I will operate from the same office in Raleigh, North Carolina, though please note the change in my email address (chodges@clayhodgeslaw.com) and phone number (919.830.5602).

My new JUSTIA website (www.clayhodgeslaw.com) should launch in the next few weeks, so look out for it. Thank you!

Clay Hodges
Hodges Law, PLLC
1620 Hillsborough Street, Suite 200
Raleigh, NC 27605
919.830.5602 (office)
919.830.4198 (mobile)
chodges@clayhodgeslaw.com
www.clayhodgeslaw.com
www.northcarolinaproductliabilitylawyer.com

My experience with Attorney Clay Hodges: background, our interaction, case outcome and my assessment 

1. Background

Having suffered from increasing discomfort in my left hip during a Swiss sabbatical from my teaching position at [an American university], I sought medical attention at a Swiss orthopedic clinic in September 2011. This led in short order (on 28 Sept. 2011) to a minimally invasive [hip] surgery by the resident specialist. The intervention was successful and the recovery uneventful – yet, alas, not long lasting. In the summer of 2017, and back in the United States, I started experiencing rapidly worsening left-hip pain that led me to consult with Dr. Roshan P. Shah (Columbia Medical Center). He advised for immediate revision surgery involving now both femoral head and acetabulum (i.e. a full classical hip replacement), since my 2011 Zurich [hip implant] had become completely dislocated. The revision surgery by Dr. Shah took place on 22 Sept. 2017, with recovery speedy, yet now happily long lasting (as of 16 November 2025).

2. Interaction with Attorney Clay Hodges

My initial attempt to seek legal redress in the United States for damages I (as a US legal resident) had suffered in consequence of the botched Zurich surgery had proved unsuccessful. This until Attorney Clay Hodges appeared on the scene and, after careful scrutiny of the material and jurisdictional complexities of my case, declared himself equal to it – meaning he was willing to join a cross-state [MDL] lawsuit against [the manufacturer], triggered by the multiple implant failures that had accumulated since the inception of the implant.

This leads to my first point of observation regarding Clay: he is a man both analytical (see his punctilious examination of my case, before committing himself) and of courage (see his willingness to tread where others fear to go).

Not surprisingly this two-fold characteristic is linked to a third, revealed to me as our multiple interactions (in writing and by phone, and lasting from March 2019 to May 2024) progressed: he is a man of great patience who will persist in his efforts until all possible avenues  of argument have been mulled over.

3. Outcome and assessment

Though the adjudicated payout to our case (fairly divided by Clay between himself and me) turned out to be modest, at each point in the process I felt I was interacting with a man of great intelligence and unshakable principle, equal to the best of my university colleagues.

[Former Client]
November 16, 2025

In 2017, the U.S. Food and Drug Administration (FDA) approved dupilumab (which goes by the brand name Dupixent) as a treatment for atopic dermatitis (commonly known as eczema). However, recent research has identified a possible link between Dupixent and cutaneous T-cell lymphoma (CTCL), a type of cancer. If you have taken (or are taking) Dupixent, you should be aware of this potential link and discuss the risks with your doctor.

An Overview of Dupixent

Regeneron Pharmaceuticals and Sanofi worked together to develop Dupixent. Dupixent is a monoclonal antibody, which means it’s a biologic, or medicine made from living organisms or parts of living organisms. It’s administered as an injection and is often used to treat moderate to severe cases of eczema where more topical treatments have been unsuccessful or aren’t possible. Dupixent is also used to treat:

• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis
• Chronic obstructive pulmonary disease
• Chronic spontaneous urticaria
• Bullous pemphigoid
• Prurigo nodularis

Dupixent works by blocking interleukins (a type of protein) from binding to cell surface receptors. Specifically, it focuses on interleukins 4 and 13, which are often produced by the body’s immune system and have been found to play a key role in the body’s inflammatory process.

Despite the wide array of conditions Dupixent can be prescribed to treat, its link to CTCL is most well-known when used with patients dealing with eczema.

Cutaneous T-Cell Lymphoma

Even though CTCL is most readily observed through its effect on the skin, it’s a type of non-Hodgkin lymphoma, or blood cancer. CTCL starts in the body’s immune system by affecting T cells. These T cells then become mutated and attack the skin. This can lead to skin lesions or rashes that sometimes get confused with eczema. Besides the appearance of eczema, other signs and symptoms of CTCL include:

• Scaly, itchy skin patches.
• Skin discoloration.
• Lumps on the skin that may or may not break open.
• Hair loss.
• Enlarged lymph nodes.
• Thickened skin on the palms of the hands and soles of the feet.

There are several different types of cutaneous T-cell lymphomas, but the two most common variants are:

• Mycosis fungoides: A slower-growing variant of CTCL, where the skin is the primary part of the body that’s affected by CTCL.
• Sézary syndrome: A faster-growing variant of CTCL where the cancerous T cells affect not just the skin, but the blood as well. Mycosis fungoides can sometimes turn into Sézary syndrome, and a common distinction between these two types of CTCL is that individuals with Sézary syndrome will have a skin rash that affects the entire body.

It’s unknown what exactly causes CTCL, but CTCL is more common in those who are male, aged 50 or older, and/or are Black.

The Link Between Dupixent and CTCL

Several studies have found a link between Dupixent and CTCL. In one study, researchers observed that individuals who took Dupixent to treat their eczema were more than four times more likely to develop CTCL. Another study found that this increased risk was more pronounced in older adult patients, and most of the CTCL diagnoses occurred within the first year of taking Dupixent. Then there’s a study which suggests that Dupixent may accelerate the progression of existing CTCL.

This is unsettling research, but more research needs to be done. One of the key issues is the fact that some individuals with CTCL will sometimes be misdiagnosed as having eczema.

Assuming people with CTCL are being misdiagnosed as having eczema and are therefore being prescribed Dupixent, does that fully explain the data that shows individuals taking Dupixent are more than four times more likely to have CTCL? If it does, then the next question is what effect, if any, does Dupixent have on how quickly CTCL progresses within the body?

There’s data that shows some people with CTCL who take Dupixent experience a worsening of CTCL symptoms.

Another possibility is that Dupixent actually causes CTCL, but again, we need more studies on this potential causation.

Potential Legal Action

Legal action has begun, but it is in the early stages. There’s been one notable case, Richardson v. Regeneron Pharmaceuticals that was filed on October 1, 2025 in U.S. District Court for the Middle District of Tennessee. The plaintiff is the daughter of a patient who took Dupixent and allegedly died as a result.

The plaintiff sets forth several causes of action, most notably that there was a failure to warn the plaintiff’s mother that taking Dupixent would increase the risk of developing CTCL or accelerate the progression of CTCL that already existed in the body.

If it turns out there’s a definitive link between CTCL and Dupixent, given the sheer number of people (hundreds of thousands) who have taken this medication, there could be an avalanche of lawsuits in the future.

As for the continued marketing and use of Dupixent, the FDA has taken minimal action so far. The most notable event so far has been the FDA adding Dupixent to the list of medications where the “FDA is evaluating the need for regulatory action.”

If there are any major developments concerning Dupixent, whether within the scientific or legal community, I’ll let you know. In the meantime, if you have any medical-related questions about taking this medication, you should talk to your primary care provider. If you have any legal questions, I’m more than happy to help. You can call me at (919) 830-5602 or contact me online to schedule a consultation.

As impressive as this all sounds, we still struggle to mimic what Mother Nature does so easily: the biomechanics of the human body. For example, in 2016, Cartiva, Inc. developed a synthetic cartilage implant (SCI) designed to address pain and reduced range of motion of the first metatarsophalangeal joint (often caused by arthritis). This is the joint where your big toe connects to the rest of your foot.

Unfortunately, the Cartiva SCI failed to meet expectations, which I wrote about last summer. Since publishing that blog post, there have been a few notable developments, including a medical device recall and a number of lawsuits getting close to trial.

The Cartiva Toe Implant Recall

On Halloween of 2024 (coincidence, I hope), Stryker issued a medical device recall of its Cartiva SCI. Stryker didn’t create the artificial cartilage implant, but Stryker acquired the Wright Medical Group NV (Wright) in 2020, and Cartiva, Inc. was a whole owned subsidiary of Wright.

The recall affected 6mm, 8mm, 10mm and 12mm sized implants distributed from July 2016 to October 2024. This amounted to a total recall and withdrawal of all Cartiva SCIs from the market. Stryker stated this recall was due to a higher-than-expected rate of problems with the implant, including the implant coming lose and moving out of place. It’s not fully known why this occurs, but potential reasons include the SCI being too smooth, shrinking, or not being properly held in place due to a weakened bone structure.

The Rise in Cartiva SCI Lawsuits

Even though the recall took place in 2024, problems with the implant had been known well beforehand. Problems with the SCI were being reported in published scientific papers as early as 2022. At least six lawsuits were filed in 2022, although some of these were voluntarily withdrawn without prejudice. “Without prejudice” means the plaintiffs could re-file their lawsuits in the future.

It’s been suspected, but not confirmed, that these cases were close to settlement or that the parties agreed to a tolling agreement. A tolling agreement is where parties to a lawsuit agree to pause the applicable statute of limitations. This can potentially provide more time for each side to negotiate a settlement or obtain more information. Despite these dismissals, more lawsuits were filed in 2024 and 2025, including the following federal cases:

• May v. Cartiva, Inc., Case No. 2:24-cv-00687
• Krolicki v. Cartiva, Inc., Case No. 1:25-cv-03415
• Peachey v. Cartiva, Inc., Case No. 2:25-cv-01217
• Hughes v. Cartiva, Inc., Case No. 2:24-cv-00319

At the beginning of 2025, it appeared as if many of these cases would go to trial or settle, but as the year goes on, this seems less likely. For instance, the Hughes case was originally scheduled for an October 28, 2025 trial, although this date was pushed back to May 26, 2026. The May case has also been delayed, with a trial date rescheduled from February 2026 to August 2026.

Allegations Made in Toe Implant Cases

Plaintiffs suing Cartiva, and/or Stryker and Wright have based their claims on one or more of the following causes of action:

• Strict product liability
• Negligence
• Misbranded and adulterated device
• Breach of express warranty
• Breach of implied warranty
• Failure to warn

Notable arguments include Cartiva misrepresenting the failure rates of the SCI, failing to properly study how the implant would perform in humans and failing to warn prospective patients of the risks of receiving this implant.

What’s Next for Cartiva?

Presumably, lawsuits will continue to be filed while a case or two goes to trial or settles. But how long it takes to actually get a trial or settlement is unknown. Then there’s the fact that new cases are consistently getting filed.

If you received a Cartiva SCI and haven’t already done so, talk to your doctor about any problems you might be having. The most common solution for problems with the Cartiva toe implant has been toe fusion surgery. This is where the bones of the big toe are fused together. This can offer pain relief, but could result in a more limited range of motion.

In addition to talking to your doctor, you might want to talk to an attorney. I’m more than happy to set up a consultation, which you can schedule by using the online contact form or calling (919) 830-5602 (direct line). Good luck.

The health risks associated with working around dust from mines and rock quarries have been known for millennia. Recently, attempts have been made to reduce the prevalence of lung problems, such as silicosis, associated with exposure to silica dust. For example, in 2016, the Occupational Safety and Health Administration (OSHA) established respirable crystalline silica standards (regulations) for workers in the construction and general/maritime industries. Despite these rules, many workers still suffer from significant and often life-threatening lung problems due to silica dust. Many of these workers come from the granite or quartz countertops industry, especially those made from engineered stone. Let’s examine the connection between engineered stone and silicosis, and what legal remedies may be available.

What Is Silica?

Silica is another name for silicon dioxide and is made up of the elements of silicon and oxygen. Silica is commonly found in nature, especially in minerals such as quartz and rocks such as granite (which contains quartz).

Quartz aggregate serves as the primary ingredient in engineered stone. Engineered stone is popular with countertops, as it’s usually cheaper than natural stone, is easier to maintain and is less prone to staining.

Because quartz (which is mostly made of silica) is the primary ingredient in engineered stone, the dust produced during the fabrication of engineered stone presents a danger to workers who don’t use proper safety and protective equipment. In most cases, engineered stone countertops contain more than 90% silica.

Why Is Silica Dangerous?

Silica on its own isn’t unusually dangerous. However, when it’s transformed into fine dust, it can be inhaled into the lungs and can cause serious health problems. This fine dust is sometimes referred to as respirable crystalline silica, or RCS. These represent silica particles that are at least 100 times smaller than the grains of sand you typically find on a beach.

RCS is often produced when materials containing silica are altered from activities such as grinding, cutting, crushing, polishing, sawing or drilling. RCS exposure can occur in workplaces that don’t involve countertops, such as sandblasting, construction, mining, foundry work, and fracking.

What Health Issues Are Associated With Respirable Crystalline Silica?

According to OSHA and the U.S. Centers for Disease Control and Prevention (CDC), workers regularly exposed to RCS have an increased chance of developing the following health problems:

• Lung cancer
• Kidney disease
• COPD (chronic obstructive pulmonary disease)
• Autoimmune disorders
• Lung and cardiovascular impairment

As serious as these are, the single biggest silica-related health concern is silicosis.

What’s Silicosis?

Silicosis is an incurable and progressive disease of the lungs. When a person inhales RCS, the particles get lodged into the lungs and cause inflammation and scarring. With enough exposure, it can cause death. Before it gets to that point, an individual will usually suffer from one or more of the following:

• Decreased lung capacity
• Shortness of breath
• Chest pain
• Weakness and fatigue
• Persistent cough
• Fever
• Night sweats
• Leg swelling
• Bluish discoloration on certain parts of the body, especially the lips.

These symptoms depend on the length and intensity of the exposure. It sometimes takes years or even decades for noticeable symptoms to occur if the exposure is not extreme. But if someone’s lungs are exposed to large amounts of silica dust in a short period of time, any of the above symptoms can occur in as little as a few months.

Does Working With Engineered Stone Countertops Cause Silicosis?

Without careful workplace safety procedures and without use of protective equipment, yes. Yes, because inhaling silica dust likely causes silicosis. In fact, the risk of silicosis and working with engineered stone is so high that there’s a ban on the importation, use, supply and manufacture of engineered stone in Australia.

However, the risk of developing silicosis is lower if proper workplace safety steps are taken, such as:

• Utilizing wet processing methods for engineered stone.
• Having special machines to scrub and vacuum the water on the floor that collects after the water’s been used to remove some of the RCS from the air.
• Installing special air handling systems to remove silica dust particles from the air.
• Having workers wear proper protective equipment, like respirators.

Unfortunately, many businesses in the engineered stone industry don’t have the resources to put these safety systems in place.

Legal Remedies for Those Suffering from Silicosis

Many lawsuits have been filed and many of them have been successful, often through settlement agreements. Yet there’s at least one that went to trial in a California state court resulting in a $52 million verdict. While this may be an outlier result, its success signals that more silicosis-related lawsuits are coming. But there are two things to note about this potential rise in silicosis litigation.

First, many of the plaintiffs are only suing the manufacturers of engineered stone, not the companies that fabricate the engineered stone into countertops. The practical reason for this is probably because manufacturers likely have more money than fabricators. After all, these fabricators are the same businesses that often lack the resources to implement sufficient workplace safety protocols for RCS. Whether most courts agree with this strategy remains to be seen.

Second, most of these cases will be individual lawsuits. Class action lawsuits are unlikely given the unique nature of the alleged injuries and their causes. Multidistrict litigation (MDL) is an option, but a previous attempt failed badly when the judge assigned to the MDL noted in a legal opinion that many of the silicosis diagnoses “were manufactured for money.” In the near future, silicosis victims who decide to sue will likely file their own lawsuits rather than take collective legal action.

If you’re suffering from a health problem you believe is connected to engineered stone or silica exposure, please talk to your doctor or primary care provider. You may need to be persistent in getting the right diagnosis, as silicosis is sometimes misdiagnosed as pneumonia, tuberculosis or pulmonary edema (fluid in the lungs). If you want to learn more about your legal rights, feel free to reach out and I’ll do my best to help. You can set up an initial consultation using the online contact form or by calling (919) 830-5602.

Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that works by mimicking a hormone that the body uses to signal that it’s full or satisfied. It was originally approved for treating type 2 diabetes (under the Ozempic brand name), but the U.S. Food and Drug Administration soon approved it to help patients lose weight (under the Wegovy brand name).

Ozempic and Wegovy have received considerable attention for various reasons, including their side effects. I’ve discussed some of these in earlier blog posts about gastroparesis and vision problems, like NAION. Unfortunately, additional serious side effects continue to be brought up, including complications from blood clots, such as deep vein thrombosis (DVT). Let’s take a closer look at semaglutide and its connection to DVT.

What Is Deep Vein Thrombosis?

According to the Mayo Clinic, DVT is where a thrombus (blood clot) forms in a deep vein. Because some of the largest veins in the body are located in the legs, DVTs often form there. When they do, there are sometimes no noticeable symptoms, but DVTs are often characterized by pain and/or swelling in the leg.

A DVT can be dangerous because it can lead to a pulmonary embolism (PE). This is where the blood clot in the vein can break loose and travel to the lungs and get stuck in an artery.

Does Ozempic Increase the Risk of DVT?

Potentially. The primary basis for connecting Ozempic to deep vein thrombosis is a study from 2021 where researchers looked at patients who took semaglutide to treat type 2 diabetes. They found that it increased the risk of DVT by 266%.

Before jumping to any conclusions about whether Ozempic causes DVT, we need to recognize that some people who take Ozempic or Wegovy may already be at greater risk for DVTs. So the classic question becomes, “Does Ozempic cause DVTs or are those already at risk for DVTs more likely to take Ozempic?” The answer to this question isn’t 100% clear, but some of the risk factors for developing DVT include:

• Lack of movement of the legs (like sitting for hours at a time)
• Obesity
• Heart problems
• Cancer
• Smoking
• Birth control pills
• Advanced age

Diabetes also increases the risk of blood clots. One reason is that those with diabetes are at higher risk of plaque buildup in the arteries. Then there’s the fact that diabetics often have higher levels of fibrinogen, which makes the blood thicker and the red blood cells more likely to stick together. So someone who decides to take Ozempic to treat their diabetes is likely already at higher risk for developing DVTs, but it’s quite possible that Ozempic could further increase this risk.

How Ozempic May Cause Blood Clots

More research is probably needed to know for sure if Ozempic increases the risk of blood clots and if so, how much that increase is. But several factors support the conclusion that Ozempic may increase the risk of developing a DVT:

• It’s widely accepted that Ozempic affects the digestive system, with recognized side effects that include diarrhea. Diarrhea can lead to dehydration, which can increase the viscosity (thickness) of blood.
• Ozempic slows down digestion, which can result in slower blood circulation, which increases the risk of blood clots.
• GLP-1 RAs affect platelets, which play a key role in coagulation.
• Rapid weight loss could increase the risk of experiencing DVT.

Current Status of GLP-1 RA Litigation

The bulk of litigation relating to Ozempic and similar drugs seems to focus on gastrointestinal side effects, such as gastroparesis, and vision problems, like NAION. Many of these cases are part of the GLP-1 RA multidistrict litigation (MDL). However, attempts to add DVT and blood-clot-related lawsuits involving GLP-1 RAs to this MDL have been unsuccessful so far.

If you’ve taken Ozempic, Wegovy, or another GLP-1 RA medication and suffered from a DVT, PE or other complication from blood clots, this doesn’t mean you can’t sue. It only means that, for now, your case won’t get added to the current MDL. That being said, the litigation involving semaglutide and similar pharmaceuticals is fairly recent. Depending on how strong the connection between Ozempic and blood clots is, we could see many more DVT lawsuits getting filed in the future and perhaps a new MDL will be created to handle many of them.

The legal future of Ozempic is very fluid right now. As more and more people take the drug and research gets done, we’ll learn more about its risks. Whether you’re currently on Ozempic or stopped taking it, if you have any health concerns relating to that medication, please reach out to your primary care provider. If you want to learn more about your legal rights, I’m happy to help. You can reach me at (919) 830-5602 or use the online contact form to schedule an initial consultation. Good luck!

Hormonal contraception injections for women have been around for decades. Unfortunately, recent studies have found a potential link between medroxyprogesterone acetate, a common type of hormonal contraception taken through injection, and intracranial meningioma, a type of brain tumor. Many women who have used this form of birth control for extended periods have also suffered from intracranial meningioma. The goal of this blog post is to examine the potential association between medroxyprogesterone acetate (Depo-Provera) and brain tumors and the current status of litigation alleging this connection.

What Is Medroxyprogesterone Acetate (MPA)?

MPA is the technical name for an injectable form of hormonal contraception for women. If you or your partner used contraception, you might not have ever heard of medroxyprogesterone acetate or MPA, but you probably heard of the brand name, Depo-Provera.

The FDA approved Depo-Provera for use as contraception in the United States in 1992. It consisted of a 150mg injection that was given every three months into the muscle of a patient. The FDA later approved a lower-dose version of the drug in 2004.

This lower-dose version was marketed as Depo SubQ Provera 104. It was similar to Depo-Provera, but instead of a 150mg intramuscular injection, 104mg of MPA was given subcutaneously (just below the skin). Depo SubQ Provera 104 was also given to women suffering from endometriosis.

The manufacturer of Depo-Provera (and the lower-dosed version) is Pfizer, along with its subsidiaries and related companies, such as Pharmacia & Upjohn, Viatris, and Greenstone (Pfizer and related companies). Pfizer and related companies claim that Depo-Provera and Depo SubQ Provera 104 are among the most effective forms of birth control, putting it in the same class as sterilization and IUDs in terms of effectiveness.

What Is Intracranial Meningioma?

Meningioma is a type of tumor that forms in the meninges, or tissues covering the brain and spinal cord. Intracranial meningiomas are tumors located in the meninges located around the brain and inside the skull. These tumors are usually benign and form at the top and outer curve of the brain, but can sometimes be malignant and/or form at the base of the brain.

Depending on the tumor’s characteristics, intracranial meningiomas can be treated with surgery and there’s only a small risk of the tumor spreading (metastasizing) to other parts of the body. However, in some cases, the tumors may grow quickly and require immediate medical treatment. Another problem with intracranial meningioma is that if it’s located in a delicate or sensitive part of the brain, treatment options may be limited.

According to the Mayo Clinic, potential meningioma symptoms could include:

• Loss of smell
• Difficulty talking
• Seizures
• Vision changes
• Hearing loss
• Headaches
• Loss of smell
• Memories loss
• Weakness in the legs or arms

Does Depo-Provera Cause or Worsen Intracranial Meningioma?

Potentially. In March 2024, the British Medical Journal (BMJ) published a study that examined data from France involving women who received surgery for intracranial meningioma between 2009 and 2018. The study analyzed data from more than 100,000 women using differing forms of hormone-based birth control.

Researchers found a connection between intracranial meningioma requiring surgery and prolonged use of different forms of hormone-based birth control (including 150mg of MPA). However, the biggest intracranial meningioma connection was with MPA. Specifically, women who took MPA for extended periods were 5.6 times more likely to have meningioma.

A more recent study from the University of Alabama at Birmingham looked at the link between MPA and meningioma and obtained results that seem to confirm those from the BMJ. More precisely, a woman who received MPA injections had a 53% increased chance of being diagnosed with meningioma. This relationship strengthened the longer the women received MPA injections.

Are There Any Meningioma MPA Lawsuits?

Yes, but it’s early in the litigation process. As of the time of this writing, there are no class action or multi-district litigation (MDL) lawsuits. Yet this could soon change, as there are at least several dozen cases involving individual plaintiffs alleging Pfizer and related companies should have done more to warn users about the potential risks with MPA and/or investigate the possible link between brain tumors and Depo-Provera.

Attorneys for some of the plaintiffs have asked the court to consolidate their cases into an MDL, although we’ll need to wait and see how the court decides to rule on these requests. If you took Depo-Provera for at least a year and have been diagnosed with meningioma, you could have a case. To learn more about your legal rights, please contact me online or by calling (919) 830-5602. If you feel fine despite receiving MPA injections and don’t have a diagnosis, you can still talk to your primary care provider, obstetrician or gynecologist about any concerns you might have.

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.

Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper Fracture Risks

Just to make things clear, practically all medical treatments come with some risks. So the question isn’t about whether there’s a risk, but the level of risk and whether a patient is properly told those risks so they can make an informed decision.

That being said, the primary issue here isn’t that there’s a bone fracture risk if you receive the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper (Zimmer CPT Hip System). This is because most artificial hips have some risk of the thigh bone breaking after the surgery. The primary issue is instead whether you’re properly told about the risk of fracturing your femur should you receive this particular artificial hip, and whether this particular artificial hip carries a heightened risk of bone fracture.

The FDA cites a UK study that found that the Zimmer CPT Hip System had a risk of thigh bone fracture that was roughly 1.4%. This doesn’t sound like much, but it’s almost double the fracture rates of comparable artificial hip products. These other artificial hips had a fracture risk that ranged between 0.6% and 1.0%.

Based on this information, Zimmer Biomet initiated a voluntary recall of the Zimmer CPT Hip System to provide updated instructions that would include the risk of femur fracture. Zimmer Biomet also explained that they would stop selling this particular artificial hip by December 2024.

How Do I Know if I Received an Affected Artificial Hip from Zimmer Biomet?

The best way is to ask your doctor or other health care professional. If you’re curious about the specific models, you can find an affected product list in the FDA’s safety communication or on Zimmer Biomet’s website (it’ll be on Attachment 2).

What Should I Do If I Received an Affected Artificial Hip?

If you don’t have any unexpected problems walking, or pain around your hip, then you’re probably fine as long as you maintain the follow-up schedule with your doctor. The FDA doesn’t recommend surgery to remove the artificial hip if you aren’t experiencing any problems with it. However, it’s still a good idea to talk to your doctor to know if you have an affected device and confirm that there’s nothing additional you need to do or avoid doing.

If you’re having problems with your Zimmer CPT Hip System, then you should contact your doctor as soon as you can. They can review your situation and recommend your next course of action. You may also want to report your issue to MedWatch, which is administered by the FDA.

If you received a hip replacement surgery that used the Zimmer CPT Hip System and aren’t having any issues with it, that’s good news. But if you’re in pain, have trouble walking, or suffered a broken femur where the artificial hip was installed, legal action might be a possibility. If you want to learn more, call me at (919) 830-5602 or contact me online. In the meantime, you can talk to your doctor if you have any questions or concerns. Good luck.

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?

Nonarteritic anterior ischemic optic neuropathy (NAION) is a type of optic neuropathy, which is a condition where the optic nerve becomes damaged. The optic nerve is what transmits information from the eye to the brain. When the optic nerve doesn’t work properly, it can lead to vision problems, including blindness. NAION is a specific type of optic neuropathy where the damage results from a reduction or stoppage of blood flow to the optic nerve.

When this occurs, the cells in the optic nerve don’t receive the oxygen or nutrients necessary for healthy vision. This optic nerve damage can lead to a painless, yet sudden vision loss. With current medical technology, this damage usually can’t be repaired, so any vision loss stemming from optic nerve damage is typically permanent.

What’s the Connection Between Ozempic and NAION?

The authors of the JAMA Ophthalmology study examined more than 16,000 patients over three years. Of this group, 710 had type 2 diabetes and 979 were overweight or obese. The study focused on these two groups and separated them based on whether or not they took a medication with semaglutide.

Among the group with diabetes who received a NAION diagnosis, 8.9% of those took medication with semaglutide, while 1.8% took a different medication for their diabetes.

Among those who were overweight or obese and received a NAION diagnosis, 6.7% took a medication with semaglutide while 0.8% of individuals took different medications.

Does This Study Mean Ozempic or Wegovy Causes NAION?

The study doesn’t conclusively say that semaglutide medications cause NAION, only that there’s a connection between taking semaglutide and NAION. This is an important distinction because of the risk factors for NAION, some of which include:

• Diabetes
• Heart disease
• Sleep apnea
• High blood pressure

It’s important to note that heart disease, high blood pressure, and sleep apnea have known connections to obesity. So it’s not yet clear if semaglutide medications cause NAION or if those who are already at risk for developing NAION are more likely to take a medication containing semaglutide. However, the increased incidence of NAION among those taking a semaglutide medication is troubling.

The study’s authors recognized that diabetes and being overweight didn’t fully explain the increase in risk for NAION. However, they also couldn’t conclude that the semaglutide was the primary reason for the increase in NAION risk. Therefore, the authors recommended further research to study this possible connection.

What Should I Do If I’m Taking Wegovy or Ozempic?

If you’re currently on a medication regimen that includes semaglutide, the American Academy of Ophthalmology does not recommend that you stop taking your semaglutide medication unless you have a loss of vision or your doctor tells you to stop taking that medication. What the American Academy of Ophthalmology does recommend is that you talk to your doctor about whether semaglutide is right for you given your unique health situation.

If you have been diagnosed with NAION or any other health problem you believe might be related to taking semaglutide, such as gastroparesis, you might have some legal options. Feel free to contact me by calling (919) 830-5602 (direct line) and I’ll see what I can do to help.

This post was written from online news sources. This post is not legal advice.

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.

Problems with the Cartiva Implant

The primary issue with the Cartiva toe implant is that it has a high rate of failure. The material, PVA Hydrogel, has a tendency to compress after being implanted. The shrinkage of the implant then leads to migration, and often results in the implant shifting out of position. When the implant moves out of place, it can cause nerve damage and result in extreme pain. Additional surgery must then be conducted to alleviate the pain and correct the PVA Hydrogel implant. In addition to pain, and additional surgery, there are also other negative health impacts of a failed Cartiva implant including infections, osteolysis (bone degeneration), cysts, and silastic granulomas (a skin tissue condition).

Basis of Cartiva Litigation

Cartiva, Inc. was the company who originally developed the Cartiva toe implant. Stryker, a global healthcare and medical device company, acquired Cartiva, Inc. in 2019 and is now the manufacturer of the Cartiva toe implant. The product was approved through a pre-market approval system. However, reports indicate that the company may not have disclosed to the FDA or the public data indicating a higher failure rate. The product label claims the failure rate is 13.5%, but this number is significantly lower than the actual reported rate of failure, with some studies indicating failure rates in excess of 50%. Stryker has not (yet) acknowledged concerning issues with the product. The company has made no effort to revise its warning label, nor does the company have plans for product recall. The failure rate and complicated health risks associated with the Cartiva implant are so significant that some health insurance agencies have refused to cover it, as they deem the implant an ‘experimental’ medicine. Individuals who have had adverse health effects after receiving the Cartiva implant have begun to file lawsuits across the country. The litigation is based on the allegation that Stryker knew about the potentially high failure rates but failed to properly warn the consumer. The volume of these cases is increasing.

If you or a loved one received the Cartiva toe implant and were met with detrimental health effects, first talk to your doctor. If you are interested in pursuing legal action, do not hesitate to reach out to Attorney Clay Hodges at (919) 830-5602 for a consultation.

Note: This blog post was written based on research utilizing the FDA website and online news sources.

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. In 2019, certain manufacturers and pharmacies stopped selling Zantac after NDMA was detected in a number of pills. Lawsuits began to pile up after this news began to spread, as plaintiffs argued that drug companies should have known that ranitidine was linked to cancer. These plaintiffs argued that companies failed to properly warn consumers about the risks of taking Zantac. In 2020, the FDA called for manufacturers and suppliers to remove the drug from the market. The injured parties are seeking compensation from former Zantac manufacturers, including GlaxoSmithKline, Pfizer, Sanofi, and Boehringer Ingelheim. Following Judge Medinilla’s ruling, these companies decided to appeal the decision, arguing that there is no reliable scientific evidence to prove that Zantac causes cancer.

The Zantac litigation initially included ten various types of cancers but has since been reduced to five: bladder, liver, esophageal, gastric, and pancreatic. Studies suggest that these cancers have the most clear linkage to Zantac usage. For more information on the specific cancers involved with this litigation, you can check out Attorney Clay Hodges’ previous Zantac post on this website. What this Decision Means For You

The drug companies have been successful in fighting these civil lawsuits over the past few years. Recently, these companies filed a motion to exclude expert testimony, and this motion was denied by Judge Medinilla. This means that plaintiffs’ experts will be permitted to present their findings to a jury, which had been denied the plaintiffs in the federal court Zantac MDL. You can read Judge Medinilla’s (lengthy) court order here. For the plaintiffs who developed certain cancers after takign Zantac for months or years, this is welcome news, particularly after the setback in the federal court MDL. Judge Medinilla currently presides over roughly 75,000 cases, with 4,000 cases also appearing in California state courts, and 2,000 cases in other state courts across the country. This ruling allows for more cases to be filed by new plaintiffs as well. If you or a loved one have been diagnosed with cancer following prolonged use of Zantac, you may now have a pathway to pursue legal action against the drug companies. First and foremost, please make sure to take care of your health and seek medical assistance. If you are interested in taking the time to discuss your legal options, now is a great time to do so. Please feel free to contact Attorney Clay Hodges at (919) 830-5602 for a discussion about your options..

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. Exposure to PFAS Surveys conducted by the Center for Disease Control (CDC) show that the majority of people in the United States have been exposed to some quantity of PFAS. These chemicals can be found in drinking water, food, and food packaging products. They can also be found in soil and water near waste sites, as well as manufacturing facilities. It is also present in fire extinguishing foam (AFFF) as mentioned above and in previous posts. In addition, these forever chemicals can be found in household products, personal care products and dust around the house. All of which is to say: there is a good chance PFAS is in your body as you read this. Mine too. Certain individuals and activities create a heightened risk of exposure. Adults who work in industrial fields, and those who work directly with PFAS-containing materials are at a higher risk of exposure. Pregnant women drink an increased amount of water, and may be at risk if their water contains these harmful chemicals. Children are also at risk of heightened PFAS exposure as they drink more water, eat more food, and breathe more air per pound of body weight. Young children also crawl around on the floor, and put things in their mouths, which can lead to PFAS exposure in carpets, dust, and household products. Health Effects of PFAS Exposure

Current studies have shown a range of health effects resulting from PFAS exposure. The most prominent is the increased risk of prostate, testicular, and kidney cancer. In women, reproductive effects have been reported such as decreased fertility, and high blood pressure in pregnant women. Children have been known to have low birthweight, bone variation, and accelerated puberty when exposed to PFAS. These chemicals also reduce the ability of the body’s immune system to fight infections, as well as hinder vaccine response. Recent Regulatory Updates On May 8, 2024, the Federal Register released an article with huge implications regarding the use of PFAS. Prior to the release of this report, on April 17, 2024, the Environmental Protection Agency (EPA) deemed two PFAS: PFOA and PFOS, as hazardous substances. This designation is pursuant to Section 102(a) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). In addition, the EPA has established the default reportable quantity (RQ) of one pound for the release of PFOA and PFOS, pursuant to CERCLA 102(b), meaning that the release of one pound into the environment has been determined to cause human injury. Any lower RQ would result in a total ban of the chemicals. What This Means for PFAS Litigation These new regulations will go into effect in July 2024, and will likely cause PFAS litigation to expand. CERCLA designation section 111(g) requires operators of any facility manufacturing or using PFAS to provide notice of the release of hazardous chemicals to potential injured parties via publication in local news sources. This means that the release of one pound of PFOA or PFOS requires a public announcement to any area who may be impacted by the release. For comparison, in 2022, over one million pounds of PFAS were released into the environment, with individual facilities releasing over 50,000 pounds. These numbers are astronomically higher than the new RQ of one pound. With the new EPA regulations, alongside the CERCLA designation, it will be much more difficult for facilities to meet the requirements for release of PFAS, and will create room for new litigation. Look for cities and states to bring litigation against manufacturers who violate these new regulatory requirements. Further, The New York Times recently reported that companies using or manufacturing PFAS should expect massive litigation in the years ahead. If you, or a loved one, have experienced adverse health effects that you believe may have been caused from exposure to PFAS, please first contact your medical provider. If these reactions have been severe, it may be worth the effort to evaluate your legal options. Please do not hesitate to reach out to attorney Clay Hodges with any questions at (919) 830-5602.

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. Adverse Effects of Kratom Use The FDA has warned consumers of a myriad of physical and psychological side effects of using Kratom. The substance has a range of negative effects on the body, ranging from relatively mundane to extremely severe. Kratom has been reported to cause dry mouth, itching, and sweating. It also increases the likelihood of gastrointestinal problems including nausea and vomiting, constipation, increased urination, lack of appetite and extreme weight loss. It can additionally cause hepatotoxicity (chemical-induced liver damage), and can lead to liver toxicity. Use of the substance can cause serious cardiovascular problems, including tachycardia (irregular heartbeat). Usage has been known to provoke seizures, and in extreme cases, the substance use has been connected to death. Kratom, while marketed to aid users dealing with opioid withdrawal, can lead to addiction itself. There is a risk of substance abuse disorder (SUD) associated with Kratom usage. Users with SUD experienced cravings for the substance, increased tolerance, used the product for longer than intended, and experienced withdrawal symptoms after stopping usage. The substance can also cause psychotic symptoms including hallucinations, delusion and confusion, and psychosis. Regulation of Kratom

Kratom has yet to be approved by the FDA for any personal or medical use. The agency warns against using the substance until further scientific studies can be conducted. The chemical compound is not controlled under the Controlled Substances Act. Additionally, the DEA has listed Kratom as a drug/chemical of concern. The substance is banned in a few states, including Georgia, Texas, and Alabama, with the latter having deemed Kratom a Schedule I controlled substance, banning it alongside Heroin and Marijuana. Kratom Litigation There have been several personal injury lawsuits filed against organizations with regards to Kratom. These claims have been filed against manufacturers and distributors for inadequate warnings about the risks of use. Plaintiffs have sought compensation for injuries, lost wages, pain and suffering, medical expenses, emotional distress, among other damages. The most common current litigation involves wrongful death, with plaintiffs in Washington, Oregon, Florida, receiving settlements in excess of one million dollars. Lawsuits have also been brought against distributors for allegedly getting users addicted to the substance. Additional litigation involves product contamination, with a salmonella outbreak being linked to Kratom products in 2018. If you or a loved one believe you have experienced health problems from Kratom use, first and foremost make sure to contact your doctor. If your physical or psychological reactions have been severe, it might be worth taking the time to assess your legal options. Feel free to contact Attorney Clay Hodges at (919) 830-5602.

Note: This post is not legal advice or medical advice.

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.

The official website handling the settlement claims process has been set up. It has eligibility information, how to submit a claim and the amount of money eligible claimants can receive. Generally speaking, if you’re eligible for an economic loss settlement payment, you could receive up to three payments.

First, there’s the Device Payment Award. This amount depends on the specific device you used. Award amounts range from $55.63 (for the DreamStation CPAP) to $1,552.25 (for the Trilogy 100/200, Garbin Plus or Aeris LifeVent).

Second, there’s the Device Return Award. This is a flat $100 payment for each recalled device that’s returned to Philips by August 9, 2024.

Third, there’s the Device Replacement Award. This is to reimburse you if you used your own money to buy a CPAP, BiPAP or ventilator device to replace an affected Philips machine. You must have purchased this replacement device on or after June 14, 2021 and before September 7, 2023.

The amount of this award depends on the price of the machine you purchased minus any financial payments you received to help pay for that machine (from an insurance company or third-party payer). The Device Replacement Award amount could also be reduced based on how many valid claims there are.

Personal Injury and Medical Monitoring $1.1 Billion CPAP Settlement

This is the big CPAP settlement that everyone is now talking about. The above-discussed economic loss settlement did not address legal claims relating to personal injuries and medical monitoring.

Medical monitoring claims are for current claimants and/or plaintiffs who aren’t aware of any health problems right now (that are related to the litigation), but believe health issues could develop in the future. As a result, the defendant agrees to pay for future medical tests and doctor visits to find any medical problems so they can be detected and treated as soon as possible.

Philips announced the $1.1 billion settlement on April 29, 2024, with the vast majority of those funds intended to pay for personal injuries. A small fraction, roughly $25 million, will go towards medical monitoring. This settlement came thanks to mediation and applies to the legal claims in the United States.

Because of how recent this settlement is, many details are still unclear. For example, we don’t know how much each victim will receive, as that amount will depend on how many people file a settlement claim and the extent of their injuries.

Additionally, it’s not clear what method will be used to calculate how much money each claimant receives. There will be a point system or formula that determines the settlement award based on factors like the severity of the personal injuries, how long the Philips BiPAP or CPAP device was used and the age of the claimant. The strength of the scientific link between personal injury and the use of the affected device might also be considered.

There are currently tens of thousands of people who are likely eligible for compensation under this settlement. Using very simple math, this means the average payout per person could potentially range anywhere from $10,000 to $100,000, although this is merely rough estimate and should not be considered the official range of settlement payouts.

Finally, we don’t know exactly when the settlement awards will be paid. That being said, we shouldn’t expect any checks to start going out until at least 2025. As I’ve said many times, the administration of settlements of this size move slowly.

If you believe you might be eligible for either settlement, it’s a good idea to talk to an attorney. You may not know which situation may apply to you until you have an initial consultation. After that, you can best decide what to do. I’m available to answer any questions you might have. You can call me at (919) 830-5602.

Note: This post is not legal advice.

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.

Let’s back up a bit and talk about this legislation that was passed in August of 2022. I’m going to call it the Camp Lejeune Water Act because that’s simple and everybody can remember it, but in any event this legislation was the culmination of years of dedicated work from concerned citizens, Marine Corps Veterans, attorneys, many people who pushed and pressed the federal government to recognize that thousands of Marine Corps service persons and their families, and the workers who worked on Camp Lejeune, were gravely harmed by decades of toxic water that surrounded the Camp Lejeune Marine Corps Base. The legislation essentially says that anyone who resided worked or was otherwise exposed to water in and around the Camp Lejeune Marine Corps Base for a period of not less than thirty days during these critical dates, August 1, 1953 to December 31st, 1987, would potentially have a claim for financial recovery against the federal government for illness suffered from this toxic water. As you can see, these dates go back far into the past: 1953 is over 70 years ago and the end date December 3, 1987 is almost 40 years ago, so the cohort of potentially injured plaintiffs would be those who were on Camp Lejeune base for thirty or more days between 1953 and 1987, and in that period of time they were exposed repeatedly to the toxic water. So we are looking at almost 35 years where thousands of people were potentially exposed and harmed by this toxic water.

Because these dates go back so far into the past, a lot of these cases will involve individuals who have passed away. You can do the math pretty quickly and recognize that some of these viable claims will be from individuals that right now would be passed away or very old; as as one example, if there was an active duty military person who enlisted in the Marine Corps in the early 50s, that person was probably born in the 1930s, which means he could well be 90 years old right now or even older, so the universe of potential claimants in this litigation could be people that are 90, 80, 70, 60, 50 years old.

The good news is that Camp Lejeune in Jacksonville eventually cleaned up the water sources around Camp Lejeune, so the end date for this exposure to toxic water is December 31, 1987. If you were in an active duty Marine in the late 1980s or 90s or 2000s, then it is most likely the case that you were not exposed to toxic water in and around Camp Lejeune. If you are currently 40 years old, and when you were 20, you lived on the Camp Lejeune base for a year or 8 months, you would not have been exposed to toxic water at Camp Lejeune.

In any event, the people that this legislation is directed toward are those who served in the Marines, were a dependent of an active duty service member, were contract workers on the Marine Corps Base, worked steadily as a civilian on the Marine Corps Base, and then lived or visited base over several months, such that the person can identify at least thirty days that they were on Camp Lejeune Marine Corps Base between 1953 and 1987, and therefore you would be able to establish that you have a claim against the government.

In the master complaint for the plaintiffs in this litigation, the language that the plaintiffs’ executive team has used is stark, essentially they say that scientists have described the Camp Lejeune water disaster as the worst public drinking water contamination crisis in our nation’s history.

The Master Complaint says that between 1953 and 1987, Camp Lejeune provided contaminated water to those on base. This water flowed out of faucets and taps and barracks, housing, buildings, elementary schools, hospital wards, and one or more studies indicate that the contaminants were 280 times higher than what the Environmental Protection Agency considers safe. The next question you maybe asking or concerned about is what kind of diseases or illness might have resulted from these particular types of contaminants, overwhelming the drinking water supply at Camp Lejeune. The short answer is many types of cancer and other diseases have occurred because of this exposure to toxic water.

Some of the cancers and other diseases that have been mentioned as associated with exposure to this contaminated water include leukemia, non-Hodgkin’s lymphoma, certain cancers like bladder cancer, kidney cancer, lung cancer, liver cancer, multiple myeloma, also Parkinson’s disease, certain types of kidney disease, end stage renal disease, systemic sclerosis and scleroderma. There seems to be quite a few potential qualifying injuries that you need to be aware of as you navigate whether you need to try to participate in this litigation, but again I want to emphasize that scientists have been studying this exposure to toxic water for decades now, both related to Camp Lejeune and generally how the human body reacts to exposure to the contaminants that have been identified in the Camp Lejeune water.

Once you file that administrative claim (by August 10, 2024), you have six months to get a response from the government, and after that you can file a lawsuit in the Eastern District of North Carolina. The deadline for filing a lawsuit is February 10, 2025.

The Master Complaint estimates that as many as one million individuals were exposed to toxic water at Camp Lejeune for the relevant period, which means there could be as many as one million claims in this case, so it’s going to be a massive litigation, it’s going to take a long time to process these individual lawsuits. This is not a class action, it is not a multidistrict litigation, which I’ve written about on this website.

This statute and the resulting litigation are great opportunities to pursue compensation if you’ve lost a loved one to cancer, and then find out that the illness was most likely based on exposure to toxic water at Camp Lejeune. If you have any questions about the Camp Lejeune litigation, feel free to call me. My direct line in the office is (919) 830-5602.

In any event, good luck. I hope you get your administrative claim filed by August 10, 2024, and I hope you are fairly compensated for these tragic diseases.

Please note that this post is for informational purposes only and is not legal advice nor intended to be legal advice. If you need a legal opinion about your particular case, contact me or another attorney.

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.

Because the FDA has not reviewed these modifications to ensure they’re safe and effective, the FDA issued a Safety Communication urging health care providers to stop using any of the three non-cleared components of the Synovo Total Hip System.

Potential Problems with the Synovo Total Hip System

Despite the FDA issuing this Safety Communication, there might not be anything wrong with the Total Hip System. Is it possible that the changes might actually make the product better? Maybe, maybe not. That being said, what changes were made?

The FDA’s Safety Communication doesn’t go into detail about what modifications Synovo made, but references a Warning Letter from March 2023 that discusses, among other things, Synovo’s changes to the Femoral Resurfacing Cup component.

Specifically, the letter outlined how the FDA cleared the Femoral Resurfacing Cup for use with cement to help attach it to the bone. However, the FDA notes that Synovo made changes to the product so that it received a different coating that would allow it to be attached to the bone without cement.

Attaching a hip replacement part to bone without cement may have some advantages, although this is apparently up for debate. Assuming for a moment that Synovo’s change to a cement-less hip implant is an improvement, they’d still need the FDA to confirm this is the case. After all, one of the reasons the FDA was created was in response to companies selling food and medical products that, at best, did not meet the marketing claims and at worst, harmed the consumer.

This isn’t to say Synovo is marketing and selling an unsafe product, but until the FDA can review the modification to the Femoral Resurfacing Cup and clear it as safe and effective, consumers and health care providers need to take notice.

What Patients Need to Do

The FDA recommends that patients who received any of the affected devices after 2019 should contact their health care provider if they experience problems with their hip implant. This includes:

• New or worsening pain
• Loosening of the hip
• Grinding or other noises coming from the hip
• Inability to put weight on the hip with the implant
• Any weakness in the hip or knee on the same side of the implant

If patients have no problems with the affected devices, the FDA doesn’t recommend surgery to remove the device. In other words, the FDA is suggesting a wait-and-see approach. However, the FDA asks patients with issues with their implants to notify the FDA through its MedWatch Voluntary Reporting Program.

FDA Recommendations for Health Care Professionals

The FDA asks that health care providers do several things, but the most notable include not buying or implanting the affected devices. These health care providers should also remove any affected products from their inventory. Finally, health care professionals should closely monitor their patients who have received the Total Hip System or any individual component affected by the Safety Communication.

If you received Synovo’s Total Hip System or one of its components after 2019, there’s no need for alarm just yet unless you’re having problems with your hip. Based on the information so far, if Synovo did anything wrong, it was not getting the necessary approval from the FDA for the changes to the components. But in an abundance of caution, pay close attention to your hip and discuss any concerns you have with your health care provider. Most likely you’ll be fine, but in case you aren’t, you want to be prepared.

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.

To better understand the significance of the new study, as well as its results, let’s first take a look at the contaminated water problem at Camp Lejeune.

Camp Lejeune Toxic Water Overview

From 1980 to 1985, water samples were collected at Camp Lejeune. These samples were taken from water supplies that visitors and residents of Camp Lejeune used to cook, drink and clean with.

The samples found various levels of industrial chemicals and solvents such as:

• Tetrachloroethylene (PCE)
• Trichloroethylene (TCE)
• Trans-1,2-dichloroethylene (DCE)
• Vinyl chloride (VC)

Some of these chemicals were found at unacceptably high levels. For example, at the Hadnot Point water treatment plant, TCE levels in 1982 were found to be at 1,400 micrograms per liter. The EPA’s maximum allowable level for TCE is 5 micrograms per liter.

Medical issues associated with these chemicals include various types of cancers, heath defects, birth abnormalities, Parkinson’s disease, and aplastic anemia.

One of the biggest challenges for those seeking compensation for exposure to the dangerous water at Camp Lejeune is proving that their medical problem was caused by the water at Camp Lejeune.

There have been various studies and research linking the chemicals found in Camp Lejeune’s water supply with the health concerns of people who lived and worked there. However, these studies were limited to certain health issues or smaller groups of individuals. As a result, the scientific evidence to support an individual’s claim that their cancer or blood disorder wasn’t as strong as it could be. It also meant that many people could have cancer caused by the contaminated water from Camp Lejeune but be unable to receive compensation.

What the New Study Found

The study examined military personnel from the U.S. Navy and Marine Corps who were stationed at Camp Lejeune or Camp Pendleton between 1972 and 1985. Civilians who worked at either base were also examined. In total, more than 150,000 service members from Camp Lejeune and more than 160,000 service members from Camp Pendleton were subject to this study. About 6,000 civilians from each base were also included.

Specific cancer rates were then compared for individuals from each base. In case you’re wondering, Camp Pendleton was used as a base for comparison because its drinking water wasn’t known to have contamination before 1986. Also, the military and civilian populations from both bases were similar in terms of demographics, training, jobs and socioeconomic factors.

The study found that military personnel who lived or worked at Camp Lejeune had at least a 20% higher risk of developing certain cancers compared to those who lived and worked at Camp Pendleton. These cancers included:

• Acute myeloid leukemia
• All myeloid cancers including polycythemia vera
• Myelodysplastic and myeloproliferative syndromes
• Cancers of the esophagus, larynx, soft tissue and thyroid
• Polycythemia vera (alone)
• B-cell lymphoma
• Squamous cell esophageal cancer
• Certain types of lung cancer

For civilians, they had at least a 20% higher risk of developing certain cancers as well, including:

• Squamous cell lung cancer
• Female ductal breast cancer
• All myeloid cancers including polycythemia vera

Why This New Study Is So Important This study is a big deal for several reasons. First, it compares similar military personnel from two different bases instead of military personnel from Camp Lejeune with the regular population (which consists mostly of civilians). This matters because service members tend to be healthier due in part to more frequent medical checkups. Comparing soldiers from one base with soldiers from another base offers a more accurate picture of cancer risks as it accounts for the fact that service members tend to be healthier than civilians.

Second, this study reviewed data from cancer registries from every state. This offers a more complete view of cancer rates and other medical statistics.

Third, the study gave a very detailed look at the relationship between various cancers and exposure to certain chemicals. Very few, if any, similar studies exist. This means anyone interested in learning more about cancer risks and potential causes can use this data, even if their primary concern relates to the general population and not members of the U.S. military.

Finally, this study offers evidence that exposure to PCE, TCE and other chemicals may have caused more cancers than originally accepted or known. From a practical perspective, this means there could eventually be a larger list of cancers (like thyroid cancer and myeloproliferative syndrome) that are eligible for compensation, whether in court or through the administrative claims process (like the Elective Option).

If you have any questions about whether you or someone you know suffered a medical problem that was the result of Camp Lejeune’s water contamination, don’t hesitate to contact my office or call me at (919) 830-5602.

For a while now, Stryker has had issues with some of its hip replacement artificial implants. One troublesome type in particular has been the LFIT V40 series. Specifically, in some of these Stryker hips corrosion forms where the femoral head connects with the femoral stem. This would often lead to taper lock failure, or a compromised joint that would loosen and cause metallosis.

This issue helped lead to a recall in 2016 and an expanded recall in 2018. One of the reasons for the 2018 recall was a higher-than-expected number of reports of the femoral head disassociating (disconnecting) from the femoral stem.

What Is Artificial Hip Disassociation?

Also referred to as “dissociation,” disassociation describes situations where the femoral head (the round, ball-like part of the hip implant) actually breaks away from the stem of the hip implant. The image at right helps illustrate what these parts do and roughly where the dissociation would occur.

What Causes the Stryker LFIT V40 Dissociation Failures?

The main reason for dissociation in LFIT V40 artificial hips is corrosion where the femoral head joins the femoral stem. This usually starts slow and goes unnoticed by the patient for many months and even years. Over time, the corrosion gets worse and likely causes metallosis. Once enough time passes, the corrosion gets so bad that the head and stem joint break apart or disconnect leading to a catastrophic failure of the hip implant.

What Causes the Corrosion?

The corrosion could be caused by excessive friction between the metal components. Ideally, when the femoral head is attached to the femoral stem, it is a perfect joint, with no movement between the two parts. Unfortunately, the Stryker LFIT V40 components often wouldn’t be properly connected. This could lead to micromotion, or a very small amount of “wiggling” between the parts. Too much movement or grinding can cause the neck to grind down (sometimes referred to as “penciling”), where the neck grinds away to a sharpened point, like a pencil. Ultimately, this could result in corrosive wear and create a dissociation failure.

How Can I Tell if My Hip Replacement Has Disassociated?

If your artificial hip implant disassociates, you’ll most likely know something is very wrong with your hip. You will likely endure one or more of the following symptoms:

• Pain and/or inflammation (the pain is often significant).
• Joint instability.
• Metallosis.
• Reduced mobility (even inability to walk).
• One leg becoming longer or shorter.
• Broken bones in areas surrounding the joint.

What Do I Need to Do If My Stryker Hip Implant Disassociates?

You’ll almost certainly need hip revision surgery (most likely, immediately). Because the corrosion leading to dissociation will be severe, this surgery will likely be extensive, requiring not just the femoral head to be replaced, but also the femoral stem. The removal of the femoral stem is a big deal because it will probably be very well-established in your femoral bone. The femoral stem can be removed, but it won’t be a pleasant experience.

I’m Feeling Fine Right Now, So Now What?

The first thing you can do is talk to your doctor to confirm if you received the affected Stryker LFIT V40 hip components. If you did, you’ll need to discuss the medical benefits of removing the V40 femoral head. If you’re lucky, only the head will need to be replaced and the femoral stem can be left alone. While this still requires revision surgery, it’s a far less complex or involved procedure. As always, rely on the advice of a trusted orthopedic surgeon for these medical decisions.

To learn more about potential issues with your Stryker LFIT V40 hip implant and what legal options you may have available, you can contact my office or call me at (919) 830-5602