Consumer Protection Products Liability Health

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Consumer Fraud Allegations For A Prescription Medical Device Do Not Pass The Test

When we think of prescription medical devices, we usually think of the sorts of devices that are implanted during surgery and tend to end up in litigation—artificial joints, pacemakers, surgical meshes, and bone cements, to...more

FDA Regulatory and Compliance Monthly Recap — August 2016

FDA issues draft guidance on use of real-world data in medical device decision-making - The Food and Drug Administration’s draft guidance provides an overview of how the agency will determine the quality and reliability...more

FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance...more

New Proposed Legislation: Doctors Must Report Med Device-Related Deaths & Injuries

Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed...more

Why the FDA Needs to Change Its Food Recall Policies

Add this to FDA’s growing list of things to do: improve the food recall initiation process. According to a memorandum published on June 8, 2016, the Office of Inspector General (OIG) of the Department of Health and Human...more

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

Advertising Law - June 2016

First Circuit Affirms Ruling Against - In a victory for the Federal Trade Commission, the First Circuit Court of Appeals affirmed a Commission ruling that website, a self-described reputation management...more

KIND Litigation – What Issues can Food and Beverage Companies Face When They Use the Term “Healthy”

If you go down the aisle of your neighborhood grocery store, you’ll find the terms “all-natural” or “healthy” emblazoned on a growing number of products—products that often garner higher prices than their competitors. Over...more

FDA Proposes Ban on Electrical Stimulation Devices for Aggressive or Self-Injurious Behavior

On April 25, the U.S. Food and Drug Administration published a proposed rule banning electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior....more

AFFs, BPs, ONJ: Understanding Alphabet Soup of Osteoporosis Treatment

The American Society for Bone and Mineral Research recently reassessed the efficacy of bisphosphonate, long hailed as a wonder drug for patients with osteoporosis, and its risk factors. Through the course of two clinical...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

Heater-Cooler Devices Linked to Infections

Heater-cooler devices are used during cardiothoracic surgeries, and other medical and surgical procedures to warm or cool a patient. They include water tanks that provide temperature-controlled water to external heat...more

Class Action Lawsuit Filed Against Fitbit

Fitbit, Inc., a manufacturer of wearable health technology, is involved in a national class action lawsuit filed on January 5, 2016 in the Northern District of California over two of its wristbands, the Charge HR and the...more

FDA Medical Device Safety Tracking System Reform

The Los Angeles Times reports that in recent years, several devices, including certain reusable medical scopes, metal-on-metal hip replacements, transvaginal meshes, and lead wires in heart defibrillators have been recalled. ...more

FDA Targets CBD Products, Claims Made in Social Media

Last February, FDA issued three warning letters to companies marketing cannabidiol (CBD) products as dietary supplements. FDA reviewed the companies’ websites and concluded that claims that CBD products could treat...more

Webinar PowerPoint Slides: Medical Apps and Devices: The Convergence of FDA, FTC, and State and Federal Regulations

These are the PowerPoint slides from this webinar: Years ago, if someone told you that computers would replace doctors for medical treatment, you would have laughed. While we have yet to reach this paradigm, mobile medical...more

Medical Apps and Devices: The Convergence of FDA, FTC, and State and Federal Regulations [Video]

Years ago, if someone told you that computers would replace doctors for medical treatment, you would have laughed. While we have yet to reach this paradigm, mobile medical applications and devices have come to the forefront...more

Off-Label Promotion and Product Liability: Are Industry’s Recent Court Wins in One Space a Win in the Other?

The pharmaceutical industry has recently felt empowered and emboldened by recent litigation that would seemingly allow companies to distribute, proactively, information about unapproved uses, i.e., off-label, so long as the...more

Health Hackers: Problems in Applying Traditional Products Liability Theories to Latent Cyber-Vulnerabilities in Medical Devices

October is National Cyber Security Awareness Month (yes, that’s a thing), so it seems fitting to write about an unprecedented alert recently released by the FDA to health care providers that warned of a medical device’s...more

A Couple of Law Review Articles We Actually Like

The last couple of times we’ve commented on new law review articles, we haven’t liked what we’ve seen very much. We’re gluttons for punishment, however, and this time we were rewarded. We found a couple of recent law review...more

Update on Opposition to ABA Hijinks

Last month, we described the proposal by the American Bar Association’s Standing Committee on Medical Professional Liability concerning legislation on “defective medical products” and punitive damages for “patient harm...more

Bad News from Europe for Makers of Life-Saving Medical Devices

In over eight years, we’ve never before blogged about a European development in prescription medical product liability. The (relatively) recent decision by the Court of Justice of the European Union (“CJEU”) in Boston...more

Feds Go After Websites Selling Suspect Medicine and Devices

Partnering with international regulatory and law enforcement agencies, the FDA last month put the screws to more than 1,000 websites that illegally sell potentially dangerous drugs and medical devices directly to consumers....more

No Prescription For Consumer Protection

Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich. It doesn’t fit, and the combination isn’t very...more

Food Recalls Increase in First Quarter of 2015

Food producers are reporting a sharp rise in food recalls so far this year. During the first quarter of 2015, the U.S. Food and Drug Administration (FDA) published notices of 118 food recalls (excluding pet foods), and the...more

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