أرشيف الوسم: Law and order

Generic drugmakers sold most opioids during overdose crisis

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Mallinckrodt Pharmaceuticals doled out lavish perks for top U.S. employees who hit or beat sales goals for prescription opioids and other drugs: six-figure bonuses and a chance to snag a coveted “President’s Club” award, which could mean vacations to Hawaii, the Caribbean or Mexico.

The company placed that same staff in charge of reporting any sales of its painkillers that appeared to be suspicious, including to distributors or pharmacies requesting extreme volumes of its most potent formulas. Asked during a federal court deposition last year whether she believed it was appropriate to put incentive-motivated sales staff in charge of calling out questionable sales, Karen Harper, who oversaw Mallinckrodt’s suspicious order monitoring system, said yes.

In fact, as the nation’s opioid overdose crisis began to explode, not a single order with the company between August 2008 and October 2010 rose from the level of “peculiar” to “suspicious,” the category that would have triggered a report to authorities, according to Harper’s deposition.

The court documents reveal a company culture that allowed Mallinckrodt to become one of the giants of the prescription opioid market at a time when overdoses were claiming tens of thousands of American lives. The company, based in England, announced a tentative $1.6 billion settlement Tuesday with state and local governments in the U.S. If finalized, the deal would end lawsuits nationwide over the company’s role in the epidemic.

Purdue Pharma has been the poster child for the U.S. opioid crisis, mostly because of aggressive marketing of its signature painkiller, OxyContin. Lesser known is the role of generic opioid manufacturers like Mallinckrodt that produced the vast majority of painkillers during the height of the overdose epidemic. While they may not have been sending sales representatives to encourage prescribing like Purdue, they were filling more and more orders for the drugs — so many that Mallinckrodt couldn’t always produce enough to fill them all.

Nationwide distribution data released in a sprawling federal court case and analyzed by The Associated Press shows that Mallinckrodt’s U.S. subsidiary, SpecGX, and another generic drugmaker, Actavis Pharma, produced the vast amount of prescription opioids distributed throughout the country.

From 2006 to 2014, Mallinckrodt’s subsidiary shipped more than 2.2 billion high-potency oxycodone pills, nearly one-third of its total in that time period, according to the data analysis. Actavis was even more prolific, shipping more than 2.4 billion pills.

The court records made public last year by the U.S. District Court in Cleveland showed some Mallinckrodt employees were more focused on sales than public safety. At least one joked about the rising use of the drugs with a customer.

In January 2009, Victor Borelli, a Mallinckrodt salesman, exchanged emails with Steve Cochrane, who worked at drug distributor KeySource.

“Keep them coming,” Cochrane wrote. “Flying out of here. It’s like people are addicted to these things or something. Oh, wait, people are.”

Borelli responded: “Just like Doritos. Keep eating, we’ll make more.” After the comment become public, the company disavowed it, calling it “callous.”

Borelli said that as a reward for sales, he got bonuses ranging from $101,000 to $119,000 from 2008 through 2010, and that he twice received the company’s President Club award. That scored him vacations to St. Thomas and other tropical getaways.

Borelli and other Mallinckrodt employees answered lawyers’ questions under oath ahead of what was expected to be the first federal trial over the toll of opioids. The company ended up settling with the plaintiffs — the Ohio counties of Cuyahoga and Summit. Other major defendants also reached deals.

Another opioid trial is scheduled to begin next month in Central Islip, New York, which has created a renewed push among drugmakers and distributors to settle thousands of opioid-related lawsuits.

Mallinckrodt agreed with lawyers suing on behalf of local governments nationwide to pay its settlement amount over eight years. Most of the money is to go into a fund intended for drug treatment and other programs to aid recovery from an epidemic that has been linked to more than 430,000 deaths in the U.S. since 2000.

The deal is still subject to some negotiations and must be approved by a bankruptcy court. It’s the first proposed opioid settlement that has overwhelming support from the key lawyers for the governments suing to try to hold the drug industry accountable for the crisis. Teva, which now owns Actavis, is negotiating a separate settlement.

In a deposition last year, Douglas Boothe, who was CEO of Actavis in the U.S. and the Americas from 2008 through 2012, was asked about the company’s responsibilities for flagging large and suspicious orders of prescription painkillers.

“I don’t think we had responsibility for, accountability for preventing diversion,” he said. “We had responsibility and accountability for making certain that the orders that we received were valid from licensed pharmacies and were within our suspicious order monitoring thresholds. … Once it goes outside of our chain of custody, we have no capability or responsibility or accountability.”

One of the main destinations for both companies’ opioids was Florida, where so-called pill mills drew people from Appalachia and beyond. One deposition from a Mallinckrodt sales representative says that 47 percent of the company’s high-potency opioids made in 2010 ended up in Florida.

Steve Becker, a former Mallinckrodt salesman who worked for the company from 2000 to 2014, said he wasn’t aware of a system for monitoring suspicious orders. When asked if employees had incentives to report such orders, he said no.

But there were incentives to sell more, Becker said in a 2018 deposition. Employees said they frequently had back orders for pain pills.

“We’re doing our due diligence in selling our product to the various accounts, and we’re doing what we’re supposed to be doing, according to the DEA,” Becker said. “When (distributors) then sell their product, it’s their due diligence to know where that product is going.”

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Mulvihill reported from Cherry Hill, New Jersey. Fenn, a data journalist, reported from New York.

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Associated Press writers Mark Gillispie in Cleveland and Julie Carr Smyth in Columbus, Ohio, contributed to this article.

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Follow Mulvihill at http://www.twitter.com/geoffmulvihill



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Key Atlantic Coast Pipeline permit heads to Supreme Court

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RICHMOND, Va. —
When plans for the 605-mile Atlantic Coast Pipeline were first unveiled in 2014, supporters of the natural gas project brimmed with enthusiasm and promises.

The pipeline would bring natural gas from West Virginia to growing markets in Virginia and North Carolina, and with it, would come economic development, thousands of jobs and reduced energy costs for consumers, supporters said.

A beaming Virginia Gov. Terry McAuliffe called it a “win-win,”saying it would be good for the environment,too, because it would help speed up the closing of aging coal plants.

Since then, the project hasfaced one setback after another, with legal challenges brought by environmental groups — prompting the dismissal or suspension of eight permits and halting construction for more than a year.

Now,three yearsbehind schedule, with a price tag that has nearly doubled to $8 billion, the project is headed to the U.S. Supreme Court for a hearingMonday on a critical permit.

Backed by the Trump administration, the project developers — Dominion Energy and Duke Energy — will ask the high court to reverse a federal appeals court ruling that threw out a permit needed for the pipeline to cross two national forests, including parts of the Appalachian Trail, the historic footpath that stretches from Georgia to Maine.

In its ruling, a three-judge panel of the Richmond-based 4th U.S. Circuit Court of Appeals sharply criticized the U.S. Forest Service for granting a special-use permit to build the pipeline through parts of the George Washington and Monongahela National Forests, and to cross the Appalachian Trail.

The court found that the Forest Service did not have the statutory authority to approve the trail crossing and said the agency had “abdicated its responsibility to preserve national forest resources.”

The question before the Supreme Court is whether the Forest Service has authority to grant rights-of-way for gas pipelines through lands crossed by the Appalachian Trail within national forests.

The project developers, joined by U.S. Solicitor General Noel Francisco, say the answer is yes, arguing the Forest Service is the agency that holds jurisdiction over land in the George Washington National Forest. But the environmental groups say the answer is no because the 2,200-mile (3,540-kilometer) scenic trail is considered a unit of the National Park System and only Congress can approve such a crossing.

Under plans for the project, a 0.1-mile segment of the pipeline would cross about 700 feet (213 meters) beneath the Appalachian Trail.

That tiny segmentis a key component of the pipeline project’s route.

“It’s important because Dominion has really bet its project on this crossing point,” said Greg Buppert, a senior attorney with the Southern Environmental Law Center, which sued on behalf of the Sierra Club and other environmental groups.

Dominion spokeswoman Ann Nallo said the company chose that crossing point after consulting with federal agencies to determine the best route for the pipeline.

“Part of the determination involved the impact on the environment,” Nallo said.

In its ruling, the 4th Circuit found that the Forest Service had “serious environmental concerns” about the project that were “suddenly, and mysteriously, assuaged in time to meet a private pipeline company’s deadlines.”

Environmental groups say the pipeline would scar pristine landscapes, put numerous rivers and streams at risk of increased sedimentation and harm sensitive species.

The stakes are high for lead developer, Dominion, a dominant corporate power in Virginia politics and favorite landing spot for government officials. U.S. Attorney General Bill Barr spent a decade on the company’s board before joining the Trump administration.

The company is counting on the project to help balance its books after aggressive purchases of other energy companies in recent years.

“Make no mistake, if that pipe is canceled, it certainly is balance sheet destructive, and it will impact Dominion’s growth rate,” said Shar Pourreza, an analyst who follows Dominion as Guggenheim Partners’ managing director for North American power and utilities.

Dominion has some heavy-hitters on its side, with support from 18 state attorneys general, more than 60 members of Congress, trade associations and labor unions.

A host of environmentalists, land owners and communities along the pipeline route have urged the Supreme Court to uphold the 4th Circuit’s ruling.

Dominion says the pipeline will bring a critical new gas supply to Virginia and North Carolina to support the shift away from coal and toward intermittent natural resources like solar. The company also says greater availability of natural gas will attract manufacturing businesses.

Critics question the assertion that the gas is needed.

In a brief filed with the Supreme Court, Virginia Attorney General Mark Herring’s office said recent analyses indicate the demand for natural gas will remain flat or decrease for the foreseeable future.

In an earnings call with investment analysts earlier this month, Dominion CEO Tom Farrell said the company is “optimistic” that the Supreme Court will issue an order reversing the 4th Circuit ruling in May or June. He said Dominion is working with the U.S. Fish and Wildlife Service on a separate permit related to endangered species and then anticipates resuming construction “across major portions of the pipeline.”

But opponents of the project emphasize that six other permits have been revoked or suspended, including a permit to build a gas compressor station in the historic African American community of Union Hill in Virginia.

“The bottom line is, no matter what happens on Monday, there are others issues,” said Lew Freeman, executive director of the Allegheny-Blue Ridge Alliance, a nonprofit coalition of 51 organizations opposing the pipeline.

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Opioid settlement still elusive as some lawyers criticize it

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Lawyers for some state and local governments say the deal being offered by companies in a sweeping national settlement over the toll of opioids isn’t enough

State attorneys general are finding a national settlement over the toll of opioids to be elusive, as some lawyers for state and local governments are renewing public criticism of the proposed deal with a group of companies led by the nation’s largest drug distributors.

A group of top state lawyers in October announced the framework for a deal that they said would be worth about $48 billion in cash, treatment drugs and services over time.

Some state attorneys general and lawyers for local governments criticized it at the time. They’re speaking up anew as the push continues to reach a deal, with a trial over opioids scheduled to start next month in New York .

In a statement Friday, Patrick Morrisey, the attorney general in West Virginia, one of the states hit hardest by the opioid crisis, said the $22 billion in cash being offered by distributors AmerisourceBergen, Cardinal Health and McKesson plus drugmaker Johnson & Johnson “is way too low.”

Under terms previously announced, Teva Pharmaceuticals would also provide a free addiction treatment drug, and the other companies would distribute it.

Morrisey also said that the money would not be allocated fairly under the plan as it stood because states’ shares would be based too much on population and not enough on the impact of the crisis.

“When addressing a national public health crisis, a global settlement shouldn’t be about a pure money grab for the states,” he said. “Monies should be targeted to those who need it most and spent on abatement.”

His statement showed that at least some attorneys general remain resolute not to accept the offer a week after 21 of them signed a letter saying they opposed the deal as offered.

Lead lawyers for more than 2,500 local governments suing the drug industry said Friday that the companies have offered an additional $1.2 billion in cash over 18 years. The lawyers said that’s not enough: “Concerns remain that the total value being proposed is not adequate nor does it provide any degree of assurance that resources will reach communities.”

The attorneys general from North Carolina, Pennsylvania, Tennessee and Texas who championed the settlement in October said it was better to have a national deal than see money go out piecemeal — while it lasts — through trial judgments.

Prescription and illicit painkillers have been linked to more than 430,000 deaths in the U.S. in the past two decades, and they’ve created financial burdens for families who have lost incomes and governments who have seen public service expenses rise as they’ve tried to deal with the crisis.

The offices of several attorneys general who have supported the deal have declined comment or not returned messages.

The companies also did not respond to messages or did not comment on Friday night.

Earlier in the week, McKesson said in a statement that it was trying to finalize a settlement settlement “that would serve as the best path forward to provide billions of dollars in immediate funding and relief to states and local communities.”

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Follow Mulvihill at http://www.twitter.com/geoffmulvihill



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Supervisor told police U-M doctor didn’t deny abuse claims

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ANN ARBOR, Michigan —
A former University of Michigan student who reported in 2018 that a doctor at the school had molested him during medical exams decades ago says he complained at the time to his wrestling coach and the school’s athletic director about the sexual abuse, according to documents released Friday by the prosecutor’s office.

The student also recalled Dr. Robert E. Anderson being known as “Dr. Drop your drawers Anderson” by athletes in the 1970s, according to the documents released to The Associated Press by prosecutors who reviewed a campus police investigation of the allegations against Anderson.

The records summarize police interviews beginning in 2018 with multiple former students reporting sexual abuse by the doctor and people who worked with him at the university’s Health Service and athletic department.

Anderson was the director of the University Health Service from 1968 until 1980 and served as a team physician for various sports at Michigan until his retirement in 2003. He died in 2008.

The university’s president this week apologized to “anyone who was harmed” by Anderson. Mark Schlissel’s comment came a day after the school announced that it had launched an investigation into the doctor’s behavior following abuse allegations from five former patients.

The documents released by the Washtenaw County prosecutor’s office show that a former Michigan wrestler wrote to Athletic Director Warde Manuel in July 2018 with details about repeated fondling during medical exams decades earlier. The name of the wrestler was redacted in records released to The Associated Press.

In a four-page letter, the former wrestler accused the doctor of touching his penis and testicles, and inserting his finger into his rectum “too many times for it to have been considered diagnostic or therapeutic for the conditions and injuries that I had.”

The first time this happened was during his freshman year in 1972, when he went to the doctor for treatment for facial cold sores, according to the letter. The wrestler saw the doctor several more times for that condition and was inappropriately touched each time, he wrote.

“I didn’t like it, but I didn’t really pay much attention to it,” the letter said. “He was the doctor and it never occurred to me that he was enjoying what I was not.”

The wrestler said the doctor touched him again during his junior season after he dislocated an elbow.

“I found it strange that I needed a penis and hernia check,” he wrote.

The wrestler told Manuel that athletes on at least two other sports teams knew about Anderson’s conduct while he was at the school.

Bill Johannesen, who coached the Michigan wrestling team in the 1970s, told police that, while none of his athletes told him they were violated by a doctor, he did remember them “laughing” and “joking” about one particular doctor who told them to “take your pants down” for a “hurt elbow.” Asked by police to recall the doctor’s name, Johannesen said: “Dr. Anderson.”

Another member of the Michigan wrestling team in the 1970s told police that the doctor gave him a rectal exam when he went for treatment of an ankle injury. His name also was redacted from the documents.

The former wrestler told police that he felt abused but that “as an 18-year-old kid, you don’t think to question stuff like that.”

According to one police report, Tom Easthope, a former vice president of student life, told police he thought he had convinced Anderson to resign from the university decades ago.

Easthope said he heard from activists that Anderson was assaulting people during medical exams and decided to fire him. He said the doctor didn’t deny the allegations against him. Easthope told police he decided to allow Anderson to resign and believed he had gone into private practice until university police contacted him in 2018.

Police who spoke to Easthope said he was “visibly shaken” when he learned that Anderson didn’t leave the university until he retired decades later.

“Easthope thought Dr. Anderson was gone, gone for good,” investigators wrote in a search warrant for a malpractice insurance company’s records on Anderson.

The report doesn’t say when Easthope said he believed Anderson resigned. A university news release dated Jan. 14, 1980, said Anderson was stepping down as director of the Health Service and returning to a senior physician role. The release also said Anderson would remain director of athletic medicine and physician to the school’s athletic teams.

The nearly 100 pages detailing the police investigation also include interviews with people who said they had not heard any complaints about Anderson. Among them was Russell Miller, who was an athletic trainer when Anderson worked with the Michigan football team. He told police that Anderson was an “unbelievable team doctor.”

According to the police report, Miller said when Anderson left his job as director of Health Services, then-athletics director Don Canham worked out a deal so Anderson could work with the football team. Miller said Anderson served as a primary care physician for most of the football staff and their families.

Miller said the thought of Anderson being investigated “shatters him,” according to the police report.

Authorities also contacted the state’s licensing and regulatory affairs agency and found that it had received a complaint of sexual misconduct against Anderson filed in May 1994. The records don’t describe the outcome of the complaint, which was closed within 10 months, and the agency’s records on the case were purged seven years later. But an agency official managed to find the name of a man who filed the complaint and provided that to the detective.

When the detective reached out, the complainant said: “I am glad someone finally called to look into this.”

The man, whose name is redacted in the records, told the detective that he was a student at the University of Michigan starting in 1973. Once he went for a routine physical at a campus health center, and during that Anderson fondled him to the point of ejaculation. He said Anderson “did not appear to react to this, nor did he say anything,” according to the detective’s summary of the interview.

The man finally filed the complaint decades later because “I couldn’t live with myself,” the detective wrote.

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Foody reported from Chicago. Dunklin reported from Dallas.

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