Health Products Liability

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News & Analysis as of

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

FDA Recalls Custom Ultrasonic

AERs (automatic endoscope reprocessor) are free-standing units used in health facilities to disinfect flexible endoscopes and scope accessories between uses. Custom Ultrasonic AERs should wash and high- level disinfect...more

FDA Proposes Ban on Powdered Gloves

The U.S. Food and Drug Administration has announced a proposal to ban most powdered medical gloves in the United States due to a health risk posed to patients....more

FDA Asks for Comments on Refurbishing and Servicing of Medical Devices

The Food and Drug Administration published a Proposed Rule in the Federal Register establishing a docket and requesting information and comments on third party entities that “refurbish, recondition, rebuild, remarket,...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

Product Liability: 2015 Year in Review

Massachusetts state and federal courts issued a number of important product liability decisions in 2015. The Product Liability and Toxic Tort Litigation Group at Nutter recently reviewed these cases. Highlighted below are...more

Essure Has Caused 303 Fetal Deaths, Independent Analysis

A gross discrepancy in the number of fetal deaths attributed to the birth control device Essure has prompted the U.S. Food and Drug Administration to analyze the data and decide whether to change the way the product is...more

$11 Million Verdict Against Gynecare Prolift Pelvic Floor Repair System Under Appeal

Ethicon Women’s Health & Urology, maker of the Gynecare Prolift Pelvic Floor Repair System, is appealing an $11 million verdict awarded to a South Dakota women injured by the defective mesh implant....more

Maker of dirty medical device hit with $623 million in penalties for kickbacks

Can the sleaze get any worse with the maker of a dirty medical device that investigators say sickened dozens and played a role in killing 21? Sadly, it can. Federal prosecutors say that the maker of a flexible scope used in...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

Metal-on-Metal Hip-Implant Case End With Significant Jury Award

If the bellwether trial of a plaintiff who suffered complications from a metal-on-metal hip implant is any indication of future verdicts, Wright Medical Technology should be worried. A jury awarded $11 million to a woman...more

Arizona Supreme Court Adopts Learned Intermediary Doctrine

The Arizona Supreme Court has issued an opinion adopting the learned intermediary doctrine in Arizona. The Supreme Court rejected the Arizona Court of Appeals’ earlier decision holding that the learned intermediary doctrine...more

Recalled Brainlab Digital Neurosurgery Device Could Pose Serious Injury, Death to Patients

A medical device created by Brainlab and marketed as easy-to-use, intuitive, precise and tailored to surgeons’ needs has been recalled by the U.S. Food and Drug Administration. Cranial-navigation systems sold by...more

Senate HELP Committee Minority Staff Report Places Blame on Manufacturers, Hospitals, and FDA Regarding Duodenoscope-Linked...

On January 13, 2016, Senator Patty Murray (D-WA), Ranking Member of the United States Senate Health, Education, Labor, and Pensions (“HELP”) Committee, released a Minority Staff Report detailing the results of a year-long...more

Fourth Circuit Upholds $1.75 Million Punitive Damages Award In Transvaginal Mesh Case

About a month ago, we reported on a Delaware trial court decision reducing a $75 million punitive award to $7.5 million in a transvaginal mesh case. Last week, in what we believe to be the first appellate decision in one of...more

FDA Classifies Transvaginal Pelvic Mesh As “High Risk” Medical Device

The U.S. Food and Drug Administration issued two final orders on Monday, January 4, 2016 to strengthen the data requirements for transvaginal surgical mesh devices that repair pelvic organ prolapse (POP). First, the agency...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

Food and Drug Newsletter - December 2015

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...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

Delaware Superior Court Cuts Punitive Damages In Transvaginal Mesh Case

Last week, we posted about a $10 million award of punitive damages in a product liability action against a manufacturer of hip implants.  We explained our view that the award was excessive, in part because hundreds of similar...more

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