Health Minister Rona Ambrose recently introduced Bill C-17, An Act to Amend the Food and Drugs Act. The bill reflects the government's promise to ensure that drug labels be written in plain language, and that the potential side effects of medication are accurately indicated. The bill also gives the government authority to require healthcare institutions to report adverse reactions.
Health Canada has announced its position on certain activities associated with unapproved medical devices and the corresponding roles and responsibilities of stakeholders and industry. Specifically, Health Canada now advises that unlicensed medical devices can be included in a request for proposal or information – a shift from its prior position that only licensed products could be the subject of such a request.
The Canadian Food Inspection Agency is asking consumers and food industry stakeholders to comment on elements of the Safe Food for Canadians Action Plan, which aims to strengthen and modernise the food safety system. The consultation will provide input into the regulations that are being developed in connection with the Safe Food for Canadians Act, which was passed in November 2012, but which is still not in force.
Claiming to act on behalf of all Quebecers who have developed inflammatory bowel disease as a result of taking the drug Accutane, Yann Lebrasseur filed a motion seeking certification of a class action. However, the Quebec Superior Court recently refused to allow the action to proceed. This decision confirms that in order to be certified, a class action must be supported by solid evidence, not just vague, general allegations.
Canada's new food safety legislation, the Safe Food for Canadians Act, was passed in November 2012 but has not yet come into force. As one of the steps leading towards the eventual implementation of the act, the government recently announced the Safe Food for Canadians Action Plan and changes to the rules governing federally inspected meat plants.
Health Canada has released a public consultation proposal to amend the Playpens Regulations under the Canada Consumer Product Safety Act. The proposal seeks to enhance infant/child safety by aligning the regulations with existing requirements under the Canadian Cribs, Cradles and Bassinets Regulations and by further aligning Canada's safety requirements with certain international standards and US requirements.
The Divisional Court of Ontario has upheld a landmark decision denying certification of a product liability class action. The court endorsed the reasons and analysis of Justice Horkins, a lower court judge who had denied certification of a proposed class action involving an anti-psychotic drug.
The Safe Food for Canadians Act has passed its third reading in the House of Commons and now awaits royal assent. The act, which consolidates four key pieces of legislation, includes a mechanism for formalising and strengthening the controls applicable to imported foods and a prohibition on the sale of foods that have been recalled by federal order.
The Ontario Superior Court of Justice recently handed down the first-ever trial decision in a product liability class action in Canada. This is the first class action to go to trial that included a claim in waiver of tort and therefore is an important decision in the development of Canadian class action jurisprudence.
A recent Ontario Superior Court decision denying certification of a pharmaceutical class action could have a significant impact on the conduct of product liability class actions in the province. In rejecting certification, the court closely analysed the claim being advanced and the common issues proposed, and concluded that the action was unsuitable for certification.
The Quebec Court of Appeal has sided with respondents Wyeth Consumer Healthcare Inc and Johnson & Johnson Inc in dismissing an appellant's motion for a class action. The appellant sought to represent parents who had purchased certain over-the-counter medicines for children, alleging that the respondents had provided no warning about the lack of efficacy of the medicines or their potential health risks.
The Quebec Superior Court recently dismissed a motion filed by a petitioner for authorisation to institute a class action against a drug manufacturer on behalf of all natural persons in Quebec who had purchased or taken a drug marketed under the name FOSAMAX®, which is prescribed for treating and preventing osteoporosis. The petitioner accused the manufacturer of negligence and failure in its duty of safety and its duty to inform in marketing the drug.
The Canadian government has introduced amendments to the Food and Drug Regulations and the Patented Medicines (Notice of Compliance) Regulations which provide an application process for the market authorisation and protection of 'extraordinary use new drugs'. Under the new regulations, manufacturers are required to demonstrate the safety and efficacy of a 'new drug' in order to obtain market authorisation in Canada.
Product liability claims relating to medicinal products are based primarily on common law principles of negligence. There is a heavy onus on manufacturers of drugs and medical devices in Canada to provide clear, complete and up-to-date disclosure to consumers concerning risks inherent in the ordinary use of their products.
The Canada Consumer Product Safety Act has received royal assent and is now Canadian law. Among other things, the act prohibits the manufacture, importation, advertisement or sale of any consumer products that pose an unreasonable danger to human health or safety.
Health Canada recently announced another consultation on regulations under the proposed Canada Consumer Product Safety Act. The intent of the proposed Administrative Monetary Penalties Regulations would be to provide details on how a penalty for a violation under the proposed act would be calculated, including 'gravity factors', weighting and penalty values
Health Canada recently announced that it will conduct a consultation regarding proposed exemption regulations pursuant to the proposed Canada Consumer Product Safety Act. The proposed exemption regulations would exempt certain classes of consumer product from compliance with specified provisions of the proposed act or other regulations made pursuant to the act.
The Canadian government has reintroduced consumer product safety legislation. This is now the third time that the legislation has been introduced. The new Canada Consumer Product Safety Act includes many of the provisions that were found in previous iterations of the legislation.
A proposed class action was commenced against Pfizer Canada Inc for alleged negligence relating to the manufacture and sale of Neurontin (gabapentin). The plaintiffs alleged that Pfizer owed a duty of care to consumers of brand and generic gabapentin. Pfizer commenced third-party claims against 21 generic drug manufacturers which manufacture and sell products containing gabapentin in Canada.
The Canada Consumer Product Safety Act recently received its third reading in the Senate. It was passed, but with amendments to the text as passed by the House of Commons. The Senate amendments were limited in scope and designed to address some of the issues that had been raised concerning the breadth and constitutionality of the enforcement powers granted under the legislation.