Burt Snell

Since joining Kirkland, Burt has been involved in the following representations:

Litigation

• Assist clients in and oversight of product litigations across the US, EU, UK, greater EMEA, Australia, Canada and South Africa.
• Assist client on terms of use and arbitration provisions and effect of OUS laws and regulations concerning advertising for certain regulated products, including the EU Product Liability Directive (PLD), EU Unfair Contract Terms Directive, EU Representative Action Directive (RAD), as well as laws of individual EU countries.
• Assist client in response to and hearing in the Hague re Position of the Dutch RIVM (Ministry of Health) and Health Inspectorate (IGJ) on third party FOIA requests, the EU Medical Device Directive (MDD), EU Medical Device Regulations (MDR) and Dutch law.
• Assist client in response to FDA FOIA litigation request.
• Assist client in litigation risk assessment in connection with product recall.
• Assist client in claims involving an alleged defective product, UK Consumer Protection Law and obligations under the UK General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018.
• Assist client in analysis of EU and India regulations and laws re: product manufacturing and distribution and defense of allegations of adulteration, nonconformity and injury.
• Assist client in response to consumer and product claims in Israel.

Regulatory

• Assist client in responses to UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) re use, indications and promotion of product and UK Medical Device Regulations.
• Assist client in analysis of FDA regulatory obligations, product recall analysis and procedure.
• Assist client in responding to creditor’s claims concerning FDA regulations and restrictions on sale of products in inventory via bankruptcy.
• Assist client in response to the European Medicines Agency’s (EMA) analysis of product safety and request for further regulatory measures.
• Assist client in response to request for HCP payment and analysis under the Australian Therapeutic Goods Administration’s (TGA) regulations and guidance, EMA regulations and guidance, and Australian law concerning effects of a transfer of value.
• Assist client in product marketing and clinical trial program in several OUS countries.
• Assist client in analysis FDA regulations and guidance concerning evaluation, selection, control, and monitoring of suppliers (including service providers) and consultants to meet specified requirements, including quality requirements.
• Assist client in responses to UK MHRA re alleged defective product.
• Assist client in response to Israeli Ministry of Health re pharmacovigilance, product claims and user labeling and information.
• Assist client in responses to German media concerning product regulatory scheme, indications, usage and advertising.
• Assist client in response concerning product’s compliance with the German Medicinal Products Act (AMG), the German and EU Product Liability Directive (ProdhaftG), and the German Civil Code (BGB).
• Assist client in responses to Australian media concerning product regulatory scheme and labeling updates.
• Assist client in draft and scope of standard response letter regarding product assessment and inspection and effect of various countries’ regulations and laws.
• Assist client in response to third party inquiry concerning clinical study of FDA regulated product.
• Assist client in responses to EU Health Authority’s inquiry concerning product indications and labeling, and relevant EU regulatory requirements.
• Assist client in UK Parliamentary inquiry and company witness presentation.
• Assist client in regulatory updates to US product and company website terms of use.
• Assist client in adverse event reporting before US FDA and EU regulators and communications on final complaint investigation and root cause determination.
• Assist client in analyses of adverse events before various OUS regulators.
• Assist client in evaluation of FDA regulations, FDA administrative actions, and Citizens Petition concerning product, and attending antitrust and litigation risks.
• Assist client on good pharmacovigilance practices in the EU and UK and International Council for Harmonisation (ICH) Guideline on Post Approval Safety Data Management.

Diligence

• Assist client in analysis of target medical device company’s regulatory, quality, post-market surveillance, clinical studies and litigation risks and compliance with EU, UK and US regulations.
• Assist client in assessment of regulatory, compliance and legal risks of FDA inspections and internal audits of clinical trial sites.
• Assist client in analysis of product and clinical trials under FDA, CLIA, HIPPA, Common Rule regulations, Federal FCA, Anti-kickback, and EKRA and potential risks.
• Assist client in analysis of FDA Biologic License Application (BLA) post-approval quality and manufacturing changes and communications with FDA.
• Assist client in analysis of product manufacturing, FDA GMPs, and due diligence on compliance and manufacturing methodology.
• Assist client in analysis of Contract Research Organization’s (CRO) compliance with FDA regulations and guidance, FDA Form 483s to clinical study sites, and potential regulatory, compliance and litigation risks.
• Assist client in analysis of target health care company’s regulatory requirements and operation, FDA inspections, Form 483s and Warning Letter, and litigation history, exposure and risks.
• Assist client in analysis of potential FDA action on target product classification, litigation considerations and risks.
• Assist client in determining state law consenting requirements for clinical and experimental studies and interplay with federal law.
• Assist client in analysis of FDA product classification, premarket notification and quality management system obligations for target company.
• Assist client in transaction involving transfer of a Drug Master File, notice to FDA and timing of transfer of IND and Drug Master Files, and potential regulatory and litigation considerations.
• Assist client in evaluation and due diligence of national and state pharmacy audits and inspection reports, SOPs, CAPAs and remediation.
• Assist client in diligence re potential sale of products marketed in the US and EU and attendant regulatory considerations for legal and contract manufacturers, manufacturing site transfer, registration, compliance with FDA Quality Management System Regulation (QMSR) and ISO 13485, and FDA and Notified body inspections.
• Assist client in due diligence re target company’s FDA compliance and attendant regulatory and litigation risks.
• Assist client in evaluation of target product manufacturing site’s FDA inspections, regulatory risks, and remediation plan.

Prior to joining Kirkland, Burt was involved in the following representations:

• Represented AbbVie and Allergan in federal and state court personal injury and class action litigation, in foreign litigation, and in U.S. and foreign regulatory, compliance, investigations, and clinical, medical and safety matters involving medical devices and pharmaceuticals.
• Represented Ethicon, Inc. and Johnson & Johnson in MDL, state court and AG litigation involving medical devices, in foreign cases and class actions, and in U.S. and foreign regulatory matters and governmental and third-party investigations.
• Represented chemical manufacturer in thousands of environmental and products liability PFAS claims in state and federal courts nationwide.
• Represented clients in several mass torts involving pharmaceuticals, as well as individual cases involving pharmaceuticals and medical devices.
• Served on numerous trial teams defending Merck & Co., Inc. in the New Jersey Vioxx® litigation, including eliciting trial testimony by witnesses leading to defense verdicts.
• Member of the trial team for AstraZeneca, which secured a defense verdict in the first trial of more than 20,000 claims involving the prescription drug Seroquel®, including eliciting favorable warning and damages trial testimony from key physicians who prescribed the medication and diagnosed the claimed injury.
• Led national and international mass tort expert teams, including in numerous very high-volume MDL waves involving 200–400 cases each and one wave where defense expert reports were served in over 550 cases on a single day.
• Served as lead trial counsel in a nursing home case situated in Pennsylvania state court, which was favorably settled for the client before trial.
• Represented companies involved in large-scale litigation and individual product liability matters involving alleged asbestos exposure, chemical contamination, foods and herbicides.
• Counseled and handled cases involving commercial and intellectual property litigation, antitrust litigation, construction and flood litigation, media and constitutional law, and third-party liens.