April 11, 2025
Stearns Weaver Miller News Update
Overview
Healthcare
The firm represents healthcare providers in various multifaceted challenges healthcare organizations face. Clients include:
- Assisted Living Facilities (ALFs)
- Clinics
- Federally Qualified Health Centers (FQHCs)
- Health Maintenance Organizations (HMOs)
- Home Health Agencies
- Hospitals
- Hospital Associations
- Institutional Healthcare Enterprises
- Laboratories
- Nursing Homes
- Outpatient Centers
- Physicians and Other Individual Licensed Healthcare Professionals
- Physician Practices
- Retirement Centers
- Skilled Nursing Facilities
Life Sciences
We frequently act as primary counsel for companies in the life sciences industry, including start-ups, emerging business enterprises and publicly-traded companies. Our life sciences clients span a wide array of industries. Clients include:
- Biotechnology
- Biotherapeutics
- Biopharmaceutical
- Clinical Trials
- Contract Manufacturing
- Diagnostics
- Drug Delivery Technology – Ingested, Injected and Transdermal
- Drug Development
- Medical Device
- Pharmaceutical – Generic and Branded/Proprietary
- Prescription Drug Processing
- Supply and Distribution – including Durable Medical Equipment (DME)
Our clients’ products span the full range of the life sciences sector and include robotic surgical systems and instruments, sterilization systems for medical devices and surgical instruments, transdermal drug delivery systems, pharmaceuticals, coronary stents and balloon angioplasty catheters, peripheral stents, cardiac mapping systems and ablation catheters, devices for treatment of abdominal aortic aneurysms, atrioventricular interval modulation therapy devices, immunotherapy drugs and devices, blood glucose monitors and test strips, human source plasma from proprietary collection facilities, tissue and tissue-derived cells, leukopaks, laparoscopic surgical instruments, surgical staples, gastric balloons, ophthalmic surgery devices, a minimally invasive gastric banding system, balloon sinuplasty systems, a device for treatment of uterine fibroids, and a developer of cell therapies, among others.
Range of Services
Administrative & Regulatory
- Obtain licenses and permits from State Boards of Pharmacy
- Provide regular HCC training to sales teams and executive management including training on Anti-Kickback Statute, the Foreign Corrupt Practices Act (FCPA), Health Insurance Portability and Accountability Act (HIPAA), and the AdvaMed and PhRMA Codes on interactions with healthcare professionals
- Develop healthcare compliance programs and policies for companies
- Corporate governance and compliance
- Medicaid reimbursement and licensure
- Regulatory filings and compliance
- Rulemaking and rule challenges
Commercialization
- Conduct securities offerings for, and mergers, acquisitions and sales of, medical device, diagnostics and pharmaceutical companies
- Draft and negotiate supply, manufacturing, purchase and sale, licensing, and distribution agreements
- Draft and negotiate joint venture and strategic alliance agreements between clients and other industry participants
- Draft and negotiate clinical trial, educational grant, consulting, and fellowship agreements between clients and health care providers, research institutes and physicians
- Draft and manage process for negotiation of clinical trial and registry agreements with universities and principal investigators on behalf of device and pharmaceutical manufacturers
- Draft and negotiate capital equipment rental and service agreements
- Negotiate group purchasing organization (GPO) and integrated delivery network (IDN) agreements as well as product purchase and sale agreements with individual hospitals in connection with representation of medical device, pharmaceutical and diagnostic companies
- Represent licensees in the license of various patents and technology owned by public university research foundations to start-up medical device and biotechnology companies
- Negotiate third-party logistics agreements
- Product life cycle management
- Proxy contest and proxy solicitation campaigns
Labor & Employment Counseling and Litigation
Real Estate
- Assist with the purchase and leasing of laboratory and pharmaceutical processing facilities, manufacturing plants, logistics centers, plasma collection facilities, and cGMP clean room facilities
- Represent FQHCs and other health care providers, in the acquisition, disposition, financing, and construction of commercial real estate projects
Medical Malpractice & Professional Liability Defense
- Catastrophic wrongful death defense
- Medical malpractice defense
- Professional liability claims
- State licensing investigations and litigation for physicians, nurses, pharmacists and other healthcare professionals
- Breach of contract and collection matters from insurers and third party payors
Medical Device, Diagnostics and Pharmaceutical Litigation
- Generic drug approval litigation and marketing exclusivity litigation under the Hatch-Waxman Act
- Intellectual property and drug and technology development disputes between rival companies
- Disputes with raw materials and other suppliers
- Product liability
- Counterfeiting
- Defend and prosecute class actions, particularly those involving antitrust or securities law violations
- Hospital reimbursement disputes
- Insurance reimbursement and disputes
- Government investigations and audits
- Antitrust violations in the pharmaceutical industry
Notable Experience
- Regularly serve as primary counsel for a number of life sciences companies, assisting with all aspects of their needs for legal services from day-to-day counseling, drafting and negotiating commercial contracts, documenting equity raises as well as merger and acquisition transactions.
- Drafted and negotiated commercial agreements for over a billion dollars in sales of products and services.
- Drafted and negotiated agreements for hundreds of millions of dollars in equity investments, including clients’ Series A, B, C and D rounds and Convertible Notes and SAFES.
- Represented clients in over 20 M&A life sciences transactions over past five years.
- For over 20 years, has represented one of the largest plasmapheresis company in the world in its nationwide leasing of plasma collection centers, logistics centers and laboratory space located in multi-tenant shopping centers or stand-alone buildings around the country. Due to the nature of the blood plasma collection industry and the client’s business operations, which is highly regulated by governmental agencies such as the FDA, the leases involve unique concepts. The client requires sterile, watertight conditions, secured areas and parking requirements that, in turn, require specific treatment in their leases. Donor centers require a multi-million dollar investment by the client and multiple years to reach full operational capacity and maximum revenue generation. Due to this significant monetary and time investment, the lease and related documents such as easements and subordination, non-disturbance and attornment agreements with the landlord’s lenders are critical and heavily negotiated.
Pharmaceutical Litigation
- Successfully defended Pfizer in Multidistrict Litigation proceedings in the Southern District of Florida involving thousands of product liability cases alleging that Zantac causes cancer.
- Argued a case of first impression before the United States Court of Appeals for the Ninth Circuit on the issue of whether a private right of action exists under the Federal Food, Drug and Cosmetic Act to compel the listing of a pharmaceutical patent with the United States Food and Drug Administration.
- Defeated Bristol-Myers Squibb in billion-dollar patent and other litigation instituted by Bristol in various federal and state courts around the country in an effort to block generic competition for the largest selling anti-cancer drug in the world, Taxol. Subsequently obtained a $65 million dollar recovery from Bristol in antitrust litigation brought on behalf of a class of direct purchasers of Taxol, arising out of Bristol’s prior efforts to block generic competition for the drug.
- Represented nationwide classes of direct or indirect purchasers in price-fixing and other antitrust litigation involving such products as buspirone (sold by Bristol-Myers Squibb Co. under the brand name Buspar®)(which case settled for nearly $300 million); nabumetone (sold by Glaxo Smith Kline under the brand name Relafen®) (which case settled for $175 million); cisplatin (sold by Bristol-Meyers Squibb Co. under the brand name Platinol®)(which case settled for $75 million); microcrystalline cellulose (sold by FMC Corporation under the brand name Avicel®) (which case settled for $50 million); organic peroxides (sold by AKZO Nobel, Elf Atochem and others) (which case settled for over $30 million); and monochloracetic acetate (which case settled for nearly $20 million).
