Kathleen Kelly is a civil litigator focusing on regulated industries, including pharmaceuticals, medical devices, food, and consumer goods. She provides strategic counseling on compliance with the Hatch-Waxman Act, Sunshine Act, federal Anti-Kickback Statute, HIPAA, False Claims Act, and Consumer Protection Safety Commission. Kathleen has experience in NDA, ANDA and OTC monograph pharmaceutical drugs, PMA and 510(k) cleared Class III and Class II medical devices, and consumer goods. She serves as national and regional counsel in state and federal courts, MDLs, and mass tort litigations.
Kathleen oversees product recalls and investigations, managing eDiscovery, contract negotiations, and all aspects of litigation, including bench and jury trials.
In 2020, Kathleen received a Healthcare Compliance Certificate from Seton Hall School of Law, complementing her wealth of knowledge in data privacy; FDA approval and regulation of new drugs and devices; Foreign Corrupt Practices Act; government investigations; healthcare fraud sentencing, penalties, and damages; OIG Compliance; and prescription drug and device marketing, and advertising.
Kathleen served as co-chair of the firm’s Women Affinity Network for three years and is dedicated to assisting and advancing her female colleagues in the legal field.
She has over 20 years' experience, and prior to joining Hinshaw in 2010, Kathleen bolstered her litigation and regulatory experience in the Boston office of a national defense law firm.
- Defense Research Institute
- The Women's Bar Association of Massachusetts
- Boston Bar Association
A selection of Kathleen’s representative cases include:
- Actively serving as national counsel to mitigate risk for a 505(b)(2) drug manufacturer in multi-district litigation arising out of the use of a generic chemotherapy drug.
- Actively serving as counsel to consumer goods manufacturers handling recalls and complaints before the Consumer Protection Safety Commission (CPSC).
- Counsel to hip stem implant manufacturers.
- National counsel to generic antihypertensive prescription drug in MDL.
- Served as national coordinating counsel and provided risk management services for a medical device manufacturer in litigation arising out of a recall of surgically implanted spinal fixation devices.
- Served as national coordinating counsel for a medical device company in mass tort litigation arising out of the use of a pain pump to deliver medication to the shoulder following arthroscopic surgery.
- Served as national coordinating counsel for a leading pharmaceutical company in litigation arising out of a professionally labeled OTC product.
- Represented national retailer in E. coli 0157:H7 outbreak and local retailer in Campylobacter litigation.
J.D., cum laude, New England School of Law, 1997
Bentley College, 1991
- U.S. Supreme Court
- U.S. Court of Appeals for the Eighth Circuit
- U.S. Court of Appeals for the Sixth Circuit
- U.S. District Court for the District of Massachusetts