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Saul Ewing LLP


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Practice/Industry Group Overview

Experienced counselors, litigators, and deal-makers, our Life Sciences attorneys assist our clients in the pharmaceutical, medical device, biotechnology, and healthcare industries in thinking – and moving – ahead.

Saul Ewing's Life Sciences Practices offers a wide range of legal services to our clients in these industries, and represents a wide array of clients – from multinational pharmaceutical and device manufacturers, to aspiring new entrants in the biotechnology field, to major teaching hospitals and healthcare systems, to community hospitals, health agencies, and practitioners, to healthcare service entities of any variety.

The attorneys comprising our Life Sciences Practices can be found in nearly every Saul Ewing department and discipline, meeting our clients' needs in litigation, risk management and risk counseling, civil and criminal investigation and enforcement, financing, corporate and transactional law, tax, general regulatory advice, reimbursement and payor relations, medical device approval, and privacy and data management counseling. We have served our clients' life sciences needs in the Mid-Atlantic region, across the United States, and internationally.

In addition to maintaining their active law practices, our Life Sciences attorneys are also frequent speakers, panelists, and participants in pharmaceutical, medical device, biotechnology, and health law seminars and presentations, and have published widely on matters affecting the life sciences industries. Our attorneys include active members in the Food, Drug & Law Institute, the Defense Research Institute, and the International Association of Defense Counsel's Drug, Device, and Biotech Committee. Our attorneys have often been quoted authorities by the media on matters affecting the life sciences industries. In just the recent past, for example, our attorneys have been quoted in USAToday, Pharmaceutical Processing, MedAd News, PharmaVoice, FDA News-Pharmaceutical Corporate Compliance Report, Managed Healthcare Executive, CN-8 Television, The Philadelphia Inquirer, The Legal Intelligencer, and various other publications on core issues such as pharmaceutical e-commerce, reimportation, federal regulatory structure and reliability, direct-to-consumer advertising, drug withdrawals, anticipated industry developments and growth areas, and other critical issues confronting these industries.

For many years, Saul Ewing's Life Sciences Practices has counseled, negotiated, advised and defended clients in the life sciences industries, accumulating a knowledge and experience reservoir that makes Saul Ewing a true destination law firm for life sciences representation. The attorneys in Life Sciences Practices focus their talents in three core areas of our clients' legal needs – managing litigation risks, pioneering transactions and strategic alliances, and conferring regulatory, privacy, and healthcare contracting advice.

Recently our Life Sciences Practices collaborated with HCPro, Inc. to provide legal insights, published materials, and seminar presentations to providers of healthcare products and services located throughout the country. Headquartered in Massachusetts, HCPro, Inc. is now recognized as one of the Nation's leading providers of integrated information, education, training, and consulting products and services in the areas of healthcare regulation and compliance. Click here to read more about the work we are doing with HCPro.

In addition to the provision of traditional legal services, Saul Ewing LLP has referring relationships with a government consulting institution, CCH Partners LLC. It serves the greater Mid-Atlantic Region.

Thinking Ahead

Saul Ewing's Firm motto is "Thinking Ahead, So You Can Move Ahead;" nowhere is this attribute more apt or more indispensable than in our Life Sciences Practices.

In order to assist our clients in moving ahead, our attorneys continually build their knowledge base, while anticipating developments that may affect the counsel and advice given to our clients, which is integral to our representation. Our Life Sciences attorneys understand this very specialized area of law, follow its changing statutory and regulatory framework, analyze the ever-evolving case law, and develop relationships with the agencies and the players essential to success.

Representative Matters

  • Saul Ewing attorneys represented an international pharmaceutical company in successfully resolving a dispute with upstream suppliers and downstream distributors arising out of damage to bulk product caused by hurricane.
     
  • Life Sciences team consulted with a major pharmaceutical company in developing a clinical laboratory business compliance program, in litigation analysis and negotiations of settlement with other major pharmaceutical companies arising from FDA investigation and enforcement proceedings, and in strategic analysis of repercussions of bankruptcy of a purchaser of intellectual property.
     
  • Life Sciences team defended one of the world's leading medical research, clinical practice, and education centers in various litigations, as well as a premier university hospital against numerous litigations involving research on deceased human subjects.
     
  • Life Sciences team defended claims involving various medical devices, including fetal monitors, intraocular lenses, cataract and vitreoretinal surgical devices, intrauterine devices, laboratory testing, latex products, medical exercise equipment, medical packaging, medical restraints, pedicle screws, piercing guns, silicone implants, and wheelchairs and lifts.
     
  • Saul Ewing attorneys defended claims involving various drug products, including a cholesterol-lowering product, a congestive heart failure pharmaceutical, a dental anesthetic, diethylstilbestrol, fenfluramine, dexfenfluramine, iophendylate contrast dye, and a third-generation antibiotic.

 
Group Presentations
  Off-Label Use of Medical Devices: Promotion and Compliance, November 18, 2009
A Summit on PA Funding Opportunities for Technology and Life Sciences Entrepreneurs, November 12, 2009
TechNite 2009, Baltimore Convention Center in Baltimore, Maryland, October 15, 2009
Mark Levy to sign copies of his book on off-label communications at FDLI's 21st Annual Advertising and Promotion Conference, L'Enfant Plaza Hotel in Washington, DC, September 21, 2009
The Impact of Supplier Quality on Your Bottom Line and Your Company's Risk, September 9, 2009
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Past Seminar Materials
  From discovery to delivery: Bio-Life-Tech 2009, December 8, 2009
ACI's 14th Annual Drug & Medical Device Litigation Conference, December 8, 2009
American Conference Institute's 13th Advanced Forum on: Structuring, Negotiating and Managing Pharma/Biotech Collaborative Agreements, November 17, 2009
Biotech 2009: Imagine. Collaborate. Innovate, November 16, 2009
2009 Mid-Atlantic Bio, Washington, DC Convention Center, November 4, 2009
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