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ALJ Dismisses FTC Data Security Claims Against LabMD Due to Lack of Actual or Likely Substantial Consumer Harm

On November 13, a Federal Trade Commission administrative law judge dismissed the FTC data security complaint against medical laboratory LabMD, potentially vindicating LabMD’s vigorous two-year struggle to deny the FTC’s...more

Administrative Law Judge Dismisses FTC’s Complaint Against LabMD In Data Breach Case, Citing Lack Of Consumer Harm

On November 13, 2015, the Chief Administrative Law Judge (“ALJ”) Of the Federal Trade Commission (“FTC”) dismissed an Administrative Complaint against LabMD, Inc. (“LabMD”) regarding its data security practices. In a 92-page...more

FDA Approves Genetically Engineered Atlantic Salmon as Safe and Effective for Human Food and Releases Related Draft Guidance on...

On Thursday, November 19th, the Food & Drug Administration (FDA) announced that it had approved an application for AquAdvantage Salmon, a type of Atlantic Salmon that has been genetically engineered to grow to market size...more

ALJ Dismisses FTC Data Breach Action Against LabMD

In the first ruling rebuking the Federal Trade Commission’s cybersecurity enforcement efforts, the FTC’s head administrative law judge dismissed the FTC’s complaint against LabMD, Inc., on November 13, stating that...more

ALJ Issues Sweeping Decision Dismissing FTC’s Action Against LabMD

On November 13, 2015, the chief administrative law judge (“ALJ”) handling the Federal Trade Commission’s (“FTC” or “Commission”) complaint against LabMD Inc. (“LabMD”) dismissed the case in its entirety. As we previously...more

LabMD vindicated in FTC row

We have been following the fight between LabMD and the FTC for years. It has been a story of high emotions, principles, standoffs, aggression, lawsuits, court decisions, Congressional hearings and accusations, all outlined in...more

FTC Case Against LabMD Dismissed Due to Lack of Harm

This past Friday the 13th was not a lucky day for the Federal Trade Commission (FTC). An Administrative Law Judge (ALJ) dismissed the FTC’s data security enforcement proceeding against LabMD on the grounds that the FTC failed...more

ALJ Dismisses FTC’s Data Security Suit Against LabMD for Failure to Prove ‘Substantial Injury’ to Consumers

In a landmark decision, an administrative law judge dismissed the FTC’s long-running data security lawsuit against Atlanta-based cancer screening laboratory, LabMD Inc., following an alleged data breach. Chief Administrative...more

The LabMD Case: Further Defining the FTC’s Enforcement Powers

The scaffolding of the FTC’s powers in the realm of cybersecurity continues to be built. On Monday, the FTC’s Chief Administrative Law Judge D. Michael Chappell issued an initial decision in the FTC’s closely watched...more

ALJ Dismisses FTC’s LabMD Complaint for Lack of Actual or Probable Consumer Harm from Cybersecurity Incidents

On Friday, November 13, Federal Trade Commission (“FTC” or the “Commission”) Chief Administrative Law Judge (“ALJ”) D. Michael Chappell issued an Initial Decision in In the Matter of LabMD, Inc. (FTC Docket No. 9357),...more

FDA Partially Stays Controversial Policy of Requiring INDs for Clinical Studies Evaluating Food, Dietary Supplements and Cosmetics

On Friday, October 30, 2015, FDA issued a Federal Register notice announcing a partial stay of the agency’s controversial Final IND Guidance entitled, “Investigational New Drug Applications—Determining Whether Human Research...more

Response Plan Rewind: The Essentials of Data Breach Response Plans

From the financial sector to the healthcare industry, and even the security business itself, hackers are creeping their way into business data systems and pilfering personal information. For financial institutions, security...more

OPM data breach update

The Judicial Panel on Multidistrict Litigation has decided that the three lawsuits filed against the OPM by the National Treasure Employees Union, the American Federation of Government Employees and Mary Woo, a former...more

Update on FDA’s Approach to Labeling Biosimilars Like Generics

The FDA approved label for the first U.S. biosimilar, Sandoz’s Zarxio, has raised concerns. Zarxio was launched on September 3, 2015 with a label that does not state that the product was approved as a biosimilar to Amgen’s...more

OPM admits 5.6 million fingerprints stolen during breach

The Office of Personnel Management (OPM) reported yesterday that fingerprint data stolen during the breach of almost 22 million Americans’ data is estimated to be 5.6 million instead of the original estimate of 1.1 million....more

OPM data breach update–$133 million contract awarded to vendor

The Office of Personnel Management (OPM) and the Defense Department announced this week that a Portland, OR based vendor has been selected to assist with breach notification and credit assistance for the almost 22 million...more

OPM Breach Update

In response to the massive OPM data breach, the government has been searching for a vendor to provide identity protection services for the almost 22 million individuals affected. Bids were due last week, and the chosen vendor...more

UK’s First Ever Right To Be Forgotten Enforcement : Google In The Firing Line Again

The UK’s Information Commissioner’s Office (ICO) has made what appears to be its first “right to be forgotten” enforcement action against Google Inc. The ICO issued the notice on 18 August 2015, ordering Google to remove nine...more

FDA issues first medical device hacking alert

Reportedly for the first time ever, the FDA recently issued a declaration that hospitals should not use a medical device manufactured by Hospira Inc. because of security flaws that could allow hackers to penetrate hospital...more

FDA's Cybersecurity Alert Puts Medical Device Users on Notice

On July 31, 2015, the United States Food and Drug Administration (FDA) issued a cybersecurity alert to health care facilities currently using certain infusion pumps manufactured by Hospira, Inc. The alert warns health care...more

Animal supplements still in limbo, facing increased FDA scrutiny

The thousands of food, agriculture and life sciences companies regulated by the federal government already face a barrage of complicated regulations. Add in significant regulatory uncertainty and a major reorganization of the...more

FDA Cites Drug Company for Kim Kardashian Endorsement

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more

OMG: Kim Kardashian Prompts FDA Warning Letter

Kim Kardashian recently trumpeted the beneficial effects of Diclegis, a pill indicated for the treatment of nausea and vomiting of pregnancy for certain women, to her over 42 million Instagram followers. One such Kardashian...more

FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...more

FCC Fines AT&T $100,000,000 for Violation of Transparency Rule

In a recent enforcement action, the FCC fined AT&T $100,000,000 for violations of the Open Internet Transparency Rule (“Transparency Rule”). The Notice of Apparent Liability (“NAL”) for Forfeiture and Order stated that AT&T...more

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