While the
opioid crisis has received a significant amount of attention, and
strategies have been put into place to try to curb the epidemic of
overuse and misuse, few of the responsible parties have been held to
account
One West
Virginia attorney has sued opioid wholesale distributors using a state
nuisance statute. Distributors should have reported suspicious activity,
yet didn’t. Farrell charges that this unlawful conduct is what has
given rise to the public nuisance of rampant opioid addiction
Cardinal
Health, one of the three largest opioid distributors in the U.S., denies
accountability, blaming the opioid crisis on doctors, pharmacists,
regulators and the Drug Enforcement Agency
However,
there’s ample evidence showing Cardinal Health ignored suspiciously
large orders, shipping an alarming number of pills into areas that
should have raised big red warning flags
Wholesale
distributors shipped 76 billion opioid pills across the U.S. between
2006 and 2012, more than 10 billion of which came through Cardinal
Health
Prescription painkillers — not illicit drugs — are now among the most commonly misused drugs in the U.S.1,2 As of June 2017, opioids became the leading cause of death among Americans under the age of 50.3 President Trump declared the opioid crisis a public health emergency that year in October.4
The following graph by the National Institute on Drug Abuse shows
the progressive incline in overdose deaths related to narcotic pain
relievers between 1999 and 2017.5
I've written many previous articles detailing the background of how
the U.S. ended up here. Unfortunately, while the opioid crisis has
received a significant amount of attention and strategies have been put
into place to try to curb the epidemic of overuse and misuse, few of
the responsible parties have been held to account. A small-town
Southern lawyer hopes to change some of that.
Can forgotten state law bring justice to West Virginia?
An article6 in Freedom Magazine describes how Paul Thomas Farrell Jr.,7 a lawyer in Huntington, West Virginia, is using a little-known state nuisance statute (West Virginia Code Section 7-1-3-KK8) to tackle the state's opioid problem. As explained in that article, the statute:9
"… prohibited things like junk piles in people's yards
and noisy bars staying open late. It called for the responsible parties
to abate the issue, that is, to remove the problem — and pay for
damages."
Farrell is using this law to sue and hold wholesale distributors of
opioids responsible, as they should have reported unusual activity, yet
didn't, which is a violation of federal law.
This unlawful conduct, Farrell says, is what has given rise to a
public nuisance — the destruction of communities due to rampant opioid
addiction. Farrell is also urging other areas to follow suit, using
similar nuisance statutes, although it's still unclear whether this
legal tactic will actually work.
Three distributors have cornered the opioid market
As noted by Freedom Magazine, there are 800 wholesale distributors
of narcotics in the U.S., with three — Cardinal Health,
AmerisourceBergen and McKesson — having cornered 85% of the market
share.
The Fortune 500 rankings of each of these wholesalers has also risen
"in direct parallel to a skyrocketing relationship to the sale of
OxyContin," Freedom Magazine notes, adding:10
"The distributors' mandated task was to detect suspicious orders —
any increase of 15 percent or more — and report them to the Drug
Enforcement Administration (DEA) monthly. Yet West Virginia, and
eventually other areas, saw prescription increases of 100, 200 even 900
percent or more in some places, but no reports were filed.
In 2001, Farrell noted, a government oversight agency reviewed
the DEA's reports on OxyContin and determined that the DEA was also
negligent. At the time, he said, DEA officers were 'underfunded,
understaffed and ill-equipped to handle the volume. We're talking about
30 million transactions.'
Over the next few years, the DEA began going after
distributors. One of the distributors' wholesale centers got caught
selling a 500 percent increase in opioids to just five pharmacies in
Florida, which all became well-known 'pill mills,' facilitating in the
process of illegal street sales of opioids further up the East Coast.
When the DEA prohibited that center from selling to those five
pharmacies, the distributor simply supplied those pharmacies from a
different center. '[Then] the DEA agent says, 'Are you kidding me?
You're still selling?' So, they hammered them,' Farrell said. The DEA
hit Cardinal with a $44 million fine and revoked the registration of
that facility."
Advertisement
Suing opioid distributors
In 2017, the DEA forced opioid manufacturers to reduce the number of
pills produced by 25%. The following year, another 20% reduction was
mandated.11
However, as the supply of opioids went down, addicted patients started
turning to readily available (and less expensive) heroin instead.
Indeed, research12 published in 2014 shows prescription opioids had by then become the primary gateway drug to heroin and other illicit drug use.
Farrell points out that while most of the blame for the narcotics
problem (both prescription and illicit) has been laid on the heads of
opioid manufacturers such as Purdue Pharma, "nobody's really picked up yet on the role the distributors have played," Farrell tells Freedom Magazine.
"So, what I'm going to do is make them abate the public nuisance."
He points out that Cardinal Health, AmerisourceBergen and McKesson are
"just as big or bigger than Purdue," and they have but one job: track
and manage the volume of drugs distributed.
After devising a recovery plan with community leaders, Farrell sued
24 distributors — including the three largest ones — along with
Walgreens and CVS, to force them to help repair the damage done to the
community.
Part of the recovery plan for West Virginia includes educating
people, especially children, about the dangers of opioids and that these
pills are "just as dangerous as a crack pipe," Farrell says.
For this, he's requesting funding from both the board of education
and the state health department to the tune of $5 million per year for
10 years for each county. For the first step in the recovery plan, the
total cost for the state's seven counties would be $350 million, but the
total abatement cost is estimated to be in excess of $1 billion.
Farrell filed his lawsuit in 2017. In 2018, it was placed in a
multidistrict litigation (MDL) in Cleveland, Ohio, along with 400 other
lawsuits. "The intent is for similar cases to be heard under one
jurisdiction to speed up the discovery process and pretrial rulings,"
Freedom Magazine explains, adding:13
"Even under the MDL, Farrell … sees his case as slightly
different. As he explained, suing a drug manufacturer frames the case as
a 'product liability case — you have to show design defect, or
labeling defect,' he said. 'I don't have to prove any of that. Mine is
public nuisance,' Farrell said …
'You broke the law in West Virginia … Let's just pick a random
number … You broke the law 10,000 times. I just have to prove it once.
You helped create a public nuisance that resulted in drug abuse,
addiction, morbidity and mortality — now you have to abate it. How do
you abate a public nuisance like that? It'll cost you about a billion
dollars. And you can write a check.'"
Cardinal Health denies accountability
A July 24, 2019, report by WOSU Radio reads:14
"An executive at Dublin-based Cardinal Health … said under
questioning recently that the business has no obligation to the public
when it comes to the amount of prescription opioid painkillers it ships
…
[I]n a deposition earlier this year, Cardinal Health counsel
Jennifer Norris was asked by a lawyer whether the company wants to
'ensure that it does what it can to prevent the public from harm?' She
answered: 'I don't know that Cardinal owes a duty to the public
regarding that.'"
This particular deposition was for a lawsuit filed by two Ohio
counties, Cuyahoga and Summit. Several drug companies and distributors
are named in this suit, the trial for which is scheduled to begin in
October 2019.
July 29, 2019, The Columbus Dispatch published an article15
headlined, "Cardinal Health: A Billion Pills in 8 Years, But No Role in
Ohio's Opioid Crisis?" As noted in this and other media reports,
Cardinal Health insists it had nothing to do with the creation of the
opioid epidemic, maintaining the crisis, "was caused by the doctors
who overprescribed the pills, the pharmacists who sold them and the
regulators who failed to catch the addictive prescription drugs flooding American communities."
However, there's ample evidence showing Cardinal Health (as well as
other distributors) ignored suspiciously large orders, shipping an
alarming number of pills into areas that should have raised big red
warning flags. Over the past decade, Cardinal Health has also paid
nearly $100 million in fines over its mishandling of narcotics,16 making its denials ring even more hollow.
Federal drug database records show wholesale distributors shipped 76
billion opioid pills across the U.S. between 2006 and 2012,17 more than 10 billion of which came through Cardinal Health.18 Keep in mind that as of 2012, the U.S. had a population of just 312.8 million.19
Between 2006 and 2014, Cardinal Health shipped over 1 billion opioid
pills into Ohio alone, and records show the number of opioids flooding
into the state from Cardinal rose by 44% in those years.20
McKesson has a similar record of shipping suspiciously large orders.
One particularly egregious example is that of Kermit, West Virginia.
In a single year (2005 to 2006), a pharmacy in Kermit — which has a
total population of 400 — took delivery of nearly 5 million doses of
opioids from McKesson.21
Cardinal shifts blame onto DEA
Cardinal Health also blames the DEA, saying the company reported all
sales details to the DEA as required, and did not have access to
complete data about shipments to individual pharmacies from other
distributors. The DEA was the only one with full access to all the data
and therefore, Cardinal believes the failure to act is on the DEA.
DEA, meanwhile, maintains Cardinal Health failed to flag suspicious
sales and even paid large fines for those failures. In an October 2,
2008, press release, DEA Acting Administrator Michele M. Leonhart said:22
"Despite DEA's repeated attempts to educate Cardinal Health on
diversion awareness and prevention, Cardinal engaged in a pattern of
failing to report blatantly suspicious orders for controlled substances
filled by its distribution facilities located throughout the United
States."
The press release, which publicized Cardinal's $34 million
settlement for failure to report suspicious sales, also pointed out
that:
"Seven Cardinal Health distribution centers received and filled
thousands of suspicious orders placed by pharmacies participating in
illicit Internet schemes, but failed to report the orders to DEA.
They did so even after an Aug. 22, 2005, meeting at which DEA
officials met with and warned Cardinal officials about excessive sales
of their products to pharmacies filling illegal online prescriptions.
The pharmacies filled purported online 'prescriptions' for
hydrocodone (contained in drugs such as Vicodin), but the prescriptions
were issued outside the normal course of professional practice and not
for a legitimate medical purpose.
The U.S. Attorneys allege that the orders that Cardinal received
from these pharmacies, and others, were unusually large, unusually
frequent and/or deviated substantially from the normal pattern."
One Cleveland, Ohio, lawsuit against Cardinal Health points out that
wholesale distributors cannot plausibly argue that they're simply
delivering goods and have no power to control the amount, like that of a
trucking company, since they are by law "required to 'maintain ...
effective controls against diversion' and to 'design and operate a
system to disclose ... suspicious orders of controlled substances.'"23
As Ohio Attorney General Dave Yost told The Columbus Dispatch,24 "They know exactly what they're hauling, where they're hauling, who they're selling to and, most importantly, how much …"
Multistate settlement discussions underway
August 6, 2019, The Columbus Dispatch published a follow-up to this ongoing story.25
According to anonymous sources, the three largest distributors —
Cardinal Health, AmerisourceBergen and McKesson — have allegedly
proposed a $10 billion, yes, folks, BILLIONS with a B, multistate
settlement to close a number of cases against them. Yet this may still
fall far short of what the opioid epidemic is actually costing us.
A Verus press release26
confirms the existence of a "comprehensive settlement" for hundreds of
communities that are part of the MDL in the Northern District of Ohio
under Judge Dan Aaron Polster, but it does not specify an amount.
According to The Columbus Dispatch:27
"The National Association of Attorneys General — handling talks
on behalf of more than 35 states — countered with a demand for $45
billion to cover costs from the public-health crisis of opioid addiction
and overdoses …
Whether the distributors and attorneys general can agree to a
deal remains uncertain. But reaching a compromise might not be the
toughest hurdle.
The distributors face almost 2,000 additional lawsuits brought by
cities and counties across the U.S., with a separate group of lawyers
leading the litigation. Getting them to sign on to any deal could prove
challenging …
A global settlement covering all opioid manufacturers and
distributors might end up costing the companies a combined $30 billion
to $55 billion, according to analysts at Nephron Research, an
independent health-care investment research firm. Wells Fargo analyst
David Maris said a final tally could be even higher, at almost $100
billion."
Johns Hopkins public health professor Caleb Alexander, an expert
witness for the defendants in the MDL under Judge Polster, who is
working on a national 10-year abatement plan, believes the cost of
abatement will be greater than $480 billion. This cost includes
addiction treatment, preventative education, foster care for children
whose parents have died from overdoses and criminal justice resources.28
Struggling with opioid addiction? Please seek help
It will be interesting to see what comes from these cases, now
numbering in the thousands and difficult to keep track of. In the
meantime, educating yourself and your family — especially your children,
but also elderly parents and grand-parents — about the dangers of these
drugs is paramount.
Regardless of the brand of opioid you use, it's vitally important to
realize they are extremely addictive drugs and not meant for long-term
use for nonfatal conditions. Chemically, opioids are similar to heroin. If you wouldn't consider using heroin for a toothache or backache, seriously reconsider taking an opioid to relieve this type of pain.
In many cases, you'll be able to control pain without using medications. In my previous article, "Billionaire Opioid Executive Stands to Make Millions More on Patent for Addiction Treatment,"
I discuss several approaches — including nondrug remedies, dietary
changes and bodywork interventions — that can be used separately or in
combination to control pain, both acute and chronic.
If you've been on an opioid for more than two months, or if you find
yourself taking a higher dosage, or taking the drug more often, you may
already be addicted. Resources where you can find help include the
following. You can also learn more in "How to Wean Off Opioids."
No comments:
Post a Comment