Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Unfortunately, the risk of a cancer diagnosis is a very real concern with many common (and not-so-common) medications. While drug companies have a legal duty to ensure that their medications are safe, these companies don’t...more
Depo-Provera, a birth control injection containing the hormone medroxyprogesterone acetate, has been widely used for decades as a convenient contraceptive option. For many women, the Depo shot offered an alternative to daily...more
The diabetes drugs Ozempic and Wegovy have been linked to an increased risk of sudden vision loss and blindness due to a rare eye condition known as NAION (non-arteritic anterior ischemic optic neuropathy)....more
In 2023, we wrote about the Supreme Court’s decision in United States ex. rel. Schutte v. SuperValu Inc. interpreting the False Claims Act’s (FCA) scienter standard to require inquiry into a defendant’s subjective knowledge....more
Depo-Provera, a commonly used injectable contraceptive, has been linked to an increased risk of meningiomas, which are a type of brain tumor. If you or someone you know has been diagnosed with a meningioma after using...more
The recent decision by the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate Depo-Provera lawsuits into MDL No. 3140 in the Northern District of Florida marks a critical step forward for individuals who...more
In 2010, as part of the Affordable Care Act, Congress resolved a highly litigated issue about whether a violation of the Anti-Kickback Statute (AKS) can serve as a basis for liability under the federal False Claims Act (FCA)....more
Women across the country are taking legal action against Pfizer, the manufacturer of Depo-Provera, alleging that the company failed to warn about the risks of developing meningiomas — generally non-cancerous but potentially...more
Earlier this month, the Law Court weighed in on a hot-button legal issue—the potential liability of opioid manufacturers for the costs of the drug epidemic. In Eastern Maine Medical Center v. Walgreen Company, the Law Court...more
Medical device, drug, food, cosmetic, and other FDA-regulated product manufacturers face the constant threat of product liability lawsuits. Claims of injuries from allegedly defective products can lead to significant...more
Lyvette Mercado Velez, a dietitian, entered into a distribution agreement with Insulet Corporation, a leading medical device manufacturer, to promote and sell diabetes treatment products and services in Puerto Rico. Shortly...more
The California Supreme Court granted review in Gilead Life Sciences v. Superior Court—a hopeful turn of events after lower courts issued decisions that resulted in an unprecedented expansion of negligence liability for...more
Diabetes and obesity drugs have skyrocketed in popularity as of late. According to a report released by Trilliant Health in September 2023, healthcare providers in the United States wrote more than 9 million prescriptions for...more
The High Court has held a limitation clause in a research agreement would be effective to limit liability for dishonesty, though not fraudulent misrepresentation. Research paper errors give rise to dispute - Innovate...more
Companies frequently encounter challenges in the manufacture and supply of their innovative products, in particular with respect to process development and production capacity. In our latest webinar, we review how key...more
ESTABLISHING DUTY IN CHILD SEX ABUSE CASES AGAINST THE JEHOVAH’S WITNESSES - In 2019, 13 states and the District of Columbia amended civil statutes to enlarge statutes of limitations for child sex abuse claims. Eight of...more
Virtual Forum on the FCPA & Anti-Corruption for the Life Sciences Industry will take place on April 14, 2021 (Eastern Daylight Time). This is the only practical, comprehensive anti-corruption event that is truly tailored to...more
Issues relating to liability for pharmaceutical, personal protective equipment (PPE) and diagnostic test businesses as well as for physicians and healthcare personnel in the coronavirus (COVID-19) context remains a salient...more
In response to a wave of questions from organizations looking to contribute to the fight against COVID-19, HHS recently clarified the bounds of immunity under the Public Readiness and Emergency Preparedness (PREP) Act, which...more
On April 8, 2020, the Office of Assistant Secretary for Health (OASH), in the U.S. Department of Health and Human Services (HHS) issued Guidance for Licensed Pharmacists, COVID-19 Test, and Immunity Under the PREP...more
Under the Public Readiness and Emergency Preparedness Act, the secretary of the U.S. Department of Health and Human Services can issue a declaration to provide immunity for individuals and entities from any liability arising...more
With more than 34.8 billion recovered by the government since 2010 under the federal False Claims Act, it has never been more crucial for private practitioners and corporate in-house counsel to keep abreast of the changes and...more