Mintz Levin

Estee Lauder Decision Highlights Waiver Argument’s Challenges

Policyholders often seek to challenge an insurer’s denial of coverage on the grounds that the insurer waived a defense relied upon to deny coverage. On September 15, 2016, the Court of Appeals in Estee Lauder Inc. v. OneBeacon…more
| Civil Procedure, Insurance

Coming Soon to a Lawbook Near You – New Cosmetic Requirements

Back in April 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act (S.1014). More recently, on September 22, 2016, the Senate Health, Education, Labor, and Pensions…more
| Consumer Protection, Products Liability

Senate Committee Membership

Key Points for Consideration - ..Sitting committee Chairs/Ranking Members are listed first in each column. ..Republicans have term limits of 6 years for Chairmanship (C) and 6 years for Ranking Membership (R)…more
| Elections & Politics

Can the Corporate Veil be Pierced Against a Former Shareholder?

A recent opinion issued by the United States District Court for the Northern District of Illinois reminds us that corporate veil-piercing liability is not exclusive to shareholders. Anyone who is in control of and misuses the…more
| Business Organizations, Business Torts, Finance & Banking, Securities Law

Attorney General Kamala D. Harris Provides New Online Tool to Report California Online Privacy Protection Act (CalOPPA) Violations

It’s time for a compliance check on those website or mobile app privacy policies, before the California Attorney General comes knocking. Attorney General Kamala D. Harris has announced the release of a new tool for…more
| Communications & Media Law, Consumer Protection, Privacy, Science, Computers, & Technology

Massachusetts Licensure of Clinics Proposed Regulations – Key Take-Aways

In previous blog posts, we addressed the Massachusetts Department of Public Health’s (DPH) proposed regulations that affect hospitals, dialysis clinics and medical marijuana programs. In this final post on DPH’s recent…more
| Health

HHS Publishes Guidance on HIPAA and Cloud Computing

On October 7, 2016, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published guidance to assist cloud service providers (CSPs) and their customers with HIPAA compliance. As discussed below, the…more
| Health, Privacy, Science, Computers, & Technology

Stuck in the Middle with the FTC

Legal actions regarding “Made in the USA” claims, whether prosecuted by the Federal Trade Commission (FTC) or through various state unfair trade practices acts, often settle early in the proceedings. For example, in 2014, the…more
| Antitrust & Trade Regulation, Civil Procedure, Communications & Media Law

Another Friendly Reminder from the CAFC – Use of “the Present Invention” is Clear and Unequivocal Evidence of Disavowal

Disavowal can occur when a patent holder disavows the full scope of claim terms in the specification or during prosecution (e.g., through the doctrine of prosecution history estoppel). In either event, disavowal requires clear…more
| Civil Procedure, Intellectual Property

CMS Releases MACRA Final Rule, Easing 2017 Reporting Requirements

On October 14, 2016, the Centers for Medicare and Medicaid Services (CMS) released the final rule for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The final rule marks the most significant reform to our…more
| Health

FDA Opens Comment Period for Harmonized SaMD Clinical Evaluation Guidance

On October 14, 2016, FDA released draft guidance entitled Software as a Medical Device (SaMD): Clinical Evaluation (the “SaMD Draft Guidance”). The draft guidance was prepared by the SaMD Working Group of the International…more
| Health, Science, Computers, & Technology

Homeopathic Products Under Renewed Scrutiny Following FDA’s Consumer Warnings

Last week, following up on a more general warning issued on September 30, FDA alerted the public that it had received at least 10 reports of baby deaths associated with the use of homeopathic teething products, as well as over…more
| Consumer Protection, Products Liability

Five Things to Know About the Mylan EpiPen “Settlement” – What It Is and What It Isn’t

Our eyebrows were raised by Mylan’s October 7, 2016 announcement that it had reached a $465 million “settlement” with the United States Department of Justice (DOJ) and “other government agencies” over its Medicaid Drug Rebate…more
| Health, Science, Computers, & Technology

FTC and DOJ Issue Proposed Updates to Antitrust Guidelines for Licensing IP

For the first time in 26 years, the FTC and DOJ (the “Agencies”) have issued proposed updates to the Antitrust Guidelines for the Licensing of Intellectual Property, last revised in 1995. The intervening quarter century brought…more
| Administrative Law, Antitrust & Trade Regulation, Intellectual Property

New Rules for New York Employers Who Use Payroll Debit Cards and Direct Deposit

As the workplace becomes increasingly digitized, both employers and employees can benefit from the conveniences technology provides. Chief among those is the convenience of electronic access to funds, which allows people to…more
| Finance & Banking, Labor & Employment Law, Science, Computers, & Technology
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