Judi concentrates in areas of mass tort and complex product liability litigation involving pharmaceuticals, medical devices, implants, infusion pumps, compounded medicines, biologics, over-the-counter drugs, solvents, acids, benzene and other mixed chemical exposures, mold, Legionella, pesticides, cosmetics, food, commercial and consumer household goods. She represents hospitals, physicians, medical practices, nurses, physical therapists, pharmacists and other health care providers in claims of negligence, medical malpractice, hospital-based toxic exposures and medical device malfunctions. Judi represents manufacturers, distributors, contract manufacturing organizations (CMO), retailers, chemical and raw ingredient suppliers and company or independent sales representatives in the life science industry. Judi’s environmental practice includes defense of claims of personal injury, property damage, remediation costs and stigmatization, due to spills and leaks of residential oil on land and tidal wetlands. Judi represents contractors, construction companies, building product manufacturers and property owners against claims of negligence, breach of contract and warranty, contribution and indemnity in construction defect and property damage matters alleging pecuniary losses and remediation costs. She is also a member of the firm’s management committee.
Judi has a broad range of experience in representing the life science industry throughout a product’s life cycle, from clinical trials, pre market and launch risk assessment and batch manufacturing, through product liability matters involving labeling, packaging and distribution, including black box warnings, off-label use and state of the art label changes, post-recall events and commercial disputes where manufacturing, packaging or servicing results in financial loss, including expenses associated with a recall.
Judi served as national coordinating counsel for New England Compounding Pharmacy in the compounding pharmacy fungal contamination mass tort as well as national counsel for several medical device companies involved in mass tort litigation arising out of the use of a pain pump to deliver medication to the shoulder following arthroscopic surgery. She was national coordinating counsel to four chemical suppliers in semi-conductor manufacturing chemical exposure litigation and served as regional counsel for Dow Corning in the silicone breast implant litigation responsible for managing the personal injury claims of over 1,000 plaintiffs and coordinating counsel for injectable silicone litigation pending nationwide. In her representation of leading hair dye and cosmetics manufacturers, Judi has successfully defended flagship products against claims of multiple chemical sensitivities (MCS), cancer, respiratory and musculoskeletal diseases.
In addition to her extensive experience defending over-the-counter and prescription drug, medical device, biologic and implant products, Judi provides counseling advice to pharmaceutical, device and cosmetic companies concerning pre-litigation risk assessments; recalls and market withdrawals of FDA regulated products; company submissions to FDA including package inserts, patient package inserts, and other labeling, warnings and NDA filings; product brochures; direct-to-consumer advertising; website content; press materials and media kits; sales and training materials and programs; pharmacovigilance and the development and use of risk minimization action plans and RiskMAP.
Drawing upon her experience in representing life sciences companies through the firm’s product liability practice, Judi represents contract manufacturing organizations and other life science companies in commercial disputes that may arise at each phase of the life-cycle of prescription, over-the-counter, personal care/cosmetic, biologic, medical device, nutritional supplement and food products. Representative matters have included disputes involving contracts and agreements governing product development; quality, equipment and cGMP issues arising during the development and manufacture of clinical trial batches; manufacturing and labeling issues for either excipients or finished products; disputes in joint ventures; as well as litigation involving the supply, manufacture and distribution for FDA regulated products. Judi also manages the complex commercial disputes that these companies often face in pre-litigation risk assessments and investigations, state and federal court actions, arbitrations, mediations and other ADR proceedings.
Judi defends claims of birth defects, autoimmune disease, fibromyalgia, orthopedic and neurologic injuries, learning disabilities, cancer, severe burns and disfigurement, and multiple chemical sensitivities using epidemiology and expert disciplines of dysmorphology, teratology, toxicology, industrial hygiene, oncology, rheumatology, neurology and others. She utilizes cutting-edge litigation management technologies such as proprietary databases, document processing, imaging and predictive coding software to manage complex litigation in an electronic environment.
In the construction defects area, Judi represents owners, management companies, developers, contractors and material suppliers against claims of negligence, breach of contract and warranty, contribution and indemnity in multi-million dollar toxic mold and water intrusion personal injury and property damage matters alleging pecuniary losses, lost revenue and payments to tenants, repair and remediation and re-design and renovation costs. Specific matters have alleged physical damage, cracked ceilings and walls, water infiltration and mold, design flaws, structural defects, and defective building materials causing property damage. She has also represented clients in matters where mold allegedly caused respiratory illnesses, autoimmune disease, allergic reactions and dermatological injuries, as well as other bodily injuries and illnesses. Judi has handled construction defect matters involving diverse issues impacting liability, damages, apportionment and coverage involving architectural design, engineering, framing, waterproofing, masonry, excavation, HVAC, foundations, sheet-rocking, plumbing, electrical work and materials manufacture. Additionally, Judi has experience defending construction accident matters on behalf of contractors and owners in which it is alleged that construction workers have been injured due to violations of Sections 200, 240 and 241 of the Labor Law of New York.