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Opioid Litigation Daily Media Report - 12/13/17
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Wallingford law department receives approval to hire outside firm for potential opioid lawsuit
Dec 12, 2017 | myrecordjournal.com (CT)
By Matthew Zabierek
The Law Department received approval from the Town Council on Tuesday to interview and hire an outside law firm that will help the town determine whether to bring legal action against opioid manufacturers. -
Montgomery County Plans Lawsuit Against Opioid Manufacturers and Distributors
Dec 12, 2017 | Bethesda Magazine (MD)
By Andrew Metcalf
Montgomery County will join a growing list of counties, cities and states filing lawsuits against prescription opioid manufacturers and distributors over deceptive marketing practices. -
Montgomery County to sue opioid manufacturers and distributors
Dec 12, 2017 | The Washington Post
By Rachel Siegel
Montgomery County will become the latest jurisdiction to file a lawsuit against manufacturers and distributors of highly addictive painkillers for those companies’ roles in the national opioid epidemic. -
York County sues drug companies, physicians for role in county’s opioid epidemic
Dec 12, 2017 | FOX 43 (PA)
By Grace Griffaton
Officials in York County say the opioid epidemic has cost the county greatly. Now, the county wants the money it lost from the crisis back. -
York County Files Suit Against Opioid Manufacturers and Distributors (PRESS RELEASE)
Dec 12, 2017 | Marketwired
By Staff
York County (PA) is one of the hardest hit communities facing escalating costs associated with combatting the opioid epidemic. Recognizing the growing burden on our taxpayers, on Friday, December 8, 2017, York County filed a complaint in the Court of Common Pleas seeking to recover damages for use of public resources to fight the opioid crisis. -
Commissioners to vote on opioid lawsuit, possible legal firm to use
Dec 13, 2017 | The Daily Courier (PA)
By Bob Stiles
Fayette County Commissioners will decide during their regular meeting Thursday whether to file suit and what law firm to use in hopes of recovering expenses incurred by the county in the opioid crisis. The commissioners interviewed one law firm on Monday and planned to question two more today in private, Commissioner Angela Zimmerlink said during Tuesday’s agenda meeting. -
Two lawsuits discussed at Dale commission meeting
Dec 13, 2017 | The Southeast Sun Enterprise (AL)
By Michelle Mann
Two unrelated lawsuits were discussed at the Dale County Commission work session Dec. 5. -
Broward County Commissioners Take First Step Towards Suing Drug Companies Over Opioid Crisis
Dec 13, 2017 | CBS Miami (FL)
By Carey Codd
Broward County commissioners are taking aim at Big Pharma over claims that the drug industry’s efforts to create easy access to prescription drugs fueled an out-of-control opioid crisis taking a toll on lives and county’s bottom lines. -
Broward moves to sue drug companies over opioids
Dec 12, 2017 | Sun Sentinel (FL)
By Dan Sweeney
The Broward commission on Tuesday ordered the county attorney to pursue a lawsuit against pharmaceutical companies to recoup the costs of treating opioid addicts. -
County considers suing drug companies
Dec 13, 2017 | The Daily Courier (NC)
By Scott Carpenter
Rutherford County is considering joining other government entities across North Carolina in suing pharmaceutical companies to combat the opioid epidemic that is sweeping the nation. Rutherford County Commissioners, will hold a special meeting on Thursday at 4 p.m., and will hear a presentation from attorneys from the law firms: Crueger Dickinson, Simmons Hanly Conroy, and Von Briesen and Roper, who will be pursuing the litigation. -
Profiting from the opioid crisis (OPINION)
Dec 13, 2017 | Bristol Herald Courier (VA)
By Jacob Stump
The destructive spectacle of opioid abuse that marks America and particularly Appalachia today is, sadly, a profitable business. Wildly profiting on the suffering of others is a symptom of the overall healthcare tragedy we’re currently experiencing. -
Council to vote on hiring law firm to sue drug makers
Dec 13, 2017 | The Journal (WV)
By John McVey
Martinsburg’s Emergency Medical Services responded to 14 heroin overdose calls in October, two of which were fatal, according to a report released Monday. -
County considers lawsuit
Dec 13, 2017 | Clinton Herald (IA)
By John Rohlf
Clinton County officials continued to contemplate Monday whether to join a lawsuit against opioid producers. -
Dakota County pursuing lawsuit against drug companies related to opioid epidemic
Dec 12, 2017 | NorthfieldNews.com (MN)
By Philip Weyhe
The Dakota County Board of Commissioners Tuesday approved initiating a lawsuit against pharmaceutical companies and distributors over negligence and unfair trade practices, including aggressive, fraudulent marketing of prescription opioid painkillers, which has fueled opioid drug addiction and strained public resources in Dakota County and across Minnesota. -
Douglas County Attorney wants to sue big opioid manufacturers
Dec 12, 2017 | KETV 7 ABC Omaha (NE)
By Erin Hassanzadeh
Douglas County is considering filing a lawsuit against the five big opioid manufacturing companies to help cover the costs of fighting the current opioid crisis. -
Lake County sues opioid makers, distributors for epidemic
Dec 12, 2017 | The News-Herald (OH)
By Andrew Cass and Tracey Read
Lake County government has made good on its promise to sue 25 opioid manufacturers, wholesale distributors and “pill mill” doctors over their roles in the opioid epidemic. -
Brad Schimel: Opioid fight continues in Wisconsin (OPINION)
Dec 13, 2017 | The Chippewa Herald (WI)
By Brad Schimel
Earlier this month, a coalition of Wisconsin counties announced their lawsuit against drug manufacturers for their alleged role in the opioid epidemic, and many have asked me why the state has not yet filed a lawsuit of its own. -
BREAKING: Harris County To Sue Pharmaceutical Companies For ‘Opioid Epidemic’
Dec 13, 2017 | Houston Public Media (TX)
By Allison Lee
Being addicted to painkillers, or opioids, is a serious health issue in Houston and nationwide. -
Travis Co. pursuing legal action in opioid crisis
Dec 13, 2017 | FOX 7 (TX)
By Noelle Newton
Travis County officials are taking on “Big Pharma.” -
Travis County joins other counties, cities suing over opioid crisis
Dec 13, 2017 | Austin American-Statesman (TX)
By Taylor Goldstein
Travis County will join dozens of other counties and cities throughout the country attempting to recover costs from the opioid epidemic by suing manufacturers, distributors and marketers of the prescription drugs. -
How one sentence helped set off the opioid crisis
Dec 13, 2017 | Marketplace
By Caitlin Esch
OxyContin went to market in 1996 with a campaign by Purdue Pharma that suggested a less abusable drug, one that doctors could prescribe for moderate pain, in addition to severe pain. -
Should Opioid Makers Pay For Collection & Disposal Of Unused Painkillers?
| The Fix
By Victoria Kim
The DEA already hosts 2 annual take-backs but one expert suggests that the service should be made available on a year-round basis. -
Physicians took multifaceted approach to opioid epidemic in 2017
Dec 12, 2017 | AMA Wire
By Andis Robeznieks
An AMA Opioid Task Force report issued this spring showed that physicians are working to help end the nation’s opioid epidemic. This includes reducing opioid prescriptions, getting educated on pain-management issues, becoming certified to provide office-based medication-assisted treatment (MAT), and making more use of prescription drug-monitoring programs (PDMPs). Here are some of other news developments AMA Wire® has reported on this year. -
Senators say the DEA has been 'hamstrung' in the fight against opiates
Dec 12, 2017 | WJLA ABC 7 (D.C.)
By Leandra Bernstein
The agency responsible for regulating the production and distribution of prescription opiates as well as preventing those drugs from making their way onto America's streets lack the tools needed to combat the worst drug epidemic in U.S. history, senators warned. -
Fox 43 Morning News
Dec 13, 2017 | WPMT (FOX)
By Harrisburg, PA
Video Link: https://app.criticalmention.com/app/#clip/view/31405870?token=c1716f2f-324c-4103-a89b-f3f43b331e4b -
I-270 News
Dec 13, 2017 | WDVM
By Washington, D.C.
Video Link: https://app.criticalmention.com/app/#clip/view/31405900?token=c1716f2f-324c-4103-a89b-f3f43b331e4b -
News4 at 5
Dec 13, 2017 | WRC (NBC)
By Washington, D.C.
Video Link: https://app.criticalmention.com/app/#clip/view/31405952?token=c1716f2f-324c-4103-a89b-f3f43b331e4b -
24 Hour News 8's Daybreak at 5:30am
Dec 13, 2017 | WISH (CW)
By Indianapolis, IN
Video Link: https://app.criticalmention.com/app/#clip/view/31405917?token=c1716f2f-324c-4103-a89b-f3f43b331e4b -
WAND News at 5
Dec 12, 2017 | WAND (NBC)
By Champaign, IL
Video Link: https://app.criticalmention.com/app/#clip/view/31405949?token=c1716f2f-324c-4103-a89b-f3f43b331e4b -
Newswatch 7 at 10
Dec 12, 2017 | KETV (ABC)
By Omaha, NE
Video Link: https://app.criticalmention.com/app/#clip/view/31405943?token=c1716f2f-324c-4103-a89b-f3f43b331e4b -
Good Day Austin
Dec 13, 2017 | KTBC (FOX)
By Austin, TX
Video Link: https://app.criticalmention.com/app/#clip/view/31405890?token=c1716f2f-324c-4103-a89b-f3f43b331e4b -
CBS Austin Morning News
Dec 13, 2017 | KEYE (CBS)
By Austin, TX
Video Link: https://app.criticalmention.com/app/#clip/view/31405906?token=c1716f2f-324c-4103-a89b-f3f43b331e4b -
Fox 7 Austin News
Dec 13, 2017 | KTBC (FOX)
By Austin, TX
Video Link: https://app.criticalmention.com/app/#clip/view/31405928?token=c1716f2f-324c-4103-a89b-f3f43b331e4b -
Fox 26 News
Dec 13, 2017 | KRIV (FOX)
By Houston, TX
Video Link: https://app.criticalmention.com/app/#clip/view/31405895?token=c1716f2f-324c-4103-a89b-f3f43b331e4b -
KOMO 4 News
Dec 13, 2017 | KOMO (ABC)
By Seattle, WA
Video Link: https://app.criticalmention.com/app/#clip/view/31405887?token=c1716f2f-324c-4103-a89b-f3f43b331e4b
Northeast (CT, MD, PA)
Southeast (AL, FL, NC, VA, WV)
Midwest (IA, MN, NE, OH, WI)
Southwest (TX)
Commentary and FYIs
Broadcast Media Coverage
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Wallingford law department receives approval to hire outside firm for potential opioid lawsuit
Dec 12, 2017 | myrecordjournal.com (CT)
By Matthew Zabierek
The Law Department received approval from the Town Council on Tuesday to interview and hire an outside law firm that will help the town determine whether to bring legal action against opioid manufacturers.
The council voted 8-1 to approve a bid waiver that lets the law department interview outside firms with expertise in opioid lawsuits and select a firm. The selected firm will investigate the impact the opioid crisis has had on Wallingford and determine the strength of the town's case. The town would then decide whether to move forward with a lawsuit.
An agreement with the selected firm would be “based upon a contingency fee with no upfront costs paid by the town,” Corporation Counsel Janis Small said in a memo to the mayor and Town Council this month.
If the town moves forward with legal action, it would join other Connecticut municipalities, including Waterbury, that have already filed lawsuits against opioid manufacturers and doctors.
“We really feel the town of Wallingford should be part of an effort to correct what is a terrible and tragic situation," Mayor William W. Dickinson Jr. said last week.
The claims of lawsuits filed by other municipalities focus on the “false and misleading marketing of opioids as an effective and non-addictive treatment for chronic pain,” Small said.
The opioid epidemic’s impact on municipalities, Small said, “includes increased insurance/healthcare and workers' compensation costs, increase in emergency room responses and an impact on police departments and the criminal justice system.”
The bid waiver was originally included on the council’s consent agenda for the meeting Tuesday, but was removed at the request of Republican Councilor Craig Fishbein.
Fishbein. the only councilor to vote against the bid waiver, questioned why the town is considering legal action when there’s been “no success shown” in past cases.
Dickinson disagreed with Fishbein and referenced a federal case in 2007 in which three former executives of Purdue Pharma pleaded guilty to criminal charges that they misled regulators, doctors and patients about the risk of addiction to OxyContin, a narcotic painkiller. The three executives agreed to pay a total of $34.5 million in fines.
“I don’t know how you can say there’s no success shown, Craig,” Dickinson said to Fishbein.
Fishbein questioned why the town doesn’t take the same position against companies that distribute alcohol, given that the drug also brings consequences to the town.
Resident Larry Morgenstein said he was pleased the bid waiver was taken off the consent agenda so it could be discussed at the meeting. Morgenstein said the potential lawsuit is an important issue and applauded Dickinson for “championing” the cause.
Council chairman Vincent Cervoni said he initially put the item on consent agenda because the town would only pay a contingency fee if it was successful in a lawsuit.
“I didn’t see this as a big budget shaker,” Cervoni said. Cervoni added he had no problem taking the item off consent agenda.
Ken Welch, founder of the Coalition for a Better Wallingford, spoke in support of the town’s potential legal action at the meeting. Since 2012, the Coalition has worked to combat drug and opioid addiction in the community.
“This is a big deal, a really big deal, for hundreds of Wallingford citizens, and it’s important that we endorse and support the lawsuit to recover the expenses in the name of those that are no longer with us and those that are still suffering,” Welch said at the meeting.
In other business, the council was scheduled to vote on whether to approve $6.2 million for a new town-wide radio system and $7.8 million for projects to replace windows at four different schools and make improvements at the middle school and high school auditoriums. The council had not acted on the items as of 8 p.m. Tuesday.
Wire reports are used in this story.
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Montgomery County Plans Lawsuit Against Opioid Manufacturers and Distributors
Dec 12, 2017 | Bethesda Magazine (MD)
By Andrew Metcalf
Montgomery County will join a growing list of counties, cities and states filing lawsuits against prescription opioid manufacturers and distributors over deceptive marketing practices.
County Executive Ike Leggett announced Tuesday that the county has hired the San Francisco-based law firm Robbins Geller Rudman & Dowd to serve as outside counsel for the county in the lawsuit.
“I wish I could stand here and tell you that Montgomery County is immune to this epidemic,” Leggett said. “Unfortunately, I cannot do that. Ask our first responders in our Fire & Rescue Service and in our police. Ask our front-line personnel in Health & Human Services.
“Death. Addiction. Broken families. Broken lives. We are living this reality today.”
Dr. Raymond Crowel, the chief of behavioral health and crisis services for the county’s Department of Health and Human Services, said 84 overdose deaths in the county were from opioids in 2016. He said the 2017 figure is expected to eclipse that number.
Crowel said holding the pharmaceutical industry accountable is a vital tool for fighting the opioid epidemic.
He noted that many painkiller users become addicted and use more and more of the drugs over time. He said children are taking the prescription painkillers from parents’ medicine cabinets and becoming addicted themselves, or sell them on the street.
County Attorney Marc Hansen said there is no upfront cost to the county to pursue the lawsuit. Robbins Geller will represent the county on a contingency fee basis, which means the law firm will pay for costs to bring the case and the county will owe nothing, even if the suit does not lead to an award of financial damages.
Hansen said the firm has experience bringing complex litigation against prescription drug companies.
Aelish Baig, an attorney with the firm, said the intent of the lawsuit is to force the drug manufacturers and distributors from using unlawful sales practices and false marketing.
Baig said the firm will focus on the companies’ failure to report suspicious sales and marketing efforts that described the opioids as not addictive.
“Defendants have made misleading statements in the public as to the safety, efficacy and dangers of these drugs,” Baig said.
She said the lawsuit will name drug manufacturers such as Purdue Pharma, Cephalon, Janssen and Cardinal Health. A complaint will be filed in either state or federal court in “a matter of weeks” that lays out the county’s case against the drug companies, she said.
Baig noted that her firm has been retained by cities and counties in Michigan and Florida to pursue opioid manufacturers for deceptive and potentially illegal corporate practices.
The move by Montgomery County follows a national wave of lawsuits by jurisdictions against opioid producers and sellers.
The Washington Post reported in July that more than 25 states, cities and counties have filed civil cases against opioid-related companies. In September, a coalition of 41 state attorneys general, including Maryland’s Brian Frosh, subpoenaed five major opioid manufacturers seeking information about how the companies marketed and sold their products.
The legal effort resembles one that reaped huge settlements from the tobacco industry in the 1990s over its attempts to downplay the dangerous health effects of smoking and project cigarettes in a favorable light in marketing efforts.
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Montgomery County to sue opioid manufacturers and distributors
Dec 12, 2017 | The Washington Post
By Rachel Siegel
Montgomery County will become the latest jurisdiction to file a lawsuit against manufacturers and distributors of highly addictive painkillers for those companies’ roles in the national opioid epidemic.
On Tuesday, County Executive Isiah Leggett (D) announced that Montgomery will go to court in the coming weeks over false marketing and other unlawful sales techniques allegedly used by manufacturers and distributors of opioids. The lawsuit will also seek to recoup taxpayer money the county has spent responding to the opioid crisis.
“Death. Addiction. Broken families. Broken lives. We are living this reality each and every day,” Leggett said.
Leggett said one goal of the lawsuit is to challenge opioid manufacturers and distributors who may understate how addicting their drugs can be.
There were 84 opioid-related deaths in the county in 2016, said Raymond Crowel, chief of behavioral health and crisis services for Montgomery’s Department of Health and Human Services. Numbers for 2017 are not yet available.
The law firm Robbins Geller Rudman & Dowd LLP will represent Montgomery on a contingency fee basis, officials said. The firm has taken on similar cases for jurisdictions in Michigan and Florida. Montgomery’s lawsuit could be handled in state or federal court.
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York County sues drug companies, physicians for role in county’s opioid epidemic
Dec 12, 2017 | FOX 43 (PA)
By Grace Griffaton
Officials in York County say the opioid epidemic has cost the county greatly. Now, the county wants the money it lost from the crisis back.
York County has brought a lawsuit against 21 pharmaceutical companies and four physicians - none of those doctors being from York County.
The county’s seeking damage costs related to how the epidemic has hurt the community over the years. Officials say the opioid epidemic has stolen from York County, and those listed in the lawsuit played a role in the loss.
"Just this past month (November), we had 19 deaths. Just in the first 5 days of December, we’ve had 10," said York County Solicitor, Glenn Smith, Esq.
Smith says the number of opioid-related deaths for 2017 is much higher than years past, adding that the drugs hurt the surrounding community and cost York County millions of dollars.
“Whether it’s the criminal justice, whether it's through the treatment system, whether it’s Children and Youth, whether it’s the coroner’s office from handling the number of deaths," he said.
Reviving those who've overdosed with Naloxone also costs the county, according to Smith. Naloxone is the overdose-reversal drug used by law enforcement and emergency officials.
The county’s seeking damage costs related to the epidemic, filing a 252 page lawsuit against those 21 pharmaceutical companies and four physicians. Smith says the county examined similar lawsuits brought against opioid manufacturers and distributors when filing this case, both within Pennsylvania and from outside the state.
“What this complaint is alleging is this was purely a matter of corporate greed," said Smith.
The county cites fraud, negligence, and unjust enrichment against all 25 defendants, saying the companies and doctors named in the suit benefited from prescription opioid use while the county suffered.
“They had a product and expanded it for what it was originally was created for, and in the process of doing so, they lied about its addictive nature and its harmful side effects," explained Smith.
The complaint states all the defendants distributed deceptive educational material to doctors, patients, and law enforcement officials, and those listed also created false statements about the efficacy of prescription opioids in treating long-term, chronic pain.
“I think what we really want ideally here is to have the amount of resources available to us to take care of this problem," stated Smith.
If the county wins, Smith says the money would be distributed to departments impacted by the epidemic and used to battle the opioid epidemic in future years.
He says the litigation is costing taxpayers nothing - the law firm, Napoli Shkolnik PLLC, is representing the county. If the county wins the case, the firm could then take a portion of whatever settlement comes out of the case.
Officials could not yet say how much the opioid epidemic has cost York County, saying the county is still calculating those numbers, although Smith says hundreds of millions could be at stake.
If you wish to read the 252-page complaint, Opioid Complaint Part 1 of 3, Opioid Complaint Part 2 of 3, Opioid Complaint Part 3 of 3.
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York County Files Suit Against Opioid Manufacturers and Distributors (PRESS RELEASE)
Dec 12, 2017 | Marketwired
By Staff
York County (PA) is one of the hardest hit communities facing escalating costs associated with combatting the opioid epidemic. Recognizing the growing burden on our taxpayers, on Friday, December 8, 2017, York County filed a complaint in the Court of Common Pleas seeking to recover damages for use of public resources to fight the opioid crisis.
The complaint which includes close to 25 defendants, alleges that the manufacturers, distributors and other entities intentionally mislead the public about the dangers of opioids. The 252-page complaint outlines the history of how these defendants downplayed the risks associated with opioids such as OxyContin, Fentanyl and Percocet. This negligent behavior has led to a significant increase in our budgets including first responder overtime, Narcan training, emergency care, treatment, loss of tourism and community productivity.
Joseph Ciaccio, a senior associate at Napoli Shkolnik, a firm the County has partnered with in this endeavor said, "York County's commitment is evident in their establishment of the 'York County Regional Opiate Collaborative', a task force formed in 2014. The economic drain on the county is ongoing and we hope to recover funds for York so they can continue to rebuild their community."
Deaths in York County related to opioid abuse including heroin have skyrocketed in recent years. In fact, in the past decade, opioid overdose deaths in York have quadrupled. Since 2016 alone, there have been 300 reported overdose deaths in York County with 19 just this past month. This is particularly alarming as the resources allocated and available are stretched. "These suits will hopefully help to establish programs on early education and the expansion of treatment options for addicts," added Shayna E. Sacks, a partner at Napoli Shkolnik.
There will be no cost to the York County taxpayers with this filing.
A team comprised of District Attorney Elect, David Sunday, Tim Barker, Chief Prosecutor for Policy and Research, and County Solicitor Glenn Smith interviewed a number of potential law firms to represent the County in this suit. The County is represented by the firm of Napoli Shkolnik PLLC in coordination with the York County Solicitor's Office.
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Commissioners to vote on opioid lawsuit, possible legal firm to use
Dec 13, 2017 | The Daily Courier (PA)
By Bob Stiles
Fayette County Commissioners will decide during their regular meeting Thursday whether to file suit and what law firm to use in hopes of recovering expenses incurred by the county in the opioid crisis. The commissioners interviewed one law firm on Monday and planned to question two more today in private, Commissioner Angela Zimmerlink said during Tuesday’s agenda meeting.
The rest of this story is under paywall: http://www.dailycourier.com/news/2017-12-13/Front_Page/Commissioners_to_vote_on_opioid_lawsuit_possible_l.html
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Two lawsuits discussed at Dale commission meeting
Dec 13, 2017 | The Southeast Sun Enterprise (AL)
By Michelle Mann
Two unrelated lawsuits were discussed at the Dale County Commission work session Dec. 5.
Whether to participate in a class action lawsuit against pharmaceutical companies and an update on an unrelated school tax lawsuit were issues brought to the table by Dale County Commission Attorney Henry Steagall.
Steagall said that he has been contacted by law firms participating in a class action lawsuit against the nation’s drug distributors for their role in the increasing opioid addiction and abuse problem nationwide, charging negligence and aggressive sales tactics.
Stegall said that his recommendation, should the commission vote to join the class action suit, is to work with the Montgomery-based Beasley Allen Law Firm. “I can’t speak to whether it’s a good lawsuit,” Steagall said. “It’s just one of those things where you join the class action and if there is a settlement one day you get a part of it.”
Dale County Commission Chairman Mark Blankenship said he had “a real problem with” the lawsuit. “People have got to take some personal responsibility for their actions,” Blankenship said. “Even in the lawsuit, it talks about the fact that the doctors are the Number 1 writer of opioid prescriptions so it looks like the doctors are partly to blame.
“I mean, the pharmaceutical company is creating a drug that helps people,” Blankenship added. “Where is it going to stop? Are we going to include the folks that sell beer because people have become alcoholics?”
Dale County Commissioner Charles “Chic” Gary disagreed with Blankenship. “The substance is so additive,” Gary said. “The pharmaceutical companies need to take a degree of responsibility for what they present to the Federal Drug Administration. (Pharmaceutical companies) are partially involved in this thing because what they are putting out there is a highly addictive prescription versus what we’ve had in the past.”
Gary said he recommended that the county join the class action lawsuit “because it’s going to continue to get worse. I think the state is also going to be involved in it.”
Steagall said his initial thought had been whether the opioid abuse issue had caused damage to the county. “But we do have to pay medical bills for the prisoners in jail,” he said.
Steagall said that he is also going to present information about the class action lawsuit to the other municipalities that he represents.
Blankenship said the issue will be an agenda item at the next voting meeting.
Neighboring Coffee County has approved an agreement for such a lawsuit with the Pensacola, Fla.-based Levin, Papantonio, Thomas, Mitchell, Rafferty and Proctor law firm. Enterprise Attorney Dale Marsh had presented information about the class action suit to the Coffee commissioners and will serve as the local liaison.
Steagall also provided a brief update on an unrelated civil lawsuit about school tax distribution.
That dispute centers on a directive from the State Department of Education to the Dale County Revenue Commissioner Eleanor Outlaw to include Enterprise and Dothan City Schools in the distribution of Dale County school taxes.
Some 600 students attending Enterprise City Schools live in Dale County and 29 students attending Dothan City Schools live in Dale County.
Thirty-third Judicial Circuit Judge Kimberly Clarke issued a restraining order prohibiting Outlaw from sending checks to Enterprise and Dothan schools pending the outcome of the litigation.
Steagall said that the Association of County Commissions of Alabama has provided an attorney to represent Outlaw. If the parties cannot come to a resolution before then, a court hearing is set for Jan. 10, 2018.
The next meeting of the Dale County Commission is Tuesday, Dec. 19, at the Dale County Government Building in Ozark. A work session begins at 10 a.m. and is followed immediately by a voting meeting. Both meetings are open to the public.
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Broward County Commissioners Take First Step Towards Suing Drug Companies Over Opioid Crisis
Dec 13, 2017 | CBS Miami (FL)
By Carey Codd
Broward County commissioners are taking aim at Big Pharma over claims that the drug industry’s efforts to create easy access to prescription drugs fueled an out-of-control opioid crisis taking a toll on lives and county’s bottom lines.
Commissioners directed the county’s attorney to recommend several law firms to handle litigation on behalf of the county. The initial batch of recommendations is due in early January.
By filing a lawsuit, the county hopes to recover some of the costs associated with dealing with the crisis like manpower for first responders, increased medical examiner expenses and costs associated with treating addicts and purchasing drugs like Narcan, which can reverse effects of an overdose.
County Commissioner Nan Rich said the county’s medical examiner estimates that hundreds will die in the county this year due to the crisis and that the county’s costs in dealing with the issue are skyrocketing.
“We don’t have enough money in this county in our human services budget — I mean, we’ve had an increase this year — but we don’t have enough money to take care of all the needs as a result of this human toll that’s taking place here.
For parents, like Kristen Tersch of Fort Lauderdale, the opioid crisis is personal. Her son, Logan, died in June after overdosing on cocaine with fentanyl in it.
“As a parent, there’s a lot of guilt, frustration and guilt, anger and confusion when you have an addict in your life,” she said.
Tersch is surrounded by photos of her son, who struggled with addiction for more than a decade. She says during that time he went through rehab, halfway houses and prison, before being released in January. A little more than 5 months later, he was dead.
“We are going to have a tough time through this Christmas holiday,” she said.
Tersch believes the county’s move to explore suing the pharmaceutical companies is a good first step and she hopes any money recovered from the companies is spent dealing specifically with the crisis.
“I would hope that what they’re looking for in reimbursement is used for addiction recovery, rehabilitation and so forth,” she said.
She also hopes that by telling her painful story, she can help others with addicts in their lives.
“If it helps somebody else, if it helps a parent maybe take a look at her children, or someone in their life — it doesn’t have to be a parent – I think it’s important,” Tersch said.
Broward County commissioners took another important step on the issue on Tuesday. They made it one of their top legislative priorities to work on at the state level in the 2018 legislative session.
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Broward moves to sue drug companies over opioids
Dec 12, 2017 | Sun Sentinel (FL)
By Dan Sweeney
The Broward commission on Tuesday ordered the county attorney to pursue a lawsuit against pharmaceutical companies to recoup the costs of treating opioid addicts.
Other cities and counties in South Florida are considering similar lawsuits. Palm Beach County decided to pursue a lawsuit last week. The suits would be similar to lawsuits against tobacco companies, which were successfully sued for offering a product that they knew was dangerous.
The commission agreed to let County Attorney Drew Meyers pick a legal team to pursue a lawsuit. Meyers’ final picks will be ranked and then presented to commissioners at their next meeting, Jan. 9.
Meyers said Broward has potentially seen losses as both an employer and a service provider to county residents.
“There is a lot of potential upside that is difficult to quantify in terms of financial benefits,” he said.
Commissioners voted 7-1, with one abstention, to move forward with selecting a legal team to pursue a lawsuit.
Before a crackdown seven years ago, Florida was known as the nation’s pill mill capital, where doctors handed out oxycodone and other powerful painkillers like candy at storefront clinics. In 2010, 98 of the top 100 opioid-prescribing physicians were in Florida, according to the Drug Enforcement Administration.
Now, medical examiners are seeing unprecedented overdose deaths caused by heroin and ultra-potent synthetic versions of the drug.
Representatives of drug makers have denied wrongdoing. In response to lawsuits, they said they have taken steps to prevent pain medication from being diverted into the black market. They argue it will take a collaborative effort of the drug industry, doctors and government to address the epidemic.
Osceola County filed Florida’s first county-level opioid lawsuit. Delray Beach hired San Diego-based law firm Robbins Geller Rudman & Dowd, whose attorneys helped to secure a $7 billion settlement against Enron in 2008.
The city intends to file its lawsuit by the end of this year, Delray Beach Mayor Cary Glickstein said.
Broward commissioners had harsh words for drug companies that might have known their medications were more addictive than they let on.
“It’s costing upwards of $800 billion to a trillion dollars nationally, so there is a fiscal impact,” said Commissioner Chip LaMarca. “If someone knew about this, they should pay more than dearly. They should pay financially and they should pay criminally.”
Commissioners were also optimistic about the success of such a lawsuit.
“I think this is going to be extremely successful litigation nationwide as we move forward with this,” said Commissioner Michael Udine.
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County considers suing drug companies
Dec 13, 2017 | The Daily Courier (NC)
By Scott Carpenter
Rutherford County is considering joining other government entities across North Carolina in suing pharmaceutical companies to combat the opioid epidemic that is sweeping the nation. Rutherford County Commissioners, will hold a special meeting on Thursday at 4 p.m., and will hear a presentation from attorneys from the law firms: Crueger Dickinson, Simmons Hanly Conroy, and Von Briesen and Roper, who will be pursuing the litigation.
"Numerous county governments in North Carolina are working with a team of law firms to participate in a multi-district litigation against the manufacturers and possibly distributors of opioid medications in an effort to combat the opioid epidemic," County Manager Steve Garrison said Tuesday.
The remainder of this article is under paywall: http://www.thedigitalcourier.com/news/county-considers-suing-drug-companies/article_c6baffd8-df87-11e7-92c7-cff4d0a29384.html
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Profiting from the opioid crisis (OPINION)
Dec 13, 2017 | Bristol Herald Courier (VA)
By Jacob Stump
The destructive spectacle of opioid abuse that marks America and particularly Appalachia today is, sadly, a profitable business. Wildly profiting on the suffering of others is a symptom of the overall healthcare tragedy we’re currently experiencing.
The pharmaceutical industry is certainly out to make profit. Take West Virginia. As reported in the Charleston Gazette-Mail, the three largest drug wholesalers (McKesson, Cardinal Health, and AmerisourceBergen) in the United States together generate total revenues exceeding $400 billion annually. From 2007 to 2012, these three companies shipped 423 million pain pills to West Virginia, earning a combined $17 billion in net income.
During that same five-year period, 1,700 people overdosed on pain pills in West Virginia.
Only in the United States, the direct-to-consumer advertising of drugs is a multi-billion-dollar business. Other countries in the world either heavily regulate or outlaw direct-to-consumer drug ads. Drug ads are strictly regulated because there is strong evidence that such ads encourage overmedication. The commercials create an environment in which doctors feel pressure to prescribe drugs, and patients ask doctors about medications they’ve seen on television.
The result is that prescription drug spending and abuse by consumers is much higher in the U.S. compared with other nations where drug ads are prohibited by law, such as the United Kingdom, Ireland, and Australia.
But it doesn’t stop there. Doctors, pharmacists and the opioid-addiction research and treatment centers that are scattered through communities are also businesses. Certainly most are honest businesses trying to earn a profit in an ethical way, but some are not.
In Sam Quinones’ recent investigation into the opioid epidemic in the United States and Appalachia, he says that opioids were heavily promoted by pharmaceutical representatives to deal with all manners of pain. Doctors started heavily prescribing them, and many opiate addicts were created.
Then pill mills started appearing. The first mills opened in Huntington, West Virginia, where someone with cash and no legitimate prescription could easily buy pills from a scurrilous doctor. The pill mill business model spread, especially throughout Appalachia.
According to WRIC news in Richmond, Virginia, James Brian Joyner, a convicted pill mill provider, lost his medical license in a Tennessee court, but continued to prescribe in Southwest Virginia at least through July 2016.
In 2015, while Joyner was still prescribing in Tennessee and Virginia, the Centers for Disease Control showed that Southwest Virginia’s border counties (Tazewell, Buchannan, Dickenson, and Wise) had the highest overdose rates in the region. Buchanan County had the most-extreme numbers, with 33 deaths per 100,000 residents.
The fact is that a lot of money is made on the whole process, from manufacturing and distributing the drugs to treating and imprisoning addicts.
However, there are substantial costs to this profit-making health-care system. The cost is externalized, which means that the people who didn’t ask or agree to pay the costs end up footing the bill.
Addicts don’t ask to be addicted to opioids, and sometimes the drug costs them their jobs, their loved ones, and even their lives. Indeed, drug overdoses are the top cause of death for Americans under age 50. Families don’t ask to pay, but they often pay a high financial and emotional cost. Communities don’t ask to pay the cost of opioid abuse, but through taxpayer-funded policing and addiction-treatment programs, they often pay a hefty price.
In the American pharmaceuticals market, we have a perverse economic situation with prescription opioids. Billions of dollars in profits for a few corporations are made on the backs of many lower- and middle-income Appalachia residents who bear the awful costs in debt, suffering and death.
Therefore, I was happy to see the widely reported news that 41 state attorneys general, including those in Tennessee and Virginia, have started putting official pressure on the pharmaceutical industry. The officials subpoenaed opioid manufacturers, distributors, and insurers; launched federal lawsuits against them; and called on them to review and change policies that promote addiction.
My concern is that these official actions represent only a superficial response. Health care, and especially pharmaceuticals, are incredibly profitable. As long as profit maximization and health care are conjoined, then making money on the suffering of people will continue to be a disturbing result of this relationship.
Jacob L. Stump is an author, professor and small business owner from Konnarock in Southwest Virginia. He is a member of the Bristol Herald Courier’s Board of Contributors. Board members are regular Opinion page contributors, and opinions expressed do not necessarily represent those of this newspaper staff and management.
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Council to vote on hiring law firm to sue drug makers
Dec 13, 2017 | The Journal (WV)
By John McVey
Martinsburg’s Emergency Medical Services responded to 14 heroin overdose calls in October, two of which were fatal, according to a report released Monday.
Both overdose deaths were on Oct. 14. The report does not give the names nor the locations of the fatalities.
“Downtime too long to provide effective resuscitation (greater than 30 minutes),” was the reason for the deaths, according to the report.
EMS personnel administered 33 doses of Narcan during the 14 calls, according to the report. Narcan is a drug that reverses the effects of heroin and opiates.
The total number of EMS calls in October was 398, according to the report.
In September, there were 16 overdose calls of 366 total EMS calls. Two overdoses were fatal. Nineteen Narcan doses were administered.
Through October, EMS personnel have responded to 138 overdoses, of which 16 have been fatal, according to the report. Fifteen have been heroin or opiate related. One was non-heroin or opiate related, meaning the overdose might have been from another drug or alcohol.
There has been at least one fatal overdose each month this year, except in May. There were four heroin or opiate deaths in August, according to the report.
Overdose responses account for 4 percent of all EMS calls, according to the report.
Through October of 2016, there were 150 overdose calls. Thirteen were fatal.
The agenda for Thursday’s Martinsburg City Council meeting calls for a vote on a resolution to retain the Skinner Law Firm “to represent the (city) in litigation against those involved in the wrongful distribution of prescription pain pills, creating a public nuisance.”
At the City Council’s October meeting, Stephen Skinner of the Skinner Law Firm proposed the city join a lawsuit against opiate-based drug manufacturers and distributors. The goal of the suit is to recoup some of the expenses to the city in dealing with the ongoing opioid epidemic.
Skinner would take the case on a contingency basis, meaning the city would not spend any money prosecuting the case. Skinner’s base contingency fee would be 25 percent plus expenses of any award or settlement of the case.
City Council members also are scheduled to vote at Thursday’s meeting on the contingency fee agreement.
Skinner has filed a similar suit on behalf of the Berkeley County Council and the Jefferson County Commission.
He spoke to the Morgan County Commission last week about joining the suit. They have not yet taken any action on the proposal.
The Martinsburg City Council meets at 6:30 p.m. Thursday in the J. Oakley Seibert Council Chambers on the second floor of city hall at 232 N. Queen St.
For a complete copy of the agenda, go to cityofmartinsburg.org/minutes-agendas/.
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Dec 13, 2017 | Clinton Herald (IA)
By John Rohlf
Clinton County officials continued to contemplate Monday whether to join a lawsuit against opioid producers.
The Iowa State Association of Counties is requesting Clinton County to join a lawsuit against opioid manufacturers. Krista Baisch, a partner at Crueger Dickinson, stated the firm has partnered with Paul Hanly at Simmons Hanly Conroy in the lawsuit. Baisch alleges certain companies profited from “their fraudulent scheme.” She believes the companies need to be part of the solution by contributing financially to counties across the nation that have incurred costs due to opioid addiction and abuse.
“We’ve identified this epidemic on a national level and at the heart of the epidemic are local governments, the counties in particular, that are struggling with the impact because it is straining their budgets in so many different ways,” Baisch said. “Everything from child care protective services to law enforcement services, to health care services. There are endless support services that counties provide that are being impacted by this epidemic.
“And we believe the law has taught us particularly from the tobacco litigation that when you have a wrong like we have here, an admitted fraud in this marketing scheme and that we can now show through national experts and medical treatises that are being written throughout the nation, that the current epidemic is directly linked back to this fraudulent conduct. That these wrongdoers need to be held responsible.”
Baisch said there are approximately 200 cases filed throughout the nation that were consolidated as of last week in the Northern District of Ohio. Baisch stated litigation will occur over the next year in which the defendants will raise legal arguments. Baisch said she feels strongly about the “law being on our side on those motions.” The motions will be wrapped up in mid-2018. The proposed damage model will then be formalized on behalf of the counties. Baisch recommended the counties interested in joining the lawsuit do so by as close to Jan. 1 as possible.
“The message we’ve been telling a lot of counties that we’ve talked to in the last couple weeks, is that the timing of these cases, is if you’re ready to get involved and if you are committed to get involved the sooner the better because once this MDL gets going, which it’s the Multi District Litigation with Judge Polster and the Northern District of Ohio, you’re going to want your name involved,” Baisch said. “You’re going to want your county involved when the attorneys get to the point of talking about the real numbers and talking to the defendants about what a settlement could possibly look like to help the county with this epidemic.”
Clinton County Attorney Mike Wolf said it is his intent to recommend the Supervisors agree to become involved in the lawsuit. He said he does not see a downside to it and stressed the impact that opioids are having on the county in juvenile court, adult court, the county jail, on the medical examiner, autopsy costs, the sheriff’s office and in the mental health field.
“We do have a situation where a baseline to be involved to see where we compare nationally is something that’s important,” Wolf said. “You could hear from Kevin’s comments specifically that there’s also going to be a large upside to possibly prevention or other damages that would be useful for the county in the future should there be then that response, in addition to just the out-of-pocket costs, that I think there’s going to be a large upside to that similar to that with the tobacco litigation.”
Baisch believes there will be a minimal burden on the counties that agree to participate in the lawsuit. She stated they are working with a third-party document collection group to handle collection of financial information from the participating counties.
“The belief at this point is that the burden on each individual county is going to be minimal because we’re going to be looking at such high-level information,” Baisch said. “We’re not going to be getting into the details. That being said, we do anticipate involvement from county employees or officials or department heads that are going to be able to point us in the right direction with our third-party document collection group to gather that information. So nobody at the county level will be collecting emails or collating spreadsheets or collecting documents or collecting paper documents or copying things. We’re hiring a third-party group called ILS that does all of that. The county’s involvement in most simple terms will be to tell us where the information is.”
The Clinton County Board of Supervisors did not take any action on the proposal, but will vote on a recommendation from Wolf at a future board meeting.
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Dakota County pursuing lawsuit against drug companies related to opioid epidemic
Dec 12, 2017 | NorthfieldNews.com (MN)
By Philip Weyhe
The Dakota County Board of Commissioners Tuesday approved initiating a lawsuit against pharmaceutical companies and distributors over negligence and unfair trade practices, including aggressive, fraudulent marketing of prescription opioid painkillers, which has fueled opioid drug addiction and strained public resources in Dakota County and across Minnesota.
The remainder of this article is under paywall: http://www.southernminn.com/northfield_news/news/article_67ad06f2-8946-57cb-90f8-a15de6b405f9.html
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Douglas County Attorney wants to sue big opioid manufacturers
Dec 12, 2017 | KETV 7 ABC Omaha (NE)
By Erin Hassanzadeh
Douglas County is considering filing a lawsuit against the five big opioid manufacturing companies to help cover the costs of fighting the current opioid crisis.
"We're taking this action because the costs of this opioid crisis are going to be overwhelming," said Don Kleine, the Douglas County Attorney.
Kleine made the case for the potential legal action at Tuesday's Douglas County Board meeting. He says the big opioid manufacturers bring in about $400 billion a year in revenue but have been negligent about making sure their drugs don't get into the wrong hands.
Kleine acknowledged Omaha's problem isn't as severe as it is in other places in the country but that he hopes the county will be ahead of the curve. He said there are already other similar cases filed in federal court right now and the judge would like to lump all of the suits together.
Kleine said if the suit moves forward, any settlement funds would go directly to the county to provide more enforcement, rehabilitation services and drug courts. He also said it would not cost the county anything to sue. The law firm they would partner with would take a 30 percent fee from any settlement the county receives.
There was no definitive decision at the county board meeting on if or when this will move forward.
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Lake County sues opioid makers, distributors for epidemic
Dec 12, 2017 | The News-Herald (OH)
By Andrew Cass and Tracey Read
Lake County government has made good on its promise to sue 25 opioid manufacturers, wholesale distributors and “pill mill” doctors over their roles in the opioid epidemic.
“This case is about one thing: corporate greed,” the 258-page suit begins. “Defendants put their desire for profits above the health and well-being of the County of Lake consumers at the cost of (residents).”
The suit was filed Dec. 11 in Lake County Common Pleas Court by attorneys from Plevin & Gallucci Co. of Cleveland; Napoli Shkolnik of Melville, N.Y.; Thrasher, Dinsmore & Dolan of Cleveland; Scott Elliot Smith of Columbus and Demer & Marniella of Berea.
The firms are working for the county on a contingency basis, meaning a fee — calculated as a percentage of any money awarded — will be charged only if the suit is successful.
The lawsuit is seeking unspecified damages from companies including Purdue Pharma, Cardinal Health and Amerisourcebergen Corp. for alleged violation of consumer sales practices, deceptive trade practices, public nuisance, fraud, unjust enrichment, negligence and negligent marketing.
They are also suing for violations of the Ohio Corrupt Practices Act and injury through criminal acts.
“In order to expand the market for opioids and realize blockbuster profits, Defendants needed to create a sea change in the medical and public perception that would permit the use of opioids ... for more common aches and pains such as lower back pain, arthritis and headaches,” the suit stated. “... Defendants persuaded doctors and patients that what they had long understood — that opioids are addictive drugs and unsafe in most circumstances for long-term use — was untrue, and to the contrary, that the compassionate treatment of pain required opioids.”
According to the suit:
• The defendants knew that opioids were effective treatments for short-term post-surgical care, trauma-related pain and end-of-life care. Yet they also knew opioids were addictive, subject to abuse and appropriate only as a last resort.
• Defendants started a “highly deceptive and unfair marketing campaign” in the late 1990s to expand the opioid market and gain “blockbuster” profits. The marketing campaign that rationalized prescribing opiates for chronic pain “opened the floodgates of opioid use and abuse,” with catastrophic results.
• In 2014, more people died of opioid overdoses in Ohio than any other state in the country.
• Lake County had a 25.6 drug overdose death rate per 100,000 population from 2011 to 2016, according to the Ohio Department of Health.
• In 2016, unintentional drug deaths affected Lake County residentsbetween 25 and 34 years old at almost double the rate of other age groups.
• Since 2010, Lake County has seen a 38 percent increase in the number of children entering the custody of county agencies, resulting in a 26 percent increase in the cost to pay for placement into alternative care. This is directly related to the opioid epidemic, as addicts either lose custody of their children or die.
• There has been a significant increase in Ohio babies born addicted to opiates. Infants afflicted with Neonatal Abstinence Syndrome spend their first months of life in heavy withdrawal and often need years of long-term care and monitoring. Almost 1,700 Ohio babies born in 2013 were addicted to drugs, according to the state Department of Health. Lake County has a higher five-year average for infant mortality than the state or country as a whole — much of this due to babies born with NAS.
• The Lake County Sheriff’s Office has seen a dramatic increase in costs due to the opioid epidemic, including more emergency calls due to overdoses, the increased use of opioid reversal drugs and more crime.
• Opioid abuse has not displaced heroin, but “rather triggered a resurgence in its use,” putting additional burdens on Lake County and local agencies.
“The intent of proceeding with this is not to address a problem, but to address possibly some relief from a problem we’ve been continually addressing,” Lake County Commissioner Daniel P. Troy said at a recent meeting. “The opiate epidemic has impacted our county and our society in so many ways.”
The case has been assigned to Judge Vincent A. Culotta.
The attorneys hired by Lake County have filed similar suits in other nearby counties including Cuyahoga and Ashtabula.
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Brad Schimel: Opioid fight continues in Wisconsin (OPINION)
Dec 13, 2017 | The Chippewa Herald (WI)
By Brad Schimel
Earlier this month, a coalition of Wisconsin counties announced their lawsuit against drug manufacturers for their alleged role in the opioid epidemic, and many have asked me why the state has not yet filed a lawsuit of its own.
Upon taking office in 2015, I made the opioid epidemic my number one priority. And rightfully so. The state’s opioid epidemic is one of the biggest public health and safety challenges in decades. Last year alone, 827 Wisconsinites died from drug overdose deaths. That’s why Wisconsin joined 40 other states to investigate the major opioid manufacturers.
In September 2017, the multi-state investigation made public that it had served investigative subpoenas, also known as Civil Investigative Demands, on the major opioid manufacturers: Endo, Janssen, Teva/Cephalon, Allergan, and Purdue Pharma. We have demanded documents and information from these companies and their related entities to determine if they engaged in unlawful practices in marketing and selling opioids.
Historically, multi-state investigations like this one have led to substantial recoveries for participating states due to the states’ broad investigative authority and ability to negotiate with companies and avoid the delays and costs associated with litigation. State attorneys general have the authority to serve subpoenas and obtain documents and information without many of the procedural hurdles and discovery challenges faced in any major litigation.
Needless to say, if the coalition of states determines a lawsuit is necessary, I will pursue this strategy. However, filing a lawsuit now will likely lead to delay tactics and endless litigation that could last many years.
For example, in 2014, the city of Chicago filed a lawsuit against the same manufacturers we are investigating. Today, the city’s case is stayed pending a decision as to whether the city will be consolidated as part of the growing Multidistrict Litigation. Meanwhile, the city faces mounting costs related to heroin overdoses with no end in sight.
As a participant in the recent successful multi-state investigations of Volkswagen and Wells Fargo, I feel confident that the investigative route we are currently taking with the opioid manufacturers will result in better outcomes for Wisconsin than we would receive if we pursued action on our own. This also is the wisest use of state resources. Multi-state investigations allow us the ability to both prepare for litigation while pursuing the possibility of a settlement. The unified voice of more than 40 states cannot be ignored by the opioid manufacturers and I intend to bring a meaningful and prompt resolution for the citizens of our state.
At the state Department of Justice, in addition to litigation, we have been using all the tools on our belt to fight this epidemic: prevention, enforcement, public awareness and treatment.
Since April 2015, we’ve safely collected and disposed of more than 330,000 pounds of unused prescription medications, preventing their potential misuse and abuse. We’ve arrested and prosecuted countless drug dealers in all corners of our state, stopping deadly drugs from flowing into our communities. For instance, on Sept. 18, the Division of Criminal Investigation arrested 18 individuals and seized approximately 1.5 kilos of heroin, recovered more than $100,000 in cash and took 18 firearms off of the street as part of just one case in Milwaukee.
We’ve focused on public awareness, and our award-winning Dose of Reality campaign to end prescription painkiller abuse in Wisconsin is a national prevention model that is now being used in Maine, Minnesota and Nebraska. Wisconsin DOJ administers treatment courts in 51 counties and two tribes, providing alternatives to incarceration for non-violent drug offenders and giving folks the ability to turn their lives around. And, we’re working to expand treatment by also leading a 43-state lawsuit against Indivior, a manufacturer whose alleged antitrust scheme blocks generic competitors and artificially high prices for those seeking a medication assisted treatment for people addicted to heroin and opioids.
I promised to prioritize public safety over politics. While filing our own individual lawsuit might serve my short-term political interests, the litigation plan and additional harm-reduction strategies we’ve employed for the last three years are in the best interest of Wisconsin and the countless victims of the state’s opioid epidemic.
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BREAKING: Harris County To Sue Pharmaceutical Companies For ‘Opioid Epidemic’
Dec 13, 2017 | Houston Public Media (TX)
By Allison Lee
Being addicted to painkillers, or opioids, is a serious health issue in Houston and nationwide.
In October, President Trump even declared the opioid crisis a “national public health emergency, under federal law.” It’s the first presidential administration to do so.
According to the Centers for Disease Control and Prevention, opioid prescribing has fueled the epidemic. It said nearly half of all U.S. opioid overdose deaths involve a prescription. And a recent government report said the US economy lost over 500 billion dollars from opioid abuse, in 2015.
But who, if anyone, should help pay for the losses?
Harris County said the drug companies should pay; just like tobacco companieswere made to pay for smoking-related health care and prevention.
“It’s exactly pharmaceutical’s tobacco moment,” said lawyer Tommy Fibich. He’s one of the several lawyers representing Harris County against a slew of pharmaceutical companies.
In an e-mailed press release, the Harris County Attorney’s office said:
Harris County Attorney Vince Ryan will file suit Wednesday against drug manufacturers and distributors, doctors and a pharmacist for their roles in promoting the opioid epidemic that has cost Harris County residents their health and even their lives and cost taxpayers millions to pay for healthcare and law enforcement.
“These are the most addictive drugs on our planet. They knew that. They promoted them in a way that caused people to be addicted to them,” said Fibich. “The problem is the companies that manufactured opioids went against every statue in law designed to protect the consumer.”
Fibich said the regulations in place should have worked, but they weren’t enforced.
“The manufacturers and distributors, primarily, managed to disregard them. They did it with impunity. And everybody was making so much money that they were willing to do it and take the risk,” said Fibich.
It’s not the first lawsuit of its kind. Lawsuits of this nature have been popping up across the country. Upshur County, in East Texas, filed a similar lawsuit in September.
Healthcare Distribution Alliance (HDA) is a national trade association that represents wholesale distributors, some of whom are involved in the lawsuit.
In a statement, HDA spokesman John Parker said:
“As distributors, we understand the tragic impact the opioid epidemic has on communities across the country. We are deeply engaged in the issue and are taking our own steps to be part of the solution – but we aren’t willing to be scapegoats.
Distributors are logistics companies that arrange for the safe and secure storage, transport, and delivery of medicines from manufacturers to pharmacies, hospitals, long-term care facilities, and others based on prescriptions from licensed physicians. We don’t make medicines, market medicines, prescribe medicines, or dispense them to consumers.
Given our role, the idea that distributors are solely responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and how it is regulated.
We are ready to have a serious conversation about solving a complex problem and are eager to work with political leaders and all stakeholders in finding forward-looking solutions.”
AmerisourceBergen, Janssen Pharmaceuticals, and Teva Pharmaceutical Industries Ltd., are also involved in the suit. They have provided News 88.7 with statements:
Janssen Pharmaceuticals: Responsibly used opioid-based pain medicines give doctors and patients important choices to help manage the debilitating effects of chronic pain. At the same time, we recognize opioid abuse and addiction is a serious public health issue that must be addressed. We believe the allegations in lawsuits against our company are both legally and factually unfounded. Janssen has acted in the best interests of patients and physicians with regard to its opioid pain medicines, which are FDA-approved and carry FDA-mandated warnings about possible risks on every product label. According to independent surveillance data, Janssen opioid pain medicines consistently have some of the lowest rates of abuse among these medications, and since 2008 the volume of Janssen opioid products always has amounted to less than one percent of the total prescriptions written per year for opioid medications, including generics. Addressing opioid abuse will require collaboration among many stakeholders and we will continue to work with federal, state and local officials to support solutions.- William Foster, spokesperson, Janssen Pharmaceuticals, Inc.
AmerisourceBergen: AmerisourceBergen and other wholesale drug distributors are responsible for getting FDA-approved drugs from pharmaceutical manufacturers to DEA-registered pharmacies, based on prescriptions written by licensed doctors and health care providers. Our role in doing so is quite widespread across different therapies, with the distribution of opioid-based products constituting less than two percent of our sales. We are dedicated to doing everything within our power as a distributor to mitigate the diversion of these drugs without interfering with clinical decisions made by doctors, who interact directly with patients and decide what treatments are most appropriate for their care. Beyond our reporting and immediate halting of tens of thousands of potentially suspicious orders, we refuse service to customers we deem as a diversion risk and provide daily reports to the DEA that detail the quantity, type, and the receiving pharmacy of every single order of these products that we distribute. We are committed to collaborating with all stakeholders, including in Texas, on ways to combat opioid abuse
Teva Pharmaceutical Industries Ltd.: Teva is committed to the appropriate use of opioid medicines, and we recognize the critical public health issues impacting communities across the U.S. as a result of illegal drug use as well as the misuse and abuse of opioids that are available legally by prescription. To that end, we take a multi-faceted approach to this complex issue; we work to educate communities and healthcare providers on appropriate medicine use and prescribing, we comply closely with all relevant federal and state regulations regarding these medicines, and, through our R&D pipeline, we are developing non-opioid treatments that have the potential to bring relief to patients in chronic pain. Teva offers extensive resources for prescribers, patients and pharmacists regarding the responsible pain management and prevention of prescription drug abuse. Teva also collaborates closely with other stakeholders, including providers and prescribers, regulators, public health officials and patient advocates, to understand how to prevent prescription drug abuse without sacrificing patients’ needed access to pain medicine.
Marc Fleming, Assistant Professor of Pharmaceutical Health Outcomes and Policy at the University of Houston College of Pharmacy, said while there is an issue in Harris County, there’s responsibility and blame all around.
“From a societal stand point, to the individual patients, to unscrupulous doctors that enable these patients with unethical prescribing of these medications,” said Fleming.
Fleming also said there are many factors contributing to opioid abuse; one being lyrics to popular songs referencing prescription medication abuse.
“These medications are commonly talked about in some of these lyrics, and so forth.” said Fleming. “One of my concerns is that we have a generation of kids that has grown up very accustomed to taking medications. So there’s nothing taboo, for this generation, about taking a medication.”
Fleming said if damages are awarded to Harris County, it would be best spent in rehabilitation, and other alternatives to help pain management; like yoga and physical therapy.
“Does your insurance cover that? Typically not,” said Fleming. “How are you going to pay for that? These are things that are not being addressed.”
Lawyers say a trial date could come in the next year.
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Travis Co. pursuing legal action in opioid crisis
Dec 13, 2017 | FOX 7 (TX)
By Noelle Newton
Travis County officials are taking on “Big Pharma.”
They're preparing to sue opioid distributors, manufacturers and marketers for harm caused to the county and its citizens.
The Centers for Disease Control (CDC) and prevention has a tab dedicated on its website to address what it refers to as an opioid epidemic. The agency said from 2000 to 2015 more than half a million people died from overdoses.
Judge Sarah Eckhardt said Travis County also suffers from opioid addiction.
"Our medical examiner's office that reviews all suspicious deaths has statistics with regard to the amount of drugs and alcohol in peoples’ systems who die under suspicious circumstances,” she said. “Plus, we've seen this incredible surge of possession of a controlled substance in our jail. We've capped our overall number of jail beds at 27-hundred so this puts a very big strain on our criminal justice system as well as putting a big strain on our health community."
She feels the public health crisis was created, in some measure, by the pharmaceutical industry pushing specific pain medicine with high addiction rates for economic reasons.
Commissioners adopted a resolution to authorize the filing of a civil suit against opioid distributors, manufacturers and marketers. They've contracted with an outside attorney to determine what actions are most appropriate. No companies have been named.
"It's always been an option for us when we see that there is an industry that is taking advantage of a circumstance and really putting people in harm's way. We have a track record of addressing these issues when we see a corporate actor that is behaving in a way that preys on Travis County residents."
Counties across the state and nation are taking the same action.
On Tuesday Pharmaceutical Research and Manufacturers of America announced a multimillion dollar initiative to combat the epidemic. Also launching a partnership with the addiction policy forum to fund state and local programs.
Eckhardt said any money gained from a lawsuit will cover costs to the county as well as address opioid addiction here locally."We take this very seriously in terms of the health of our community and Travis County residents who are suffering with addiction,” said Eckhardt.
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Travis County joins other counties, cities suing over opioid crisis
Dec 13, 2017 | Austin American-Statesman (TX)
By Taylor Goldstein
Travis County will join dozens of other counties and cities throughout the country attempting to recover costs from the opioid epidemic by suing manufacturers, distributors and marketers of the prescription drugs.
“This has been a long time coming,” Travis County Judge Sarah Eckhardt said Tuesday. “This puts a very big strain on our criminal justice system as well as putting a big strain on our health community.”
Most of the specifics of the suit are still being worked out, officials said. Eckhardt said the county will work with attorneys to determine who will be named in the suit, what charges will be brought and when.
More than two dozen states, cities and counties, including several in Texas, have filed such lawsuits against pharmaceutical companies, claiming the companies aggressively marketed the drugs and lied about the risks to make money.
Upshur County in East Texas was the first Texas county to file suit in late September, and Dallas, Tarrant, Kendall, Kerr and Bexar counties have indicated they plan to sue as well. Eckhardt said Travis County will likely consolidate with other interested parties to form one suit.
Texas has not filed suit so far, but Attorney General Ken Paxton announced in June that he was joining a bipartisan coalition of state attorneys general to investigate whether manufacturers have used illegal methods to market and sell opioids and to determine their role in the crisis.
According to the federal Centers for Disease Control and Prevention, 91 Americans die every day from opioid overdoses, and deaths from prescription opioids, including oxycodone, hydrocodone and methadone, have more than quadrupled since 1999.
A University of Texas study in 2014 found that Travis County had an overdose death rate of 2.3 per 100,000 people, one of the lowest rates among large Texas counties.
Eckhardt and others have compared the wave of opioid-related suits hitting pharmaceutical industry to those that hit the tobacco industry in the 1990s, when cigarette companies agreed to pay billions of dollars in fines in the largest civil settlement in history.
Drug companies have largely denied wrongdoing. The Pharmaceutical Research and Manufacturers of America declined to comment Tuesday about the litigation targeting the industry, but the trade group issued a press release pledging to fund state and local programs and assist in policy changes to address the crisis.
“We are deeply committed to addressing the opioid crisis and advancing solutions that will make a meaningful difference for families and communities,” organization President and CEO Stephen J. Ubl said in the press release.
Some legal experts note a difference between the tobacco lawsuits, which involved customers using the products as intended, and the opioid lawsuits, which point to abuse of drugs beyond what a doctor prescribed, if a doctor prescribed the drugs at all.
“It is difficult to persuade courts that FDA-approved prescription drugs are defective and that their warnings are inadequate,” Richard Ausness, a University of Kentucky College of Law professor, told the Atlantic in June.
Scott Hendler, one of the attorneys hired by Travis County, emphasized to Travis County commissioners in November the harm he alleges the companies have caused by aggressively pushing drugs they knew were highly addictive, then leaving local governments and other agencies to deal with the consequences. Hendler argued there are similarities between pharmaceutical companies and drug cartels.
“The only difference … is that the drug cartels are distributing illegal drugs and the pharmaceutical industries are distributing what are legal but their methods are really illegal,” Hendler said. “They have created pill mills. They have marketed to physicians and prescribers in ways unheard of 10 years ago.”
Hendler said drugs that were developed for cancer-related pain have now been “repackaged and remarketed to people for minor back pain or post-surgical pain.”
The drugs are so addictive that abuse problems often result from legally prescribed drugs and cause addictions so unrelenting they often take months of rehabilitation to overcome, he said.
“I think that taking it on now to interdict the source of the problem is the way to combat it,” Hendler said.
Commissioners approved a resolution last month to retain the Lanier Law Firm; Hendler Lyons Flores PLLC; the law office of Richard Schecter P.C. and Reich & Binstock LLP to represent the county, and they revised the resolution Tuesday.
The attorney’s fee arrangement is 25 percent of gross recovery plus reimbursement of expenses, capped at 35 percent total, Eckhardt said. If the county prevails, fees will be paid only from what is recovered in the lawsuit, and no money will be paid from the county’s general fund or any special fund, according to the resolution.
If Travis County recoups any money from the suit, Eckhardt said, it would go toward criminal justice and social service programs related to the opioid crisis.
“This is not a lawsuit for profit,” she said. “This is a lawsuit in order to recover costs and address opioid addiction by Travis County residents from a public health perspective because this public health crisis has been created, in some measure, we believe, by practices of the pharmaceutical industry.”
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How one sentence helped set off the opioid crisis
Dec 13, 2017 | Marketplace
By Caitlin Esch
Audio Link: https://www.marketplace.org/2017/12/13/health-care/uncertain-hour/s02-4-sentence-helped-set-off-opioid-crisis/
OxyContin went to market in 1996 with a campaign by Purdue Pharma that suggested a less abusable drug, one that doctors could prescribe for moderate pain, in addition to severe pain.
At the center of the company’s marketing aimed at physicians was a single sentence in OxyContin’s original label:
“Delayed absorption as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug.”
Purdue’s marketing campaign relied on that sentence, which claimed OxyContin was believed to be less likely to be abused than other prescription opioids, according to depositions from various sales reps and physicians that were pitched on the drug. But that claim was not backed up by clinical studies.
Officials from Purdue Pharma, the company behind OxyContin, said in depositions from a 2004 West Virginia lawsuit that the company did not hold clinical trials to show that OxyContin was less likely to be addictive or abused. Purdue sales reps leaned heavily on that messaging of lower abuse potential to push the drug during the first six years following its launch.
Marketplace reviewed hundred of pages of court documents — including some that were recently unsealed — that shed light on the relationship between the Food and Drug Administration, the agency responsible for monitoring and approving prescription drugs, and Purdue between 1995 and 2001.
After launching, Purdue marketed OxyContin aggressively. “Dedicate 70% of your time selling Oxycontin!!!!!!!!!!!” reads a sales strategy memo dated Feb. 27, 2000. “We are selling Oxycontin 70% of the time!!!!!” reads another. “Remember to sell Oxycontin 70% of the time,” reads a less enthusiastic email dated March 1, 2000.
According to a GAO report, Purdue spent approximately six to 12 times more on promotional efforts during OxyContin’s first six years on the market than it had spent on its older product, MS Contin, during its first six years, or than had been spent by Janssen Pharmaceutical Products L.P., for one of OxyContin’s drug competitors, Duragesic.
And its efforts worked: OxyContin became one of the most prescribed narcotics in the country. Purdue has made over $35 billion in sales from OxyContin since it began marketing the drug in 1996, according to data from IQVIA. And OxyContin also became one of the most abused pharmaceutical drugs in U.S. history.
The sentence would remain on OxyContin’s label for more than five years before the FDA removed it and put a “black box warning” on the drug, signifying the drug’s serious or life-threatening risks.
OxyContin, and that highly-marketed sentence, arguably helped push open the floodgates to the country's opioid epidemic. Between 1999 and 2015 alone, 300,000 people died from overdoses involving OxyContin and other opioids.
'If it ain't in the label it ain’t in the launch'
Before a drug reaches the market, the FDA approves the label, also known as the package insert. It’s one of the most powerful tools the FDA has in regulating a drug’s use.
A label is a long and detailed document that includes information about who the drug is for, how it should be used, side effects and clinical studies. Every prescription drug has one. And every sentence is meticulously negotiated between a drug company and the FDA.
“There is nothing fought over, struggled over, agreed on — eventually. Or in a sense, disagreed on, as much as the package insert,” said former FDA medical officer Dan Spyker.
Spyker helped write package inserts for drugs and medical devices in the 1990s. He did not work on OxyContin while at the FDA, but he did go on to work for Purdue after he left the agency.
“The FDA can have any package insert they want … no matter what the [drug company] says,” Spyker explained. “But as you can imagine, we have respect and responsibility for the [drug companies] as well. So we've always worked hard with [them].
The label is important not just for medical information but for advertising reasons.
“The cliché that we bounced back and forth was, ‘if it ain't in the label it ain’t in the launch,’” Spyker said.
OxyContin’s original package insert was approved by the FDA in 1995. Among the usual clinical study information and side effect profile was the crucial sentence:
[INSERT PHOTO FROM STORY HERE]
The part about “delayed absorption” basically meant that the drug doled out the active ingredient, oxycodone, over time. This claim was supposedly based on the view that was one would be less likely to abuse it because you wouldn’t get a rush all at once, as you would with an immediate-release drug, like Percocet.
The phrase became a marketing mantra for the company. Patients would no longer have to take several doses during the day. The 12-hour release would mean fewer prescriptions and fewer spikes in pain. In 2016, the Los Angeles Times investigated Purdue’s claims that the drug lasted 12 hours and found that the release time was actually as short as six hours in some patients.
The other marketing mantra was in the rest of the sentence: “is believed to reduce the abuse liability of a drug.”
“There's a caveat here, the sentence says it's ‘believed’ to reduce the abuse liability of a drug,” said Dr. Caleb Alexander, an associate professor of epidemiology and medicine at the Johns Hopkins Bloomberg School of Public Health and the chairman of an FDA advisory committee on drug safety for neurologic diseases. “They're not stating that it does reduce the abuse liability of a drug. This is a slippery slope.”
The sentence should never have been allowed in the label because there are were no clinical studies to back it up, Alexander said.
“Not without data,” he said. “I mean, show me the data. Show me the studies. Show me the abuse liability studies.”
So where did that sentence come from? How did it wind up in an FDA-approved label?
When contacted by Marketplace, the FDA would not comment specifically about its relationship with Purdue during that time period.
The agency did say in a statement that it “continues to evaluate labels for opioids, including OxyContin,” and that it “is focused on making sure to learn from the lessons of the past to inform the actions we take moving forward, including a shift in the agency’s policy efforts to consider how opioids are used not just by appropriate patients but also by people who are using them for non-medical reasons.”
According to Purdue, the sentence came from the FDA.
“The 'delayed absorption' sentence was added to the label at FDA’s suggestion, not Purdue Pharma’s, and FDA did not require Purdue to do any clinical studies to back up the delayed absorption statement,” Purdue Spokesman Robert Josephson said in a written statement to Marketplace.
But the court documents obtained by Marketplace portray a more complicated story.
For the last 13 years, some of these documents were in an envelope marked “sealed” in a West Virginia county courthouse. Marketplace received permission from a judge to review the documents from a lawsuit the state attorney general brought against Purdue Pharma in 2001 alleging misleading marketing tactics in West Virginia. It was settled in 2004 for just $10 million and many of the documents were sealed.
The focus group
Among the most revealing documents was a 57-page focus group report that Purdue commissioned in 1995, ahead of OxyContin’s launch, called “Purdue Frederick Company Focus Group Research & Findings: OxyContin for Non-Cancer Pain Management.” Purdue commissioned the market research, conducted in New Jersey, Connecticut and Texas, to understand what approximately 40 rheumatologists, surgeons and family doctors thought of OxyContin and how likely they would be to prescribe it for moderate to severe noncancer pain, like pain from arthritis or after-surgery pain.
Before 1995, prescribing painkillers as strong as OxyContin for anything other than severe pain or cancer pain was controversial.
The focus group report provided recommendations on how to “pursue a marketing effort to position OxyContin as a treatment for noncancer pain.” Among them were:
- “The product be positioned for treatment of severe pain only, as none of the doctors would use a Class II narcotic for moderate pain that does not relate to cancer.” A Class II narcotic, formally called a Schedule II, is a drug that, according to the DEA, is a narcotic with “high potential for abuse.”
- “The product should only be positioned to physicians in non-triplicate states, and within these areas, focusing on the rheumatologists and PCPs [primary care providers] as the initial targets.” Triplicates states are states that require doctors to provide three copies of any prescription for a Schedule II drug — one for the doctor, one for the pharmacist who filled the prescription and one to state regulators. When these focus groups were being conducted, there were less than a handful of triplicate states, including New York, California and Texas. The doctors in Texas said they rarely used narcotics of that strength to treat noncancer pain because the paperwork for strong drugs like OxyContin was extensive. “The mere thought of the government questioning their judgement created a high level of anxiety in the focus group room among the doctors,” reads the report.
- Purdue should conduct clinical studies on noncancer patients. If Purdue could show its new drug was less likely to be abused, it could convince more doctors to prescribe it for noncancer pain and “dramatically impact on [sic] the long term sales volume of OxyContin for treatment of noncancer pain.”
Purdue did not conduct those suggested studies before launch. But it did market the drug for moderate noncancer pain anyway, citing the sentence “Delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of the drug.”
Purdue’s Josephson said the report did not influence the writing of the drug label’s sentence.
Regardless, the report shows the company’s interest in expanding its market.
“They didn't want to get put in the cancer bucket,” said Alexander of Johns Hopkins, who is an expert on pharmaceutical regulations and reviewed the documents for Marketplace. “And what have we seen over the past 20 years? The vast majority of injuries and deaths from prescription opioids have occurred among people that don't have cancer, that have chronic, noncancer pain.”
Documents from another court case include a letter, written by a physician from Tennessee to Purdue, requesting that its representative not return to his practice because he disagreed with her sales pitch. He wrote that they had “philosophical differences about narcotics and their addictive potential.”
“I am advising you NOW I do not ever wish to speak to her again,” he wrote. In a signed affidavit, he explained his concern:
Specifically, she told me that OxyContin was less likely to addict patients because of its formulation. I questioned her basis for making such claims, and she stated that her company had instructed her to make such representations. I expressed my disagreement with her, but she continued to make these assertions. On March 30, 2000, [she] again called upon me in an effort to promote OxyContin. She again claimed OxyContin was safer and less addictive than other opioids. I again expressed my disagreement with her claims, and the conversation escalated to a shouting match.
When asked about their conversation during her deposition, the sales rep said: "That wasn't my practice to discuss addiction."
One thing that was not disputed: Purdue executives said they did not conduct any studies to prove OxyContin was less likely to be abused or less addictive. Robert Reder, the former vice president of medical affairs and worldwide safety at Purdue, testified that the company did not think it was necessary since OxyContin was already considered a Schedule II drug and therefore already regulated.
Robert Reder’s deposition from July 15, 2003:
Q: Do you recall any abuse potential studies for OxyContin in that timeframe?
A: No.
Q: What about after that timeframe?
A: No.
Q: Has there ever been any abuse potential studies on OxyContin?
A: Abuse potential studies of the nature we discussed earlier?
Q: Yes.
A: No, because it’s a Schedule II drug, so the abuse potential is already recognized and defined in law.
Q: Has there ever been any comparative abuse potential studies between immediate release oxycodone and OxyContin products?
A: Not to my knowledge.
Q: And that includes both your company and also outside of your company?
A: Yes.
Q: Did Purdue ever consider doing any abuse potential studies comparing immediate release oxycodone products to OxyContin?
A: No, because they’re both Schedule II products.
Q: What about comparative studies between OxyContin and Vicodin?
A: No, we didn’t see the need to further define the Schedule II characteristics of oxycodone.
Court documents obtained by Marketplace include a draft OxyContin label from December 1994, written before the focus group report. That draft label does not contain the abuse liability sentence.
A draft version from August 1995, just a few months after Purdue received the focus group report, reveals the sentence had been added in the track changes that Purdue sent back to the FDA.
Reder said he thought the FDA suggested the sentence.
Q: Were you surprised to see that added in the label?
A: Surprised? No. There are a lot of changes. To me, it was FDA’s representation of their ideas of how the label should read.
Q: Had you discussed with the FDA about a desire to add the hypothesis we talked about earlier about delayed absorption?
A: No.
Q: They did it on their own?
A: As best I can recall, yes.
Q: And you never asked them why you [sic] added this?
A: No. It seemed obvious.
Q: It seemed obvious to change from “we have not done any studies about the controlled release oral dosage form as regards to abuse liability” to change it to “delayed absorption is believed to reduce the abuse liability?”
A: Well, what it says is, if I can find it, “delayed absorption as provided by OxyContin tablets is believed to reduce the abuse liability of a drug.” So it’s a more general statement underpinned by the rate hypothesis. It’s believed to. It doesn’t say it definitely does. So it made sense in the context of that time and the information that was available.
Q: Don’t you have to have — are you aware of — in terms of making sense, you had provided no studies to the FDA that said this dosage form appears to have a reduced liability, correct?
A: Yes.
Q: Yet somebody at the FDA on their own initiative decided to add that phrase?
A: I believe that’s what happened. Yes.
Q: Were you grateful for them adding that phrase?
A: To me I didn’t — it didn't — to me it was a useful piece of information to a practitioner. I didn’t feel one way or the other about it except that it might be useful.
In another deposition, Reder acknowledged that he wrote the words “delayed absorption” in a draft of the label, but he said he thinks he did it while on the phone with the FDA.
Former FDA medical officer Curtis Wright, who led the FDA’s review of OxyContin, testified that he also does not remember who wrote it, but said, "the label makes an extremely weak statement about a class of drugs.” Two years after leaving the FDA, Wright took a job at Purdue.
Both Wright and Reder declined to comment for this story.
More than 20 years later, it’s still unresolved who exactly wrote the sentence, but some lawyers argued that the idea behind it came from Purdue.
The black box label
The company's marketing campaign to convince doctors to prescribe OxyContin for moderate pain worked: prescriptions for musculoskeletal pain increased twentyfold between 1996 and 2000.
The FDA became concerned about OxyContin abuse, according to minutes from a series of 2001 meetings with Purdue Pharma.
Marketplace obtained the minutes from a meeting between the FDA and Purdue that took place in the FDA’s offices in April 2001. Those minutes state that “the agency is taking the recent upsurge of prescription drug abuse and specifically OxyContin abuse and diversion very seriously. Purdue opened by stating that they have a two-decade history of responsible marketing of opioids but recognize that OxyContin has become a problem.”
But, the drug’s label did not accurately describe what kind of patients should receive OxyContin, the FDA’s medical reviewer Dr. Sharon Hertz said during the meeting.
"The indication of’ moderate to severe pain for patients who need to be on opiates for more than a few days’ is broad and may not adequately reflect the intended population,” the meeting notes read. “The label should clearly state that this drug product should only be used in patients who require opiates for an extended period of time, that it should not be utilized for first-time treatment of pain, and that this is not for intermittent use. She further stated that a black box warning for overdose, abuse and death may be appropriate.”
Black box labels are reserved for drugs that have “serious or life-threatening risks,” according to the FDA.
In the April meeting minutes, Purdue expressed it was “willing to address the issues regarding labeling, promotion, surveillance, distribution, etc. as necessary and hope that the efforts required of Purdue will apply to all opioids.” The company also “stressed the importance that the discussion remain confidential.”
A key discussion during the meeting was regulation. Purdue did not want OxyContin to be different from other Schedule II drugs: “They are concerned that they may create a perception that this drug is different. They would like to concur with the Agency’s request that if the Agency will request the same of other companies.”
An FDA official responded, “The immediate concern was OxyContin … and that other drugs will be addressed in time.”
In May 2001, Purdue enacted its 10-point plan designed to address the abuse problem, according to company spokesman Josephson. The plan included mailing educational brochures, developing and sponsoring training for law enforcement and health care professions, and creating PSAs aimed at teens.
After the meeting, in July 2001, the FDA approved a new label for OxyContin. The changes included adding a black box warning to the label signifying the drug’s serious or life-threatening risks, and removing the sentence “Delayed absorption as provided by OxyContin tablets is believed to reduce the abuse liability of a drug” from the drug’s label that the FDA originally approved in 1995. The label also said it lacked data to “establish the true incidence rate of addiction in chronic pain patients.”
“The stunning thing is that this was written in 2001. I mean, it's 2017, so we're talking 16 years later,” said Alexander of Johns Hopkins. “Since this time, the problem has only progressively gotten worse and worse, year over year. … And so even in 2001, you know, the alarm had already sounded about this stuff.”
In 2007, Purdue and three top executives admitted that the company, “with the intent to defraud and mislead,” marketed OxyContin as less addictive and less abusable. It paid $600 million in fines and other payments and its executives paid a total of about $35 million in fines.
Currently, more than 100 states, cities and counties still have active lawsuits involving OxyContin against the pharmaceutical company. Purdue has proposed ending all the lawsuits in one global settlement to avoid further litigation, Bloomberg reported last month.
The sentence took regulators six years to remove from the label. But by that point, the OxyContin brand was born, and the country is still grappling with the consequences.
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Should Opioid Makers Pay For Collection & Disposal Of Unused Painkillers?
| The Fix
By Victoria Kim
The DEA already hosts 2 annual take-backs but one expert suggests that the service should be made available on a year-round basis.
Given the role of some drug makers in escalating the opioid crisis, it does not seem implausible that they should shoulder part of the effort in dealing with excess supplies of unused painkillers sitting in people’s homes.
This suggestion was made by Keith Humphreys, a professor of psychiatry at Stanford University—that perhaps there should be a mandate for opioid manufacturers to collect and dispose of the pills they made themselves.
Federal legislation passed in 2010 allows for organizations like pharmacies, hospitals, and clinics to have prescription drop-off services year round. But few are taking advantage of the law, Humphreys noted. There’s little financial incentive for these organizations to offer such services, which must be maintained and monitored carefully. Collected prescriptions must then be destroyed, an additional cost to the organization.
Humphreys recently tackled the issue in the Washington Post, writing that opioid manufacturers could absorb some of the cost of these services, by paying “a few bucks per returned bottle of pills to the patient and to the drop-off location operator.”
It’s estimated that every year, roughly 200 million opioid prescriptions in the United States “are not finished by the patient for whom they are intended,” writes Humphreys, who is also an affiliated faculty member at Stanford Law School and the Stanford Neurosciences Institute.
“No one knows how many unused opioid pills lie forgotten in American medicine cabinets and sock drawers, but it’s surely in the billions,” he continued.
According to the CDC, most people who abuse prescription opioids get them from a friend or family member. Most are given, while others buy or steal them from loved ones’ medicine cabinets.
Every year, the Drug Enforcement Administration (DEA) hosts two prescription drug take-back events across the United States. At recent events, they’ve been hitting record numbers of collections. At the last take-back event in late October, the DEA reported collecting 456 tons of pills across more than 5,300 collection sites—almost six tons more than April’s take-back event.
One initiative in Iowa is taking a different approach to unused prescription drugs in one area where tons of prescription medications normally go to waste—nursing homes. When residents pass away or move out, their medications are either incinerated en masse or flushed down the toilet.
Instead, SafeNetRx, the non-profit organization leading the medication redistribution efforts, collects these unexpired medications from nursing homes and then redistributes them to patients who otherwise could not afford them.
“All that medicine is perfectly good and perfectly safe,” said Rep. Nicholas Duran (D-Miami) who is trying to bring a similar initiative to Florida. “Rather than being burned up, it could be put back to some great use.”
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Physicians took multifaceted approach to opioid epidemic in 2017
Dec 12, 2017 | AMA Wire
By Andis Robeznieks
An AMA Opioid Task Force report issued this spring showed that physicians are working to help end the nation’s opioid epidemic. This includes reducing opioid prescriptions, getting educated on pain-management issues, becoming certified to provide office-based medication-assisted treatment (MAT), and making more use of prescription drug-monitoring programs (PDMPs). Here are some of other news developments AMA Wire® has reported on this year.
Physicians and students being educated on safe opioid prescribing. The AMA Opioid Task Force report noted that 118,550 physicians completed courses offered by state and specialty societies on opioid prescribing, pain management, addiction and other related topics in 2015 and 2016. These efforts continued in 2017 with the Maryland State Medical Society (MedChi) facilitating free training programs on the how to use the Screening, Brief Intervention and Referral to Treatment strategy and how to make better use of the state’s PDMP. “One of our roles is education outreach,” MedChi CEO Gene Ransom said.
Modules on safe opioid prescribing for chronic pain and “what every prescriber should know” about opioid morbidity and mortality were made available on the AMA Educational Center website.
Amid an epidemic, these physicians are taking action. Physicians such as Dr. Wakeman and David Dickerson, MD, are taking immediate action to help patients. As director of the University of Chicago Medicine’s acute pain service and chair of its Pain Stewardship Program, Dr. Dickerson advocates for a holistic approach that includes customizing care for individual patients, reducing the supply of opioids vulnerable to diversion and increasing access to MAT.
New role and practice model for pediatric primary care. There are too few pediatric physicians specializing in addiction medicine and too few inpatient treatment beds, according to Sharon Levy, MD, director of the Adolescent Substance Abuse Program at Boston Children’s Hospital and the American Academy of Pediatrics representative on the AMA Opioid Task Force. The solution advocated by Dr. Levy includes integrating opioid use disorder treatment into pediatric primary care.
Payers and policymakers need to follow evidence. Strong evidence exists on how to treat opioid-use disorder. The challenge is getting payers and policymakers to understand it so that physicians and other health professionals are better able to follow it, according to Sarah E. Wakeman, MD, medical director of the Substance Use Disorders Initiative at Massachusetts General Hospital. “We spent many decades trying to punish people into getting well,” Dr. Wakeman said, and this approach has not worked.
President directs declaration of opioid public health emergency. In his October announcement, President Donald Trump encouraged states to seek a waiver from a 1970s Institute for Mental Disease exclusion rule restricting Medicaid funding for inpatient treatment to facilities with no more than 16 beds. A report from the president’s Commission on Combating Drug Addiction and the Opioid Crisis had recommended this move as “the single fastest way to increase treatment availability across the nation.”
The president’s announcement was welcomed by the AMA, and Patrice A. Harris, MD, chair of the AMA Opioid Task Force, stressed that
“Ending the epidemic will require physicians, insurers, drug manufacturers, and the government to follow through with resources, evidence-based treatment plans and smart public policies at the national and state levels,” Dr. Harris said.
Requirements of the Mental Health Parity and Addiction Equity Act not being met. That was the conclusion of a study looking at seven major health plans in New York and Maryland. The study cited other research that found only 10 percent of the 20.8 million of people who met addiction criteria received any treatment, in part because barriers to insurance coverage remain hard to identify. Also, enforcement of the Parity Act is driven by consumer complaints, but families and patients often don’t know what their coverage is supposed include, or how or where to complain.
AMA urges attorneys general to follow Schneiderman’s lead. Last year, New York Attorney General Eric Schneiderman reached an agreement with Cigna to end prior authorization for MAT. He followed it up in January with an agreement with Anthem to do the same. The AMA followed up that news with a letter to the National Association of Attorneys General urging them to work with insurers in their states to take action against MAT prior authorization requirements.
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Senators say the DEA has been 'hamstrung' in the fight against opiates
Dec 12, 2017 | WJLA ABC 7 (D.C.)
By Leandra Bernstein
The agency responsible for regulating the production and distribution of prescription opiates as well as preventing those drugs from making their way onto America's streets lack the tools needed to combat the worst drug epidemic in U.S. history, senators warned.
The agency responsible for regulating the production and distribution of prescription opiates as well as preventing those drugs from making their way onto America's streets lack the tools needed to combat the worst drug epidemic in U.S. history, senators warned.
WASHINGTON (Sinclair Broadcast Group) — The agency responsible for regulating the production and distribution of prescription opiates as well as preventing those drugs from making their way onto America's streets lack the tools needed to combat the worst drug epidemic in U.S. history, senators warned.
On Tuesday, senators raised their concerns at a hearing with a representative from the Drug Enforcement Administration (DEA), arguing that the agency has been "hamstrung" by a law passed in 2016. At the same time, lawmakers warned that the lax enforcement by the DEA has allowed the pharmaceutical industry to profit from the deadliest drug addiction crisis in the nation's history.
"I'm convinced pretty much that this bill is not the right thing to do, that it has hamstrung the DEA," Sen. Diane Feinstein (D-Calif.) said of the 2016 law imposing new limits on the DEA's ability to suspend suspicious drug shipments.
"I believe it's well enough known that there's an overabundance of opiates, it's well enough known that the companies are making a lot of money from opiates, and the DEA ought to take a most conservative position now and really go after people who abuse or violate the law," Feinstein continued.
At issue is the 2016 Ensuring Patient Access and Effective Drug Enforcement Act(EPAEDEA), a bill passed unanimously in the House and Senate and then signed into law by President Barack Obama. At the time, the bill was aimed at improving patients' legitimate access to drugs, like opiates, that are carefully monitored under the Controlled Substances Act. Prior to the passage of the law, thousands of pharmacies and drug manufacturers were complaining about stopped drug shipments, which inconvenienced patients and business.
However, months after the bill's passage, the DEA's chief administrative law judge, John Mulrooney II, wrote in a Marquette Law Review that the new EPAEDEA imposed a new, heavy burden on drug enforcement, making it more difficult for the agency to suspend suspicious drug shipments and prevent drugs from pouring into America's streets.
"If it had been the intent of Congress to completely eliminate the DEA’s ability to ever impose an immediate suspension on distributors or manufacturers, it would be difficult to conceive of a more effective vehicle for achieving that goal," Judge Mulrooney wrote.
Both The Washington Post and "60 Minutes" picked up on the new legislative impediment to combating the overprescription crisis. In October, The Washington Post reported that under the new law, "Congress effectively stripped the Drug Enforcement Administration of its most potent weapon against large drug companies suspected of spilling prescription narcotics onto the nation’s streets."
Moreover, the Post asserted that the law made it "virtually impossible for the DEA to freeze suspicious narcotic shipments from the companies," a standard that ensured the pharmaceutical industry could continue selling billions of dollars worth of prescription drugs without the threat of law enforcement disrupting their supply lines.
In testimony on Tuesday, the DEA's Acting Assistant Administrator for the Diversion Control Division, Demetra Ashley, affirmed Mulrooney's concerns, telling lawmakers that "the DEA along with the Department of Justice supports a change in the legislation."
Prior to the passage of the law, the DEA was able to preemptive stop the shipment or distribution of prescription opiates that they believed would be diverted into unlawful channels and abused, she explained. Under the current law, they essentially have to wait until an individual has been hurt or killed to stop the drug companies from making a suspicious shipment.
"Prior to the legislation we were in the preventive mode," she said. "The current legislation requires that we establish a 'substantial likelihood' of immediate death, bodily harm and abuse."
While she was reluctant to discuss the exact changes DEA wanted to see, Ashley told lawmakers that the agency would like to "continue using the legislation as it previously was, to prevent" the diversion of drugs.
Lawmakers on both sides of the aisle were open to legislative changes that would better allow DEA to prevent drug abuse, but others were outraged at the failure of U.S. drug enforcement to staunch the flow of drugs into communities across the country.
According to Sen. John Kennedy (R-La.), the problem is much bigger than fixing a statute. "When 14 billion pills are being distributed and we only have 323 million Americans, that tells me that's 41 pills per person for every man, woman and child in America. And that is absurd," Kennedy stated.
As the opioid epidemic was reaching its height, the DEA was allowing pharmaceutical companies to produce a record number of pills. In 2014, the agency was allowing manufacturers to produce nearly 160,000 kilograms of Oxycodone and over 80,000 kilograms of Hydrocodone, or approximately 14 billion pills. In recent years, the DEA has significantly lowered its production quota for prescription opiates. In 2017 and 2018, the DEA cut prescription drug quotas by more than 40 percent from their peak and expects the cuts to continue in 2019.
Despite the DEA cutting back on the number of pills prescribed to Americans, Kennedy is not convinced that the DEA has the tools it needs, nor is it using the tools it has to effectively combat the opioid epidemic. "I don't know what the problem is with DEA, except I know they're not succeeding. That's clear."
Sen. Amy Klobuchar (R-Minn.) is among the Democrats calling for a complete repeal of the statute so the DEA can preemptively block drug diversions and impose real costs on drug manufacturers.
"This is the tobacco issue of our time," Klobuchar said. "You have a situation where a number of these manufacturers have literally gotten people hooked ... and that companies were not being straight with doctors, with hospitals and mostly with regular citizens about the incredibly addictive nature of these products."
That issue has prompted 41 state attorneys general to band together to investigate how the drug industry promoted the use of prescription opiates. It has also prompted hundreds of drug-ravaged counties, cities and towns to file lawsuits against drug manufacturers.
Sen. Claire McCaskill (D-Mo.) insisted that drug enforcement officials "don't have the tools they need," and argued that her bill to repeal the statute and allow the DEA to preemptively stop suspicious drug shipments will help empower the agency and fight the drug scourge.
"There's a lot of lip service about opioids around this building," she said, "but now is an opportunity for us to give the DEA the tool it really needs."
The opioid epidemic was responsible for the deaths of more than 33,000 Americans in 2015. More than 15,000 Americans died from an overdose of prescription opiates. In recent months, the presidential commission on opioid abuse reported that this addiction crisis did not start in the streets, but in doctor's offices and hospitals around the country.
One of the most egregious cases of drug overprescription occurred in Kermit, West Virginia, a town of fewer than 400 residents. Over the course of two years, a single pharmacy in that town received 9 million prescription pain pills, enough drugs for every man, woman and child to have 31 pills every day for two years, or approximately 22,500 pills per person.
"Nobody can look at those numbers without realizing there's a problem there," said Sen. Patrick Leahy (D-Vt.). "The manufacturers are making a huge amount of money, but people are dying."
Leahy further expressed concern that the DEA either lacks the tools to combat the opioid epidemic or it has failed to effectively use the tools it has available.
A number of lawmakers stood behind the decision to pass the bill, including its chief author in the Senate, Orrin Hatch (R-Utah), and in the House, Rep. Tom Marino (R-Penn.).
Back in October, Marino was under consideration to become President Trump's Drug Czar and serve as the head of the White House Office of National Drug Control Policy. However, Marino withdrew his nomination after The Washington Post and "60 Minutes" reported on his central role in crafting the Ensuring Patient Access and Effective Drug Enforcement Act.
In a statement issued on Tuesday, the congressman argued against the veracity of the media reports which claimed Marino, Hatch and the bill's other sponsors were receiving large campaign contributions from the pharmaceutical industry. "I have been involved with and supported law enforcement throughout my life. I would never introduce or support legislation that would make it easier for dangerous drugs to proliferate," Marino said.
Hatch argued that the criticism of the bill has been "deeply frustrating," saying the reports failed to take into account the problem of supply chain disruptions reported by a large number of legitimate patients and providers.
"This wasn't some effort to help drug companies kill people," Hatch asserted. "This was an effort to ensure DEA's praiseworthy effort to stem abuse don't end up hurting legitimate patients."
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Dec 13, 2017 | WPMT (FOX)
By Harrisburg, PA
Rough Transcript: york county officials are filing a lawsuit against 21 pharmaceutical companies -- including johnson and johnson. four physicians are also named in the suit -- all accused of launching the nationwide opioid crisis. fox43's grace grifaton reports -- york county is now seking damage costs related to how the epidemic has harmed people in the county. officials say the opiod epidemic has stolen from york county. <'just this past month we had 19 deaths. just in the first 5 days of december, weve had 10.' opiods claiming lives, hurting the surrounding community, and costing york county millions- according to the county solicitor. 'whether its the criminal justice, whether its through the treatment system, whether its children and youth, whether its the coroners office from handling the number of
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Dec 13, 2017 | WDVM
By Washington, D.C.
Rough Transcript: welcome back; montgomery county the possibility of suing opioid manufacturers. w-d-v-m's kylie khan has the story. << ike leggett: i wish i could stand here and tell you that montgomery county is immune to this epidemic. unfortunately i cannot do that. kylie khan, reporting: the county executive asked and the county council approved the hiring of an outside law firm, robbins geller, rudman and dowd, to look into any wrongdoings by opoid manufacturers. the county is looking to be reimbursed for taxpayer resources used to respond to the opioid cris. hans riemer: there are broken families, broken lives, and no
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Dec 13, 2017 | WRC (NBC)
By Washington, D.C.
Rough Transcript: both the monetary aspect, but also change in behavior as it relates to the addictive nature of these drugs. >> the county says the lawsuit will be filed in a matter of weeks and will focus on the manufacturers' alleged marketing claims that opioids are nonaddictive. >> opioid deaths impact almost every community in this country, and now the district of columbia may require all of its police patrols to carry the quick-acting antidote medications. but as tom sherwood reports, police warn it could become an expensive burden. >> Reporter: at the d.c. council, a quick tutorial on stopping an overdose. >> this is a really simple nasal spray. it is a plunger and it is like one spritz up and that's it. >> Reporter: antidrug activists like shea la say narcan is a lifesaving drug for several types of overdoses. >> overdoses on painkillers, overdoses on heroin, and fentanyl which is what a lot of folks are worried about now. >> Reporter: council man allen says opioid abuse is growing.
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24 Hour News 8's Daybreak at 5:30am
Dec 13, 2017 | WISH (CW)
By Indianapolis, IN
Rough Transcript: the city of bloomington is the latest city to sue opioid manufacturers and distributors. the city of indianapolis announced a similar lawsuit last month. bloomington officials say they plan to detail their lawsuit later this morning. the leaders are scheduled to speak to reporters at 9:30 this morning at the monr county courthouse. (scott) also in monroe county - the needle-exchange program will coinue until at least 2019. monroe county started its program back in 2016.
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Dec 12, 2017 | WAND (NBC)
By Champaign, IL
Rough Transcript: coles county officials are looking into coles county officials are looking into joining a lawsuit to help fight the opioid crisis. this week... county officials reviewed a possible lawsuit against opioid manufacturers and distributors. the effingham county board is also looking into joining the lawsuit
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Dec 12, 2017 | KETV (ABC)
By Omaha, NE
Rough Transcript: the douglas county attorney wants to take the fight against opioids to the companies that make them. don kleine tells the county board he plans to sue five manufacturers. >> we're taking this action because the costs of this opioid crisis are going to be overwhelming. they overwhelm our ability for the health and safety of our residents. rob: kleine says drug companies are negligent when it comes to keeping opioids out of the wrong hands. he says any money from the lawsuit would go toward county enforcement, rehab, and drug courts.
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Dec 13, 2017 | KTBC (FOX)
By Austin, TX
Rough Transcript: legal team to pursue a civil lawsuit against opioid distributors, manufacturers, and marketers. it's in response to the current opioid cris. 3 according to the c-d-c, 91 americans die from an opioid overdose each day. travis county judge sarah eckhardt feels the pharmaceutical industry helped create the cris, in part, by pushing highly addictive pain medication for economic reasons. she says the county has seen a significant uptick in crime associated with drugs and alcohol, as well as a surge in possession of a controlled substance in the jails. yesterday, commissioners finalized the language on a resolution to file a civil suit. 3 "It's always been an option for us When we see that there is an industry that is taking advantage of a circumstance and really putting people in harm's way. We have a track record of addressing these issues when we see a corporate actor that is behaving in a way that preys on Travis County residents." 3 counties across the state
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Dec 13, 2017 | KEYE (CBS)
By Austin, TX
Rough Transcript: it is currently a 6:15 am. thank you for waking up with cbs austin. the national opioid epidemic, a lawsuit against manufacturers. for the county commissioners voted to move forward with a lawsuit. they say opioids have caused harm to travis county and its citizens. commissioners plan to go after manufacturers, distributors and marketers of the drug.
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Dec 13, 2017 | KTBC (FOX)
By Austin, TX
Rough Transcript: 3 travis county has hired a legal team - to pursue a civil lawsuit: against opioid distributors, manufacturers and marketers. the goal is to gain damages caused by the effects of the current opioid cris. 3 according to the c-d-c, 91 americans die from an opiod overdose per day. travis county judge sarah eckhardt feels the pharmaceutical industry helped create the cris, in part, by pushing highly addictive pain medication for economic reasons. she says the county has seen a significant uptick in crime associated with drugs and alcohol as well as a surge in possession of a controlled substance in the jails. commissioners finalized the language on a resolution to file a civil suit tuesday. 3 "It's always been an option for us When we see that there
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Dec 13, 2017 | KRIV (FOX)
By Houston, TX
Rough Transcript: Jose: happening today, harris county is taking action to fight the local opioid epidemic. harris county attorney vince ryan will file a lawsuit against drug manufacturers and distributors, doctors and a pharmacist for their roles in promoting opioids.
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Dec 13, 2017 | KOMO (ABC)
By Seattle, WA
Rough Transcript: >>> everett and tacoma's lawsuits against oxycontin maker purdue pharma are consolidated with more than 100 cases against the company. they will now be heard by a federal judge in northern ohio. the lawsuits claim the company falsely claimed the risk of opioid addiction was low and that they misled doctors and patients on the benefits and risks. purdue pharma disputes the claims. >>>
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