Winnipeg lawsuit seeks billions of dollars for failed plan to manufacture COVID-19 vaccine in Manitoba

An American company that manufactures vaccines is being sued in Winnipeg for billions of dollars following a failed plan to produce a COVID-19 vaccine supply in Manitoba during the pandemic.

Alberta vaccine company Providence Therapeutics Holdings contacted U.S.-based Emergent BioSolutions in January 2021 about producing tens of millions of doses of a COVID-19 vaccine developed by Providence.

The vaccine was to be made at a facility in Winnipeg operated by Emergent's affiliated Canadian company, Emergent BioSolutions (Canada).

In a lawsuit filed at Manitoba Court of King's Bench in Winnipeg on June 13, Providence alleges Emergent made numerous misrepresentations to secure the work of developing and manufacturing the COVID-19 vaccine.

Providence is seeking damages in the billions of dollars from Emergent: $1.012 billion US for misrepresentation, the same amount for negligence, and again that amount for breach of an agreement.

The statement of claim also seeks $12 million US from Emergent in restitution for unjust enrichment from payments made by Providence to Emergent for work that was not properly concluded.

The lawsuit alleges Providence would have received "substantial financial benefit" from commercial development of its vaccine, had the plan gone ahead.

In February 2021, then Manitoba premier Brian Pallister announced the province would buy two million doses of COVID-19 vaccine from Providence Therapeutics, on the condition it would be approved for use in Canada.

At the time, Pallister said the poor availability of vaccines from the federal government was a limiting factor in getting Manitoba's population immunized.

In the lawsuit, Providence now alleges Emergent Canada's existing facility in Winnipeg could not accommodate "the work required to produce the commercial volumes of the PTX COVID-19 Vaccine."

It says Emergent was not "highly competent" in commercial development of mRNA vaccines, that it did not have reliable manufacturing capabilities for the vaccines, and it lacked capacity and equipment in the Winnipeg facility.

Employees of Emergent were not properly trained to do the work needed for commercial development of the vaccine, and there were not enough employees to carry out the work for 24 hours a day, the lawsuit alleges.

"Emergent Canada and Emergent, whether negligently, deliberately or as a result of gross negligence or otherwise, were never able to produce a manufacturing process and were never able to deliver commercial batches during the entire term" of the agreement with Providence, the court document alleges.

"Emergent's failure to develop the manufacturing process and reasonably and efficiently progress the work of manufacturing the commercial volumes was at all times negligent and a breach of the standard of care expected," the claim says.

It also says Providence provided the Emergent companies with "extensive proprietary information" for its processes used in developing clinical batches of its COVID-19 vaccine.

"Emergent has previously made and continues to make use of the Providence know-how to advance its own business interests including to develop mRNA products for customers other than Providence," the lawsuit alleges.

The result was "profits improperly gained by Emergent," the claim alleges.

CBC contacted Emergent, which is based in Maryland, and a spokesperson said the company had not yet been served with the statement of claim.

The Calgary lawyer for the plaintiff, Providence Therapeutic Holdings, declined to comment on the lawsuit.

The court document says Providence, throughout its involvement with Emergent, was involved in "ongoing efforts to seek final regulatory approval" of its COVID-19 vaccine.

Providence lost the ability to achieve a "streamlined regulatory approval" that was available only until the end of 2022, the claim alleges, which meant Providence "lost the highly valuable opportunity" to deliver its vaccine to market in 2021 or 2022.

The lawsuit alleges Emergent was negligent in not being able to do accurate inspections of PTX COVID-19 vaccine vials, and in an inability to identify solutions when there were deviations in test batches of the vaccine.

It alleges Emergent failed to "conduct a reasonable number of test batches" in order to develop the manufacturing process.