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senate Bill S. 1584

Should Opioid Manufacturers & Executives be Held Financially & Criminally Responsible for the Opioid Crisis?

Argument in favor

The opioid epidemic in the U.S. has unquestionably been fueled by pharmaceutical companies’ aggressive marketing tactics. However, as the Johnson & Johnson settlement in Oklahoma illustrates, even when successful, state-level suits aren’t generating large enough settlements to pay for the damages wrought by the opioid crisis. Federal-level fines and prison time for executives of companies engaging in manipulative practices are needed to hold guilty parties responsible.

Robert j.'s Opinion
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08/29/2019
You all know how we like to lock up drug dealers. Here’s our chance.
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Jan's Opinion
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08/29/2019
They turned a blind eye to excessive amounts of product going into communities. They chose profits over responsibility. Absolutely, hold them accountable.
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08/29/2019
Wasn’t there some talk many moons ago about holding Corporations, their Executives and their large shareholders accountable for Crimes, or negligence, and other torts for causing harm to Citizens, Consumers, General Public, Employee’s, Etc.? Wasn’t Ken Lay and other Enron executives held accountable for their unethical, corrupt, immoral acts and behaviors? Didn’t we talk about holding auto manufacturers accountable for vehicles that cause harm and death to drivers, passengers and the general public? The pharmaceutical manufacturers and the Congress members that helped the Pharmaceutical companies market and push the opioids should all be held accountable for the death and harm the opioid crisis has caused. Politicians directly involved in pushing legislation that may have weakened existing protections or made it easier for Corporations to market and distribute highly toxic and addictive drugs, should be the first to go to prison or receive the death penalty for all of the deaths they have caused directly or indirectly. The Guilty Politicians should also refund all compensation they have received since they became a politician, including any and all donations from Pharmaceuticals, or pharmaceutical supply-chain and other industry campaign donations. This should go back at least 4 decades. The money should go to the victims, their families and other funds to address related injuries.
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Argument opposed

Holding pharmaceutical companies solely responsible for the opioid epidemic, as this bill seeks to do, is a massive oversimplification of the issue. The American healthcare system, overly aggressive prescribing by doctors, and even the Centers for Medicaid and Medicare have also played a role in this crisis. Punishment should be meted out to all involved parties, not just pharmaceutical companies. It also may be impossible to jail pharmaceutical company executives as punishment for their companies’ marketing practices, deceptive or not, as they may not have been involved.

Deirdre 's Opinion
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08/29/2019
I’m sorry but people were addicted and dying from heroin overdoses for eons but oh yeah they were poor and weren’t white. It seems that whenever white people start dying from something than it becomes an epidemic. Such as the crack epidemic which btw people are still using crack. Yes these corporations need to be held accountable for what they did but the people who actually did the drugs need to be held accountable for their actions too. By making big pharma and the doctors scapegoats you are giving people who are addicts a way out. I think we should look at what “the war on drugs” has really done. All it has done is created a black market that cartels and countries are benefiting from. So start by giving people healthcare that works for them such as mental health access. People who do drugs and alcohol have mental health issues and need help. So maybe we should have big pharma provide the monies for proper healthcare for addicts, setting up rehabs that fit the person.
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Bryan's Opinion
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08/29/2019
No...the manufacturers created a product that is doing exactly what it’s designed to do while publishing the risks. Medical professionals who over prescribe them are individually responsible as well as the patients who abuse them. This is a slippery slope that will open the door to litigation for manufacturers in every industry (auto, firearm, ladders, etc) to be liable for some else’s misuse.
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JTJ's Opinion
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08/30/2019
No people are supposed to be responsible for themselves. Besides this will just raise the drug prices everyone is complaining about.
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bill Progress


  • Not enacted
    The President has not signed this bill
  • The house has not voted
  • The senate has not voted
      senate Committees
      Committee on Health, Education, Labor, and Pensions
    IntroducedMay 21st, 2019

What is Senate Bill S. 1584?

This bill — the Opioid Crisis Accountability Act of 2019 — would prohibit a drug manufacturer from engaging in illegal marketing and distribution practices, including falsely advertising, promoting, or marketing that an opioid has no addiction-forming or addiction-sustaining qualities or risks; supplying states or communities with a quantity of opioids that is not medically necessary; or failing to report any order or pattern of orders that would cause a reasonable person to believe the opioids were not being dispensed in a medically reasonable manner.

Any company found to be in violation of this bill would be fined 25% of the profits from their opioid products. Drug manufacturers who illegally advertise, market, or distribute an opioid product would be stripped of any remaining period of market exclusivity for that opioid product. They would also lose half the remaining exclusivity period on any other opioid products they have on the market.

Pharmaceutical company executives whose companies are found to have engaged in manipulative practices when marketing opioids would be subject to a minimum of 10 years in prison. They would also be fined an amount equal to their compensation package.

This legislation would also fine any company found liable for contributing to the opioid epidemic $7.8 billion (10% of the opioid crisis’ annual cost). 

Funds collected under this bill would be used to establish a reimbursement fund for those affected by the opioid epidemic. They would also be used to support programs and activities to combat the opioid crisis.

Impact

Opioid epidemic; opioid overdoses; opioid abuse; opioids; pharmaceutical companies; pharmaceutical companies that sell opioids; pharmaceutical company executives; and criminal liability for pharmaceutical executives.

Cost of Senate Bill S. 1584

A CBO cost estimate is unavailable.

More Information

In-DepthSen. Bernie Sanders (I-VT), a candidate for the 2020 Democratic presidential nomination, reintroduced this bill from the 115th Congress to prohibit illegal marketing and distribution of opioids; create criminal liability for top company executives; penalize drug manufacturers who illegally advertise, market, or distribute an opioid product; and require drug makers to reimburse the United States for their products’ negative economic impact

“We know that pharmaceutical companies lied about the addictive impacts of opioids they manufactured. They knew how dangerous these products were, but refused to tell doctors and patients. While some of these companies have made billions each year in profits, not one of them has been held fully accountable for its role in an epidemic that is killing tens of thousands of Americans every year. At a time when local, state and federal governments are spending many billions of dollars a year dealing with the impact of the opioid epidemic, we must hold the pharmaceutical companies and executives that created the crisis accountable.”

In an interview when he introduced this bill in the 115th Congress, Sen. Sanders argued that it was needed to hold opioid companies accountable for paying for the opioid crisis: 

“At a time when local, state and federal government are spending many billions of dollars a year, those people will be held accountable and asked to contribute to help us address the crisis. It shouldn’t just be the taxpayer that has to pay for the damage that they did.”

Original Senate cosponsor Sen. Michael Bennet (D-CO) adds

“Communities across the country are being ripped apart by the opioid epidemic. Multi-billion-dollar pharmaceutical companies and their executives reaped large profits for years while their questionable marketing and distribution practices precipitated a devastating public health crisis. It is far past time for Congress to ensure opioid manufacturers, distributors, and executives fund our response to the crisis they created. Our bill will support programs that combat the opioid crisis and ensure we hold companies and their executives accountable for any future misconduct.”

Rep. Tulsi Gabbard (D-HI), also a candidate for the 2020 Democratic nomination, has sponsored the House version of this legislation in both the 115th and 116th Congresses. She says

“Opioid companies have lied, cheated, and profited from the addiction and death left in the wake of the crisis they helped create. The criminal nature of these companies’ actions have destroyed lives and families, and overwhelmed the criminal justice and public health systems. This bill provides tools to hold those like Purdue Pharma accountable for preying on patients using deceptive marketing tactics, as they proliferated these highly-addictive and destructive drugs on our streets.”

Original House cosponsor Rep. Ro Khanna (D-CA) adds

“When I visit the communities that have been ravaged by the opioid epidemic, I see the victims of unscrupulous pharmaceutical companies that have put profits over the patients they were intended to serve. This bill holds opioid manufacturers and their executives accountable for decades of dishonest sales practices and malicious drug distribution. Over the past 20 years, more than 400,000 people have died of opioid overdoses, and millions more have been stricken by addiction. Their loved ones deserve justice.”

In 2017, Dr. Ronald Hirsch, vice president of the regulations and education group at R1 Physician Advisory Services, called on Congress to convene hearings on the opioid epidemic to compel top pharmaceutical company executives, the Joint Commission, Press-Ganey, the Centers for Medicare and Medicaid Services (CMS), and hospital executives to testify as to their roles in the crisis. He drew a parallel between the opioid crisis and tobacco in the nineties, arguing that a Master Settlement Agreement is needed for the opioid crisis as well:

“Blame must be placed; it is the American way. In 1998, the Tobacco Master Settlement Agreement was signed between the four largest tobacco companies and the attorneys general of 46 states. This agreement set limits on advertising and provided payments to states to cover the cost of tobacco-related illnesses. Could there be any better parallel? The co-conspirators [in the opioid crisis have created the] current crisis and should be required to enter into an Opioid Master Settlement Agreement to pay for treatment and prevention efforts for all those affected by their nefarious activities.” 

Pacific Standard health and drug policy writer Francie Diep notes that states have provided a “natural experiment” showing the effect that painkiller sales have on opioid misuse and death. In a 2011 Centers for Disease Control and Prevention (CDC) study, researchers found that opioid sales quadrupled while, at the same time, overdose deaths involving opioids also almost quadrupled, and the proportion of people in addiction treatment centers saying they had an opioid addiction increased 600%. The CDC also found that states with higher-than-average opioid sales also tended to have higher-than-average death rates.

In a study published in JAMA Network Open in January 2019, a team of researchers found a clear link between aggressive opioid marketing and overdose deaths. In their study, they analyzed a non-research-related marketing of opioid products from August 1, 2013 to December 31, 2015 (a total of $39.7 million in opioid marketing targeted to 67,507 physicians). They found that the more aggressively opioids were marketed to doctors in a given county, the more overdose deaths that county experienced a year later. 

At the American College of Physicians annual meeting, Dr. Charles Reznikoff argued that the health care system, not pharmaceutical companies, bears the most responsibility for the opioid crisis. In his remarks, Reznikoff noted that other countries are handling the opioid very differently from the United States: France began allowing any doctor to prescribe buprenorphine for opioid use disorder (OUD) in 1995, leading to a 10-fold increase in buprenorphine prescribing and an 80% reduction in the overdose death rate. Today, half of all people with OUD in France are on addiction medications, compared with 15% in the U.S. In Portugal, Reznikoff added, “They basically stopped incarcerating people with opioid addiction” in favor of treating opioid addiction as a public health, rather than criminal, issue. Thanks to this, Portugal moved from having the highest rate of opioid death in Western Europe to now having the lowest rate — today, Reznikoff noted, Portgual’s opioid death rate is 1/50th of the death rate in the U.S.

This legislation has three Democratic Senate cosponsors in the 116th Congress. Its House companion, sponsored by Rep. Tulsi Gabbard (D-HI), has one House cosponsor, Rep. Ro Khanna (D-CA). Neither bill had received a committee vote as of August 26, 2019. This legislation is endorsed by Public Citizen, CREDO, American Medical Student Association (AMSA), National Collaborative for Health Equity and Prescription Justice.

Last Congress, this legislation had three Democratic Senate cosponsors.Its House companion, sponsored by Rep. Gabbard, had five Democratic House cosponsors. Neither bill received a committee vote last Congress.


Of NoteOpioid pain relievers were marketed by pharmaceutical companies as non-addictive in the 1990s. During that time, health care providers began prescribing them at higher rates. It soon became clear that these medications are highly addictive. 

By 2017, both prescription and non-prescription opioid abuse were so rampant, the federal government declared a public health emergency and announced a 5-Point Strategy to Combat the Opioid Crisis with five specific strategies for the Dept. of Health and Human Services (HHS) HHS to execute against:

  • Improving access to treatment and recovery services;
  • Promoting use of overdose-reversing drugs;
  • Strengthening our understanding of the epidemic through better public health surveillance;
  • Providing support for cutting edge research on pain and addiction; and
  • Advancing better practices for pain management

Nearly 70% of the more than 70,000 drug overdose deaths in 2017 involved an opioid. Today’s rate of opioid overdose is six times higher than it was 20 years ago. Over the period 1999-2016, the number of opioid overdose deaths more than tripled, causing U.S. life expectancy as a whole to fall for three consecutive years from 2015-2017. In total, the opioid epidemic is estimated to have cost the U.S. over $1 trillion from 2001-2017 — and it’s estimated to cost another $500 billion by 2020.

Several states, including Ohio and Kentucky (which is among the hardest hit by drug addiction), have filed lawsuits against opioid manufacturers for fueling the opioid crisis. Observing this, Sen. Sanders says, “The real legal struggles have taken place at the state level. It seems to me that it’s appropriate to take that fight ... here to the federal government.”

In a landmark ruling on August 26, 2019, drugmaker Johnson & Johnson was ordered to pay $572 million for its part in fueling Oklahoma’s opioid addiction crisis. Since 2000, about 6,000 people have died from opioid overdoses in Oklahoma. During the seven-week non-jury trial, lawyers for the state argued that Johnson & Johnson carried out a years-long marketing campaign that minimized opioids’ addictive risks and promoted their benefits. The state’s lawyers called the company an opioid “kingpin” and argued that its marketing efforts created a public nuisance as doctors over-prescribed opioids, leading to a surge in overdose deaths in the state. 

Johnson & Johnson denied wrongdoing, arguing that its marketing claims had scientific support. It also claimed that its painkillers, Duragesic and Nucyntha, comprised only a small fraction of opioids prescribed in the state. 

The judge in the case, Judge Thad Balman, concluded that prosecutors proved that Johnson & Johnson contributed to a “public nuisance” in its deceptive promotion of opioids. In his ruling, he said, “Those actions compromised the health and safety of thousands of Oklahomans. The opioid crisis is an imminent danger and menace to Oklahomans.”

The amount that Johnson & Johnson has been ordered to pay is much lower than the $17.5 million Oklahoma officials requested. In fact, according to estimates detailed in Judge Balman’s decision, the $572 million payment will only fund Oklahoma’s opioid recovery plan for a single year. Reacting to this, University of Kentucky law professor Ricahard Ausness asked, “If Johnson & Johnson is responsible for the opioid epidemic as a long-term problem, why only provide enough money for one year?"

After the Oklahoma ruling, Johnson & Johnson’s share price rose because investors had been expecting a much larger fine. Jared Holz, healthcare strategies for Jefferies, said, “The expectation was this was going to be a $1.5bn to $2bn fine, and $572m is a much lower number than had been feared."


Media:

Summary by Lorelei Yang

(Photo Credit: iStockphoto.com / fstop123)

AKA

Opioid Crisis Accountability Act of 2019

Official Title

A bill to hold pharmaceutical companies accountable for dubious marketing and distribution of opioid products and for their role in creating and exacerbating the opioid epidemic in the United States.

    You all know how we like to lock up drug dealers. Here’s our chance.
    Like (53)
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    I’m sorry but people were addicted and dying from heroin overdoses for eons but oh yeah they were poor and weren’t white. It seems that whenever white people start dying from something than it becomes an epidemic. Such as the crack epidemic which btw people are still using crack. Yes these corporations need to be held accountable for what they did but the people who actually did the drugs need to be held accountable for their actions too. By making big pharma and the doctors scapegoats you are giving people who are addicts a way out. I think we should look at what “the war on drugs” has really done. All it has done is created a black market that cartels and countries are benefiting from. So start by giving people healthcare that works for them such as mental health access. People who do drugs and alcohol have mental health issues and need help. So maybe we should have big pharma provide the monies for proper healthcare for addicts, setting up rehabs that fit the person.
    Like (23)
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    This depends entirely on whether a company proactively hid facts, willfully ignored their own sales statistics which would have clearly shown abusive distribution patterns, and/or lied to protect profits in lieu of ensuring public safety. I think there are clear examples of this for some companies. I think others may have simply responded to provide services for those prescribed to take their medications. There is a lot more to this then just avowing the big pharma is inherently evil and a wealthy source a revenue to support governmental rehab services. Not to diminish the significance of stopping abusive/harmful practices that violate public trust for profits - it is not clear why this special legislation is needed. I would think that existing law and legal precedents exist which should govern legal action. It would be easy for juries to be emotionally swayed by the 'evil's of big pharma' to bring about judgements that principally benefit the lawyers capable of swaying the emotions of a jury. I would hate to further open that door without clear cause to do so.
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    They turned a blind eye to excessive amounts of product going into communities. They chose profits over responsibility. Absolutely, hold them accountable.
    Like (32)
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    A drug dealer is a drug dealer.
    Like (19)
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    No...the manufacturers created a product that is doing exactly what it’s designed to do while publishing the risks. Medical professionals who over prescribe them are individually responsible as well as the patients who abuse them. This is a slippery slope that will open the door to litigation for manufacturers in every industry (auto, firearm, ladders, etc) to be liable for some else’s misuse.
    Like (18)
    Follow
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    Wasn’t there some talk many moons ago about holding Corporations, their Executives and their large shareholders accountable for Crimes, or negligence, and other torts for causing harm to Citizens, Consumers, General Public, Employee’s, Etc.? Wasn’t Ken Lay and other Enron executives held accountable for their unethical, corrupt, immoral acts and behaviors? Didn’t we talk about holding auto manufacturers accountable for vehicles that cause harm and death to drivers, passengers and the general public? The pharmaceutical manufacturers and the Congress members that helped the Pharmaceutical companies market and push the opioids should all be held accountable for the death and harm the opioid crisis has caused. Politicians directly involved in pushing legislation that may have weakened existing protections or made it easier for Corporations to market and distribute highly toxic and addictive drugs, should be the first to go to prison or receive the death penalty for all of the deaths they have caused directly or indirectly. The Guilty Politicians should also refund all compensation they have received since they became a politician, including any and all donations from Pharmaceuticals, or pharmaceutical supply-chain and other industry campaign donations. This should go back at least 4 decades. The money should go to the victims, their families and other funds to address related injuries.
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    Absolutely positively!!!!!
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    Yes support S 1584 Bernard Sanders Opioid Crisis brought on by greed and lack of ethics. Publicly Hold those responsible and demand compensation to fund programs to help drug addicts and their broken halted lives, with physical/emotional stability and coping skills
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    Yes. They lied about the drugs being addictive. And, make gun manufacturers/companies liable for the results of their products.
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    Especially criminally accountable. I get so frustrated and angry that we take such a hardline approach to drug dealers on the street but just give fines to executive drug dealers like they are somehow above the law. Pharmaceutical CEO’s arguably cause more death and destruction than street drug pushers yet are not held to the same consequences personally and criminally.
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    Yes, partially. AND The Congressmen/Senators who allow it to be even legal! AND THE ADDICT THEMSELVES ARE GUILTY. No one forces the crap down their throats. Yet at the same time these companies 100% KNOW if it's addictive. And the Congress/Senate are such sell-outs that we outta put them behind bars to allow it. I don't care what party either. Lock em up! They're hurting people for profit... AND KNOW IT!🤬
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    Yes, but a reactive response has proven to be not nearly enough. We need to require irresponsible corporate practices lead to the funding of essential support systems to keep more people out of harms way. Funding for effective societal safeguards should not be solely the responsibility of the taxpayers. Especially when it is the irresponsible corporate practices which amplified the societal damage. Instead the funds collected from fines, and a hefty Corporate restitution payment should be used to augment the taxpayers dollars and to build the safety nets/support systems needed to protect future generations.
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    Gee, the republiKKKon’s only care about locking up drug dealers that are black or brown or junkies that are black and brown in order to fill their for profit prisons. Thank you Bernie for going after the white drug dealers.
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    If a drunk driver is responsible for the death of who they crash into, then the drivers of the pharmaceutical companies are responsible as well. White collar crime has been on a rampage for years and they never get more than a laughable fine, compared to their profits. Put these board members in jail and you might see them be more ethical!
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    Yes.
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    Hold executives of opioid responsible companies personally and criminally accountable.
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    Yes, absolutely-these predators have profited greatly by the intentional misery of unsuspecting vulnerable Americans. They should pay through the nose and jail time might deter others from engaging in such heinous crimes against humanity. Poor people of color are serving long prison terms for possessing/selling petty amounts of drugs -many out of desperation to survive. These drug companies and their henchmen are responsible for the destruction of millions of lives. They should pay dearly.
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    Opioids do not work on chronic pain. These drugs are used to enslave vulnerable people, and always have been.
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    Hold manufacturers accountable for the opioid crisis.
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