Tag Archives: opioid crisis

OxyContin maker Purdue Pharma pleads guilty to criminal charges

By Mike Spector

NEW YORK (Reuters) – Purdue Pharma LP pleaded guilty to criminal charges over the handling of its addictive prescription painkiller OxyContin, capping a deal with federal prosecutors to resolve an investigation into the drugmaker’s role in the U.S. opioid crisis.

During a court hearing conducted remotely on Tuesday before U.S. District Judge Madeline Cox Arleo in New Jersey, Purdue pleaded guilty to three felonies covering widespread misconduct.

The criminal violations included conspiring to defraud U.S. officials and pay illegal kickbacks to both doctors and an electronic healthcare records vendor, all to help keep medically dubious opioid prescriptions flowing.

Members of the billionaire Sackler family who own Purdue were not part of Tuesday’s court proceedings and have not been criminally charged. They agreed in October to pay a separate $225 million civil penalty for allegedly causing false claims for OxyContin to be made to government healthcare programs such as Medicare. They have denied the allegations.

Purdue Chairman Steve Miller entered the guilty plea on the company’s behalf and admitted to its criminal conduct under questioning from Assistant U.S. Attorney J. Stephen Ferketic. Of the three criminal counts against Purdue, two were for violations of a federal anti-kickback law while another charged the Stamford, Connecticut-based company with defrauding the U.S. and violating the Food, Drug and Cosmetic Act.

Purdue’s plea deal carries more than $6.5 billion in penalties, most of which will go unpaid. A $3.54 billion criminal fine is set to be considered alongside trillions of dollars in unsecured claims as part of Purdue’s bankruptcy proceedings.

Purdue agreed to pay $225 million toward a $2 billion criminal forfeiture, meanwhile, with the Justice Department foregoing the rest if the company completes a bankruptcy reorganization dissolving itself and shifting assets to a “public benefit company” or similar entity that steers the $1.775 billion unpaid portion to thousands of U.S. communities suing it over the opioid crisis.

A sentencing imposing those penalties is set to come down the line, near the time Purdue receives court approval for a bankruptcy reorganization.

(Reporting by Mike Spector in New York; Editing by Chris Reese and Giles Elgood)

U.S. appeals court rejects novel opioid settlement framework

By Nate Raymond

(Reuters) – A federal appeals court on Thursday overturned a judge’s approval of a novel plan by lawyers representing cities and counties suing drug companies over the U.S. opioid crisis that would bring every community nationally into their settlement talks.

The 6th U.S. Circuit Court of Appeals by a 2-1 vote declined to approve an unprecedented “negotiation class” of 33,000 cities, towns and counties who could have a vote on whether to accept any settlements proposed with drug manufacturers and distributors.

U.S. District Judge Dan Polster in Cleveland, who oversees 2,900 opioid lawsuits, approved the framework last year to promote a global settlement.

It would allow cities and counties that have not sued to participate in settlement talks. Any settlement would need to win support of at least 75% of class members to be approved.

While companies do not have to use the negotiation class to settle cases, many including the drug distributors McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp objected.

Many state attorneys general, who have cases against the companies not before Polster, also objected, arguing the ruling could complicate their own settlement talks and interfere with states’ rights over their political subdivisions.

U.S. Circuit Judge Eric Clay said the federal rule that allows for class actions to jointly litigate cases does not authorize what Polster approved.

“However well-intentioned the district court’s actions might be, the fact of the matter is that the court, when it certified the negotiation class, exercised power it did not have,” he wrote.

The plaintiffs’ lawyers and companies did not immediately comment.

Some companies have proposed deals that do not use the framework including the three distributors and drugmakers Johnson & Johnson and Teva Pharmaceutical Industries Ltd, who in October 2019 proposed deals worth a collective $48 billion.

Negotiations are ongoing and dollar amounts have been shifting.

(Reporting by Nate Raymond in Boston; Editing by Bill Berkrot)

Exclusive: While battling opioid crisis, U.S. government weighed using fentanyl for executions

By Jonathan Allen

NEW YORK (Reuters) – The U.S. Department of Justice examined using fentanyl in lethal injections as it prepared last year to resume executing condemned prisoners, a then untested use of the powerful, addictive opioid that has helped fuel a national crisis of overdose deaths.

The department revealed it had contemplated using the drug in a court filing last month, which has not been previously reported.

In the end, it decided against adopting the drug for executions. Attorney General William Barr announced in July his department instead would use pentobarbital, a barbiturate, when it resumes federal executions later this year, ending a de facto moratorium on the punishment put in place by the administration of U.S. President Barack Obama.

But the special consideration given to the possibilities of fentanyl, even as federal agents were focused on seizing illegal imports of the synthetic opioid, show how much has changed since the federal government last carried out an execution nearly 20 years ago.

Many pharmaceutical companies have since put tight controls on their distribution channels to stop their drugs being used in executions.

As old supply chains vanished, many states, and the federal government in turn, have been forced to tinker with their lethal recipes. They have experimented with different drugs, in some cases leading to grisly “botched” executions in which the condemned prisoners have visibly suffered prolonged, excruciating deaths, viewed by some as a breach of the constitutional ban on “cruel and unusual” punishments.

In 2017, Nebraska and Nevada announced they would use fentanyl, which is 100 times more powerful than morphine, in new multi-drug execution protocols.

By 2018, the U.S. Justice Department was also examining the “use of fentanyl as part of a lethal injection protocol,” according to a three-page internal memorandum from March 2018 by the director of the department’s Bureau of Prisons.

The Justice Department revealed the memo’s existence in an August court filing after a federal judge ordered it to produce a complete “administrative record” showing how it arrived at the new pentobarbital execution protocol announced in July.

The full contents of the memo are not public. It is not known why the department decided to examine fentanyl, what supply channels were considered or why it ultimately rejected fentanyl as a protocol. The government’s court filing shows the only other named drug examined as the subject of a department memo was pentobarbital, the drug it now says it wants to use in December and January to kill five of the 61 prisoners awaiting execution on federal death row.

Wyn Hornbuckle, a department spokesman, declined to share a copy of the memo or to answer questions about the government’s execution protocol.

Mark Inch, who was the Bureau of Prisons’ director at the time, acknowledged in a brief telephone interview writing the memo. Inch, who abruptly resigned a couple months after writing the memo, declined to answer questions, in part because he said it would be in conflict with his current role running Florida’s Department of Corrections.

Doctors can prescribe fentanyl for treating severe pain. In recent years, illegal fentanyl has become a common additive in bootleg pain pills and other street drugs, contributing to the tens of thousands of opioid overdose deaths in the country each year. Even tiny quantities can slow or stop a person’s breathing.

Earlier this year, an Ohio lawmaker proposed using some of the illegal fentanyl seized from drug traffickers to execute condemned inmates.

‘FUNDAMENTALLY WRONG’

Death penalty researchers say that just because a drug is deadly does not mean it is always appropriate as an execution drug.

“I don’t think it’d be a surprise that the government would be looking at alternative methods of carrying out lethal injection, and fentanyl has been in the news,” Robert Dunham, the director of the Washington-based non-profit group the Death Penalty Information Center, said in an interview.

“But there is just something fundamentally wrong about using a drug implicated in illegal activities as your method of executing prisoners.”

In August 2018, Carey Dean Moore became the first person in the United States to be executed using a protocol that included fentanyl.

Nebraska prison officials injected him with fentanyl and three other drugs. Moore took 23 minutes to die. Witnesses said that before succumbing, Moore breathed heavily and coughed and that his face turned red, then purple.

(Reporting by Jonathan Allen; Editing by Cynthia Osterman)

Exclusive: OxyContin maker Purdue Pharma exploring bankruptcy – sources

FILE PHOTO: Bottles of prescription painkiller OxyContin pills, made by Purdue Pharma LP sit on a counter at a local pharmacy in Provo, Utah, U.S., April 25, 2017. REUTERS/George Frey

By Mike Spector and Jessica DiNapoli

(Reuters) – OxyContin maker Purdue Pharma LP is exploring filing for bankruptcy to address potentially significant liabilities from thousands of lawsuits alleging the drug manufacturer contributed to the deadly opioid crisis sweeping the United States, people familiar with the matter said on Monday.

The deliberations show how Purdue and its wealthy owners, the Sackler family, are under pressure to respond to mounting litigation accusing the pharmaceutical company of misleading doctors and patients about risks associated with prolonged use of its prescription opioids.

Purdue denies the allegations, arguing that the U.S. Food and Drug Administration-approved labels for its opioids carried warnings about the risk of abuse and misuse associated with the drugs.

Filing for Chapter 11 protection would halt the lawsuits and allow the drugmaker to negotiate legal claims with plaintiffs under the supervision of a U.S. bankruptcy judge, the sources said.

More than 1,000 lawsuits accusing Purdue and other opioid manufacturers of using deceptive practices to push addictive drugs that led to fatal overdoses are consolidated in an Ohio federal court. Purdue has held discussions to resolve the litigation with plaintiffs’ lawyers who have often compared the cases to widespread lawsuits against the tobacco industry that resulted in a $246 billion settlement in 1998.

A Purdue bankruptcy filing is not certain, the sources said. The Stamford, Connecticut, drug maker has not made any final decisions and could instead continue fighting the lawsuits, they said.

“As a privately-held company, it has been Purdue Pharma’s longstanding policy not to comment on our financial or legal strategy,” Purdue said in a statement.

“We are, however, committed to ensuring that our business remains strong and sustainable. We have ample liquidity and remain committed to meeting our obligations to the patients who benefit from our medicines, our suppliers and other business partners.”

Purdue faces a May trial in a case brought by Oklahoma’s attorney general that, like others, accuses the company of contributing to a wave of fatal overdoses by flooding the market with highly addictive opioids while falsely claiming the drugs were safe. The court proceedings will be televised.

Purdue tapped law firm Davis Polk & Wardwell LLP for restructuring advice, Reuters reported in August, fueling concerns among litigants including Oklahoma Attorney General Mike Hunter that the company might seek bankruptcy protection before the trial.

(Reporting by Mike Spector and Jessica DiNapoli in New York)

Largest-ever U.S. border seizure of fentanyl made in Arizona: officials

Packets of fentanyl mostly in powder form and methamphetamine, which U.S. Customs and Border Protection say they seized from a truck crossing into Arizona from Mexico, is on display during a news conference at the Port of Nogales, Arizona, U.S., January 31, 2019. Courtesy U.S. Customs and Border Protection/Handout via REUTERS

By David Schwartz

PHOENIX (Reuters) – U.S. border agents have seized 254 pounds (115 kg) of fentanyl that was stashed in a truck crossing into Arizona from Mexico, marking the largest single bust of the powerful opioid ever made at an American border checkpoint, officials said on Thursday.

The 26-year-old Mexican driver of a cucumber-toting tractor-trailer was arrested after agents on Saturday at the border station in Nogales discovered the fentanyl in a secret compartment, U.S. Customs and Border Protection officials said.

Fentanyl, a synthetic opioid 100 times stronger than morphine that can kill with a 2-milligram dose, has been blamed for fueling an opioid crisis in the United States. It gained notoriety after an overdose of the painkiller was deemed to have killed pop singer Prince in 2016.

The United States had a record 72,000 deaths from drug overdoses in 2017, with opioids responsible for most of those fatalities. President Donald Trump has declared opioid addiction a public health emergency.

The latest seizure in Nogales is the largest-ever confiscation of fentanyl by the U.S. Customs and Border Protection agency, officials said in a statement.

The fentanyl was worth an estimated $3.5 million, based on valuation criteria of the U.S. Drug Enforcement Administration, Hugo Nunez, a spokesman for U.S. Customs and Border Protection, said in an email.

The drugs were found after the truck was pulled over for a secondary inspection and drug-sniffing canines picked up an odor, Michael Humphries, the Nogales Area Port director, told reporters.

The driver, Juan Antonio Torres-Barraza, was charged in federal court in Tucson with two counts of drug possession with the intent to distribute.

An attorney for Torres-Barraza could not immediately be reached for comment.

Another 395 pounds (180 kg) of methamphetamine, worth about $1.1 million, also was confiscated from the truck, officials said.

“Fentanyl is trafficked into the United States largely from China and Mexico but it is not possible to determine which country is a bigger supplier, the DEA said in a report in October.

The U.S. Department of Justice, in a report last year to the U.S. Congress, has said the drug is primarily shipped to the United States from China through cargo containers or international mail. But Chinese fentanyl is sometimes sent to criminal groups in Mexico or Canada and smuggled across the border, the report said.

Last month, Mexican officials busted a fentanyl lab in Mexico City.

(Editing by Alex Dobuzinskis and Dan Grebler)