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
Molecular diagnostics company Enzo Biochem, Inc. has reached settlements resolving investigations in relation to a 2023 data breach by the attorneys general (AG) for Connecticut, New Jersey, and New York. Enzo has agreed to...more
The Federal Trade Commission has pursued aggressive and creative expansion of its antitrust enforcement efforts under the Biden administration, and the pharmaceutical industry is no exception. Indeed, in a recent interview,...more
On August 30, 2024, Alexion and Samsung Bioepis filed voluntary dismissals in all of their pending patent proceedings related to Soliris® (eculizumab) biosimilar Epysqli® (eculizumab-aagh), including Case No. 1:24-cv-00005...more
In July, the U.S. Department of Justice (DOJ) and U.S. Attorneys Offices announced several large False Claims Act (FCA) settlements stemming from qui tam whistleblower suits....more
DaVita is a regular target of government enforcement actions involving fraud and illegal kickbacks. It has an extensive history of violations and settlements....more
Last week, the Department of Justice (DOJ) announced that Rite Aid, ten subsidiaries, and affiliate pharmacies agreed to settle allegations that Rite Aid violated the Controlled Substances Act (CSA) and the False Claims Act...more
The ECJ confirms its intolerance against conduct that is viewed as originator companies buying off competition from generic companies about to enter the market and thereby unduly prolonging their monopoly. Such conduct, which...more
On July 10, the Department of Justice (DOJ) announced a nearly $410 million settlement with Rite Aid Corporation to resolve allegations that Rite Aid and its affiliates ignored red flags and knowingly dispensed unlawful...more
On 22 February 2024, the US Department of Justice (DOJ) published the statistics for federal civil fraud recoveries in Fiscal Year (FY) 2023. The DOJ announced that the “government and whistleblowers were party to 543...more
Second Circuit Affirms “Pay for Delay” Dismissal: On May 13, 2024, the Second Circuit affirmed dismissal of antitrust claims brought by wholesalers, retailers, and employee benefit funds that alleged they overpaid for the...more
On Monday, May 13, 2024, the U.S. Court of Appeals for the Second Circuit affirmed Judge Lewis Liman’s decision dismissing Plaintiffs’ reverse payment class actions for failure to state a claim. In re Bystolic Antitrust...more
Amgen and Sandoz reached a settlement in Case No. 1:23-cv-02406 (D.N.J.) on April 29 just hours before a New Jersey District Court Judge (Christine O’Hearn) was scheduled to announce her ruling on Amgen’s preliminary...more
A coalition of AGs reached a settlement in principle with Amneal Pharmaceuticals, Inc., to resolve allegations that it contributed to the opioid epidemic in its role as a drug manufacturer. According to the coalition, Amneal...more
Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements related to alleged kickbacks, medically...more
Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement...more
On March 18, 2024, Fresenius Kabi (“Fresenius”) and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada. The terms of the...more
Welcome to the Class Action & MDL Roundup, our quarterly review of decisions and settlements in the class action arena. In this edition, student-athletes win an NIL round, Canadians in California isn’t personal...more
On March 4, 2024, the PTAB granted Biocon and Janssen’s joint motion to terminate IPR2023-01444 due to a settlement reached prior to an institution decision. The parties announced in a press release that their settlement and...more
Robins Kaplan Secures Historic $12.2 Million Settlement in a Section 1983 Jail Deliberate Indifference Case - Scott County Jail officials failed to report detained man’s injuries and allowed video evidence to be deleted. ...more
News Briefs - State AGs Urge Congress to Reform Pharmacy Benefit Managers - A bipartisan group of 39 state attorneys general sent a letter to Congress urging lawmakers to take "decisive action" to reform pharmacy benefit...more
We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab). The settlements cover Canada, the European Economic Area, and...more
This week, DEA announced it has entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the protracted dispute born out of a May 2, 2018 Order to Show Cause (“OTSC”) and Immediate...more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
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