Ontario Health Minister Eric Hoskins is calling on the federal government to prosecute the pharmaceutical giant whose pain pill triggered Canada's deadly opioid epidemic.
"As we continue to work together to address problematic opioid use in Canada, it is important that Purdue Pharma be held accountable for any inappropriate or potentially illegal activities in the marketing of OxyContin in Canada," Dr. Hoskins says in a letter to federal Health Minister Jane Philpott, a copy of which was obtained by The Globe and Mail.
The Stamford, Conn.-based company has acknowledged in the United States that its marketing of OxyContin was misleading, but it has not made a similar admission in Canada. The company's marketing encouraged doctors to prescribe opioids more widely for everything from back pain to fibromyalgia. Canada is the world's second-highest per-capita user of prescription painkillers.
On Wednesday, an Ontario court approved a $20-million settlement in a class-action lawsuit against Purdue brought by Canadians who became addicted, or their families.
A spokesman for Dr. Philpott said the minister is in regular contact with her provincial and territorial counterparts to discuss any actions that will assist in "turning the tide" on the opioid crisis. "We will continue to explore our options when it comes to addressing past and current causes of this opioid and overdose epidemic," Andrew MacKendrick said in an e-mail.
Dr. Hoskins is urging Ottawa to use its powers under the federal Food and Drugs Act (FDA) to prosecute Purdue. In the United States, Purdue and three of its executives paid $634.5-million (U.S.) in 2007 to settle criminal and civil charges against them for misbranding OxyContin as less addictive than other pain medications.
"As you know, the FDA prohibits the selling or advertising of a drug 'in a manner that is false, misleading or deceptive,'" Dr. Hoskins says in the letter.
Settlement of the long-standing class-action lawsuit could make it difficult for the Ontario government to pursue its own legal action to seek compensation from the company for health-care costs, lawyers say. The $20-million (Canadian) to settle the lawsuit includes $2-million for the provinces and territories, which were parties to the agreement.
The settlement also must be approved by the courts in Saskatchewan, Quebec and Nova Scotia before it becomes final. It is not an admission of liability by Purdue.
"If the settlement is approved, there is an argument to be made by Purdue that the compensation question has been resolved in the $20-million settlement," said Ray Wagner, a Halifax lawyer whose firm launched the class action in 2007.
Grant Perry, vice-president of corporate and government affairs at Purdue, declined to comment on whether the provinces would have any further legal recourse against the company.
In response to Dr. Hoskins's push for federal action, Mr. Perry said Purdue markets its products in Canada in compliance with "all relevant rules, regulations and codes, including the Food and Drugs Act."
Dr. Hoskins says "serious consideration" of a prosecution is warranted under one of three sections of the FDA, including 31.4, which says anyone who "knowingly or recklessly causes a serious risk of injury to human health" is committing a crime. Under recent revisions to the act, section 31.4 carries the highest maximum penalties: five years in prison plus a fine left to the court's discretion, with no cap on the financial penalty. A Health Canada spokeswoman said these penalties could not be applied to situations that arose before the act was strengthened.
The proposed class-action settlement would cap a legal battle that began a decade ago between the company and lawyers representing as many as 1,500 Canadians who became addicted to OxyContin after their doctors prescribed it. The average payout to each of the 1,000 to 1,500 claimants would range from $13,000 to $18,000. OxyContin generated $31-billion (U.S.) in revenue for Purdue.
The class-action accuses Purdue of knowing that anyone who took OxyContin would be at risk of becoming addicted to it and suffer withdrawal symptoms if they stopped. But at no time were these risks disclosed.
Canada's opioid epidemic traces its roots to the introduction of OxyContin 21 years ago. Until the mid-1990s, opioids were used primarily for terminal cancer patients. In 1996, Health Canada approved OxyContin to relieve pain that was moderate to severe. Purdue distinguished OxyContin from its rivals by promoting its time-release formula – the pill was designed to be digested over 12 hours.
Company sales reps persuaded doctors to expand their use of opioids beyond treating cancer pain by pushing the notion that OxyContin posed a lower threat of abuse and dependence than other, faster-acting painkillers, the class-action suit alleges. The drug was the top-selling long-acting opioid in Canada for more than a decade.
OxyContin also became a lightning rod in the early 2000s, as reports of opioid dependence and overdoses exploded. Purdue pulled OxyContin from the market in 2012, shortly before the patent was to expire.
A host of other, stronger drugs filled the void when OxyContin was taken off the market, including illicit fentanyl, which began appearing on the streets in Canada in 2012, leading to a sharp spike in opioid-related deaths.