Life Sciences: Biotechnology / Pharmaceuticals / Medical Devices
- Successfully pursued former employees who had violated non-competition and non-solicitation agreements with biotech companies.
- Act as outside general counsel to nonprofit disease research entity for all transactions; program compliance; contracting; HIPAA compliance; governance challenges and compliance.
- Regularly provides general counsel guidance to biotechnology/life science companies on a wide range of contract, employment, financing, policy and regulatory compliance matters.
- Assisted medical device manufacturer with investigating and resolving a serious manufacturing error, including guidance through an FDA recall and investigation.
- Worked with medical device company on product that supports diabetics with 510k transfers; protection of IP in pipeline and acquired devices/get FDA approval/litigation, strategy, etc.
Emergency and Outpatient Care Centers
- Represented ambulatory surgery center as general counsel, advising on reimbursement and payor negotiations, joint venture with large hospital system, employee and HR matters and contract issues.
- Assisted nonprofit hospital with closure of free clinic.
- Assisted nonprofit health care research and advocacy with inception and execution of accreditation program.
Emerging Growth Companies
- Successfully lead multiple due diligence investigations in emerging growth companies for world’s largest angel investment group.
- Advised emerging growth pharmaceutical company with employment and HR matters, including trade secret protections.
Health Care Providers
- Guided a large primary care practice in dealing with accusations of inappropriate behavior against a physician owner, terminating the physician owner and represented the practice before the state board of medicine.
- Advised health care provider on claims of caregivers’ inappropriate behavior by its clients, including advising on investigation, response to client, PR issues and conclusion of investigation.
- Regularly assist individual MDs and DO’s with complaints against them to the state board of medicine and/or the National Practitioners’ Data Bank and reciprocal investigations and enforcement action.
- Developed HIPAA compliance product for clients, including policies and procedures, training, regulatory compliance and related issues.
- Assisted large mental health provider with HIPAA breach investigation and reporting, business divorce, employee matters and non-competition and wage litigation.
- Assisted administrator of deceased psychiatrist with regulatory compliance in closing practice.
Health Care Technology and Health Information Technology
- Identified and resolved legal and regulatory data privacy obstacles for health care IT client to develop a first-of-its-kind health information exchange (HIE) product for cross-border data exchange.
- Draft and review all contracts for health care IT data software client with hospital groups.
- Draft all master service agreements for IT vendor in pharma development space including products for global clinical trial project management, analytics, HIPAA and data privacy regulation.
- Represented health care software and analytics company in corporate restructuring, finance and contract matters with large group purchasing organizations, allowing the company to provide services to GPO’s representing over 90% of all US hospitals.
- Regularly provides general counsel guidance to health IT companies on a wide range of contract, employment, financing, policy and regulatory compliance matters.
Home Health Care Provider Services
- Advised physiotherapy and home health client in the complex acquisition of the assets of another agency and forming a new entity in compliance with state and federal department of health change of ownership regulations.
- Successfully pursued former employees who had violated non-competition and non-solicitation agreements with home health care companies.
- Successfully litigated a complex business divorce on behalf of a home health agency against a former owner.