News & Analysis as of

Product Defects Medical Devices

Oberheiden P.C.

Hernia Mesh Litigation: What a Global Settlement Would (and Wouldn’t) Mean for Patients and Their Families

Oberheiden P.C. on

Recent events suggest that a global settlement in the longstanding hernia mesh multidistrict litigation (MDL) is on the horizon. Most recently, the parties jointly submitted two case management orders on July 5, 2024—CMO #52...more

Searcy Denney Scarola Barnhart & Shipley

The Role of the FDA in the Exactech Recall: A Critical Analysis

Exactech has issued multiple recalls for its implantable joint replacement devices over the past few years. While Exactech has largely issued these recalls voluntarily, it has done so at the request—and with the oversight—of...more

Searcy Denney Scarola Barnhart & Shipley

Lessons Learned from the Exactech Recall: How We Can Improve Medical Device Safety in the Future

In response to scrutiny from the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. Despite these recalls—which began in...more

Searcy Denney Scarola Barnhart & Shipley

Alternatives to the Exactech: Exploring Other Surgical Tools and Techniques

Over the past couple of decades, hundreds of thousands of patients in the United States have received defective medical implants manufactured by Exactech. While the U.S. Food and Drug Administration (FDA) has identified...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

Gardner Law on

Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Searcy Denney Scarola Barnhart & Shipley

A Timeline of the Exactech Recall: How it Unfolded

Exactech has recalled hundreds of thousands of implantable ankle, knee, hip and shoulder replacement devices over the past few years. If you or a loved one received an Exactech implant in 2004 or later, it will be important...more

Searcy Denney Scarola Barnhart & Shipley

The Legal Implications of the Exactech Recall for Patients and Hospitals

Exactech is a manufacturer of medical implants, including ankle, knee, hip and shoulder replacement devices. Unfortunately, due to poor manufacturing practices and quality control issues, Exactech has been forced to recall...more

Searcy Denney Scarola Barnhart & Shipley

What to Do If You've Been Affected by the Exactech Recall

If you have had problems with an Exactech ankle, knee, hip or shoulder implant, you are not alone. At the request of the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective ankle,...more

Searcy Denney Scarola Barnhart & Shipley

Exactech Shoulder Replacement Systems: What You Need to Know

Exactech is a medical device company that has faced numerous lawsuits in recent years. These lawsuits have focused on various issues with the company’s implantable medical devices, including issues that the company has...more

Searcy Denney Scarola Barnhart & Shipley

The Exactech Recall: A Quick Synopsis and Update on What You Need to Know

Exactech is a medical device company that manufactures implantable joint replacements. It is also a company that has faced numerous lawsuits related to its products in recent years. In many cases, Exactech has acknowledged...more

Napoli Shkolnik

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

Napoli Shkolnik on

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

Searcy Denney Scarola Barnhart & Shipley

The Impact of the Exactech Recall on Patient Safety

Exactech has recalled hundreds of thousands of its implantable medical devices. This includes ankle, hip, knee and shoulder implants that the company shipped to doctors’ offices and hospitals across the country. These recalls...more

Jones Day

Reversal of Burden of Proof Under Proposal for a New EU Product Liability Directive

Jones Day on

In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more

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

Better Health Care Newsletter - October 2023

Noise and light can be bad for us just like dirty water and air - The picture-perfect spot to live our healthiest lives would be temperate, with fresh air, sparkling water, and night skies ablaze with stars. It would...more

Console and Associates, P.C.

Patients Raise Concerns Over Safety of Bard PowerPort

The Bard PowerPort, often known as the "BardPort," is a subdermal medical device designed to facilitate the connection of a catheter for the administration of intravenous fluids or medication. However, since its launch, there...more

Dechert LLP

Unprecedented Escalation of Injunction by French National Agency for Medicines and Health Products Safety

Dechert LLP on

In June 2021, Philips notified the ANSM of a field safety action that related to the potential risk of degradation and inhalation of carcinogenic compounds from the sound-absorbing foam used in its ventilation devices for...more

White and Williams LLP

Montana Significantly Revises Its Product Liability Laws

White and Williams LLP on

On May 4, 2023, Montana changed its product liability laws when the Governor signed SB 216, which was effective upon passage and applies to claims that accrue on or after May 4, 2023. Among the changes is the adoption of a...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

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

FDA knew of, but didn’t act on little devices’ deadly racial problems

Until the coronavirus pandemic struck, few regular folks knew about pulse oximeters, much less had one on hand for urgent use. The devices, which fit over a finger, are supposed to give fast readings on the levels of oxygen...more

Robins Kaplan LLP

Update on Exactech Knee, Hip, and Ankle Implant Recall Lawsuit

Robins Kaplan LLP on

Robins Kaplan LLP is examining the recent recall of orthopedic devices that were manufactured by Exactech for hip, knee, and ankle implants. Since 2021, Exactech has recalled approximately 185,000 devices with the latest...more

Epstein Becker & Green

Unpacking Averages: Common Root Causes Driving Medical Device Recalls

Recalls have always been a bit of a double-edged sword. Obviously, companies hate recalls because a recall means their products are defective in some manner, potentially putting users at risk and damaging the brand. They...more

Console and Associates, P.C.

Final Bellwether 3M Earplug Trial Ends at $77.5 M Verdict.

A federal jury in Florida awarded $77.5 million in damages, including $72.5 million in punitive damages, to a former soldier who filed a claim alleging that his hearing loss resulted from defective 3M Co. earplugs. The case...more

Shook, Hardy & Bacon L.L.P.

Defeat Design Defect Claims Before They’re Filed

During product development, it’s not unusual to discover certain failure points in a surgical robot’s design. For example, certain components, like nuts or bolts or screws, may become brittle when exposed to various...more

Faegre Drinker Biddle & Reath LLP

It’s an MDL World: Agreement is enough, or is it?

The JPML held its second hearing of 2022 at the end of March. We addressed the results of the first hearing recently here, and further observed the JPML’s trend over the course of the last several years in forming fewer MDL...more

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

As recall of sleep apnea devices expands, U.S. prods firm to act faster

Federal officials have ramped up the pressure on a Dutch conglomerate over its expanding but slow recall of sleep apnea breathing devices relied on by millions of increasingly angry U.S. patients. The Justice Department...more

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