Sheva Sanders 612.335.1588e-mail| vCard
Our Life Sciences and Health Practice attorneys help solve the complex legal and regulatory issues critical to business for established and emerging pharmaceutical, biotechnology, health care (including digital health), animal health, environmental, biologics and medical device companies. Our multi-disciplinary team includes attorneys who combine deep industry experience with strong health law, corporate, intellectual property and product liability capabilities, helping health care and life sciences companies from start-ups to international organizations, achieve their goals. Many of our life sciences attorneys have worked in-house at major health care and life sciences companies, including device manufacturers, hospitals, and health plans, giving them insight into industry dynamics and implementation challenges and equipping them to offer practical solutions. In addition, several attorneys have advanced degrees in biology, microbiology, biotechnology, chemistry, agricultural biochemistry and engineering, giving our team the legal experience and technical understanding that life science companies need, particularly in their formative stages. We have experience representing a diverse spectrum of health care and life sciences companies, involved in research, development, technology transfer, commercialization, and, ultimately, delivery of innovative products and services to patients and other consumers.
Our Life Sciences and Health Practice attorneys help solve the complex legal and regulatory issues critical to business for established and emerging pharmaceutical, biotechnology, health care (including digital health), animal health, environmental, biologics and medical device companies. Our multi-disciplinary team includes attorneys who combine deep industry experience with strong health law, corporate, intellectual property and product liability capabilities, helping health care and life sciences companies from start-ups to international organizations, achieve their goals.
Many of our life sciences attorneys have worked in-house at major health care and life sciences companies, including device manufacturers, hospitals, and health plans, giving them insight into industry dynamics and implementation challenges and equipping them to offer practical solutions. In addition, several attorneys have advanced degrees in biology, microbiology, biotechnology, chemistry, agricultural biochemistry and engineering, giving our team the legal experience and technical understanding that life science companies need, particularly in their formative stages. We have experience representing a diverse spectrum of health care and life sciences companies, involved in research, development, technology transfer, commercialization, and, ultimately, delivery of innovative products and services to patients and other consumers.
SCOPE OF SERVICES Successfully navigating the complex state and federal regulatory framework applicable to health care and life sciences companies requires a deep knowledge of the health care industry and numerous bodies of state and federal law, as well as keeping abreast of enforcement trends. In order to ensure that expertise is available to you, Stinson has a cross-disciplinary team focused on providing services to the health care and life sciences industries. Our team will work with you and your company to provide sophisticated, pragmatic solutions to your legal challenges. Our Health Care and Life Sciences practice focuses on laws, regulations, and transactional issues particularly relevant to life sciences and health care companies, including guidance in bringing innovative health care products and services to market, and includes representation in the following areas, to name a few: Intellectual Property and Technology Collaborations, licensing, tech transfer and strategic alliances Counseling on corporate IP strategy and infringement avoidance Patent and trademark preparation, prosecution and maintenance IP enforcement and defense litigation Patent post grant review proceedings Due diligence and IP support for mergers and acquisitions Regulatory and Compliance Fraud and abuse laws (e.g., anti-kickback, civil monetary penalty, Stark law, state law) HIPAA, GDPR, FTC, state privacy and confidentiality Internal investigations Licensing, credentialing and peer review activities Coding, coverage and reimbursement, including defending against exclusion, recoupment and offsets Compliance audits, investigations, training and programs Contract research organizations (CROs) and clinical trials FDA compliance (e.g., off-label promotion issues, product labeling, recalls, ANDA) Manufacturer, distributor, sales force and vendor relationships Medicare, Medicaid, TriCare and VA regulation Network enrollment, administration and formation Representation of third party administrators (TPAs) and pharmacy benefit managers (PBMs) Sunshine Act and state aggregate spend compliance Telemedicine and remote health monitoring Corporate Finance Loans Private equity financing Public and private equity, including tax-exempt financing Strategic corporate investments Venture capital and emerging companies Transactions, Governance and Business Counseling Strategic mergers and acquisitions Business entity organization, formation, and governance Vertical integrations including health plan-provider combinations and hospital-clinic combinations Review, analysis and drafting of contracts, including physician and non-physician provider contracting, management and administrative services agreements Joint ventures, including physician-hospital joint ventures, accountable care organizations (ACOs) Litigation Administrative and regulatory hearings Antitrust and trade regulation Business torts Class action Intellectual property enforcement and infringement defense Product liability White collar defense, including qui tams Other Relevant Services Employment and labor law Government relations Tax and exempt organization law Leasing of hospital and other clinical facilities and equipment RELEVANT EXPERIENCE Representing a life sciences company in the conduct of an internal investigation relating to whistleblower allegations of off-label promotion. Representing a device importer/distributor in the conduct of a recall. Developing national strategies for innovative product offerings by device and pharmaceutical companies in telehealth, remote monitoring, genome sequencing and drug delivery. Representing life sciences companies before federal (DOJ, FDA, CMS) and state (Department of Health, Department of Insurance, professional licensing boards), in connection with investigations, inquiries, disputes and requests. Representing a private pharmaceutical company in connection with raising more than $30 million in start-up and mezzanine financing through a series of U.S. and overseas debt and equity offerings. Representing drug manufacturers in a diverse range of competition cases including cases brought under federal and state antitrust and competition laws in more than 35 states. Representative cases include In re Ciproflaxin Hydrochloride Antitrust Litigation, In re Cardizem Hydrochloride Antitrust Litigation, In re Brand name Pharmaceutical Drugs Antitrust Litigation and Clayworth v. Aventis Pharmaceuticals Inc. Representing a Fortune 500 company, as lead investor, in connection with a $20 million convertible preferred stock investment in a molecular technology company. Representing several large colleges and universities in their efforts to patent and commercialize bioscience and other technologies. Representing a variety of life sciences companies in their patent and trademark filings throughout the world. Serving as IP counsel for an early stage life sciences company's spin-out of its technology for a field of use to a non-U.S. company Representing Sanofi-Aventis U.S. LLC in anti-trust litigation involving patent settlements. Serving as national counsel for an international pharmaceutical company responsible for coordinating more than 100 product liability cases filed in various state court and federal districts, including two multidistrict litigations. Representing both brand name and generic drug manufacturers in product liability litigation throughout the U.S. Representing drug manufacturers in mass tort suits alleging heart disease, heart failure, stroke and wrongful death from hormone replacement therapy prescription medication. Representing a drug manufacturer in a suit brought in Florida involving allegations that our client monopolized the anticoagulant market. Serving as co-lead and liaison defense counsel for medical device manufacturer in multidistrict litigation involving dual modular hip replacement prostheses. Representing pharmaceutical and device manufacturers in product liability suits involving pain pumps. Serving as counsel for ERISA and non-ERISA disputes for group health plans and their third-party administrators. REPRESENTATIVE CLIENTS We work with the following types of life sciences companies: Academic Medical Centers Animal Health Companies Biologics Clinical research organizations (CRO) Clinical/surgical supplies Diagnostic research Dietary supplement & General nutrition Genomic testing and personalized medicine Group purchasing organizations Inventors Investigators Medical device Patient assistance programs Pharmaceuticals & Vaccines Pharmacies, including retail, mail-order, specialty and compounding pharmacies PBM Plant science Resellers and distributors
Successfully navigating the complex state and federal regulatory framework applicable to health care and life sciences companies requires a deep knowledge of the health care industry and numerous bodies of state and federal law, as well as keeping abreast of enforcement trends. In order to ensure that expertise is available to you, Stinson has a cross-disciplinary team focused on providing services to the health care and life sciences industries. Our team will work with you and your company to provide sophisticated, pragmatic solutions to your legal challenges.
Our Health Care and Life Sciences practice focuses on laws, regulations, and transactional issues particularly relevant to life sciences and health care companies, including guidance in bringing innovative health care products and services to market, and includes representation in the following areas, to name a few: