North Carolina Product Liability Lawyer Blog

FDA Issues Warning: Increased Risk of Thigh Bone Fractures With Zimmer Biomet CPT Hip System Femoral Stem

Published on: October 1, 2024 | By Clay Hodges

Artificial hips offer a new lease on life to many thousands of people each year. They provide recipients the opportunity for independent living and mobility they might not otherwise have. Unfortunately, they also come with risks, one of the most prominent being metallosis. But there’s also another potential risk where the femur (thigh bone) could break.

The femur is the largest and strongest bone in the body. Yet the process of implanting an artificial hip, along with the older age of most patients who receive artificial hips, means there’s a greater risk of a thigh bone fracture. If this happens, artificial hip revision surgery may be needed.

The U.S. Food and Drug Administration (FDA) recently issued a safety communication alerting patients with the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper of an increased risk of thigh bone fracture. Let’s take a look at this safety communication and what you should do if you received this implant.

New Study Links Ozempic to Vision Problems

Published on: August 19, 2024 | By Clay Hodges

Many people have gotten off insulin and/or lost significant weight thanks to Ozempic. This is the brand name of a drug with semaglutide as the active ingredient and has been prescribed to many patients struggling with diabetes. Semaglutide is also the active ingredient in Wegovy. This is the brand name for a similar medication that’s essentially a higher-dose version of Ozempic and is intended primarily for individuals looking to lose weight.

However, like most other prescription medications, Ozempic and Wegovy have their fair share of side effects and issues. One of the most publicized and unpleasant is gastroparesis, which has led to some legal action that I wrote about last year. Then in July 2024, a study published by JAMA Ophthalmology indicated a possible link between semaglutide and nonarteritic anterior ischemic optic nerve neuropathy. Let’s take a closer look at this study and what it could mean if you or someone you know is taking Ozempic or Wegovy.

What Is Nonarteritic Anterior Ischemic Optic Neuropathy?

Cartiva Toe Implants Pose High Risk of Failure; Lawsuits Increasing

Published on: July 8, 2024 | By James Hodges

The Cartiva toe implant has become a commonly used device aimed at relieving symptoms of arthritis in the big toe. It has, however, been known to fail at an abnormally high rate, causing pain, loss of motion, and even additional surgery. If you or someone you know has experienced adverse health effects from receiving the Cartiva toe implant, you may want to keep reading.

About the Cartiva Implant

The Cartiva toe implant was manufactured to treat symptoms of big toe arthritis. This type of arthritis occurs when cartilage is damaged, or worn down, in the big toe joint. The degraded cartilage causes the bones to rub together, which can lead to pain, stiffness, and swelling. The Cartiva implant is a synthetic replacement for the degraded cartilage. Its primary purpose is to reduce bone-on-bone friction in the metatarsophalangeal joint in the big toe. It is specifically molded from Polyvinyl Hydrogel (PVA Hydrogel), and is roughly the size of a popcorn kernel. Prior to this implant, the only viable treatment option for big toe arthritis was a difficult fusion surgery that left the patient with limited mobility. This product became the first openly accessible alternative to fusion surgery.

More than 70,000 Zantac Lawsuits to Move Forward in Delaware State Court

Published on: June 28, 2024 | By James Hodges

A Delaware Superior Court Judge has allowed roughly 75,000 plaintiffs to be heard in Delaware courts regarding whether the drug Zantac caused cancer. This is a massive turn of events, as nearly 50,000 similar lawsuits were dismissed in federal courts just two years ago. In 2022, the federal judge in the multidistrict litigation in Florida determined that the expert witness reports and testimony were not based on adequate science. Judge Medinilla, by contrast, ruled that the expert testimony should be heard in court with regard to the causation between Zantac and cancer. Ultimately, she determined that the strength of each side’s scientific arguments should be heard and considered by juries.

History of Zantac Regulation and Litigation

The heartburn medication commonly known as Zantac has been available on the market for decades, and was once one of the world’s top selling drugs. It is used to treat many gastrointestinal disorders including heartburn, duodenal ulcers, gastroesophageal reflux disease, and esophagitis. Zantac is known to contain an active ingredient called ranitidine. This molecule has been shown to degrade into NDMA (N-Nitrosodimethylamine) over time and when exposed to heat. NDMA is a known carcinogen.

New Developments in PFAS Regulation Will Spur Massive Litigation

Published on: June 11, 2024 | By James Hodges

Most of you reading this are aware that PFAS belong to a family of compounds that are widely used in products, such as fire fighting foam, stain repellant coatings, and nonstick surfaces. Attorney Clay Hodges has written about PFAS in Aqueous Film-Forming Foam (AFFF) on this blog site. Please check out those previous blog posts if you are looking for more specific information regarding AFFF. There have been recent developments in the litigation surrounding PFAS, which this article will dive into, as well as provide background information about the chemicals themselves.

What are PFAS?

Per- and Polyfluoroalkyl Substances are a group of man-made chemicals that have been used in various industrial and consumer products since the 1940s. Known as ‘forever chemicals,’ they take an extended amount of time to break down in the environment, and in the human body. There are thousands of different PFAS: Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS) are two of the most widely used PFAS, and are the subject of recent EPA regulation, which will be discussed later in this article.

Kratom: Increasing Popularity Reveals Troubling Side Effects

Published on: June 5, 2024 | By James Hodges

Kratom (mitragyna speciosa) is a tropical leaf native to Southeast Asia. While the plant is indigenous to Asia, the use, and abuse, of the plant has become much more common in the United States over the last decade. Today, you can easily purchase products made from kratom leaf online as well as in brick-and-mortar stores. The substance is manufactured into various vehicles of consumption including concentrated powder capsules, chewable tablets and gummies, and liquids. The leaves can also be crushed and smoked, and also brewed into herbal tea.

Common Uses of Kratom

In low doses, the leaf has been known to produce a stimulant effect, with users reporting increased physical energy and alertness. When taken in higher doses, the opposite occurs: the substance produces sedative effects. Kratom is used to self-treat physical pain, coughing, and diarrhea. It is commonly used to aid in treating psychological disorders such as anxiety and depression. The substance is also used to aid individuals with opioid withdrawal, and opioid use disorder.

Philips Agrees to $1.1 Billion CPAP and BiPAP Settlement

Published on: May 1, 2024 | By Clay Hodges

It appears as if Philips’ legal problems concerning their CPAP and BiPAP machines in the United States may be coming to an end. Late last year, there was a tentative settlement concerning the plaintiffs’ economic loss claims. Then just recently, a court not only approved the economic loss settlement proposal, but Philips just agreed to pay $1.1 billion to settle the personal injury and medical monitoring claims. Let’s take a closer look at this CPAP settlement and what plaintiffs and future claimants can expect.

Economic Loss Settlement

In October 2023, the U.S. District Court for the Western District of Pennsylvania (District Court) issued an order preliminarily approving a settlement concerning the economic loss claims. These are claims that relate to the financial losses connected to the purchase of the affected machines. In April 2024, the District Court granted final approval of that settlement.

August 10, 2024: Important Camp Lejeune Administrative Claim Deadline

Published on: April 17, 2024 | By Clay Hodges

Today I will discuss the Camp Lejeune toxic water litigation, and if there is one fact that I can leave you with in this post, it is this: the deadline for bringing an administrative claim is August 10, 2024.

The Camp Lejeune legislation that was passed about two years ago is rather extraordinary, and what it has done is allowed people who were injured years and sometimes decades ago to bring a current viable claim against the federal government for serious illness and injury suffered as a result of toxic water in and around the Camp Lejeune Marine Corps Base, but if you have a claim and do not file an administrative claim with the US Navy by August 10, 2024, then you will be out of luck, and you will have no recourse to compensation.

Now the good news is filing the administrative claim, which starts the ball rolling to identify to the federal government that you want to bring a claim, filing that administrative claim is somewhat straightforward. I do not believe individuals should represent themselves in this matter. I believe you need an attorney who’s familiar with this litigation to handle that process for you, but the good news is the administrative claims process is not nearly as complex as actually filing a lawsuit, which you certainly will have to do in the months after you file an administrative claim, so write down the date, put it on a Post-it note, or tape it to your refrigerator; and you need to contact an attorney immediately if you believe you or someone you loved, even a deceased parent, or even a grandparent, may have been harmed by exposure to the toxic water at Camp Lejeune.

FDA Issues Warning About the Synovo Total Hip System

Published on: February 29, 2024 | By Clay Hodges

Artificial hips offer many patients the opportunity to live active and full lives, but sometimes they don’t always work as intended. Thankfully, these are relatively rare situations. Unfortunately, if it’s your artificial hip that fails, there’s not much comfort in knowing the artificial hips in most other patients work as designed. Because an artificial hip failure can be such a serious problem, the U.S. Food and Drug Administration (FDA) takes steps to ensure artificial hip medical devices receive adequate review and scrutiny before being approved for use in patients. One such step is to confirm that if a company modifies an already approved product, those changes also receive appropriate FDA approval and oversight. Apparently, Synovo Production, Inc. (Synovo) failed to obtain these necessary FDA approvals after making changes to one of Synovo’s hip replacement products. Let’s take a look at what products are affected and what action the FDA has taken.

Affected Medical Devices

Synovo makes the Total Hip System (also known as the Total Hip Replacement System and the Preserve and Endotec BP), which the FDA cleared for medical use. However, the FDA claims that Synovo has made significant modifications to the following three components of this system: Femoral Resurfacing Cup, Acetabular Fixation Cup and Acetabular Bearing. Some of these components are also stand-alone products.

New Study Reinforces Link Between Contaminated Water at Camp Lejeune and Cancers

Published on: February 15, 2024 | By Clay Hodges

The Camp Lejeune “Elective Option” has been open for a while now and allows eligible individuals affected by contaminated water from Camp Lejeune to seek monetary compensation for their injuries. The goal of this administrative process is to make it faster and easier to receive monetary compensation and avoid going to court.

A potential problem with the Elective Option is that it’s only available to those with officially recognized medical conditions. Another issue is that it has predetermined monetary payouts for certain injuries. This means it can result in certain people receiving less compensation than if they sued in court.

However, the window for filing suit will close soon. Most individuals have until August 2024 to start the administrative claims process. Luckily, a new scientific study was released that may make it easier for those harmed by Camp Lejeune contaminated water to obtain damages for their injuries.

Initial Consultation919-546-8788

★★★★★

I was involved in a case for the faulty hip replacements. Clay Hodges represented me. I can't say enough about how much he has helped me. Clay was able to win multiple settlements on my behalf with most of them being the maximum amount able to be awarded. Matt J.

Clay, thank you sir for making a disheartening experience at least palatable, you and your staff were honest, caring and understanding through the entire process of my wife’s hip replacements, while monetary settlements never make the pain and suffering end, it sometimes is the only way people can fight back to right a wrong. J. V.

We are absolutely pleased with how Clay Hodges handled my husband’s hip replacement claim. He always kept us informed of the progress. And, his work resulted in a settlement which we are extremely pleased. Thank you, Clay! Carol L. & Norm L.