News & Analysis as of

Food and Drug Administration (FDA) Bodily Injury

Harris Beach PLLC

Defending Benzoyl Peroxide Acne Product/Benzene Litigation

Harris Beach PLLC on

This year, a laboratory issued a report wherein it claims to have tested over-the-counter and prescription acne products containing benzoyl peroxide and found what it deemed to be “unacceptably high” levels of benzene. In...more

Console and Associates, P.C.

Parents Bring Kratom Lawsuits Following Overdose Deaths and Other Serious Injuries

Kratom, a natural substance derived from the leaves of the Mitragyna speciosa tree, has recently gained notoriety for its potential dangers. While proponents cite its therapeutic benefits, concerns have surged about its...more

Searcy Denney Scarola Barnhart & Shipley

Searcy Denney Is Pursuing Claims on Behalf of Families Affected by Dangerous WanaBana Applesauce Pouches

Our firm is actively pursuing claims against WanaBana USA and other companies on behalf of families affected by WanaBana USA’s dangerous applesauce pouches. On October 28, 2023, the U.S. Food and Drug Administration (FDA)...more

Napoli Shkolnik

Product Liability: How it Works For and Against Victims of Defective Medical Devices

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Crafting the perfect medical device is never an exact science—but a patient should never suffer because of defects in a product that was intended to improve their quality of life. Determining whether a device manufacturer or...more

Console and Associates, P.C.

Federal Investigation of Anterior Growth Guidance Appliance (AGGA) Dental Device Prompts Wave of Lawsuits

When a doctor suggests that a medical device may help you, they’ll explain a little bit about how the device works; however, truly understanding how any given device works often requires either a medical or scientific...more

Searcy Denney Scarola Barnhart & Shipley

FDA Reports Sterilization Issues in EzriCare Factory: Bacterial Contamination in Artificial Tears Products

Earlier this year, the US Center for Disease Control and Prevention (“CDC”) spotted an outbreak of a rare bacterial infection in 11 (now 16) different states, associated with multiple different infection types, particularly...more

Nutter McClennen & Fish LLP

Product Liability 2021 Year in Review

Massachusetts federal and state courts issued several important product liability decisions in 2021. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows...more

Console and Associates, P.C.

Philips CPAP Recall Update: Shocking Revelation From FDA Investigations and More

What is the latest with the CPAP lawsuits? As 2022 begins, the thoughts of sleep apnea patients and their families are, naturally, returning to the Philips CPAP machine recall 2021....more

White and Williams LLP

Making Safer Robotic Devices

White and Williams LLP on

...Robots are everywhere – but perhaps just not how everyone imagined them. For decades, the promise of robots brought to mind devices like R2D2 and C3PO, or perhaps Rosie the Robot from The Jetsons – autonomous, intelligent...more

Searcy Denney Scarola Barnhart & Shipley

Did Bayer Hide Behind Sealed Court Documents To Tout Essure?

Contraceptive Is Linked to Injuries and Deaths and Now Is the Subject of Lawsuits - Bayer, the company that manufactured and marketed the dangerous birth-control device Essure, is looking more and more like a bad actor as...more

Nutter McClennen & Fish LLP

Product Liability 2019 Year in Review

Massachusetts state and federal courts issued a number of important product liability decisions in 2019. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more

Shook, Hardy & Bacon L.L.P.

The FDA’s Latest Warning: A Good Reminder Regarding the Litigation Risks of Off-Label Use

Last week, the FDA issued a warning against the use of robotic surgery for mastectomy and other cancer-related procedures. ...more

Cozen O'Connor

ALERT: U.S. Supreme Court Grants Certiori to Decide Whether FDA Excluded Warnings Pre-Empt State Law Claims

Cozen O'Connor on

The U.S. Supreme Court today agreed to consider a Third Circuit ruling that revived litigation over Merck’s alleged failure to warn about a risk of femoral fractures from its osteoporosis drug Fosamax. The precise question...more

Patrick Malone & Associates P.C. | DC Injury...

FDA Falls Asleep in Reporting Faulty Surgical Device

The FDA’s Medwatch program is supposed to enhance patient safety by publicizing adverse medical events, but you have to wonder how effective it is when the feds wait more than four months to post a serious problem with a...more

Searcy Denney Scarola Barnhart & Shipley

FDA Rallies Around Pradaxa with New Study, Still No Antidote

A review by the FDA finds no additional risk of myocardial infarcation (MI) or a heart attack when Pradaxa (dabigatran) is compared to Coumadin (warfarin). An MI occurs when blood suddenly stops flowing to parts of the heart...more

Searcy Denney Scarola Barnhart & Shipley

FDA: Proposal to Call Pelvic Mesh High-Risk, Require Testing

A major move toward public safety may be one step closer with the U.S. Food and Drug Administration announcing this week that it will put a proposal out for public comment that would reclassify pelvic organ prolapse (POP)...more

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