Health Law Advisor

When we think about the top players in the medical device development space, we often see device company sponsors, clinicians, scientists, and FDA regulators as the ones driving the process. But what about the patient perspective? Does that get factored in?

On May 3, 2019, FDA established a docket to collect public input on a proposed list of patient preference-sensitive areas for medical device review, and posed certain related questions (comments are due July 2, 2019). By identifying these key areas (which it committed to as part of the reauthorization of the Medical Device User Fee ...

Following a two-day meeting by a Food and Drug Administration (“FDA”) advisory committee on breast implant safety earlier this year, FDA on May 2, 2019, released a statement announcing that no breast implant models will be banned from the U.S. market at this time. Also described in the statement are a number of measures the agency is undertaking in order to assist women in making more informed decisions regarding breast implants.

The March 26, 2019, meeting of the General and Plastic Surgery Devices Panel was convened to discuss issues and concerns related to the benefit-risk ...

As we previously reported, on April 9, 2019, the New York City Council passed Int. 1445-A, which prohibits employers from pre-employment drug testing for marijuana and tetrahydrocannabinols (“THC,” the active ingredient in marijuana). On May 10, 2019, Int. 1445-A became law by operation of the New York City legislative process, which automatically made the bill law after 30 days without action by Mayor de Blasio. The law becomes effective May 10, 2020, giving New York City employers one year to prepare.

Under the law, employers, labor organizations, and employment agencies ...

On February 19, 2019, New Jersey Governor Phil Murphy signed into law A 3975 (“the Law”), which significantly expanded the state’s the Family Leave Act ("NJFLA"), Family Leave Insurance Act ("NJFLI"), and Security and Financial Empowerment Act (“SAFE Act”). We prepared an Act Now Advisory, summarizing the extensive changes made by the Law, including, among other things, the expanding and making uniform the definition of “family member” for all three laws, and, effective June 1, 2019, extending the NJFLA to employers that have 30 or more employees.

In response to ...

On May 7, 2019, the Department of Justice (“DOJ”) released new guidance for trial attorneys in the DOJ’s civil division regarding how entities under False Claims Act investigation can receive credit for cooperation.  The release of this new guidance follows public comments delivered in March by Michael Granston, director of DOJ’s civil fraud section, noting that DOJ was considering issuing additional guidance on cooperation credit related to False Claims Act matters.

The policy explains that cooperation credit in False Claims Act cases may be earned by “voluntarily ...

On April 30, 2019, Assistant Attorney General Brian Benczkowski announced that the Department of Justice (“DOJ”) had published an updated version of the Criminal Division's 2017 guidance publication “Evaluation of Corporate Compliance Programs.”  In making the announcement, Assistant Attorney General Benczkowski said the update was designed to “better harmonize the prior Fraud Section publication with other Department guidance and legal standards.”  He noted that DOJ also sought “to provide additional transparency in how [it] will analyze a company's ...

This Employment Law This Week^® Monthly Rundown discusses the most important developments for employers heading into May 2019.

NYC is set to become the first city to ban pre-employment marijuana drug testing. With a growing number of jurisdictions legalizing the medical and adult recreational use of marijuana, it’s no surprise to see the emergence of additional employment-related laws. The New York City Council recently passed a bill that would prohibit marijuana drug testing for prospective employees as a condition of employment. The Council passed the bill on April 9 ...

June 6, 2019 at 8:00 a.m. – 10:00 a.m.

NYC Roundtable Event

Our colleagues Denise M. Dadika, Michael F. McGahan, Kathleen M. Premo, and Ian Carleton Schaefer will be participating in an upcoming interactive roundtable discussion "Managing in the #MeToo Era: The Latest Legal Developments and Their Implications for Health Care Employers" on the implications of the #MeToo movement for members of the health care industry. The program will include an in-depth discussion on:

• creating a workplace environment free from harassment and discrimination, including the critical role ...

On Friday April 26, 2019, the US Department of Health and Human Services (“HHS”) issued a notification regarding HHS’ use of Civil Monetary Penalties (“CMP”) under the Health Insurance Portability and Accountability Act (“HIPAA”) as amended by the Health Information Technology for Economic and Clinical Health (“HITECH”) Act.  https://www.federalregister.gov/documents/2019/04/30/2019-08530/enforcement-discretion-regarding-hipaa-civil-money-penalties.  The notice provides: “As a matter of enforcement discretion, and pending further ...

Florida has been at the forefront of some very interesting healthcare M&A activity in the past year, including an influx of private equity and consistent growth in Hospital and Health Plan vertical integration.  Unless subject to antitrust filing requirements, these high profile transactions are typically carried out under veils of confidentiality and announced upon completion.  However, Florida M&A is not insulated from recent Florida House health reform initiatives.  If the Florida House gets its way, the pace of healthcare transactions in Florida may hit a speed bump in the form ...