Laboratory Defense

Gibbons has represented the two largest private clinical laboratories in the world in hundreds of matters throughout numerous jurisdictions across the country, including New York, New Jersey, and Pennsylvania in our Mid-Atlantic region, as well as Ohio, Illinois, Missouri, Texas, California, Florida, and Arizona. We also represent smaller clinical laboratories and laboratory-related companies. The Laboratory Defense Team has advised clients on risk management strategies, litigation defense, regulatory compliance, privacy matters, reference lab arrangements, and reporting, and provides crisis management counsel involving retesting and recall programs. We also negotiate and draft a wide variety of agreements, including clinical trial agreements, confidentiality agreements, consulting agreements, and laboratory and other services agreements.

The Laboratory Defense Team has successfully litigated and advised on laboratory cases involving wrongful death or birth, cancer causation, “fear of cancer” and medical monitoring claims, and genetic syndromes. Additionally, we represent diagnostic laboratories in matters involving the complex sciences of cytology, pathology (including dermatopathology), and toxicology, in litigation arising out of gynecologic cancers, neurological birth defects, blood disorders, genetic diseases, skin cancers, terminations of pregnancy, and drug abuse. Gibbons is one of very few firms in the country with such extensive experience in this area.

Gibbons attorneys have handled the broadest range of laboratory testing cases, involving allegations of failure to transmit results (e.g., HIV, PSA); failure to timely report critical, stat, and alert values (glucose, lithium, PT-INR, platelets); specimen mishandling and mix-up (prostate biopsy, core breast biopsy); incorrect testing (21 hydroxylase for CAH); misdiagnosis involving hematology (malaria), cytology (Pap smears), pathology (melanoma), and pre-natal testing (Tay-Sachs, MS-AFP, etc.); and cytogenetics (translocations, deletions). We have served as national counsel to Quest Diagnostics for Pap smear litigation.

In addition, the Laboratory Defense Team has an active compliance, risk, and crisis management practice. For example, we are counsel to the largest municipal hospital and healthcare system in the U.S. regarding its laboratory services, including contracts, multistate regulatory compliance, and risk management consultation. We have advised clients on the preparation of adequate requisition forms, consent forms, and similar documentation for various types of testing. Representative clients include Quest Diagnostics, LabCorp, and several others, which we counsel on regulatory compliance, privacy matters, reference lab arrangements, and reporting. We also counsel the manufacturer of the only FDA approved test for high-risk HPV, providing risk management and litigation consulting.

Our attorneys interface with multiple state boards of health and other officials regarding the establishment of specimen collection facilities and transportation of specimens across state lines for testing. In addition, Gibbons regularly presents on-site risk management seminars to doctors, nurses, laboratory professionals, insurance companies, and risk management associations nationwide, which cover such topics as, for example, laboratory testing, best laboratory practices, and emerging standards of care in cervical cancer screening.