False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
On October 18, Judge Rebecca Beach Smith of the Eastern District of Virginia approved a $70 million settlement in an antitrust case, with more than $23.3 million awarded to the plaintiffs’ attorneys. This case helpfully...more
Precedential and Key Federal Circuit Opinions - MALVERN PANALYTICAL INC. v. TA INSTRUMENTS-WATERS LLC [OPINION] (2022-1439, 11/1/2023) (Prost, Hughes, and Cunningham) - Prost, J. The Court vacated the district court’s...more
As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more
United States prisoners file an inordinate number of often frivolous lawsuits. In federal district courts alone, prisoners filed more than 28,000 last year. With time on their hands, and influenced by plaintiff attorneys’...more
In a move that reminds us that successful defendants can—and should—seek attorneys’ fees in the right case, a magistrate judge in the U.S. Court of Appeals for the Ninth Circuit awarded pharmaceutical company Aventis Pharma...more
Massachusetts AG Maura Healey sued healthcare marketing company Publicis Health, LLC (“Publicis”) under a theory of public nuisance and for violations of Massachusetts’s consumer protection law over Publicis’s alleged role in...more
PATENT CASE OF THE WEEK - Amneal Pharmaceuticals LLC v. Almirall, LLC, Appeal No. 2020-1106 (Fed. Cir. June 4, 2020) - In the Federal Circuit’s only precedential case this week, the Court addressed issues relating to...more
In Amneal Pharmacueticals LLC v. Almirall, LLC, the Federal Circuit professed to address a question it had not considered before: whether attorney's fees and a exceptional case determination was available for fees and costs...more
A dispute regarding attorney Steven Johnson’s right to fees from William Drake, an individual who hired Johnson to pursue a product liability claim, was made considerably more complicated by conflicting forum provisions in a...more
A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more
By Memorandum Order entered by The Honorable Leonard P. Stark in Reckitt Benckiser LLC v. Aurobindo Pharma Limited et al., Civil Action No. 14-1203-LP (D.Del. October 16, 2017), the Court denied Defendants motion for...more
The Business Court last week knocked down a fee request of Plaintiffs' class action counsel to $500,000, from the $660,000 requested, in an Order in Nakatsukasa v. Furiex Pharmaceuticals, Inc., 2015 NCBC 68. The...more
This Legal Insight updates our Legal Insight dated June 25, 2013, regarding the Delaware Chancery Court case captioned PharmAthene, Inc. v. SIGA Technologies, Inc., Civ. Action No. 2627-VCP, in which K&L Gates LLP serves as...more
Texas follows the American Rule, which provides that litigants may recover attorneys' fees only if specifically provided for by contract or statute. One such statute — Section 38.001 of the Texas Civil Practice Remedies Code...more
In a recently released decision, a federal court in New York has declined to overturn a jury’s $153.3 million verdict against vitamin C manufacturer Hebei Welcome Pharmaceutical and its parent, North China Pharmaceutical...more