Science, Computers & Technology Constitutional Law

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Court Grants Standing Against Coca-Cola Employer for Breach of Employee Information

The decision does not change the law on what is necessary to prove standing, although it does reinforce the notion that a plaintiff will have standing if he or she can allege a concrete injury. In the latest in a slew of...more

District Court Rules That Smartphone Passcodes Are Testimonial; Protected by Fifth Amendment

In Securities and Exchange Commission v. Huang, the district court held that the Fifth Amendment protected two former employees against having to disclose their personal passcodes for company-issued smartphones to government...more

Change Coming to FDA’s “Intended Use” Regulations?

Over at the Drug And Device Law Blog, our colleagues call attention to proposed changes to the “intended use” regulations for prescription drugs and devices, 21 C.F.R. §201.128 and 21 C.F.R. §804.1, somewhat hidden within a...more

FDA Regulatory and Compliance Monthly Recap — September 2015

Pacira sues FDA, alleging it illegally attempted to restrict truthful and non-misleading speech about its post-surgery pain drug Exparel - The drugmaker filed a First Amendment suit seeking an injunction to prevent the...more

Post-Grant Challenges in Life Sciences: A Midyear Assessment

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

Reply Brief filed in Spokeo v. Robins – Oral Argument next on Nov. 2

In its reply brief in Spokeo v. Robins, petitioner Spokeo comes out of the gate with the consequential argument that for Robins to prevail, the Supreme Court must accept his position that every violation of a statutory right...more

Fiat moves to dismiss proposed class action suit

Late last week, Fiat filed a Motion to Dismiss the proposed class action against it following reports of hacking into vehicle information systems and its announcement that it was recalling 1.4 million Dodge, Ram and Jeep...more

Policy and Legal Implications of Implementing Renewable Energy at Scale: Supply and Demand Geographic Mismatch (Part 2 of 6)

The Problem: Supply and Demand Geographic Mismatch Because much of America’s renewable energy supply is inland and demand is on the coasts (about 52% of the U.S. population is coastal), demand cannot meet supply without...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

Data Breach Class Claims Survive Clapper

On appeal to the Seventh Circuit, a three-judge panel opinion written by Chief Judge Woods reversed the lower court. Remijas v. Neiman Marcus Group, LLC, No. 14-3122, 2015 WL 4394814, at *3 (7th Cir. July 20, 2015). The panel...more

Circuit Split on Standing in Data Breach Class Actions Survives Clapper

Last Friday, the Seventh Circuit Court of Appeals denied a retailer’s petition for rehearing en banc of a three-judge panel opinion holding that plaintiffs whose credit card information was stolen in a data breach had...more

It’s Déjà Vu All Over Again: FDA Sued Again in Off-Label Promotion Case

To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more

Arizona’s Revenge Porn Law Remains on Indefinite Hold

Earlier this year, the Arizona Legislature made major revisions to Arizona’s revenge porn law, Arizona Revised Statutes § 13-1425. Arizona is neither the first nor the only state to prohibit the unauthorized disclosure...more

New York v. Aleynikov: New York State’s Penal Code (Like Federal Criminal Law) Does Not Cover Electronic Reproduction of Source...

In 2009, Sergey Aleynikov was a computer programmer employed by Goldman Sachs to write high-frequency trading code. He accepted an offer to join a new Chicago-based company, Teza Technologies. Before he left Goldman Sachs,...more

First Amarin Pharm v. FDA, Now Pacira Pharm, Inc. v. FDA

The Southern District of New York certainly is becoming a hotbed for issues relating to the FDA’s ability to take enforcement action against manufacturers who promote their FDA-regulated products for uses outside the approved...more

New French Act on Intelligence Services: Impacts on Technical Operators

The newly enacted French legislation on intelligence services ("Loi relative au renseignement") has been almost entirely approved by the French Constitutional Court and shall fully enter into force by December 2015, at the...more

The Telehealth Top 10 for 2015

Telehealth continues to be an innovative alternative to traditional brick-and-mortar medicine. The number of providers offering telehealth services is rapidly increasing and states are enacting laws requiring health plans to...more

A Classy Affair: Class Action Lawyers Race to Courthouse in Wake of Ashley Madison Data Breach

Illicit affairs have always imposed risks – from marital discord and divorce to boiling bunnies and Maury appearances. However, when old-school adultery met new-school technology on the Ashley Madison infidelity website,...more

Guest Post - Game of Thrones, the FDA Under Attack, An In-House View of Amarin

Today's guest post is a first for this blog in two ways, first, our guest poster is anonymous. Second, our guest post is from an in-house source. The two are, of course, related. While it is important to us as lawyers that...more

Status Updates: Appeals court upholds anti-cyberbullying law; better marketing through neural networks; restaurant owner turns the...

Cruel intentions. Laws seeking to regulate speech on the Internet must be narrowly drafted to avoid running afoul of the First Amendment, and limiting such a law’s applicability to intentional attempts to cause damage usually...more

Batting Down Generic Plaintiffs’ Amarin Hail Mary Pass

We received a couple of odd anonymous comments to our “breaking news” post about the Amarin First Amendment victory for truthful off-label promotion. Both of them raised the same suggestion: “Does the logic of this opinion...more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs

The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more

Newest FDA Newsletter from AGG

Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and...more

Another One Bites the Dust: FDA Doesn’t Like the Fishy Smell of the Latest Court Decision on Off-Label Dissemination

In the most recent court decision, Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. August 5, 2015), a U.S. District Court granted Amarin's preliminary injunction to...more

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more

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