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Opioid Litigation Daily Media Report - 4/5/18

Commentary and FYIs

Speculative lawsuits aren't the cure for opioid addiction (Opinion)
Apr 5, 2018 | The Hill
By Robery Henneke & Chance Weldon

The opioid problem is at a crisis level, but targeting pharmaceutical companies because of their deep pockets may enrich a few, but will fail to benefit many. Recently, personal injury lawyers have been chasing Texas counties to file lawsuits on a contingent fee basis against pharmaceutical manufacturers for the cost of dealing with opioid abuse. The basic theory in these cases is that pharmaceutical manufacturers and distributors are to blame for the opioid crisis and that taxpayers have had to shoulder the costs of paying for people living with addiction.
Blood Money: A New Foundation From Big Pharma Tackles Opioids (Opinion)
Apr 5, 2018 | Inside Philanthropy
By Paul Karon & David Callahan

When a profit-thirsty global corporation causes a devastating public health crisis, what should we think when it steps forward with a philanthropic pledge to address that crisis? Nothing good.
With the drug industry as its partner, an addiction policy group invites tough questions
Apr 5, 2018 | STAT News
By Lev Facher

Jessica Hulsey Nickel had only just begun to speak at a House hearing last month when a man in the back corner of the committee room stood, unfurling a paper banner and shouting toward the witness stand.
Drug Marketing and Advertising Under Fire
Apr 4, 2018 | PharmaExec.com
By Jill Wechsler

Even though Scott Gottlieb challenged FDA restrictions on truthful communications about regulated products as a private commentator on pharma policy, he is taking a more measured approach to expanding off-label promotion as FDA commissioner. A high-level FDA working group is “taking a hard look” at how the First Amendment relates to FDA policy, exploring what the agency can to do to “refresh” and bring more “clarity” to its regulations, commented chief counsel Rebecca Wood at the DIA advertising and promotion conference in March.
Fred Goldenberg: Fixing opioid crisis isn’t easy (Opinion)
Apr 4, 2018 | Traverse City Record Eagle (MI)
By Fred L. Goldenburg

According to the Centers for Disease Control and Prevention (CDC) the 10 leading causes of death in the U.S. are now heart disease, cancer, unintentional injuries, chronic respiratory diseases, stroke, Alzheimer’s disease, diabetes, the flu, kidney disease and suicide.
FDA Head Puts Spotlight On Internet's Role In Opioid Crisis
Apr 4, 2018 | Law360
By Emily Field

The head of the U.S. Food and Drug Administration on Wednesday said internet service providers and social media companies should join the fight against the opioid crisis by cracking down on illegal online sales of drugs like fentanyl that are fueling the epidemic.
Attorney General Leslie Rutledge in spat with cities and counties over opioid lawsuits
Apr 5, 2018 | Arkansas Times (AR)
By David Ramsey

Attorney General Leslie Rutledge this week filed an emergency petition to the state Supreme Court asking that a prosecuting attorney representing the state be mandated to withdraw from a lawsuit filed against opioid makers and distributers by a coalition of cities and counties.
Laxalt met with top trial attorney over possible opioid litigation, months before local governments pushed for separate lawsuit
Apr 5, 2018 | The Nevada Independent (NV)
By Riley Snyder

Attorney General Adam Laxalt met with an influential personal injury attorney over potential litigation against opioid manufacturers, months before criticizing a municipality for partnering with the same firm.
Surgeon general urges more Americans to carry opioid antidote naloxone
Apr 5, 2018 | CNN
By Susan Scutti & Robert Jimison

The US surgeon general issued an advisory Thursday recommending that more Americans carry the opioid overdose-reversing drug, naloxone.
Justice Department offers its help to move opioid settlement talks forward
Apr 4, 2018 | FiercePharma
By Eric Saganowsky

After settlement talks hit a snag last month in closely watched national prescription opioid litigation, the federal government is hoping to offer its assistance to move the negotiations forward. The Department of Justice has filed a motion to participate in settlement talks as a "friend of the court."

Southwest (OK, NV)

Las Vegas may sue opioid makers
Apr 4, 2018 | Las Vegas Review Journal (NV)
By Jaime Munks

The city of Las Vegas may join the legal fight against opioid manufacturers to recoup dollars spent on battling the addictive drugs.
Okla. Tribe Says Drug Cos. Played Major Role In Opioid Abuse
Apr 4, 2018 | Law360
By Andrew Westney

Walmart, Purdue Pharma LP, McKesson Corp., CVS Health Corp. and other drug manufacturers, distributors and pharmacies have played a major role in worsening opioid abuse among tribe members, the Muscogee (Creek) Nation alleged in a complaint filed in Oklahoma federal court Tuesday.

Southeast (NC, FL, GA)

Scotland County set to join lawsuit against opioid companies
Apr 4, 2018 | WPDE (NC)
By Tonya Brown

Scotland County Board of Commissioners approved joining a lawsuit with other counties this week against opioid manufacturers and distributors, according to Scotland County Manager Kevin Patterson.
Five behavioral health agencies in Florida file lawsuit against
Apr 5, 2018 | WCTV (FL)
By Jake Stofan

Five of Florida’s seven behavioral health managing agencies are joining the wave of lawsuits against big pharma for its part in the opioid crisis.
BOC to join opioid lawsuit
Apr 4, 2018 | Jackson Herald Today (GA)
By Staff

Jackson County could soon join other Northeast Georgia communities in a class-action lawsuit against opioid manufacturers and distributors.

Northeast (MA)

Chilmark selectmen vote to join opioid suit
Apr 4, 2018 | MV Times (MA)
By Rich Saltzburg

On the recommendation of selectman Jim Malkin, Chilmark selectmen voted unanimously to join a Kopelman and Paige lawsuit against opioid manufacturers.

West (WY)

Northern Arapaho Tribe Sues Opioid Companies
Apr 4, 2018 | Wyoming Public Media
By Melodie Edwards

The Northern Arapaho Tribe on the Wind River Reservation has filed a lawsuit against some of the country’s biggest opioid manufacturers and distributors.

Broadcast Media Coverage

Good Day Arkansas
Apr 5, 2018 | Little Rock, AR
By KLRT (Fox)

Video Link: https://app.criticalmention.com/app/#clip/view/34035687?token=8d200d57-6e57-4acb-b012-5011406fe507
KARK 4 Today
Apr 5, 2018 | Little Rock, AR
By KARK (NBC)

Video Link: https://app.criticalmention.com/app/#clip/view/34035778?token=8d200d57-6e57-4acb-b012-5011406fe507
NewsChannel 2 at Sunrise
Apr 5, 2018 | Utica, NY
By WKTV (NBC)

Video Link: https://app.criticalmention.com/app/#clip/view/34035810?token=8d200d57-6e57-4acb-b012-5011406fe507
Daybreak - Early
Apr 5, 2018 | Little Rock, AR
By KATV (ABC)

Video Link: https://app.criticalmention.com/app/#clip/view/34035850?token=8d200d57-6e57-4acb-b012-5011406fe507
NBC 2 News Today at 5am
Apr 5, 2018 | Ft. Myers, FL
By WBBH (NBC)

Video Link: https://app.criticalmention.com/app/#clip/view/34036434?token=8d200d57-6e57-4acb-b012-5011406fe507
6 News at 11
Apr 4, 2018 | Lansing, MI
By WLAJ (ABC)

Video Link: https://app.criticalmention.com/app/#clip/view/34036959?token=8d200d57-6e57-4acb-b012-5011406fe507
KOCO 5 News at 6pm
Apr 4, 2018 | Oklahoma City, OK
By KOCO (ABC)

Video Link: https://app.criticalmention.com/app/#clip/view/34037385?token=8d200d57-6e57-4acb-b012-5011406fe507
KELOLAND News at Five
Apr 4, 2018 | Rapid City, SD
By KCLO (CBS)

Video Link: https://app.criticalmention.com/app/#clip/view/34037410?token=8d200d57-6e57-4acb-b012-5011406fe507
WALB News 10 at 6
Apr 4, 2018 | Albany, GA
By WALB (NBC)

Video Link: https://app.criticalmention.com/app/#clip/view/34037497?token=8d200d57-6e57-4acb-b012-5011406fe507
Fox 5 News at 1:00pm
Apr 4, 2018 | San Diego, CA
By KSWB (Fox)

Video Link: https://app.criticalmention.com/app/#clip/view/34037671?token=8d200d57-6e57-4acb-b012-5011406fe507

Commentary and FYIs

Speculative lawsuits aren't the cure for opioid addiction (Opinion)

Apr 5, 2018 | The Hill

By Robery Henneke & Chance Weldon

The opioid problem is at a crisis level, but targeting pharmaceutical companies because of their deep pockets may enrich a few, but will fail to benefit many. Recently, personal injury lawyers have been chasing Texas counties to file lawsuits on a contingent fee basis against pharmaceutical manufacturers for the cost of dealing with opioid abuse. The basic theory in these cases is that pharmaceutical manufacturers and distributors are to blame for the opioid crisis and that taxpayers have had to shoulder the costs of paying for people living with addiction.
The more basic theory is this: personal injury trial lawyers have pitched county judges and commissioners on a get-rich-quick scheme — hire us to sue and your county may receive millions from these wealthy companies without costing the counties a nickel. What is missing from these discussions is how any court judgment or settlement will benefit the thousands stuck in the abyss of addiction.
First, it’s just a bad legal theory. To recover damages, the counties would have to show that opioid manufacturers were negligent, and that their negligence was the primary cause of the problem. But all opioids on the market have to first be approved by the Federal Food and Drug Administration — an expensive, exhaustive, multiyear process — and then prescribed by a state-licensed physician.

It is difficult to argue that a manufacturer objectively “should have known” that opioids were too dangerous for consumption when all the relevant state and federal authorities have held that the product is safe. Indeed, Texas law provides a heavy presumption that manufacturers are not liable for harms arising from a product or medicine that complies with state and federal regulations.
Second, this sort of litigation sets a dangerous precedent.Since the era of the common law, courts have held that manufacturers are not be liable for injuries arising from the clear misuse of their products. For example, baseball bats are used to commit numerous violent crimes every year, but the Louisville Slugger company is not held financially liable for injuries caused when its bats are used for assaults, because bats are not inherently dangerous, even though they may become so if used improperly.
Similarly, there is nothing inherently evil about opioids. When used as properly prescribed, opioids are effective medicine that help people recover from injuries and deal with extreme pain. Much of opioid addiction is a result of abuse and illegal choices by patients and doctors, not simply the drug itself. To hold opioid manufacturers liable for the improper use of their products, would open the floodgates for lawsuits seeking compensation against manufacturers of any product involved in an injury or crime.
Finally, this litigation is reminiscent of the big tobacco settlements from the 1990s, in which lawyers in the early lawsuits split billions of dollars in fees.
Yet, despite all of the funds paid by the tobacco industry, tobacco remains the leading cause of preventable death, disease, and disability in the United States, with nearly 40 million U.S. adults that still smoke cigarettes. As Texas counties rush to court to sue over opioid addiction, the poor track records of past analogous lawsuits should give policy makers pause that this is a pathway to a viable solution.
But nothing in this world is free. Frivolous litigation against drug manufacturers will drive up the cost of drugs and further burden an overcrowded court system that already takes way too long to divvy up justice. Multi-party litigation affords legislators and policy makers the excuse to not take any action while the court cases are pending. Finally, there is no guarantee that any funds paid, if ever, will go towards treatment or rehabilitation. Instead of through personal injury litigation, opioid abuse and addiction issues are best left to the legislative branch for areas that fall within the proper role of government.
At the end of the day, responding to drug abuse in our communities will require tough decisions by local politicians and more importantly, voluntary actions by individuals, families, civic groups, and churches. Those are the right tools for the job, not the courts.
Robert Henneke (@RobHenneke) is the director and Chance Weldon is an attorney with the Center for the American Future at the Texas Public Policy Foundation.

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Blood Money: A New Foundation From Big Pharma Tackles Opioids (Opinion)

Apr 5, 2018 | Inside Philanthropy

By Paul Karon & David Callahan

When a profit-thirsty global corporation causes a devastating public health crisis, what should we think when it steps forward with a philanthropic pledge to address that crisis? Nothing good.
First some background.
The opioid epidemic—with its component scourges of addiction, overdose, death, crime and wrecked lives—has been in the news for years, now. In 2017, the U.S. Department of Health and Human Services declared it a public health emergency and unveiled a plan to combat the epidemic. But addicted Americans are still dying by the tens of thousands each year. In parts of the U.S., morgues have been overwhelmed by soaring deaths of young adults.
As we've reported, philanthropy has been slow to respond. While grantmakers have long supported drug and alcohol addiction services, this has never been a big area of funding. And about a decade ago, it got even smaller when the Robert Wood Johnson Foundation, the nation's largest grantmaker focused on health, wound down its substance abuse work. That left the Conrad N. Hilton Foundation as one of the few big national foundations working in this area when the devastating opioid epidemic began metastasizing during the Obama years. Even as the death toll rises, major foundations have yet to respond to the opioid problem with the numbers or dollars you'd expect in response to the nation's top public health emergency.
We've written frequently about the too-short list of funders who have started to steer serious grant money towards opioid treatment. Much of the opioid-related philanthropy comes from smaller funders working at the local level.
Now, it looks like opioids are finally getting a dedicated, national-scale foundation—albeit one with modest resources. Last week, the global healthcare and pharma giant McKesson Corporation announced the formation of a new foundation dedicated to combating opioid abuse. McKesson has promised $100 million for the effort.
McKesson says its new opioid foundation will focus on education, policy and access to life-saving treatments, such as opioid overdose reversal medications. Details—about leadership, strategic priorities, and criteria for giving—will be announced in the coming months. The foundation is part of a larger set of initiatives on opioids by McKesson that involve tighter prescription controls, including efforts to reduce fraudulent prescribing, and development of limited-dose packaging. McKesson is already a supporter of the Opioid Safety Alliance, Allied Against Opioid Abuse, and Community Anti-Drug Coalitions of America.
But don't start cheering just yet.
These moves come as McKesson finds itself under legal attack by regulators who see its profit-hungry fingerprints all over the opioid epidemic. Among those going after the company is Kentucky Attorney General Andy Beshear, who filed a lawsuit against McKesson in January, stating,Kentuckians can finally put a name to a major reason for the pill mills, drug epidemic and overdose deaths in our state. McKesson knowingly and intentionally distributed enormous quantities of prescription opioids throughout Kentucky with total disregard for our health and safety. This reckless behavior fueled our catastrophic drug epidemic that every community is facing.
Among other things, the suit alleges that from January 2010 through December 2016, McKesson distributed an eye-popping 18.4 million doses of prescription opioids in Floyd County alone—or 477 opioid pills for every person living in the county. The company also shipped millions of prescriptions to other counties in Kentucky. Nearly 6,000 state residents died of drug overdose deaths between 2012 and 2016.
The state alleges that McKesson ignored any number of red flags by "filling massive and/or 'suspicious' orders of unusual size, orders deviating substantially from a normal pattern, and ... shipping drugs into the Commonwealth without adequate policies and procedures in place to detect suspicious orders, failing to report to appropriate authorities such 'suspicious' orders, and failing to halt such excessive and suspicious shipments."
The company has denied Kentucky's charges. It faces nearly 200 other lawsuits for its role in the opioid epidemic, including one mounted by a county in West Virginia. It was also the focus of an explosive segment on 60 Minutes in December.
Now, after making billions from opioids, McKesson is investing relative chump change in a foundation to fight opioids. It's clearly looking to buy good publicity amid an onslaught of negative coverage. If the company were really interested in making things right, it would add another zero onto its philanthropic commitment.
That said, it's hard not to welcome more resources to the underfunded battle against opioids. Even if it's blood money, this new funding can still do some good.
McKesson's gift is hardly the first time that a bad actor has offered up ill-gotten winnings to achieve positive change. At Inside Philanthropy, we've often weighed the moral issues in these cases, and, in general, have concluded that nonprofits should take the money.
The new McKesson opioid foundation will be a separate entity from the company's philanthropic arm, the McKesson Foundation, which was created in 1943 and primarily funds work in cancer.

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With the drug industry as its partner, an addiction policy group invites tough questions

Apr 5, 2018 | STAT News

By Lev Facher

Jessica Hulsey Nickel had only just begun to speak at a House hearing last month when a man in the back corner of the committee room stood, unfurling a paper banner and shouting toward the witness stand.
“I would like to know how much money the Addiction Policy Forum has received from the pharmaceutical industry,” yelled Randy Anderson, a well-known addiction treatment and recovery advocate in Minneapolis. “We’ve asked the question and no one will tell us. I figured I’d fly here today and ask.”
A congressman tried to gavel Anderson quiet. Committee aides scurried to fetch police. Nickel — the target of Anderson’s protests and Addiction Policy Forum’s president and CEO — ignored the interruption and continued with her testimony about legislation that would reshape federal laws regulating addiction treatment. When the hearing finished two hours later, no one besides Anderson had raised questions about potential conflicts of interest.
Despite Anderson’s difficulty in getting her attention, Nickel’s three-year-old nonprofit is increasingly in the spotlight, both for its high-profile advocacy work and its close ties with drug makers. The vast majority of the group’s funding comes from pharmaceutical companies, some of whose executives sit on its advisory board. Overshadowed by APF’s funding sources, however, is a more striking connection: Until last fall, Nickel was concurrently working as a lobbyist for Alkermes, the maker of a drug used to treat opioid addiction, while heading the nonprofit.
In interviews with STAT, Nickel brushed off concerns about her work with Alkermes and her group’s multimillion-dollar partnership with PhRMA, the drug industry lobbying group, calling those reservations “an old way of thinking.”
“We need to be collaborating with industry, companies that have R&D budgets,” Nickel said. “The folks that cure diseases need to be at the table with us, so I stand by this partnership. I stand by the decision.”
Increased attention to the epidemic, however, has created an undeniable business opportunity for many drug companies. A spending bill passed earlier this year added $3 billion in funding for initiatives specific to the opioid crisis. Budget caps allow for many more billions to be spent in 2020 — a significant chunk of which is destined to fund medications used to treat opioid use disorder. The bills Nickel testified about before the Energy and Commerce Committee are likely to authorize much of this spending.
With Capitol Hill purse strings newly loosened, the companies that make medications critical for treatment of opioid use disorder — many of which fund APF — are positioned to earn millions as treatment is expanded. Those coming changes have heightened the fears of advocates wary of APF, which declined to specify dollar amounts for the funding it has received from industry partners.
“Transparency and accountability are paramount, and we have to hold our leaders to higher standards,” said Jesse Heffernan, a recovery advocate based in Wisconsin.
Heffernan, the former national empowerment and outreach coordinator at the advocacy group Faces & Voices of Recovery, has also been in early-stage discussions with Sen. Tammy Baldwin (D-Wis.) about pharmaceutical industry influence more broadly.
“When we have leaders like those from many national organizations like APF being tied to any kind of pharmaceutical money,” Heffernan said, “we need them to step up and talk about it.”Political connections
Whatever legislation Congress passes to deal with the opioid crisis — key Republicans in the House hope for a vote prior to Memorial Day — much of the law is likely to focus on access to medication-assisted treatment.
The draft legislation now before Congress includes a provision requiring many providers of addiction treatment receiving federal grants to ensure access to all FDA-approved forms of medication-assisted treatment for opioid use disorder.
Methadone, among the oldest, is the cheapest of the four. A second form of MAT, buprenorphine, has a number of manufacturers. Only one company, Alkermes, makes an increasingly popular third option — Vivitrol. A fourth MAT option comes from Indivior, an injectable form of buprenorphine that is also long-acting. Braeburn makes another injectable buprenorphine product it hopes will receive FDA approval shortly.
Alkermes is among the original funders of the Addiction Policy Forum, while Indivior and Braeburn are also listed as APF sponsors. The multiyear partnership with PhRMA is worth “tens of millions,” the trade association said. Each of the group’s industry partners said it had made the contributions without restrictions.
And from 2014 to 2017, Nickel is listed by name in $760,000 worth of lobbying disclosures for work on behalf of Alkermes through a separate consulting firm.
Nickel, who lost her father to opioid use disorder at an early age and whose mother passed away after years in recovery, said her group’s relationships with drug companies have proven valuable in APF’s fight to wind down the current opioid epidemic. Already, the group has used industry money to implement ambitious projects that advocates say could make life easier for individuals seeking treatment and their families.
APF is mapping addiction treatment and recovery resources in each of the nation’s roughly 3,000 counties; orchestrating yearly events on Capitol Hill for families impacted by substance use disorders; and took a lead role in planning a drug development event later this month alongside the Food and Drug Administration and National Institutes of Health.
Taking pharma money is more the norm than the exception among nonprofits that work on addiction issues in Washington. Despite APF’s funders, Nickel insists the policy the group advocates for is determined by two factors: science, and the needs of the families it works with.
But APF is noteworthy for its close connections across Capitol Hill and federal agencies, which have allowed the group a central role in policy discussions.
In June, Nickel testified before a White House commission on combating the opioid crisis. In late 2017, APF invited stakeholders to a brainstorming session with APF and policy staffers for the House Energy and Commerce Committee, a key committee shaping opioid legislation, according to emails obtained by STAT. A committee spokeswoman denied such a meeting ever took place.
“We’ve been asked to submit ideas to House Leadership regarding suggestions for legislation to address addiction, like a CARA 2.0,” APF’s chief operating officer, Jay Ruais, wrote in the October email. APF confirmed to STAT in November that it was working with lawmakers from both parties on opioids legislation.
The group will honor House Majority Leader Kevin McCarthy (R-Calif.) at an awards dinner later this month. Nickel herself was a legislative aide to Sen. Rob Portman (R-Ohio) over a decade ago when he served in the House.
And most recently, APF has been jointly planning, with FDA and NIH, a patient-focused drug development event planned to take place April 17. The event will invite individuals and families impacted by substance use disorder to share their perspectives regarding what medicines have been useful and what is lacking in the current treatment landscape.
An FDA spokesman said the agency, after receiving a proposal from APF to run a patient-focused drug development event, liked the group’s idea so much that it decided to take the event over and run it internally, with logistical and outreach support from APF.
APF has also reached into the federal research world for talent, hiring Maureen Boyle — formerly the chief of the science policy branch at the National Institute on Drug Abuse — as the group’s chief scientific officer in December.
“Folks that say we shouldn’t be collaborating with the FDA or NIDA or NIH, or companies that make medicines for our disease space — I think those are folks that are stuck in an old way of thinking,” Nickel said. “Those that can give us better medicines, better treatments, better pathways for our families, they need to be at the table with us.”
By and large, established voices in Nickel’s orbit agree.
“This is pretty labor-intensive, expensive stuff, and nobody else has done it,” said Sue Thau, a policy consultant for the Community Anti-Drug Coalitions of America and a member of APF’s board of directors. “That’s what [Nickel] is using the money for.”Treading cautiously
Others are less convinced that the cost of collaborating with industry is worth the benefits.
“The practice of funding astroturf patient advocacy organizations is an industry-wide practice,” said Leo Beletsky, a public health and law professor at Northeastern University who focuses on drug policy. “This is no different, and certainly there is a huge business opportunity that Alkermes has happened upon here.”
After a New York Times report in February, the voices crying foul became louder. The story highlighted APF’s partnership with PhRMA and detailed a meeting Nickel attended at which industry lobbyists pushed Minnesota lawmakers to reject a proposed tax on prescription opioids.
“The pharmaceutical industry is now attempting to co-opt and otherwise influence individuals and families to take the pressure off a mounting onslaught of civil lawsuits and state opioid tax bills,” Facing Addiction, a national nonprofit geared toward addiction treatment and recovery advocacy, wrote on its website in February, directing readers to the Times report.
Still, addiction experts emphasize that medication-assisted treatment is a hugely valuable approach to help counter the opioid epidemic. And legislation that widens access to such medicines is, broadly, a good thing.
Some experts did question the requirement, in the draft legislation, that federally funded providers of substance use disorder treatment provide access to every FDA-approved drug on the market. That language has become common in legislation focused on addiction treatment, but has taken on added significance as new, expensive forms of MAT gain approval.
The cost of Vivitrol and of Indivior’s injectable drug are a large part of some advocates’ concern that compelling their presence in every addiction treatment setting could, in fact, pose a barrier to traditional and cheaper forms of medication.
“I’m in favor of requiring addiction treatment providers to offer the first-line treatments” of buprenorphine and methadone, said Dr. Andrew Kolodny, the co-director of Opioid Policy Research Collaborative at Brandeis University. “[But] if you make a provider do all or none, that’s making it harder for them to do what I think is essential.”Spurring transparency
Because of APF and other groups’ connections to the drug industry, some advocates have hung their hopes on a pending bill from Sen. Claire McCaskill (D-Mo.) that could force more transparency. The bill would require any nonprofits receiving federal money — which APF does, in the form of grants from the Substance Abuse and Mental Health Services Administration — to disclose the value of all contributions from industry.
McCaskill released a report in February about chronic pain advocacy groups that later proved to have been funded by pharmaceutical companies. As a follow-up to that report, she is planning legislation to force added transparency from pharmaceutical groups regarding their contributions to nonprofits.
In the meantime, some in the recovery sphere are treading cautiously. Lori Erion, the founding director of the Ohio-based group Families of Addicts, said she stopped working with APF’s state chapter there due to concerns about industry influence.
“I have no doubt the intentions of Addiction Policy Forum are good,” she told STAT. “However, I am concerned that advocating for the people could be skewed when the largest part of their funding comes from big pharma. I founded FOA Families of Addicts and know the funding struggles well that we face. For me, it’s a matter of integrity and doing what is best for the people. I wish APF the best.”
But hopes that the Addiction Policy Forum might cease to accept pharmaceutical money, or play a less central role in national advocacy, are unlikely to be realized, as their work forging partnerships with other national organizations and issuing grants to advocacy groups around the country continues.
“I think it’s foolish to think that some inexperienced and new activists are going to divide the recovery advocacy movement,” said Patty McCarthy Metcalf, the executive director of Faces & Voices of Recovery, a national treatment and recovery group that has partnered with APF.
“[Nickel has] never taken a position she doesn’t fully believe in,” Thau said. “She’d give the money back before she’d do that.”

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Drug Marketing and Advertising Under Fire

Apr 4, 2018 | PharmaExec.com

By Jill Wechsler

Even though Scott Gottlieb challenged FDA restrictions on truthful communications about regulated products as a private commentator on pharma policy, he is taking a more measured approach to expanding off-label promotion as FDA commissioner. A high-level FDA working group is “taking a hard look” at how the First Amendment relates to FDA policy, exploring what the agency can to do to “refresh” and bring more “clarity” to its regulations, commented chief counsel Rebecca Wood at the DIA advertising and promotion conference in March.
Wood noted that the agency also is reviewing a recently issued —and delayed—new rule on “intended use” of regulated products, which raises important issues on how approved drug labels relate to product use. A final guidance issued in December 2017 clarifies how marketers should clearly and prominently display product names in print, broadcast, and online ads to avoid confusion or deception. This advisory may facilitate FDA efforts to modify current policies that require presentation of long lists of side effects in direct-to-consumer (DTC) broadcast ads, based on agency research indicating that consumers better understand and remember more targeted risk information (see sidebar on facing page). More safe harbors for additional types of promotional speech also are under review. A draft guidance published in January 2017 would permit marketers to present healthcare economic information (HCEI) to payers, formulary committees, and “similar entities” to help these knowledgeable experts make coverage and reimbursement decisions. A notable section further outlines how sponsors may provide payers with advance information on investigational drugs and devices to facilitate early coverage decisions on important pipeline therapies.
Another guidance presents a strategy for marketers to communicate information that is not in the FDA-approved label for a marketed therapy, but is “consistent with” FDA-required labeling, or CFL. Such messages must be truthful and not cause harm, and may be useful in presenting new product comparative information or discussing additional adverse reactions, patient subgroup analysis, or conveniences in product use. Marketers have submitted proposals to OPDP for utilizing this new approach, while seeking further clarification and examples from the agency.
Opioid abuses
FDA’s deliberative process for liberalizing off-label promotion also reflects the mounting legal attack on pharma sales and advertising practices for feeding the nation’s opioid epidemic. States and municipalities have brought hundreds of lawsuits against opioid manufacturers and distributors for aggressive marketing activities that have spurred inappropriate and excessive prescribing of painkillers. Private plaintiffs’ attorneys and Native American tribes are joining the attack, and the Department of Justice recently said it, too, would seek to recover costs for federal government opioid treatment programs by becoming involved in legal actions.
The plaintiffs allege that manufacturers deceived patients and caused harm by underwriting false, deceptive, or unfair marketing practices, often overstating benefits and downplaying risk of addiction, particularly for extended-release formulations. Prosecutors also are probing company use of speakers’ bureaus to channel funds to high prescribers, as seen in the case brought in March by the US attorney of New York against five physicians for accepting bribes in the form of speaking fees to increase prescriptions of Insys Therapeutics’ fentanyl spray.
Investigations into opioid marketing have raised questions about industry support of medical and patient advocacy groups that promoted broader prescribing of pain medicines. In February, Sen. Claire McCaskill (D-Mo) issued a report on financial ties between opioid makers and distributors and advocacy groups as part of her ongoing investigation into the role of industry sales and marketing in fueling the opioid epidemic. The analysis reported that five firms gave nearly $9 million over five years (2012-2017) to 14 organizations that promoted opioid use for chronic pain, countered claims of addictive risks, and opposed prescribing limits.
Purdue Pharma responded earlier this year by promising to limit marketing activities for opioids, following similar actions by other manufacturers, including Endo, Teva, Allergan, and Johnson & Johnson. Instead of sales reps promoting OxyContin prescribing, Purdue said it will distribute prescribing guidelines prepared by the Centers for Disease Control and Prevention (CDC). Perhaps Purdue hopes to avoid paying millions more in fines, as it has done over the last decade to settle civil and criminal charges related to Oxy marketing. But penalties may mount for all manufacturers as public agencies seek billions to support costly addiction and rehab programs.
Opioid marketing also has drawn rebukes from FDA’s Office of Prescription Drug Promotion (OPDP), which has cited firms for overstating benefits and limiting or omitting critical risk information in promotional materials. A February untitled letter charges Collegium Pharmaceutical for failing to display important risk information about its Xtampza oxycodone extended-release capsules at a trade show booth. Last year, OPDP sent a warning letter to Cipher Pharma for overstating benefits and omitting risk information on its ConZip opioid agonist, despite a boxed warning and specific limitations on product use. Durect Corp. and Pain Therapeutics received letters in September 2016 for using websites to promote an investigational extended-release pain medicine, Remoxy, as safe and effective.

At the beginning of this year, moreover, FDA and the Federal Trade Commission sent joint warnings to 11 companies for producing and distributing dietary supplements and holistic medicines that made unapproved claims for treating opioid addiction or withdrawal symptoms. While OPDP compliance actions have declined in recent years, these warnings illustrate that violative marketing of pain pills and overdose treatments will draw enforcement action.

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Fred Goldenberg: Fixing opioid crisis isn’t easy (Opinion)

Apr 4, 2018 | Traverse City Record Eagle (MI)

By Fred L. Goldenburg

According to the Centers for Disease Control and Prevention (CDC) the 10 leading causes of death in the U.S. are now heart disease, cancer, unintentional injuries, chronic respiratory diseases, stroke, Alzheimer’s disease, diabetes, the flu, kidney disease and suicide.
Unintentional injuries moved into third place last year because of the increase in accidental drug overdoses. The CDC said 161,374 people died of unintentional injuries, a 9.7 percent increase from 2016, with 63,000 people dying of synthetic opioid overdoses, such as Oxycontin and fentanyl.
We’ve heard a lot about the opioid epidemic over the last year, culminating with the current administration calling for tougher laws, harsher sentencing and even calling for the death penalty for drug traffickers. Historically this get-tough-on-crime stance just doesn’t work.
In a recent article posted on the Vox website, Mark Kleiman, a drug policy expert at the Marron Institute at New York University, said “We did the experiment. In 1980, we had about 15,000 people behind bars for drug dealing. And now we have about 450,000 people behind bars for drug dealing. And the prices of all major drugs are down dramatically. So, if the question is do longer sentences lead to a higher drug price and therefore less drug consumption, the answer is no.”
In addition to tougher sentencing laws, there is a call for doctors to reduce the writing of prescriptions for opioids. But opioids play a legitimate role in pain management. To place this on the shoulders of the doctors is unfair. They certainly must share in the burden of this epidemic, but by no means did they start it.
It starts with the never-ceasing desire of the pharmaceutical companies to make a profit. When Purdue Pharma LP sent 21 million Oxycontin tablets to a West Virginia town of 2,900 people over a one-year period, you would think that someone, anyone, would question the quantity. Yet no one did.
When Oxycontin, a synthetic form of heroin, was introduced in 1995 brothers Arthur, Mortimer and Raymond Sackler (all physicians), founders of Purdue Pharma LP, developed a marketing program that convinced reluctant physicians that using Oxycontin for a full range of pain control was safe and effective. The outcome of this advertising blitz is that, according to Forbes, the Sackler family is worth $13 billion and since 2000 approximately 340,000 Americans have died by opioid overdose.
U.S. Senator Claire McCaskill (D-MO) has recently released a report calling into question the role of Purdue Pharma LP, Insys Therapeutics, Janssen Pharmaceuticals owned by John & Johnson, Mylan, and Depomed in contributing to the opioid epidemic. Each of these companies produce one or more opioids and have spent millions of dollars in political contributions and lobbying efforts to stop any legislation aimed at curtailing use of their drugs. Plus, McCaskill is accusing them of funneling additional millions to pain management advocacy groups that promoted the use of their medicines to their members.
When you consider that each of the CEO’s of these five companies earns an average of $18 million a year and their companies have annual revenues of billions of dollars, it’s no wonder they fight so hard to maintain the status quo. Yet every month another 5,500 people die from misuse of their products.
When President Trump said that one drug trafficker could be responsible for the death of 2,000 people, he was referring to the guy you meet in the parking lot to buy your “fix” — not the guy wearing the $5,000 Italian Brioni suit sitting in the corporate board room. But really, they are one and the same.
Incarceration isn’t the answer.
We need treatment centers adequately funded and staffed. We need alternative treatment plans that don’t depend on popping another pill. We need to stop perpetuating the advertising method that, in the space of a 30-second TV commercial, synthesizes every ailment down to a new pill. We need to get corporate money out of politics and stop the buying of influence.
We need far less rhetoric and more concrete action to stop this unrelenting scourge.

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FDA Head Puts Spotlight On Internet's Role In Opioid Crisis

Apr 4, 2018 | Law360

By Emily Field

The head of the U.S. Food and Drug Administrationon Wednesday said internet service providers and social media companies should join the fight against the opioid crisis by cracking down on illegal online sales of drugs like fentanyl that are fueling the epidemic.
FDA Commissioner Scott Gottlieb said there’s ample evidence that narcotics are being advertised and sold online and internet companies simply aren’t taking practical steps to find and take down these illegal listings for opioids. Many illegal drugs entering the U.S., including products laced with lethal doses of synthetic opioid fentanyl, are being bought online and shipped in the mail, Gottlieb said at a national opioid crisis forum in Atlanta.

“Although the sale of prescription opioids without a valid prescription is illegal, the FDA continues to see these products in the packages we inspect,” Gottlieb said in prepared remarks. “And we find offers to purchase opioids all over social media and the internet, including Twitter, Facebook, Instagram, Reddit, Google, Yahoo and Bing.”

A recent congressional investigation found that it was easy to find fentanyl advertised online, pay for it in cryptocurrency, a credit card or even a prepaid gift card and have it shipped via international mail to anywhere in the U.S., Gottlieb said.

The investigation identified more than 500 financial transactions totaling $230,000 linked to 300 people in 43 states, and even traced seven people who died from fentanyl overdoses to these online sales, Gottlieb said.

“The easy availability and online purchase of these products from illegal drug peddlers is rampant and fuels the opioid crisis,” Gottlieb said.

While internet companies might be reluctant to take on a policing role, it wouldn’t be the first time they’ve done so, Gottlieb said.

“ISPs and social media sites have stepped in to crack down on illegal activities when they’ve been forced to, such as when it comes to the sale of child pornography,” Gottlieb said. “And we’ve also seen them step in when some advertising offended their political prerogatives.”

But when it comes to opioids, the FDA hasn’t seen meaningful, voluntary actions, Gottlieb said, even though the scope of the public health emergency caused by opioids requires internet companies to change their mindset and adopt a more responsible, collective approach to eliminating illegal online sales of opioids.

The FDA wants to work with internet companies and to that end, it will host a summit meeting with internet CEOs, academics and advocacy groups to work on solutions, like changing search algorithms to show potential opioid purchasers pages offering valid treatment programs, Gottlieb said.

Three internet companies disputed Gottlieb's characterization of how they handle illegal opioid promotions on their platforms. A Twitter spokeswoman on Wednesday told Law360 that it has long-standing policies against ads promoting sales of illegal goods, and its rules ban people from using Twitter to carry out illegal activity.

"With other tech companies, we have met with officials to discuss ways we can support U.S. government efforts to fight the opioid crisis," the spokeswoman said.

Reddit two weeks ago updated its marketplace policies to further clarify sales of controlled or illicit goods, including opioids, is not allowed, a company representative told Law360 on Wednesday. Reddit moderators and its trust and safety team also actively screen for posts promoting opioid sales, according to the representative.

Similarly, a Facebook representative told Law360 that it takes down content facilitating activities like drug sales and regularly responds to law enforcement requests for information relating to illegal drug sales.

Representatives for other internet companies didn't immediately respond to requests for comment on Wednesday.

Additionally, Gottlieb said the time may also have come for health care providers who prescribe opioids to go through mandatory training on pain management and addiction treatment.

“Too many doctors from around my generation were trained in a manner that encouraged prescribing that was far too liberal,” said Gottlieb, who is 45 years old.

The training could also include information about appropriate dosing and length of opioid prescribing for the most common outpatient procedures, Gottlieb said.

The FDA reviewed opioid prescription use in nearly 1 million patients and found wide variations in painkiller prescriptions. For laparoscopic appendectomies, the average prescription was for 30 tablets, even though the FDA’s analysis estimated that on average, patients might only need one day’s worth of medication.

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Attorney General Leslie Rutledge in spat with cities and counties over opioid lawsuits

Apr 5, 2018 | Arkansas Times (AR)

By David Ramsey

Attorney General Leslie Rutledge this week filed an emergency petition to the state Supreme Court asking that a prosecuting attorney representing the state be mandated to withdraw from a lawsuit filed against opioid makers and distributers by a coalition of cities and counties.
A spat has been brewing for some time between the attorney general's office and the coalition of local governments over litigation strategy, with potentially millions of dollars in damages at stake.

Rutledge fired the first public shot in the turf war on Monday, asking the state Supreme Court to disallow Scott Ellington, the Prosecuting Attorney for the Second Judicial District of Arkansas, from bringing claims on the state's behalf as part of the lawsuit filed by the coalition of cities and counties in Crittenden County Circuit Court on March 15. That lawsuit, now with all 75 counties and 15 cities as co-plaintiffs, names more than 60 defendants, including major pharmaceutical companies like Perdue Pharma, as well as retailers, pharmacists and medical providers. Ellington was included as a plaintiff, acting on behalf of the state. Rutledge argues that this is improper and that only the attorney general should bring lawsuits for the state. Rutledge filed her own lawsuit on behalf of the state against three major opioid manufacturers on March 29, in Pulaski County Circuit Court.

The convoluted backstory here is that the counties and municipalities, which also filed a separate lawsuit in federal court, wish to pursue this case in state court, which has various strategic advantages. However, that venue is likely only possible if the state is a plaintiff. The coalition of counties and cities tried to get Rutledge on board, and according to court filings there were a number of meetings and discussions over a period of months about the matter. However, they couldn't come to an agreement and Rutledge declined to participate, potentially meaning that the case would get kicked to a federal court in Ohio that is handling hundreds of lawsuits against opioid manufacturers. As a workaround, the coalition approached Ellington to bring the claim on behalf of the state.

Rutledge, meanwhile, claims that the participation of the counties and cities — and the inclusion of the state, despite her disapproval, in the lawsuit filed in Crittenden County — may end up forcing the state's own attempt to bring a lawsuit to be kicked to the federal court in Ohio. She argues that the actions of the coalition and Ellington jeopardize millions of dollars in potential damages that could be awarded to the state.

In court filings, both sides in the dispute lob barbs at each other for contracting with outside, private attorneys from out of state.

Rutledge says that the attorney general's office only became aware that Ellington was going to participate on behalf of the state when it received a copy of the complaint form from one of the coalition's counsel the day after it was filed. She says that no suggestion of that possibility had been made and the attorney general's office would have objected if it had.

Affidavits filed in response by Arkansas Municipal League executive director Don Zimmerman and Association of Arkansas Counties executive director Chris Villines counter that the cities and counties made a good faith effort to cooperate with the attorney general's office, only to be stonewalled by Rutledge, who was determined to act without them and to file her lawsuit first (a feat she didn't manage).

The affidavits describe frequent communications with the attorney general's office throughout last winter, aiming for "cooperative action" and "joining forces." According to the affidavits, the cities and counties were set to meet with the attorney general's office in person on January 25. However, the day before the meeting, Rutledge publicly announced that she had hired outside firms to launch an investigation and potential litigation against opioid manufacturers. She had given no notice of the plan to the cities and counties, according to Zimmerman and Villines. The planned meeting nevertheless took place, and according to the affidavits, "the Counties and Cities advocated for the many benefits of unity, including a collective and concerted action in state court" and stated that they "wished to work cooperatively in the same case with the state, by and through the attorney general." At that meeting and in the many discussions that followed, according to the affidavits, the coalition made clear that while they wished to cooperate, the state would be included in the legal action they brought even if the attorney general refused to participate.

In the weeks that followed, according to the affidavits, frequent attempts to communicate continued but things went downhill:
The flow of information was always one way. ... The attorney general never disclosed what she planned to do. By March, it was increasingly clear that the attorney general had no intention of woking together on joint litigation in response to the Arkansas Opioid Epedemic. It also appeared that the attorney general's representatives were stalling the filing of a complaint by the Counties and Cities to allow her to catch-up with a goal of filing first. But, only on behalf of the State, thereby undermining the Counties' and Cities' united strategy. ... On Thursday, March 15, the Counties and Cities learned that the Attorney General planned to file her own complaint, abandoning the Counties and Cities, and attempting to preclude them from including the State as a party in their case.
At that point, the cities and counties filed their lawsuit, and using a legal claim that is disputed by Rutledge, brought in Ellington to represent the state as a plaintiff "because the intertwined nature of the claims made it critical for the counties and cities to include the state as a party in their case."

Attempts to negotiate continued after the cities and counties filed their lawsuit, but by that point, things got ugly. The attorney general's office accused the coalition's lawyers of ethical violations and demanded that they dismiss their lawsuit. According to Zimmerman and Villines, by late March, the attorney general's office was either avoiding communication or making impossible demands.

In her petition filed in the Supreme Court on Monday, Rutledge wrote, "This case is about who represents the people and the State of Arkansas." The attorney general, she argued, has exclusive authority to manage the state's civil legal affairs. "By vesting that authority exclusively in the Attorney General," she wrote, "the General Assembly sought to avoid intragovernmental conflict and to ensure that the State speaks with one voice."

Ellington's action, she said, jeopardizes the state's ability to pursue its own case against opioid manufacturers. The claims made in the coalition's lawsuit, she wrote, "differ significantly from — and in some cases conflict with — those made in the State's Opioid Litigation."

Rutledge notes, accurately, that certain complaints against opioid manufacturers can only be made by a state attorney general, the only one statutorily authorized to seek civil penalties under the Deceptive Trade Practices Act and the Medicaid Fraud False Claims Act. The dispute is whether the Crittenden County lawsuit would interfere with the separate lawsuit she filed on behalf of the state in Pulaski County. She argues that it would: "[T]he potential preclusive effect of legal determinations made in the Crittendent Litigation could result in the loss of millions of dollars in damages that would otherwise have been awarded to the people of Arkansas."

The heated complaint also states that the maneuver threatens to undercut the state's sovereignty and principles of democracy:

Ellington's unlawful actions have impaired the State's sovereignty and threaten to hamstring our statewide constitutional officers' ability to carry out the will of the people. Indeed, permitting a single prosecutor — who is accountable to only someArkansans — to direct the entire State's actions would set a dangerous precedent that is inconsistent with principles of representative government.
Reached by telephone, Ellington said, "I said if she's not going to get involved, I don't mind carrying the water. ... My involvement is important for the cities and counties — unless or until the attorney general takes over and steps in, with some assurances that she'll work with the cities and counties. The cities and counties had to have a state anchor."

"I never meant to cross the attorney general," Ellington said. "I was not intending to get into any kind of spitting contest."

However, Ellington has no intention of voluntarily withdrawing, because he believes his involvement is an important service for the cities and counties. "My mayors, my county judges, my police chiefs, and my sheriffs all have a valid interest," he said. "I signed on to assist them."

In a response to Rutledge's petition, filed in the Supreme Court today, Ellington wrote that he "concluded—as did nearly every Arkansas county and city—that the strategy of uniting Arkansas governments in litigation against the opioid industry is wise and benefits the counties, cities, and most importantly to Respondent, the State."

Ellington argues that Rutledge's claim to "exclusive" power to sue on behalf of the State of Arkansas is not supported by the statutory text or case law, and he makes various technical arguments against the validity of her petition. He also argues that the state is free to separately pursue claims not covered in the Crittenden County case, which he says "does not threaten any rights of the state to assert civil penalties under claims delegated to the attorney general."

For Ellington, here's the heart of the matter:
Respondent understood that Arkansas Attorney General Leslie Rutledge declined numerous invitations to join the cities and counties in a unified front, instead electing to abandon them and proceed on her own volition, as is now confirmed by the instant Petition. Respondent decided to fulfill his duty as a duly-elected Arkansas prosecutor to advocate on behalf of the State in court and does not regret his decision.
Rutledge wrote in her petition that "time is of the essence" because the pharmaceutical companies named as defendants in her lawsuit have a practice of trying to push opioid-related state litigation into federal court.

"Moreover," she wrote, "the State's sovereign interests are implicated with every passing moment by the filing of a complaint in the State's name without the permission of the State's exclusive legal representative in such matters."

She asked the court for a response by Thursday.

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Laxalt met with top trial attorney over possible opioid litigation, months before local governments pushed for separate lawsuit

Apr 5, 2018 | The Nevada Independent (NV)

By Riley Snyder

Attorney General Adam Laxalt met with an influential personal injury attorney over potential litigation against opioid manufacturers, months before criticizing a municipality for partnering with the same firm.
Laxalt and a top deputy, J. Brin Gibson, met with attorney Robert Eglet on June 23, 2017 to discuss “opioid litigation,” according to a copy of the Republican attorney general’s calendar obtained by The Nevada Independent through a public records request.
The meeting came just a few weeks after state lawmakers had approved a little-noticed, last-minute amendment in the waning hours of the 2017 Legislature that removed a set of caps on fees recoverable by outside law firms that enter into “contingent fee” contracts with the state. Senate Majority Leader Aaron Ford, a partner at Eglet’s law firm, helped get the amendment passed.
Although Laxalt had a week earlier announced the state’s involvement in a 41-state coalition of attorneys general investigating potential unlawful practices by opioid manufacturers, his office said in a statement on Wednesday that Eglet had requested the meeting after the announcement was made.
“Within days, plaintiff’s attorney Robert Eglet requested a meeting with Attorney General Laxalt and his staff,” spokeswoman Monica Moazez said in an email. “The office agreed to the meeting and listened to Mr. Eglet’s presentation. After the presentation, the office ultimately decided that Nevada was best positioned to succeed by continuing to participate in the bipartisan multistate investigation by 40 attorneys general.”
Moazez said that the attorney general still believed the multi-state group — which served subpoenas to major drug companies Purdue, Endo, Janssen, Teva/Cephalon and Allergan in September — was the “most cost and legally effective option available” to the state.
“While this office commends the determination of local jurisdictions to protect residents, we continue to believe Nevada is best positioned in the bipartisan multistate effort of 40 attorneys general,” she wrote. “We continue to hope that any lawsuits by local jurisdictions do not unintentionally undermine our ongoing bipartisan investigation.”

In an earlier email, Eglet said he had lobbied for the change in law on contingent fees after being told that Laxalt was interested in hiring outside counsel to assist the state on a contingent basis, and said Laxalt’s office seemed “enthusiastic” at the meeting about the firm bringing such a case forward.
“This was done in large part because we were told that Laxalt was interested in retaining outside counsel to pursue an opioids case on behalf of the state,” he wrote in the email.
Although he chose not to partner with Eglet, Laxalt reached out to Reno Mayor Hillary Schieve in November 2017 expressing concern that her plan to enter the city into a separate lawsuit against opioid manufacturers would undermine the state’s involvement in the ongoing multistate investigation.
He and Nevada Consumer Advocate Ernest Figueroa followed up in a letter telling Schieve that her intentions could “unintentionally undermine” any settlement funds Nevada might receive as part of the multistate lawsuit.
“More specifically, we believe that a lawsuit by the City of Reno could thwart our office’s ongoing investigation, any potential discussions with opioids manufacturers, and any potential agreements that could uniformly address the opioid crisis in Nevada,” they wrote in November.
Schieve responded to the letter by stating Laxalt’s request was “unsupported” and pitted “Nevadans against Nevadans.” The Reno City Council voted in January to retain Eglet Prince as part of a lawsuit against opioid manufacturers.
The firm has entered into contracts with Reno, Clark County and North Las Vegas, and has presented to a wide variety of other municipalities throughout the state over entering into similar contingent-fee suits.
The attorney general’s office has typically defended its approach on opioid litigation, saying that its current involvement in the multistate investigation was done to avoid “inevitable delays” and could better position the state to engage in its own lawsuit somewhere down the line.
“State attorneys general retain the authority to serve subpoenas (as we did in September of last year), and obtain information and documents without major procedural hurdles and challenges that litigation presents,” Moazez wrote in the email. “What’s more, participating in a national investigation where each state can share resources, tactics and experiences, poises Nevada to be fully prepared to pursue a lawsuit and resolution, if and when needed.”
Laxalt’s calendar also revealed several one-on-one meetings with top national and state figures, including a breakfast meeting with Deputy U.S. Attorney General Rod Rosenstein on June 26 ahead of his appearance at the National Sheriffs’ Association Conference in Reno.
He participated in a conference call with EPA administrator Scott Pruitt on July 13, as part of a briefing over the Waters of the United States rule. Laxalt in 2015 entered Nevada into a lawsuit with 12 other states challenging the Obama administration’s expansion of the rule, which covers federally protected waters under the Clean Water Act. Laxalt also had scheduled a July 14 call with MGM Resorts CEO Jim Murren.

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Surgeon general urges more Americans to carry opioid antidote naloxone

Apr 5, 2018 | CNN

By Susan Scutti & Robert Jimison

The US surgeon general issued an advisory Thursday recommending that more Americans carry the opioid overdose-reversing drug, naloxone.
The drug, commonly known as Narcan, can very quickly restore normal breathing in someone suspected of overdosing on opioids, including heroin and prescription pain medications.
Dr. Jerome Adams emphasized that "knowing how to use naloxone and keeping it within reach can save a life." To make his point, Adams relied on a rarely used tool: the surgeon general's advisory. The last such advisory was issued more than a decade ago and focused on drinking during pregnancy.
Adams noted that the number of overdose deaths from prescription and illicit opioids doubled in recent years: from 21,089 deaths across the nation in 2010 to 42,249 in 2016.
America's top doctor attributed this "steep increase" to several contributing factors, including "the rapid proliferation of illicitly made fentanyl and other highly potent synthetic opioids" and "an increasing number of individuals receiving higher doses of prescription opioids for long-term management of chronic pain."
"Research shows that when naloxone and overdose education are available to community members, overdose deaths decrease in those communities," Adams said. Naloxone is used by police officers, first responders and emergency medical techs to reverse opioid overdoses. Adams added that increasing both the availability of naloxone and effective treatment is critical to ending the opioid epidemic.
Speaking at the National Prescription Drug Abuse & Heroin Summit in Atlanta on Thursday morning, Adams addressed the potential "moral conflict" felt by some people who believe that providing naloxone "doesn't make a difference," since many people with drug addictions will just "go on and misuse substances again."
"Well, that would be like me saying 'I'm not gonna go do surgery on this trauma patient because they're just gonna go out and speed again,' " he said.
Adams noted that in most states, people who are or who know someone at risk for opioid overdose can get trained to use naloxone properly and also may receive naloxone by "standing order" -- without a prescription -- from pharmacies or some community-based programs.
"No mother should have to bury their child ,and especially not when there's a life-saving medication that virtually anyone can access," Adams said. "It is for this reason that I am issuing the first Surgeon General's Advisory in 13 years."

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Justice Department offers its help to move opioid settlement talks forward

Apr 4, 2018 | FiercePharma

By Eric Saganowsky

After settlement talks hit a snag last month in closely watched national prescription opioid litigation, the federal government is hoping to offer its assistance to move the negotiations forward. The Department of Justice has filed a motion to participate in settlement talks as a "friend of the court."
In a filing (PDF) this week, the U.S. government said it has a "unique interest and expertise" in the issues and can help the sides reach a deal. A friend of the court provides info that “is timely, useful, or otherwise necessary to the administration of justice," the government wrote in its Monday filing.
Although it won't be a plaintiff in the litigation, the government said its "substantial financial stake in combating the opioid epidemic has implications for the proper allocation of any monetary settlement of the claims asserted in the multidistrict litigation."
Judge Dan Polster, who's overseeing hundreds of lawsuits grouped in his court, wrote earlier this year that the sides had a "productive" discussion about a potential agreement. Then, last month, those talks hit some "barriers," according to the judge. To resolve the outstanding issues, the court moved forward with a "limited litigation track" that includes discovery and bellwether trials.
Now, the federal government wants to lend "information and expertise to assist the parties and the court in reaching a comprehensive and effective resolution of the issues in this case," according to the filing.
Hundreds of cities and counties around the U.S. are suing opioid companies and distributors for their role in the addiction crisis, alleging drugmakers "grossly misrepresented" opioid risks and distributors failed to monitor suspicious orders. Among those suing is New York City, which is seeking $500 million itself. Numerous states have sued opioid drugmakers, as well.
The DOJ has already filed a "statement of interest" in the multidistrict litigation, backing the claims by cities and counties. Such a filing would allow it access to a portion of a potential settlement, Reuters reported at the time.
Aside from the lawsuits from cities and counties, state attorneys general are investigating opioid drugmakers, and the federal government is pursuing its own litigation, according to a press release.

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Southwest (OK, NV)

Las Vegas may sue opioid makers

Apr 4, 2018 | Las Vegas Review Journal (NV)

By Jaime Munks

The city of Las Vegas may join the legal fight against opioid manufacturers to recoup dollars spent on battling the addictive drugs.
The City Council voted 5-1 on Wednesday to start a competitive bidding process, seeking an outside law firm to represent the city in a potential lawsuit against opioid manufacturers and distributors to recover money spent battling what’s widely considered a national epidemic.
Municipalities nationwide have filed similar lawsuits, arguing they’ve incurred significant costs prosecuting related crimes and on medical and rehabilitation services.
“I urge the city to consider holding them accountable for some of the costs, the vast costs, to our community,” said Dr. Mel Pohl, chief medical officer for the Las Vegas Recovery Center.
The council’s Wednesday vote doesn’t mean the city will move forward with legal action, which Clark County, North Las Vegas and Reno and the state have already initiated.
Attorney Robert Eglet, whose firm Eglet Prince has filed other opioid-related lawsuits, asked the council for more than the usual allotted time to speak on Wednesday.
“I’m not here in any way to try to solicit this case today,” Eglet said.
Mayor Carolyn Goodman declined to give Eglet extra time, citing fairness, and said he submitted a in-depth documents on the issue to the city. The council heard from a group of veterans who described their experiences with prescription opiates.
U.S. Rep. Ruben Kihuen, D-NV, also advocated for the city to join the legal fight at Wednesday’s council meeting.

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Okla. Tribe Says Drug Cos. Played Major Role In Opioid Abuse

Apr 4, 2018 | Law360

By Andrew Westney

Walmart, Purdue Pharma LP, McKesson Corp., CVS Health Corp. and other drug manufacturers, distributors and pharmacies have played a major role in worsening opioid abuse among tribe members, the Muscogee (Creek) Nation alleged in a complaint filed in Oklahoma federal court Tuesday.
The federally recognized Muscogee (Creek) Nation, which is one of the largest in the United States, said Purdue and Endo Health Solutions Inc., as the manufacturers of opioids, “have engaged, and continue to engage, in a massive marketing campaign to misstate and conceal the risks of treating chronic pain with opioids.”

Meanwhile, opioid distributors McKesson, Cardinal Health Inc. and AmerisourceBergen Corp. and pharmacies CVS, Walmart and Walgreens Boots Alliance Inc. have ”routinely and continuously violated” their legal obligations to fight the diversion of opioids, the tribe said in its complaint.

“The defendants’ misconduct, and failure to comply with their legal obligations, has led to an epidemic of prescription opioid abuse,” Muscogee (Creek) Nation Attorney General Kevin Dellinger said in a statement Tuesday. “In order to protect the health, safety, and welfare of all our citizens, we seek to hold these companies accountable for their negligence and wrongdoing within the Muscogee (Creek) Nation.”

There are now hundreds of suits making allegations against drug manufacturers and distributors over opioids, which have since been consolidated into multidistrict litigation in Ohio.

The Cherokee Nation, another large, Oklahoma-based tribe, filed one of the early suits by a tribe in April 2017, and the St. Croix Chippewa Indians of Wisconsin and North Carolina’s Eastern Band of Cherokee Indians have brought federal court actions in their respective states.

In January, the Flandreau Santee Sioux, the Rosebud Sioux and the Sisseton-Wahpeton Oyate went after a slew of companies — including drugmakers such as Teva Pharmaceutical Industries Ltd. and Janssen Pharmaceuticals Inc. and distributors such as Cardinal Health and AmerisourceBergen — in South Dakota district court, alleging that they have knowingly fueled the growing opioid epidemic to boost their own profits.

The Muscogee (Creek) Nation's suit alleges violations of the Lanham Act, nuisance, negligence, unjust enrichment and civil conspiracy.

John Parker, a spokesman with trade association Healthcare Distribution Alliance, whose members include AmerisourceBergen, McKesson and Cardinal Health, has said in response to the profusion of opioid litigation that “the idea that distributors are responsible for the number of opioid prescriptions written defies common sense” and that “those bringing lawsuits would be better served addressing the root causes, rather than trying to redirect blame through litigation.”

Representatives for the companies were not immediately available to comment Wednesday.

The Muscogee (Creek) Nation is represented by Attorney General Kevin Dellinger and First Assistant Attorney General Lindsay Dowell; Richard W. Fields of Fields PLLC; Scott D. Gilbert, Richard Shore, Mark A. Packman, Michael B. Rush and Jenna A. Hudson of Gilbert LLP; Lloyd B. Miller, Don Simon and Whitney A. Leonard of Sonosky Chambers Sachse Miller & Monkman LLP; Adam Scott Weintraub, Terry Scott O'Donnell and Thomas Michael Affeldt of Savage O'Donnell Affeldt Weintraub & Johnson; and William S. Ohlemeyer of Boies Schiller Flexner LLP.

Counsel information for the companies was not immediately available.

The case is Muscogee (Creek) Nation v. Purdue Pharma LP et al., case number 4:18-cv-00180, in the U.S. District Court for the Northern District of Oklahoma.

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Southeast (NC, FL, GA)

Scotland County set to join lawsuit against opioid companies

Apr 4, 2018 | WPDE (NC)

By Tonya Brown

Scotland County Board of Commissioners approved joining a lawsuit with other counties this week against opioid manufacturers and distributors, according to Scotland County Manager Kevin Patterson.
The other counties include Onslow, Surry, Brunswick, Yadkin, Richmond, Buncombe, New Hanover and Rockingham.
The suit says opioid manufacturers and distributors prescribed certain drugs on claims that they were safe and not highly addictive.
Several counties in our area including Marion, Dillon and Horry Counties have filed similar lawsuits against opioid manufacturers and distributors.

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Five behavioral health agencies in Florida file lawsuit against

Apr 5, 2018 | WCTV (FL)

By Jake Stofan

Five of Florida’s seven behavioral health managing agencies are joining the wave of lawsuits against big pharma for its part in the opioid crisis.
The lawsuit blames the industry for misleading marketing practices, which contributed to the over prescribing of painkillers.
The Apalachee Center in the state’s capitol is on the frontline of the opioid crisis.
Dr. Jay Reeve runs the center and says over the past five years, opioid addicted patients have gradually become a bigger part of the center’s overall costs.
“Between 15 and 18 percent of all the folks that come into our detox unit are coming because of opioid related issues,” said Dr. Reeve.
The funding for the center is distributed by Big Bend Community Based Care led by Mike Watkins.
He says state and federal funding hasn’t kept up with the growing cost of the crisis.
“We have about 15 people a day dying in the state of Florida for opioid abuse and those monies aren't coming even close to the expenses that we're barring,” Watkins said.
Big Bend is one of five managing agencies in the state have filed suit against Big Pharma. They want to collect the cost of treating addicts.
The suit blames drug maker's marketing practices for the rampant overprescribing of opioids.
“The manufacturers and the distributors worked very specifically to market a product that was unsafe,” Watkins continued.
The result?
More addicts. Which means more people are in need of services and tax payers are on the hook for the costs.
The exact cost to tax payers hasn’t been calculated yet, but nationwide the crisis is believed to cost more than a hundred billion a year.
All but two of the managing agencies in the state have signed on to the suit.

More than 200 cities and counties across the country have also filed lawsuits blaming Big Pharma for costs associated with the opioid crisis. Attorney General Pam Bondi is also investigating the companies, which could result in a suit on behalf of the state.

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BOC to join opioid lawsuit

Apr 4, 2018 | Jackson Herald Today (GA)

By Staff

Jackson County could soon join other Northeast Georgia communities in a class-action lawsuit against opioid manufacturers and distributors.
The Jackson County Board of Commissioners reviewed a resolution Monday night that would add the county to a list of other area counties in the planned lawsuit. The BOC is slated to take action on the proposal at its April 16 meeting.
The planned lawsuit would allege that manufacturers and distributors of opioids misrepresented the addictive risks of the drug, fraudulently marked opioids and failed to follow federal laws in reporting excessive opioid sales in some communities.
“We all know opioids are a crisis today, including in Jackson County,” said county manager Kevin Poe.

Area counties involved in the proposed lawsuit are being represented by the law firm of Blasingame, Burch, Garrard & Ashley of Athens.

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Northeast (MA)

Chilmark selectmen vote to join opioid suit

Apr 4, 2018 | MV Times (MA)

By Rich Saltzburg

On the recommendation of selectman Jim Malkin, Chilmark selectmen voted unanimously to join a Kopelman and Paige lawsuit against opioid manufacturers.
After joining selectmen from Aquinnah, Oak Bluffs, and West Tisbury at the Howes House in West Tisbury last Thursday, Malkin reported to the board that he listened to a presentation outlining the litigation
"The essence of this presentation is there is a multi-state, multi-community action being taken against the manufacturers and distributors of opioids,” Malkin said. Like tobacco litigation of the past, the suit(s) work on the basis that the makers of the opioids knowingly distributed a harmful product, he said.
Malkin described the litigation not as a class action suit, but bundle of suits. The difference being, he said, each community, if there’s a settlement reached, “can choose to participate in the settlement or continue the litigation.” The litigation has no upfront cost to the communities, but the firm takes 10 percent of any settlement, he said.
Compensation is two-pronged: ambulance, Narcan, and training reimbursement, among other things, and funds for education and training facilities.
Malkin said town counsel, who attended the presentation, saw no downside to joining the litigation.
West Tisbury town administrator Jennifer Rand said West Tisbury selectmen recently heard a presentation and will vote at a future meeting.

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West (WY)

Northern Arapaho Tribe Sues Opioid Companies

Apr 4, 2018 | Wyoming Public Media

By Melodie Edwards

The Northern Arapaho Tribe on the Wind River Reservation has filed a lawsuit against some of the country’s biggest opioid manufacturers and distributors.
The tribe says addiction to opioid medications has hit tribal communities harder than any other in the country. The tribe says they've seen increases in child welfare and foster care cases, as well as a need for more health and therapy services.
Northern Arapaho Business Council Co-chair Lee Spoonhunter says the Northern Arapaho Tribe decided to file the lawsuit in hopes of stopping the destruction of lives on the Wind River Reservation. In a press release, he added, “We encourage other Tribes to join us in this important effort.”
According to Indian Health Services data, Native Americans have the highest rate of opioid overdose death rates of any race in the U.S. The complaint filed on Monday alleges that opioid manufacturers hurt the tribe by flooding the market with a known addictive substance and concealing the potential effects from consumers while benefiting from the epidemic financially.
The Northern Arapaho expect to join a multi-state lawsuit against opioid manufacturers in the Northern District of Ohio in collaboration with other tribes and communities.

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Broadcast Media Coverage

Good Day Arkansas

Apr 5, 2018 | Little Rock, AR

By KLRT (Fox)

Video Link: https://app.criticalmention.com/app/#clip/view/34035687?token=8d200d57-6e57-4acb-b012-5011406fe507
Rough Transcript: attorney general leslie rutledge and u-s- senator tom cotton want tougher penalties for drug dealers--- including the death penalty. the two briefed arkansans o their state and federal efforts--- including law enforcement and parents who have lost children to drugs. rutledge is suing three opioid manufacturers. cotton is sponsoring legislation to allow stricter prison sentences for dealers of fentanyl... which he has called a "weapon of mass destruction." he told the crowd what 100 pounds of the substance is capable of. ((sen. tom cotton/(r) arkansas))"to give you a sense of how potent it is, by some estimates, that's enough to kill up to 18 million people, vastly more than the most powerful nuclear weapon 8:31 AMknown to mankind." ((susanne)) both cotton and rutledge say they're open to the idea of expanding the death penalty for drug dealers--- something president trump has mentioned. ((susanne)) a bi-partisan bill calls for action specifically to help women and babies who are opioid dependent. senator sheldon whitehouse from rhode island says it's heartbreaking to see an infant going through the agonies of withdrawalâ the comprehensive addiction recovery act 2.0 is designed to help addicted mothers and their babies born with addictions. the legislation would authorize $100 million dollars for the treatment of pregnant and new moms, and an additional $60 million for treatment of opioid dependent newborns. in: 15-20"senator sheldon whitehouse, ri: in some cases, the mom is an active addict and then in order to deal with protecting the babyâ sure that you're getting the mom into treatment " the bill will also increase civil and criminal penalties for opioid manufacturers that allow addictive pills to get into the wrong hands... improve prescription drug monitoring and prescribing practices.... as well as

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KARK 4 Today

Apr 5, 2018 | Little Rock, AR

By KARK (NBC)

Video Link: https://app.criticalmention.com/app/#clip/view/34035778?token=8d200d57-6e57-4acb-b012-5011406fe507
Rough Transcript: attorney general leslie rutledge and senator tom cotton are open to the death penalty for drug dealers. yesterday the two discussed new efforts on the state and federal level to stop the opioid crisis. rutledge is suing three opioid manufacturers. senator cotton is sponsoring legislation - allowing stricter prison sentences for dealers of fentanyl- which he calls a quote "weapon of mass destruction.". ((sen. tom cotton/(r) arkansas))"to give you a sense of how potent it is, by some estimates, that's enough to kill up to 18 million people, vastly more than the most powerful nuclear weapon known to mankind." ((isabella)) 215 cities in the state and all 75 counties have filed a law suit - accusing opioid manufacturers of pushing the drugs in the early 2000's. essentially leading to hundreds of overdose deaths.

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NewsChannel 2 at Sunrise

Apr 5, 2018 | Utica, NY

By WKTV (NBC)

Video Link: https://app.criticalmention.com/app/#clip/view/34035810?token=8d200d57-6e57-4acb-b012-5011406fe507
Rough Transcript: Otsego county is aiming to help fight the opioid and herion epidemic. all otsego.com is reporting that the county plans to sue big pharma. the goal is to recoup some of the cost of fighting the epidemic.the board of representives hired a law firm out of new york city... to sue the companies whose practices contributed to the read of heriolocally. last december oneida county announced a similar lawsuit. the otsego county sheriff is allowing the

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Daybreak - Early

Apr 5, 2018 | Little Rock, AR

By KATV (ABC)

Video Link: https://app.criticalmention.com/app/#clip/view/34035850?token=8d200d57-6e57-4acb-b012-5011406fe507
Rough Transcript: arkansas attorney general leslie rutledge joined with senator tom cotton to talk about opioid addiction. rutledge and cotton held a news conference wednesday afternoon to discuss how the opioid epidemic has led to a surge in the use of other stronger drugs -- like fentanyl. arkansas is among the states suing opioid manufacturers alleging they created the problem in arkansas. cotton and rutledge met with families of arkansans who lost their battle with opioid addiction. "....we have to get care for those young men and women in our society who succumb to the ravages of addiction but we have to get tough on the drug dealers who pedal the poison on our streets ..." law enforcement officials, state lawmakers and county prosecutors joined the leaders at that news conference.

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NBC 2 News Today at 5am

Apr 5, 2018 | Ft. Myers, FL

By WBBH (NBC)

Video Link: https://app.criticalmention.com/app/#clip/view/34036434?token=8d200d57-6e57-4acb-b012-5011406fe507
Rough Transcript: 5 o florida's a 7 behavioral health managing agencies are joing the wave of lawsuits against big pharma for its part of the opioid cris says jackson 5 tells us the lawsuit blames the industry for misleading marketing practices. ultimately contributing to the overprescribing of painkillers. >> lachey center in the state's capital is on the front line of the opioid crisis. doctor jay reeves runs the center he says over the past 5 years opioid-addicted patients have gradually become a bigger part of the center's overall costs between the 1518% of all the folks coming to a detox unit are coming because of opioid related issues to the funding for the center is distributed by big ben community based care led by mike want can regions that has referred to earlier, he says state and federal funding hasn't kept up with the growing cost of the 5:16 AMcris we about 15 people a day dying in state of florida. for abuse those monies are coming even close to the expenses that were bare. big bend is one of 5 managing agencies in the state filed suit against big pharma they want to collect the cost of treating attics the suit blames drugmaker's marketing practices for the rampant overprescribing of opioids the manufacturers and distributors work very specifically. to market a product that was on safe. the results. more attics which means more people are in need of services and taxpayers are on the hook for the costs the exact cost to taxpayers hasn't been calculated yet. but nationwide the crisis is believed to cost more than a billion each year. all but 2 of the managing agencies in the state have signed on to the suit. >> it was a just a fan reporting now more than 200 cities and counties across the country have also filed law suits blaming big pharma for costs associated with the opioid

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6 News at 11

Apr 4, 2018 | Lansing, MI

By WLAJ (ABC)

Video Link: https://app.criticalmention.com/app/#clip/view/34036959?token=8d200d57-6e57-4acb-b012-5011406fe507
Rough Transcript: the u-s territory of puerto rico is the latest government to sue a pharmaceutical company - over its alleged role in the opioid epidemic. officials from the island territory say - purdue pharma mis-represented the risk of abuse and addiction - for its opioid painkillers. the lawsuit seeks to hold the company responsible - for all costs incurred by puerto rico - to combat the epidemic. opioid distribution more than doubled in puerto rico between 1999 and 2013. more than 16 hundred fatal overdoses were reported - between january of 2007 - and march of 2016. purdue denies the allegations.

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KOCO 5 News at 6pm

Apr 4, 2018 | Oklahoma City, OK

By KOCO (ABC)

Video Link: https://app.criticalmention.com/app/#clip/view/34037385?token=8d200d57-6e57-4acb-b012-5011406fe507
Rough Transcript: new tonight, the muscogee creek nation is suing several opioid manufacturers and drug stores. the tribe says the groups didn't do enough to stop opioid addiction. the lawsuit says more than 2300 people died of drug overdoses between 2014 and 2016. the muscogee creek nation says the addiction rate among native americans is 64% higher

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KELOLAND News at Five

Apr 4, 2018 | Rapid City, SD

By KCLO (CBS)

Video Link: https://app.criticalmention.com/app/#clip/view/34037410?token=8d200d57-6e57-4acb-b012-5011406fe507
Rough Transcript: the national law firm former u-s attorney brendan johnson is a part of is expanding. robins kaplan has moved its sioux falls office into equity square in downtown sioux falls. before this, johnson was the only attorney who worked out of the sioux falls location. now the company has also added two other attorneys. johnson says he's seen a lot more business, likely because of word-of-mouth and some high-profile cases. one of those cases involves a lawsuit on behalf of three native american tribes against major manufacturers and distributors of opioids.

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WALB News 10 at 6

Apr 4, 2018 | Albany, GA

By WALB (NBC)

Video Link: https://app.criticalmention.com/app/#clip/view/34037497?token=8d200d57-6e57-4acb-b012-5011406fe507
Rough Transcript: dougherty county plans to launch a lawsuit against pharmaceutical companies and manufactures for their role in the opioid epidemic. county commissioners chose an athens-based law firm to represent them litigation. blasingame, burch, garrard and ashley won the vote monday. the group represented over 100 women who were injured after using faulty uterine mesh. they tell us that was the biggest lti district litigation in u-s history. now they want to tackle the opioid epidemic within south georgia communities. spencer lee, dougherty county attorney: "th damages here will be specific to dougherty county, they'll be specific to athens, they'll be specific to macon. our damages have gotten bigger terms if i talk about it with michael fowler to see if we've got any." the city of tifton hired the same firm to represent them in the opioid litigations.

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Fox 5 News at 1:00pm

Apr 4, 2018 | San Diego, CA

By KSWB (Fox)

Video Link: https://app.criticalmention.com/app/#clip/view/34037671?token=8d200d57-6e57-4acb-b012-5011406fe507
Rough Transcript: every county in arkansas suing pharmaceutical companies for what they call a push of opioids. naming Purdue Pharma, endo pharmaceuticals and Johnson and Johnson, along with the distributors, doctors, pharmacists, retailers. 75 counties, 215 cities say that the company is to blame for the hundreds of overdoses. they want those companies to pay for things like treatment and

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