News & Analysis as of

State and Local Government Medical Devices

Hogan Lovells

State Licensing Spotlight – Medical Device Manufacturers & Distributors: Compliance Strategies for Avoiding or Reducing Penalties

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Medical device manufacturers and distributors have come under increasing scrutiny from state licensing agencies and operating without a required license may lead to severe consequences. These can include financial penalties;...more

Hogan Lovells

Prescription Medical Device Manufacturers, Distributors, and the NABP: The Role in State Licensing

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The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers and distributors. Although the NABP does not directly regulate the...more

Hogan Lovells

State Licensing Spotlight – Prescription medical device manufacturers & distributors: Regulatory considerations applicable to...

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State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own licensing requirements, which can...more

Gardner Law

State Licensing Requirements: Are You Prepared?

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Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not the final step. Before selling your products in most states, you must navigate state licensing...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 1, January 2024

The Current Status of Privacy Laws Across the United States - Unlike the General Data Protection Regulation (GDPR) in the European Union (EU), the United States does not have a nationwide comprehensive data privacy law....more

Perkins Coie

Washington State’s New My Health My Data Act Will Likely Result in Insurance Coverage Disputes

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Washington state recently passed the My Health My Data Act (the Act), which will almost certainly lead to an explosion of consumer lawsuits and follow-on insurance coverage disputes. The measure is intended to protect...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 3, March 2023

Amazon Sued for Not Telling New York Store Customers about Tracking Biometrics - “Thanks to a 2021 law, New York is the only major American city to require businesses to post signs letting customers know they’re tracking...more

Bradley Arant Boult Cummings LLP

Alabama CON Report - February 2023

I. Certificate of Need Program - A. AL2022-033, North Alabama Specialty Hospital, LLC, Huntsville, AL: Proposes to add sixteen (16) long term acute care (LTAC) beds to its existing thirty-one (31) bed LTAC hospital in...more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Device Developments of 2022

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

Faegre Drinker Biddle & Reath LLP

Summary of HB1125: Deceptive Lead Generation

Lawsuit advertisements—specifically ones that target prescription drugs and medical devices—can be dangerous. Nationwide, dramatized and exaggerated legal ads have flooded both televisions and the internet, often masquerading...more

Foley Hoag LLP

Product Liability Update - February 2021

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MASSACHUSETTS - Massachusetts Supreme Judicial Court Holds State Law Claims Against Manufacturer Of FDA-Approved Medical Device “Parallel” Federal Law Requirements And Hence Are Not Preempted Despite Failure To Identify...more

Faegre Drinker Biddle & Reath LLP

Ninth Circuit Affirms Dismissal of Breast Implant Cases on Preemption Grounds

The Ninth Circuit has confirmed in quadrophonic sound that plaintiffs cannot avoid preemption by relying on vague and speculative allegations to establish a parallel claim. The court affirmed the dismissal of four lawsuits...more

Bass, Berry & Sims PLC

Improper Billing of “P-Stim” Devices is Focus of Recent FCA Settlements

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Improper billing for electro-acupuncture using a “P-Stim” device (or peri-auricular stimulation device) has been the subject of two False Claims Act (FCA) settlements already in 2021, following a trend of such enforcement...more

Foley Hoag LLP

Product Liability Update: October 2020

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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

Sheppard Mullin Richter & Hampton LLP

CCPA Amendment Adds Needed Clarity for Medical & Research Community

An amendment to the CCPA recently passed through the legislature, adding some much needed clarity to HIPAA-regulated entities, research institutions and other life science and medical device companies. CCPA in its current...more

Searcy Denney Scarola Barnhart & Shipley

Hospitals & Nursing Homes: Old Dangers on the Increase During a Pandemic?

Hospitals in Florida and the rest of the country generally are careful about safety measures, staff-to-patient ratios and infection control. There are specific standards of care they must meet in the communities they serve. ...more

Pillsbury Winthrop Shaw Pittman LLP

The Regulation of Medical Waste During COVID-19

The rapid spread of the coronavirus has generated new interest in the regulation of medical waste. The COVID-19 crisis is generating a significant amount of regulated medical waste....more

Sheppard Mullin Richter & Hampton LLP

Seize The Day (and the PPE) – An Overview of State and Local Rules Governing the Possession and/or Sale of Personal Protective...

As the Federal Government struggles to secure a sufficient volume of Personal Protective Equipment (“PPE”) – i.e., gloves, masks, gowns, face shields, etc. – for the nation’s health care workers and first responders, states...more

Mintz - ML Strategies

COVID-19 Insights Week In Review — April 8, 2020

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As the coronavirus pandemic spreads across the nation, your team at ML Strategies continues to monitor legislative and regulatory updates at the federal and state level. Each week, ML Strategies will provide weekly updates...more

Mintz - ML Strategies

What You Need to Know: State and Federal Updates Related to COVID-19

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...On Monday, House Speaker Nancy Pelosi, Majority Whip James Clyburn, Transportation & Infrastructure Committee Chairman Peter DeFazio, and Energy & Commerce Committee Chairman Frank Pallone held a press conference on a...more

Troutman Pepper Locke

N.J. Order Suspends Elective Medical Procedures, Seeks Medical Supplies From Businesses

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On March 23, New Jersey Gov. Phil Murphy issued Executive Order 109 — the state’s latest directive relating to COVID-19. ...more

Downs Rachlin Martin PLLC

Vermont Health Care Update 02-28-20 - An analysis from DRM's Health Law Team

House overrides minimum wage veto - On a vote of 100-49, the House voted to override Gov. Phil Scott’s veto of the minimum wage bill. The bill will raise the state’s minimum wage to $11.75 in 2021, and $12.55 in 2022, and...more

Downs Rachlin Martin PLLC

Vermont Health Care Update 02-17-2020 - An analysis from DRM's Health Law Team

Push to end surprise medical billing - The Senate Finance Committee heard from providers and health insurers on S.309, a bill that prohibits certain provisions in contracts between health insurers and health care...more

Seyfarth Shaw LLP

Close Was Not Close Enough: First Circuit Denies Executive’s Implied Covenant Claim For Unpaid Equity Compensation Related To A...

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Seyfarth Synopsis: On November 27, 2019, the United States Court of Appeals for the First Circuit held that, under Massachusetts law, a terminated employee asserting a claim for being deprived of lost compensation in breach...more

McGuireWoods Consulting

Illinois 2020 Legislative Session Preview

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The Illinois legislature started the year with high hopes, with Democrats holding the governor’s office as well as super majorities in both chambers. In January, Democratic Governor J.B. Pritzker was inaugurated, along with a...more

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