Faegre Baker Daniels

Second Circuit: Stored Communications Act Warrants Cannot Reach Overseas Data

On July 14, 2016, the Second Circuit Court of Appeals determined that a warrant issued under the Stored Communications Act (SCA) is subject to the same territorial restrictions as a traditional warrant: the government’s reach is…more
| Civil Procedure, Constitutional Law, Criminal Law, Privacy, Science, Computers, & Technology

FDA Offers Draft Guidance for Generic Drug Label Updates

In July 2016, the U.S. Food and Drug Administration (FDA) published draft guidance outlining when drug companies should update a generic drug’s label after the brand name drug on which the generic is based has been withdrawn for…more
| Communications & Media Law, Health

Congress Passes GE Labeling Bill, President Obama Expected to Sign Bill Into Law

On July 14, 2016, after more than a year of on-and-off debate and failed attempts at legislative compromise, Congress finally passed a bill to require the creation of a federal labeling standard for bioengineered food within two…more
| Communications & Media Law, Conflict of Laws, Consumer Protection, Elections & Politics, Science, Computers, & Technology

EEOC Adjustment to Proposed Revision to EEO-1 Reports Fail to Address Significant Concerns Raised by Employers

Employers nationwide reacted strongly to the Equal Employment Opportunity Commission's (EEOC) January 2016 proposed rule that would require federal contractors and other employers with 100 or more employees to report summary…more
| Government Contracting, Labor & Employment Law

EEOC Adjusts Proposed Equal Pay Data Rule

Employers nationwide reacted strongly to the Equal Employment Opportunity Commission’s (EEOC) January 2016 proposed rule that would require federal contractors and other employers with 100 or more employees to report summary…more
| Labor & Employment Law

Flying Pigs and False Claims

On July 7 the Fourth Circuit invoked Flying Pigs to vacate a lower federal court judgment in a Medicaid false claim case, even though neither the lower court nor any of the parties asked it to. The case started in 2007,…more
| Civil Procedure, Government Contracting, Health

How to Comply With China's Revised Workplace Safety Requirements

Workplace safety incidents have been an issue in China throughout the 21st century, a consequence of the rapid growth of the country’s economy, the pursuit of high profits at the expense of safety and lax government oversight…more
| International Law & Trade, Law Practice Products & Services

NLRB, Seeking to Connect to "Reality of Today's Workforce," Changes Organizing Standard

The National Labor Relations Board (NLRB) continues to change the rules governing the relationships between employers, employees and unions in an effort to give unions new ways of organizing. On July 11, 2016, the NLRB issued…more
| Labor & Employment Law

Same Per-Click Rule, New Rationale

On July 7 CMS issued a proposed rule reaffirming its position that the Stark Law prohibits “per-click” rent payments when the lessor is the one referring the patients to the lessee for the “click,” e.g., the test or procedure. …more
| Health

Proposed 409A Regulations Provide Clarity and Some Flexibility

On the same day it released proposed regulations under Section 457 — as reported in our "New 457 Regulations for Nonqualified Deferred Compensation Plans of Tax-Exempt and Government Employers" update —the IRS released proposed…more
| Labor & Employment Law, Finance & Banking, Taxation

Federal Circuit Holds Again That BPCIA's 180-day Notice Is Mandatory

On July 5, 2016, the Federal Circuit affirmed a district court's preliminary injunction against proposed biosimilar manufacturer Apotex, holding that Apotex was enjoined from entering the market until Apotex: (1) provides notice…more
| Health, Intellectual Property, Science, Computers, & Technology

FDA's Draft Guidance to Help Manufacturers in Labeling Biosimilars

The passage of the Biologics Price Competition and Innovation Act (BPCIA) in 2010 paved the way for the introduction of biosimilars in the United States. Biosimilars are large-molecule drugs that are highly similar, but not…more
| Health, Science, Computers, & Technology

Pharmacy Settles Claim for Filling Forged Rx’s, as Trend Continues

There was a time when liability—criminal or civil—for drug abuse or forged prescriptions usually lay only with the abuser or the forger and those who actively helped them. Those days are long gone. First, we had PDMPs…more
| Civil Procedure, Health

Hospital Liability for Life-Saving Efforts?

Hospitals are in the business of saving lives. So they don’t usually face liability for trying to do just that. But a July 5 Georgia Supreme Court decision is a reminder that it’s up to the patient—not the hospital or…more
| Civil Procedure, Health

When Damages May Exceed the Statutory Med Mal Cap

Dr. Steven Nathanson is the defendant in a medical malpractice case involving the death of a patient. On June 24 the court rejected his motion for summary judgment on his claim that punitive damages are barred by West…more
| Civil Procedure, Health
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