Methadose class-action lawsuit filed against B.C.

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Laura Shaver had abstained from using illicit opioids for about seven years when British Columbia replaced its supply of methadone with a new version called Methadose.

The change in 2014, which affected all of the province’s roughly 15,000 methadone patients at the time, led Ms. Shaver to experience debilitating withdrawal symptoms that she thought she had left behind for good.

Ms. Shaver is now the lead plaintiff in a proposed class-action lawsuit filed against the B.C. Ministry of Health, the College of Pharmacists of B.C., and the maker of Methadose.

A statement of claim filed in B.C. Supreme Court this week alleges that the province’s switch from the old methadone formula to Methadose “had the same adverse effects, including relapse, overdose and death, on thousands of [opioid agonist therapy] patients in the province.”

“It felt like death,” Ms. Shaver, 42, said in an interview. "I felt like I had no power. I didn’t know whose body I was in, whose mind was thinking. It had been so long since I felt any withdrawal symptoms that it was so scary. To me, withdrawal means death. I would rather be dead than go through withdrawal, in all seriousness.”

Ms. Shaver relapsed to illicit opioid use within one week of the switch in February, 2014, and overdosed eight times in the following years, just as illicit fentanyl began supplanting the opioid supply and driving an unprecedented surge in overdose deaths in B.C.

The statement of claim said the change is “among the contributing causes of the overdose epidemic which has resulted in tens of thousands of overdoses and approximately 5,000 overdose deaths in B.C. since 2013,” the legal document continued.

Users who spoke to The Globe and Mail said the old formula typically staved off withdrawal symptoms for 24 hours, and sometimes more. With Methadose, many reported withdrawal symptoms in 12 to 16 hours.

At least three published scientific studies, involving hundreds of patients, found that the change disrupted treatment, led to an increase in illicit-drug use and produced considerable health and social harms.

The lawsuit also names the maker of the treatment, Mallinckrodt PLC in the United States and Mallinckrodt Canada ULC.

The statement of claim says that Mallinckrodt, the college and province entered into an “exclusive exchange” agreement that added Methadose to the province’s Pharmacare Plan C, for those on income assistance, and removed the old formula.

It accuses the province and college of digging “their heads into the ground and [refusing] to acknowledge or consider the risks of Methadose, even as the tragic evidence of those risks mounted around them.”

The claims have not been proven in court.

The Globe reported last November that Terry Lake, the B.C. health minister who oversaw the switch, said he had heard within months that some people were not doing well, and sought a briefing and review from the ministry, which included advice from the College of Pharmacists of B.C.

“The signal to me was, ‘Let’s see how things go.’ [The experts said] it seemed to be heading in the right direction,” Mr. Lake told The Globe in November. “When you’ve got recommendations from the College of Pharmacists and people that are well-versed in this stuff, I tend to put a lot of weight on that kind of expert advice."

The B.C. Ministry of Health and the College of Pharmacists of B.C. declined to comment for this story. Mallinckrodt did not respond to requests for comment. The ministry, college and the Canadian division of the pharmaceutical company have three weeks to respond, while the U.S. division has 35 days.

Last May, after years of lobbying from drug-user activists, the province made a third version of methadone, called Metadol-D, eligible for regular benefit coverage through PharmaCare. And in October, it made the old methadone formula available in exceptional circumstances to those who do not benefit from Methadose or Metadol-D.

Lawyer Jason Gratl, who represents Ms. Shaver, said the lawsuit’s two objectives are to restore broad patient access to the old formula and to secure compensation for those who have been injured by the switch.

“They knew within months of this forced change that it wasn’t working, that it was causing instant problems,” Mr. Gratl said. “There were catastrophic consequences of overdose and death, [and] an unbelievably extreme overdose epidemic with thousands of people dying.”

That the province would choose not to provide broad access to the old formulation amid the overdose crisis is “beyond my understanding,” Mr. Gratl said.

The original methadone formulation consists of a white, crystalline powder that is diluted in a liquid – often an orange-flavoured juice – before it is dispensed daily to patients. Methadose is a cherry-flavoured liquid that does not require mixing. It is 10 times stronger than the old formulation, which means patients get the same amount of methadone in 1/10th the amount of liquid.

The B.C. Ministry of Health, along with the colleges of pharmacists and physicians and surgeons, said in 2014 that Methadose was safer because it does not require manual mixing, and doses are therefore more likely to be consistent. It also does not need refrigeration.

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