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Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 5, September 2024

Spilman Thomas & Battle, PLLC on

Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the Biden administration's proposed insurance rule regarding mental health and substance use...more

Oberheiden P.C.

Understanding the Risks (and Costs) of Defective Abiomed Impella Heart Pumps

Oberheiden P.C. on

Abiomed, Inc., a subsidiary of Johnson & Johnson, is facing lawsuits across the country related to the company’s Impella heart pumps. Since June of last year, the company has issued multiple recalls for these implantable...more

Stikeman Elliott LLP

Regulatory Amendments Impacting Drug and Medical Device Recalls Coming Into Force

Stikeman Elliott LLP on

On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more

Stikeman Elliott LLP

Palmer v. Teva Canada Ltd.: Court of Appeal Confirms No Compensation for Risk “In the Air”

Stikeman Elliott LLP on

In Palmer v. Teva Canada Limited, the Ontario Court of Appeal upheld the lower court’s decision to deny certification of a proposed product liability class action seeking damages for the alleged increased risk of being...more

Epstein Becker & Green

Unpacking Averages: Analyzing the Relationship Between MDRs and Recalls

Epstein Becker & Green on

Recently Colleen and Brad had a debate about whether Medical Device Reports (“MDRs”) tend to trail recalls, or whether MDRs tend to lead to recalls. Both Colleen and Brad have decades of experience in FDA regulation, but we...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

Nelson Mullins Riley & Scarborough LLP

Potential Nitrosamine Contamination Results in Another Voluntary Pharmaceutical Recall

Nelson Mullins Riley & Scarborough LLP on

On March 22, 2023, at the request of the U.S. Food and Drug Administration (“FDA”), Ascend Laboratories LLC. (“Ascend”) issued a voluntary nationwide recall of certain lots of Dabigatran Etexilate Capsules, a blood thinner...more

Console and Associates, P.C.

Some OTC Supplements Contain Tadalafil, According to the FDA

Console and Associates, P.C. on

In recent months, the Food and Drug Administration (FDA) announced several recalls related to natural supplements that were found to contain tadalafil and its analogs, the active ingredients in Viagra and Cialis. In its...more

Console and Associates, P.C.

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

Console and Associates, P.C. on

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

Knobbe Martens

Two Drugs Recalled Due to Manufacturing Issues

Knobbe Martens on

Two pharmaceutical companies have issued recalls in December due to manufacturing issues that may impact the safety and quality of their drug products. ...more

Searcy Denney Scarola Barnhart & Shipley

Is Rapid Really a Good Thing? — FDA-Approved Over-the-Counter COVID-19 Test Recalled

Searcy Denney Scarola Barnhart & Shipley on

Over 400,000 COVID-19 rapid test kits have been recalled by Australian manufacturer Ellume. The reason? Way too many false positive results. “At Ellume, we understand that trust is central to fulfilling our purpose...more

Faegre Drinker Biddle & Reath LLP

Growing Safety Risk for Hospitals: Spiraling Medical Device Recalls

Faegre Drinker Biddle & Reath LLP on

Everyone knows that the number of medical device recalls is on the rise. Here are two telling examples of the growth. In 2003 a total of 604 recalls were reported to the FDA, while last August a single manufacturer recalled...more

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