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.
RECENT PUBLICATIONS + SPEAKING ENGAGEMENTS
Frequently lectures, chairs professional seminars and publishes articles on topics including pre-litigation risk assessment, federal preemption of pharmaceutical labeling claims, defense of 501(k) medical devices, Daubert issues, strategy in document-intensive mass tort litigation, and other issues where law and science intersect.
Authored or co-authored Harris Beach Legal Alerts, including:
- "New York’s Appellate Division Affirms Summary Judgment Based on Lack of Specific Causation of Toxic Exposure to Gas" (April 2022).
- "Amendments to Comprehensive Insurance Disclosure Act, CPLR 3101(f), Mitigate Burden to Civil Defendants" (March 2022).
- "California Supreme Court Decision Gives Relief to Defendants Seeking to Prevent their Prior Discovery Depositions from Being used at Trial" (March 2022).
- "New York State Comprehensive Insurance Disclosure Act and Amendments to CPLR 3101(f) Implicate Defendants’ Disclosure Obligations in Civil Litigation" (January 2022).
- "New York Medical and Life Sciences 2021 Year in Review" (January 2022).
- "Appellate Decision Permits COVID-19 "Take-Home" Suit to Proceed" (January 2022).
- "PREP Act Preemption: 'There is no COVID-19 Exception to Federalism'" (December 2021).
- "Update to Legal Alert: Summary Judgment Reversed In Toxic Tort Matter Involving Bladder Cancer and Exposure to O-Toluidine" (December 2021).
- "In Lennon v. 56th & Park(NY) Owner LLC, the Second Department Expands Applicability of Collateral Estoppel in Workers’ Compensation Findings" (September 2021).
- "Court Orders EPA to Take Final Action on Rules Regarding Dispersant Chemicals Used In Mitigating Ocean Oil Spills" (August 2021).
- "HHS Further Amends Declaration Under the PREP Act to Address Influenza and COVID-19 Impact and Add Pharmacist Vaccinators" (August 2021).
- “Toll or Suspension? New York Appellate Division Provides Clarity” (June 2021).
- "SCOTUS Extends Specific Jurisdiction to Ford in Products Cases" (March 2021).
- "Breast Implant Multidistrict Litigation Claims Pared Down by New Jersey Federal Court" (March 2021).
- "HHS Further Amends Declaration Under the PREP Act to Expand COVID-19 Vaccinators" (February 2021).
- "New York Medical and Life Sciences 2020 Year in Review" (January 2021).
- "Sweeping Changes to Uniform Rules for the Supreme Court and County Court" (January 2021).
- "New York’s First Department Limits the Ability for Defendants to Testify as to Custom and Practice in Medical Malpractice cases" (January 2021).
- "Two New York Appellate Court Decisions Affirm Default Orders Dismissing Plaintiffs’ Complaint" (January 2021).
- “New York High Court Recognizes "American Pipe" Cross-jurisdictional Class Action Tolling but Dismissal Restarts the Clock” (December 4, 2020).
- “New York Second Department Limits the Ability for Defendants to Testify as to Custom and Practice in Medical Malpractice Cases” (November 24, 2020).
- “Recent Cases from New York’s Second Department Clarify What is Necessary for a Pre-Note of Issue Dismissal” (November 24, 2020).
- “FDA and FTC Take Action Regarding Pandemic-Related Products” (November 9, 2020).
- “FDA Limits Respirator Manufacturers who can Apply for Authorization Under EUA” (October 30, 2020).
- “New York Supreme Court Allows Plaintiff to Plead Statutory Fraud Claim with Medical Malpractice Negligence Cause of Action” (September 16, 2020).
- “New Jersey Supreme Court Finds Products Liability Act Does Not Bar Consumer Fraud Act Claims Alleging Express Misrepresentations” (August 20, 2020).
- “New York Federal Court Finds Italian Tomato Labels Not Misleading in Consumer Fraud Class Action” (August 13, 2020).
- “The Case of the Exploding Can of PAM: Plaintiffs’ Product Liability Claims Don’t Stick” (June 16, 2020).
- “New York Federal Court Dismisses Breast Implant Products Liability Claim on Preemption Grounds” (May 12, 2020).
- “FDA’s Emergency Use Authorization Expands Class of Mask Manufacturers and Distributors Entitled to Immunity” (April 27, 2020).
- “NIOSH-Approved Masks Defined as Covered Countermeasures for Liability Immunity Under Amended PREP Act Declaration” (April 16, 2020).
- “Government Issues Immunity to Liability for COVID-19 Countermeasures” (Mar 26, 2020).
- “New York Medical and Life Sciences: 2019 Year in Review” (Jan 31, 2020).
- “FDA Proposes Strengthening Warning Labels on Breast Implants” (Oct. 24, 2019).
- “FDA Requests Worldwide Recall of Certain Textured Breast Implants” (Aug. 7, 2019).
- “Court Decision Highlights Key Role of Expert Witness in Food Manufacturer Suits” (June 21, 2019).
- "FDA Determines Textured Breast Implants Do Not Require Safety Ban" (May 2019).
- "FDA Committee Addresses Safety of Breast Implants" (March 2019).
- "FDA Issues Warning for Robotically Assisted Mastectomies and Other Cancer Surgeries" (March 2019).
- "Medical and Life Sciences Year in Review: Last Year’s Lessons Shape This Year’s Outlook" (February 2019).
- "Significant New York Drug and Device 2017 Product Liability Decisions" (February 2018).
- "NY High Court Rules on Wrongful Birth Statute of Limitations" (January 2018).
- "Successor Liability Claim Dismissed Against Medical Device Manufacturer" (December 2017).
- "Treating Physician Testimony Wins Plavix Product Liability Case Under NY Law" (September 2017).
- "Drug Product Liability Action in NY Declined to Apply the "Heeding Presumption" (September 2017).
- "New York State Court Orders Production of Discovery in Native Format with Metadata; Costs Born by Producing Party" (March 2017).
- "FDA Medwatch: - Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)" (March 2017).
- "Federal Court Judge Grants Summary Judgment in Hip Repair Device Case: Hip case breaks the right way" (March 2017).
- "FDA Medwatch: Chlorhexidine Gluconate Antiseptics-Rare But Serious Allergic Reactions" (February 2017).
- "New York Medical and Life Science 2016: Year in Review" (January 2017).
- "FDA Issues New Guidance for Cybersecurity in Medical Devices" (January, 2017).
- "New York Medical and Life Science 2015: Year in Review" (January 2016).
- "To Be or Not To Be: Recent New York Case Law on Prenatal Torts" (December 3, 2015).
- "New York Court of Appeals: Medical Device Fragment Left in Patient in Surgery Qualifies as Foreign Object re: CPLR §214-a" (June 25, 2015).
- "Summary Judgment Granted in Medical Device Product Liability Action" (May 11, 2015).
- "New York State Enacts Rule Requiring Redaction or Omission of Personally Identifiable Information/Confidential Personal Information in Filed Court Papers" (February 26, 2015).
- "FDA Taking Hands-Off Approach to Oversight of Low-Risk Medical Devices" (February 2015).
- "New York Medical and Life Sciences 2014: Year in Review" (February 2015).
- "Pharmaceutical Update: FDA Guidance on Drug Compounding and Outsourcing Facilities" (September 2014).
- "Nanotechnology Update: FDA Guidance on Cosmetics and Products" (July 2014).
- "New York Court of Appeals Reinforces Frye Standard in Dismissing Plaintiff’s Mold Claims for Lack of Causation" (April 2014).
- "Legal Impact of the Recent FDA Acetaminophen Dosage Guideline on Prescribers and Pharmacists" (April 2014).
- "Adverse Effects of the FDA-Proposed Rule on Mensing Preemption" Harris Beach Advisory (March 2014).
- "New York Court of Appeals Decision Refuses to Create A New Equitable Cause of Action for Medical Monitoring" (January 2014).
- "FDA News: MedWatch Consumer Voluntary Reporting Forms Revised to be More Consumer-Friendly / Final Rule Issued for Unique Device Identification System" (September 2013).
- "Federal Preemption: Supreme Court Finds Claims for Injuries from Generic Pharmaceuticals Barred by FDA Rules" (August 2011).
- "Supreme Court of the United States Applies Express Preemption to Medical Device Common Law Tort Claim" (March 2008).
- "Does Supreme Court’s Ruling in Favor of Big Tobacco Mean an End to Large-Dollar Jury Awards?" (March 2007).
- "Parker v. Mobil: New York High Court Articulates Standard for Causation in Low Dose Benzene Exposure Toxic Tort Action" (December 2006).
- "New York County Supreme Court Finds Scientific Evidence Related to Mold and Human Illness Does Not Meet the Frye General Acceptance Standard" (October 2006).
- "FDA Issues New Drug Labeling Rules Supporting Preemption of Warning Claims" (March 2006).
- "New York Appellate Court Bars Indemnity Claims by a Condominium Owner Where the Owner May Have Some Negligence in Not Remediating a Mold Condition" (February 2006).
- "New York Appellate Court Prevents Mass Tort Plaintiffs from Invoking Toxic Tort Statute of Limitations Tolling Provision Where Expert Affidavit Lacks Specificity" (November 2005).
- "McFat is Back: Recognizing the “Catch-All” Nature of N.Y. G.B.L. §349 and Respecting the Liberality of Notice Pleading Under the Federal Rules" (February 2005).
Authored and published numerous articles, including:
- "New York Medical and Life Sciences: Year in Review 2021", as published in: New York Law Journal (March 9, 2022) and DRI’s In-House Defense Quarterly (Winter 2022).
- "Medical and Life Sciences Industry Team Co-Leader Judi Abbott Curry Outlines Importance of Quality Assurance Departments" (November 2021).
- "DRI For Life: Lessons from Disaster," DRI's For The Defense (September 2017).
- "FDA Final Guidance for Content and Format of ‘Dear Doctor Letters’/Dear Health Care Provider (DHCP) Letters," DRI’s RX for the Defense (June 27, 2014).
- "FDA Proposes Equal Rights to Brand and Generic Manufacturers to Change Product Labeling," American Bar Association, Section of Litigation, Products Liability, News & Developments (April 23, 2014).
- "Risk Management; Pre Launch Product Liability Risk Assessment; The Best Defense is a Good Offense." Good Clinical Practices Medtech Workshop (March 2012).
- "Medical Devices" chapter for the American Bar Association e-book publication FDA Regulation of Nanotechnology (February 2012).
- "Weighing the Impact of Statistically Insignificant Information Against a Shareholder’s ‘Right to Know’ in Matrixx Initiatives, Inc., et. al. v. Siracusano, et. al.," DRI The Voice (November 2011).
- "The Safe Cosmetics Act – Proposed 2010 Legislation" American Bar Association TTEL TIPS Practice News (Spring/Summer 2011).
- "Purchasing Company Assets Without Taking On Liabilities" New York Law Journal (September 9, 2010).
- "The Federal Preemption Debate in Pharmaceutical Labeling Products Liability Actions” 43 Tort Trial & Ins. Pract. L.J. 35 (2008).
- "Deference to the FDA’s Preamble,” 26(3) LJN’s Product Liability Law & Strategy (2007).
- "Navigating the FDA's Recent RiskMAP Guidance," 24(7) LJN’s Product Liability Law & Strategy (2006).
- "Indoor Air Quality and Sick Building Syndrome—Are You Allergic to Your Building, or Your Boss?" DRI’s Toxic Torts and Environmental Law Committee Newsletter (2006).
- "2004 Report on the Health Consequences of Smoking: Breathing Life into an Old Defense," DRI's For The Defense (October 2005).
- "Case Management Orders in Mass Tort Litigation," Martindale Hubbell (September 2005).
- "Mass Tort Litigation: Using Case Management Orders,” DRI’s For The Defense (August 1999).
Presentations include:
- The Evolving World of Covid Vaccine Liability Immunity – “In-House Warrior" Podcast - Corporate Counsel Business Journal (February 2022).
- Litigation Trends in Telemedicine, Medical Malpractice and Healthcare, presented to insurance executives (February 2021).
- "Recent Developments in Litigation in the Life Science Industry- 2017 Developments and 2018 Outlook" presented to underwriters and insurance executives (May 15, 2018).
- "Cybersecurity Litigation: What the Hack Do We Do" CLE/CE (2016).
- "Obesity: The Growing Body of Law" CLE/CE (2014).
- "Social Media - Risk & Strategy for Life Sciences Companies," Medmarc Webinar (2014).
- "Off-Label Promotion of Drugs and Devices: Quandaries, Problems and Issues in the World of Social Media," Medmarc Annual Counsel Meeting (2013).
- "FDA Warning Letters Issued to Clinical Trial Stakeholders in 2012," MedTech Association (2013).
- "Clinical Trials as a Source of Product Liability Claims, Managing the Risk Clinically and Financially," MedTech Association (2013).
- "Pre-Launch Product Liability Risk Assessment," MedTech Association (2012).
- "Good Clinical Practices," MedTech Association (2012).
- "Supreme Court Round-Up: Decisions of Interest," Federal Preemption CLE/CE (2011).
- "Size Does Matter: The Impact of Nanotechnology on Human Health and the Environment," ABA TTEL Annual Meeting (2009).
- "The Future of Nanotechnology for Drugs and Devices," Medmarc Annual Counsel Meeting (2008).
- "Toxic Torts 101” Introduction to Liability Theories and Defenses in Toxic Tort Litigation," The Hartford Insurance Company (2007).
- "Risky Business? Charting the Course Through FDA’s RiskMAP Guidance and Its Implications in Pharmaceutical Litigation," Mealeys Defense Strategies in Pharmaceutical Litigation Conference (2006).
- "Defending Tort Claims Against Drug Products and Medical Devices," Zurich NA Insurance Company (2005).
