor's 'business decisions' to decide. But then DEA would fine them and charge them if they saw flaws. Cool.

DEA never, not once saw ANY defendant mention 'Standard of Care. Pain as a fifth vital sign. Responsible opioid prescribing. Joint Commission. Intractable Pain Act. WA's 1999 Regs on Dr of Discipline. WA's prescribing guidelines.' Seems ... unlikely?

Oh wait DEA SPECIFICALLY told the distributors that they were not to second-guess the doctors/ARNP who prescribed opioids/treated pain.

Is that because government is not supposed to interfere with the practice of medicine?

Funny. State just asked DEA witness if the metrics the defendants used were 'reasonable' - this is after DEA repeatedly said they would not endorse or approve any monitoring systems. But now they get to vote on whether it was reasonable after the fact? Which is it?

And we're back from the lunch break. This afternoon's link is below.

We resume w/state continuing to question witness former DEA unit chief Ruth Carter about the previous nerdy maths from Lacey Keller. But first the witness is excused while parties chat.

There is a 'running objection' by defense to various things - which, apparently the judge can eventually sustain and strike tons of testimony later if he so chooses. For now, lots of stuff is on the record.

"Is it your opinion that a shipping a high volume of opioids into a population is a red flag" Yes.

Alternately there are lots of people having surgeries, suffering traumas, battling cancers or other serious & painful illnesses. Every attempt to 'red flag' leaves people in pain.

Even IF a pharmacy was intentionally diverting controlled substances in WA over time that's the *pharmacy* breaking laws and 'putting people at risk'. The pharmacy -if state could prove they knowingly diverted substances OUTSIDE OF LEGIT RX - is the guilty party. The end. 🤷‍♀️

STATE IS FINALLY DONE WITH THE WITNESS. At long last. She steps out while parties do some 'housekeeping' legal discussions. Stay tuned for cross.

Witness returns, and McKesson's counsel takes point for the defendant's cross-examination.

Witness confirms that SOME diversion was prevented by defendants' efforts, but doesn't know how much.

McKesson asks: Did RAN recruit you to be a paid trial witness the very night you left the DEA?

Witness wants to see RAN's testimony, so it's pulled up. Which says pretty much that. She says wasn't *recruited* by him, state objects to that characterization. Just sustains it.

SHE HAS MADE ROUGHLY $1.9 MILLION DOLLARS AS A TRIAL WITNESS in seven different opioid trials.

Wow.

She made $170-$180k per year at DEA. Sooo. This would be very much more then.

"Can you tell us any manufacturer, distributor, or pharmacy in the United States that you can tell met their obligations with respect to prescription opioids?"

"No, I cannot."

Huh.Not a single manufacturer, distributor, or pharmacy -not ONE in the country- did the right things?

State objects to the defendant's line of questioning as "witness does not represent the DEA".

Oh I'm sorry. Was she not testifying for literal hours all day about the DEA and speaking on behalf of that agency?!

Some obvious hostility from McKesson's counsel, but - that's to be expected.

Lots of objections from state, but - as judge keeps ruling - there's more leeway on cross. (IANAL but that seems to be the deal).

Fascinating. Witness wrote a detailed list of "elements of an effective suspicious order monitoring program" while at DEA which was circulated internally. And IT WAS NEVER PUBLISHED PUBLICLY.

Distributors were left to their own devices to figure it out, then get penalized.

Imagine your boss saying: come up with a process for a thing. You ask: OK what does it need to do, what's the criteria? Boss says guess. You say, OK I've sketched out a process, how does it look? Boss says: not saying, just don't eff it up. You roll it out. Boss fires you.

Then Boss fines you, cites you for criminal mistakes, and publicly announces how you screwed up and 'endangered the public'. THEN when your boss leaves the company? He makes millions of $$ testifying against you in court for the same thing. Not one court. SEVEN COURTS.

AND you eventually learn - your boss actually DESIGNED THE CRITERIA FOR THE THING AGES AGO AND JUST NEVER TOLD YOU, but circulated it around to other people.

I just. Anyway we're in the mid-afternoon break and if you can't tell - this whole thing is still such nonsense.

And we're back. Witness is out of the courtroom while parties argue about her statements/admissibility/line of questioning from defense.

Judge rules: defense's objection is overruled. Bringing back the witness to proceed with cross (still by McKesson's counsel).

Interesting - defense is asking DEA's Ruth Carter about state's previous witness Lacey Keller and her background, experience with ARCOS, and her new/unique metric she used in this case. Carter was not familiar - but cited Keller's analysis as fact IN HER OWN TESTIMONY this AM.

Judge: "The DEA is not a defendant in this case."

Yes. Can we talk about that at all? No?

Defense: "Are you aware that Ms. Keller was just doing math, not making judgements. She said she was not an expert on which data to analyze and which metrics to run?"

Nope. That guidance came from the state of WA, apparently.

Lots of questions about how witness Carter did NOT review flagged orders in this case - not one. For any of the three defendants. Just the due diligence reports.

Defense is really going to town with variations of this question.

From earlier: "If you are called to testify as an expert witness on behalf of the State in this trial, you're not going to say that you ID'd a specific individual order that was shipped to a pharmacy in WA supplied by any of the distributors here that was actually diverted."

No.

"You also cannot tell if any of these orders were for legitimate medical purposes"

No.

"You cannot tell if ALL of them were for legitimate medical purposes."

No.

🤷‍♀️

"Can you describe Lacey Keller's 'Common Sense Metric' for me?"

You mean right now? Or earlier?

No. I mean, if you give me a script then yes I can reasonably explain it.

<pulls up depo transcript where she said no, it was not her area of expertise>

Depo was from July 2021.

"Did any defendant use Lacey Keller's (new, unique metric she created by request of the state) on their data?"

I don't know.

Did you see she ran her new metric against the wrong data year?

Whoops.

"You are aware that it is prescriber's responsibility to determine medical need when they write a prescription for opioids?"

Yes I am aware.

"You understand they are only supposed to write them within a doctor-patient relationship, and when there's medical need?"

Yes.

You are aware that DEA regs cite that the responsibility lies with the PRESCRIBER, right?

Yes.

Cites federal reg title 21 § 1306.04:

ecfr.gov/current/title-…

Defense is going on to say per that reg - a corresponding responsibility rests with the pharmacist who fills the prescription.

Basically: there are multiple gatekeeping legal responsibilities between the distributor and the public. Like, SERIOUS levels of gatekeepers.

***"You agree it would be a public health problem if patients could not receive the medicines for which they had a legitimate medical need."***

YES.

IF ONLY SOMEONE AT DEA KNEW THEY WERE ACTIVELY PREVENTING THIS FROM HAPPENING ON AN ONGOING BASIS AND HAVE FOR YEARS. 🤬

Aug 17, 2015 letter from DEA by this witness, Ruth Carter:

"The DEA has consistently supported the prescribing and dispensing of controlled substances for the legitimate treatment of pain within acceptable medical standards."

When questioned, she said: yes, legitimate pain.🤔👀

Hoo-boy. In 2005 the DEA solicited public comments on the dispensing of controlled substances for the treatment of pain - here:

deadiversion.usdoj.gov/fed_regs/rules…

Several state's Attorneys General joined together to write a public comment (I cannot find it - it may predate public access online) RAISING CONCERNS about barriers of access to pain care. Like 25 states and D.C.

WASHINGTON STATE'S AG WAS AMONG THEM.

I gotta try to find that letter - which was just entered in to evidence - because it has some deadly accurate statements which were true in 2005, and are even more true now. I would love to see if it's our current AG's name attached. Stay tuned.

Meanwhile, we've moved on to a WA state campaign to 'remove deadly rx opioids from the public" in 2017, with our current AG's name attached - which says 'Most misused medication comes from family or friends".

Which . .not the distributors' responsibility, there.

This is the document they were just discussing/quoting. State objected; defense points out it is the WA AG's name on it - THE PLAINTIFF IN THIS CASE.

Heh. Judge overrules state's objection.

doh.wa.gov/Portals/1/Docu…

Ooh ! The FSMB gets a shout-out here! That would be the Federation of State Medical Boards, which has advocated for humane and appropriate pain care nationwide (which is sadly not what has happened in recent years). fsmb.org

Moving really fast past stuff interesting to me - but skipping to where we are:

Defense asks witness about the DEA production quotas for controlled substances which they set every year.

State objects; Judge overrules.

painnewsnetwork.org/stories/2021/1…

Interesting - I've not heard this detailed before, but (obviously) the largest piece of the opioid production quota is for prescriptions for people with pain - not research, not industry. Human people with pain.

DEA has slashed production quotas six years in a row now. 😢

Interesting. We're adjourning for the day and will resume cross of Ms. Carter in the morning, which will take the full day.

There was a flurry of interesting stuff there in the last hour - I scribbled some notes but I'm going to take a breather before trying to decipher them.