W.Va. Court Rules in Favor of Drug Wholesalers
“Federal judge in W.Va. rules in favor of drug distributors in landmark opioid trial,” (WCHS).
Why I think the judge’s ruling is BS.
The City of Huntington and the County of Cabell sued three drug companies (Wholesalers) responsible for distributing hydrocodone and oxycodone or opioids. Their claim was AmerisourceBergen Drug Co., Cardinal Health Inc., and McKesson Corp. were responsible for the increase in addiction in the county and Huntington.
The claim was based off of the numbers of pills shipped to the county and the city. The Wholesalers claim “they ‘just’ ship what the pharmacies order. ‘We just ship.’ We do not know where it ends up. Neither do we know how it is being used.”
A Federal District Court ruled against the city and the county.
As you read, I think you will see differently than what the Wholesalers claim.
Information
Market Size: Cabell County population is estimated at 93,418 in 2021 according to the US Census Bureau. This is down from 94,350. Much of the population lived in the city of Huntington. West Virginia is losing population.
Dosage Sent to Huntington and Cabell County:
- During the nine-year period, an average of 39.9 hydrocodone and oxycodone doses per person were shipped nationally in the US.
- An average of 72 doses per person were shipped to West Virginia. Within West Virginia.
- 122 doses per person were shipped to Cabell County and the city of Huntington.
There was a heavy concentration of hydrocodone, oxycodone, etc. dosage directed to Cabell county and the city of Huntington. It is not possible to reconcile the number of dosages being sent with the population legally. The population stats are taken from the US Census. Manufacturers of drugs do not do distribution, various companies do
Wholesalers:
As a part of the Supply Chain, Wholesalers buy large quantities of drugs from pharmaceutical companies, warehouse them, and distribute them to pharmacies. The 3 main wholesalers, which account for about 85% of the market, are AmerisourceBergen, Cardinal Health, and McKesson. Pharmacies.
The Story:
Wholesalers are intimately involved in the purchase and supply of drugs to any part of the country. Given the population of Cabell County and the city of Huntington, it is impossible for the Wholesalers not to know the amounts being ordered by pharmacies were beyond normal usage for the population of the ~94,000 people in this area of West Virginia. Wholesalers have to know demand quantities in order to plan shipments from manufacturers. It is also impossible for the Pharmacy Benefit Managers not to be aware of the amounts of drugs being purchased were not normal.
The argument used by the Wholesalers is they are unaware of why the numbers of pills are being ordered by pharmacies. Wholesalers claim they “just” ship what the pharmacies order. We just ship. We do not know where it ends up. Neither do we know how it is being used. AmerisourceBergen Drug Co., Cardinal Health Inc., and McKesson Corp.
I find their comments hard to believe as these drugs and ingredients are controlled substances. The ingredients and inventories are closely monitored. Also, I am guessing each company has or had a program which monitors the ordering of dangerous drugs such as opioids besides manufacturing and inventories.
I choice McKessons policy to highlight. Links to the other policies are available below.
McKessons policy:
“Our CSMP uses sophisticated algorithms designed to monitor for suspicious orders, block the shipment of controlled substances to pharmacies when certain thresholds are reached and report those blocked orders to the DEA. We are proud of our CSMP and are dedicated to ongoing enhancements.”
“About McKesson’s ‘Controlled Substance Monitoring Program‘”
– Thorough customer due diligence and ongoing oversight: McKesson performs comprehensive analyses on prospective pharmacy customers before agreeing to supply prescription medications.
– Advanced customer purchasing analysis: Using complex and dynamic algorithms, McKesson has developed a robust system to help identify suspicious orders for controlled substances.
– Regular ARCOS reporting: McKesson reports controlled substances transactions to the DEA via the DEA’s automated ARCOS drug reporting system.
– Tightly controlled physical supply chain: Controlled substances are locked, monitored and stored in two DEA-regulated spaces.
– Regular customer education: McKesson has been proactive in educating its customers about the importance of compliance with DEA and state agency regulations.
– Ongoing state and federal collaboration efforts: McKesson is an active participant in state and federal legislative efforts around controlled substances.
Also advertised on the McKesson’s Pharmaceutical Distribution site; “McKesson has an experienced CSMP team comprised of more than 70 team members in Regulatory Affairs CSMP with over 290 years of cumulative DEA and DOJ law enforcement experience.”
This sounds like a pretty tight policy with checks and balances. There are Good Manufacturing Practices (partially reflected above) and separately Good Distibution Practices to be followed. McKesson and the other two would follow Good Distribution Practices.
As quoted below and taking into consideration ordering practices versus population within Cabell County. The Wholesalers should have been all over the over ordering as well as the FDA (pr appropriate agency).
Wholesale distributors should monitor their transactions and investigate any irregularity in the sales patterns of narcotics, psychotropic substances or other dangerous substances. Unusual sales patterns that may constitute diversion or misuse of medicinal product should be investigated and reported to competent authorities where necessary. Steps should be taken to ensure fulfilment of any public service obligation imposed upon them. Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use
The US follows the same Good Distribution Practices as the European Union.
The big three Wholesalers AmerisourceBergen Drug Co., Cardinal Health Inc., and McKesson Corp. have a responsibility to ensure the drugs they supply from manufacturers are being used safely.
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Cardinal’s Overall CSMP Presentation: Controlled Substance Monitoring Program (CSMP) (cardinalhealth.com), and Cardinal-health-ir-presentation.pdf (cardinalhealth.com)
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AmerisourceBergen Drug Co. Policy: ABC_SafeandSecureDistributionofControlledSubstances_Sept2019.pdf (q4cdn.com)
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Judge David Faber’s Ruling:
Briefly, “The opioid crisis has taken a considerable toll on the citizens of Cabell County and the City of Huntington. And while there is a natural tendency to assign blame in such cases, they must be decided not based on sympathy, but on the facts and the law. In view of the court’s findings and conclusions, the court finds that judgment should be entered in defendants’ favor.”
Faber said the state’s law against public nuisances has only been applied to conduct interfering with public property or resources, not the distribution or sale of a product. He said extending the meaning would be “inconsistent” with the history and “traditional notions” of a nuisance.
My opinion? Based on the Wholesaler’s CSMP and the DEA, the Wholesalers have the responsibility of monitoring demand as to whether the demand is reasonable or not. The demand for Cabell County is far higher than other areas of West Virginia.
“an average of 39.9 hydrocodone and oxycodone doses per person were shipped nationally in the US. An average of 72 doses per person were shipped to West Virginia. Within West Virginia, 122 doses per person were shipped to Cabell County and the city of Huntington.”
What I believe. Three times the amount was sent to Cabell County and Huntington as compared to the US. Fifty percent more was sent to the same as compared to all of West Virginia. These are the facts. I also suspect there are more deaths per 1000 in Cabell County and Huntington (maybe more on this later) then the rest of West Virginia. West Virginia is one of the worse states for addition.
Is Opioid usage a public nuisance? Yes, it is. From what the judge has stated, the argument was not the right one. Maybe file again with a different argument. Better legal minds than mine can determine such. I can see the issues.
Notes:
McKesson’s Controlled Substance Monitoring Program | McKesson
Closing Statements End In Trial Over Holding Companies Liable For Opioid Crisis : NPR
McCann said data shows AmerisourceBergen and Cardinal Health were responsible for about 98% of the 14.8 million hydrocodone and oxycodone dosage units sent to four Fruth Pharmacies in Cabell County.
Four Rite Aid stores in the county received 8.8 million units, and while the company sent 63% of the doses itself, McKesson sent larger, stronger amounts of the drug. Two-thirds of the shipments received by four CVS stores came from Cardinal Health, McCann said.
McKesson attorney Paul Schmidt and Mahady said the plaintiffs were focusing on the highest numbers from the data that support their case and changing the scales on graphs to make them appear more impressive.
Nine Cabell pharmacies controlled half of opioid market, expert says | News | herald-dispatch.com
The Ruling: “The opioid crisis has taken a considerable toll on the citizens of Cabell County and the City of Huntington. And while there is a natural tendency to assign blame in such cases, they must be decided not based on sympathy, but on the facts and the law. In view of the court’s findings and conclusions, the court finds that judgment should be entered in defendants’ favor.”
Faber said the state’s law against public nuisances has only been applied to conduct interfering with public property or resources, not the distribution or sale of a product. He said extending the meaning would be “inconsistent” with the history and “traditional notions” of a nuisance.
Federal judge rules in favor of pharmaceutical companies in West Virginia opioid case (wvnstv.com)
Federal judge rules in favor of major drug companies in landmark opioid trial (wsaz.com)
Spreading falsehoods is also a bitch. Debunked from a number of sources, none of which you’d probably accept. https://www.snopes.com/fact-check/biden-place-medal-of-honor-backwards/
RW
Please ignore it. This is a spammer. It also appears under other names also. Thank you If it seems unreasonable in content, you can be certain it will be deleted shortly.
I know that 40 or 80 pills per person sounds like a lot, and taken as an average for an entire population it is, but as someone who has chronic pain and can only take an opiate because of other medical issues, the amount of pain pills I go through would curl your hair.
My first prescription was written as nominal 3 a day as needed, but not to exceed 6. That would be over a thousand pills a year, if I did need 3 a day. After not quite 10 years of being unable to take anything else, my tolerance was to the point that I needed to up my dosage of opiate. My doctor asked what would be the most I thought I might need, and my answer was 4 a day. This was before the government started restricting prescriptions, but when she calculated what my standard 90 day supply would be we dropped the number down to 240. In point of fact that 90 day supply would last more like 5 months, because as needed is not all day every day.
Now of course, they can only prescribe 30 days at a time and they have dropped that down to 3 a day again. If I got my prescription redone every month that is still over a thousand a year. As it is I probably get closer to 500 a year, but that is still a lot of pills, and I take every one of them. If I were in constant pain like many people are it would be a lot more.
Yes, on an individual basis 122 does not sound like a lot. Certainly when presented as you have. However, that number is 122 for every person in that town/city. Every person. That is a lot, especially when the you consider the average for every one in the nation or everyone in WVa.
My point was it doesn’t take many people like me to inflate the averages. My use would cover the needs of 100 normal post-surgical prescriptions for the same stuff. My husband had a hernia operation and used 3 or 4 pills before he switched to plain Tylenol. His prescription was for 50, but they would not do that today. When they set up a way to return unused medications at my pharmacy, the total number of opiates they received was more than all the other types put together.
There probably were a lot of pill mills, but raw numbers and simple averages do not tell the whole story. It is a sore point with me because I get really tired of being treated like a junky. Most people on pain meds are not, but you might have trouble realizing that from some of the press.
Jane:
Of course, this is not about you. Neither are you are a junky and neither are many people.
I am sure amongst the 94,000 in the county of Cabell there is a minority of people who benefit from the use of Hydrocodone, Oxycodone, and in particular Purdue’s OxyContin. If you have been following the series of articles I have written on Angry Bear, I feel confident you know I take this seriously. Some while back, I was asked to write on OxyContin and how it had been sold as being nonaddictive through the misuse of the Porter and Jick letter citing the use of Hydrocodone and Oxycodone in hospital settings.
Purdue and other manufacturers dropped the words hospital settings from their sales pitch to doctors in the promotion of OxyContin, as a result, it was over prescribed and abused due to it being promoted as safe. It is addictive.
The question is why is Cabell County and Huntington so unusual? The Wholesalers who control 95+ percent of the distribution of these drugs are mandated by various governmental departments to monitor their shipments of restricted access drugs. The judge was in error to allow their excuse of “we ship what they order” when the ordering surpasses what is typical of ordering practices within the state of West Virginia. Over ordering is a “flag” which should have been investigated. It wasn’t, it was ignored, and they made their blood money.
West Virginia is one of the worst states for opioid abuse. It is also one of the poorest. It ranks 49th. Joe Manchin (if you read my other post) gave a speech to Congress attempting to deny one administrator from being appointed to an FDA(?) position because he voted to approve a particular opioid. He gave the example of one young and pretty, blonde and well to do woman as a reason this Opioid should never have been approved. She died because on the addiction. She was clean for a period of time and slipped backwards. She bought her last dose of unknown brand of opioids from a street seller. She took it while in her car and died immediately as it was laced with Fentanyl. This was Manchin’s beef, a pretty, young blonde, white woman who family had money.
Does Joe talk about Cabell County? Was he all over the Wholesalers in an attempt to find out why they over ship to Cabell County? To Joe, West Virginia is John Denver’s “Heaven Sent” like his houseboat is named and from which he talks down to voters. It sounds like Cabell County and Huntington have a little bit of hell going on. Why isn’t he finding out what the real issues are there?
I am understanding your plight. Still, this must be looked at and examined. The courts ignored it, as did the Wholesalers, and Manchin could give a damn.
Joe Manchin Telling a story
Jane, I’m very aware of what has happened to those people who do need the medicine but now have a hard time getting it, if they can get it at all. In my state due to laws past a few years ago, the ability to get opioid med virtually dried up as doc’s were to afraid to prescribe along with all the documentation.
As is too typical in our nation, there is an over reaction by the politicians to a problem like the opioid crisis.
Have no fears. I’m sorry if I made you feel the need to be defensive.