Pharmaceuticals and Healthcare
High Court provides guidance on the interpretation of “defect” under the Consumer Protection Act 1987
In a landmark judgment on the meaning of "defect" under the Consumer Protection Act 1987 ("the Act"), Mr Justice Hickinbottom in the High Court case of Wilkes v DePuy adopted an objective test for safety by reference to what the … Continue reading
Filed under Pharmaceuticals and Healthcare, Product safety
New sentencing guidelines for corporate manslaughter and health and safety offences come into force today
The Sentencing Council has published guidelines to be used by Judges when sentencing corporate manslaughter, health and safety offences and food safety and hygiene offences. The guidelines will apply to all sentences passed on or after 1 February 2016 irrespective … Continue reading
The UK Consumer Rights Act 2015 – key changes that every consumer business should be aware of
The Consumer Rights Act 2015 represents a significant development in the regulation of consumer contracts under UK law. It consolidates and brings consistency to rules that were previously spread across a wide range of different Acts and Regulations. It also … Continue reading
ECJ lowers level of proof required to prove ‘defect’ in medical products
In Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt and Another the European Court of Justice gave a purposive interpretation to the definition of “defect” for the purposes of the EC Product Liability Directive 85/374/EEC in the context of medical devices.
Filed under Europe, Pharmaceuticals and Healthcare, Product recall, Product safety, UK
Australian complementary medicines review: have your say
On 20 January 2015, the Department of Health announced that it is calling for submissions in relation to its review of the regulation of complementary medicines. The review is being undertaken by an expert panel and forms part of a … Continue reading
Filed under Australia, Pharmaceuticals and Healthcare
ACCC v Pfizer – some guidance to pharmaceutical companies on navigating competition risk
The Federal Court of Australia has recently dismissed the ACCC’s case against pharmaceutical company Pfizer. The ACCC alleged that Pfizer had misused its market power and engaged in prohibited anti-competitive exclusive dealing. Continue reading
Filed under Australia, Pharmaceuticals and Healthcare
Consultation on new sentencing guidelines for corporate manslaughter and health and safety offences
The Sentencing Council for England and Wales has launched a consultation on new guidelines to be used by courts when passing sentence for corporate manslaughter and health and safety offences. This follows a review of sentences passed by the courts … Continue reading
FDA proposes revised guidance for distribution of scientific/medical publications addressing “off-label” uses—and faces free speech concerns
The US Food and Drug Administration (FDA) has issued a revised draft guidance setting forth FDA’s views on the dissemination of certain information regarding “off-label” uses of drugs or medical devices. While the FDA has sought to clarify its position … Continue reading
Recent developments since PLIVA v Mensing: Towards a generic rule of pre-emption for drug makers
Joseph G. Falcone and Michael R. Kelly, Product Liability Law & Strategy 32 (2013) On 7 October, 2013, the US Supreme Court denied review of Demahy v. Schwarz Pharma, Inc., 702 F.3d 177 (5th Cir. 2012), effectively terminating this state … Continue reading
Filed under Pharmaceuticals and Healthcare, United States