Dr. Bluni has been recognized by Chambers USA: America’s Leading Lawyers for Business, Super Lawyers Massachusetts, LMG Life Sciences, and Managing IP – IP Stars.

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Danny regularly tries cases and arbitrations in Tennessee, Arkansas and Mississippi. He has tried an arbitration or case in 16 states and three foreign countries. He is known as a practical problem solver who has a keen sense of a client’s ultimate business objective and keeps that in focus throughout the life of the case.

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Gary advices clients in matters relating to the approval and commercialization of products that are regulated by the Food and Drug Administration and other federal and state agencies. Gary has substantial experience advising clients on all aspects of product approvals; product launches and commercialization including advertising and promotion; leading compliance-related investigations; developing and implementing regulatory and healthcare compliance programs; advising on patient support programs; and managing competitor disputes. In addition, Gary regularly advises clients on matters relating to healthcare fraud and abuse, clinical trials, informed consent, drug safety issues, product liability, recalls, responding to 483s, warning letters and complete response letters, drug and device quality and manufacturing issues, and life cycle management. Gary also represents companies in transactional matters including distribution and purchasing agreements, pharmacy agreements, clinical trial agreements, payor agreements, manufacturing and supply agreements, physician agreements, research agreements and co-promotion agreements.

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Laura also draws on her enforcement experience to provide clients with practical regulatory advice regarding compliance with federal and state health care fraud and abuse law, particularly under the federal Physician Self-Referral Law (Stark Law), Anti-Kickback Statute (AKS), and FCA, and their state analogs. In addition, Laura helps clients conduct internal investigations, prepare and negotiate self-disclosures to regulators including HHS-OIG and the Centers for Medicare and Medicaid Services (CMS), and obtain advisory opinions from HHS-OIG. She also helps clients negotiate corporate integrity agreements (CIAs) with HHS-OIG and counsels clients on creating and maintaining effective compliance programs.

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Ms. Florence’s extensive experience across multiple matter types allows her to keep one step ahead of potential issues and proactively identify impact areas for clients in the industry. She applies this insight in advising FDA-regulated companies, genomic laboratories and other health care providers regarding fraud and abuse and FDA regulatory compliance in several contexts, including in connection with internal investigations, corporate integrity agreement implementation and corporate compliance programs assessments. In addition, Ms. Florence frequently serves as a subject-matter expert on high-stakes transactions, and has advised clients on more than 300 transactional matters.

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Michelle primarily counsels pharmaceutical, medical device, and biotech clients on legal and compliance issues related to product commercialization and related sales, marketing, and reimbursement activities. Michelle reviews promotional content and medical communications, advises on fraud and abuse matters and related issues, provides direction regarding field and account management, and supports clients’ compliance initiatives, including the development of policies/SOPs, training, and monitoring and auditing programs. Michelle also negotiates, drafts and reviews commercial and government contracts, including discount and rebate agreements with health plans/PBMs, retail/specialty pharmacies, GPOs, wholesalers, and other healthcare entities. In addition, she handles distribution agreements and other fee-for-service consulting and service arrangements common in the life sciences industry.

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A skilled advocate and creative problem-solver, Sarah works enthusiastically to understand and master the products she is entrusted to defend, whether in a single-plaintiff case or a mass tort setting. Sarah’s clients frequently request her counsel on complex scientific, engineering, and regulatory matters, in and out of the courtroom. Sarah also has extensive first- and second-chair trial experience, defending high-stakes product liability matters on behalf of major manufacturers and downstream supply chain entities

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Ross regularly conducts internal investigations, both of alleged misconduct and to proactively assess risk, on behalf of major life sciences companies and corporations across all industries. He has conducted 100+ internal compliance investigations for pharmaceutical companies alone. Ross is recognized in the 2018 edition of The Legal 500 as among the leading attorneys in the US for Health Care: Life Sciences.

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Richard leads a team of 18 lawyers in several offices of the firm who have worked closely with him in successfully handling MDLs and other litigation with a national scope. Together, with the assistance of numerous other attorneys throughout Nelson Mullins’ nationwide platform, the team has successfully litigated and resolved thousands of cases around the country.

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