Growing Concerns Surrounding the Opioid Addiction Epidemic

The opioid crisis in Canada and elsewhere continues to grow with often tragic results. In Canada, one life was lost every two hours related to opioids in 2018¹.  How did we get to this point? What is being done to address this widespread crisis, and how is the insurance industry responding?

For centuries, opioids have been used for pain relief. Initially reserved for the treatment of acute and terminal illness pain, prescriber attitude about opioids began to change after aggressive marketing by pharmaceutical companies, and also following the publication of a medical journal article in 1980²,  which challenged the practice of only prescribing opioids for acute pain because it declared that those with chronic pain rarely became addicted. This article was used as evidence that few became addicted to opioids. The article influenced prescriber attitude about the use of opioids and they began to be prescribed for all pain control³, including post-operative pain.

The medical discipline, however, has documented that controlled drugs, such as opioids, pose the potential for abuse and diversion. Despite that, the aggressive marketing of controlled substances, including OxyContin (introduced in 1996) by Purdue Pharma, resulted in over-prescription and misuse, resulting in patient overdoses and deaths⁴.

Purdue Frederick Company, Inc., an affiliate of Purdue Pharma, was charged with marketing OxyContin “as less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications.”⁵ Purdue pleaded guilty to misbranding OxyContin, with the intent to defraud or mislead, a felony under the federal Food, Drug, and Cosmetic Act. 21 U.S.C.A. §§ 331(a), 333(a)(2) (West 1999) and three Purdue executives pleaded guilty to the misdemeanor charge of misbranding, solely as responsible corporate officers⁶.

The effective treatment of pain, particularly chronic pain, continues to challenge the medical community. Doctors began prescribing opioids for all pain as pharmaceutical firms promoted their benefits as a non-addictive option. North America has the highest number of opioid users in the world --Canada is second only to the U.S. in prescription opioid use. Once opioids were in the prescribed medication main stream, their abuse and illegal use became a reality and the numbers of misusers and abusers of opioids has continued to increase dramatically.  The number one opioid killer in Canada is fentanyl, which is as much as 100 times more potent than morphine and 50 times more potent than heroin.

Toll of Opioids is Widespread
Acute and chronic pain management requires balancing symptom management with the risk of misuse and abuse of medications. Long-term opioid use leads to the development of physical dependence and the need to consume more opioids to achieve the initial level of pain relief. Unfortunately, opioids have a high risk of addiction, even when used as prescribed because they trigger the release of endorphins, which dampen the perception of pain and produce a feeling of well-being. Taking opioids for more than a few days increases the potential for chronic use and the possibility of addiction.

Consumers of opioids who wish to taper or decrease their medication face withdrawal (with symptoms including pain, agitation, fatigue, hallucinations, sweating and vomiting). As one of the first symptoms of withdrawal is increased pain,  the opioid consumer may incorrectly believe that this symptom is an indication of the drug’s effectiveness and therefore continue to use opioids.

The toll of opioids includes not only addicts and their family and friends, but also the cost to healthcare agencies, law enforcement and criminal justice systems. Treating patients for addiction is more expensive than prescribing painkillers. According to the Public Health Agency of Canada (PHAC), between January 2016 and March 2019, an estimated 12,800 Canadians died from apparent opioid-related overdoses⁹.

According to Canadian Institute of Health Information (CIHI), the Northwest Territories, Yukon and British Columbia lead in the number of opioid poisonings (defined as the incorrect use of an opioid that results in harm)¹⁰. In 2018, Ontario and British Columbia led in the number of deaths in Canada, with 1,471 and 1,525 deaths, respectively¹¹.  Deaths may be either accidental or intentional (i.e., suicide).

Litigation Against Opioid Distributors and Manufacturers
With 80% of the global supply of opioids consumed in the U.S.¹², litigation against opioid manufacturers and distributors has primarily been focused there, with class actions initially centered on pharmaceuticals involved in creating the crisis. Purdue Pharma, the manufacturer of OxyContin, has been the focus of opioid litigation in the U.S. for more than a decade, and just recently announced it was filing for Chapter 11 bankruptcy protection.

Litigation against opioid manufacturers includes allegations that the companies exaggerated the benefits of the medication -- that they knew the drugs were overly prescribed because doctors were not warned of the extremely addictive nature of the narcotics and the need to strictly limit doses prescribed. Allegations against distributors include the claim that they violated the U.S. Controlled Substances Act by failing to alert law enforcement of suspicious purchases, such as orders of unusual size, frequency or pattern.

Lawsuits also claim pharma companies lobbied doctors and politicians to artificially increase the use of opioids. Distributors and manufacturers such as McKesson Corporation, Purdue Pharma, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) have been and continue to be sued. Thousands of claims have been filed against opioid companies.

Lawsuits against opioid makers are not confined to the U.S. In May 2017, Purdue Pharma agreed to settle with 2,000 plaintiffs for $20 million¹³.  As of May 2019, more than $1 billion in lawsuits have been filed in Canada against the implicated opioid pharmaceutical companies>¹⁴, including Purdue Pharma, Bristol-Myers Squibb and Apotex. Suits have been filed in British Columbia, Ontario and Quebec. It remains to be seen what actions will occur in the remaining provinces and territories.

Insurance Carriers and Opioid Coverage
  As calls for accountability are mounting, there are concerns that the breadth of the litigation could expand to include others in the supply chain, such as retailers, hospitals, physician offices and clinics. As the lawsuits progress, plaintiffs and defendants are waiting and watching to see what case law stems from them.

Insurance policies will often have language that severely restricts coverage or excludes coverage, thus avoiding this exposure. For example, opioids are listed on CNA’s Specified Products Exclusion Endorsement. Insurance underwriters and brokers need to continue monitoring litigation trends and their impact on coverage for pharmaceutical manufacturers and distributors. Coverage options available to Life Sciences companies that manufacture or distribute opioids will continue to evolve.

Learn More About the Opioid Crisis
For more information about the opioid crisis and its impact in Canada, including help resources, visit the Government of Canada’s opioid crisis page. More information is also available through various provincial governments, including the Ontario Ministry of Health and Ministry of Long-Term Care.   In common with other provincial and territorial regulatory authorities, the College of Physicians and Surgeons of Ontario has published many useful guidelines and positions including appropriate opioid prescribing guidance.

_{¹ Government of Canada. (2019). National Report: Apparent Opioid-related Deaths  in Canada. Retrieved at https://health-infobase.canada.ca/datalab/national-surveillance-opioid-mortality.html
² New England Journal of Medicine. (1980). Addiction Rare in Patients Treated  with Narcotics. Retrieved at https://www.nejm.org/doi/10.1056/NEJM198001103020221.
³ Mayo Clinic. (2018). How Good Intentions Contributed to Bad Outcomes: The  Opioid Crisis. Retrieved at https://www.mayoclinicproceedings.org/article/S0025-6196(17)30923-0/pdf
⁴ Am J Public Health. (2009). The Promotion and Marketing of OxyContin:  Commercial Triumph, Public Health Tragedy. Retrieved at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2622774/
⁵ U.S. District Court for the Western District of  Virginai Abingdon Division. (2007).United  States of America v. The Purdue  Frederick Company, Inc., et al. Retrieved at https://casetext.com/case/united-states-v-purdue-frederick-co
⁶ Ibid at page 1.
⁷ McMaster University. (2017). The 2017 Canadian Guideline for Opioids for  Chronic Non-Cancer Pain. Retrieved at http://nationalpaincentre.mcmaster.ca/guidelines.html
⁸ Ibid.
⁹ PHAC. (2019). National Report: Apparent Opioid-related Deaths in Canada.  Retrieved at https://health-infobase.canada.ca/datalab/national-surveillance-opioid-mortality.html.
¹⁰ CIHI. (2018). Opioid-Related Harms in Canada, December 2018. Retrieved at https://www.cihi.ca/sites/default/files/document/opioid-related-harms-report-2018-en-web.pdf
¹¹ Public Health Agency of Canada (PHAC). (2019). National Report: Apparent  Opioid-related Deaths in Canada. Retrieved at https://health-infobase.canada.ca/datalab/national-surveillance-opioid-mortality.html#AORD.
¹² Kennedys Law. (2017). The Opioid Epidemic: A  Painful Threat to Europe?. 
¹³ The Globe and Mail. (2017). Purdue Pharma agrees to settle OxyContin class-action suit. Retrieved at https://www.theglobeandmail.com/news/national/purdue-pharma-agrees-to-settle-oxycontin-class-action-suit/article34861736/
¹⁴ BioSpace. (May 16, 2019). $1.1 Billion in Lawsuits Filed Against Opioid Makers in Canada. Retrieved from https://www.biospace.com/article/lawsuits-filed-against-opioid-makers-in-canada/.}