As a commercial litigator, Sheena McKie has been a part of some of Australia's (and the world's) most high-profile, large-scale class actions, complex commercial and product liability litigation.

Sheena has a particular focus on the healthcare and life sciences sector, including disputes involving pharmaceutical and medical devices. She also guides her clients through the complex regulatory and legislative regimes established by therapeutic goods legislation and the National Health Act (PBS pricing).

Sheena's product liability and product safety advisory practice covers product-related aspects of the Australian Consumer Law, including safety defect provisions and the set-up, notification and management of voluntary product recalls.

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Expertise

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Litigation and Dispute Resolution

Johnson & Johnson (Australia) Pty Limited: Sheena is representing Johnson & Johnson Medical Pty Ltd and two overseas manufacturing entities in the defence of class action proceedings involving Australian claimants who allege they suffered complications relating to surgical mesh and tape products. The hearing ran for more than 85 sitting days over more than seven months.

Merck & Co., Inc. and Merck Sharp & Dohme (Australia) Pty Limited (MSDA): Sheena represented Merck & Co Inc and Merck Sharp & Dohme (MSD) Australia Limited in the defence of representative proceedings involving claimants alleging to have suffered cardiovascular injuries due to their consumption of VIOXX, a COX-2 inhibitor. On 11 May 2012, we secured an historic High Court win in these proceedings.

ABC Learning Centres: Sheena advised Morgan Stanley Private Equity Asia in relation to the high-profile recovery action in the Supreme Court of New South Wales against ABC Learning Centres (in liquidation) (receivers and managers appointed) for recovery of damages after investing $70m just prior to the demise of ABC Learning Centres.

ACL penalty proceedings: Sheena represented a national retailer in ACCC penalty proceedings arising in respect of product safety and product recall issues.

Janssen-Cilag Pty Ltd: Sheena represented Janssen-Cilag in an Administrative Appeals Tribunal challenge in relation to the content of a competitor's product information for a biosimilar medicine.

See Litigation and Dispute Resolution

Class Actions

Johnson & Johnson (Australia) Pty Limited: Sheena is representing Johnson & Johnson Medical Pty Ltd and two overseas manufacturing entities in the defence of class action proceedings involving Australian claimants who allege they suffered complications relating to surgical mesh and tape products. The hearing ran for more than 85 sitting days over more than seven months.

Merck & Co., Inc. and Merck Sharp & Dohme (Australia) Pty Limited (MSDA): Sheena represented Merck & Co Inc and Merck Sharp & Dohme (MSD) Australia Limited in the defence of representative proceedings involving claimants alleging to have suffered cardiovascular injuries due to their consumption of VIOXX, a COX-2 inhibitor. On 11 May 2012, we secured an historic High Court win in these proceedings. 

Mergers & acquisitions class action risk advice:Her familiarity with the Australian class actions environment means Sheena can advise local and international companies with advice on how to address class action risk in the context of corporate mergers and acquisitions. 

See Class Actions

Product Liability

Johnson & Johnson (Australia) Pty Limited: Sheena is representing Johnson & Johnson Medical Pty Ltd and two overseas manufacturing entities in the defence of class action proceedings involving Australian claimants who allege they suffered complications relating to surgical mesh and tape products. The hearing ran for more than 85 sitting days over more than seven months.

Merck & Co., Inc. and Merck Sharp & Dohme (Australia) Pty Limited (MSDA): Sheena represented Merck & Co Inc and Merck Sharp & Dohme (MSD) Australia Limited in the defence of representative proceedings involving claimants alleging to have suffered cardiovascular injuries due to their consumption of VIOXX, a COX-2 inhibitor. On 11 May 2012, we secured an historic High Court win in these proceedings.

ACL penalty proceedings: Sheena represented a national retailer in ACCC penalty proceedings arising from product safety and product recall issues.

Large-scale product recall and remediation action: Sheena acted for a national retailer in a large-scale consumer goods product recall and remediation action. This involved engaging subject-matter experts to provide expert advice and reports, project management and liaison with regulators.

Product liability and product safety advisory practice: Sheena regularly provides advice to Australian and overseas clients in a range of industries on product liability, product safety and recall issues and the Australian Consumer Law. These issues include safety defect provisions and mandatory standards, set-up, notification and management of voluntary product recalls, mandatory notifications of serious injury, illness or death, and consumer guarantees. As part of this work, Sheena is experienced in liaising with the Australian Competition and Consumer Commission as well as State and Territory regulators across Australia. 

See Product Liability

Pharmaceutical and Medial Devices

Regulatory and pricing advisory practice: Sheena regularly provides advice to Australian and overseas clients in the pharmaceutical (consumer and animal health) and medical device industries on their obligations under Australian law and industry codes. Her work includes PBS pricing and judicial review applications, regulation of innovative medical device products, the marketing and promotion of pharmaceutical and medical device products, product safety and recall issues and clinical trial agreements, as well as liaising with the Therapeutic Goods Administration and Commonwealth Department of Health.

Johnson & Johnson (Australia) Pty Limited: Sheena is representing Johnson & Johnson Medical Pty Ltd and two overseas manufacturing entities in the defence of class action proceedings involving Australian claimants who allege they suffered complications relating to surgical mesh and tape products. The hearing ran for more than 85 sitting days over more than seven months.

Merck & Co., Inc. and Merck Sharp & Dohme (Australia) Pty Limited (MSDA): Sheena represented Merck & Co Inc and Merck Sharp & Dohme (MSD) Australia Limited in the defence of representative proceedings involving claimants alleging to have suffered cardiovascular injuries due to their consumption of VIOXX, a COX-2 inhibitor. On 11 May 2012, we secured an historic High Court win in these proceedings.

Janssen-Cilag Pty Ltd: Sheena represented Janssen-Cilag in an Administrative Appeals Tribunal challenge in relation to the content of a competitor's product information for a biosimilar medicine. 

See Pharmaceutical and Medical Devices

Healthcare and Life Sciences

Regulatory and pricing advisory practice: Sheena regularly provides advice to Australian and overseas clients in the pharmaceutical (consumer and animal health) and medical device industries on their obligations under Australian law and industry codes. Her work includes PBS pricing and judicial review applications, regulation of innovative medical device products, the marketing and promotion of pharmaceutical and medical device products, product safety and recall issues and clinical trial agreements, as well as liaising with the Therapeutic Goods Administration and Commonwealth Department of Health.

Johnson & Johnson (Australia) Pty Limited: Representing Johnson & Johnson Medical Pty Ltd and two overseas manufacturing entities in the defence of class action proceedings involving Australian claimants who allege they suffered complications relating to surgical mesh and tape products. The hearing ran for more than 85 sitting days over more than seven months.

Merck & Co., Inc. and Merck Sharp & Dohme (Australia) Pty Limited (MSDA): Sheena represented Merck & Co Inc and Merck Sharp & Dohme (MSD) Australia Limited in the defence of representative proceedings involving claimants alleging to have suffered cardiovascular injuries due to their consumption of VIOXX, a COX-2 inhibitor. On 11 May 2012, we secured an historic High Court win in these proceedings. 

Janssen-Cilag Pty Ltd: Sheena represented Janssen-Cilag in an Administrative Appeals Tribunal challenge in relation to the content of a competitor's product information for a biosimilar medicine. 

See Healthcare and Life Sciences

Australian Consumer Law

ACL penalty proceedings: Sheena represented a national retailer in ACCC penalty proceedings arising in respect of product safety and product recall issues. 

Product liability and product safety advisory practice: Sheena regularly provides advice to Australian and overseas clients in a range of industries on product liability, product safety and recall issues and the Australian Consumer Law. These issues include safety defect provisions and mandatory standards, set-up, notification and management of voluntary product recalls, mandatory notifications of serious injury, illness or death, and consumer guarantees. As part of this work, Sheena is experienced in liaising with the Australian Competition and Consumer Commission as well as State and Territory regulators across Australia.  

See Australian Consumer Law

Knowledge

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