Don’t Ask What Money Can Do For the Opioid Plaintiffs, Ask What Pharma Can Do For Them

Jennifer Oliva’s insightful commentary on Oklahoma’s settlement with Purdue Pharma and the Sackler family detailed the settlement terms and posed important questions about the sufficiency of the agreed damages. I’d like to push a little further on a couple of fronts.

First, what does the journey from Cleveland, Ohio to Norman, Oklahoma tell us about the opioid litigation and the multi-district (MDL) process, some aspects of which I have addressed elsewhere. Second, while dollar figures (expressed in profits, harms, and even philanthropy) have dominated the headlines, should we be paying more attention to non-monetary remedies?

Read More

Call for Proposals: Addressing the Health Care Needs of Justice-Involved Populations

The Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law and Annals of Health Law & Life Sciences invite original submissions for presentations at our Thirteenth Annual Health Law Symposium: Addressing the Health Care Needs of Justice-Involved Populations. The Symposium will take place at Loyola University Chicago School of Law on Friday, November 15, 2019 beginning at 9:00am.

The Symposium will explore legal barriers that justice-involved populations face in accessing health care, and address how those barriers can be alleviated. “Justice-involved populations” generally refers to individuals who are incarcerated in prisons, jails, immigrant detention centers, juvenile detention centers, on probation, or individuals who are otherwise involved with the U.S. justice system. Read More

Recent Developments in Opioid Litigation: A Re-Cap, Visual Aid, and Summary of Outstanding Inquiries

Media reports suffered no shortage of hot takes concerning opioid “arch-villain” Purdue Pharma’s agreement to pay $270 million to settle its OxyContin lawsuit in Oklahoma. The highlights of that settlement include Purdue’s payment of $102.5 million to fund a new Center for Addiction Studies and Treatment at Oklahoma State University, $60 million for attorney’s fees and litigation expenses, $20 million worth of drugs to treat opioid use disorder, and $12.5 million to cover the opioid-related costs incurred by Oklahoma’s local governments. Members of the Sackler family, who were not named as defendants in the litigation, also agreed to contribute an additional $75 million to Oklahoma over a five-year period.

A noteworthy concentration of the media coverage dedicated to Purdue’s Oklahoma settlement has involved speculation regarding its potential impact on the numerous outstanding opioid cases in other states as well as the myriad federal cases aggregated in the opioid multidistrict litigation (Opioid MDL) before the United States District Court for the Northern District of Ohio. The New York Times, for example, was quick to claim that the Oklahoma resolution “could jolt other settlement talks with [Purdue], including those in a consolidated collection of 1600 cases overseen” in the Opioid MDL. The Wall Street Journal similarly reported that “Purdue Pharma LP has forged the first deal to resolve more than 1,600 lawsuits blaming the OxyContin maker for fueling the opioid crisis, a move that could lay the groundwork for the resolution of the rest of the litigation.”

Read More

hand reaching for blue pills

Author Q&A: Reducing High-Dose Opioid Prescribing

Sara Heins, PhD
Sara Heins, PhD, Associate Policy Researcher, RAND Corporation

From 1999 to 2017, almost 218,000 people died in the United States from overdoses related to prescription opioids. Overdose deaths involving prescription opioids were five times higher in 2017 than in 1999, according to the CDC.

Previous research has indicated that patients who receive higher doses of prescription opioids have an increased risk of overdose and mortality. In response, several states have established Morphine Equivalent Daily Dose (MEDD) thresholds that convert opioid prescriptions to their equivalent dose in morphine and divides the total prescription by the number of days the prescription is intended to last, allowing for comparison among different opioid formulations and strengths. MEDD policies set thresholds for prescribers, which may only be exceeded in limited circumstances, such as when being prescribed to certain patient groups or as short-courses.

Sara Heins, PhD, an associate policy researcher at RAND Corporation, used policy surveillance to track MEDD policies through June 1, 2017 (data are available on LawAtlas.org). She published an article in Pain Medicine on March 13 that describes U.S. MEDD policies.

We asked Dr. Heins a few questions about her work and this recent publication. Read More

Public Health Approaches to the Opioid Crisis: Overcoming Obstacles to Community-Driven Solutions

Register now for “Public Health Approaches to the Opioid Crisis: Overcoming Obstacles to Community-Driven Solutions,” a lunchtime panel on April 1. 

The opioid epidemic has hit people from all walks of life. In my duties as an acute care nurse practitioner in a busy suburban emergency department I have taken care of a lot of people who face opioid addiction, ranging from young men to elderly woman.

It is an epidemic that doesn’t discriminate. There are some people who have been hit particularly hard.

In my practice, these tend to be people with housing insecurity, job instability and who are marginalized for an array of reasons. We know that people with substance use disorder often have chronic pain or medical issues. Co-morbid trauma-related mental health issues are also very common. Efforts to reduce access to opioids has been a major component of policy and practice. This has included prescribing limits and prescription monitoring programs, with the intent that limiting access will reduce the likelihood of either initial use or ongoing substance misuse. Read More

Close up on a pile of yellow pain pills

Addressing the Opioid Epidemic Starts with How We Treat Pain

As a nurse practitioner in a busy suburban emergency department, pain is my job. Pain is one of the most common reasons people come to an emergency department (ED). It could be abdominal pain, chest pain, back pain or even emotional pain, including depression or suicidal ideations. Pain is a driver for people seeking medical care. We have made pain into a vital sign, and we ask, “How would you rate your pain on a scale of 1 to 10?” a mandatory question for any patient who steps through our door.

This whole concept evolved circa 1987 when the Institute of Medicine urged healthcare providers to use a quantified measure for pain. It gained even more traction in 1990 when then president of the American Pain Society, Dr. Mitchell Max, called for improved means to assess and treat pain. The term “oligoanalgesia” gained popularity in the published literature, meaning that we weren’t giving enough pain medication to patients in the ED, in clinics or in any other healthcare setting. Healthcare providers responded. We asked about and we thought, more effectively treated pain to address this issue.

Read More

blurry, shadowy human figure in black and white

Measuring the Opioid Crisis: The Need for Standardized Cause-of-Death Reporting

By J. Alexander Short

All too often, the modern opioid epidemic is reduced to numbers. Over 70,000 drug overdose deaths occurred in the United States in 2017. This marked a substantial increase from the more than 63,000 deaths reported in 2016. So many news articles, books, and even policymakers depend on these numbers as an accurate measure of the opioid crisis. However, can we rely on their accuracy?

Unfortunately, there are surprising inconsistencies in the reporting of drug overdose deaths that warrants further investigation. Read More

The Emergency Department is The “New” Frontier of Public Health

I had always considered my field of expertise to be emergency medicine. I worked through the ranks as an emergency medical technician, then onward as a paramedic, which included a nine-year stint on a busy medical helicopter. I worked in disaster medicine, and was the associate director of a Harvard-affiliated disaster medicine fellowship in Boston. My current practice is as a nurse practitioner in a busy suburban emergency department (ED) and I am still active in emergency medical services as a SWAT medic and as an educator.

The emergency part of what I do is the exciting part —the part that stimulates the excitatory neurotransmitters that flood the brain, preparing it to act quickly and concisely.

We are selling ourselves short, however, when we label this role as “emergency” providers. Instead, “public health provider” is a much more appropriate term to use, because emergency departments and those who provide care there are really public health workers.

All of us who practice in emergency medicine know that real emergencies are few and far between. Our day-to-day is much more mundane. We deal with many urgent issues as well as some less urgent, primary care problems. We may even spend time filling printer paper or bringing a patient their lunch. We may help to find someone a homeless shelter, send a family home with warm coats for the kids, or pack up a bag with food and toiletries for a young girl we feel is being trafficked.

In light of all this, the purpose and the policies of the emergency department need to be redefined. Read More

hand reaching for blue pills

Should Non-opioid Analgesics have “Opioid Sparing” as a Label Claim?

Most meetings of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) are held to review a New Drug Application (NDA), usually for a novel opioid preparation. But, on November 15, the AADPAC discussed the concept and implications of “opioid sparing” as a potential product label claim for a non-opioid type of medication.

Although trends in outpatient opioid prescriptions appear to be heading in an encouraging direction (see figure below), the demonstration that a non-opioid medication could further decrease the overall use of opioids for acute pain has obvious implications for the amount of opioids prescribed and taken by patients who undergo painful surgical procedures. This will also decrease exposure in the community where prescribed opioids may become diverted for recreational use.

In recent years, some across-the-board measures (e.g. state laws that limit the duration of prescribed opioids) have attempted to reduce opioid prescribing, but as the FDA emphasized in their presentation at the meeting, these “one size fits all” strategies will not account for individual patient variation, and may lead to inadequate pain treatment in some patients. Read More

close up of the back of a baby's head while breastfeeding

Toxic Breastmilk: When Substance Abuse Relapse Means Death for Baby

Recently, a nursing mother in Pennsylvania made national headlines when her infant died from ingesting a combination of fatal drugs through breastmilk.  According to the coroner’s report, the infant died from a combination of methadone, methamphetamine, and amphetamine toxicity. The Bucks County District Attorney charged the mother, Samantha Jones, who also has a two-year old child, with criminal homicide. According to published reports, Jones was undergoing Medication Assisted Treatment (MAT) and receiving doses of methadone to treat her addiction to opioid painkillers.

Multiple commentators swiftly voiced opposition to the District Attorney, decrying the criminal charges against Jones, arguing it is “highly problematic” to levy criminal charges against a person undergoing treatment for Substance Use Disorder.

Read More