Preview Newsletter
Opioid Litigation Daily Media Report - 3/15/18
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Jackley: State gets $27M tobacco settlement, sues drugmakers
Mar 15, 2018 | Associated Press
By Staff
South Dakota will get $27.5 million that has been tied up in a long legal dispute between the state and large tobacco companies, Attorney General Marty Jackley said Wednesday. -
South Dakota sues opioid makers as litigation swells
Mar 14, 2018 | Reuters
By Jonathan Stempel
South Dakota on Wednesday sued three major drugmakers, accusing them of deceptively marketing prescription opioids and contributing to a nationwide epidemic. -
Complaint: 'Drug epidemic of mass proportions' fueled by pharma companies
Mar 15, 2018 | Argus Leader (WI)
By Dana Ferguson
Three pharmaceutical companies undersold the risks associated with their opioid painkillers, driving a "drug epidemic of mass proportions," a lawsuit filed Wednesday alleges. -
Milwaukee County sues prescription drug-makers and distributors behind the opioid crisis
Mar 14, 2018 | Milwaukee Journal Sentinel (WI)
By Don Behm
Milwaukee County sued several pharmaceutical drug-makers and distributors Wednesday in federal district court in Milwaukee for creating a public nuisance and violating federal racketeering laws while contributing to a local opioid epidemic of addiction and overdose deaths. -
NY Opioid Litigation Won't Be Stayed; Lawyers Seeking 1,000 More County-Plaintiffs
Mar 15, 2018 | Forbes
By Daniel Fisher
A New York judge has refused to stay lawsuits by a number of New York counties against opioid manufacturers and distributors, rejecting arguments that the Food and Drug Administration hasn’t yet determined whether narcotic painkillers are unnecessarily dangerous - a central question in any litigation. -
False Claims Act An Unlikely Tool In Opioid Crackdown
Mar 14, 2018 | Law360
By Daniel Wilson
The U.S. Department of Justice recently signaled it will aggressively use the False Claims Act as one of several tools to clamp down on the ongoing opioid epidemic, but it remains to be seen how far it can go using a civil fraud law to help address a broad public health issue. -
Native American overdose deaths surge since opioid epidemic
Mar 14, 2018 | Fox Business
By Frank Miles
Native Americans may be the most affected by the opioid epidemic that has spread across the U.S., and federal officials are looking for solutions. -
Tribes Need Gov't Funding To Fight Opioids, Senate Panel Told
Mar 15, 2018 | Law360
By Andrew Westney
Native American tribal officials and federal agency representatives painted a bleak picture of the impact of opioids on Indian Country for the Senate Committee on Indian Affairs on Wednesday, with the tribal officials calling for increased and more direct federal funding to tribes to combat the opioid epidemic. -
President Trump to visit Manchester on Monday to discuss opioid crisis
Mar 15, 2018 | WMUR9 (NH)
By John DiStaso
President Donald Trump is coming to New Hampshire next week for the first time since the final night of 2016 general election campaign to talk about the opioid crisis that continues to plague the state. -
GOP Senator: Solve Opioid Crisis Through Community, Not Policy
Mar 14, 2018 | MedPage Today
By Shannon Firth
Trying to understand who gets addicted to opioids, and what drives them to drugs in the first place, can help shape a response to the issue, according to a Republican lawmaker. -
Trump, Trials Target Drug Company Shareholders in Opioid Cases
Mar 15, 2018 | New Boston Post (MA)
By Ira Stoll
The opioid addiction issue is headed for the next stop on what is now a well-worn path: from public health crisis, to subject for award-winning and heart-tugging journalism, to payday for trial lawyers. -
Addressing the opioid crisis on the front end with the Opioid Quota Reform Act (Opinion)
Mar 14, 2018 | The Hill
By SENS. RICHARD DURBIN (D-ILL.) AND JOHN KENNEDY (R-LA.)
Our nation is in the midst of an unparalleled opioid abuse crisis that is devastating communities of all sizes in every state. In 2016, more than 42,000 Americans died from an opioid overdose—more than 115 people each day. From Illinois to Louisiana and all of the states in between, we have met too many families who are coping with the devastation wrought by opioid abuse. From Congress to doctors, pharmacists to manufacturers, we must use every tool at our disposal to confront this epidemic. -
House panel to examine 25 opioid bills next week
Mar 14, 2018 | The Hill
By Rachel Roubein
The House Energy and Commerce Committee plans to consider 25 bills aimed at combating the opioid crisis during a two-day legislative hearing next week. -
Opioids: A Crisis Decades In the Making
Mar 15, 2018 | WebMD
By Sonya Collins
In 1980, Jane Porter and Hershel Jick published in a prominent medical journal the results of their study of pain among hospital patients. -
Opioid lawsuit filed on behalf of Limestone County
Mar 14, 2018 | The News Courier (AL)
By Staff
Beasley Allen law firm has filed its fourth lawsuit against opioid manufacturers and distributors on behalf of an Alabama city or county government, the firm announced Wednesday. This time, it's for Limestone County. -
Law firm files opioid lawsuit on behalf of Limestone County
Mar 14, 2018 | Decatur Daily (AL)
By Marian Accardi
Montgomery-based law firm Beasley Allen has filed a federal lawsuit on behalf of Limestone County against more than 20 opioid manufacturers and distributors. -
City of Anniston joining fight against opioid crisis
Mar 15, 2018 | WAFF (AL)
By Staff
A local county government is joining the fight against the opioid crisis. -
West Virginia Towns Flood Opioid Companies With Lawsuits
Mar 15, 2018 | Charleston Gazette-Mail
By Lacie Pierson
The governing bodies of nine towns and two counties in West Virginia have filed lawsuits alleging drug manufacturers and distributors failed to follow state and federal law to prevent the distribution and abuse of prescription pain medication thorough the Mountain State. -
Barbour leaders join opioid lawsuit
Mar 15, 2018 | The Inter-Mountain (WV)
By Brooke Binns
The Barbour County Commission has voted to take part in an opioid lawsuit, joining legal action taken by several other counties across the state. -
Bossier first parish to file opioid suit in Louisiana, joining nationwide trend
Mar 14, 2018 | Shreveport Times (LA)
By Nick Wooten
Bossier Parish has filed a federal lawsuit against drug companies, joining a nationwide trend of local governments seeking payouts for costs allegedly incurred by taxpayers to deal with the opioid crisis plaguing the nation. -
St. Louis County files lawsuit against opioid manufacturers
Mar 14, 2018 | Duluth News Tribune (MN)
By Staff
St. Louis County on Wednesday filed its civil lawsuit against multiple opioid drug manufacturers alleging a “widespread campaign of unfairly, deceptively, and fraudulently marketing and promoting opioids” in violation of Minnesota Law. -
Marion County to sue drug companies over opioid crisis
Mar 14, 2018 | Marion Star (OH)
By Sarah Volpenhein
Marion County will likely number among dozens of other counties and cities across the state that are suing pharmaceutical companies for their role in the opioid crisis. -
South Bend plans to file federal lawsuit against opioid manufacturers
Mar 15, 2018 | South Ben Tribune (IN)
By Staff
South Bend is the latest among dozens of cities and counties across Indiana announcing plans to sue opioid manufacturers and distributors, accusing them of being a major contributing factor to the state's opioid epidemic. -
Houghton in on opioid lawsuit
Mar 14, 2018 | The Daily Mining Gazette (MI)
By Garrett Neese
Houghton County has joined a mass-action lawsuit against opioid manufacturers. -
Tribe in Oklahoma sues opioid manufacturers, distributors
Mar 14, 2018 | Associated Press
By Staff
A tribe in Oklahoma has filed a lawsuit accusing 26 drug manufacturers and distributors of contributing to the tribe’s opioid epidemic by fraudulently misrepresenting the risks and benefits of addictive painkillers. -
Calling opioids a ‘public nuisance,’ Androscoggin County joins nationwide lawsuit
Mar 14, 2018 | Sun Journal (ME)
By Steve Sherlock
After last month joining a growing list of Maine municipalities and counties that are part of a nationwide lawsuit against opioid manufacturers, Androscoggin County commissioners passed an order claiming the opioid epidemic is a public nuisance. -
KSFY Morning News
Mar 15, 2018 | Sioux Falls, SD
By KSFY (ABC)
Video Link: http://app.criticalmention.com/app/#clip/view/33597934?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3 -
KDLT News Today
Mar 15, 2018 | Sioux Falls, SD
By KDLT (NBC)
Video Link: http://app.criticalmention.com/app/#clip/view/33597948?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3 -
KELOLAND This Morning
Mar 15, 2018 | Sioux Falls, SD
By KELO (CBS)
Video Link: http://app.criticalmention.com/app/#clip/view/33597965?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3 -
Good Morning KOTA Territory
Mar 15, 2018 | Rapid City, SD
By KOTA (ABC)
Video Link: http://app.criticalmention.com/app/#clip/view/33597990?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3 -
12 News This Morning
Mar 15, 2018 | Milwaukee, WI
By WISN (ABC)
Video Link: http://app.criticalmention.com/app/#clip/view/33598006?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3 -
Fox 6 Wake-Up News at 6
Mar 15, 2018 | Milwaukee, WI
By WITI (Fox)
Video Link: http://app.criticalmention.com/app/#clip/view/33598041?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3 -
WSBT News First Thing in the Morning
Mar 15, 2018 | South Bend, IN
By WSBT (CBS)
Video Link: http://app.criticalmention.com/app/#clip/view/33598044?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3 -
KBJR 6 and Range 11 News Today
| Duluth, MN
By KBJR (NBC)
Video Link: http://app.criticalmention.com/app/#clip/view/33597967?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3 -
FOX23 News This Morning
Mar 15, 2018 | Tulsa, OK
By KOKI (Fox)
Video Link: http://app.criticalmention.com/app/#clip/view/33598157?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3 -
WAFF 48 News at 10
Mar 15, 2018 | Huntsville, AL
By WAFF (NBC)
Video Link: http://app.criticalmention.com/app/#clip/view/33598174?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3 -
ABC 7 News at 5:00
Mar 15, 2018 | Washington, DC
By WJLA (ABC)
Video Link: http://app.criticalmention.com/app/#clip/view/33598183?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3
South Dakota Suit
Milwaukee County, WI Suit
Commentary and FYIs
Southeast (AL, WV, LA)
Midwest (MN, OH, IN, MI)
Southwest
Northeast (ME)
Broadcast Media Coverage
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Jackley: State gets $27M tobacco settlement, sues drugmakers
Mar 15, 2018 | Associated Press
By Staff
South Dakota will get $27.5 million that has been tied up in a long legal dispute between the state and large tobacco companies, Attorney General Marty Jackley said Wednesday.
Jackley's office said the agreement settles a long dispute over enforcement of a 1998 settlement that requires tobacco companies to compensate 46 states, including South Dakota, for public health costs from smoking-related illnesses. The companies had argued the state wasn't properly enforcing tobacco-control laws, Jackley said.
Alaska and North Dakota this week announced tobacco settlements for $26 million and $34 million. In South Dakota, Jackley said the settlement money will go to a state fund for education to "help teachers and their students."
The Education Enhancement Trust Fund currently provides funding for state aid to education and the South Dakota Opportunity Scholarship, according to the Bureau of Finance and Management.
"I'm here today to really announce the conclusion of one lawsuit that's significant to the state and the beginning of another," Jackley told reporters at a press conference in which he also said that his office is suing several prescription drug manufacturers for deceptively marketing opioid medications.
The civil complaint dated Wednesday was filed in state court against Purdue Pharma, Endo Health Solutions and Janssen Pharmaceuticals. South Dakota is among more than a dozen states that have filed lawsuits against drugmakers.
The lawsuit alleges the drug companies broke state deceptive trade and Medicaid fraud laws, and created a public nuisance by spreading false information about the risks and benefits of opioid medications. The state is seeking damages, civil penalties and an end to any current "unlawful promotion of opioids."
Janssen Pharmaceuticals spokesperson Jessica Castles Smith said in a statement that the company's actions to promote the medications were appropriate and responsible. She said the allegations against the company are "baseless and unsubstantiated."
Purdue and Endo didn't immediately return requests for comment from The Associated Press.
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South Dakota sues opioid makers as litigation swells
Mar 14, 2018 | Reuters
By Jonathan Stempel
South Dakota on Wednesday sued three major drugmakers, accusing them of deceptively marketing prescription opioids and contributing to a nationwide epidemic.
Marty Jackley, the state's attorney general, announced civil claims against Purdue Pharma LP, a unit of Endo International Plc and Johnson & Johnson's Janssen unit.
The lawsuit makes South Dakota at least the 16th U.S. state to sue manufacturers over opioids, which can be used to treat pain.
Jackley said the drugmakers have violated Medicaid fraud laws and state deceptive trade laws, and created a public nuisance by spreading false information about opioids' risks and benefits.
He said their conduct has fueled abuse of opioids in South Dakota, where nearly 596,000 prescriptions for a total of 39.3 million doses were filled in 2017.
South Dakota's population is about 870,000.
"Pharmaceutical companies that knowingly and deceptively harm consumers must be held accountable," Jackley said in a statement.
Purdue and Janssen said in separate statements they were committed to finding ways to curb opioid abuse, and rejected the respective allegations against them. Endo declined to comment.
Opioids, including prescription painkillers and heroin, played a role in a record 42,249 U.S. deaths in 2016, up 47 percent from 2014, according to the U.S. Centers for Disease Control and Prevention.
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Complaint: 'Drug epidemic of mass proportions' fueled by pharma companies
Mar 15, 2018 | Argus Leader (WI)
By Dana Ferguson
Three pharmaceutical companies undersold the risks associated with their opioid painkillers, driving a "drug epidemic of mass proportions," a lawsuit filed Wednesday alleges.
The State of South Dakota in a civil lawsuit alleged that Purdue Pharma, Janssen Pharmaceuticals and Endo Health Solutions in the 1990s began marketing the painkillers for chronic pain despite their addictive qualities. They then succeeded in efforts to promote the drugs using "intentional deception and misrepresentation," the complaint continues.
A spokeswoman for Janssen Pharmaceuticals said the allegations were baseless and defended the company's effort to outline the risks and benefits of the painkillers.
Attorney General Marty Jackley told reporters in Sioux Falls that he filed the suit in an effort to hold the companies accountable for false advertising that allowed painkiller prescriptions to balloon in South Dakota.
"Everyday people in South Dakota are suffering from this opioid epidemic, and we can't continue to wait," Jackley said. “The effect is obvious, we’re starting to see an increase in opioid deaths."
The state also joined a multi-state investigation into pharmaceutical companies' role in the national opioid epidemic in June.
Jackley and Senate Majority Leader Blake Curd, R-Sioux Falls, said that any funds won through the civil litigation would be used to increase prevention education and treatment options in the state.
"We can put those resources to good use in South Dakota and really help people because they’ve been damaged, and I want to see that change,” Curd said.
Jessica Castles Smith, a spokesperson for Janssen Pharmaceuticals, said the company's marketing efforts were "appropriate and responsible."
"The labels for our prescription opioid pain medicines provide information about their risks and benefits," Smith said in a statement, "and the allegations made against our company are baseless and unsubstantiated."
A spokeswoman for Endo Health Solutions said the company doesn't comment on current litigation. A spokesperson for Purdue Pharma didn't immediately respond to a request for comment Wednesday.
Jackley also announced on Wednesday that the state secured $27.5 million that had been held up in a lawsuit between tobacco companies and the state. That funding will be deposited into a fund that benefits K-12 education in the state.
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Milwaukee County sues prescription drug-makers and distributors behind the opioid crisis
Mar 14, 2018 | Milwaukee Journal Sentinel (WI)
By Don Behm
Milwaukee County sued several pharmaceutical drug-makers and distributors Wednesday in federal district court in Milwaukee for creating a public nuisance and violating federal racketeering laws while contributing to a local opioid epidemic of addiction and overdose deaths.
"We will show in court that their intentional lies and misdeeds are the primary driver of one of the worst addiction epidemics this country has ever seen," County Corporation Counsel Margaret Daun said in a statement.
"It doesn't matter if you are a drug dealer spreading product on the street or a publicly traded Fortune 500 company," she said.
"If you are complicit in taking the lives of the people of Milwaukee County, then we are coming after you," Daun said. "It is time to go on offense and force these drug companies to pay for the damages that we have incurred as a result of their conduct."
The lawsuit attempts to eliminate the threat to public health by halting the dumping of prescription painkillers into the community and seeks to recover millions of dollars the county has spent on treating addictions, law enforcement and other services aimed at curbing the opioid crisis, county officials said Wednesday at a courthouse news conference.
"These corporations have made billions of dollars off the sale and distribution of opioids and have done so in part by destroying lives and ripping communities apart," County Executive Chris Abele said.
An average of just under eight opioid prescriptions were handed out for every 10 residents of the Milwaukee area in 2016, the federal Centers for Disease Control and Prevention reported.
Studies show that 30% of patients who are prescribed an opioid for a month become addicted to the painkiller, Abele said.
There were 401 drug-related deaths in Milwaukee County in 2017 and most of those involved opioids, according to the county medical examiner's office.
More than five times that number of people, at least 2,016, received emergency treatment for an opioid overdose last year in the county.
"Lives hang in the balance every single day and as we fight this fight in the street, we must also fight it in the courtroom," County Board Chairman Theodore Lipscomb Sr. said.
Six of the largest prescription drug manufacturers in the U.S. aggressively marketed opioids as a safe treatment for pain and lied about the risks of long-term opioid use and addiction, according to Daun.
The three largest wholesale drug distributors violated federal law by failing to monitor, report and halt suspicious activity in the size and frequency of opioid shipments to pharmacies and hospitals, Daun said. The companies were obligated under federal law to detect and warn authorities of dangerous drugs for non-medical purposes.
"They turned a blind eye while millions of highly addictive opioid pills flooded our community," she said.
Drug manufacturers named in the lawsuit: Purdue Pharma of Delaware and New York; Cephalon Inc. and Teva Pharmaceuticals USA of Delaware and Pennsylvania; Janssen Pharmaceuticals of Pennsylvania and New Jersey; Endo Health Solutions and Endo Pharmaceuticals of Delaware and Pennsylvania; Allergan and Actavis of Ireland, California, Delaware and New Jersey; and Mallinckrodt of Ireland, Missouri and Delaware.
Purdue Pharma is the maker of OxyContin and Dilaudid. OxyContin is its best-selling opioid and makes up around 30% of the market for prescription painkillers with sales of up to $2.99 billion a year, the lawsuit says.
Endo Pharmaceuticals is the maker of Percocet and Percodan.
Mallinckrodt makes and markets generic oxycodone. In July 2017, the company agreed to pay $35 million to settle a series of allegations by the U.S. Justice Department that it failed to detect and notify federal authorities of suspicious orders of controlled substances.
Endo Pharmaceuticals is the maker of Percocet and Percodan. Janssen Pharmaceuticals makes a fentanyl skin patch. Cephalon makes a fentanyl lozenge. Fentanyl is a pain medication 50 times more powerful than heroin.
Wholesale drug distributors named in the lawsuit: McKesson Corp. of Delaware and California with a distribution center in Windsor, Wis.; Cardinal Health Inc., of Ohio with a distribution center in Hudson, Wis.; and AmerisourceBergen Drug Corp. of Delaware and Pennsylvania.
Those three companies control 85% of the prescription opioid distribution market in the U.S., according to the lawsuit.
In this lawsuit, Milwaukee County is represented by a consortium of state and national law firms. The law firms will be paid only if the county receives a financial settlement as a result of the claims against the drug-makers and distributors.
Separately, 60 of Wisconsin's other 71 counties have filed lawsuits in federal district court in Milwaukee against the makers of prescription opioid painkillers. Those counties are represented by Crueger Dickinson LLC in Whitefish Bay and Simmons Hanly Conroy LLC in New York City.
The lawsuits allege the opioid-makers misled local physicians, patients, health care providers and health care insurers with a campaign of misinformation that claimed using opioids to treat chronic pain was safe for most patients and that the drugs' benefits outweighed the risks.
Those lawsuits seek compensation for millions of dollars that the counties spent on social services, courts, law enforcement, health services and emergency care in responding to the opioid epidemic.
Dozens of other states, cities and counties throughout the U.S. have filed similar lawsuits attempting to hold pharmaceutical drug-makers and distributors accountable for bad faith business practices and misrepresentation in marketing of opioids.
Other opioid lawsuits filed in federal courts have been consolidated before a federal judge in Ohio. Milwaukee County's lawsuit also could be moved there, according to Daun.
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NY Opioid Litigation Won't Be Stayed; Lawyers Seeking 1,000 More County-Plaintiffs
Mar 15, 2018 | Forbes
By Daniel Fisher
A New York judge has refused to stay lawsuits by a number of New York counties against opioid manufacturers and distributors, rejecting arguments that the Food and Drug Administration hasn’t yet determined whether narcotic painkillers are unnecessarily dangerous - a central question in any litigation.
In a two-page order issued March 14, Judge Jerry Garguilo of the Suffolk County Supreme Court said he found “no compelling reason to impose a stay of proceedings” until the FDA completes its own review of the benefits and risks of opioids. The lawsuits by most of the counties in New York, which have been consolidated in Garguilo’s court, are “backward-looking” toward allegedly fraudulent marketing materials and tactics the drug companies used to convince doctors and patients their products had low risk of addiction.
The decision increases the pressure on manufacturers and wholesalers to either win dismissal of these cases or prepare for an accelerated trial schedule. Under New York law, municipal plaintiffs have priority in setting their cases for trial, said Paul Napoli of Napoli Shkolnik, the private law firm representing many of the counties under contingency fee contracts.
“The judge has done what judges around the country have consistently done,” Napoli said. “The first hurdle the drug companies are seeking - a stay - is not appropriate for these circumstances and unwarranted.”
Napoli said at least 500 of the nation’s 3,200 counties have sued and plaintiff lawyers hope to soon get that number to 1,500, which some lawyers consider critical mass for a settlement.
“It’s our belief the only way we can get a resolution is to set the matter for trial,” Napoli said.
Judge Garguilo hears arguments on motions to dismiss the New York cases on Monday, Napoli said. The defendant companies argue they can’t be held liable for selling a legal product sold only with a doctor’s prescription whose distribution was controlled and overseen, from manufacturing to retail sales, by federal and state regulators.
The plaintiffs argue manufacturers used a variety of tactics, including misleading marketing materials and highly paid physician-influencers, to convince prescribing physicians their products were safe for treating chronic pain when, in fact, they were highly addictive.
In the order, Judge Garguilo rejected the defendants’ claim that the FDA has exclusive authority to determine whether, in effect, opioids should be sold for anything other than relieving the pain of terminal illness. Regardless of what the FDA determines, the judge said, the municipal plaintiffs have the right to seek redress for their costs associated with addiction.
“Because the focus of this lawsuit is on the state of scientific knowledge that existed when the defendants made their marketing claims, there is no risk of inconsistent rulings, and none of the current studies will have any bearing on whether the defendants’ representations were misleading when made,” the judge wrote. The court isn’t being asked to decide the risks and benefits of opioids but whether the defendants misrepresented those risks and benefits, he added.
In case the defendants didn’t grasp the judge’s ultimate goal, the judge restated his “previously expressed desire” for a “prompt resolution of this matter.” The federal judge overseeing multidistrict litigation in Ohio, Judge Dan Aaron Polster, has similarly urged defendants to engage in settlement talks, although a global resolution of the litigation could prove difficult to negotiate.
In addition to hundreds of cases consolidated in federal court, the defendants face a wave of litigation in state court, like the New York cases, as well as lawsuits and investigations by state attorneys general and the federal government. Any settlement would have to protect the defendant companies from future lawsuits over the same issue and that may be difficult to negotiate given all the concurrent litigation in different courts.
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False Claims Act An Unlikely Tool In Opioid Crackdown
Mar 14, 2018 | Law360
By Daniel Wilson
The U.S. Department of Justice recently signaled it will aggressively use the False Claims Act as one of several tools to clamp down on the ongoing opioid epidemic, but it remains to be seen how far it can go using a civil fraud law to help address a broad public health issue.
Abuse of the potent painkillers has been a growing problem over the past two decades, both as more drugs have come onto the market and as health care professionals' attitudes toward prescribing opioids for managing chronic pain have became more permissive.
That has led to the deaths of tens of thousands of people, a crisis U.S. Attorney General Jeff Sessions has repeatedly said he wants to curb.
“We have no time to waste,” he said in a February statement. “Every day, 180 Americans die from drug overdoses. This epidemic actually lowered American life expectancy in 2015 and 2016 for the first time in decades, with drug overdose now the leading cause of death for Americans under age 50.”
In line with that, the DOJ in its most recent health care fraud "takedown" in July 2017 — an annual coordinated blitz on health care fraud against the government — specifically targeted opioids.
That was followed by Sessions in August announcing the creation of the DOJ’s Opioid Fraud and Abuse Detection Unit, a pilot program involving a dozen assistant U.S. attorneys in nine key states who will focus on investigating and prosecuting prescription opioid-related fraud.
And in January, the attorney general said the Drug Enforcement Administration would launch a 45-day “surge” aimed at opioid diversion, poring over reports it receives from manufacturers and distributors to look for unusually high volumes of prescriptions or other unusual patterns.
But while the DOJ’s early opioid-related moves under Sessions largely focused on criminal and administrative enforcement, the department has also made some moves toward civil enforcement to help curb the epidemic, including using the False Claims Act where it can.
The attorney general on Feb. 27 announced the formation of the DOJ’s Prescription Interdiction & Litigation Task Force, which will “aggressively deploy and coordinate all available criminal and civil law enforcement tools” to target the opioid epidemic. That would include the use of the FCA, Sessions said, while noting that Medicare had spent more than $4 billion on opioid prescriptions in 2016 alone.
“The hardworking taxpayers of this country deserve to be compensated by those whose illegal activity contributed to those costs,” Sessions said in a speech announcing the task force. “And we will go to court to ensure that the American people receive the compensation they deserve.”
Then in a Feb. 28 speech to the Federal Bar Association, a transcript of which was made public on March 8, Deputy Associate Attorney General Stephen Cox further called out the FCA as “a powerful tool to pursue all of those in the opioid distribution chain that are responsible for the improper marketing, distribution, prescription and diversion of opioids” and as “a tool we are increasingly using to address the opioid crisis.”
Although the DOJ has previously used the FCA to target claims involving related classes of drugs, such as the now-withdrawn anti-inflammatories Bextra and Vioxx, it is an unusual — if not unprecedented — move for it to say it intends to use the anti-fraud statute to specifically address a public health crisis, attorneys told Law360.
“This is first instance of that sort of flavor being added to [FCA enforcement] that I can think of,” McDermott Will & Emery LLP partner Tony Maida said.
And despite the tough talk, the actual reach of the FCA as a tool for addressing the opioid epidemic may be fairly limited, attorneys said.
Cox in his speech, for example, had pointed to a $7.5 million September settlement withGalena Biopharma Inc. over allegations it paid kickbacks to doctors to prescribe Abstral — which uses the potent opioid fentanyl — as an example of the type of cases it intends to bring.
That case is similar to one brought by New Jersey in October — part of a broader trend of states and localities filing their own civil actions to address overprescribing — claiming that Insys Therapeutics Inc. had improperly marketed its drug Subsys. Subsys, like Abstral, is a fentanyl-based treatment, and Insys’ marketing scheme was described by then-State Attorney General Christopher Porrino as “nothing short of evil.”
But those two cases involve drugs that have “very narrow” indications for use, approved for treating breakthrough cancer pain, when other opioids are often approved for wider use, Manatt Phelps and Phillips LLP partner Jacqueline Wolff noted.
“Other opioid products might not be as limited, and therefore it would be more difficult to find that the manufacturer or the distributor engaged in some kind of abusive conduct that would form the basis of a False Claims Act case,” she said.
Further complicating the issue, Wolf said, is the Second Circuit’s 2012 Caronia ruling. That decision found that truthful, non-misleading off-label marketing does not violate the Food, Drug and Cosmetic Act. And doctors are — when otherwise acting free from unlawful influence like kickbacks — legally allowed to prescribe drugs for off-label use, she noted.
Given that court precedent, as well as the fact that many opioids are generic drugs that are not heavily marketed, the circumstances that would lead to an FCA case may simply not come up on a regular basis, Wolff said.
Regardless of how frequently it ultimately uses the FCA as an opioid enforcement tool, however, attorneys said the increased attention from the DOJ nonetheless warrants increased vigilance from companies across the entire pharmaceutical supply chain, from manufacturers through to pharmacies.
Prescribers such as doctors and dentists — and their employers — should also be aware of the new focus, and even companies on the periphery such as insurers, pharmaceutical benefit managers, and drug testing and treatment clinics should also be wary, they said.
“It’s up and down the supply chain, including the physician organization or employer, whoever that could be — not just practices but health systems," Maida said. "Frankly, in a civil context, the relator or the government is usually looking for a deep pocket in order to obtain to obtain a civil recovery. The deep pocket may not actually be the prescriber.” -
Native American overdose deaths surge since opioid epidemic
Mar 14, 2018 | Fox Business
By Frank Miles
Native Americans may be the most affected by the opioid epidemic that has spread across the U.S., and federal officials are looking for solutions.
A hearing Wednesday in the nation’s capital shed light that overdose deaths in Native American communities have skyrocketed in the time the epidemic has swept America.
Native Americans and Alaska Natives saw a fivefold increase in overdose deaths between 1999 and 2015, Dr. Michael Toedt told the U.S. Senate Committee on Indian Affairs.
Centers for Disease Control and Prevention figures indicate the increase in that period was higher for Native Americans than any other group, jumping to roughly 22 deaths for every 100,000 people in metropolitan areas, and nearly 20 for every 100,000 people in non-metropolitan areas.
But the statistics, while staggering, may represent an undercount for Native Americans and Alaska Natives by as much as 35 percent, because death certificates often list them as belonging to another race, said Toedt, who is the Indian Health Services’ chief medical officer.
The hearing in Washington comes as a growing number of tribes file lawsuits against drug manufacturers and distributors, saying they misrepresented addiction risks.
A few states over on Wednesday Milwaukee County officials filed suit against 13 drug companies on behalf of county taxpayers claiming 336 people died from opioids in the county last year, more than double the number from five years earlier, according to Fox 6 Milwaukee.
“Make no mistake, there is blood on their hands and there should be a stain on their conscience,” Milwaukee County Corporation Counsel Margaret Daun told Fox 6 Milwaukee.
Federal officials, back in D.C., said the opioid epidemic is straining tribal resources.
U.S. Attorney John Anderson of New Mexico said tribal leaders in a northern stretch of the state had called for solutions.
One pueblo police chief described losing a brother and sister to overdoses, he said.
“The opioid epidemic knows no boundaries,” Anderson said, “and so our pueblos are equally affected by heroin and prescription opioids.”
Several senators questioned whether a decline in prosecutions in Indian Country cases also had contributed to the crisis.
“We need a plan and it can’t just be about treating the addiction,” said Sen. Heidi Heitkamp, D-N.D. “It needs to be a plan that gets law enforcement on the ground.”
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Tribes Need Gov't Funding To Fight Opioids, Senate Panel Told
Mar 15, 2018 | Law360
By Andrew Westney
Native American tribal officials and federal agency representatives painted a bleak picture of the impact of opioids on Indian Country for the Senate Committee on Indian Affairs on Wednesday, with the tribal officials calling for increased and more direct federal funding to tribes to combat the opioid epidemic.
During a committee oversight hearing, Jolene George, the behavioral health director for the Port Gamble S’Klallam Tribe in Washington, said that the overdose rate for Native Americans is over twice the rate for whites in the state, reflecting a surge in overdose deaths among Native Americans nationwide.
And George said that the opioid epidemic has been “overwhelming” to the tribe’s law enforcement and social services as well as its housing programs, which don’t have the resources to deal with the problem.
“The crisis has ripped the fabric of our community,” George told the committee. “The loss through death or addiction of parents, children, brothers and sisters, uncles and aunts, nieces and nephews, and cousins to this crisis has been devastating, and will impact the Port Gamble S’Klallam Tribe for generations. We are doing what we can to fight it, and we want to work with you to eradicate this crisis once and for all.”
George said that a lack of adequate funding to tackle opioids is “a major barrier” and that funding should not only be increased, but provided directly to tribes to make sure that funding to respond to the crisis doesn’t hurt other services.
She said that Congress’ inclusion of $6 billion to fight opioids in the recently enacted Bipartisan Budget Act of 2018 was welcome, but said those funds shouldn’t be passed through the states.
“Direct funding of tribal programs is important as it ensures that funds are available to tribal governments like ours that have culturally appropriate programs and mechanisms in place for fighting the opioid epidemic,” George said.
One bill to ensure direct funding for tribes is S. 2270, the Mitigating the Methamphetamine Epidemic and Promoting Tribal Health Act, introduced by committee member Sen. Steve Daines, R-Mont.
Samuel Moose, the director of human services at Fond du Lac Band of Lake Superior Chippewa and treasurer of the National Indian Health Board, told Daines on Wednesday that “anything that’s going to provide us sustainable funding for our tribal programs, something we can change or redirect based on how we see the need for our communities, is critical to us addressing this issue.”
George said that funding through grants “creates a competition of resources, not just between tribes but even other local agencies we work with,” and doesn’t reflect the federal government’s government-to-government relationship with tribes.
Wednesday’s hearing, titled “Opioids in Indian Country: Beyond the Crisis to Healing the Community,” followed a November roundtable hosted by the committee on similar issues.
Committee Vice Chairman Sen.Tom Udall, D-N.M., touted legislation that grew out of the roundtable to back tribes’ efforts to address the impacts of opioids, a bill he co-sponsors called the Opioid Response Enhancement Act, which would establish a set-aside for tribes under the 21 Century Cures Act grant program.
The hearing also saw testimony from representatives of the Indian Health Service, U.S. Department of Justice and the Substance Abuse and Mental Health Services Administration at the U.S. Department of Health and Human Services.
John Anderson, the U.S. attorney for the district of New Mexico, said that the opioid crisis in the state has been “particularly acute,” and that the DOJ is focusing on law enforcement collaborations with the Bureau of Indian Affairs as well working with the IHS on prescription drug monitoring.
“Our goal is clear: We must continue working in partnership with tribal, federal, state and local partners to respond to the opioid epidemic and to support communities that are affected by the crisis,” Anderson said.
While the committee members handled the federal officials fairly gently on Wednesday, Sen. Heidi Heitkamp, D-N.D., told Anderson that “law enforcement comes first” in tackling opioids, and that the reason why federal prosecutors have increasingly declined to take on prosecutions in Indian Country criminal matters in recent years is “you don’t have quality investigations.”
“You’re the only jurisdiction in Indian Country,” Heitkamp said. “And when you don’t show up, we don’t have law enforcement. And when there’s no law enforcement, we have mayhem and get-out-of-jail-free zones for drug dealers.” -
President Trump to visit Manchester on Monday to discuss opioid crisis
Mar 15, 2018 | WMUR9 (NH)
By John DiStaso
President Donald Trump is coming to New Hampshire next week for the first time since the final night of 2016 general election campaign to talk about the opioid crisis that continues to plague the state.
Two sources with knowledge of the visit confirmed to WMUR Wednesday that the president will make two official stops in Manchester next Monday afternoon.
The sources said he will hold an event at Manchester Community College and then stop at the Manchester Central Fire Station. Additional details have yet to be disclosed.
It will be Trump's first visit to the state since he held a rally on Nov. 7, 2016 -- the night before the general election -- at the SNHU Arena.
Next Thursday, three days after Trump's visit, Vice President Mike Pence is scheduled to make a political appearance at a fundraiser for Gov. Chris Sununu. That event is scheduled for the Manchester Downtown Hotel, formerly the Radisson.
Trump promised during his campaign for the Republican presidential nomination and in the general election that he would address the opioid epidemic if elected. He made the promise several times during stops in New Hampshire.
In late October 2016, just more than a week before the general election, Trump held a roundtable discussion in downtown Manchester, flanked by former U.S. Rep. Frank Guinta and law enforcement officials.
He also told a crowd at a rally at the same stop at the Radisson, “As I said when I won the New Hampshire primary, I promised the people of New Hampshire that we would stop drugs from pouring into your community and I guarantee you, we will.
“We’re going to work with people. We’re going to set up programs. We’re going to try everything we can to get them unaddicted.”
But Trump has come under criticism from the Democratic members of the New Hampshire congressional delegation, who have charged that while Trump spoke strongly about addressing the opioid crisis, he has not followed through with action.
“The president must finally begin fulfilling his promise to deliver treatment resources,” Sen. Jeanne Shaheen said following Trump’s State of the Union address on Jan. 30. "Over the past year, President Trump has only devoted lip service to respond to the opioid epidemic."
State drug czar David Mara said he hopes Trump’s visit indicates future federal funding for the opioid crisis will go to states with the greatest need, including New Hampshire.
“I think it's a great opportunity to showcase what has happened right within this city. Over 3,000 people have gone (to Safe Stations at Manchester fire stations) for help (with drug addiction),” Mara said. “I feel good with the effort, I feel good with what people are doing, but we need to do more.”
Saint Anselm College political professor Chris Galdieri said he believes Trump’s visit is about more than opioid crisis policy.
“He's been involved in a number of controversies (and) accusations that the vote was not fair, calling the state a drug-infested den in an email last summer, that sort of thing,” Galdieri said. “So I think, politically, this is an effort to try to repair some bridges and look ahead to 2020.”
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GOP Senator: Solve Opioid Crisis Through Community, Not Policy
Mar 14, 2018 | MedPage Today
By Shannon Firth
Trying to understand who gets addicted to opioids, and what drives them to drugs in the first place, can help shape a response to the issue, according to a Republican lawmaker.
At an American Enterprise Institute (AEI) briefing on Tuesday, Sen. Mike Lee (R-Utah) tied the roots of the opioid abuse epidemic in the U.S. back to the Civil War, and the "social turmoil" that followed. The war "robbed Americans of a sense of purpose" that left people vulnerable to addiction, just as opioids were entering the country, he stated.
A Republican lawmaker and policy experts explored the role of social and cultural factors in the opioid epidemic and ways to address the crisis during an AEI panel discussion on Tuesday.
Lee added that he sees parallels with that crisis and the current epidemic. "The people most vulnerable to opioid addiction are often lonely and cut off from sources of personal fulfillment. And by that I mean family, meaningful work, and engagement with friends and with neighbors."
Lee and others gathered at AEI to discuss "The Numbers Behind the Opioid Crisis" -- a recent report from the Social Capital Project of the Joint Economic Committee, for which Lee serves as chair. The research initiative focused on "the evolving nature, quality, and importance" of social relationships to the nation.
People who are divorced or unmarried account for 32% of all American adults (ages ≥25), he said, but also accounted for 71% of opioid overdose deaths in the U.S. in 2015. Adults with only a high school education are also "disproportionately likely" to die from an opioid overdose, he added.
Other key findings of the report include:In 2016, 64,000 people died from drug overdoses, with two-thirds of those overdoses attributable to opioids.Prescription pain relievers "freely given by friends and family" represent 40% of the drugs taken by "abusers."In 2015, 40% of adults had only a high school diploma or equivalent degree but "accounted for 68% of opioid overdose deaths."From 2009 to 2014, the proportion of children whose cases of "out-of-home placement" related to a parent's drug or alcohol use increased from 29.4% to 35.1%.
Lee underscored the second point, noting "most people don't ultimately get their pain pills through a legitimate prescription."
He cited AEI resident scholar Sally Satel, MD, who recently penned an op-ed for Politico, highlighting the "false narrative" that the opioid crisis has been largely fueled by patients becoming addicted to opioids prescribed by doctors. Satel is a practicing psychiatrist at a Washington methadone clinic, and a lecturer at the Yale University School of Medicine in New Haven, Connecticut.
In the piece, Satel wrote that while the number of opioid prescriptions "did increase markedly from the mid-1990s to 2011," and "some people became addicted through those prescriptions," surveys and reviews of the data show "only a minority of people who are prescribed opioids for pain become addicted to them, and those who do become addicted and who die from painkiller overdoses tend to obtain these medications from sources other than their own physicians." The op-ed has drawn nearly 100 comments to date. (Leaders of Physicians for Responsible Opioid Prescribing, which urges that the drugs be prescribed sparingly, subsequently wrote a rebuttal.)
There are no easy legislative solutions to the crisis, Lee cautioned, while also warning against "knee jerk responses" by the federal government.
"There is strong evidence that the government has itself done substantial harm by, among other things, paying for a flood of pain pills through Medicaid and the Medicare Prescription drug program," he stated.
Instead, Lee called for solutions at a local level. The opioid epidemic is strongest in "already eroding communities" and its most vulnerable targets are those who are already isolated, he said.
"If we're going to the halt the spread of opioids, and if we have any hope of stopping the next drug crisis, then we need to build resilient families and resilient communities. That's a project that can be accomplished only at the community level; only at the personal level," he said.
He cited two treatment programs in Utah as examples of such community building. Odyssey House is a not-for-profit which steers people with addiction away from the criminal justice system and into supportive treatment. The Other Side Academy is a 2-year program for people who have already detoxed that aims to prevent relapse by helping individuals find work.
Five years after graduating, more than two-thirds of participants in the Other Side program are "crime-free" and "drug-free," Lee said. "The examples could be multiplied."
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Trump, Trials Target Drug Company Shareholders in Opioid Cases
Mar 15, 2018 | New Boston Post (MA)
By Ira Stoll
The opioid addiction issue is headed for the next stop on what is now a well-worn path: from public health crisis, to subject for award-winning and heart-tugging journalism, to payday for trial lawyers.
The lawyers are poised to do to prescription drug companies, pharmacy chains, and drug distributors what they did to tobacco companies and asbestos manufacturers — wring from them a multibillion dollar settlement, with a sizeable chunk going to the lawyers themselves.
They may even do so with an assist from President Donald Trump. “Hopefully we can do some litigation against the opioid companies,” Mr. Trump said earlier this month at a White House “Opioids Summit.” “I think it’s very important because a lot of states are doing it, but I keep saying, if the states are doing it, why isn’t the federal government doing it? So that will happen.”
Somehow the Democrats usually on high alert at the risk of President Trump “interfering” with the “independent” Justice Department apparently managed to make peace with the presidential involvement, so long as it involved Mr. Trump siding with the trial bar against the for-profit pharmaceutical industry.
The Justice Department was acting as Mr. Trump was talking. On March 1, federal government lawyers filed a “statement of interest of the United States of America” before Judge Dan Polster of the U.S. District Court for the Northern District of Ohio. Judge Polster is presiding over the consolidated cases known as In Re: National Prescription Opiate Litigation. It is so vast that just the docket listing the names of the parties and their lawyers is 222 pages long.
The potential damages involved are vast. The federal lawyers, who asked the judge for 30 days to “evaluate” whether to participate in the lawsuits, cited a report by the president’s Council of Economic Advisors, who “estimated that in 2015, the economic cost of the opioid crisis was $504 billion.”
It wasn’t so long ago that Republican presidents stood for reining in civil litigation rather than piling on to it. But then again, it wasn’t so long ago that Republican presidents stood for free international trade rather than tariffs, either.
As usual in these sorts of cases, “liability” is likely to be more about having the deep pockets available to fund settlements than with any thoughtful or thorough reckoning with moral or logical responsibility. Don’t expect much effort to target the congressmen and senators who voted for the ObamaCare legislation that expanded insurance coverage for these drugs, or for the Food and Drug Administration bureaucrats who approved them, or, with few exceptions, the doctors who prescribed them. Certainly don’t blame any of the users themselves. The targets of the suits instead are mostly large publicly traded companies — Abbott Laboratories, CVS Health, Costco, Express Scripts, Wal-Mart — whose shareholders will wind up paying the price of any settlement.
Also as usual, there is little consideration given to the potential unintended consequences. The same issue of the New York Times that carried the news of the government’s statement of interest before Judge Polster also carried a book review lamenting the “sluggish progress” and “dry pipeline” in developing new medicine to treat mental illness.
It’s already so expensive to discover a new prescription medicine and to go through the clinical trials required to prove safety and efficacy that most big drug companies have more or less given up on early-stage research and development, preferring instead to purchase smaller, venture-funded start-ups whose products show promise. Adding the possible costs of litigation and settlement for potential abuse even after a product has been approved by the FDA makes the hurdle for investing in a new drug even higher.
Mr. Trump is fond of invoking the “forgotten man.” It’s a category that might include people with diseases that go uncured because drug companies are spending on lawyers, settlements, or insurance premiums instead of on research and development.
That’s not to say that the drug companies are entirely blameless. If evidence proves that their employees or executives intentionally engaged in fraudulent behavior in connection with opioid abuse, those individuals should be held accountable. But the idea of making public company shareholders foot the bill for a public health crisis is so flaky and potentially counterproductive that it’s the sort of thing only a trial lawyer, or a politician, could have dreamed up.
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Addressing the opioid crisis on the front end with the Opioid Quota Reform Act (Opinion)
Mar 14, 2018 | The Hill
By SENS. RICHARD DURBIN (D-ILL.) AND JOHN KENNEDY (R-LA.)
Our nation is in the midst of an unparalleled opioid abuse crisis that is devastating communities of all sizes in every state. In 2016, more than 42,000 Americans died from an opioid overdose—more than 115 people each day. From Illinois to Louisiana and all of the states in between, we have met too many families who are coping with the devastation wrought by opioid abuse. From Congress to doctors, pharmacists to manufacturers, we must use every tool at our disposal to confront this epidemic.
While there are many factors that have caused this crisis, one factor that cannot be ignored is the enormous volume of legal opioids being manufactured each year. Fourteen billion opioid doses are now put on the market annually—enough for every adult American to have nearly a one month prescription of pills. The sheer volume of available opioids exceeds what is called for under current guidelines for medical use. And as powerful painkillers are aggressively marketed and prescribed at high rates, it heightens the risk for illicit diversion and abuse. For example, we know that four in five new heroin users first began their addiction with prescription painkillers.
While it is well-known for its critical role in disrupting illegal drug trafficking, it may come as a surprise to many that the Drug Enforcement Administration (DEA) also plays an important gatekeeper role when it comes to the production of opioids. DEA is responsible for setting annual quotas to determine the amount of schedule I and II controlled substances – such as oxycodone and hydrocodone – that can be manufactured each year. For years, DEA had approved significant increases in opioid quotas; for example, from 1993 to 2015, the aggregate production quota for oxycodone increased 39-fold. Such increases occurred largely because current law forces DEA to only consider limited factors when setting quotas. Those factors include things like past sales and estimated demand, but do not include such factors as diversion, abuse rates, or overdose deaths. Why should DEA not consider the downstream effects of the drugs it approves for production?
By making targeted changes to DEA’s quota-setting authority, we can help address the opioid crisis on the front end instead of simply reacting to the consequences of the flood of opioids on the back end in our communities. That’s why we have introduced the “Opioid Quota Reform Act,” a bipartisan bill to enhance DEA’s existing quota-setting authority to focus on preventing opioid diversion and abuse. Our legislation would direct DEA to consider additional factors, like diversion, abuse, overdose deaths, and public health impacts, when setting annual opioid quotas. It would also improve transparency in the quota-setting process and require DEA, if it approves any annual increase in opioid quotas, to explain publicly why the health benefits of the increase outweigh the potentially harmful consequences.
Successfully stemming the tide of the opioid abuse epidemic will require an all-hands-on-deck response. A common-sense place to start is at the beginning, by reforming DEA’s opioid quota process in a way that preserves access for legitimate medical use while strengthening the agency’s ability to sensibly and proactively adjust quotas in light of the epidemic we face. The “Opioid Quota Reform Act” can make a real difference that will save lives.
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House panel to examine 25 opioid bills next week
Mar 14, 2018 | The Hill
By Rachel Roubein
The House Energy and Commerce Committee plans to consider 25 bills aimed at combating the opioid crisis during a two-day legislative hearing next week.
The panel is working to hammer out a series of bipartisan bills with the goal of getting legislation to the House floor by Memorial Day.
The hearing next week focuses on an array of public health and prevention measures aimed at stemming an opioid crisis that shows no signs of abating.
Some of the bills focus on the Food and Drug Administration (FDA), such as one directing the agency to provide clearer data collection guidelines to help claims for products that could be used in place of an opioid.
Another would clarify the FDA’s authority to take into account misuse or abuse when approving an opioid.
On a call with reporters, a committee aide said FDA Commissioner Scott Gottlieb has been “highly engaged” in the process and met with panel Chairman Greg Walden (R-Ore.) and Health Subcommittee Chairman Michael Burgess (R-Texas).
Other bills include directing the Health and Human Services Department to create an electronic database on nationwide strategies to combat the opioid crisis, helping hospitals craft protocols for discharging patients who had an opioid overdose and more. Another measure aims to help the National Institutes of Health research nonaddictive medications for pain.
The hearing on the 25 bills is the second in the panel’s series on the opioid epidemic, the third of which will focus on insurance coverage and treatment. The first examined eight bills on patient safety and enforcement-related measures.
On the other side of the Capitol, a bipartisan group of eight senators released a follow-up to the Comprehensive Addiction and Recovery Act (CARA), dubbed CARA 2.0, in late February. The Senate Health Committee has been holding a series of hearings on the opioid epidemic and aims to craft legislation to combat the crisis.
The two chambers will have to combine their efforts to send it to the president’s desk.
A second committee aide pointed to a member day the panel had in October, saying many of the ideas for bills came from lawmaker suggestions there. The aide said “these bills and this process is a uniquely House process. We’re excited to see what the Senate and the administration are doing and we’re looking forward to working together with them.”
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Opioids: A Crisis Decades In the Making
Mar 15, 2018 | WebMD
By Sonya Collins
In 1980, Jane Porter and Hershel Jick published in a prominent medical journal the results of their study of pain among hospital patients.
These simple words about patients who took opioids would be used -- and misused – for decades:
“We conclude,” the doctors wrote in a letter to the editor, “that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction.”
Nearly four decades later, Jick said he regrets that he and Porter ever published their work. But they are hardly to blame for what would come.
Pain, Pills, and Death
An estimated 100 million Americans live with long-term pain. For decades, medicine’s overwhelming response has been prescription opioids like hydrocodone and fentanyl. Retail pharmacies dispensed more than 214 million opioid prescriptions in 2016. That’s more than 66 prescriptions for every 100 people and more prescriptions than any other country in the world.
In 2015, a reported 2 million Americans ages 12 and older were addicted to prescription pain relievers. In 2015 and 2016, nearly 117,000 Americans died from opioid overdoses. That’s more than the number of U.S. soldiers killed in the Korean, Vietnam, Iraq, and Afghanistan wars combined.
The numbers are so massive, they’re hard to comprehend. They have led dozens of cities and states, joined by the U.S. Justice Department, to sue opioid manufacturers and distributors as the federal government tightens regulations on opioid prescribing and calls the epidemic a public health emergency.
And it started with the mistaken idea that opioids were not addictive.
There’s plenty of blame to go around, from companies that used questionable marketing to make opioids the go-to for pain treatment, to the doctors who failed to change their habits even as patients’ bodies piled up, to the insurance companies that may not cover alternatives to opioids.
Because the drugs are so addictive, some patients, too, played a role in the crisis. Lax regulation and tracking allowed some to “doctor shop”: If one doctor refused to prescribe opioids, there’s another just down the street who might.
War on Pain
In their 1980 study, Jick and Porter wanted to find out whether hospital patients who received narcotics for acute pain for a short time became addicted to them. They reviewed the medical records of about 39,000 hospital patients. Nearly 12,000 of them received opioids while they were in the hospital. Four developed addiction to them. They reported their findings in a letter to the editor in the New England Journal of Medicine.
The patients that Porter and Jick observed “weren’t being treated with chronic opioid therapy for chronic pain, so the observation had no bearing at all on the risk of developing addiction” with chronic use, says Daniel Tobin, MD, medical director of Adult Primary Care at Yale-New Haven Hospital in New Haven, CT. He focuses on long-term pain management and opioid safety. “But this letter to the editor became doctrine.”
A study found that Porter and Jick’s five-sentence letter was cited 608 times in support of opioids. In 80% of those citations, the authors did not note that the patients received the drugs in the hospital.
A 1986 study in the journal Pain, which observed 38 patients, concluded again that opioid addiction was extremely rare.
“If we were talking about (blood pressure) medication, doctors would want rigorous evidence from long-term trials. We were ready to use opioids more freely before we had that data. I’d say physicians should take some of the responsibility,” says William Becker, MD, a core investigator in the Pain Research, Informatics, Multimorbidities & Education (PRIME) Center of Innovation at the VA Connecticut Healthcare System in West Haven, CT.
The ‘Fifth Vital Sign’
Around the same time, the medical community started paying more attention to the treatment of pain.
In the 1980s, the HIV epidemic called the medical profession’s attention to the under treatment of pain. “It triggered a worldwide outcry about the underutilization of opioids in the treatment of pain and how doctors needed to do a better job of treating chronic pain,” says Walter Ling, MD, a psychiatrist and founding director of the Integrated Substance Abuse Programs at the University of California-Los Angeles.
In 1996, increasing concern about untreated pain led the American Pain Society, a group of health care professionals and scientists that promote changes in public policy and medical practice to reduce pain-related suffering, to declare pain the “fifth vital sign.” That suggests it’s just as important for health care professionals to evaluate and address pain in every patient visit as it is to address the four common vital signs: temperature, pulse, breathing rate, and blood pressure.
While patients’ perception about their own pain is important, there is no test or instrument to verify it.
“Of course, pain is not a vital sign. There’s no objective test for it,” Tobin says. “We only have patients’ self-reports.”
That same year, Purdue Pharma released a new opioid prescription medication called OxyContin. In the 1998 OxyContin promotional video “I Got My Life Back,” targeted at doctors, a doctor explains that opioid painkillers are the best pain medicine available, they have few if any side effects, and fewer than 1% of people who use them get addicted.
OxyContin, originally sold in 80 milligram tablets, was appropriate, its label said, “for the management of moderate to severe pain where use of an opioid analgesic is appropriate for more than a few days.”
“The drug companies were ‘educating’ the doctors,” Ling says. “But there’s a very thin line between educating doctors and promoting your product.”
At the same time, drug reps were everywhere. They traveled from clinic to clinic, promoting their drugs while offering doctors gifts such as travel and lodging at expensive medical conferences in exchange for a visit to their booth. “They were literally throwing money at us,” says Joji Suzuki, MD, a psychiatrist who specializes in substance abuse at Brigham and Women’s Hospital in Boston. “These were the Wild West days when drug reps had free rein.”
Other Options Cheaper, Safer
Opioid painkillers aren’t the only pain medications available. They were just more aggressively marketed. Studies have shown that over-the-counter ibuprofen or a combination of ibuprofen and acetaminophen may treat pain better than opioids. Topical creams, certain antidepressants called SNRIs, and nerve pain medications such as gabapentin can ease chronic pain in some people, too. Other therapies, like yoga, acupuncture, physical therapy, and exercise, have also shown benefit for some.
While opioid manufacturers were “educating” doctors, American medical schools offered little or no training in the management of long-term pain. In 2010, only 1 in 5 American medical schools had any formal instruction on the topic. Among those, some schools required fewer than 5 hours of instruction. “In the absence of adequate education, pharmaceutical manufacturers stepped into the void with the message that long-term opioids were unquestionably safe and effective,” Becker says.
In 2003, the FDA warned the company its advertisements and promotional materials, which claimed OxyContin was less addictive than other opioids, were breaking federal law.
“The combination in these advertisements of suggesting such a broad use of this drug to treat pain without disclosing the potential for abuse with the drug and the serious, potentially fatal risks associated with its use, is especially egregious and alarming in its potential impact on the public health,” the agency wrote.
In 2007, the company agreed to pay $634 million to settle criminal and civil charges over its “long-term illegal scheme to promote, market and sell OxyContin,” according to an FDA press release issued at the time.
Today, Purdue Pharma publicly supports state and federal programs to fight the opioid epidemic, including encouraging prescribers to consult prescription-drug-monitoring program databases and repeating the CDC’s call to shorten the duration of first opioid prescriptions. The drug company distributed the CDC's guidelines to prescribers and pharmacists when they were first released.
“Our industry and our company have and will continue to take meaningful action to reduce opioid abuse,” the company says in a statement. The company says it supports efforts to limit the length of first prescriptions of opioids and vows to continue research into new, non-opioid pain medications.
But the horse was already out of the barn before the FDA’s warning to Purdue Pharma in 2003.
Both the Veterans Administration and the Joint Commission, the independent organization that accredits American hospitals, had also declared pain the fifth vital sign. Health care professionals took notice when, soon after, a doctor was fined $1.5 million for under treatment of pain in an 85-year-old patient who died of lung cancer. “Under treatment of pain became a form of malpractice, of medical abuse,” Ling says.
By 2006, the Centers for Medicare and Medicaid Services launched a patient-satisfaction survey that would affect how much reimbursement hospitals got. Among other questions, the survey asked patients whether their pain was well managed.
“It behoved hospitals to push opioids as much as they could to keep patients happy,” Becker says.
A Way Forward?
Though opioid prescribing is still high, it peaked in 2010 and has continued to fall. In 2014, there was a steeper decline in opioid prescriptions after new laws took effect that required patients to see their doctor every time they wanted a refill of certain painkillers, Jones says.
The requirement made it a little harder for people to get opioids, and it may have raised doctors’ awareness of how much of the medication their patients were taking.
As of October 2017, in response to comments from doctors, the U.S. Department of Health and Human Services no longer considers hospitals’ pain management scores on patient satisfaction surveys in its reimbursement decisions for Medicare and Medicaid patients. The agency also plans to take another look at pain management survey questions and may revise them, says Jones.
These policy changes are intended to cut prescribing but not end access to the drugs altogether. “There are patients who do benefit from opioids,” says Daniel Tobin, MD, medical director of adult primary care at Yale-New Haven Hospital in New Haven, CT. He focuses on long-term pain management and opioid safety. “For those patients who benefit without evidence of harm, you don’t need to just take it all away. I would hate to see the pendulum swing too far.”
But there is some evidence that the proverbial pendulum has already begun to swing too far, according to a recent article in The New England Journal of Medicine. “The increase in opioid-related mortality fueled by injudicious prescribing and increasing illicit use of both prescription and illegal opioids has led some clinicians to simplify their lives by discontinuing prescribing of opioid analgesics,” the authors of the article write.
The authors say that halting opioid prescribing altogether would cause patients to suffer and could push some to seek out illegal opioids, like heroin, on the street.
“We need to find a middle ground,” says Tobin, “where we’re being deliberate and careful about prescribing.”
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Opioid lawsuit filed on behalf of Limestone County
Mar 14, 2018 | The News Courier (AL)
By Staff
Beasley Allen law firm has filed its fourth lawsuit against opioid manufacturers and distributors on behalf of an Alabama city or county government, the firm announced Wednesday. This time, it's for Limestone County.
The Limestone County Commission passed a resolution Dec. 18 approving representation for the county in potential litigation against contributors to the opioid addiction crisis. The agreement is free to the county, and the firms that represent the county will retain 30 percent of any proceeds awarded by a judge.
Beasley Allen has previously filed lawsuits on behalf of the city of Greenville and Houston and Barbour counties in Alabama and Sumner County in Tennessee. The firm is also representing the state of Alabama in its lawsuit against Purdue Pharmaceuticals.
"Opioid abuse has reached epidemic proportions in the United States," Beasley Allen lawyer Rhon Jones said. "We are seeing a huge cost in human lives and a burdensome financial toll on communities struggling to battle the problem. Providing city and county resources to battle the opioid crisis causes local governments to take a huge financial hit, draining funds away from other critical government services and creating an ongoing financial burden."
A state-by-state health care analysis released in April 2015 estimated the cost of opioid abuse in Alabama to be more than $234 million.
In Limestone County, the Sheriff's Office has seen a rise in arrests for illegal possession of opioids.
Sheriff Mike Blakely told The News Courier in December many of those arrested with illegal opioids brought them into the county from somewhere else.
However, the costs to investigate opioid-related crimes, house those arrested for the crimes and deal with health care issues such as drug withdrawal symptoms or poor health related to opioid abuse falls on Limestone County. That cost is also rising.
In fiscal year 2015, the county's total inmate health care costs were $495,275. Two fiscal years later in 2017, those costs had risen to $566,982. The county is currently in its 2018 fiscal year.
The complaint filed by Beasley Allen alleges the marketing of these drugs contributed to the creation of the opioid epidemic.
"The conduct of these drugmakers and distributors is some of the most egregious I've ever seen," Athens lawyer John Plunk said. "Communities like ours are struggling to meet the challenges of caring for our citizens, who are the victims of the opioid epidemic and need services ranging from law enforcement assistance to medical care."
Limestone County will be represented by Plunk as well as Jones and Beasley Allen lawyers Rick Stratton, Will Sutton and Ryan Kral.
Headquartered in Montgomery, Beasley Allen is one of the largest plantiffs firms in the country and was named to Law360's Most Feared Plaintiffs Firms list in 2015. The firm had three of its 2016 verdicts, including talcum powder ovarian cancer litigation, included in the National Law Journal's Top 100 Verdicts.
Defendants include Purdue Pharma L.P.; Purdue Pharma Inc.; The Purdue Frederick Company Inc.; Teva Pharmaceutical Industries LTD.; Teva Pharmaceuticals USA Inc.; Cephalon Inc.; Johnson & Johnson; Janssen Pharmaceuticals Inc.; Ortho-McNeil-Janssen Pharmaceuticals Inc., now known as Janssen Pharmaceuticals Inc.; Janssen Pharmaceutical Inc., now known as Janssen Pharmaceuticals Inc.; Noramco Inc.; Endo Health Solutions Inc.; Endo Pharmaceuticals Inc.; Allergan PLC, formerly known as Actavis PLS; Watson Pharmaceuticals Inc., now known as Actavis Inc.; Watson Laboratories Inc.; Actavis LLC; Actavis Pharma Inc., formerly known as Watson Pharma Inc.; Mallinckrodt PLC; Mallinckrodt LLC; McKesson Corp.; Cardinal Health Inc.; and AmerisourceBergen Drug Corp.
The complaint is filed in the U.S. District Court for the Northern District of Alabama in Birmingham.
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Law firm files opioid lawsuit on behalf of Limestone County
Mar 14, 2018 | Decatur Daily (AL)
By Marian Accardi
Montgomery-based law firm Beasley Allen has filed a federal lawsuit on behalf of Limestone County against more than 20 opioid manufacturers and distributors.
The complaint alleges the marketing of these drugs contributed to creating the opioid epidemic.
Limestone County is represented by four Beasley Allen lawyers as well as Athens lawyer John M. Plunk, according to Beasley Allen.
A news release from Beasley Allen said this is the fourth lawsuit the firm has filed on behalf of an Alabama city or county government. The firm is also representing the State of Alabama in its opioid lawsuit against Purdue Pharmaceuticals, the release states.
The lawsuit was filed in the U.S. District Court for the Northern District of Alabama.
The Limestone County Commission voted 4-0 in December to retain Plunk to represent the county in a lawsuit seeking all civil remedies against companies in the chain of distribution of prescription opiates responsible for the opioid epidemic.
“We don’t know if we’ll get anything out of this,” County Commission Chairman Mark Yarbrough said at the time of the commission’s vote, “but maybe it’ll work as a deterrent.”
Yarbrough said there are no up-front costs to the county.
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City of Anniston joining fight against opioid crisis
Mar 15, 2018 | WAFF (AL)
By Staff
A local county government is joining the fight against the opioid crisis.
Beasley Allen filed its fifth lawsuit against opioid distributors and manufacturers on behalf of an Alabama city or county government on Wednesday. The complaint, which was filed on behalf of the city of Anniston, claims that the marketing of opioids has contributed to the creation of the epidemic and a public health and safety crisis.
“In addition to its huge toll on human life, the opioid epidemic has an economic cost of about $504 billion annually to communities throughout the country. Alabama has four cities in the top 15 in the nation with the highest rates of opioid abuse, including Anniston.” said Rhon E. Jones, the lawyer representing Anniston. He added, "Alabama has four cities in the top 15 in the nation with the highest rates of opioid abuse, including Anniston."
The lawsuit also claims that the local governments have taken a huge economic hit while battling the crisis.
Beasley Allen, which has five lawsuits for the state, is also representing Greenville, Houston County, and the State of Alabama
Three other Alabama cities, Gadsden, Montgomery, and Tuscaloosa, also rank in the top 15 in the nation with the highest rates of opioid abuse.
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West Virginia Towns Flood Opioid Companies With Lawsuits
Mar 15, 2018 | Charleston Gazette-Mail
By Lacie Pierson
The governing bodies of nine towns and two counties in West Virginia have filed lawsuits alleging drug manufacturers and distributors failed to follow state and federal law to prevent the distribution and abuse of prescription pain medication thorough the Mountain State.
The 11 lawsuits filed in U.S. District Court of Southern West Virginia this week range throughout the state, from Parkersburg along the Ohio River to three towns in Greenbrier County in the east and as far south as Logan.
The lawsuits are the latest string of legal actions taken by local governments to hold the companies accountable for the opioid epidemic.
Each lawsuit names as defendants different drug companies and pharmacy chains that service those communities.
Among the defendants are drug companies named in previous suits filed by other local governments in the state. They include AmerisourceBergen Drug Corporation, Cardinal Health, McKesson Corproation, H.D. Smith Wholesale Drug Co., and The Harvard Drug Group.
Each local government claims the pharmaceutical companies failed to comply with laws requiring them to monitor, detect, investigate, refuse and report suspicious orders of prescription opiate medications.
That failure to comply with the laws led to millions of prescription opiates being distributed largely unchecked in the affected communities, leading to the rise of the opioid addiction epidemic in the state.
The cities and towns filing suit this week were Quinwood, Rupert and Rainelle, all in Greenbrier County, Milton, Smithers, Sutton, Logan, Summersville and Parkersburg. The county commissions for Nicholas and Braxton counties also filed lawsuits in federal court.
Between 2007 and 2012, 40 million prescriptions of opiates, mostly hydrocodone and oxycodone, were distributed in and around the city of Milton in Cabell County. During that time frame, Milton's population was between 2,300 and 2,500, according to the U.S. Census Bureau.
In a news release, Tom Skaggs, mayor of Smithers, said city officials were making every effort to combat the opioid epidemic.
"Considering the opioid distributors are flooding our state and city with these drugs, I feel it necessary to join the other suits to make these companies aware that we will not tolerate this action any longer," Skaggs said in the release.
Each local government is seeking damages to remedy the impact of the opioid epidemic as well as a form of compensation for the strain on municipal and county resources, including police, fire and emergency service workers who treat those suffering from opioid addiction and respond to other related calls for help.
The plaintiffs are represented by Rusty Webb of Webb Law Centre in Charleston, and John Hurst of Motley Rice in Morgantown, according to court records.
U.S. District Judge John Faber will preside over the cases.
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Barbour leaders join opioid lawsuit
Mar 15, 2018 | The Inter-Mountain (WV)
By Brooke Binns
The Barbour County Commission has voted to take part in an opioid lawsuit, joining legal action taken by several other counties across the state.
Commission President Phil Hart said he believes the opioid epidemic is affecting communities in Barbour County.
“It was brought to our attention that over a time period of 2007 to 2012, there were over 5 million opium pills distributed in Barbour County,” Hart said. “When those numbers were brought to the commission, we just couldn’t believe it.”
A complaint filed by Mullens and Mullens PPLC, counsel for Barbour County Commission, reads, “Within the last 20 years a scourge infected this country in the form of a public health epidemic caused by widespread addiction to opioids like Oxycontin and Percocet, as well as generic forms of oxycodone and hydorcodone.
“During the creation and inflation of this epidemic, the Manufacturer (sic) and Distributor Defendants (sic) as defined herein, knew of the dangerously addictive qualities and high rates of loss and misappropriation (“diversion rates“) of their drugs. These actors profitably staged themselves to play a significant role in creating a public nuisance of historic proportions,” the order continues.
Hart added he believes cases related to opioids have an adverse effect on the county, emphasizing cases related to opioids are affecting the judicial system.
“It affects the finances, because there are people coming into the regional jail, which costs the county $48.50 per day for one individual. … It affects our school systems, and our judicial system is overwhelmed,” he said. “There has been legislation passed this year for another judge to be added to Barbour and Taylor counties. … The abuse and neglect cases have just about doubled, which has taken up much of the time of the circuit judge, and our law enforcement — so many crimes are stemming back to drugs.”
The complaint also states the “misuse, abuse and overdose of prescription pain pills” has and will continue to “destroy lives, ruin state and local economies, and forever alter the welfare of citizens of Barbour County.”
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Bossier first parish to file opioid suit in Louisiana, joining nationwide trend
Mar 14, 2018 | Shreveport Times (LA)
By Nick Wooten
Bossier Parish has filed a federal lawsuit against drug companies, joining a nationwide trend of local governments seeking payouts for costs allegedly incurred by taxpayers to deal with the opioid crisis plaguing the nation.
The lawsuit mirrors those filed in other jurisdictions nationally. The Bossier Parish lawsuit, filed Dec. 29, has been moved from U.S. District Court in Shreveport to Ohio, where all the lawsuits nationally are being consolidated.
Bossier Parish was the first parish in the state to file, The Advocate reports.
In the suit, attorneys representing the parish accuse manufacturers and distributors of "operating a continuous criminal empire in violation of federal and state law" that "engaged in a pattern of racketeering activity."
"In broad brush strokes, what is happening is this epidemic did not happen on its own," said John Young, an attorney apart of the team representing various Louisiana parishes in opioid suits.
The lawsuit accuses the defendants of developing a well-funded marketing scheme to spread false and deceptive messages about the benefits and risks of long-term opioid use to both doctors and patents.
The defendants used direct marketing and unbranded advertising to promote the drugs. Unbranded advertising was put out by third parties because it is not submitted to or typically reviewed by the FDA, the suit alleges.
"These deceptive statements were not only unsupported by or contrary to scientific evidence, they were contrary to pronouncements and guidance from the United States Food and Drug Administration and the Centers for Disease Control and Prevention," the suit alleges.
Further, the suit alleges that the companies fraudulently concealed the harm of opioids, overstated their benefits, and failed to monitor, report and prevent suspicious orders.
The parish is seeking relief for costs related to opioid addiction, such as providing medical care, including for overdoses and deaths; treatment, counseling and rehabilitation services; and law enforcement and public safety.
The suit estimates that opioid misuse and addiction costs governments $78.5 billion a year, which accounts for health care costs, lost productivity, addiction treatment and criminal justice expenses, the suit states.
Bossier's opioid prescribing rate is 95.3 prescriptions per 100 people, according to data from the Centers for Disease Control.
Bossier's suit is now part of a multi-district litigation being heard in Ohio with similar cases from states and territories across the nation including New York, Minnesota and Puerto Rico.
Multi-district litigation is a special federal procedure designed to streamline pretrial proceedings by joining similar cases into one action, according to the American Bar Association.
"This judge has taken a very aggressive approach," Young said. "He's basically said that he's leaving 2018 open for discovery and settlement discussions. His plan is to start setting trials in 2019."
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St. Louis County files lawsuit against opioid manufacturers
Mar 14, 2018 | Duluth News Tribune (MN)
By Staff
St. Louis County on Wednesday filed its civil lawsuit against multiple opioid drug manufacturers alleging a “widespread campaign of unfairly, deceptively, and fraudulently marketing and promoting opioids” in violation of Minnesota Law.
St. Louis County Attorney Mark Rubin said he filed the suit, in the works for months, against Purdue, Teva, Janssen and Endo enterprises.
The ten-count complaint includes claims arising under Minnesota’s public-nuisance statute, False Claims Act, Prevention of Consumer Fraud Act, false-advertising statute, Unlawful Trade Practices Act, and Uniform Deceptive Trade Practices Act, as well as state-law claims for fraud, negligence, gross negligence and unjust enrichment.
The lawsuit was approved in November by the St. Louis County Board. The suit asks for damages, penalties and an injunction prohibiting future violations.
The case is similar to hundreds of other cases filed by states and local governments across the country in response to the opioid epidemic, with government officials alleging the companies knew their products were being aimed at vulnerable adults and were causing addiction that spurred massive social costs, including medical, law enforcement, social service and prison costs as well as premature deaths.
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Marion County to sue drug companies over opioid crisis
Mar 14, 2018 | Marion Star (OH)
By Sarah Volpenhein
Marion County will likely number among dozens of other counties and cities across the state that are suing pharmaceutical companies for their role in the opioid crisis.
The Marion County Commissioners passed a resolution last week allowing the county to take legal action against drug manufacturers and distributors and joining with the Marion County Prosecutor in asking a judge for permission to hire an outside law firm to handle the lawsuit.
"It's a disease now. We've got to do something about it or we're going to be in bad shape," said Marion County Commissioner Ken Stiverson. "Just another tool to use in the correction of addiction."
Marion County Common Pleas Court Judge William Finnegan said he has given his approval for the county to hire outside counsel for the suit.
The county intends to hire Greene, Ketchum, Farrell, Bailey and Tweel, a West Virginia-based law firm that represents numerous counties and cities in suing drug companies.
“It’s rather a specialized area of law and quite simply the prosecutor’s office doesn’t have anyone that has experience in that area,” Finnegan said when explaining why he gave the go-ahead to hire outside counsel.
Marion County has not filed anything yet. The lawsuit would be filed in U.S. District Court for the Northern District of Ohio.
The county would not pay any legal fees unless there is recovery, such as monetary damages, as a result of the lawsuit, according to the resolution passed by the county commissioners.
Hundreds of counties and cities across the state and country have filed lawsuits against pharmaceutical companies, seeking damages for the financial burden that the opioid crisis has placed on local governments and seeking to abate the opioid epidemic.
Among those counties is neighboring Morrow County, whose county commissioners filed a 171-page complaint in December against numerous drug manufacturers and distributors, including Purdue Pharma, Cephalon and Cardinal Health.
The Morrow County Commissioners also are represented, in part, by Greene, Ketchum, Farrell, Bailey and Tweel. Their lawsuit alleges that opioid manufacturers "aggressively pushed highly addictive, dangerous opioids, falsely representing to doctors that patients would only rarely succumb to drug addiction" and that prescription drug makers "aggressively advertised to and persuaded doctors to prescribe highly addictive, dangerous opioids and turned patients into drug addicts for their own corporate profit."
The Morrow County suit alleges the companies were negligent, committed fraud and were involved in racketeering and corrupt and deceptive practices.
In Marion County, there were 28 drug overdose deaths in 2016, according to the counts by the Marion County Coroner's Office. That was the second-highest total since the opioid crisis began, surpassed only in 2014, when 29 people died of drug overdoses by the county coroner's count.
Marion County Commission President Kerr Murray said the commissioners decided to go forward with the lawsuit on the advice of the county prosecutor’s office.
“All in all, it probably would be some financial consideration for the problems that the opioid problem has caused,” Murray said.
The litigation will likely takes years. The county commissioners do not anticipate seeing any money out of the suit anytime soon, but Stiverson said any money from the suit would likely go toward something to do with addiction, though that would depend on the needs of the time.
“It’ll probably be some time before we ever see anything,” he said, adding that the pharmaceutical companies would not give in without a lengthy fight.
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South Bend plans to file federal lawsuit against opioid manufacturers
Mar 15, 2018 | South Ben Tribune (IN)
By Staff
South Bend is the latest among dozens of cities and counties across Indiana announcing plans to sue opioid manufacturers and distributors, accusing them of being a major contributing factor to the state's opioid epidemic.
Mayor Pete Buttigieg briefly mentioned taking legal action Tuesday during his state of the city speech. The city confirmed Wednesday it had signed an agreement with an outside firm to represent South Bend in its federal lawsuit. The city would not name the law firm it is working with.
Marshall and LaPorte counties have already filed lawsuits in federal court and St. Joseph County has also announced plans to file a lawsuit. Similar lawsuits are not only increasing across Indiana, but around the U.S. as well.
The lawsuits are seeking financial restitution for the increased costs cities and counties are facing to address the opioid crisis. Opioid manufacturers are being accused of deliberately misleading the public about the high risk of addiction to opioids and telling doctors the narcotics were a safe treatment option for long-term treatment of chronic pain.
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Mar 14, 2018 | The Daily Mining Gazette (MI)
By Garrett Neese
Houghton County has joined a mass-action lawsuit against opioid manufacturers.
The County Board Tuesday approved participating in the suit after tabling the matter in February so commissioners could review information on the issue.
At February’s board meeting, attorneys Mark Bernstein of the Sam Bernstein Law Firm of Farmington Hills and Paul Novak of the Detroit office of Weitz & Luxenberg gave a presentation on the suit.
The suit would seek monetary compensation for the damage done to the county, Bernstein said. It would also demand the court order the companies to add practices that will limit the diversion and misuse of the product and how they are marketed.
In Houghton County, there have been 80 prescriptions per year for every 100 people, Bernstein said.
County Administrator Eric Forsberg said the county can include costs such as cases where residents were hospitalized last year and sent to detox.
The county would also be able to count the cost of a new drug detective hired by Upper Peninsula Substance Enforcement Team West.
In all likelihood, Forsberg said, Houghton County’s case will not go to trial. Instead a selection of test cases will be chosen as stand-ins for subsets of the participating municipalities (such as rural or urban). Those verdicts will be used to project amounts for the other participants.
“I don’t know how finite they want us to get, but they would assist us in identifying those costs,”Forsberg said.
After direct costs are deducted, the county would receive 70 percent of the money, with the lawyers receiving the other 30 percent.
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Tribe in Oklahoma sues opioid manufacturers, distributors
Mar 14, 2018 | Associated Press
By Staff
A tribe in Oklahoma has filed a lawsuit accusing 26 drug manufacturers and distributors of contributing to the tribe’s opioid epidemic by fraudulently misrepresenting the risks and benefits of addictive painkillers.
The lawsuit filed by the Ponca Tribe Tuesday is similar to a number of other lawsuits against opioid manufacturers and distributors nationwide, The Oklahoman reported.
The lawsuit alleges that opioid manufacturers and distributors “flooded the market with false declarations designed to convince doctors, patients and government entities that prescription opioids posed a low risk of addiction.” It alleges those false claims have resulted in an opioid epidemic, with 1 in 10 Native Americans over the age of 12 using prescription pain medicine for nonprescriptive purposes.
“Virtually every tribal member has been adversely impacted by the opioid epidemic,” the tribe said. “This epidemic has been growing for years and the effects of this crisis have only been exacerbated by defendants’ efforts to conceal and minimize the risks of opioid addiction.”
The tribe is seeking a jury trial and an injunction that prohibits drug manufacturers and distributors from engaging in “unfair or deceptive practices.”
Drug manufacturers listed as defendants said opioid abuse is a serious health issue, but deny wrongdoing.
“Our actions in the marketing and promotion of these medicines were appropriate and responsible,” said Jessica Castles Smith, spokeswoman for Janssen Pharmaceuticals Inc. “The labels for our prescription opioid pain medicines provide information about their risks and benefits, and the allegations made against our company are baseless and unsubstantiated.”
John Puskar, director of public affairs for Purdue Pharma LP, said his company also denies the allegations made against it and looks forward to presenting its defense.
“As a company grounded in science, we must balance patient access to FDA-approved medicines, while working collaboratively to solve this public health challenge,” Puskar said.
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Calling opioids a ‘public nuisance,’ Androscoggin County joins nationwide lawsuit
Mar 14, 2018 | Sun Journal (ME)
By Steve Sherlock
After last month joining a growing list of Maine municipalities and counties that are part of a nationwide lawsuit against opioid manufacturers, Androscoggin County commissioners passed an order claiming the opioid epidemic is a public nuisance.
The order, requested by the attorneys representing communities throughout the country, puts the county on record saying that the growing epidemic is affecting county resources, including enforcement, treatment and the high cost of lives.
“It makes sense that if we join the lawsuit that we need to recognize that it is a problem to have standing,” Commissioner Noel Madore of Lewiston said during last week’s meeting.
Maine saw a record 418 people die from opioid overdoses in 2017, an 11 percent jump from the previous year’s 376 deaths, according to the Maine Attorney General’s office.
The motion declaring “the opioid epidemic and its effects on the county are a public nuisance” passed by a 4-2 vote, with Isaiah Lary of Wales and Bonney Starbird of Auburn voting against the order.
Androscoggin County joins several Maine municipalities that have already signed on to the lawsuit, including Lewiston, Auburn, Portland, Bangor, Biddeford, Saco, Sanford and Waterville. Kennebec County will consider signing on later this month.
The county retained the New York law firm of Napoli Shkolnik, which is spearheading the nationwide lawsuit being filed by hundreds of communities.
Napoli Shkolnik has partnered with the Auburn firm of Trafton, Matzen, Belleau and Frenette to help represent its Maine clients.
Lary had concerns about being part of the lawsuit. He wondered why opioid manufacturers were being singled out. He felt a similar case could be made against the alcohol industry and other vices. He wondered why the county isn’t also suing them.
In addition, Lary feared the county was opening itself up to libel by joining the suit.
‘I’d like to see it in writing that we’re not liable,” Lary said.
After Lary asked to spend legal fees to have the county’s own lawyer look over the agreement, commissioners voted to end discussion and adopted the order.
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Mar 15, 2018 | Sioux Falls, SD
By KSFY (ABC)
Video Link: http://app.criticalmention.com/app/#clip/view/33597934?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3
Rough Transcript: south dakota attorney general marty jackley has filed a lawsuit against three prescription drug manufacturers for deceptively marketing opioidmedications. jackley filed the civil colaint in state court agains purdue pharma -- endo health solutions -- and janssen pharmecuticals. the lawsuit alleges the drug companies broke state deceptive trade and medicaide fraud laws -- and spread false information about the risks and benefits of opioids. 13:55:35 they have created a public nuisance public health nuisance and what the law requires is that if you create tat you have to abate i or fix it. the state is seeking damages -- civil penalties --nd an end to any current unlawful promotion of opioids. nearly 6-hundred thsand opioidprescriptions were witten in south dakota just last year.
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Mar 15, 2018 | Sioux Falls, SD
By KDLT (NBC)
Video Link: http://app.criticalmention.com/app/#clip/view/33597948?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3
Rough Transcript: the state is among the latest to go after the makers and sellers of prescription painkillers. the attorney general's office has filed a civil lawsuit against three major manufacturers --purdue, endo and janssen. jackley alleges the three were deceptive in their marketing tactics and sale of prescription opioids. and that's fueling addiction. when people can no longer get a prescription... some turn to the black market for illegal drugs. "everyday people in south dakota are suffering from this opioid epidemic and we can't continue to wait. i believe that these particular manufacturers knew exactly what they were doing." jackley also announced a settlement with major tobacco companies worth 27 and a half million dollars. that money will be used towards education in south dakota. jackley's office says the settlement avoids decades of potential alaska and north dakota this week also announced settlements for $26 million and $34 million. new statistics show overdose deaths in native american communities have skyrocketed in the time the opioid epidemic has swept the u.s... federal data shows native americans and alaska natives saw a fivefold increase in overdose deaths between 1999 and 2015. the u.s. senate committee on indian affairs held a hearing on wednesday as a growing number of tribes file lawsuits against drug manufacturers and distributors, saying they misrepresented addiction risks.
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Mar 15, 2018 | Sioux Falls, SD
By KELO (CBS)
Video Link: http://app.criticalmention.com/app/#clip/view/33597965?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3
Rough Transcript: the south dakota attorney general's office announced a civil lawsuit yesterday against three prescription drug manufactures. the lawsuit accuses purdue, endo and janssen of using deceptive marketing and sales of prescription opioids. "their misrepresenta tion of the risks and the benfits of opioids, and their conduct in trying to conceal that information," said jackley. jackley says it's a big issue for the state, and he believeshese companies have misled medical professional he says they should be held responsible for fixing the opioid problem across the ountry. the lawsuit demands manufacturs stop tir unlawful promotion of opioids and correct their misrepresentations.
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Mar 15, 2018 | Rapid City, SD
By KOTA (ABC)
Video Link: http://app.criticalmention.com/app/#clip/view/33597990?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3
Rough Transcript: south dakota attorney general marty jackley has filed a lawsuit against several prescription drug manufacturers for deceptively marketing opioidmedications. jackley filed the civil complaint wednesday against purdue pharma, endo health solutions and janssen pharmaceuticals. the lawsuit alleges the drug companies broke state deceptive trade and medicaid fraud laws and created a public nuisance by spreading false information about the risks and benefits of opioid medications. the defendants didn't immediately return requests for comment.
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Mar 15, 2018 | Milwaukee, WI
By WISN (ABC)
Video Link: http://app.criticalmention.com/app/#clip/view/33598006?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3
Rough Transcript: state of addiciton. milwaukee county takes on the makers of opioids. the county has filed a lawsuit against 13 opioid manufacturers and distributors. the lawsuit argues the drug makers push the pills to doctors and patients while the distributors don't do enough to monitor the drugs. >> our community has simply had enough. it's hard to go on offense. -- because of their lies and wrongdoing. andy: a record 336 people died from drug overdoses in milwaukee county in 2017, a majority of which involved opioids.
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Mar 15, 2018 | Milwaukee, WI
By WITI (Fox)
Video Link: http://app.criticalmention.com/app/#clip/view/33598041?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3
Rough Transcript: milwaukee county.... accusing drug companies of having blod on their hands... and now it's suing them. angelica reports the county is seeking money to deal with the opioid epidemic. milwauke county sues 13 drug companies. sayin the they have blod on their hands because of the opioid epidemic. county officials have hired four law firms to help in the case. the suit was filed in federal court on wednesday. milwaukee county is suing both drug manufacturers and distributors. it is time to go on ofense and force the drug companies to folow the law and pay for the damages that we have incured :47 because of their lies and wrongdoing :49 the lawsuit is separate from 64 other wisconsin counties hat have joined forces. milwaukee county's top lawyer says that's because milwauke has some unique challenges because of the opioid epidemic. read more from the entire lawsuit filed by the county - chck it out on our home page on fox6 now dot com.
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WSBT News First Thing in the Morning
Mar 15, 2018 | South Bend, IN
By WSBT (CBS)
Video Link: http://app.criticalmention.com/app/#clip/view/33598044?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3
Rough Transcript: south bend is the latest city.. announcing plans to sue opioid manufacturers and distributors. the lawsuit.. accuses those companies of being a major contributing factor to the state's opioid epidemic. according to our reporting partners at the south bend tribune.. city officials.. confirmed it has signed an agreement with an outside firm to represent south bend in a federal lawsuit. the lawsuit is seeking financial restitution for the increased costs.. being faced.. to address the opioid crisis.
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KBJR 6 and Range 11 News Today
| Duluth, MN
By KBJR (NBC)
Video Link: http://app.criticalmention.com/app/#clip/view/33597967?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3
Rough Transcript: saint louis county has officially filed a lawsuit against companies who have promoted opioids in violation of minnesota law. the defendants will involve drug companies affiliated with teva... janssen... endo... and purdue. authorities say the ten-count complaing includes claims under the state s public- nuisance statute... prevention of consumer fraud act...the false-advertising statute... among others. the county is looking for relief in damages... penalties... and an injunction prohibiting future violations. the saint louis county attorney s office says the case is similar to hundreds of other cases filed by states and local governments across the country as a response to the opioid epidemic.
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Mar 15, 2018 | Tulsa, OK
By KOKI (Fox)
Video Link: http://app.criticalmention.com/app/#clip/view/33598157?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3
Rough Transcript: the ponca tbe is suing 26 drug makers for their role in the opioid epidemic.the lawsuit claims opioid addictiohas caused the tribe to suffer losses to social serves and has hurt the health and welfare of their peop.the lawsuit says the drug manufacturers pushed prescription opioid use-- through the use of large-scale marketing. more details-- other tribes are sing over the same thing. we told you last month when the cherokee nation áre-filedá their lawsuit-- after a federal judge ruled the tribe's court system did not have jurisdiction over opioid distributors.the new lawsuit was filed in january-- naming several major companies.
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Mar 15, 2018 | Huntsville, AL
By WAFF (NBC)
Video Link: http://app.criticalmention.com/app/#clip/view/33598174?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3
Rough Transcript: beasley allen has filed its fifth lawsuit against opioid manufacturers and distributors on behalf of the city of anniston and limestone county. the complaint alleges the marketing of opioids has contributed to the current opioid epidemic, and is a public health and safety crisis. the firm also is representing the state of alabama in its opioid lawsuit against purdue pharmaceuticals. alabama has four cities in the top 15 in the nation with the highest rates of opioid abuse, including anniston. they are gadsden, montgomery, and tuscaloosa.
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Mar 15, 2018 | Washington, DC
By WJLA (ABC)
Video Link: http://app.criticalmention.com/app/#clip/view/33598183?token=0c0ea847-9cb3-42b3-a548-828fe87f95e3
Rough Transcript: the city of alexandria suing drug manufacturers about the opioid crisis in america. that lawsuit and one in dickenson county are the first of their kind in virginia. they seek $150 million in damages. we will keep track of the suits as they move through the courts.
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