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Health Consumer Protection

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

The State AG Report Weekly Update

by Cozen O'Connor on

Consumer Protection- 14 AGs Oppose Rollback of FCC Net Neutrality Protections- 14 Democratic AGs, led by Illinois AG Lisa Madigan, submitted comments urging the Federal Communications Commission (“FCC”) to ensure open...more

A Sometimes Overlooked Fact About Express Warranty

by Reed Smith on

The warranty is “express.” Before you say, “Well, duh,” this sometimes actually does matter. Here’s how. Most complaints in product liability actions involving prescription medical products that include express warranty...more

More on King v. Bryant and Health Care Arbitration Agreements

by Ward and Smith, P.A. on

As discussed in an earlier article, the North Carolina Supreme Court recently held, in King v. Bryant, that physicians have a fiduciary relationship with their patients due to the special relationship of trust and confidence...more

HIPAA in the Age of Ransomware

According to a recent US Government Interagency report, ransomware is the fastest growing malware threat, targeting users of all types, including health care facilities. This past spring, for example, the WannaCry ransomware...more

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a...more

DeepMind Deal with NHS Trust Reveals Privacy Concerns

Back in 2015, DeepMind, a Google company, signed a deal with the Royal Free NHS Foundation Trust. The deal allowed DeepMind access to 1.6 million patients health information as well as the ability to develop an app called...more

A Double Whammy for California Design Defect Claims

by Reed Smith on

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue. Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803...more

EMA Calls for Public Consultation on Clinical Trial Protocol, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more

EMA Green Lights New EudraVigilance System for Adverse Reactions, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...more

FTC Intervenes in Physician Practice Acquisition in North Dakota

On June 22, 2017 the Federal Trade Commission (FTC) filed an administrative complaint and a request for a preliminary injunction in federal court to block a proposed physician practice acquisition in North Dakota (the...more

FDA Reorganizes ORA Staff, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

On May 15, 2017, the Food and Drug Administration's ("FDA" or "Agency") Office of Regulatory Affairs ("ORA") began implementing a "Program Alignment Initiative." The Initiative requires the ORA staff, who are charged with...more

House Energy And Commerce Committee Hearing Examines Role Of The Department Of Health And Human Services In Health Care...

by King & Spalding on

On Thursday, June 8, 2017, the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce convened to hear testimony from representatives from the HHS and CMS to discuss the findings of two...more

Anthem Agrees to Pay Over $100 Million to Settle Data Breach Lawsuit: Cybersecurity Trends

by CloudNine on

One of the most notable data breaches in recent years was the one suffered by health insurer Anthem involving the personal information of nearly 80 million individuals. It looks like they are going to pay up big to make the...more

FDA: Still in Action on Food Safety Violations

by Kelley Drye & Warren LLP on

Vigorous food safety enforcement for basic violations continues under the leadership of new FDA Commissioner, Dr. Scott Gottlieb. On June 20, on the heels of an adverse FDA inspection, FDA announced that the U.S. Marshals...more

The State AG Report Weekly Update

by Cozen O'Connor on

Charities- New York Attorney General Reaches Settlement with Breast Cancer Charity over Fraud Allegations- New York AG Eric Schneiderman reached a settlement with the Breast Cancer Survivors Foundation, Inc. (“BCSF”)...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

Seventh Circuit Finds Exclusive Dealing in Hospital-Payer Case Pro Competitive

“But what is more common than exclusive dealing?” Affirming summary judgment for defendant Saint Francis Medical Center, the Seventh Circuit recently held that the hospital’s contracts with health care insurers—though...more

Private Needle Exchange Programs Do Not Require Local Approval: Massachusetts Supreme Judicial Court Weighs In

Last week, in a case being watched locally and nationally, the Massachusetts Supreme Judicial Court (“SJC”) ruled that local government approval is not required for the operation of a private needle exchange program and that...more

FDA Says Viewers Catch a Fleeting Glimpse; Can’t Hear What You’re Saying to Sponsor of Ad with Mismatched Audio and Visual Risk...

by Arnall Golden Gregory LLP on

Recently, FDA’s Office of Prescription Drug Promotion (OPDP) issued its first Untitled Letter of the year, citing a direct-to-consumer TV advertisement for a prescription weight- loss drug. According to OPDP, the ad made...more

OCR Publishes Checklist and Infographic for Cyber Attack Response

OCR released a simple checklist and infographic last week to assist Covered Entities and Business Associates with responding to potential cyber attacks. As cybersecurity remains a pressing concern for health care entities,...more

FDA Announces Delay in Compliance Dates for Revised Nutrition Fact Requirements

by Kelley Drye & Warren LLP on

The FDA announced today that it was delaying implementation of the final rule promulgated in May 2016 that revised regulations governing Nutrition Facts labels on food and dietary supplements. The rule initially set a...more

Marketer In Hot Water for Inconspicuous TCPA Consent Language

by Klein Moynihan Turco LLP on

A recent decision issued by the United States District Court for the Northern District of Illinois has brought renewed emphasis to the importance of prominently displaying TCPA consent language in Internet marketing. In a...more

FDA Warns Against Products Claiming to Cure Cancer

by Fox Rothschild LLP on

The Food & Drug Administration (“FDA”) regulates cancer drugs and devices, both for use by humans and pets. Such drugs and devices must obtain FDA approval or clearance before they can be marketed or sold to consumers, so...more

ECRI Institute Releases Guidance on How to Protect Your Medical Device Systems

by Knobbe Martens on

The ECRI Institute released new guidance in its article: “Ransomware Attacks: How to Protect Your Medical Device Systems” on May 18, 2017. The report recommends various protective actions for hospitals to take and points to...more

Has the CMS Done an About Face as it Relates to Arbitration?

by Steptoe & Johnson PLLC on

Has the Centers for Medicare & Medicaid Services (CMS) abandoned its previously adopted Final Rule prohibiting mandatory nursing home arbitration?  The recent decision by the CMS to forego its Fifth Circuit appeal of the...more

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