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Safe or Good? We All Have Choices to Make

I planned to write about the inspired, better-than-sliced-bread security option of using fingerprint authentication to protect our mobile devices. That imploded. In 2014, and earlier this year, courts in Virginia and...more

The Supreme Court - May 2016 #2

The Supreme Court of the United States issued decisions in six cases today: Spokeo, Inc. v. Robins, No. 13-1339: The Fair Credit Reporting Act of 1970 (“FCRA”) imposes a number of requirements regarding the creation and...more

U.S. Supreme Court Proposes Change to Rules Applicable to Searches of Electronic Data

The United States Supreme Court — which establishes rules of civil and criminal procedure, subject to the objection of Congress — has proposed a significant amendment to the rules applicable to searches of electronic data...more

More Questions than Answers – The DOJ’s Sudden Change in Tactics in the Apple iPhone Encryption Dispute

In the ongoing iPhone encryption battle between the Department of Justice (“DOJ”) and Apple, March 22, 2016 might have been a pivotal moment in the national discourse on digital privacy rights, encryption, and the bounds of...more

FDA and Amarin Pharma Reach Milestone Settlement Allowing Off-Label Drug Promotion

A milestone Settlement Agreement was reached March 8, 2016 between the Food and Drug Administration and Amarin Pharma, Inc. that expressly allows Amarin to promote its drug product, Vascepa®, for unapproved – i.e.,...more

Ninth Circuit Addresses Probationers’ Cell Phone Searches by Police

The centrality of cell phones to our daily lives, and the wide array of sensitive information those phones may carry, creates a complex and ever-evolving series of issues over the amount of privacy we can expect to be...more

Amarin and FDA Reach Settlement Agreement in Off-Label Speech/First Amendment Case

On March 8, 2016, Amarin Pharmaceuticals, Inc. (“Amarin”) and the Food and Drug Administration (“FDA” or the “Agency”) reached a settlement agreement in a closely followed case involving Amarin’s First Amendment rights to...more

iWon’t: Apple’s Face-Off with the DOJ

In what is quickly becoming one of the closest-watched cases in the country, Apple is now at loggerheads with the Department of Justice and FBI over its refusal to unlock the iPhone of one of the San Bernardino shooters....more

"One-Two Punch: Amarin Settlement Order and Vascular Solutions Acquittal Further Erode Off-Label Promotion Enforcement Regime"

In an apparent first, the U.S. Food and Drug Administration (FDA) has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a prescription drug. This concession...more

National Debate on Digital Privacy Shows No Signs of Slowing

The Justice Department’s dispute with Apple related to encryption on the iPhone used by one of the San Bernardino shooters has reinvigorated the national debate on digital privacy. Though it is not clear how the California...more

K&S Effort Leads to Acquittal in Conspiracy and Misbranding Case Against Medical Device Company

On February 29, 2016, Minneapolis-based medical device company Vascular Solutions, Inc. (“VSI”) and its CEO Howard Root were acquitted by a jury of conspiracy and misbranding charges in a closely-followed trial in San...more

Apple vs. FBI: The House Judiciary Committee Hearing and Takeaways

Among the major headlines dominating not only the recent news cycle, but also this week’s RSA Conference in San Francisco, has been Apple’s challenge to the federal government’s request that Apple assist in unlocking the...more

Rival Court Decisions Reflect Shifting Views on Privacy in Public

With the spotlight on one high-profile battle that pits privacy rights against public safety interests, another crucial, similar dispute is making its way through the courts. How to evaluate new technology and its potential...more

Should Apple Always Have a Key to All iPhone Data? To Some iPhone Data?

On February 16, 2016, U.S. Magistrate Judge Sheri Pym of the U.S. District Court for the Central District of California issued an Order under the All Writs Act directing Apple Inc. to cooperate with efforts by the Federal...more

Backdooring Investment Security (On the Apple Case)

There's lots of talk about information security with the Apple case. But, perhaps just as important, the case also raises important concerns relating to investment security and to the predictability of our markets and laws. ...more

FBI Recruits Apple to Help Unlock Your iPhone

It is a well-known maxim that “bad facts make bad law.” And as anybody even casually browsing social media this week likely has seen, the incredibly tragic facts surrounding the San Bernadino attacks last December have led...more

Federal Court Orders Apple to Unlock San Bernardino Gunman’s Phone

Apple must help the FBI unlock an iPhone used by one of the attackers in the San Bernardino, Calif. assault in December, a federal magistrate judge ruled this week. The ruling handed the government an important victory in an...more

"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement and Litigation"

For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...more

First Amendment Follow-Up

The other day, we posted about, inter alia, the Department of Justice’s proposed jury instruction, in the Vascular Solutions case in Texas conceding the legality of truthful off-label promotion. In that post we asked, “Has...more

California Updates Privacy Rights with the Electronic Communications Privacy Act

Starting on New Years Day 2016, a new law will prohibit California law enforcement agencies from compelling California residents and businesses to turn over metadata or electronic communications (e.g., texts, emails,...more

California Gives the Fourth Amendment a 21st Century Makeover

The average American today generates more media than they did at any other point in history, and the ease with which our communications, photos, and videos are sent and stored digitally means most of us have more media stored...more

Should Smartphone Manufacturers Be Legally Compelled to Unlock Users’ Devices?

Picture this: A criminal defendant is indicted for three counts related to the possession of methamphetamine, and federal prosecutors obtain a warrant for the defendant’s iPhone. But the iPhone is passcode protected, and...more

The Limits to Ordering Computer Monitoring as a Special Condition of Supervised Release in the Federal Court System

There are limits to when a Federal District Court Judge may order computer monitoring by United States Probation as a special condition of supervised release. While it can be argued that individuals on supervised release...more

California Law Enforcement and Industry Gain Procedural Certainty with Historic Cal-ECPA Bill

On October 8, 2015, Governor Jerry Brown of California signed into law Senate Bill 178, known as the California Electronic Communications Privacy Act (Cal-ECPA). Cal-ECPA mandates that California law enforcement agencies...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

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