The Cherokee Nation has filed a lawsuit in the Cherokee Nation District Court against six distribution and pharmacy companies, claiming that they have unjustly profited through over-prescribing and selling opioids.

The companies included in the lawsuit include three pharmaceutical companies: McKesson Corporation, Cardinal Health, and Amerisource Bergen. It also includes three pharmacies: CVS, Walgreens, and Walmart. The lawsuit claims that it was the companies’ responsibility to monitor opioid prescriptions and orders in Cherokee Nation, identify the red flags present, and report those issues to the federal government. Essentially, the companies should have noticed warning signs like individual patients trying to fill prescriptions from multiple doctors, or driving long distances to fill prescriptions for no apparent reason.

The lawsuit details the horrific effects that prescription opioids have had on the community, noting that American Indians are more likely to die from drug overdoses than other ethnic groups. Annual deaths from opioid overdose have doubled in Cherokee nation between 2003-2014, and now outnumber deaths from car accidents. It also points out that young people have been hit particularly hard. It reads:

A 2014 study funded by the National Institute on Drug Abuse found a much higher prevalence of drug and alcohol use in the American Indian 8th and 10th graders compared with national averages. American Indian students’ annual heroin and OxyCotin use was about two to three times higher than the national averages in those years.

The lawsuit also details the issues with women who are addicted to opioids and become pregnant, as well as the harm to the community as a whole when drug addiction and crime rise. The Cherokee Nation is seeking restitution for health care costs for those who have been affected by opioid addiction.

Cherokee Nation isn’t the first area to file a lawsuit against companies for the metoiric rise in opioid issues around the U.S.–earlier this year, Everett, Washington became the first city to sue a painkiller manufacturer. A tiny town in West Virginia, called Kermit, sued McKesson, AmerisourceBergen, Cardinal health, Miami-Luken, AD Smith Corporation and a former Kermit pharmacy, Sav-Rite Pharmacy. Those are just a couple examples–there have been others, and until the opioid crisis in the U.S. is under control, there are sure to be more.

In the Cherokee Nation lawsuit, the companies named in the suit have either elected not to comment or have pointed out that they have stringent policies in place to deal with opioid abuse, or that addiction is the real issue.

Anneliese Mahoney

Anneliese Mahoney is Managing Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

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Researchers have recently seen a sharp increase in babies–particularly babies born in rural areas–with Neonatal Abstinence Syndrome (NAS). This means that the babies are essentially born addicted to the drugs that their mothers used when pregnant. This phenomenon is just yet another depressing side effect of the sharp increase in the number of people addicted to opioids in the United States.

According to the study, which was published online earlier this week in JAMA Pediatrics, the increase of babies born with NAS in rural areas rose dramatically between 2004 and 2013. During that time period in rural areas, the incidences of NAS increased from 1.2 cases per 1,000 hospital births to 7.5 cases per 1,000 hospital births. It’s important to note that cases in cities rose as well, just not as sharply. In cities, there were 1.4 cases per 1,000 hospital births in 2004, and 4.8 cases per 1,000 hospital births in 2013. There was also some variability from state to state. Hawaii saw the lowest rate, at .7 cases per 1,000 births. West Virginia saw the highest, with 33.4 cases per 1,000 births. The researchers did acknowledge that the increase in cases could also come from the fact that there’s increased recognition of the symptoms, and better reporting metrics than there used to be.

But these numbers aren’t that surprising if you’ve paid attention to the nationwide opioid crisis. Rural areas have been particularly hard hit. Dr. Joshua Brown, a researcher at the University of Florida College of Pharmacy in Gainesville, told Business Insider:

Substance abuse is generally higher in rural communities, where an inability to afford or access care as well as the stigma associated with addiction may mean fewer mothers get the help they need to stop using heroin or abusing prescription painkillers during pregnancy.

President Barack Obama has recently taken some action to try to ameliorate the opioid crisis. The 21st Century Cures Act was recently passed by Congress and signed by Obama, and designates a significant amount of money specifically to fighting the opioid epidemic. This could be a boon for rural communities struggling with addiction, but as shown by recent evidence, there’s still a lot of work to be done.

Anneliese Mahoney

Anneliese Mahoney is Managing Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

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One of the tendencies people have when combating a problem is the tendency to over-correct. Rather than taking a moderate approach in the first place, they move from one extreme to another. Our drug and alcohol policy sometimes appears to be following that same tendency. Like the boom and bust of capitalism, we put cocaine in our soda and then switched to putting those who use the drug in jail. In the current climate, we have gone from drug companies and doctors promoting opioid painkillers as a life-saving innovation to defeat pain, to restricting the drugs we can use to combat addiction out of fear that it might contribute to the problem even more.

It is of course not an either/or proposition, yet we currently don’t place restrictions on opioid painkillers in the way that we restrict drugs used to treat those who are addicted to opioids. The fear is that if people have unlimited access to drugs like Suboxone they will abuse them rather than use them in recovery. Suboxone is a drug that can mimic some of the effects that opioids have on the brain in order to diminish cravings for and withdrawal from actual opioids. Addicts might also sell drugs like Suboxone to others. We’ve seen this happen with prescriptions for other drugs–in fact, it continues to be a major contributor to the opioid epidemic–so it is not surprising that this fear exists.

Some people will undoubtedly abuse access to Suboxone and drugs like it, the same way that some people abuse cough syrup, which is now restricted in many places. But do the potential abuses of Suboxone and other opioid addiction treatment drugs justify how we restrict them? Or are they such a necessary tool in combatting drug addiction that we should look for alternate means to prevent their abuse so more people can utilize them?

The Devil In the Details

To better understand restrictions on drugs like Suboxone we first need to understand exactly what these drugs do and how they can be dangerous.

When you take an opioid painkiller the drug activates the opioid receptors in the brain, which both blocks pain and creates the high associated with opioids. The more you take the less it becomes about reducing pain and the more it involves achieving that high. Eventually, the brain becomes accustomed to the opioid’s presence and you need more to get high, or even just to maintain normalcy and avoid withdrawal. Because of the way the body processes opioids, once you are chemically addicted to the drug you’ll never get rid of that reaction to it; your brain is permanently wired that way. Many people can and do quit using opioids and avoid addictive behaviors, but the inability to reset your brain chemistry to where it was originally is one of the things that makes opioid addiction particularly difficult to overcome.

Drugs that activate these opiate receptors in the brain are referred to as agonists. A full agonist opioid is a drug like heroin. An antagonist is a drug that attaches to the opiate receptors in the brain but does so without activating them, therefore blocking the opioid from attaching to those receptors. Antagonists, such as Naloxone, are typically used to reverse opioid overdoses and can have no opioid effect at all.

Why People are Uncomfortable With Suboxone

The trouble with Suboxone, in terms of getting skeptics’ approval to use it for addiction treatment, is that while it acts as an antagonist (it blocks opioids) it also acts as a partial agonist. Meaning that it works the same way an opioid does but to a lesser degree. So Suboxone will have some opioid effect–such as suppressing withdrawal symptoms and cravings for an addict–without providing a high.

It is the unique nature of drugs like Suboxone, which are both antagonists and partial agonists, that makes them so effective for the treatment of opioid addiction. They are able to deal with the symptoms of withdrawal and cravings that make addiction recovery so difficult as well as prevent addicts who relapse from getting the chemical rewards for their slip, which keeps that behavior from reinforcing the addiction. But it has led some to argue that giving Suboxone treatment to addicts is simply replacing one addiction with another. This same rationale is what limits maintenance treatment in drug courts, which you can read more about here. It’s an understanding of addiction that focuses on willpower and personal responsibility–which are important elements in combating addiction–but doesn’t give full credit to the best practices determined by the science of how certain drugs affect the body.

This video introduces some of the reasons–from the perspective of an addict and from medical professionals–why treatments with drugs like Suboxone are so effective.

Why Suboxone?

In fact, using partial agonists like Suboxone in treatment isn’t just one effective treatment option, it is the most effective treatment option. Opioid addicts who use the more common rehabilitation model of a 12-step Narcotics Anonymous style program without using opioid replacement medications are twice as likely to have a fatal overdose compared with addicts who use these medications. There have also been numerous studies that show that using these medications leads to other improvements in quality of life and reduces HIV transmission.

This is not to say that psychological treatments and communal supports such as Narcotics Anonymous are not a key component to addiction recovery. But they are often not enough to help most opioid addicts. Most opioid addicts would benefit from access to medications as well. This is like treating a cardiac condition by reducing stress through yoga and getting a pet. Both of those things are treatments that can help in your recovery but are part of a more complex treatment plan that includes other lifestyle changes and medication. A drug addiction recovery plan that dismisses medication as a potential tool is, according to many medical professionals, as unethical as a treatment plan for heart disease that ignores medication.

Regulations and Restrictions

Because of the fear that addicts will personally abuse or sell Suboxone and other partial agonists, federal regulations restrict the amounts that doctors can prescribe. In their first year practicing, doctors can treat 30 patients, and in subsequent years, they can treat 100 patients. This may seem like a lot, but in communities with thousands of addicts needing treatment and few doctors, these restrictions can prevent many people from getting these medications. Senators Ed Markey and Rand Paul introduced a bipartisan bill last year, known as The Recovery Enhancement for Addiction Treatment Act, which would allow nurse practitioners and assistants to administer these drugs, raise the first year cap from 30 patients to 100, and create a pathway for certain doctors to eliminate the patient cap altogether after their first year.

Recently the TREAT Act passed through the HELP Committee (Health, Education, Labor and Pensions). In the video below, Senator Rand Paul gives a brief explanation of why he is promoting this policy change:

Restrictions on Suboxone reduce its supply, and therefore, curtail its potential for abuse. But since there is no similar restriction on the amount of painkillers that doctors can prescribe–which is a huge contributing factor to the massive increase in opioid addiction and the sale of opioids–it makes little sense to restrict Suboxone. The use of Suboxone and other partial agonists won’t actually produce a high for an addict so there is less incentive for an addict to try to obtain Suboxone illegally when he or she could try to get full agonists and get high.

There are some drugs that can be used to replace opioids that produce similar euphoric effects, in a lesser quantity, but not all of them do. At best, the use of Suboxone will prevent withdrawal symptoms and block a full opioid from taking effect, which is exactly why they are helpful to addicts trying to quit their addiction. So while they could be misused and sold, their misuse isn’t damaging in the same way that misusing a prescription for Vicodin would be.

A better strategy for curtailing drug abuse would be to regulate the amount of full agonists that can be prescribed; if we are going to regulate anything. But this regulation would run into some of the same concerns that the current regulations for Suboxone do. Rather than encouraging or requiring proper training for those who are allowed to prescribe these drugs, regulations place a one-size-fits-all rule in every community. There may be some doctors in areas that have more patients in real need of opiates, just as there are communities where the demand for Suboxone has far outstripped doctors’ ability to provide treatment. Like the current regulation of Suboxone, regulations for painkillers would also reduce the supply of the drugs–but placing restrictions that are too harsh on painkillers reduces everyone’s ability to get them–even those who legitimately need them.

Conclusion 

Regulations on drugs like Suboxone are an understandable reaction to a situation that has many lawmakers panicked. If the supply of drugs is causing a problem, then cracking down on the supply of drugs seems like the solution. The idea that the answer to bad drugs may be MORE drugs seems counterintuitive. And it is a tough sell in a culture that has been trained to treat addiction more like a psychological or spiritual dilemma than a medical one.

But drug addiction is a complex problem with psychological and medical components. Ignoring either of those elements makes combating addiction much more difficult and places more barriers in front of those in recovery. Changes in policy that allow patients to get individualized treatment for their illness, versus hoping you win the Suboxone lottery, will ultimately lead to better outcomes. Doctors do need appropriate training to deal with the specific issues involving opioid addiction. The medical profession has much to answer for when it comes to the promotion and prescription of unnecessary painkillers. But throwing the baby out with the bathwater and restricting their ability to prescribe effective treatment just because they had a hand in causing the disease is not effective.

Resources

The Washington Post: Getting Pain Killers Is Easy. Getting Help For Pain Killer Addiction Is Hard

The Huffington Post: Senate Bill Would Dramatically Alter Treatment For Heroin Addiction

Senator Edward Markey: TREAT Act One-Pager

The Daily Beast: Why Drug Rehab Is Outdated, Expensive and Deadly

Serenity Recovery: Kentucky Just Passed A New Law To Help Addicts

WJHL: New Tennessee Law Puts Restrictions on Suboxone, Subutex Prescribing

NAABT: What’s This Agonist/Antagonist Stuff?

PEWCharitableTrusts: States, CDC Seek Limits On Painkiller Prescribing

Mary Kate Leahy

Mary Kate Leahy (@marykate_leahy) has a J.D. from William and Mary and a Bachelor’s in Political Science from Manhattanville College. She is also a proud graduate of Woodlands Academy of the Sacred Heart. She enjoys spending her time with her kuvasz, Finn, and tackling a never-ending list of projects. Contact Mary Kate at staff@LawStreetMedia.com

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In light of the prescription drug abuse epidemic, the Food and Drug Administration (FDA) is cracking down on the labeling of opioid painkillers. According to the FDA, immediate-release opioid painkillers will now carry what is called a “black box” warning, which will warn about the “risk of abuse, addiction, overdose and death.”

The new labeling will also state that prescribing immediate-release opioid painkillers “should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options are inadequate or not tolerated.” There will also be clearer instructions for dosage and dosage changes throughout treatment.

Immediate-release opioid painkillers include almost 175 different brands and generics, including Vicodin and Percocet. According to the Chicago Tribune:

Those medications, which often combine oxycodone with lower-grade medications, are among the most commonly used drugs in the U.S. and account for 90 percent of all opioid painkillers prescribed.

The extensions of these warnings apply particularly to the immediate-release painkillers; the FDA already upped labeling restrictions for extended-release painkillers in 2013. Extended-release painkillers were thought to be a bigger risk for addiction, but after the labeling changes in 2013, increased cases of overdoses, addiction, and death continued. In 2014, there was a high of 19,000 deaths related to the misuse of opioid painkillers, according to the CDC.

There’s also a worrisome connection between opioid painkillers and heroin use–given that some individuals who have become addicted to painkillers eventually turn to heroin once they are no longer able to access painkillers, or because heroin is often cheaper. If you combine deaths from opioid painkillers and heroin, the number of fatalities in 2014 jumps to almost 29,000.

Despite the fact that this labeling comes with a very good intention–cutting down on the abuse of opioids and resulting tragic deaths. However, some experts say that the FDA isn’t going quite far enough. Dr. Andrew Kolodny, the executive director of Physicians for Responsible Opioid Prescribing, pointed out that the new labeling still does not recommend maximum amounts. According to the New York Times Dr. Kolodny stated:

Without an upper dose or maximum duration of use on the label, I don’t think the change will have much of an impact.

As heroin and prescription drug abuse remain huge issues in the U.S., it’s laudable that the FDA is trying common-sense approaches to address them. The Obama administration is pushing for action by federal agencies and governors, so we should probably expect to see more efforts to combat drug addiction in the coming months.

Anneliese Mahoney

Anneliese Mahoney is Managing Editor at Law Street and a Connecticut transplant to Washington D.C. She has a Bachelor’s degree in International Affairs from the George Washington University, and a passion for law, politics, and social issues. Contact Anneliese at amahoney@LawStreetMedia.com.

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Federal Drug Enforcement Agents (DEA) made unannounced visits on Sunday to multiple National Football League teams as part of a continuing investigation. Agents investigated the San Francisco 49ers, Tampa Bay Buccaneers, and Seattle Seahawks. This investigation was fueled by  a class action lawsuit brought against the NFL last summer.

In May 2014, the NFL painkiller lawsuit was brought by approximately 1,300 former players claiming in essence that the team doctors “intentionally, recklessly and negligently created and maintained a culture of drug misuse, substituting players’ health for profit.” Specifically, the plaintiffs claim that since 1969, team doctors have been supplying medications in ways that constituted a dangerous misuse, and that the doctors fraudulently concealed the dangers and side effects from players in order to keep them on the field. They believe that the NFL placed priority of profit before the health of the players. Plaintiffs claim that they have sustained severe injuries from this medical misfeasance, including but not limited to heart attacks, kidney failures, and addiction. The NFL has requested that the federal judge dismiss the suit.

Among other defenses, the NFL is likely to assert that the plaintiffs are barred by the statute of limitations, which is a legal device to ensure that claims are brought in an efficient matter. Specifically, these statutes set the maximum period in which a plaintiff can wait before filing a lawsuit. If the lawsuit is not brought within the time frame then the right to make a claim on that matter is lost. In some instances, however, a statute of limitations can be extended, or tolled, based on a delay in discovery of the injury. This would enable the plaintiff to have an extended period beyond the statute of limitations to bring such action upon the defendants once injury is discovered, and to prevent unjust enrichment.

In California, the statute of limitations for a personal injury suit is two years. In other words, from the time the cause of action occurred–in this case the date of injury–the plaintiffs’ have two years to bring forth a lawsuit. The NFL will likely argue that the statute of limitations has expired, and bar Plaintiffs from bringing the lawsuit. Specifically, it would argue that some of the specific actions brought within the complaint date back to 1969, which far exceeds the statute of limitations.

Under the delayed discovery rule, the statute of limitations deadline is tolled and time does not start to run until the Plaintiffs’ discover, or by the exercise of reasonable diligence should have discovered, the injuries or harm and that it was caused by the wrongdoing of the defendants. The plaintiffs’ have argued just that. In their amended complaint, they claim that the statute of limitations should be tolled, on grounds that they had not discovered, and had no good reason to know of their injuries until recently. Specifically, they argue that league doctors did not reveal the names of medications, and there were poor records regarding dispensing medication. Thus, such acts constituted concealment, which ultimately caused the plaintiffs’ injuries.

The NFL is clearly under a lot of heat at the moment. It still has the NFL Concussion Litigation going on, and the DEA’s visits last Sunday only added fuel to the fire with the current lawsuit. This case is still being heard in the northern district of California on the ruling of NFL’s motion to dismiss, but my gut tells me that there will be no dismissal. If that is the case, it will be interesting to see how the statute of limitations arguments play out, and more importantly, what actions are implemented within the NFL.

Melissa Klafter

Melissa Klafter has a JD from St. John’s University School of Law and plans to pursue a career in Personal Injury Law. You can find her binge-watching her favorite TV shows, rooting for the Wisconsin Badgers, and playing with her kitty, Phoebe. Contact Melissa at staff@LawStreetMedia.com.

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Roger Goodell’s job may be harder than it looks. The ongoing debate over the Redskins name-change seems to have reached its apex under Goodell, and the commissioner’s decision to police illegal hits by increasing fines and penalties has left him with few fans among active players. Still, Goodell’s largest challenge may be satisfying the former players.

Last May several ex-NFL players filed suit in federal court claiming the NFL recklessly and illegally fed players painkillers as a means to keep them on the job. Several players, including ex-Bills star Marcellus Wiley have argued that the amount of painkillers consumed during his playing days left him with partial renal failure in his kidneys. Other players argue that the culture of painkiller dependence turned them into drug addicts upon leaving the league. Former lineman Ross Tucker has defended the NFL, arguing that the plaintiffs are deflecting personal responsibility and just looking for handouts from the League’s deep pockets. But most ex-players don’t feel that way, and that’s a growing problem for Roger Goodell.

While America remains fixated on the record-setting deals for young NFL stars, its often forgotten that many of its old stars are struggling, both physically and financially. The painkillers suit comes on the heels of the League’s concussion suit, another multi-million dollar lawsuit filed by former players. Retired NFL players also recently met with Congressional members to discuss the difficulties they and their caregivers have faced in retirement. Many of their issues stem from the fact that NFL contracts generally remain non-guaranteed, and players’ health benefits expire five years after defection from the League. These issues, combined with the grim reality of the neurodegenerative disease now plaguing many ex-players, have forced retirees to take their former employer to court.

Can Goodell win this game? Experts say that the suit faces numerous hurdles, like obtaining class certification and proving causation. But even if this latest suit is dismissed,  NFL retirees are not likely to go away without a fight.  The National Football League is the world’s top-grossing sports league, (which also happens to be insulated from paying income tax), and Goodell himself was paid more than $44 million as recently as 2012. At some point the NFL is going to have to share a larger part of that pie with its former players by rebooting their pensions. If not, Goodell and his League’s public image may go down faster than a Cadillac off Alligator Alley.

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Andrew Blancato (@BigDogBlancato) holds a J.D. from New York Law School, and is a graduate of the University of Massachusetts, Amherst. When he’s not writing, he is either clerking at a trial court in Connecticut, or obsessing over Boston sports.

Featured image courtesy of [Tom Woodward via Flickr]

Andrew Blancato

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