Over the last three years, the Health Care Fraud Prevention and Enforcement Action Team (HEAT) has recovered over $10.2 billion in healthcare fraud settlements, many involving pharmaceutical compan...read more
The Food and Drug Administration (“FDA”) quietly fired a new salvo in the battle over in-plant inspection photography when it released its 2012 update to the Investigations Operations M...read more
This conference commenced from FDLI, Editor-in-Chief, Michael Levin-Epstein. FDLI’s Intellectual Property Throughout the Drug Development Lifecycle, commenced with the first of four panel dis...read more
Since 2009, when the second edition of Off-Label Communications: A Guide to Sales & Marketing Compliance was released, there have been many interesting and challenging developments facing drug ...read more
by Jonathan S. Kahan, Jennifer A. Henderson, Kelliann H. Payne, and Kirstin L. Dunham The Food and Drug Administration’s (“FDA’s” or “the agency’s”...read more
by Ralph Hall and Michelle Mercer For fifteen years, everyone has acted as if Lohr is the final answer to whether there is product liability preemption for 510(k) cleared devices. Courts and...read more
by Bruce Patsner, MD Introduction The past several years have seen a virtual tsunami of lawsuits filed against various manufacturers of different surgical mesh products inserted by physici...read more
by Alexandra S. Marzelli Picture it: a would-be informant, with top secret security clearance, approaches law enforcement personnel claiming to have vital information with national ...read more
by Andrew B. Ulmer and Colleen Tersmette The Leahy-Smith America Invents Act (“AIA”), enacted on September 16, 2011, provided a major reform to United States patent law and becom...read more
by Khara Minter FDLI recently held its first Medical Device Regulation and Litigation Conference in Washington, DC. On June 18, 2012, this boutique program brought together a diverse group o...read more