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
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
Suboxone is a medication used to treat opioid addiction, containing buprenorphine and naloxone. While Suboxone is highly effective in helping individuals overcome opioid dependence, there have been concerns about its...more
Crafting the perfect medical device is never an exact science—but a patient should never suffer because of defects in a product that was intended to improve their quality of life. Determining whether a device manufacturer or...more
Depression during pregnancy, or prepartum depression, is a common condition that an estimated ten percent of women in the United States experience. The development of selective serotonin reuptake inhibitors (“SSRI”) offered...more
Are you a diabetes patient who took Ozempic? Did you take Wegovy in hopes of losing weight? Have you suffered life-changing gastrointestinal issues since you’ve been taking Ozempic or Wegovy? If so, you are not alone....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
The Bard PowerPort, often known as the "BardPort," is a subdermal medical device designed to facilitate the connection of a catheter for the administration of intravenous fluids or medication. However, since its launch, there...more
A patient’s decision to take any prescription medication is a very personal one that requires the patient to weigh several variables, including the potential benefit the medication could provide as well as the possible risks....more
When a doctor suggests that a medical device may help you, they’ll explain a little bit about how the device works; however, truly understanding how any given device works often requires either a medical or scientific...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
In Westfield National Insurance Co. v. Quest Pharmaceuticals, the Sixth Circuit held that two insurers owed no coverage obligations to Quest Pharmaceuticals in connection with 77 lawsuits filed against it alleging misconduct...more
Some important insurance decisions were handed down over the past month. We begin in Ohio, where public nuisance claims by state and local governments over opioids and lead paint were on full display. In Acuity, the...more
Medications containing Acetaminophen are one of the most commonly used pain relievers worldwide. The chemical compound is an active ingredient in over 600 medicines. For most people, Acetaminophen is benign and can be used to...more
What is the latest with the CPAP lawsuits? As 2022 begins, the thoughts of sleep apnea patients and their families are, naturally, returning to the Philips CPAP machine recall 2021....more
The intravitreal (eyeball) injection drug Beovu hasn’t even been on the market for two years, but its history has been eventful. This medication was meant to help patients with an eye problem known as wet age-related...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
Contraceptive Is Linked to Injuries and Deaths and Now Is the Subject of Lawsuits - Bayer, the company that manufactured and marketed the dangerous birth-control device Essure, is looking more and more like a bad actor as...more
Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...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
Massachusetts state and federal courts issued a number of important product liability decisions in 2019. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more
U.S. Congress found it necessary to provide manufacturers of biomaterials—component parts or raw materials for implantable medical devices—protection from liability in litigation involving the manufacture and use of an...more
Last week, the FDA issued a warning against the use of robotic surgery for mastectomy and other cancer-related procedures. ...more
The U.S. Supreme Court today agreed to consider a Third Circuit ruling that revived litigation over Merck’s alleged failure to warn about a risk of femoral fractures from its osteoporosis drug Fosamax. The precise question...more
A treatment protocol combining Ritalin, a stimulant commonly used for ADHD, and a form of Cognitive Behavioral Rehabilitation known as “Memory and Attention Adaptation Training” (MAAT) shows great promise for improving...more
As a part of the recent speed racing bills through Congress, they have put up HR 1215. Quite erroneously, they have titled it: “Protecting Access to Care Act of 2017”. A read of the act’s text quickly tells any objective...more