North Carolina Product Liability Lawyer Blog

FDA Criticized for Flawed and Delayed CPAP and BiPAP Recall

Published on: December 22, 2023 | By Clay Hodges

I’ve written extensively about problems with some Philips CPAP and BiPAP machines, including alleged injuries, affected machines, recalls, and potential litigation. That litigation is ramping up, but a new concern has arisen over the FDA’s inadequate and delayed recall process.

Specifically, governmental safeguards designed to protect the public from faulty or dangerous medical devices may not be working properly. Using the Philips recall situation as a prime example, let’s examine what going on with the U.S. Food and Drug Administration (FDA) and why there might be room for improvement in how it handles potentially dangerous medical devices.

The FDA’s Role in Keeping Consumers and Patients Safe

Ozempic Label Does Not Include Gastroparesis Warning

Published on: December 13, 2023 | By Clay Hodges

I recently wrote about the start of what may become a wave of lawsuits against the maker of Ozempic due to certain side effects from that medication. In particular, several users claim that Ozempic and related drugs caused their gastroparesis, or the slowing (or stopping) of food from the stomach to the small intestine. The primary argument is that the Ozempic label did not contain adequate warnings concerning potential side effects.

After this litigation began, Novo Nordisk (the maker of Ozempic) updated the Ozempic’s label. Could this have been in response to the existing litigation or fear of future litigation? We don’t know, but let’s take a look this recent product label change, including how it relates to earlier changes and the labels for similar drugs.

An Overview of Ozempic and Related Medications

Elective Option for Camp Lejeune Contaminated Water Claims (Part 2)

Published on: November 22, 2023 | By Clay Hodges

Let’s jump back into our discussion of the Elective Option in the Camp Lejeune toxic water litigation. In this Part 2 we will discuss qualifying injuries, proven exposure to toxic water, and the settlement possibilities within the Elective Option:

How Do I Prove I Have a Qualifying Injury?

You’ll need to provide medical documents indicating you were diagnosed and/or treated for a qualifying injury. These must be original or certified copies. If it’s impossible to provide either, you’ll need to sign a sworn statement explaining why you can’t provide an original or certified copy along with an uncertified copy.

Elective Option for Camp Lejeune Contaminated Water Claims (Part 1)

Published on: November 16, 2023 | By Clay Hodges

The Camp Lejeune toxic water litigation continues to chug along in the U.S. District Court for the Eastern District of North Carolina, with no major developments. This isn’t too surprising given how it’s still early in the overall litigation. However, there’s been a major development in the administrative claims process.

Specifically, the U.S. Department of Justice (DOJ) and the U.S. Department of the Navy have announced something called an “Elective Option.” On paper at least, this is designed to help speed up the time it takes for claimants to receive compensation, as well as ease the burden of proving claims.

This may seem like welcome news, because as of the time of this writing, there are almost 100,000 administrative claims filed with the Navy. But a claimant should be vigilant and make sure the compensation offer under this option is reasonable and fair.

An Update to Philips CPAP and BiPAP Machine Recall

Published on: October 13, 2023 | By Clay Hodges

Philips Respironics (Philips) is a major manufacturer of the CPAP and BiPAP machines that help people with central sleep apnea and obstructive sleep apnea. Philips also makes ventilators that have no doubt saved lives in hospitals and other healthcare settings. These machines use a special type of foam to reduce the sound and vibration coming from these devices. Unfortunately, the foam Philips chose years ago can degrade and injure users, which eventually led to a 2021 CPAP recall. Let’s take a look at a recent development concerning Philips and its ventilator, CPAP and BiPAP products.

A Brief Overview of How We Got Here

In June 2021, the U.S. Food and Drug Administration (FDA) issued a Safety Communication notifying the public that Philips had recalled certain BiPAP, CPAP and ventilator machines. There were concerns that the polyester-based polyurethane (PE-PUR) foam used in these devices could break down, allowing small bits of foam to enter a person’s body. The FDA also mentioned that the foam could off-gas and release harmful gasses into the machine’s airflow causing additional harm.

Ozempic Gastroparesis Lawsuits: An Overview

Published on: September 12, 2023 | By Clay Hodges

You’ve probably heard about the blockbuster drug, Ozempic. Maybe you’re already taking it or perhaps you were just watching the Oscars earlier this year. Either way, it’s hard to not know about Ozempic and its growing popularity to not just treat type 2 diabetes, but also weight loss.

As helpful as Ozempic is to lower blood sugar and/or weight, it’s also known for some unpleasant side effects. One possible side effect is gastroparesis, which has led to one of the first lawsuits linked to Ozempic.

What Is Ozempic?

Aqueous Film-Forming Foam (AFFF) and PFAS Litigation Update, Part 2

Published on: July 25, 2023 | By Clay Hodges

Back in June I wrote a blog post about a possible $1.185 billion settlement between several defendants in the Aqueous Film-Forming Foams (AFFF) Products Liability Litigation MDL No. 2873 (AFFF MDL). This is a large amount of money, but given how many people and municipalities may have been harmed, this is almost a drop in the bucket when it comes to how much more money could be at stake here. In fact, just a few weeks later, there was news of another viable settlement in the AFFF MDL.

The 3M Settlement

According to its June 22, 2023 press release, 3M announced a potential settlement with public water suppliers, many of which are plaintiffs in the AFFF MDL. The settlement amount will be at least $10.3 billion. This money would be used to help public water suppliers remove perfluoroalkyl and polyfluoroalkyl substances (PFAS) from municipal water supplies as well as fund continued water testing.

Tepezza and Hearing Problems: What You Need to Know

Published on: June 10, 2023 | By Clay Hodges

Horizon Therapeutics (Horizon) makes a drug called Tepezza (teprotumumab-trbw). It is a relatively new drug approved by the FDA to treat the symptoms of Thyroid Eye Disease (TED). These symptoms include bulging of the eyes, swelling, eye pain, double vision and redness of the eyes. TED is a rare medical condition involving inflammation of the tissue around the eyes.

When made available in early 2020, Tepezza was the first FDA-approved drug to treat TED. Despite being approved by the FDA, many patients who have received this medicine have reported various side effects. One of the more notable is that many patients have started complaining about hearing problems.

Does Tepezza Cause Hearing Problems?

Aqueous Film-Forming Foam (AFFF) and PFAS Litigation Update

Published on: June 5, 2023 | By Clay Hodges

A while back I published a blog post discussing the potential health problems associated with aqueous film-forming foam (AFFF). Specifically, I discussed how it contained several chemicals (PFAS) that could potentially harm humans.

At the time of that blog post, some major litigation concerning AFFF had just begun. But a few years have now passed and we might have a potential settlement involving many of the litigants. Before I get to the settlement, let me provide some background information to better put things in perspective.

How Is AFFF Potentially Harmful?

Camp Lejeune Contaminated Water Litigation Update

Published on: May 12, 2023 | By Clay Hodges

In a previous blog post, I mentioned how the Camp Lejeune litigation was starting to pick up. Specifically, the court scheduled a status conference to discuss pre-trial matters like protecting evidence and identifying witnesses. Even though we’re still in the early stages of litigation, a few things have happened since then that I’d like to discuss.

An Overview of the Camp Lejeune Lawsuits

The water at the U.S. Marine Corps Base Camp Lejeune (Camp Lejeune) is safe to drink and use. But it wasn’t always this way, especially during the decades before 1987. During that time, the water at Camp Lejeune contained various chemicals which could result in serious health problems.

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