News & Analysis as of

Manufacturers Product Defects Food and Drug Administration (FDA)

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

Hissey, Mulderig & Friend, PLLC

Women With Broken Paragard Copper IUDs May Qualify to File a Lawsuit

Women whose Paragard copper IUD broke during removal or while being implanted may be eligible to file a lawsuit and receive compensation for their injuries. Thousands of women who were injured by broken Paragard IUDs have...more

Jones Day

California Supreme Court Will Review Novel Negligence Theory for Pharmaceutical Manufacturers

Jones Day on

The Situation: The California Supreme Court recently granted review of a California Court of Appeal decision, Gilead Life Sciences, Inc. v. The Superior Court of the City and County of San Francisco, that made waves in the...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

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

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

Hissey, Mulderig & Friend, PLLC

Paragard IUD Litigation Update: First MDL Bellwether Trial Scheduled for October 2024

The first bellwether trial in the nationwide litigation over the copper IUD Paragard is scheduled to go to trial in Georgia in October 2024. More than 2,200 lawsuits have been filed against Teva Pharmaceutical and...more

Hissey, Mulderig & Friend, PLLC

Thousands of Women Report Paragard Copper IUDs Broken During Removal, FDA Data Shows

Federal health officials have received thousands of reports of women whose Paragard copper IUDs broke when they were being removed. Hundreds of women with broken Paragard IUDs have filed lawsuits against the manufacturers of...more

Nutter McClennen & Fish LLP

Product Liability 2022 Year in Review

Massachusetts federal and state courts issued several important product liability decisions in 2022. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...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

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

Searcy Denney Scarola Barnhart & Shipley

FDA Issues Warning About the Risk of STAR Ankle Component Breaking in Patients

This past March 2021, the U.S. Food and Drug Administration (FDA) issued a safety communication that provides information and recommendations for patients who have or are considering a STAR (Scandinavian Total Ankle...more

Skadden, Arps, Slate, Meagher & Flom LLP

Recent Enforcement Settlements Highlight Continued Scrutiny of Quality and Manufacturing Issues

Three recent settlements demonstrate the U.S. Department of Justice’s (DOJ’s) continued scrutiny of product quality and manufacturing issues in the medical device industry. Using the civil False Claims Act (FCA) and the...more

Holland & Knight LLP

Medical Manufacturer Prevails in Massachusetts Product Liability Suit

Holland & Knight LLP on

When someone is deciding whether to undergo a medical procedure, they think about a lot of things: How much does the procedure cost? What are the risks? What are the benefits? They probably don't consider whether their...more

Hogan Lovells

FDA updates VMSRP instructions for summary MDR reporting – including reasons for possible program exclusion

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) updated the information regarding its Voluntary Malfunction Summary Reporting Program (VMSRP) on the FDA Medical Device Reporting (MDR) web page....more

Faegre Drinker Biddle & Reath LLP

Indiana State and Federal Courts Rule That Manufacturing Defect Claims May Survive Preemption in PMA Context

Indiana courts have recently addressed preemption issues in matters involving devices approved by the Food and Drug Administration (FDA) through the premarket approval (PMA) process. First, the Indiana Court of Appeals...more

Troutman Pepper

Sanitizing Hand Sanitizer — Managing FDA-Recalled Hand Sanitizer

Troutman Pepper on

In 2020, even the hand sanitizer is potentially suspect. Retailers, distributors and corporate purchasers are now grappling with the added problem of clearing their shelves of it and stopping employees from using the Food and...more

Searcy Denney Scarola Barnhart & Shipley

Breast Implants Made by Allergen — At Least 12 Cancer Deaths

A U.S. Food & Drug Administration (FDA)-prompted Class 1 recall one year ago led an Ireland-based company to stop manufacturing and marketing its cancer-causing, textured breast implants and tissue expanders. The recall, the...more

BCLP

U.S. Liability Considerations for Product Manufacturers Shifting Production to New Products to Assist in Pandemic Response

BCLP on

An issue of concern for some manufacturers during the COVID-19 outbreak is the issue of potential liability in a product liability lawsuit if they switch their manufacturing process to produce items they don’t normally...more

Butler Snow LLP

COVID-19 and Product Liability: Current Trends and Future Implications

Butler Snow LLP on

It has been four months since the world learned of coronavirus disease 2019 (“COVID-19”), the new strain of coronavirus causing respiratory infection in its victims. With nearly 154,000 confirmed cases and a current death...more

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

Courts, by too readily sealing records, contributed to opioid crisis, report finds

The blame and shame for the opioid-drug overdose crisis that kills tens of thousands Americans annually has moved to yet another set of individuals and institutions now — judges and courts that handled Big Pharma lawsuits and...more

Cozen O'Connor

How Smart is it for Medical Devices to Learn New Tricks? The FDA Seeks Feedback On Its Proposed Regulatory Framework for...

Cozen O'Connor on

In the shadow of the FDA’s new Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device, manufacturers are left to contemplate enhanced product liability exposure. AI-powered devices ingest...more

Akin Gump Strauss Hauer & Feld LLP

A Client’s Guide to FDA Recalls

Recent FDA Recall Highlights & Developments - • The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more

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