#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? 🤔
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.
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.
adai.uw.edu/wadata/opioid_…
adai.uw.edu/wadata/opioid_…
#WAOpioidTrial Defense tried to ask about the massive uptick in Meth death rates, but ... state objected as it was covered by Cardinal's defense yesterday. The defense teams are supposed to agree on a point person. They can't re-litigate the same points over and over. EFFICIENCY.
#WAOpioidTrial And now we are here. Note the green line. "Commonly prescribed opioids" were involved in nearly 80% of deaths in 2006, down to 27.48% in 2020.
adai.washington.edu/WAdata/deaths.…
adai.washington.edu/WAdata/deaths.…
#WAOpioidTrial Defense is trying to discuss this - btw if you haven't played with the interactive charts at ADAI - they are FASCINATING. You can click on/off various substances to highlight various things for WA state.
adai.washington.edu/WAdata/major_d…
adai.washington.edu/WAdata/major_d…
#WAOpioidTrial Defense is trying hard to get to ask Dr. Banta-Green about how many more deaths involve Meth than involve RX opioids in recent years, per ADAI data.
But the judge is very serious about not allowing multiple defense lawyers to ask same/similar questions. Derp.
But the judge is very serious about not allowing multiple defense lawyers to ask same/similar questions. Derp.
#WAOpioidTrial Cardinal defense asked a few questions yesterday about "is counseling required for patients seeking MAT" - like should counseling BE required, which of course no - no one should be forced to get counseling, IMHO. McKesson's counsel is asking same, now. But why?
#WAOpioidTrial "Low Barrier Care" keeps coming up also; we're reviewing an email Dr. Banta-Green sent to himself w/notes. Basically offering Bupe first (or at least, really quick) to people struggling w/OUD seeking care. Like: get them MAT and quick, not tons of hoops to jump.
#WAOpioidTrial State is in redirect. They pull up a quote from a Banta-Green paper: "The results of this study show an overall increase in opioid deaths and an inverse relationship between heroin and RX opioids". The interesting thing ... is both parties highlighted this.
#WAOpioidTrial My hunch is that state will try to say RX opioid misuse led directly to a commensurate heroin/fentanyl misuse. (Many studies refute this)
Defense will say "opioid substance did not matter. The rate of misuse has always remained the same".
It's interesting.
Defense will say "opioid substance did not matter. The rate of misuse has always remained the same".
It's interesting.
#WAOpioidTrial The wildcard being: Meth. It's been a problem along the west coast for ages, and meth use has made a resurgence of late.
Will state try to say that RX *opioid* use/misuse let to METH use/misuse? Because .. . how? Also how would defendants be responsible? 🤔🤷🏽♀️
Will state try to say that RX *opioid* use/misuse let to METH use/misuse? Because .. . how? Also how would defendants be responsible? 🤔🤷🏽♀️
#WAOpioidTrial In a local newspaper article from 2005: "With more of the drugs around, there's been a greater opportunity for illicit use and more deaths' Banta-Green said.
But just prior he'd said "undertreatment of pain led the MQAC to <encourage more opioid RX> for pain."
But just prior he'd said "undertreatment of pain led the MQAC to <encourage more opioid RX> for pain."
#WAOpioidTrial Lots more dancing around what they can ask him, and - one more old quote where Banta-Green said "RX opioids can be safe and effective when used properly, but also can be dangerous" (paraphrasing) aaaand - we're done with Banta-Green.
Who I am sure is relieved.!
Who I am sure is relieved.!
#WAOpioidTrial Next up: State will play a deposition from an Amerisource Bergen employee, a local here from Auburn, WA.
She held jobs from customer care up to regulatory compliance manager/director and such. Let's watch.
She held jobs from customer care up to regulatory compliance manager/director and such. Let's watch.
#WAOpioidTrial She is asked if she had any 'regulatory compliance training or experience" prior to the gig. She says no.
As a person who got assigned repeated regulatory compliance responsibilities at one of the world's largest tech companies: Me neither. 🤷🏽♀️
As a person who got assigned repeated regulatory compliance responsibilities at one of the world's largest tech companies: Me neither. 🤷🏽♀️
#WAOpioidTrial While I am 100% certain that TODAY there's formal training & maybe certifications for doing SOMS & diversion control & all that - BACK THEN the companies were having to figure it all out on their own. It's not like there was a hiring pool of credentialed experts.!
#WAOpioidTrial Heck even the DEA wouldn't give guidance or blueprints on how the distributors could or should do SOMS. The specific regulations said "figure it out". And each company was not allowed to know the details of the other companies' order history to compare notes. !
#WAOpioidTrial To now grill the company's employees retroactively about "DID YOU HAVE EXPERIENCE WITH SOMS REGULATORY COMPLIANCE" when it was new territory for ALL the distributors . . . seems disingenuous. To me.
#WAOpioidTrial Grooooaaaan. We're back to asking distributor employees if they recall how/when various pharmacies reached their controlled substance order thresholds, if they were warned in advance and if so by who and when, etc. etc. Just. Tedious.
#WAOpioidTrial The state is trying to show that of the MILLIONS of orders placed for pharmaceutical meds to supply pharmacies in Washington state over the past 20+ years or more, perhaps on occasion some employee maybe screwed up and didn't conduct due diligence over C2 orders.
#WAOpioidTrial And you know what? I'll concede that MAYBE on occasion, someone did. Sure. It happens. I any industry.
But EACH ORDER was governed by DEA oversight. Each pharmacist. Each pharmacy. Each order. Each prescriber. Every time.
If an employee shipped an order?
But EACH ORDER was governed by DEA oversight. Each pharmacist. Each pharmacy. Each order. Each prescriber. Every time.
If an employee shipped an order?
#WAOpioidTrial IT STILL would require: a DEA-licensed doctor/ARNP writing an RX. A DEA-licensed pharmacist reviewing said RX. Probably an insurance company approving/denying that RX claim.
The distributors did not ship containers of RX opioids directly to the streets of WA.
The distributors did not ship containers of RX opioids directly to the streets of WA.
#WAOpioidTrial Grumble. I still can't believe we're entertaining this trial.
This #LitigationNarrative is making trial attorneys rich and solves NOTHING.
Lest we forget: State's attorneys have made $2 billion WITH A B on opioid trials so far. 🤬
reuters.com/legal/litigati…
This #LitigationNarrative is making trial attorneys rich and solves NOTHING.
Lest we forget: State's attorneys have made $2 billion WITH A B on opioid trials so far. 🤬
reuters.com/legal/litigati…
#WAOpioidTrial
The state of Washington, in all seriousness - via deposition - just entered in to evidence an internal AmerisourceBergen slide which said: "DEA Sucks".
Yep.
The state of Washington, in all seriousness - via deposition - just entered in to evidence an internal AmerisourceBergen slide which said: "DEA Sucks".
Yep.
#WAOpioidTrial Oh good, AM break time. I need coffee. And to scritch my dog's belleh for a bit because . .. whew.
I don't know how much more "this individual pharmacy order from 20 years ago - can we look at this one order threshold change request" I have in me, folks. 😳
I don't know how much more "this individual pharmacy order from 20 years ago - can we look at this one order threshold change request" I have in me, folks. 😳
#WAOpioidTrial And we're back. New deposition, new person. Some kind of advocate about regulatory responsibilities? Perhaps from an industry advocacy group?
Let's see where this goes.
Let's see where this goes.
#WAOpioidTrial Okay got it. While DEA remained INCREDIBLY VAGUE about 'suspicious order monitoring systems' and 'effective controls against diversion', when it came to VAULT STORAGE of c2s for distributors, they were VERY specific. And I do mean VERY.
ecfr.gov/current/title-…
ecfr.gov/current/title-…
#WAOpioidTrial So when a medication got classified as a C2 each distributor had 45 days to get vault storage upgraded to VERY specific requirements. VERY. And there were very few contract/companies which were qualified to BUILD those VERY specific vaults which met the regs.
#WAOpioidTrial So the industry (apparently) spun up an advocacy group to try to negotiate with DEA and FDA - yes we need secure storage but these timeframes and lack of qualified builders jeopardize the ability to get meds to the public, how do we solve this.
#WAOpioidTrial Here ya go. Here's SOME of the regs. It's all I could fit in one screenshot. Go ahead, find someone to build you this. In 2007, when it was brand new. Good luck.
#WAOpiodTrial ANYHOW. In this depo this person who was in the advocacy group is being asked if any of the defendants (or group members, specifically) did various things for SOMS, etc.
Which .. seems like hearsay to me. Because she wasn't in those companies? Clearly IANAL. 🤷🏽♀️
Which .. seems like hearsay to me. Because she wasn't in those companies? Clearly IANAL. 🤷🏽♀️
#WAOpioidTrial So the industry group created "industry compliance guidelines" (drafted, reviewed, consulted with DEA, counsel, etc. etc.) and published them. Now the witness is being asked via depo various details about which companies complied, who attended meetings, etc.
#WAOpioidTrial So. This distributor industry group created these guidelines for DISTRIBUTORS. Not anyone else. Eventually DEA and Walgreens had some unrelated kerfluffle, and someone cited their ICG (industry compliance guidelines) in their comms. But ICG wasn't FOR Wags.
#WAOpioidTrial The ICG were for WHOLESALE distributors not big chain pharmacies. Witness makes that clear. Interrogator says "BUT YOU SHARED THEM THO, RIGHT?"
She says: We shared them with other trade groups for them to leverage.
BUT YOU SAID INDUSTRY GUIDELINES.
Yes. Ours.
She says: We shared them with other trade groups for them to leverage.
BUT YOU SAID INDUSTRY GUIDELINES.
Yes. Ours.
#WAOpioidTrial Literally the plaintiff is trying to somehow find fault with this trade group coming up with ways to comply with DEA requirements.
If other companies/industries misused/misinterpreted those guidelines . .. this is the original group's fault somehow?
If other companies/industries misused/misinterpreted those guidelines . .. this is the original group's fault somehow?
#WAOpioidTrail Ooh while I was looking for that gif the parties started to squabble a bit over admitting 'business records' into evidence, yadda yadda.
<lawyer stuff I cannot begin to comprehend>
Judge: Objection sustained. (Defense wins that one!)
<lawyer stuff I cannot begin to comprehend>
Judge: Objection sustained. (Defense wins that one!)
#WAOpioid: Interrogator (asked witness on Jan. 23, 2020): Do you recall who attended that one meeting in 2007 and whether they were provided with these presentation materials?
<13 years later>
Um. No. Nor could most people remember EXACTLY WHO ATTENDED A LARGE MEETING.🙄
<13 years later>
Um. No. Nor could most people remember EXACTLY WHO ATTENDED A LARGE MEETING.🙄
#WAOpioidTrial Oh hey, defense agreed and so did the judge.
That was hella-vague. You are not allowed to ask people to wildly speculate about answers they do not know, it turns out.
Who knew??
That was hella-vague. You are not allowed to ask people to wildly speculate about answers they do not know, it turns out.
Who knew??
#WAOpioidTrial The trade group asked DEA for blinded, anonymized ARCOS data for their members back in like 2009 to help with SOMS designs and such. Because by law, they did not have access to competitor order data. DEA refused. Until 2019 when they were ordered to by Congress?
#WAOpioidTrial Literally the distributors asked the DEA for blind data to HELP them improve diversion control. DEA not only refused suggestions and guidance - they refused requests for blind data which could have helped the distributors as well.
https://twitter.com/funchefchick/status/1486768648832249856?s=20
#WAOpioidTrial DEA finally agreed to provide anonymized ARCOS data to the distributors in ~2018. They added functionality to ARCOS so users could see the last six months 'number of businesses that had sold a particular controlled substance to <customers>'. Cool. Finally.
#WAOpioidTrial Trial is adjourned for lunch; the AM link is no longer functioning. Back at 1:30PM PT.
Did you ever stumble across something startling and big and terrifying and also stupid so that you can't even come up with a snappy one-liner?
Yeah. I'm on a break.
Did you ever stumble across something startling and big and terrifying and also stupid so that you can't even come up with a snappy one-liner?
Yeah. I'm on a break.
#WAOpioidTrial We're back with this afternoon's link, good only until court adjourns today (typically 4pm PT).
State is playing a deposition recording from a Mr. Lambert from McKesson. So far the questions are re: opioid marketing. Let's tune in.
State is playing a deposition recording from a Mr. Lambert from McKesson. So far the questions are re: opioid marketing. Let's tune in.
#WAOpioidTrial State is trying to get McKesson to say their marketing efforts to were "SELL MORE OPIOIDS". Their dude is saying instead: "Helping to ensure that when a doctor writes an RX, that medication is there for the patient to access."
Which is elegant. Also true. Neener.
Which is elegant. Also true. Neener.
#WAOpioidTrial State is reviewing various marketing efforts for various C2 meds from 2010. "Here's a med you can stock in your pharmacy, in case someone prescribes it in your community."
Yes. How dare they advertise a legal, FDA-approved, RX-required medication TO PHARMACIES.🙄
Yes. How dare they advertise a legal, FDA-approved, RX-required medication TO PHARMACIES.🙄
#WAOpioidTrial HEH. State asks McKesson's guy if they ever 'auto-shipped' opioid meds to pharmacies w/o them specifically ordering them. Because that sounds super sketchy, right? Just SHIPPING OPIOIDS like that.
State asks him to name them: Suboxone. Butrans. MAT meds!
State asks him to name them: Suboxone. Butrans. MAT meds!
#WAOpioidTrial In other words: No, they didn't automatically ship pain meds to pharmacies proactively, out of control.
They DID auto-ship Medication-Assisted Treatment meds for Opioid Use Disorder to HELP ppl w/addiction.
I don't think that went how State thought it would.😉
They DID auto-ship Medication-Assisted Treatment meds for Opioid Use Disorder to HELP ppl w/addiction.
I don't think that went how State thought it would.😉
#WAOpioidTrial There's been several times when McK's guy has been asked "Do you know <wildly vague answer>" and he replies: I don't know. Which is believable. Super vague Qs.
Follow up Q: "Okay but how would you find out if you wanted to know?"
"I . . just don't know?" I mean?
Follow up Q: "Okay but how would you find out if you wanted to know?"
"I . . just don't know?" I mean?
#WAOpioidTrial Q; "Earlier you were talking about a spreadsheet. Can you tell me about that? What was it?"
Well, Joey, a spreadsheet is when . ..
Well, Joey, a spreadsheet is when . ..
#WAOpioidTrial Okay I might have gone a little GIF-happy after lunch. Some kind of weird therapy.
ANYWAY we are on the afternoon break; court will resume in about ten mins.
Also, the judge has a broken toe! That dude is having a rough month. (Because COVID earlier). Hugs.
ANYWAY we are on the afternoon break; court will resume in about ten mins.
Also, the judge has a broken toe! That dude is having a rough month. (Because COVID earlier). Hugs.
#WAOpioidTrial Aaand next witness from the State. It's another video deposition; this time a person from Cardinal Health.
She looks super nervous in the video recording. 😬
She looks super nervous in the video recording. 😬
#WAOpioidTrial Same line of questions they asked the McKesson person: the distributor (Cardinal) conducted various marketing activities as the conduit between manufacturers and the pharmacies.
Marketing! The new 3rd rail of legal liability? I guess?
🤷🏽♀️
Marketing! The new 3rd rail of legal liability? I guess?
🤷🏽♀️
#WAOpioidTrial "How do you ensure that your marketing activities do not contribute to suspicious orders?"
Well, funny story - the DEA regulations don't actually define what "suspicious orders" are, so . . .
HOW COULD ONE KNOW.?
Well, funny story - the DEA regulations don't actually define what "suspicious orders" are, so . . .
HOW COULD ONE KNOW.?
#WAOpioidTrial "You DON'T know the medical needs of the community, DO YOU?"
Um, no.
You don't know how many scripts have been filled for <substances> by that pharmacy, DO YOU?
Nope.
I'm sorry - is she expected to be omnipotent? Know every pain condition in EVERY community?!
Um, no.
You don't know how many scripts have been filled for <substances> by that pharmacy, DO YOU?
Nope.
I'm sorry - is she expected to be omnipotent? Know every pain condition in EVERY community?!
#WAOpioidTrial State of WA to Cardinal employee: So you don't check the claims or the efficacy of the <FDA-approved pharmaceutical> products being promoted through you?
YOU MEAN AFTER THE FDA HAS APPROVED THEM??
Seriously. WTAF. This person is NOT an MD or an ARNP or a PharmD.
YOU MEAN AFTER THE FDA HAS APPROVED THEM??
Seriously. WTAF. This person is NOT an MD or an ARNP or a PharmD.
#WAOpioidTrial I am just befuddled here. Sorry for the GIF storm but there's not enough characters to convey the WTAF-itude of these questions this afternoon.
I just.
I JUST.
🤦🏽♀️
🤷🏽♀️
I just.
I JUST.
🤦🏽♀️
🤷🏽♀️
#WAOpioidTrial Cardinal had a program to provide flat-screen tvs in select pharmacies to run content to distract patients while they waited for RX to be filled.
With 'lower perceived wait times and potential sales uplift".
THOSE BASTARDS.
</sarcasm>
With 'lower perceived wait times and potential sales uplift".
THOSE BASTARDS.
</sarcasm>
#WAOpioidTrial Cardinal had various ways to communicate w/pharmacy customers: they would include hardcopy paper in totes w/their pharmacy orders; an email flash distribution; fax blast. Sometimes ads for opioids (along with ALL OTHER meds) were included. Until they weren't. 🤷🏽♀️
#WAOpioidTrial Literally every question:
Would that have been offered to OPIOID manufacturers?
It was offered to all manufacturers.
WOULD THAT INCLUDE OPIOID MANUFACTURERS.
Again, all. All manufacturers.
Dude. It was all manufacturers. Stop trying to make it sound sinister.
Would that have been offered to OPIOID manufacturers?
It was offered to all manufacturers.
WOULD THAT INCLUDE OPIOID MANUFACTURERS.
Again, all. All manufacturers.
Dude. It was all manufacturers. Stop trying to make it sound sinister.
#WAOpioidTrial Cardinal sold ad space amongst their various comms to pharmacies to the manufactures (1/2 page on hard copy, some space in email or fax distribution, etc). Some of these they never offered for opioid meds, others (I think) they did.
To pharmacies. Not patients.
To pharmacies. Not patients.
#WAOpioidTrial If it is legal for pharmaceutical manufacturers to advertise legal prescription medications (and hey - that's a worthy conversation in general) THEN IT IS LEGAL.
Until/unless someone passes legislation saying it's illegal to market/advertise . . then it's legal.
Until/unless someone passes legislation saying it's illegal to market/advertise . . then it's legal.
#WAOpioidTrial By which I mean: Ppl may not like it that RX opioids were advertised. I get it.
Get a law passed? While you are at it should marketing of RX meds to the public be allowed at ALL? I have thoughts.
Can't demand companies 'know better' when they've broken no laws.
Get a law passed? While you are at it should marketing of RX meds to the public be allowed at ALL? I have thoughts.
Can't demand companies 'know better' when they've broken no laws.
#WAOpioidTrial And we're wrapping up for the day, and the week. Discussing the plan for Monday.
State will wrap up this video depo, and then call . .. a new all-day witness then. More deets later.
Whew. This was a looong trial day, team.
Peace out!
State will wrap up this video depo, and then call . .. a new all-day witness then. More deets later.
Whew. This was a looong trial day, team.
Peace out!
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