“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
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run75441 considers the following as important: AmerisourceBergen Drug Co., and McKesson Corp., Cardinal Health Inc., Healthcare, law, opioids, West Virginia
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“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)