August 18, 2019

The Opioid Crisis and Medical Malpractice: History, Issues, and Case Law

The leading cause of injury death in the United States is drug overdose – in the last 20 years more than ten times the number of people that died in the Vietnam war, have died in drug overdoses related to opioids. As the Opioid Addiction Crisis is spiralling out of control, thousands of cases are filed against multiple manufacturers by loved ones, overburdened states and illicit drug rings tracked down. The complexity of the crisis requires the input of a lawyer specialized in medical malpractice to sort out who to sue for your losses.

What is an opioid?

An opioid is a very strong pain reliever that acts on the nervous system. It is a drug resembling opium in addictive properties. Some prescription opioids are made directly from the poppy plant, and others are made from synthetic compounds.

Opioids can be prescribed for pain relief but are very addictive, and often, people will resort to buying illegal opioids such as heroin, which is an extremely dangerous drug. Pill-mills have been found to lace fake opioid medications with fentanyl, which is even stronger than heroin.

The fatal overdose death rates have reached crisis proportions.

How does an opioid act on the brain?

There are special opioid receptors in many areas of the brain involved in feelings of pleasure and pain – the opioid binds with these receptors and activate them to block pain signals and at the same release large amounts of dopamine (pleasure hormone).

These receptors are also found in the spinal cord and other organs.

The rush of dopamine reinforces the good feeling of taking the opioid and thus starts the addiction cycle of wanting to take more and feel good more often.

What are the effects caused by taking an opioid?

Taking an opioid relieves pain in the short term, and makes the patient feel relaxed and happy. Harmful effects include drowsiness, euphoria, confusion and slow breathing. In some cases, the patient may experience nausea or constipation.

Misuse of the drug slows down the breathing to the point of hypoxia, where the brain is deprived of enough oxygen. This causes short-term and long-term neurological effects and seriously damages psychological functioning.

If too much is taken in too short a period, it can lead to coma, permanent brain damage or have fatal consequences.

It is particularly dangerous when prescribed to older, chronic or confused patients, as it is easy to overdose when taking a large number of medications. A large number of drugs also increase the risk of interactions. A slow metabolism negatively impacts the breakdown of the drug’s components in the system, which can also lead to an accidental overdose.

Opioid use during pregnancy often leads to miscarriage and low birth weight or neonatal abstinence syndrome, where the baby is born with an opioid addiction and suffers withdrawal symptoms.

Sharing drug paraphernalia obviously may lead to other infections such as hepatitis or HIV.

Common prescription opioids

Several slang terms are used to describe opioids, such as Oxy, Vikes and Percs.

Prescription opioids include:

  • Codeine
  • Hydrocodone (Vicodin)
  • Oxycodone (OxyContin, Percocet)
  • Morphine (Kadian, Avinza)
  • Oxymorphone (Opana)

What are the effects of long-term use of prescription opioids?

Long term use of prescription opioids can lead to the following conditions:

  • Tolerance – needing higher doses to have the same effect
  • Dependence – neurons change and will only function in the presence of the drug and patients will require medical assistance to stop taking it
  • Addiction – active drug-seeking behavior that is compulsive and uncontrollable and becomes a chronic disease that creates major changes in the brain leading to harmful behaviors.

Withdrawal symptoms are extremely uncomfortable and painful, which makes it difficult to stop the abuse of opioids. Naloxone can be administered in the case of overdose, and in November 2017 the FDA approved a small nerve stimulation device called NSS-2 Bridge to assist with withdrawal.

Fatal drug overdoses have tripled in the last two decades, and cause 115 deaths a day, nearly half of them from prescription opioids. The rate of prescriptions has increased dramatically (three times as high as two decades ago), while the number of people reporting pain has remained stable at around 11%.

According to the CDC, the likelihood of long-term use increases according to the length of the initial prescription and increases sharply after day 3 and 5, see the CDC graph below:

What are the implications for public health?

The Opioid Misuse Crisis is decimating public health programs in some states, including Michigan, and services are straining to assist with the crisis. Law-enforcement is overburdened, and even libraries are complaining about having to deal with drug-addicts seeking free and open warm spaces.

In Western Massachusetts where they are experiencing a dramatic spike in fatal opioid overdoses, men with substance abuse problems, that have not committed any crimes, are sent to prison where a special wing has been designated for court-ordered addiction treatment.

All demographic groups are affected by this crisis, and it is now rapidly increasing in African Americans.

Issues contributing to the crisis include:

  • Inadequate management of pain
  • Poor access to addiction facilities
  • Poverty
  • Poor harm-reduction services (for example needle exchanges)
  • Poor prescribing habits
  • Lack of legal tools to prevent over-prescribing
  • Devious marketing tactics by pharmaceutical companies
  • Lack of oversight
  • Inadequate resource allocation to law enforcement and public health

Many researchers have investigated the crisis and proposed the following steps:

  • Multifaceted and collaborative law enforcement and public health approach
  • The mobilization of a comprehensive local, state, and national response to the opioid crisis
  • Improve public health
  • Follow CDC guidelines on clinical practice
  • Safer prescribing (which includes drug testing before prescribing)
  • Destigmatization of the crisis
  • Additional spending on harm reduction
  • Improve data collection for improved resource allocation
  • Criminal justice policy reforms
  • Regulatory changes related to controlled substances

History of the Opioid Misuse Crisis

According to the CDC, more than 400,000 people have died from opioid related overdoses in the last two decades, which came in three waves:

  • First wave – higher prescribing rates for opioids in the ‘90s with the death rates rising drastically from 1999.
  • Second wave – started in 2010 with heroin deaths increasing rapidly.
  • Third wave – beginning 2013 synthetic opioids started cause increasing rates in overdose deaths. This includes IMF (illicitly manufactured fentanyl), heroin, cocaine and counterfeit pills.

The CDC developed the Prevention for States and Data-driven Prevention Initiative, as well as the Enhanced State Opioid Overdose Surveillance program. However, a collaborative program including all medical personnel, public health, community-based organizations and the communities are required to tackle this program, including law enforcement and the judicial communities.

The NIH launched the National Pain Strategy and concurred with the overarching programs outlined above, working with the Interagency Pain Research Coordinating Committee and the National Institutes of Health’s Pain Consortium as well as the private sector.

Where does the law stand on the opioid crisis?

The Opioid Misuse Crisis was declared a “Public Health Emergency” in October 2017 by President Trump and the HHS Office for Civil Rights, and a package of bills aimed at fighting the crisis was signed.

Several Ivy League Law Schools have become involved in solving the crisis – looking at it from many perspectives such as public health, mental health, social justice and race, insurance law and economics. Many are questioning the ethics and legal ramifications of continued opioid prescriptions in the light of the crisis, and are looking into criminal, civil, policy and regulatory solutions.

Following the recommendations of the CDS on opioid prescriptions for pain management, many states have implemented new laws and regulations regarding prescribing practices.

Washington state legislated rules with regard to chronic pain management as early as 2010, and cut down on volumes following the CDC guidelines, which prompted the shut-down of 8 Seattle Pain Management Centers; however, Massachusetts passed the first law in 2016, setting a 7-day limit on first-time prescriptions of opioids.

Hundreds of bills relating to opioid use have been considered in the last few years, and by the end of 2018, at 33 of the states have passed legislation with limits, requirements or guidance for prescribing opioids. Limits vary between 3, 5, 7 and 14 days and some have set dosage limits in MME’s (morphine milligram equivalents).

Most of the laws apply to acute pain management, and exempt substance abuse care, chronic or cancer pain management and palliative care. Several have explicit rules for prescribing to minors.

NCLS: Diagram of laws enacted regarding opioid prescriptions

Many have enacted laws providing immunity for carrying and administering Naloxone (an antidote used in overdoses) and provide stock to law enforcement and first responders as well as chronic or palliative care patients.

Legal cases related to the Opioid Misuse Crisis

Janssen & Johnson & Johnson – State of Oklahoma

In a landmark ruling in the first case to go to trial, amongst thousands of cases brought against drug manufacturers by cities and states, the judge ordered Johnson & Johnson to pay $572 million in damages in Oklahoma on August 26, 2019. Oklahoma State sued for $17.5 billion, claiming they fueled the opioid crisis that claimed more than 6,000 lives in the state.

The case was brought by the Oklahoma Attorney General Mike Hunter. Judge Balkman said it is clear the company deceptively marketed their painkillers and helped to foster a crisis, via their subsidiary Janssen, that led to increased rates of addiction, neonatal abstinence syndrome and overdose deaths. He said they contributed to a ‘public nuisance’ in the deceptive marketing of highly addictive drugs. His ruling includes that the company will fund an ‘abatement plan’ for care for addicts, families and communities.

It is the first time that a pharmaceutical company is being held liable for the worst drug epidemic in American history. The company announced that it would appeal the decision.

Purdue Pharma reported offering settlement in the billions

The AHLA (American Health Lawyers Association) reported that several newspapers claimed on the 27th of August 2019 that the Slacker Family that owns Purdue Pharma, has been blamed for the bulk of the opioid crisis are ready to propose a settlement against thousands of lawsuits against the company and family members.

It is alleged that the Slackers will relinquish ownership of the company and pay at least $3 billion of their own money to settle suits, which could total $12 billion. If this happens, they will be the first company amongst two dozen or more pharmaceutical manufacturers, distributors and retailers being sued.

First reported by NBC, U.S. District Judge Dan Aaron Polster, who oversees the consolidated federal lawsuit or over 2,000 plaintiffs, apparently said that the leaders are considering the offer. It is reported that the company would declare bankruptcy and become a public benefit trust company, with all its profits going to the governments that filed lawsuits.

However, it is also claimed that Purdue already settled a lawsuit in Kentucky for $24 million related to claims against their marketing of OxyContin and tried to keep the records sealed.

Projection of $150 billion in potential Opioid damages renewed

Bloomberg reported that the J&J settlement that the bear case scenario of $150 billion in damages predicted by an analyst is coming closer to fruition. A Berenberg analyst, Patrick Trucchio renewed his April projection for liabilities for $150 billion, including more than 45 states and 2,000 localities seeking a settlement of $100 billion.

Does the Opioid Misuse Crisis affect Michigan?

In 2017 there were more deaths in Michigan from drug overdoses than car accidents, according to the Michigan government’s opioid epidemic by the numbers pages. With 11.4 million opioid prescriptions written in 2015, that equates to 115 prescriptions per 100 people, and a 17x increase of overdose deaths. With these staggering numbers it is surprising that the state has no specific laws restricting the prescription of opioids; however, they do provide prescription guidelines and updated monitoring systems and naloxone standing orders, in addition to a Drug Abuse Hotline and information on treatment centers.

Sadly, a University of Michigan analysis showed that nearly one-third of Michigan counties have no opioid-addiction medication-based treatment services and substantial barriers to access exists across the state, forcing the burden of the crisis onto the cities, counties and state:

  • Michigan ranks 8th in number of deaths
  • 14th in overdose rate
  • Of the 20 counties with the highest overdose rate, 6 had no medication-based treatment
  • 75% of officials reported the needs for treatment programs are unmet

In another study, 24 of Michigan’s 83 counties were considered High Risk (for high mortality), the highest ratio in the country.

If you, a family member or friend are struggling with opioid addiction, get assistance urgently, and if you have suffered a loss due to this crisis, consult an attorney at Cochran, Kroll & Associates, P.C. for a complimentary case evaluation. We never charge a fee unless we resolve your case.

Eileen Kroll, a registered nurse and personal injury trial attorney, at Cochran, Kroll & Associates, P.C. can assist you with managing the complexities of a medical malpractice suit in Michigan. Call Eileen or any member of our legal team at 1-866-MICH-LAW (1-866-642-4529).

Nikole has a special interest in medico-legal issues and holds post-basic degrees in medical law and business. She has developed quality improvement and safety plans for many practices and facilities to prevent medico-legal issues and teaches several courses on data protection and privacy, legal, medical examinations and documentation, and professional ethics. She has been writing professionally on legal, business, ethics, patient advocacy, research and medico-legal issues in articles, white papers, business plans, and training courses for over thirty-five years.

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