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Product Defects Food and Drug Administration (FDA)

Oberheiden P.C.

Everything You Need to Know About the Bard PowerPort Lawsuits

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The medical device manufacturer Bard is facing hundreds of lawsuits over its Bard PowerPort device. These lawsuits allege that the device was defectively made and caused significant medical problems when it broke....more

Oberheiden P.C.

Allergan Breast Implant Lawsuits: 6 Things to Know

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Thousands of lawsuits have been filed against the Ireland-based medical device company Allergan for a unique type of blood cancer that has been linked to its textured breast implant. The U.S. Food and Drug Administration...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

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

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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

ArentFox Schiff

California Supreme Court to Review Newly Created Duty to Market a “Safer” Product Even in the Absence of a Defect

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On May 1, the California Supreme Court granted Gilead Science Inc.’s request to review a California appellate court’s holding that the pharmaceutical manufacturer must defend against negligence claims stemming from its...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

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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

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

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

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

White and Williams LLP

Montana Significantly Revises Its Product Liability Laws

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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

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

Nelson Mullins Riley & Scarborough LLP

Heartburn for Valisure: Controversial Testing Lab Under Fire

In early December, a federal judge tossed plaintiffs’ expert evidence and dismissed some 2,450 lawsuits in the sprawling litigation involving the heartburn medication Zantac. U.S. District Judge Robin L. Rosenberg’s December...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

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

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

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

Butler Snow LLP

20 Questions to Ask When Defending a Medical Device Case

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In the game of “20 Questions,” one player secretly chooses an object and the other players are allowed 20 questions to identify it. In that spirit, answering the following 20 questions may identify a defense strategy that...more

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

Poor FDA communication harms patients, taxpayers, other agencies

Critics are slamming the federal Food and Drug Administration for dropping the ball in informing the U.S. officials who run the Medicare, Medicaid, and veterans’ health programs about crucial regulatory decisions, leading the...more

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