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
A popular New Year’s trend is to say “goodbye” to all the things that didn’t serve you in 2023, as you usher in new intentions and habits for 2024. Although there were many great trial outcomes and continuing scientific wins...more
Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more
Until recently, Ozempic was a little-known diabetes medication. But, when mainstream media outlets and even medical schools began touting the drug’s weight loss benefits, Ozempic was quickly thrust into the national...more
Earlier this year, the US Center for Disease Control and Prevention (“CDC”) spotted an outbreak of a rare bacterial infection in 11 (now 16) different states, associated with multiple different infection types, particularly...more
Federal Appeals Court Dismisses Challenge to Interim PFAS Guidance, Leaving Important Questions Unresolved - A federal appeals court dismissed a challenge to EPA's interim guidance for PFAS levels in drinking water,...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
Public nuisance claims have long been understood to rest on “an unreasonable interference with a right common to the general public.” Typically, litigation sought recovery for damages in connection with (among other...more
DUSTING SPRAY DEATHS AND INJURIES - Robins Kaplan LLP is investigating and litigating “dusting” cases, which arise when someone inhales—or “huffs”—compressed gas dusting spray for its intoxicating effects while driving and...more
Litigation Update - On January 30, 2020, class action, consumer protection and pharmaceutical lawyers from around the country will be in federal court in Tampa, Florida to argue before a panel of federal judges whether...more
After years of limited guidance, the Supreme Court has finally provided direction to lower courts on the issue of preemption when they delivered their opinion in Merck v. Albrecht. “Preemption” is a common defense used by...more
Until now, the perception that New Jersey law on expert admissibility was weaker than the Daubert standard used in federal courts and many other states - combined with New Jersey being home to so many pharmaceutical and...more
It’s almost inevitable; once a company grows its market to a certain size, its stakeholders are likely to face class-action litigation. Despite a downward trend in class-action defense expenditures from 2011 to 2014, spending...more
Government Initiative Promises $1.1 Billion in Research Funds - The U.S. Department of Health & Human Services’ National Institutes of Health has launched a brand-new – and much-necessary – initiative to combat the...more
U.S. Attorney General Creates Task force To Address Epidemic - The opioid crisis in America exists because both the illegal and prescription forms of the drug are highly addictive and commonly abused....more
Shook, Hardy & Bacon Partner Cary Silverman has authored a report for the U.S. Chamber Institute for Legal Reform examining the effects of advertising soliciting plaintiffs for lawsuits targeting prescription drugs and...more
Last month, the U.S. Supreme Court clarified the scope of specific personal jurisdiction in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco Cty., 137 S. Ct. 1773 (2017) (“BMS”). Mass tort defendants...more
Someone asked what was one of the most challenging cases I have worked on as a drug and medical device litigator for the past 23 years. It was the Vioxx litigation....more