Academic Medical Centers
Developed an agreement among five AMCs for cooperative multi-center clinical trial research designed to facilitate the ability of all five institutions to attract clinical research as a group.
Represented a large health system client in the class action antitrust lawsuit filed by several medical residents against various hospitals and medical schools that sponsor residency programs, as well as several medical organizations, such as the American Association of Medical Colleges, the American Hospital Association, the American Medical Association, and the National Resident Matching Program. The lawsuit alleges that the match of medical students to residency programs, the accreditation rules for residency programs, and several surveys of resident stipends/benefits were part of a conspiracy to reduce the stipends and other benefits provided to medical residents in violation of antitrust laws.
Represented a university and a not-for-profit consortium of universities in connection with the construction of a 1,750-bed student dormitory and multiuse facility in Chicago. This representation included: (1) structuring and forming the consortium; (2) negotiating a redevelopment agreement with the City of Chicago; (3) obtaining the necessary public approvals and required tax exemption; and (4) handling related federal income tax matters and the issuance of $150 million in tax-exempt bonds.
Represented a teaching hospital in a joint venture with oncologists to (1) purchase PET/CT scanners, linear accelerators and other equipment used in the diagnosis and treatment of cancer and (2) lease that equipment to the hospital for use in its cancer center.
Counseled a prominent teaching hospital on how to structure its multimillion-dollar personal services and clinical research support arrangements with the hospital's affiliated university and faculty plan to comply with federal anti-kickback and physician self-referral laws.
Biotechnology
Represented a major New York area university in the preparation and negotiation of a patent license agreement with a biotechnology start-up company. The license was for a diagnostic test for an important childhood disease based on the presence of a disease susceptibility gene. The test is currently under consideration for FDA approval.
Evaluated the microarray patent landscape to determine the freedom of a European biotechnology company. The company used the evaluation to plan its strategy for further development and commercialization.
Prepared patentability, freedom to operate, and infringement opinions for small and large biotechnology and pharmaceutical companies including Pharmacia and Sigma Aldrich Corporation. The opinions were used by the companies to determine courses of action for acquisition, merger and research development plans.
Health Information Technology Companies
Advised an Internet disease management company regarding State practice of medicine laws, drafted agreements (e.g., Web Site Terms and Conditions, Privacy Policy, Membership/User Agreements, etc.), and provided guidance regarding the HIPAA privacy and security regulations.
Completed a Federal and comprehensive multi-state survey of anti-kickback, self-referral and fee-splitting laws and regulations and provided advice on an organizational structure designed to comply with such laws. In addition to providing general advice on corporate/transactional matters, firm attorneys drafted the company’s Internet agreements as well as its membership/user agreements and physician participation agreements.
Provided privacy, security and regulatory counseling to a publicly traded application service provider and software vendor servicing health plans and insurance companies.
Provide a large health information technology vendor with the full array of compliance counsel including reviewing contract agreements with providers to assure compliance with State and Federal fraud and abuse laws as well as compliance with the HIPAA Private Rule and its State counterparts.
Provided advice to a large health care data clearinghouse on structuring its operations in compliance with State and Federal privacy obligations, including the HIPAA Privacy Rule and State law restrictions on the use and disclosure of social security numbers.
Represented a top 10 financial institution in the Federal marketing and deployment of electronic claims and payments processing technologies with the Department of Veterans Affairs and Centers for Medicare & Medicaid Services.
Hospitals and Health Systems
Assisted a teaching hospital in restructuring its cardiovascular surgery program, which involved recruiting a nationally recognized cardiovascular surgeon to assume the role of chair of the newly created cardiovascular services department and negotiating and drafting the medical director agreement, professional services agreement, and other ancillary agreements between the surgeon, his professional corporation, and the hospital.
Represented a teaching hospital in a joint venture with oncologists to form a limited liability company (1) to purchase state-of-the-art equipment, including PET/CT scanners, linear accelerators and other equipment used in the diagnosis and treatment of cancer and (2) to lease that equipment to the hospital for use in its cancer center.
Represented a group of hospitals in connection with the restructuring of their existing senior and subordinated debt agreements and negotiation of a new health care receivables purchase facility.
Insurers & Managed Care Organizations
Served as counsel to a hospital, medical center and health plan in connection with a series of publicly and privately issued bonds, totaling approximately $100 million, for improvements to existing structures and the development of new facilities.
Provided legal services in connection with the sale of a health maintenance organization jointly owned by the hospital and a medical school to a national health plan.
Provided ERISA-related assistance to a host of entities in the design, implementation, administration, and revision of qualified pension and profit sharing plans, welfare plan arrangements, benefit plans, executive compensation programs, profit-sharing, and stock options, among other benefit offerings.
Advised an insurer concerning its dual role as plan sponsor and provider of insurance coverage to its in-house plans.
Counseled an insurance company concerning prohibited transaction issues in transactions involving insurance company separate accounts with ERISA plan investors and governmental plan investors not subject to ERISA.
Represented major institutional clients with respect to amendments to post-retirement medical benefit plans in order to reduce or eliminate extremely large potential liabilities.
Defended a major insurer under investigation by the Department of Health and Human Services Office of Inspector General for alleged violations of the Medicare Secondary Payer rules.
Medical Devices
Representation of Fastenetix, LLC, a developer of medical devices used in orthopaedic procedures, including spinal fusion and arthroplasty devices, in connection with a patent infringement and breach of contract litigation against one of the world’s leading medical device manufacturers involving products representing annual sales in the multiple hundreds of millions of dollars.
Representation of SpineCore, Inc., a medical device company in the spine arthroplasty market in connection with its formation, angel financing, Series A Preferred Stock financing with Warburg Pincus and The Vertical Group, and its ultimate sale to Stryker Corporation, a leader in the worldwide orthopedic market and one of the world's largest medical device companies, for $380 million.
Representation of Orthocon, Inc., a specialty pharmaceutical and medical device company focused on the development of new and innovative products for the orthopedic and spine surgery markets, in connection with its $10 million Series A Preferred Stock financing with Canaan Partners and BB Biotech. Orthocon’s lead product, the Xybrex™ Anesthetic Matrix, is a proprietary, completely absorbable anesthetic matrix applied intraoperatively to act as a bone hemostatic agent as well as a drug delivery carrier to reduce postoperative pain.
Representation of ElectroCore, LLC, a developer of platform technologies for use in treating patients using proprietary electrical signals that stimulate nerves and other tissue, thereby modulating the behavior of patients’ muscles, nerves, organs, or other tissue to provide positive treatments for the patient’s ailments. ElectroCore’s proprietary signals are designed initially to treat acute bronchoconstriction associated with severe asthma attacks, hypotension and post-operative ileus.
Representation of K2 Medical, LLC, a medical device company developing innovative technologies in the spine and orthopedic markets, in connection with its formation, acquisition of in excess of 40 patents and initial equity financing, as well as healthcare regulatory matters.
Pharmaceuticals/Chemicals
Representation of a joint venture among The Dow Chemical Company and industry leaders in the fields of analytical testing and consulting of chemicals and related products in the formation and initial funding of the joint venture and licensing of the joint venture’s intellectual property.
Representation of AD-4 Pharma, an emerging growth company developing random lead compound screening programs through the potential of the latest rational drug design techniques coupled with novel guidance systems for pharmacophore structures, in connection with corporate and intellectual property matters.
Physicians and Physicians’ Groups
Represented a multi-specialty physician group in connection with a government investigation of managed care contracting practices.
Represented a corporate provider of laser eye surgery services in a merger transaction valued at nearly $100 million.
Counseled a group of cardiologists in connection with their relationship with a large hospital that had a regional heart center, for the management of hospital’s cardiac services line.
Counseled medical providers regarding the structure of, and participation in, a provider network
Structured the affiliation between one of the system’s hospitals and a large multi-specialty medical group. This matter involved the extension of a subordinated loan facility to the medical group to satisfy the solvency requirements of its provider-sponsored health maintenance organization, and the negotiation of equity participation by the hospital in the medical group.
Professional Societies & Trade Associations
Advised a Medical Society in connection with its role in facilitating dialog between a major insurer and local physicians concerning managed care contracting.
Assisted a trade association of hospitals and health systems in revising its corporate governance policies to reflect the principles of corporate responsibility set forth in the Sarbanes-Oxley Act of 2002, including the development of a
Code of Ethics for senior financial personnel and a whistleblower protocol.
On behalf of a large health system client, Sonnenschein is involved in the class action antitrust lawsuit filed by several medical residents against various hospitals and medical schools that sponsor residency programs, as well as several medical organizations, such as the American Association of Medical Colleges, the American Hospital Association, the American Medical Association, and the National Resident Matching Program. The lawsuit alleges that the match of medical students to residency programs, the accreditation rules for residency programs, and several surveys of resident stipends/benefits were part of a conspiracy to reduce the stipends and other benefits provided to medical residents in violation of antitrust laws.
Conducted a nation-wide preemption analysis under the HIPAA and State privacy laws affecting insurers and health care providers.
Provided antitrust and other regulatory counseling to a State association of medical groups.
Provided policy and other guidance regarding regulatory issues affecting association members.
Provided regulatory advice on issues of interest to association members and advocated for improvements in enforcement activities undertaken by the Centers for Medicare & Medicaid Services.
Represent a national high profile cancer foundation in the development of a national health plan for cancer — including elements of research and development, detection and prevention, treatment and survivorship issues. Sonnenschein assisted the foundation in the development of authorization legislation, Federal appropriations, and Congressional relations, including high profile meetings and events with Senators, Members of Congress, and the White House in support of the client’s agenda.
