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
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
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
Texas Pharmaceutical Marketer Sentenced for $59 Million Medications Fraud Conspiracy - On July 12, Quintan Cockerell, a Texas pharmaceutical marketer, was sentenced to over two years in prison and ordered to pay more than...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
DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to Opioid Dispensing - On July 10, the US Department of Justice (DOJ) announced that Rite Aid Corporation and 10 of its...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
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
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
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
We are pleased to bring you our 11th 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
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
Walmart has offered to pay $3.1 billion to settle thousands of lawsuits filed against the deep-pocketed retailing giant, accusing it of complicity through its nationwide pharmacy operations in the lethal opioid abuse and...more
On September 29, 2022, Massachusetts Attorney General Maura Healey announced that Medicaid managed care and pharmacy benefits giant Centene Corporation agreed to pay $14 million to resolve claims that it overcharged...more
Paper Company Applicant Denied Job Because of ADHD Medication, Federal Agency Charged - DALLAS – Memphis-based International Paper Co. will pay $65,000 and furnish other relief to settle a disability discrimination lawsuit...more
Several days ago, Biogen Inc. announced that it had reached a settlement to resolve a whistleblower lawsuit under the False Claims Act (FCA). Relator’s claims were based on allegations that Biogen’s speaker and consultant...more
In January of 2018, Robins Kaplan LLP filed a lawsuit against the nation’s largest opioid manufacturers and distributors on behalf of three Tribal Nations in South Dakota. It was one of the first complaints filed by a Tribe...more
DOJ Continues To Prosecute PPP Fraud - Earlier this week, Ana Soto of Newark, Delaware pled guilty to fraudulently obtaining and spending money received through Paycheck Protection Program (“PPP”) loans. Between March...more
The end of 2021 was marked by several significant developments in the wave of litigation that has resulted from the opioid crisis of the last several years. These developments, however, are sufficiently inconsistent that it...more
Pharmacist Sentenced to 70 Months in Prison for Prescription Drug Fraud - An Orange County-based pharmacist and owner of TC Medical Pharmacy pled guilty to one count of health care fraud and was sentenced to 70 months in...more
Just as attorneys generals for more than a dozen states inch toward a multibillion-dollar settlement with a drug maker faulted for its big role in the start of the opioid abuse and drug overdose crisis, that health menace is...more
On November 12, 2020, Genentech filed a complaint in the Eastern District of Texas alleging that the Centus Biotherapeutics, Ltd., Fujifilm Kyowa Kirin Biologics Co., Ltd., Fujifilm Corp., and Kyowa Kirin Co, Ltd....more
Over the last two months, McKinsey & Company — one of the world’s largest consulting firms — resolved matters with all 56 state attorneys general regarding investigations into its role in providing marketing and consulting...more
This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more