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This article was produced in partnership with The Philadelphia Inquirer,
which was a member of ProPublicas Local Reporting Network in 2020-21.
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Reporting Highlights
Delayed Justice: After a whistleblower exposed the criminal behavior of
Endo, a drug manufacturer, the Justice Department waited more than a
decade to bring charges against the company.
A Steep Discount: Federal agencies said Endo owed up to $7 billion in
criminal fines, back taxes and other charges. The government settled this
year for just $200 million.
Winners and Losers: Endo is still selling narcotics. Lawyers made $350
million. A few executives shared $95 million in bonuses. Thousands of
opioid victims are to share $40 million.
These highlights were written by the reporters and editors who worked on
this story.
This spring, the Justice Department announced a major victory against a
drug firm that manufactured billions of opioid painkillers. Endo Health
Solutions, the agency said, would face $1.5 billion in fines and
forfeitures and plead guilty to a corporate criminal charge.
Prosecutors said the massive fine would hold accountable a suburban
Philadelphia company that profited by misrepresenting the safety of their
opioid products and using reckless marketing tactics to increase sales.
But in the end, federal prosecutors offered far friendlier terms than
those trumpeted by the agency.
Endo would not have to pay the $1.5 billion in criminal penalties, which
was already a deep discount from the billions federal officials said Endo
owed for dodging taxes and driving up Medicare costs.
In what amounted to a liability fire sale by the Justice Department, the
companys woes with the federal government would all be resolved by a $200
million payment.
In sentencing Endo in federal court in May, Judge Linda Parker wondered
how the amount paid to the U.S. could be so low.
I dont understand. I really dont understand, Parker said. I just
dont understand how it went from $1 billion to $200 million.
Federal prosecutor Benjamin Cornfeld explained: Endo was broke.
The reality is that there are limited funds available because the debtors
were in bankruptcy, Cornfeld said.
But a fuller explanation, drawn from corporate filings, interviews, and
criminal court and bankruptcy records, shows how the DOJ, after years of
aggressively prosecuting opioid companies, delayed for a decade a winning
criminal case against Endo. In the intervening years, Endo vastly expanded
its narcotic-pill empire before executing a corporate escape plan.
Codenamed Project Zed, the plan allowed Endo to restructure its debt to
retain control of the company and hand out $95 million in executive
bonuses before seeking protection in bankruptcy. The result for U.S.
taxpayers: Endo paid a tiny fraction three pennies on the dollar of
the $7 billion that officials said it owed the U.S. government, including
$4 billion in taxes.
Endo is not a household name. But by 2018, a year when 15,000 Americans
overdosed and died on prescription painkillers, Endo and the firms it
purchased had sold 33 billion opioid pills over two decades, almost three
times the number sold by Purdue Pharma, the Sackler familys OxyContin
powerhouse.
Though federal prosecutors first learned about Endos criminal behavior in
a 2013 whistleblower suit, they dropped their investigation, even as they
doggedly pursued Purdue. By the time DOJ prosecutors revived the
allegations against Endo early this year, the company was bankrupt.
Hundreds of lawyers, paralegals and financial advisers litigated Endos
bankruptcy, billing more than $350 million. Some lawyers charged more than
$2,000 an hour. Paul Leake, Endos lead attorney, said in a court filing
that the bankruptcy plan extinguished Endos liabilities for a fraction
of the debtors total criminal and civil exposure.
Individual opioid victims didnt fare as well. They got just $40 million
from Endo a sum that works out to about $1,000 per victim. In
comparison, people hurt by bankrupt Purdue, the poster firm for the U.S.
painkiller trauma, were to share up to $750 million. Purdue victims are to
receive sums ranging from $3,500 to $48,000.
Margo Siminovitch, an attorney representing opioid victims, was the
fiercest critic of the plan. At the bankruptcys last major hearing, she
told the judge that lawyers in the case earned hourly rates that exceed
what an opioid victim whos had their life devastated is going to get.
Endo came with a strategy purposely intended to reduce payments to opioid
victims, Siminovitch said in an interview. All of the [Endo] opioid
victims were burned by this process, in that they were going to get
virtually nothing.
Profiting From Pain Management
Spun out of DuPont Merck in 1997, Endo the name is Greek for inside
set out to make money in the changing landscape of pain management, and
for 20 years it did just that.
The company started with Percocet: It upped the per-pill opioid dosage and
whipped up sales through promotions and a contest among salespeople where
BMW corporate cars were the prize. Revenue soared.
Endos next big bet was Opana ER, an extended-release painkiller that won
the Food and Drug Administrations approval in 2006. Opana ER became its
flagship opioid, Endos answer to Purdues OxyContin. Endo launched the
brand with a $48 million marketing campaign and began, in a phrase Endo
used internally, hyper-targeting heavy opioid prescribers.
To ease deep-seated concerns over opioid addiction, Endo also linked up
with other pharma companies to try to reshape the public image of
prescription narcotics. The firm poured millions into advocacy front
groups, notably the American Pain Foundation, which contended doctors
feared opioids because they mistakenly think their patients will become
addicted. The foundation shut down the day a Senate committee announced
it was probing the industry groups.
Larry Romaine, Endos senior vice president for sales, told subordinates
in a 2012 voicemail that salespeople had to be laser focused on selling
Opana ER. If we have reps out there, I dont care who they are, that
cant sell Opana ER clinically, they cant be with Endo. OK? he said.
His voicemail and other material from inside Endo, including emails,
became public court records in lawsuits filed against the company.
Endo declined to comment for this story and would not respond to detailed
questions sent to the firm. Former Endo employees, including those whose
communications were entered into court records and are cited in this
story, did not return emails and phone calls seeking comment.
In an email sent in 2009, Endo sales manager Bret Anderson wrote to his
team, referencing requirements to identify and cut off doctors who
prescribed suspiciously high volumes of opioid drugs, with a warning that
if too many doctors were flagged it could hurt business. I also consider
the rule: if you are not aware of any major issues, it is probably not a
problem.
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In a 2009 email, Endo manager Bret Anderson told staffers that reporting
too many doctors who were prescribing suspiciously high volumes of opioids
could harm business, saying, it may risk that territory being a viable
territory. Credit:Documents obtained by ProPublica and The Philadelphia
Inquirer. Highlighting added by The Philadelphia Inquirer.
At Endos headquarters, Linda Kitlinski oversaw Endos education programs
for doctors for 16 years. In 2009 she sent an email to her husband
documenting her concerns that Endos senior leadership was pressuring
her to improperly use her program as a sales tool. Soon after she raised
these issues internally, her boss called her into his office and warned
her that she had nearly been fired because she was an impediment to the
business. She needed to stop playing policeman.
When Endo salespeople alerted bosses to dangerous doctors, lawsuit
testimony revealed that the company, unlike other manufacturers, never
reported those suspicions to the Drug Enforcement Administration. Those
reports were required by law.
In Alabama, Endo sales reps made 1,200 visits to a Mobile clinic where two
doctors wrote thousands of Opana ER prescriptions after Endo knew the
clinic to be engaged in abuse, the government said this year in its
criminal case against Endo. Prosecutors said the clinic had a crowded
waiting room with intoxicated customers, armed guards and medical staff
abusing controlled substances on-site.
In Knoxville, Tennessee, where Endo sold more Opana ER pills than in New
York City, Los Angeles and Chicago combined, a sales rep reported to
supervisors that one doctor had patients waiting in the parking lot in
lounge chairs, and it is just a matter of time before the DEA closes him
down.
In Pittsburgh, more than 100 pharmacies refused to fill prescriptions for
a reckless doctor, yet Endo continued to supply him. He was the nations
largest Opana ER prescriber, according to an Endo email.
Doctors in those clinics were eventually sentenced to prison.
Separately, records show that of Endos 20 biggest Opana ER prescribers in
the Medicare program in 2016, four clinic operators would later be
convicted of running multimillion-dollar pill mills. A fifth would lose
her medical license for dangerous prescribing.
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Linda Kitlinski, who oversaw Endos education program for doctors, sent an
email to her husband in 2009 contending that senior management was
pressuring her to use her program as a sales tool. The email was made
public as evidence in New York states lawsuit against Endo. The drug
company settled the suit in 2021 for $50 million. Credit:Documents
obtained by ProPublica and The Philadelphia Inquirer. Highlighting and
redactions added by The Philadelphia Inquirer.
As it became clear that opioids were causing a health crisis, Endo came up
with a response. It engineered a new, purportedly safer pill with a hard
outer shell to make it more difficult to extract the active opioid,
branding it as Opana ER with Intac Technology.
But there was a big problem: The FDA found the retooled drug to be no
safer than the old version. For three years, the agency warned Endo that
the pill could be readily prepared for injection an even riskier high
than snorting because of the danger of sharing needles.
Within Endo, Bob Barto, the vice president for regulatory affairs, warned
in a 2010 email against using the Intac slogan because we dont have any
data to demonstrate that the technology conveys any benefit to the
patient.
Endo leaders didnt drop the marketing approach. In the new drugs slogan,
the company said the pills were designed to be crush resistant, stopping
short of saying they actually were crush resistant.
In early 2012, William Best, an Endo executive who dealt with regulators,
emailed internally to say he was comfortable with promoting Opana as
designed to be safe. While acknowledging that the language might provoke
FDA disapproval, Best wrote, it is likely to be a warning letter.
As the company began selling its new formulation, the firm declared in
marketing material: At Endo, we are doing our part to limit abuse.
Warning Signs for Endo
In 2013, a whistleblower emerged from the Endo salesforce. Her name was
Loretta Reed.
A veteran in the pharma industry, Reed had worked for Endo for seven years
when she filed a lawsuit in Philadelphia federal court alleging that top
executives were intent on selling the updated version of Opana ER as
safer, despite the FDAs rejection of that claim. The 50-year-olds job
was to market Endos pain drugs to doctors in the Atlantic City, New
Jersey, area.
Endo leaders distributed marketing gimmicks, notably kits with samples of
Opana ERs new hard covering, Reed disclosed. Salespeople deployed the
kits, she said in the suit, to demonstrate the toughness of the pills,
pounding samples with hammers and microwaving them the kinds of
misleading tactics cited later as part of Endos guilty plea.
But while hammering and microwaving demonstrated the new pills exterior
strength, it left doctors uninformed about the other ways the narcotic
active ingredient, oxymorphone, could be extracted by abusers, including
by cutting, chewing, grinding and heating the pills for injection.
Endos marketing was purposely designed to fraudulently manipulate
prescribing physicians, Reeds suit charged. She said the companys
management misled the sales force about the FDAs concerns.
Indeed, Endos own research, provided to the FDA in 2016, showed that many
users switched to shooting up when abusing the product.
In 2017, a senior medical adviser with the Centers for Disease Control and
Prevention investigated the role Opana ER had played in an HIV outbreak in
Indiana after doctors diagnosed 135 people with the disease, all of them
tightly concentrated in a rural county. Narcotics users had extracted the
oxymorphone from Opana ER and shot it up, with many sharing needles.
In his report, the CDC investigator quoted a drug user as saying that once
Opana ER added its hard cover, You had to cook them. It pretty much
forced me to have to inject really.
Said another: I couldnt find any [original] Opanas or other pain
medicine to snort. It became almost non-existent. So I was turned on to
shooting up. So thats pretty much how that went down.
Reeds allegations of mislabeling were strikingly similar to those made by
an Endo salesperson eight years earlier. In a 2005 federal lawsuit, sales
rep Peggy Ryan had reported that top executives had relentlessly pushed
the sales force to sell the nonopioid shingles drug Lidoderm off-label for
everything from sore backs to carpal tunnel. Ryan declined to comment for
this story.
Federal prosecutors had embraced Ryans suit, using her to gather
evidence. Ryan wore a wire for the FBI for two years. The criminal
investigation advanced slowly, but in early 2014, Endo admitted it had
illegally misbranded Lidoderm. It paid a $192 million fine and signed a
corporate integrity agreement promising to improve its ethics. The deal
permitted it to keep doing business with Medicare, despite a law mandating
that criminal pharma firms be cut off.
As for new whistleblower Reeds allegations involving Endos leading
narcotic painkiller a far more dangerous drug than Lidoderm the
Justice Department took them seriously at first. Federal officials put
together a task force of prosecutors and FDA investigators.
By the fall of 2014, eight months after charging Endo over Lidoderm,
prosecutors had decided to end their probe regarding Opana ER,
Philadelphia court documents show. That led Reed to withdraw the case in
2015. Prosecutors would not discuss their reasons for dropping the Opana
ER investigation.
The Justice Department did not answer questions in detail for this
article, but in a statement it praised the deal it finally reached with
Endo this year that secured a victory for American taxpayers and other
stakeholders.
Reeds lawsuit aside, Endo still saw promise in opioids. New chief
executive Rajiv De Silva, who took charge in 2013, executed an ambitious
acquisition strategy, taking on debt to buy Par Pharmaceuticals, a maker
of generic opioids that was churning out billions of pills a year, for $8
billion.
The timing was terrible. After Endos expensive wager on Par, the national
conversation over opioids darkened. Tens of thousands had overdosed and
social costs exploded. Cities and counties across the nation, linking up
with aggressive personal-injury law firms, sued opioid players at every
rung of the business, from pillmakers to distributors to pharmacies to
doctors. More than 40 state attorneys general joined together to demand
compensation from opioid firms.
In 2017, the FDA held two days of emotional public hearings on Opana ER
that laid bare its dangers.
Not long after, the agency asked Endo to take Opana ER with Intac
Technology off the market, a first in modern times for an approved opioid.
If Endo didnt remove the drug, the FDA said it would. Endo complied. By
then, Endo had made $543 million in profits over six years selling the
painkiller.
In 2018, federal prosecutors subpoenaed opioid-related records from Endo.
After the FBI contacted Reed, now living in Florida, about the allegations
made in her withdrawn Philadelphia case, her lawyer, Eric Young, refiled
the whistleblower suit in Florida. But it would be another five years
before federal prosecutors would bring criminal charges against Endo.
Launching Project Zed
As the feds delayed, Endo acted.
Facing a growing wave of lawsuits, Endo spent heavily on legal fees
ultimately paying $345 million. Its fierce legal strategy generated its
own controversy as Endos leading defense firm, Arnold & Porter, faced
repeated allegations that it wasnt fighting fair.
One New York state prosecutor in a civil trial accused the law firm of
concealing vast troves of smoking-gun evidence proving Endos grave
misconduct.
In California, a judge barred testimony from former Endo senior director
Kitlinski after Arnold & Porter and other defense law firms did not turn
over her 2009 memo.
In Tennessee, the legal hardball became a debacle for both Endo and Arnold
& Porter. A judge there held them in contempt and found that they had
engaged in a coordinated strategy to deprive opponents of information.
The judge demanded that Arnold & Porter apologize to the court and that
its attorneys take an ethics refresher class.
Arnold & Porter declined to comment, but referred reporters to previous
statements. The firm said at the time it had acted in good faith and
regretted that any document had been produced late. It said its lawyers
had worked hard to locate and turn over all relevant documents and had
even offered to pay for additional depositions to go over issues raised in
any belatedly revealed material.
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In 2020, a Tennessee judge held Endos lead defense firm, Arnold & Porter,
in contempt for failing to disclose potentially damaging information. The
firms chair apologized to the court, and more than 100 Arnold & Porter
attorneys involved in Endo cases nationwide took an ethics class to
satisfy the judges order. Credit:Documents obtained by ProPublica and The
Philadelphia Inquirer.
Endo turned to another big law firm, Skadden Arps in New York, to deal
with a declining business and potential bankruptcy. From Endos
perspective, the lawyering here proved more successful. Skadden Arps
helped develop a plan that Endo confidentially codenamed Project Zed.
When companies declare bankruptcy, all the businesses and people who are
owed money file proofs of claims to be paid. These creditors are divided
into groups, and those with the strongest legal claims are placed in
higher tiers for payment and thus are more likely to recover funds.
Distressed companies have gotten aggressive with rearranging debt so that
some creditors may leapfrog others through a process called uptiering.
Endo completed sweeping uptiering transactions in 2019 and 2020, putting
liens on assets and replacing unsecured debt with secured debt. Endo said
its uptiering under Project Zed gave the firm time to seek settlements for
opioid lawsuits by extending debt deadlines.
But the uptiering also shrank the funds available to deal with Endos
opioid liability. State attorneys general initially sought $3.3 billion
from Endo for its role in the epidemic, according to bankruptcy court
records. They lost bargaining power, though, as the business declined and
Endo uptiered debt. Before Endo filed for bankruptcy, the state
prosecutors settled for $274 million.
In total including pre-bankruptcy lawsuit settlements with a few
individual states and payments to private organizations and victims Endo
paid about $635 million for the ravages of the opioid crisis.
In their deal, the Sacklers and Purdue agreed to pay $6 billion in
compensation, with most of the money going to state and local governments.
Teva and Allergan, pharmaceutical companies that merged their generic
opioid businesses, are to pay $6.5 billion.
Mallinckrodt, the nations biggest opioid pill maker, agreed to pay $1.7
billion in opioids damages in 2022 in its first bankruptcy. It filed a
second bankruptcy last year and cut its payment to $700 million.
In the Endo bankruptcy, lawyers for opioid victims and other unsecured
creditors labeled Project Zed a scheme to wall off assets, alleging it
amounted to fraud. Endo denied the fraud allegations.
Its all the more unfortunate, attorneys for opioid victims and
unsecured creditors said in court filings, that the victims of Endos
conduct in this should also be the victims of the opioid crisis from which
Endo profited handsomely.
In interviews, legal experts called uptiering a dangerous trend. Opioid
victims are kind of like sitting ducks, Berkeley Law professor Kenneth
Ayotte said. Opioid victims, he said, dont have contracts to protect
themselves against these transactions.
As it failed to pull out of a financial tailspin, Endo accelerated bonuses
to about two dozen executives. Records show a total of $95 million was
paid in less than a year.
Four days after the last bonus round of $22 million was paid to chief
executive Blaise Coleman and his three top lieutenants, Endo filed its
bankruptcy petition in federal court in New York. The total Endo paid its
top bosses dwarfed the controversial $7 million in pre-bankruptcy bonuses
granted to a handful of Purdue executives.
The bonuses immediately came under fire from a federal bankruptcy
watchdog, opioid victims and many creditors. The critics told U.S.
Bankruptcy Court Judge James Garrity Jr. that the payouts violated a law,
championed by then-Sen. Ted Kennedy, D.-Mass., nearly 20 years ago after
scandals involving windfalls paid to executives of bankrupt firms, most
notably Enron.
In interviews, professors who specialize in bankruptcy said that the
bonuses appeared to be an end run around Kennedys reforms. It looks like
pre-petition theft, said Gregory Germain, a widely published bankruptcy
expert at the University of Syracuse.
Skadden lawyer Lisa Laukitis defended the bonuses in a bankruptcy hearing.
These are not windfall payments that were made to line the pockets of
executives on the eve of the filing, she said.
The bankruptcy went on for months. Hedge funds and other investors led
by GoldenTree Asset Management, a New York firm that specializes in buying
distressed debt agreed to use their secured debt to buy Endo out of
bankruptcy. In negotiations to take ownership, the group sweetened the
deal by increasing the payments going to individual opioid victims and
other unsecured creditors. As part of the deal, the critics dropped their
complaints about Project Zed and the bonuses.
Garrity, the judge in New York, confirmed Endos bankruptcy plan in March.
Federal prosecutors, engaged in a parallel criminal investigation of Endo,
had reached their own deal. All that remained was for Parker, the judge in
the criminal court in Michigan, to approve the intertwined deals.
Winners and Losers
On the afternoon of May 2 in Detroit, federal prosecutors and Endos
defense lawyer explained to Parker how the financial penalty facing Endo
had dwindled to $200 million.
Along with the criminal fine, a final global resolution signed by U.S.
officials and Endo wiped out virtually all of the potential $4 billion IRS
bill. The agreement also mostly erased claims of another $1.5 billion for
false health care billing and Medicare costs generated by the opioid
crisis.
Endos attorney, Carole Rendon, a former U.S. attorney from Cleveland,
blamed the misconduct at the firm on a very small number of rogue
salespeople.
She told the judge the company had cleaned up its act, including firing
its 375-member opioid sales staff back in 2016. The firm at one point had
called them pain solution brand ambassadors.
A near-defunct Endo subsidiary pleaded guilty to a misdemeanor, allowing
the parent company to again sidestep a law barring convicted firms from
doing business with federal health care programs. No Endo executives or
employees were criminally charged in the case. Endo is still selling
Percocet and other opioids that bring in 7% of its revenue.
With the bankruptcy case closed, law firms and financial advisers won big.
Skadden Arps billed for the labor of nearly 350 lawyers and paralegals.
Its total fees: $114 million.
Two law firms, Akin Gump and Cooley LLP, represented painkiller victims.
In total, the lawyers and other advisers for victims are set to receive
$48 million more than the $40 million Endos individual opioid victims
are to share in a court-approved trust.
Reed, the Endo opioids whistleblower, received a reward of about $1.9
million.
Stockholders got wiped out. More than 3,000 victims lawsuits were ended.
And Endo continues to reward its veteran and new top executives, setting
aside more than $80 million in a stock pool for them, board members and
other key employees. It gave former CEO Coleman a $6.1 million parachute
when he resigned in August.
Individual victims still need to be compensated. If the number of
individual victims holds steady, arithmetic shows they might each receive
about $1,000 after administrative costs from the court-approved trust.
Under the $750 million Purdue plan, the largest checks, for $48,000, were
to go to family members who lost someone to a fatal overdose.
The Rappold family has filed for compensation. They lost Nicholas Rappold,
21, a kosher deli waiter and community college student. He was found
slumped in his car in 2010, dead from an overdose. Rappold received
various prescriptions, including for Percocet, from Dr. Stan Li in the
weeks leading up to his death, according to court records from Lis
criminal trial. Li banked thousands in cash from selling painkillers at
his New York City clinic to customers who lined up around the block.
Nicholas mother, Margaret, faulted the way Endo and other firms marketed
to Li. The doctor died in prison while serving a 10-year sentence for
manslaughter in the fatal overdoses of her son and a 37-year-old former
stockbroker.
Just to get sales, they dont care what they sell, said Margaret
Rappold, 75, who works at a school cafeteria. Whether its good for you
or not good for you.
While she says money would never make up for the loss of her boy, it could
defray her expenses, including her sons $14,000 funeral.
So far, the Rappolds and other families have found collecting difficult.
They have had to deal with paperwork filled with legalese and footnotes, a
short deadline for seeking money, an application website that didnt work
and, most significantly, rules that barred thousands of victims from
getting help.
Emily Walden, a Kentucky woman whose son, T.J. Walden, died at age 21 on a
camping trip after taking Opana given him by a friend, followed the Endo
saga closely until she realized that the trust will only help if victims
had a doctors prescription for an Endo narcotic.
These prescriptions were not falling off trucks, Walden said. They
marketed these drugs inappropriately and wrongly and flooded the streets.
They did nothing about it because money was number one.
Some 90,000 individual victims initially filed opioid claims against Endo.
Already, two-thirds of them have dropped out.
You can reach reporter Bob Fernandez at ***@gmail.com. You
can reach reporter Craig R. McCoy at ***@comcast.net.
--
November 5, 2024 - Congratulations President Donald Trump. We look
forward to America being great again.
The disease known as Kamala Harris has been effectively treated and
eradicated.
We live in a time where intelligent people are being silenced so that
stupid people won't be offended.
Durham Report: The FBI has an integrity problem. It has none.
Thank you for cleaning up the disaster of the 2008-2017 Obama / Biden
fiasco, President Trump.
Under Barack Obama's leadership, the United States of America became the
The World According To Garp. Obama sold out heterosexuals for Hollywood
queer liberal democrat donors.