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.

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.

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

Not all artificial hips fail. Many total hip replacement surgeries are successful. Unfortunately, artificial hips, particularly “metal-on-metal” hips, have “failed” at a rate much higher than previous artificial hip systems, whose components typically consisted of a combination of metals, plastics, and ceramics. The metal-on-metal design placed a metal ball or head directly into a metal acetabular cup. By using a metal cup and a metal ball, these artificial hips forced metal to rub against metal with the full weight and pressure of the human body. As long as the metals held up, all would be well. But it turned out that this intense pressure and movement often caused the metals to grind and deteriorate, and too often releasing metal particles into the surrounding tissue and into the bloodstream. In other artificial hip failures, such as with the Stryker LFIT v40, femoral heads can malfunction due to a failure in the taper lock. The taper lock is the part of the hip prosthesis that connects the femoral head to the stem. This can cause the neck on the femoral stem to grind down (sometimes referred to as “penciling”) and can even lead to a full disassociation (more on that below).

In still other artificial hip failures, the plastic liner (between the cup and ball) deteriorates and causes the total artificial hip system to fail. Polyethylene liners are very important in an artificial hip because over the years, it will serve as a buffer between the metal cup and also the metal femoral head or ball, so it can protect against excessive grinding of the hip components. But the studies have shown that Exactech hip plastic liners have been breaking down and showing signs of premature wear.

Please note that with any hip replacement surgery, there will be a period of rehabilitation. Even with great surgery results, the patient will suffer some soreness, stiffness, and a period to regain strength, mobility, and comfort. From the hundreds of people I have spoken with over the years who have undergone hip replacement surgery, even successful hip replacements do not turn you into a completely pain-free eighteen year old athlete.

For many patients, however, particularly those who received the metal-on-metal hip, there may come a point when they wonder if their artificial hip has failed. But given that all hip surgeries initially come with some discomfort and pain, how do they know if their hip has failed.

Let’s start with the basics:

What Is an Artificial Hip Failure?

Artificial hips fail in several ways:

1. Pain. This would be pain that lingers after the period of rehabilitation, or which arises months or years after the implant surgery. There is no marker for the precise amount of pain necessary to define a failure. If you are in pain, you need to assume that something is wrong and you need to schedule an examination.
2. Swelling. The area around your hip replacement should not swell after the period of surgery and rehab is past. Swelling is a sign of a problem.
3. Metallosis. This is the build up of metal levels in the blood and/or in body tissue. When a metal-on-metal artificial hip cup and ball grind together, tiny shavings can be released into the body, elevating metal levels. A simple blood test can identify metallosis.
4. Loosening components. This is when a component like the acetabular cup has become loose and shifted or moved. It can hurt (see #1).
5. Disassociation. In some cases, the femoral head and stem actually separate or break apart. In these cases, the hip and the leg are no longer connected. This can be caused by (for example) corrosion in the V40 femoral heads.
6. Inflammation of tissue. This is where the hip area becomes swollen, warm, red, and often painful, as a reaction to the hip failure and/or as a result of infection.
7. Pseudotumor. This is abnormal tissue growth that occurs as a reaction to metal particles being released near the site of the hip replacement. A pseudotumor is noncancerous. Pseudotumor does not always cause pain or other noticeable symptoms.
8. Sounds. Other the years, several clients have reported that their hip has begun to make ominous sounds, such as grinding, whistling, popping, or thumping. Your artificial hip should not make noises.

Understand that with most hip failures, several of these conditions may be present, not just one. You may have pain, and swelling, and loosening components. Sometimes you may have all the symptoms.

What Might Artificial Hip Failure Feel Like?

1. Pain. This is nearly always the first red flag. With artificial hip failure, there will likely be unusual pain and discomfort. As doctors like to say, “always listen to your body.” If something doesn’t feel quite right, it may not signal artificial hip failure. But it could.
2. Popping sounds. I’ve had people tell me that their failing artificial hip actually made noises. The popping sound typically comes from a component that is loose or becoming dislocated. It often occurs with pain.
3. Swelling or heat coming from the hip area. A sign of infection.
4. Uncertainty. The hip feels insecure, as if the person’s leg may “give out” while walking or standing. In other cases, the hip feels as if it is locking up on the person.
5. (Almost) nothing at all. Oddly, with some artificial hip component failures, you may not notice symptoms. This is when an artificial hip failure can be most frustrating; something is wrong, but you can’t detect anything serious. For years, one person I spoke with did not feel abnormal pain, but only some discomfort after walking for long periods on hard surfaces (like asphalt). The blood tests showed slightly elevated metal levels, but not outrageously high numbers. After several years, the pain grew incrementally, and the patient eventually chose revision surgery. The revision surgery revealed a very loose cup, dark metallic fluid, inflamed tissue around the hip, and other problems. Clearly the artificial hip components had failed, and revision surgery was necessary, even overdue. But the individual for years believed everything was “good enough.”
6. Other sensations. The human body can simply react in all kinds of ways. If the feeling is unpleasant, something may well be wrong.

Despite all this unpleasantness, there is no need to panic. Panic is not good for anyone. But I do believe you must take ownership of your medical care. If something “does not feel quite right,” schedule an appointment with your orthopedic surgeon. Ask questions. Ask for a blood test. Ask more questions. Keep a symptoms journal, which I wrote about here. Stay after it.

And call me if you have legal questions: (919) 830-5602.

No specific client information was used in writing this article. And of course, I am no doctor, and this is not medical advice.

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

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

The FDA’s Role in Keeping Consumers and Patients Safe

The primary mission of the FDA is to regulate a large class of medical and consumer goods and products. Most of these include:

• Food (the regulation of certain foods is handled by another federal agency, the U.S. Department of Agriculture)
• Drugs (prescription and over-the-counter)
• Biologics (medical products that are biological, such as vaccines, gene therapy, and tissue products)
• Medical devices
• Devices that emit radiation
• Cosmetics
• Veterinary products
• Tobacco

The FDA’s primary goal in regulating these products is to make sure they’re safe and/or provide adequate warnings to the general public about their risks. This is especially true with medical devices and pharmaceutical drugs, which usually go through an extensive approval process that occurs before a device or medication gets sold to the general public.

Unfortunately, this approval process isn’t perfect. After a product hits the market, unexpected problems can arise. To deal with this, the FDA orders and/or oversees product recalls. The Philips BiPAP and CPAP machine recall has shed some light on how this recall process might not work as well as it should.

How the FDA Recall Process Should Work

The FDA requires certain entities (like medical device makers) to report problems with their devices to the FDA. Healthcare professionals and patients may also submit reports.

These reports go to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. The FDA is then supposed to review each report and take appropriate action. Given how there could be thousands of medical devices in use, as well as the fact that a report may not be 100% complete (or truthful), the FDA won’t necessarily take immediate action if there’s just one negative report about a certain device.

But the FDA is supposed to analyze the data over time to identify any trends or patterns with a particular device or group of devices. One bad report may not mean anything. But several dozen bad reports when only a few hundred devices are in active use could be a sign of a problem. The FDA can then decide to order a recall themselves or suggest to the manufacturer that it should initiate a voluntary recall.

Why the FDA Recall Process May Be Broken

According to an investigative report by ProPublica, there are several problems with MAUDE in the recall process. First, mandatory reporters (like medical device companies) should submit reports in a timely fashion. This generally means filing a report within 30 days of a patient’s death or a device malfunction. However, these reports often get filed late.

How late? Well, ProPublica’s report found that Philips (and its related subsidiaries) filed at least 60,000 reports late since 2010. Many of these reports were late by several years. Of these 60,000 reports, at least 3,700 reports involved Philips breathing machines and ventilators.

Second, medical device makers often need to provide follow-up information to the FDA. During this follow up process, the FDA requires the companies to change the dates of when the companies first learned of the problem. This new date is usually later, meaning the records in MAUDE appear to show that the device company learned of the problem later than they actually did.

In addition to the ProPublica report, there was a 2011 report from the U.S. Government Accountability Office (GAO) that looked into how the FDA conducts its recalls. It found multiple problems within the recall oversight process, such as:

• The FDA often took more than a year to complete a recall (the FDA had a goal of completing them in 90 days).
• The FDA did not analyze the recall data to find systemic problems in the medical devices, such as common causes for problems leading to the recalls.
• The FDA did not always follow its own recall procedures, such as inspecting the manufacturing facility of a medical device maker.
• The FDA had inconsistent procedures that led to inconsistencies in recall effectiveness.
• The FDA did not have specific parameters in place to determine whether a medical device company properly completed its recall.

What’s Being Done About This Problem?

As of December 13, 2023, Senators Richard Durbin and Richard Blumenthal have sent a letter to the GAO asking them to update the 2011 report by investigating the FDA’s oversight of medical device recalls and identify ways the process could be improved.

Senator Blumenthal has also sent an October 10, 2023 letter to the FDA and U.S. Department of Justice (DOJ) asking them to “take immediate action” against Philips relating to allegations that it knew its ventilators and breathing devices were dangerous due to complaints it received, but withheld this information from the FDA. We’ll now have to wait and see how the FDA, DOJ and GAO respond to these letters.

If you’re using a Philips breathing machine that’s subject to a recall, please talk to your healthcare provider about whether you should continue using it. If you think you’ve been harmed by your machine, you might have some legal options. To discuss what these are, you can call me at (919) 830-5602 or contact my office.

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

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

An Overview of Ozempic and Related Medications

The U.S. Food and Drug Administration (FDA) approved Ozempic in 2017 to help individuals deal with Type 2 diabetes. Over the next few years, the FDA approved similar drugs using the same active ingredient as Ozempic, such as Wegovy. This medication is essentially a higher-dose version of Ozempic aimed at helping individuals lose weight.

There was also Rybelsus, which is like Ozempic, but the medication gets taken orally with a pill. In contrast, Ozempic and Wegovy are injected through the skin.

The labels for all of these drugs have undergone revisions over the past few years since their initial approval. The most recent update to Ozempic’s warning label concerns a condition called ileus.

What Is Ileus?

Ileus is a medical condition where the bowel does not work properly. This can lead to an intestinal blockage which can be a serious health issue and require immediate medical attention.

The connection between Ozempic and Ileus is not definite. The FDA notes that one reason for the labeling change is the result of voluntary reports about potential problems with the medication.

Many of these reports come from the FDA Adverse Event Reporting System (FAERS), which is open to the public. This means consumers, doctors, pharmaceutical companies and other health professionals can submit information to this system.

Seeing adverse reactions to Ozempic on FAERS doesn’t automatically mean Ozempic was the cause nor does it establish how often these problems could occur. That being said, as of September 30, 2023, there were 16,854 adverse reaction cases involving Ozempic on FAERS. Of these cases, 34 are claimed to involve ileus.

However, if Ozempic causes ileus, the number of cases reported to FAERS will probably rise. And there’s research data to support this link.

A study published in 2023 looked at rats given exenatide for one month. Exenatide is similar to semaglutide, which is the active ingredient in Ozempic. The results showed that the length of the rats’ small intestines increased by 9% and the weight of the small intestines increased by 31%. This enlarging of the small intestine could lead to intestinal obstructions.

The study also noted that the risk of intestinal obstruction goes up over time while taking exenatide. So the longer someone takes Ozempic, they could be increasing their risk of developing ileus.

Label History of Ozempic

The label for Ozempic has received multiple updates, and not just for ileus. Since it was introduced, Ozempic has gone through five label changes:

• First label change: Came in 2020 and added language mentioning that Ozempic could be used to reduce the risk of heart attack, stroke or death in diabetic patients with heart disease.
• Second label change: Came in 2021, with notable changes relating to the risk of hypoglycemia and serious allergic reactions, such as anaphylaxis.
• Third label change: Came in March 2022, with most of the additions relating to potential risk of acute gallbladder disease.
• Fourth label change: Came in October 2022 and discussed pregnancy risks when taking Ozempic.
• Fifth label change: This is the most recent update and it came in September 2023. Significant updates involve the risk of severe hypoglycemia and ileus was added as an adverse reaction.

What About Gastroparesis?

What’s interesting about the Ozempic label updates is that none of them mentions gastroparesis as an adverse reaction. However, the updates have included additional information about delays with gastric emptying, but only within the context of drug interactions.

In contrast, Eli Lilly’s Mounjaro label includes more impactful wording when it comes to gastroparesis. Specifically, it states that patients with a history of severe gastroparesis should not take Mounjaro as the medication has not been studied in patients with severe gastrointestinal disease.

Mounjaro’s label has also gone through fewer label updates, with the sole update coming in July 2023. In this update, major changes include risk of severe allergic reactions, pancreatitis and thyroid C-cell tumors. There was also mention of ileus as an adverse reaction.

If you think you’ve suffered a side effect from taking Ozempic and you believe it caused ileus, gastroparesis or any other notable health concern, be sure to mention it to your primary care provider. If these adverse reactions have been severe, it might be worth talking to a lawyer about your legal options. Feel free to contact my office or call me at (919) 830-5602.

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

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

What Is Ozempic?

The active ingredient in Ozempic is semaglutide, which is a glucagon-like peptide-1 (GLP-1) receptor antagonist. GLP-1 is a hormone that affects how much insulin the body produces in response to eating food. GLP-1 also affects appetite.

The U.S. Food and Drug Administration (FDA) approved Ozempic in 2017 to treat type 2 diabetes. A few years later, the FDA approved Wegovy. Wegovy is basically a higher-dose version of Ozempic and is primarily used to help patients lose weight. There’s also FDA-approved Rybelsus, which is semaglutide in pill form (Ozempic is taken through an injection). These drugs are made by Novo Nordisk, which is enjoying massive profits from the sale of these medications.

As popular as Ozempic has been to treat diabetes and lose weight, it has its fair share of adverse reactions. Many of these relate to digestion. According to Novo Nordisk, some of these side effects include:

• Diarrhea
• Abdominal pain
• Nausea
• Vomiting
• Constipation

While not listed as an official side effect, Novo Nordisk notes that Ozempic may slow down how quickly food leaves the stomach. Novo Nordisk mentions this because it could reduce the effectiveness of an oral medication a person is taking.

One of the ways Ozempic works is by having food take longer to leave the stomach. As a result, someone eating will feel fuller faster, and for a longer period of time. The problem is when the stomach completely stops (or dramatically slows down) the movement of food from the stomach. This can sometimes lead to gastroparesis.

What Is Gastroparesis?

The National Institute of Diabetes and Digestive and Kidney Diseases defines gastroparesis as “a disorder that slows or stops the movement of food from your stomach to your small intestine, even though there is no blockage in the stomach or intestines.” The stomach digests food and moves it to the small intestine through its muscles, so that’s why gastroparesis is sometimes referred to as stomach paralysis.

After you eat food, your stomach’s muscles work to start the digestion process and pass the food to your small intestine. Depending on your health, what you eat and how much you eat, it takes anywhere from a few hours to eight hours for food to go from your stomach to your small intestine. But with gastroparesis, food might stay in the stomach for much longer, up to a few days. Here are some of the most common symptoms of gastroparesis:

• Feeling full even though it’s been several hours after eating or immediately after you start eating
• Vomiting
• Heartburn
• Abdominal pain
• Excessive burping
• Diminished appetite
• Feeling bloated
• Nausea

For many people, there’s no known cause for their gastroparesis. However, when there is a known cause, it’s often diabetes. High blood sugar over time can damage nerves that control stomach muscles. This can result in the stomach muscles becoming weak or not working at all.

Does Ozempic Cause Gastroparesis?

The exact link between gastroparesis and Ozempic is not yet clear. Recall from the above section that one of the biggest causes for gastroparesis is diabetes. So there’s the question of whether Ozempic causes gastroparesis or worsens it in patients who already have it, but don’t know it.

It should be noted that Ozempic’s label provides no warning for gastroparesis as a side effect. However, Prevention.com mentions that during the clinical trials, none of the test subjects reported having gastroparesis.

Is There an Ozempic Lawsuit Relating to Gastroparesis?

Yes. In August, Jaclyn Bjorklund sued Novo Nordisk, as well as Eli Lilly, the makers of Mounjaro. Mounjaro is the brand name for tirzepatide, which is similar semaglutide in how it works. Bjorklund claims that she took both Ozempic and Mounjaro and that they both led to her physical injuries.

In her legal complaint, Bjorklund alleges that because she took these two medications, she suffered from gastroparesis and other gastrointestinal problems, such as gastroenteritis. Bjorklund states that her vomiting from taking these medications was so severe, she lost some of her teeth.

The crux of Borklund’s case is that Eli Lilly and Novo Nordisk failed to properly warn of the risk of gastroparesis and gastroenteritis. While Ozempic came with important safety information that mentioned that food might stay in the stomach longer, Bjorklund asserts that this wasn’t done to warn prospective Ozempic users of the drug’s side effects. Instead, it was mentioned within the context of drug interactions when taking another medication orally.

Will There Be More Lawsuits Relating to GLP-1 Drugs?

Most likely. If there really is a link between gastrointestinal problems (like gastroparesis) and GLP-1 medications, then Bjorklund’s case is probably the first of many.

What Happens Next with the Ozempic Litigation?

There will likely be more lawsuits and more studies further clarifying the connection between GLP-1 drugs like Ozempic and gastrointestinal issues. Based on the available information (so far) and Bjorklund’s lawsuit, it doesn’t seem like Ozempic, Wegovy and Rybelsus are inherently bad drugs that must be removed from the market. Instead, patients and their doctors might need more information before deciding on medications.

Collective litigation is also a possibility, although it’s more likely going to come in the form of multidistrict litigation rather than a class-action lawsuit. This is because personal injury lawsuits tend to have enough differences in the various plaintiffs’ legal and factual claims that a class action lawsuit isn’t possible.

If you’ve taken a GLP-1 medication like Ozempic and suffer from serious stomach and/or intestinal issues like gastroparesis or gastroenteritis, it’s possible you could take legal action. To learn more about your rights, it’s best to talk to an attorney, especially one that focuses on product liability personal injury cases. If you know one already, get in touch with them. Or you can call me at (919) 830-5602 and I’ll see how I can help.

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

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

Does Tepezza Cause Hearing Problems?

According to Tepezza’s own website, 10% of Tepezza patients report hearing problems. But not everyone who takes Tepezza will suffer from hearing issues. Of those that do, there may be a wide range of complaints reported. Some of the reported hearing issues include:

• Partial and/or permanent hearing loss
• Fluid plugging one or both ears
• Reduced ability to hear certain sounds
• Trouble perceiving the loudness of sounds
• Ringing of the hears (tinnitus)

The most prominent hearing issues seem to be tinnitus and partial and/or permanent hearing loss.

Tepezza works as an insulin-like growth factor-1 receptor inhibitor and it’s believed that insulin-like growth factor-1 plays a major part in causing TED. However, there have been studies that establish a likely connection between insulin-like growth factor-1 and hearing problems.

Has the FDA Taken Action Concerning Tepezza?

As of the time of this writing, it doesn’t appear the FDA has taken any actions concerning this medication, including recalls or safety alerts.

Are There Any Lawsuits Alleging Tepezza Caused Hearing Problems?

Yes. Some of the claims allege Horizon:

• Knowingly withheld or misrepresented information concerning the hearing-related risks of using the medication;
• Did not properly test Tepezza;
• Failed to properly warn doctors and patients about the hearing-related risks of taking the drug; and
• Continued to market Tepezza to patients despite being aware of its potential problems.

In early 2023, Tepezza lawsuits started getting filed around the country, such as this one filed in Georgia. As of June 2, 2023, there were 37 cases in federal court, spread out over eight districts. All of these cases were recently consolidated into multi-district litigation (MDL).

The MDL will be known as “In re: Tepezza Marketing, Sales Practices, and Products Liability Litigation, MDL No. 3079.” The cases subject to the MDL are being transferred to the Northern District of Illinois, likely to be presided over by Judge Thomas M. Durkin.

What’s Next for the Tepezza MDL?

This MDL was just created, so it’s not likely anything significant will occur for the next few months. What’s most likely is that cases will continue to be added to the MDL and the litigants will figure out how to conduct discovery.

In a few years, a handful of bellwether trials may begin. Once these trials conclude, there’s a greater chance for a global settlement, as the outcome of the bellwether cases will give each side a better idea of how strong (or weak) their cases are.

If you have any questions about Tepezza or think you might want to take part in this MDL, feel free to call me at (919) 830-5602 (direct line). Good luck.

It’s been a few months since President Biden signed the Camp Lejeune Justice Act of 2022 (CLJA) into law. I’ve written several posts discussing this new law, but none of those posts have gone into detail about how and why the drinking water at U.S. Marine Corps Base Camp Lejeune caused so much harm to so many individuals for so long. Camp Lejeune water contamination, sadly, occurred for decades, and it’s important to understand how it happened and how it hurt people. In this blog post, we’ll examine:

• How the water got contaminated
• What chemicals or toxins contaminated the water
• What health effects resulted from the contamination

Where Did the Camp Lejeune Drinking Water Become Contaminated?

There were multiple locations. According to the Agency for Toxic Substances and Disease Registry (ATSDR), the finished water (water used for drinking, cleaning, bathing, etc.) at Camp Lejeune came from the following eight water-distribution plants:

• New River
• Hadnot Point
• Tarawa Terrace
• Holcomb Boulevard
• Courthouse Bay
• Rifle Range
• Onslow Beach
• Montford Point/Camp Johnson

The ATSDR reports that only the following three water-distribution plants were contaminated with high levels of harmful chemicals: Hadnot Point, Tarawa Terrace and Holcomb Boulevard. However, Hadnot Point and Tarawa Terrace suffered the worst contamination.

Water Contamination at the Hadnot Point Water-Distribution Plant

The Hadnot Point water source provided water to several locations, such as Mainside Barracks and several family housing locations (Berkeley Manor, Hospital Point, Paradise Point and Midway Park).

The primary contaminant in the water was trichloroethylene (TCE), but other contaminants included perchloroethylene/tetrachloroethylene (PCE), benzene, vinyl chloride and trans t-1,2-dichloroethylene (DCE). These chemicals came from various sources, including waste disposal sites, underground storage tanks and chemical spills from industrial locations.

To give you an idea of how bad the contamination was at Hadnot Point, in 1982, the TCE levels in the drinking water was 1,400 parts per billion (ppb) even though the allowable limit was just 5 ppb. That’s 280 times the allowable limits. Which is horrifying.

Water Contamination at the Tarawa Terrace Water-Distribution Plant The Knox Trailer Park and Tarawa Terrace family housing unit were major users of water from the Tarawa Terrace water-distribution plant. The main contaminant found in the water was PCE, which came from an off-base dry cleaning business.

In 1985, PCE was detected in the water from Tarawa Terrace at a concentration of 215 ppb, although the allowable limit was 5 ppb.

Water Contamination at the Holcomb Boulevard Water-Distribution Plant The water contamination at this location is believed to be less severe, as much of the contaminated water used in the Holcomb Boulevard drinking system came from Hadnot Point. Despite the smaller amount of contamination, the level of chemicals in drinking water, such as TCE, PCE and DCE, is believed to have significantly exceeded allowable limits.

What Health Problems Were Caused by the Chemicals in the Camp Lejeune Water?

The human body is complex and there are often various factors that determine whether someone gets sick after exposure to something harmful. That being said, there’s plenty of research that explores the risks of exposure to many of the chemicals found in the Camp Lejeune drinking water. But factors that could affect how these chemicals harm people include:

• Amount of exposure (how much of the toxin was in the water you were exposed to)
• Method of exposure (inhalation of water vapor containing contaminants versus having it touch your skin or drinking it)
• Duration of exposure (how long you were on base)
• At what point in your life you were exposed (as a baby versus as a child or adult)
• Your personal characteristics (such as eating and exercise habits, as well as genetics and family history)

Even though the exact cause of a specific health issue in a particular individual can be complex, scientific research can still conclude that certain health effects are caused by certain chemicals.

The ATSDR states that there’s sufficient evidence to conclude that the following chemicals found in the contaminated water at Camp Lejeune cause the following health problems:

• TCE: Cardiac defects, Non-Hodgkin’s lymphoma and kidney cancer
• PCE: Bladder cancer
• Benzene: Leukemia and Non-Hodgkin’s lymphoma
• Vinyl chloride: Liver cancer

There are other health problems that the ATSDR recognizes are linked to a specific toxin:

• TCE: Leukemia, liver cancer, multiple myeloma, end-stage renal disease, Parkinson’s disease and Scleroderma.
• PCE: Non-Hodgkin’s lymphoma and end-stage renal disease
• Benzene: Multiple myeloma

Finally, there are health problems that have positive associations between an ailment and exposure to a specific chemical.

• TCE and/or PCE: chonal atresia, eye defects, low birth weight, fetal death, major malformations, miscarriage, neural tube defects, oral cleft defects, small for gestational age, breast cancer, cervical cancer, esophageal cancer, lung cancer, ovarian cancer, prostate cancer, rectal cancer, Hodgkin’s disease, impaired immune system function, neurological effects, neurobehavioral performance deficits, severe, generalized hypersensitivity skin disorder
• Benzene: Miscarriage, aplastic anemia and myelodysplastic syndrome
• Vinyl chloride: Brain cancer, lung cancer, liver cirrhosis and soft tissue cancer

Conclusion

One or more of your health problems may have been caused by exposure to contaminated water at Camp Lejeune. But if you want to receive compensation for your injuries, you’ll have to provide evidence to support your claims. Depending on your situation, it might be a good idea to have a competent injury attorney help you with this process.

If you have any questions, feel free to give my firm a call at (919) 830-5602. I’ll do my best to help you.

Marine Corps Base Camp Lejeune (Camp Lejeune) is an important military base and training facility for the U.S. Marine Corps. Located on the coast of North Carolina, many Marines and their families have spent extended time at this base. In fact, before law school I was an English instructor at Coastal Carolina Community College, located just a few miles away from Camp Lejeune. I taught hundreds of students who were active-duty Marines or Marine-dependents, and many of them lived or worked on the base.

However, from at least August 1, 1953 to December 31, 1987, many of the base residents were likely exposed to toxic chemicals from the drinking water. And this exposure has potentially led to a variety of serious medical issues, including death.

But for the time being, taking legal action for injuries relating to toxic water exposure at Camp Lejeune has been impossible. But the likely enactment of a new federal law should change that.

Camp Lejeune Water Contamination

According to the Agency for Toxic Substances and Disease Registry, much of the drinking water at Camp Lejeune was contaminated with a variety of chemicals, including:

• Trichloroethylene
• Tetrachloroethylene
• Vinyl chloride

Exposure to the drinking water at Camp Lejeune that contains these and other chemicals has been linked to health ailments, such as:

• Kidney cancer
• Bladder cancer
• Liver cancer
• Non-Hodgkin lymphoma
• Leukemia
• Cardiac defects
• Multiple myeloma
• Adverse birth outcomes
• Parkinson’s disease
• Aplastic anemia

Veterans who meet certain requirements are eligible for disability benefits from the U.S. Department of Veterans Affairs. But this has not properly compensated all affected individuals. Attempts to file civil suits have failed, largely because of something called a statute of repose.

What’s a Statute of Repose?

A statute of repose places a deadline on when potential plaintiffs can file a lawsuit. It’s very similar to a statute of limitations in that it essentially bars any legal action unless it’s brought by a specific deadline. But a statute of repose differs from a statute of limitations in one key way.

The statute of repose “clock” begins after the defendant does something. It has no relation to when the plaintiff got injured or discovered their injury. In contrast, a statute of limitations “clock” typically starts after the plaintiff was injured or when they should have discovered the injury with reasonable effort.

In plain English, this means if you’re a plaintiff, you do not want a statute of repose to apply, because it can extinguish your rights to pursue a case even before you are aware that you have a case.

When it comes to water contamination injuries from Camp Lejeune, for now, the statute of repose applies. And in North Carolina, based on the relevant dates when Camp Lejeune’s drinking water was contaminated, the deadline to file a civil suit has passed.

Even though North Carolina’s statute of repose has been amended, these changes didn’t apply retroactively. This meant that previously time-barred cases could not be resurrected. But thanks to a soon-to-be enacted federal law, victims of Camp Lejeune toxic drinking water exposure could get their day in court.

Honoring Our PACT Act of 2022

For the past few years, there have been multiple attempts to pass the Camp Lejeune Justice Act that would allow individuals exposed to the hazardous chemicals in Camp Lejeune’s drinking water to sue the federal government. These prior attempts have failed, although it appears there might be future success.

The Camp Lejeune Justice Act of 2022 was included as part of the Honoring Our PACT Act of 2022, which just passed the U.S. Senate. It’s very similar to the version that was passed by the House of Representatives earlier, but due to changes made in the U.S. Senate, it needs to go back to the House of Representatives to be voted on again. It’s expected to pass and quickly signed into law by President Biden.

What Does the Camp Lejeune Justice Act of 2022 Do?

Assuming it gets enacted, the Camp Lejeune Justice Act of 2022 will eliminate the ten-year statute of repose with respect to bringing a personal injury lawsuit due to toxic water exposure at Camp Lejeune. To be eligible to take advantage of the Camp Lejeune Justice Act of 2022, an individual must meet all of the following requirements:

• Must have been on base for at least 30 days between August 1, 1953 and December 31, 1987. This includes those who may not yet have been born, but whose mothers were pregnant and on-base at this time.
• Must first file a claim to the appropriate federal agency pursuant to 28 U.S. § 2675 and have that claim denied.
• File the lawsuit in the U.S. District Court for the Eastern District of North Carolina (my “home” district).
• Begin the lawsuit within two years of the law going into effect or 180 days after having a claim denied by a federal agency, whichever is later.

As for recoverable damages, plaintiffs can’t recover punitive damages. Also, any compensation relating to toxic water exposure from Camp Lejeune that was received through the VA, Medicare or Medicaid will offset any damage award received from a Camp Lejeune Justice Act of 2022 lawsuit.

Another thing potential plaintiffs should keep in mind is that if they sue under the Camp Lejeune Justice Act of 2022, they can’t bring any other civil suit against the United States under any other law.

What Now?

Now we wait for the Camp Lejeune Justice Act of 2022 to become law. So there are no current lawsuits filed under this law. However, as mentioned earlier, all signs indicate that it will go into effect very soon.

In the meantime, if you believe you have been exposed to contaminated water after spending time at Camp Lejeune, you should consider talking to an attorney about obtaining compensation for any injuries you may have suffered. Feel free to call me at (919) 830-5602 if you have any questions.

If you’ve used a Philips Respironics (Philips) CPAP or BiPAP machine to help with your sleep apnea, then there’s a good chance you’re aware that your Philips machine could be subject to a recall. I’ve written about this recall, as well as the health risks related to it and potential legal options if you’ve been harmed by your defective CPAP or BiPAP machine. In this blog post, I’ll look at one of the reasons why using one of these defective machines is so dangerous. I’ll focus on some of the studies that support the possibility that using one of these Philips machines could put you at greater risk for developing cancer.

How Do the Philips CPAP and BiPAP Machines Potentially Cause Cancer?

Many Philips CPAP and BiPAP machines (as well as Philips ventilators, but this blog post won’t focus on those) are made with polyester-based polyurethane (PE-PUR) foam. This foam is used to reduce the perceived sound and vibration coming from the CPAP and BiPAP machines. This is because many people who use these machines only use them when trying to sleep. So it’s important to make the machine as quiet as possible.

The problem is that the PE-PUR foam may break down and harm the user in two potential ways. The first way is when the foam physically falls apart so that the user inhales or ingests small bits of foam. The second way is when the foam releases harmful chemical gasses (off-gassing) which the user then breathes in. It’s this off-gassing that possesses the greatest risk for cancer.

What Kind of Chemicals Are the Recalled Machines Releasing?

There are many chemicals potentially off-gassed by the recalled BiPAP or CPAP machines. Some of these chemicals include:

• Dimethyldiazene (aka: azomethane)
• Phenol (aka: carbolic acid)
• Toluenediamine
• Toluene diisocyanate

Some of these can be classified as volatile organic compounds, or VOCs. Perhaps you’ve heard of these and how they should be avoided whenever possible. Various studies have examined these and related chemicals and the negative health effects they may have, including cancer.

“Cancer Incidence and Mortality in the Swedish Polyurethane Foam Manufacturing Industry” (British Journal of Medicine, 1993)

This study examined the effects of exposure to toluene diisocyanate and methylene diphenyldiisocyanate in the work setting. The researchers found that exposure to these chemicals resulted in a higher risk of rectal cancer and non-Hodgkin’s lymphoma.

“Infant Exposure to Emissions of Volatile Organic Compounds from Crib Mattresses” (Environmental Science and Technology, 2014)

This study compared crib mattresses made of polyurethane foam to crib mattresses made out of polyester foam. The authors of this study observed that both types of foam released VOCs, but that mattresses with polyurethane foam released a greater variety of VOCs.

“Carcinogenic Risk of Toluene Diisocyanate and 4,4’-Methylenedophenyl Diisocyanate: Epidemiological and Experimental Evidence” (Critical Reviews in Toxicology, 2001)

This article looked at the limited number of studies that examined the cancer-causing properties of Toluene Diisocyanate and 4,4’-Methylenedophenyl Diisocyanate. The goal was to see if these chemicals caused cancer through exposure in the work setting.

No definite conclusions were obtained, but the authors noted both chemicals likely damaged cellular DNA. Combined with the fact that these chemicals caused cancer in laboratory animals, the authors suspected that these chemicals could cause cancer in humans through exposure at work.

Do the Recalled Philips BiPAP and CPAP Machines Cause Cancer?

There’s evidence to suggest there is a link. But assuming there’s a link between the PE-PUR foam from faulty CPAP and BiPAP machines and cancer, the question remains of what amount of exposure to PE-PUR foam is sufficient to dramatically increase the risk of cancer. Additional studies are looking into this question. Still, it seems clear that prolonged exposure to PE-PUR foam can be harmful to your health.

You can expect that in any lawsuit alleging cancer, Philips will attempt to argue that the plaintiffs’ cancer was caused by something else, such as their lifestyle choices or what they did for a living.

Keep in mind that even if using a recalled Philips BiPAP, CPAP or ventilator did not give you cancer, it could have still harmed your health. So if you have any sustained symptoms that might be related to using your Philips machine, don’t hesitate to talk to your doctor. And if you want to learn about your possible legal options, feel free to give me a call (919.830.5602). Good luck.

Millions of people use the CPAP and BiPAP machines to alleviate symptoms of sleep apnea, so there’s a lot of people that should be interested in this topic. I’m going to move pretty quickly through this information, but I do want to start from the very beginning:

What is a CPAP and a BiPAP machine?

CPAP stands for continuous positive airway pressure. This machine is programmed to produce pressurized air at one steady air pressure level. The way this works is if you want to change the air pressure on any CPAP machine, you have to reset the device’s settings. CPAP machines are extremely common. There are millions of CPAP machines in use and they’re used to treat obstructive sleep apnea.

Obstructive sleep apnea disrupts your sleep patterns because the condition causes you to take pauses in your breathing. Sometimes this occurs because your air pathways briefly collapse, or there’s something that blocks them, but in any event those who suffer from sleep apnea often lose air as they’re sleeping at night, and it’s very disruptive to sleep and it can cause adverse health effects. That’s where the CPAP machine comes in because with this steady pressurized air, it keeps the air pathways open throughout the night, so you can get a decent night’s sleep.

The BiPAP or bi-level positive airflow pressure machine has two settings for air: one pressure for inhaling and a lower pressure for exhaling. This device is not used as commonly as the CPAP machine, but it’s for those who can’t tolerate the CPAP machine as well for a variety of health reasons. And this BiPAP machine is useful in treating central sleep apnea, which is slightly different from obstructive sleep apnea. Now, there is a third machine that is subject to recall in this related to the CPAP and BiPAP machines and that is the ventilator. We won’t talk much about that today, but ventilators may also be subject to this recall because they use the same materials inside the machine that Philips companies use with CPAP and BiPAP machines. So those are the three big machine devices that are subject to a recall for 2021.

The major players in this emerging large-scale litigation are the Philips Companies. That’s Philips North LLC, Philips Holding USA and Philips Respironics Company, and Royal Philips, a foreign company. These companies have produced millions of these machines over the last few decades, and very recently announced the recall. In April 2021 in the Philips quarterly report, Philips noted that there were some potential issues with these machines, the CPAP, BiPAP and ventilator machines, but no recall in April. There was just a indication that the company had recognized some problems occurring. In June 2021, the Philips company issued a formal recall for several of the machines they manufactured. Obviously the Companies worked really fast from April 26 to June 14, to get to the recall, but I think it’s important to note that this recall came very late in the game, and that is to say that early investigations indicate that adverse events were occurring with the CPAP and BiPAP machines well before April 2021, and that there is an issue of whether Philips should have issued a recall months or even years sooner than they did. But in any event Philips did issue the recall on June 14, 2021.

On July 22, 2021 the FDA classified the recall as Type 1. For those of you who may not know, Type 1 is the most serious type of recall and the language that the FDA uses in a Type 1 recall is that there’s a reasonable probability to cause serious injury or death. So it’s serious and not to be taken lightly. That’s where we are right now. The United States has millions of machines out there that are all subject recall.

Why the CPAP Recall?

The big question is why are these machines being recalled? Unfortunately these machines were manufactured with a material that we now understand can be very problematic and harmful to the human body. Philips utilized a polyester-based polyurethane foam, that was used to reduce the sound and the vibration that occurs when the CPAP machine is on and it’s generating air. This polyester-based polyurethane (or “PE-PUR”) foam is used in the Philips CPAP machines and BiPAP machines. Even the ventilator machines use this particular type of material. As it turns out that the PE-PUR foam is not resistant to water degradation. This is a condition called hydrolysis which can cause the foam to break down when exposed to water. The PE-PUR foam breaks down and degrades when exposed to water and there is naturally moisture in these machines because air is being passed through the hose and mouth-covering, which is exposed to breath, which has moisture in it. The studies found that the foam was breaking down and tiny particles and pieces, can break apart from the foam and a human being using the CPAP machines can inhale it or swallow it, ingest it. That is a very serious problem.

It’s important to point out that there is a different type of foam that is slightly more expensive but is highly resistant to hydrolysis and that is a polyether based polyurethane. Philips allegedly chose not to use this safer foam. This turned out to be a pretty significant mistake because the polyether-based likely would have not have caused any of these troubles, and there may not be a recall here, and I wouldn’t be writing and talking about it.

Two Ways the CPAP Machine Can Injury the Patient

The two main problems that have been recognized as a part of this PE-PUR foam breakdown. The first is foam degradation. Reports have shown in lab testing that the foam may degrade and produce particulates. These particulates can enter the person’s air pathway and it can be inhaled and that can cause all kinds of problems. I’ve heard of one case where an individual using a CPAP machine woke up after having found a small piece of the foam physically inside his mouth. I don’t think that’s common, but clearly the foam is degrading and that’s one of the significant problems with this PE-PUR foam.

The second problem that Philips and lab tests have shown is the concept of off-gassing. Lab testing has shown that chemicals can be admitted from this polyester based polyurethane foam and can be inhaled. These gases can be inhaled by the users of the machine. So those there are two issues that the medical community consumer, advocacy groups are looking at and certainly Philips as the emerging defendants in this unfortunate recall. So if you are a user of a CPAP machine or BiPAP machine, you are probably wondering which devices are subject to the recall. There is a long list, but some of the ones that are subject to recall would the E30, the Dream Station, the System One series of CPAP machines, the Dorma 400 and 500, the Remstar, the Trilogy 100 and the A-series BiPAP type machines.

In Part II next week we will take a look at the injuries that can occur and the emerging CPAP litigation.

Note: This information has been gathered from media reports and publicly available court filings. Philips has denied some of these allegations, and for plaintiffs to win their cases against Philips, these facts must be proven in court.

Philips Respironics (Philips) is a leading manufacturer of CPAP and BiPAP machines to help individuals treat their sleep apnea. Philips also makes ventilators which are often used in the medical setting. Earlier this summer, they announced a recall of many of these devices due to the potential harm they could cause their users. Let’s take a quick look at the nature of this recall and the resulting litigation.

Why Is There a Recall?

A variety of ventilators, CPAP and BiPAP machines produced by Philips use polyester-based polyurethane (PE-PUR) foam. The purpose of this material is to reduce the sound and vibration from these devices. However, this foam may break down and injure the user. It’s suspected that high heat and humidity could make this problem worse.

What Are the Potential Injuries?

There are two potential types of injuries from the PE-PUR foam. First, the foam could fall apart into little bits that make their way into the air that the device pushes into the user’s lungs. Second, the foam could off-gas, or release harmful chemicals into the airflow from the device. Either of these events could result in the following injuries:

• Irritation to the eyes, skin and respiratory tract
• Sinus infection
• Cough
• Organ damage (such as to the kidneys and liver)
• Headache/dizziness
• Asthma
• Cancer
• Nausea
• Vomiting

What Machines Make Up the Recall?

Philips has reported that roughly 80% of the machines being recalled are used to help individuals with sleep apnea. These include the following ventilators, BiPAP and CPAP machines:

• E30
• DreamStation ASV
• DreamStation ST, AVAPS
• SystemOne ASV4
• C-Series ASV
• C-Series S/T and AVAPS
• OmniLab Advanced+
• SystemOne (Q-Series)
• DreamStation
• DreamStation Go
• Dorma 400 and 500
• REMstar SE Auto
• Trilogy 100 and 200
• Garbin Plus, Aeris, LifeVent
• A-Series BiPAP Hybrid A30 (not marketed in the United States)
• A-Series BiPAP V30 Auto
• A-Series BiPAP A30 and A40

Philips CEO stated that about three to four million machines are affected by the recall and it could take a year to fully repair or replace the affected machines.

What Should I Do If I’m Using One of These Machines?

You should stop using the machine and immediately talk to your healthcare provider. Depending on your medical issue and your ability to find an alternative treatment or device, it’s possible that your doctor could recommend you continue using the recalled device.

You should also consider registering your recalled device with Philips. This will allow you to get the most current information regarding the status of your machine’s recall and any relevant updates from Philips.

Could I Take Part in a Lawsuit Against Philips?

If you used one of the affected devices then yes, you may have a legal claim against Philips. What you could potentially recover and how you do it will largely depend on the nature and extent of your injuries.

If you only suffered financial injuries, your damages might be limited to your out-of-pocket costs and medical monitoring (future preventative care expenses you’ll have to pay to make sure your use of the Philips device didn’t make you sick).

But if you have physical injuries then your damage could be far higher, especially if they’ve been seriously hurt. For instance, if the PE-PUR foam gave you terminal cancer, your legal recovery will likely be far higher than if you suffered a minor headache for a few weeks.

As for how you might obtain your legal recovery, there are two likely scenarios. First, you take part in a class-action lawsuit. You’re more likely to join this type of lawsuit if you’re only suing due to limited financial injuries.

Second, there’s multi-district litigation or an MDL. This is where you file your own lawsuit, but due to similarities to so many other cases, your case gets consolidated. This merging of cases will only last for pre-trial matters, like discovery. Being part of an MDL is more likely if you’re seeking compensation for physical injuries.

Many affected users have already filed lawsuits against Philips. There’s at least one class-action lawsuit and dozens of individual cases. Philips has already asked for many of these cases to get consolidated into an MDL. The court is currently in the process of deciding this issue.

If you or someone close to you is affected by this recall, or you have additional questions, please call me at (919) 830-5602. If you’re not ready to talk to a lawyer, you can get more information about what’s going on from the FDA’s Safety Communication and Philip’s recall notification.

It sounds like an exotic fruit, or perhaps a cute little pet name, but touching or eating paraquat dichloride (paraquat) can result in nasty consequences. This toxic substance has a significant history, but more recently, has been linked to Parkinson’s disease. As a result, the herbicide has been subject to litigation. In this blog post, we’ll take a look at paraquat and the emerging lawsuits.

What Is Paraquat?

Historically, paraquat has had two main uses. First, and sadly, it’s been an effective way of committing suicide. Ingesting just one sip could result in death. In fact, when South Korea banned the herbicide in 2011, its overall suicide rate fell 10% and its suicide rate by herbicide or fungicide dropped by more than 46%.

The second and more mainstream use of paraquat is as an herbicide, usually to kill weeds. The U.S. Environmental Protection Agency (EPA) has classified paraquat as a Restricted Use Pesticide. This means that the EPA knows the herbicide is so dangerous, only individuals with the appropriate license can use it. Paraquat lawfully used in the United must also have the following modifications:

• Adding a special dye to the liquid form of paraquat to prevent confusing it with a beverage.
• Giving it a strong smell to warn people that they are in its vicinity.
• Placing a vomiting agent in the substance to automatically induce vomiting in cases of accidental ingestion.

Paraquat has been very popular as an herbicide because it works on contact, it works quickly and it sometimes works better than other popular alternatives, like herbicides containing glyphosate (such as Roundup). Paraquat’s use has increased lately given the extensive litigation due to glyphosate’s alleged link to non-Hodgkin’s lymphoma.

But now, litigation involving paraquat is growing because of its apparent link to Parkinson’s disease.

Paraquat’s Possible Link to Parkinson’s Disease

The risk of significant, short-term exposure to paraquat has been known for a long time. It’s the long-term effects of less drastic levels of exposure that have been slowly making their way to the general public. However, these aren’t brand new developments and dozens of countries around the world have already banned its use.

For example, a 2009 study mentioned the possible link between Parkinson’s disease and applying paraquat close to residential homes. A 2011 study found that people who used paraquat or rotenone were 2.5 times more likely to develop Parkinson’s disease. And a 2013 meta-analysis looked at 104 studies concerning the link between Parkinson’s disease and pesticide and solvent exposure. It found that exposure to paraquat or maneb was associated with a two-fold increase in the risk of getting Parkinson’s disease.

These are just a few of the studies finding a link between Parkinson’s disease and paraquat. So it’s no surprise that there have been lawsuits alleging that the herbicide has caused people to contract Parkinson’s disease.

The Status of Paraquat Litigation

The first major case concerning paraquat came in 2017, when the plaintiffs alleged the makers, distributors and sellers of paraquat were responsible for their injuries, including Parkinson’s disease. They relied on multiple legal theories, such as:

• Strict product liability – design defect
• Strict product liability – failure to warn
• Negligence
• Public nuisance
• Breach of implied warranty of merchantability

Since then, dozens of lawsuits in both state and federal courts have been filed against Syngenta, Chevron and other companies involved in the sale, manufacture or distribution of the dangerous substance. Due to the unique nature of the injuries many of these plaintiffs have suffered, these cases likely cannot be litigated with a class-action lawsuit.

To help handle these lawsuits in a more efficient manner, they might get consolidated into multi-district litigation, or MDL. In early April, one of the plaintiffs in a federal paraquat case filed a motion to transfer all of the federal lawsuits into an MDL.

If an MDL is created, it won’t happen immediately. Over the next few weeks and months, the U.S. Judicial Panel on Multidistrict Litigation will have a hearing (or two) to decide if an MDL is warranted and if so, how it should be set up. Then once there’s an MDL, it will often take a few years to complete discovery and conduct bellwether trials.

If there are any notable changes in this litigation, I will provide an update. If you were exposed to paraquat, or have any questions, don’t hesitate to reach out to me on this website’s contact page or give me a call at (919) 830-5602.

Clay: So Chet as a medic you would supervise and train soldiers in the proper use of hearing protection? But you also said the Army beat into your heads the importance of protecting your hearing in whatever you were doing in the field?

Chet: Absolutely. In fact, for a long time, they had the annual hearing exam requirement. And it was like a pre-deployment requirement, you couldn’t deploy unless you had your hearing exam for that year. So the command was interested in tracking, hearing issues, to make sure that you know, not everybody’s going to go deaf. Does that make sense?

Clay: Sure. Absolutely.

Chet: They actually tried to enforce the annual hearing exam requirement. And that’s why it was important. And it was actually a safety checklist that carries protection beyond every range. And in an area where the noises were above 75 decibels where it could impact hearing, earplugs should be available.

Clay: So I think it goes without saying that in your many years of service you were exposed to very loud noises a lot?

Chet: Absolutely. There were times we did a lot of shooting on a range for a day, sometimes you have experienced was this pain from the sharp cracks. Or if you’re shooting in a confined space, it’s even more also to sometimes just the pressure from a blast would impact your ears as well. Or even just helicopters, or some of those helicopters, not necessarily Blackhawks. [Other helicopters] were really, really loud. They could get really, really loud if you’re going to be flying on them for a while. It definitely took a while after the helicopter left before you felt like you can hear normally again. You had that just walked out of a concert sensation. Hearing everything. Then it just took a while after you got where you’re going for your hearing to come back.

Clay: So I think you said you wore the 3M Earplugs, which were made by the 3M company or at least sold by the same company for years?

Chet: Yeah, I’ve had boxes of those 3M Earplugs. And we placed them on the range. And we’ve issued them out at different times. Those were disposable in our view, because we get a big box, we use them for the day, just throw them away. At one point it was kind of funny during my career, they actually issued a little case to put your earplugs in, that you had to have clipped onto your uniform. So that actually occurred at some point during my career, because that’s how big of an issue it was to the command that everybody protect their hearing that they actually had to carry your earplugs around. And that earplug case would have held the 3M Earplugs. At some point, they had to come in if you had your hearing tests, and they would give you a couple of earplugs sized to your ear. But you lose those quickly. They’re small, especially if you’re out training and you get knocked in the head and they come out. That’s why the earplugs like the 3Ms. We always had them they’re readily available. And if you lost a set you just went to your medic or to like to me and I would give you another pair.

Clay: And so the soldiers would lose the 3M Earplugs or they would fall out and just any number of reasons to lose them, but including they would fall out of your ear?

Chet: Sure, yeah, a lot of times during training if they weren’t properly seated in the ear if there’s now that we know there’s a potential defect, which would cause them to come out more often. And if it’s nighttime, forget about looking for him. Or if you’re out in the field, forget looking in the grass, you just go to the medic and say, “Hey, do you have another pair of the 3M earplugs?”

Clay: Have you known fellow soldiers who suffered permanent hearing loss?

Chet: Yeah, there’s quite a few people I know who have suffered hearing loss and actually wear hearing aids today, as a result of their service in the military and exposure to loud noise they now wear hearing aids.

Clay: How about you? How’s your hearing?

Chet: In the silence I have ringing. You know, when it gets really quiet, I hear low ringing or humming in my ears.

Clay: So now that you’ve retired from the army, have you sat around with some of your soldier buddies and heard them complain of hearing damage; you already mentioned that guys with hearing aids? But, have you heard more talk of that? Or is it just been a common complaint for a long time?

Chet: Usually towards the end of the guy’s career is when you hear more complaining about hearing and stuff, and other things. But I still get together with a lot of my friends; just went to retirement ceremony for one of my students when I was an instructor, he retired last week; there’s not so much complaining, but as much as just joking about how we broke this and how he broke that.

Clay: So, how’s retired life?

Chet: Retired life is good. I do real estate here in the coastal area in North Carolina, from Wilmington to Southport and that whole area. It’s nice. Working on getting home inspector certified. I just keep branching out and doing different things. Just keeping occupied.

Clay: I bet you’re staying busy. Well, Chet, I appreciate your service to the country. And I appreciate your talking to me today.

Chet: Anything I do to help my fellow service members. If you don’t mind I also work with the Honor and Valor Foundation. It’s a small nonprofit out of Waccamaw. And my family and I host Wounded Warrior families out to the lake for the day. Just give them a break primarily from Fort Bragg. And they also do fishing and hunting and other trips.

Clay: Oh, that’s tremendous.

Chet: And they have a Facebook page. It’s Honor & Valor Foundation. It’s a small group. So just put that out there.

Clay: Absolutely. I hope people will check it out.

Chet: And you’re invited to bring your family any time.

Clay: I would love that. Chet thank you so much.

Note: This conversation was lightly edited and condensed for clarity. You can also listen to the interview on my podcast.

You likely know there is massive litigation emerging around 3M Company’s Combat Arms, dual-sided earplugs. These 3M Earplugs were sold to the U.S. government and distributed to members of the military in a huge contract over a period of 12 or 13 years. And many lawsuits have been filed recently that allege that these 3M Earplugs were defective, and they left thousands and thousands of soldiers with permanent hearing loss or tinnitus. It’s called noise-induced hearing damage. So my friend Chet Sechrest will talk about the unique ways that soldiers are exposed to loud noises. And it’s not always what you think; it’s not simply shooting a rifle or getting trained and the use of weapons or rifles, but also it could be serving as a mechanic for heavy engines, or being exposed to loud tanks or other industrial equipment. And as Chet points out, it could also simply be taking rides on very loud helicopters over and over again without the proper hearing protection. But that’s enough of an introduction. Let’s get to my Q&A with Chet Sechrest.

Clay: Chet was an Army Ranger and a member of Special Forces. He pulled three tours of duty in Iraq. So Chet, how long did you serve in the military?

Chet: I served a total of 27 years and nine months in the military.

Clay: So almost 28 years. When did you first enlist?

Chet: I started November 1st in ’83 came in the army as an 11 Bravo, an infantry guy, and I was assigned to the first Ranger battalion and I’m kind of thankful because it provided a base of knowledge that has benefited me throughout my career.

Clay: What was your first job back in the military first thing in 1983-84?

Chet: My first job was I was just a rifleman, in our Ranger company, Bravo Company, first 75th Ranger battalion. And our job was to train to defeat the enemy, accomplish the mission, whatever was assigned to us. Being in the Ranger battalion was a lot different than being in a regular infantry battalion. Because at the time, there were only two Ranger battalions. Currently, there’s a regiment, there are three Ranger battalions. But being there, we had so much more opportunity to actually really train. So we actually did a lot of had a lot of training opportunities, fired a lot of rounds to help me become the best soldier I can be. And I appreciate that.

Clay: So you had a ton of experience through that period, shooting rifles and shooting weapons?

Chet: Oh, absolutely. And then figure out the rest of my career and Special Forces.

Clay: When did you start training to be an Army Ranger?

Chet: I was assigned to the first Ranger battalion after I finished my AIT. So that was our early ’84. And I went to the rep range or indoctrination program. It’s changed since then, even after I completed that I went to my Ranger company and I was in Bravo Company, third platoon. And I stayed there for almost a year. Then they sent me to Ranger School. And I came back and stayed there for a little while and moved on to other things in the military.

Clay: Tell me about the Army Rangers.

Chet: It’s an all-volunteer organization. Everybody that is assigned there wants to be there. So not only did they volunteer to join the army, volunteered to be infantry combat arms, volunteer to go to airborne school. But they also volunteered to try out for the Ranger Regiment, and go through the selection process, and be selected. So it was a pleasure to work with everybody else that wanted to be there as much as I wanted to be there. Unlike regular army units where, “Okay, we appreciate your volunteering for the army, hey, that’s great. We’re gonna send you over here with a lot of other people that really don’t want to be here either.” So, but what’s different about the Rangers is the mutual motivation that you received from your brothers and sisters, as part of the regiment to complete the mission, and just improve yourself as a soldier.

Clay: It matters a lot when you’re surrounded by like-minded people.

Chet: It makes a night and day difference, especially if you work with some other units where the thought process is . . . I’ll say is not the same. But the motivation is not the same. You can see it. It really helps you as an individual excel more when you know the person to your left or right is doing the same thing with you, encouraging you, motivating you. You’re part of the team that lasts forever because even though I’m retired now, a lot of my friends I’ve known from the early ’80s. We still talk; we still get together. You know, you have a brotherhood for life.

Clay: Oh, man, that’s great. So you were also a member of the Special Forces?

Chet: Oh, yeah, I wanted to further my career, look at doing some other things. And in ’86, I was up for re-enlistment and I tried out for the 18 Delta Special Forces medical Sergeant program, went through the program I graduated, I was assigned first to 10th Special Forces Group, but before Fort Devens now they’re at Fort Carson. And I was at Fort Devens for about five years. And then I went to I was in third better. And then I went to the first battalion and Panzer in Germany for a couple years. And then did a road instructor tour at Fort Bragg, the Special Warfare Center in school. And then from there, I went to third group, a second battalion, spent a tour there got to go a lot of places I hadn’t been before, and then went from there to civil affairs when it was a special forces assignment only. After that, they were standing up a new unit of operational advisors, asymmetric warfare group. By command, SAR major suggests that it would be a good opportunity for me. So I tried out and got selected and worked in as an operational advisor for the asymmetric warfare group. And then came back to civil affairs when they were forming a new MLS. They were pushing all the Special Forces, serious guys, out, and they asked if I would come back and help build the MLS and had a lot of job satisfaction. So affairs when I was there in Special Forces. So I agreed and I came back to Fort Bragg and retired out of the civil affairs in 2011.

Clay: You’ve covered a lot of ground. So you told me that you’ve had three tours in Iraq?

Chet: Yeah, I mean, I deployed any time my country asked me to deploy. So they were all different durations, primarily where I’ve been to Baghdad, some other places. That was, you see a lot that you look back on and can learn in many different ways. It’s interesting when you look back to collect the lessons learned how much you can learn, if you pay attention to a lot of things that we usually don’t like, our discussion here on hearing this a major issue and it’s something that is pounded on you from basic training all the way through the end of your career is hearing protection. And even deployed, they want to make sure you’ve got hearing protection. And when you look back on some of this stuff, I guess you can see sometimes where the ball was dropped in different places, and proper products, things like that.

Clay: You were telling me that you collected hostile fire pay. How do you qualify for hostile fire pay?

Chet: Well, a lot of service members serve in countries that, you know, we’re providing training or aid to where the climate is considered hostile, whether it’s a criminal threat or a threat from potential combat operations, and another area bleeding over into where you’re at. There’s just any place where, you know, you take your weapons, you’ve got ammunition, you’re prepared to defend yourself. But they labeled it as hostile fire pay, not necessarily combat day.

Clay: So let’s talk about your work as a medic. Obviously, you’ve treated injured soldiers. Tell me about that. Talk to me about your exposure to injured soldiers either on the battlefield or in some other area?

Chet: Sure, I run the gamut from A to Z. And I’m thankful that I was trained as a special forces medic, which is a higher level of training, helps me better treat my patients having that level of training. And believe it or not, I still keep my paramedic credentials current. I just restarted them again in March. But yeah, I’ve seen trauma through illness, infants through old people and the full range in many different environments, from combat environments, refugee environments, humanitarian disaster and environments and just other things where we’ve had to provide aid and treatment to not just our service members, but allied service members and the local population.

Clay: You mentioned that in the Army that you were drilled and trained and reminded about the need for hearing protection, did you yourself train other soldiers in proper hearing protection?

Chet: It was one of my duties first as the team medic, and then I was also a battalion medic twice. And, yeah, we do a risk management, risk assessments matrix before we do any training and earplugs are right on there, you don’t go out to a shooting range or demolition range without hearing protection. You can’t even go up with a line and shoot unless you have the hearing protection. So it’s a requirement, you know, for me as the medic, because I’m the medical person responsible on-site to ensure everybody has the proper hearing protection in. So at different times, some people have the pelters some people have other sod-type hearing devices. Other times, it’s the different plugs that you would put in your ears. And depending on what we got, like the 3M products, we would read the instructions and use them accordingly. And assume based on proper application of the instructions, the hearing protection would provide the protection required when conducting the training did not result in any hearing loss.

Clay: So I think it’s pretty obvious that you have seen soldiers whose hearing was damaged from a firefight or a battlefield or some other trauma?

Chet: Oh, it’s a little of everything, because we just don’t shoot our guns in combat operations, but even more in training operations. So a lot of times, even in the training environment, you know, when you’re actively involved in shooting or collecting demolition operations, or even flying in helicopters because some of the helicopters get really, really loud for flying for a long flight and you don’t have your protection and you’re going to feel like you walked out of a concert hall when you step out of the helicopter. But I definitely have seen guys come off the line, you know, complaining, you know, their ears hurt because the plugs came out or weren’t placed properly after shooting a couple of rounds. And it’s definitely happened more than once.

Clay: That’s interesting. Of course, helicopters are no doubt extremely loud environments, or can you think of some other loud environments and you’ve mentioned several, so you may not but can you think of some other loud environments where it just was loud, not just rifle shots, but we often don’t think of helicopters even though that’s an incredibly loud machine.

Chet: You look at all the service members that work on the flight line. So they’re exposed to helicopters, aircraft jet noises. You look at people that work on heavy machinery and enclosed places, that the noise is just really loud that they’re supposed to be wearing earplugs or earmuffs to protect their hearing. It’s a requirement that so many different places beyond shooting bullets and blowing things up that can damage your hearing, like truck drivers. All your engine mechanic says we have huge diesel generators that guys go out and repair. So you’re looking at mechanics, it’s something we take for granted. But mechanics are also exposed to loud noise at decibels above 85, which could cause some type of hearing damage. So there are so many different areas within the military system, Air Force, Army, Navy, Marine, where servicemembers can be impacted by adverse sounds.

Clay: Great points. And you’ve already touched on the training exercises. But obviously, that might be where you’re exposed as a soldier to the loudest noises because the training takes place a lot more than your exposure to combat?

Chet: Yes, that’s correct. Some units that train more are exposed to a lot more. A lot of special operation units have higher budgets and shoot a lot more rounds or conduct demolitions and other training to a higher frequency. So their exposure rates are going to be a lot higher than other service members that might say only be required to qualify once a year, which means they get like nine rounds to zero their weapon, and then they get 40 rounds to try to qualify, then that’s all they shoot for the year. So it varies.

In Part 2 we’ll go deeper into the ways soldiers and service members are often exposed to dangerously high noise levels, and how Chet used 3M Earplugs and later developed hearing loss.

Note: This conversation was lightly edited and condensed for clarity.

Firefighters have a host of tools available to them to fight fires. Some of these are simple, like high-pressure water. Others are more state-of-the-art, like forward-looking infrared handheld cameras and aerial drones. One of the special tools in a firefighter’s arsenal is aqueous film-forming foam, or AFFF. This “fire foam” has served as a highly effective fire suppressant for about half a century. Unfortunately, exposure to this substance has been linked to serious health problems, including cancer.

Let’s take a closer look at AFFF, its relationship to cancer and what it means for those who might have been exposed.

What Is AFFF?

AFFF is a special liquid that firefighters use to fight fires caused by flammable liquids, like gasoline and jet fuel. AFFF works by creating a foam layer over the flammable liquid, which makes it much harder for that liquid to burn.

The primary components in AFFF that gives it this fire suppression quality are perfluorooctanesulfonic acid (PFOS) and perfluorooctane acid (PFOA). Both of these chemicals belong to the family of per- and polyfluoroalkyl substances (PFAS), a group of compounds that are widely used in consumer products, such as stain repellant coatings and nonstick surfaces.

Given how effective AFFF is at putting out these types of fires, AFFF became widely used in many settings. These locations include airports, military bases and places where large amounts of flammable liquid might be kept. This includes petroleum refineries and storage facilities.

This meant that many firefighters, first responders and military personnel were exposed to large amounts of PFOA and PFOS through the on-the-job use of AFFF. Civilians may have also been exposed when the PFOS and PFOA from the AFFF contaminated the groundwater surrounding military bases, refineries and airports.

What helps make PFOA and PFOS so dangerous is that once it’s released into nature, it will persist for a very, very long time.

How Is AFFF Dangerous to People?

PFOA and PFOS can enter the human body in many ways. It can be orally ingested, absorbed through the skin or inhaled from the air. Then once in the body, it doesn’t pass through or get metabolized. Instead, it sits around and accumulates with each subsequent exposure.

When enough of either chemical builds up in the human body, it may cause a variety of health problems, including:

• High cholesterol
• Ulcerative colitis
• Thyroid disease
• Testicular cancer
• Kidney cancer
• Ovarian cancer
• Prostate cancer
• Bladder cancer
• Pregnancy-induced hypertension

The idea that PFOS or PFOA might cause cancer is especially troubling. But there is not yet a conclusive link between cancer and PFOA and PFOS. Most studies so far either suggest an increased risk of cancer or show an increased risk that is so small, it may be statistically insignificant. The International Agency for Research on Cancer has concluded only that PFOA is “possibly carcinogenic to humans.”

It’s also not fully understood how PFOA or PFOS causes cancer in humans. At least one study found evidence that exposure to these chemicals might lead to cancer because the chemicals might:

• Suppress the immune system
• Increase the proportion of free radicals in the body
• Lead to rapid tissue growth
• Make changes to DNA
• Affect how cells communicate with each other

Even though the link between PFOS and PFOA with cancer is not known with 100% certainty, many manufacturers of these chemicals have stopped production.

Has Anyone Sued After Being Exposed to AFFF?

Yes. And these lawsuits have potential. That’s because there have already been a number of large personal injury legal settlements relating to PFAS or PFOS exposure.

For example, in 2017, DuPont and Chemours agreed to pay $671 million to settle thousands of cases where plaintiffs alleged that they became sick when PFOA allegedly leaked into local water supplies.

It’s this case that created the “C8 Science Panel,” which is one of the leading studies examining the effects PFAS may have in humans. The C8 Science Panel concluded that there was “a probable link between exposure to [PFOA] and testicular cancer and kidney cancer.”

In 2018, 3M settled a lawsuit for $850 million brought by the state of Minnesota. In this case, the state of Minnesota alleged that PFAS created by 3M had contaminated drinking water in the Twin Cities Metropolitan area.

Following in Minnesota’s footsteps, the state of Michigan has recently brought several suits for PFAS contamination due to the use of AFFF.

When it comes to AFFF lawsuits, most of the personal injury cases are in the multi-district litigation (MDL), In Re: Aqueous Film-Forming Foams Product Liability Litigation, MDL 2873. This MDL consists of about 500 cases in the U.S. District Court for the District of South Carolina.

Many of the plaintiffs are firefighters and allege that their personal injuries, such as cancer, are the direct result of exposure to PFOA, PFOS and/or precursors to PFOA and PFOS. A few of the major causes of action include:

• Negligence
• Products liability – defective design
• Products liability – failure to warn
• Misrepresentation and fraud

Some cases have been brought individually and others as a proposed class action. There are also dozens of defendants, although 3M is one of the most commonly sued company.

What’s Next for AFFF Litigation?

The AFFF MDL is still in the early stages of litigation, with some defendants still filing an answer while other litigants have begun discovery. And thanks to the coronavirus pandemic, the litigation will move even more slowly.

Even if this MDL reaches a global settlement, it will probably take a few years to get to that point, with at least a few bellwether trials being held before then.

In the meantime, if you want to know if PFOA, PFOS or other PFAS-related chemicals have been found in a water supply near you, the Environmental Working Group has an interactive map that shows the location of water tests that have shown various levels of PFAS contamination.

Safe and Unsafe Activities and Sports Clay: What are some sports that you would discourage [after hip replacement surgery]? I know there is a huge range of results and people who are dealing with certain physical issues. But are there any sports you’ve seen as a physical therapist that you say “Do not do this after hip replacement surgery?”

Amy: Oh absolutely and just to clarify my youngest total hip replacement patient was eleven. This child had a very aggressive cancerous tumor that invaded her hip, and so she had what is called a Ewing sarcoma. And so, they ended up having to take the hip give her a new hip, and her big goal was she wanted to be able to drive a car. I mean that is really important. So, she was eleven when the process started and she did not drive a car. So, and I have treated, I actually had a ninety five year old who had, so the spectrum of age is even greater than thirty five to eighty two.

Clay: Sure.

Amy: But there are absolutely some things that are just absolute no’s. And most of them are things that make sense, like contact sports. So things like football, rugby, soccer. There was a great little study that came out, I think it was in 2011. Anyway, it basically looked at all of these different sports and it reviewed all of the literature and it was looking at what are the things that we know are absolute no-no’s.

Amy: And we know this because the literature shows us that these people had high rates of failure in their hips. Oh and by the way, this recommendation basically it was a systematic review and when they made these recommendations, they qualify them into three categories. So, the first category was not recommended after a total hip and so the contact sports hockey, football, soccer, rugby, any long distance running. And that just make sense.

Amy: A lot of people take a toll on their hips by doing a lot of running, and that does not mean that running causes hip arthritic changes that create a total hip that necessitated total hip replacements. Do not misunderstand that, but there is a wear and tear process that goes on with people that are running hundreds of miles a month. So, singles tennis, it gets down to just the numbers of steps that go through that new part; racquetball, squash, snowboarding, and that is because of the risk of dislocation for snowboarding.

Amy: High impact aerobics, fast pitch baseball and softball, because of sliding and contact. The kicking that is involved in many of the martial arts is not recommended. Water skiing and handball. So those are the things that under the category of not recommended. And I will tell people flat-out “Listen, you had a bad hip, you have gone through this process to get a good hip. Be nice to it, protect it.” I understand that you are putting yourself at great risk of early failure or other complications, like dislocation and things like that that necessitate revision. So that is in the not recommended category, and then they created this other category that they call “recommended with experience.” And this actually, again, makes sense. Cross-country skiing and downhill skiing, that is not the time to start learning to ski after you have had a new joint. Now, if you have been a lifelong skier and you have the experience, by all means do it. Make a choices. Mogul fields are probably not a great idea.

Clay: Right.

Amy: If you can cross country ski downhill ski safely. Doubles tennis again, not the time to take up tennis if you have never played in your whole life and you finally have a new hip. Now is not the time to take that up. But if you have been an avid tennis player, so I would absolutely and I have a lot of patients that have gone back and my brother included in that category who has gone back onto the tennis court with a joint replacement.

Amy: Ice skating not hockey. But ice skating is okay if you have experience doing that, things like rollerblading same thing kind of inline skating and Pilates. So those are things that we recommend that are qualified as recommended with experience. I will also add now, this study came out, this recommendation, systematic review was published in 2011. Surfing goes into that category. So if you are a surfer, absolutely if you have experience on a board, you are absolutely prepared to get back on that board after a hip replacement. Not the time to start introducing that into your sport life.

Clay: See it makes sense that if you have got experience you can keep yourself from potential injury.

Amy: Precisely, and then the list of things that are highly recommended because again, you know when you are in the rehab world what you realize that people go through the surgeries for they do it purposefully and it is usually to return to some type of function or activity, that they are arthritic or their painful joint would not let them take part in, so golfing, swimming, doubles tennis, stair-climbing, so like the elliptical walking, speed walking hiking, stationary biking, bowling, these are all things that are highly recommended. We want you to go back to these things because they are going to be healthy for you. They are going to sustain the strength in the mobility that you have recovered at that new joint. But they are also going to be safe for it. They are not going to put your new joint at risk.

Clay: I see. Well that gets to the point that staying active is absolutely essential. That you do not want to pick up downhill skiing necessarily, but you absolutely after hip surgery want to be active in something. And so, it is good to get going.

Amy: I am a physical therapist. I think we all should move. We should move, that is what our bodies are designed to do. They are not designed to sit and be sedentary. They are designed to move us through space.

What It Feels Like When Artificial Hips Fail Clay: Well, that is right. So, I have known you for quite a while and I know you have had patients that have had hip replacement surgeries fail. Can you tell me what symptoms you notice when a patient might come in and say “I had surgery a year and a half ago or two and a half years ago and something feels different. Something sounds different”? Talk about artificial hip failure.

Amy: Sure. Absolutely, well probably, so there are different reasons that hips can fail. But the number one thing that people complain of is pain that is out of context to what they should be experiencing at that point during the rehab process or during the recovery process. So obviously, you have had a joint replacement. We expect it to be swollen. We expect it to hurt. We expect it to be sluggish. It is not going to move well.

Amy: So, there is an expectation of some pain following the surgery but there is a point where that pain should be resolving. And it should be integrating and it usually lives as the tissue is healing. So the bony tissue is healing, where the new hip implant, the new appliance, has been mated with the bony surfaces, so that healing takes place and then the soft tissue around that joint is healing and you are becoming more mobile. So, that pain should frankly just gradually decrease until it is gone.

Amy: When someone’s hip has failed, that does not happen. The other thing that is really interesting, or I think that is telling, is that typically these patients have pain even when they are not moving, and a significant amount of pain. Now again, initially immediately after the surgery, it is normal to have night pain that makes it tough to be comfortable. But after a couple of weeks after a hip replacement, you should be able to sleep for periods of time. Many times people have so much pain that they cannot sleep. Like, it keeps them awake.

Amy: Nocturnal pain is always something that worries me because at the end of the day, we are kind of hardwired to get rest but pain prohibits that. To me, that is, I am always going to look very carefully at this patient because that should be something that initially pain management should be taken care of, so medications, icing, making sure that your activity levels are appropriate for that stage of your recovery.

Amy: If all of those things are in line, and this person is still telling me, “I slept an hour.” I do not like that. Immediately that is a red flag to me that I need to take a really close look at what is going on with this patient. So, pain is out of context to what the pain level should be at that point. Pain that is occurring without moving. So, it is not mechanically driven pain.

Amy: Any type of mechanical clicking, grinding, and these are things that people will sometimes report, you know, it clicks, it grinds, it snaps. Some people have reported they can actually feel it move. So those are things that tell me that something organically is not healthy in that hip, in that newly replaced hip.

Clay: Let me follow up on that. Is it your medical view that a successful hip replacement surgery should end with no pain at all after the rehab is over, and after the recovery is over that there should be little to no pain?

Amy: Absolutely, and when that does not happen, if let us say, and I have seen this before, I have had people show up a year after hip replacement and they say, “You know my hip still bothers me.” And upon assessment, there might be a really good reason. You are profoundly weak, you did not build the strength around this joint to give it stability. So your pain is actually not in the actual hip itself, it is in the pelvis because of the forces that are going through hip joint that and the musculature of the strength is not adequate to control those forces.

Amy: So, sometimes there is a reason that someone has got pain a year later. But in the absence of something like that going on, no, you should not have pain. That is the whole reason that you have this new hip put in. So if you are continuing to have pain, I tell my joint replacement patients that it takes a year to recover from these big surgeries. But that is a pretty reasonable expectation from any orthopedic surgery, be it a rotator cuff repair, an ACL reconstruction, certainly a knee or a hip replacement, or a shoulder replacement. It is not uncommon to have some discomforts and stiffness and irritability up to a year, but after that, no, it should not happen. It should not be painful. So there is a very big difference between, “like I am still aware of it” versus “this thing I can not put weight through it. It hurts so much. I can not walk. I can not sleep. I can not ascend or descend stairs. I can not lift my leg to put it into a car.” These are things that I have seen in failed hips.

Clay: Yes.

Amy: Or even just give way where you weight bear on the leg, on that failed hip, and they will fall. That is a result of a failure.

Part 3 next week.

My friend Amy Dougherty is a physical therapist in North Carolina and operates Outer Banks Physical Therapy. She is a graduate of the University of North Carolina at Chapel Hill (where I also attended college and law school). She is an outstanding physical therapist and is beloved by her patients on the Outer Banks. Amy answers many of your questions about hip replacement surgery, metal-on-metal artificial hips, and the problems that have arisen from these hip products.

Clay: I want to focus on hip replacement surgery and I know you work with patients who are dealing with that kind of surgery every week. So let me start by asking what are a few reasons a person might need a hip replacement surgery?

Amy: You know, the most common reason is arthritic changes in the hip. So basically arthritis, that is the most common reason. Other reasons can include things like trauma. Some people have congenital mal-alignments where, it is basically called dysplasia where through the process of their development in utero and then following their bony surfaces of the femur, that is the long thigh bone and the acetabulum which is in the pelvis. They do not form correctly, so they might have ill-formed femoral heads. They might have ill-formed or ill-shaped acetabulum. So, the ball and the socket are not really designed well to weight bear. So, a lot of folks that, especially in a young population, that have early onset hip replacements. It is more likely the result of some type of congenital dysplasia. It could be a trauma. So, but arthritic changes is the number one reason and I have total hip replacement patients in my clinic every day. Very popular surgery, yes.

Clay: Very common especially once you get into the middle age and even older.

Amy: Absolutely. It is very common.

Clay: Well, how soon would physical therapy start after a total hip replacement?

Amy: Typically, the PT shows up within 24 hours of your surgery when you are in the hospital. So, what you can expect is basically after you come out of recovery, the physician or the nurse will come and talk with you and tell you when you will start your first PT. Sometimes, it is within 12 hours. It really is all dependent on the amount of time that is projected to be your discharge. Time or day, and that is something that actually frankly is changing dramatically over the course of the last 18 to 24 months. So total hip replacement surgeries are moving from being a two-day event in the hospital, which is what we used to see very commonly, to most likely being a predominantly outpatient surgery within the next five years.

Clay: Outpatient surgery–is that right?

Amy: That is right, and there is some pretty reasonable science to support why transitioning to outpatient is a great idea and is basically because of infection rates and things like that. And so, they are looking, I mean they being the world of orthopedic surgeons and the world of joint replacement specialist. They are looking to transitioning. It is already happening in some places, not on the Outer Banks, but it is happening in some larger cities where they are doing small groups of folks who are good candidates, so they are essentially very healthy people who frankly do not need to be hospitalized. They can go to an Ambulatory Care Center and safely receive a total hip replacement and go home that same day.

Clay: Could it also be maybe that recovering at home is a happier place for people?

Amy: No question. All of us would rather be home than at the hospital, and so the biggest issues that come into play are first and foremost safety, so you have to be safe to go home. Once you are in the recovery room you have to be medically stable. Pain needs to be adequately manage and that is something within the Joint Replacement Community, that is really becoming more and more well-researched and well-managed is how to keep people comfortable while they are recovering from this very big surgery. That is a big event, so managing the pain, making sure that they are safe to ambulate because you can walk on that new hip pretty much as soon as their block wears off as soon as anesthesia allows.

Clay: So whenever you come home, whether it is the same day or a couple days later and the patient is able to get to your office, how soon– so walk us through what PT might look like in the first visit to your office and then in the weeks that follow.

Amy: Typically, I will sometimes see people that are coming straight from the O.R. Basically, they may spend a day and a night in the hospital they come home and they are usually starting with me within a day or two of being home. So sometimes I will see them immediately post-op, some surgeons want those patients to be seen at home anywhere from two to four weeks. Generally based on surgeon preference. Sometimes it has to do with family logistics in that patient might live alone. They can not drive those first couple of weeks. So there are some issues that play into the decision making on whether they start outpatient, which is my clinic, or whether there is seen at home for home-based physical therapy. But if you come to my clinic the first thing that is going to happen is you are going to undergo an assessment, and that is basically where after doing a bunch of intake paperwork, where we make sure that you are actually medically stable, we start talking about your function. We start talking about “Hey, how are you doing?” What is your pain like?” We use pain scales and I expect because it has become such a big movement in orthopedics to better manage people’s pain so that they move.

Because we know that one of the things that is most helpful after joint replacement surgery, be at a hip or knee, is the ability to move. If you have got so much pain, you can not move all of a sudden, your risk factors go up substantially in regards to blood clot or onset of pneumonia. So, we know that moving is important. We will talk about your pain. Make sure that your pain is being adequately managed and then we will start looking at that lower extremity. I will have you walk for me. I will look at edema, will look at bruising, depending on whether your surgical dressings are off or not. I will look at the surgery site. Make sure it all looks good clean and dry, occlusive bandages or it should be in place at that point and then, just basically initiate the onset of PT which is assessing, and then addressing strength loss this most in deficits. We spend a lot of time talking about precautions, because there are some precautions after hip replacements depending on the approach that the surgeon has taken. So, there are some options available in regards to whether you have what is called an anterior approach or posterolateral approach. And so, there are some precautions and we make sure that the patient is well versed in that, and understands why the precautions are important. And then, we start to exercise, we start to move.

Clay: I know it is different for different patients based on how fit they might be, how young they might be. But how long does that therapy last working with you? And then when do you say “Okay, you are free to go but take these exercises home with you and make sure you do them”?

Amy: We start immediately. We start the first day they are there. Nobody leaves my clinic without having things to work on at home.

Clay: And so how long do those exercises last with you versus when you say “Okay you are released from me and you can do these at home without me”?

Amy: Frankly, it depends, and what I have come to realize through a lot of years of clinical practice is the fitness level that someone takes into the operating room. Absolutely dramatically affects how long they are with me. So, if you are pretty active, pretty strong, pretty fit, you just have a bad hip, and you can be all those things by the way, and still have a bad hip. So if you are pretty mobile and you have maintained pretty decent strength pre-op, you are not going to spend much time with me. A couple weeks, maybe. If you are really debilitated and we see this very commonly in people who have really put off having the joint replacement, maybe waited a lot longer than they should have.

Sometimes, there is a concomitant problems going on at the knee, at the foot and ankle, on the contralateral side, will see some problems that affect their ability to ambulate. And at the end of the day, with a hip replacement, our goal is generally normalize gait. I mean, that is what we are looking for and everything that normalized gait entails and so that strength, mobility, balance, neuromuscular control of the extremity. So at the end of the day, that is really what we are looking for is normal gait.

That is what frankly people that are having their hips replaced, they will tell you “I can not walk. I can not ascend or descend the stairs.” I live at the beach, you know people’s inability to get onto the beach is a huge issue. So because you take gait, and now you put it on an unstable surface like sand and the demands are exceptionally greater to be able to walk the beach than are to walk on the sand. So that is something in that first visit that we talk about “What are your goals?” I will specifically ask the patient when I am interviewing them, when I am evaluating them “What are your goals?” [and] “What is it that you have this hip replacement for a reason?” [and] “It is an optional surgery. Your life did not depend on you getting a hip replacement. So, what are your goals?”, “What did you decide, you have decided to make this commitment of time, money, risk, you have done those things to do something. Is it to be able to get through the night without pain?” For some people, that is their ultimate goal. Most people, it is mobility. I want to be able to get onto the beach, you know, some people I work in a beach community. I have patients that their goal is: I need to get back on my surfboard.

Clay: Right.

Amy: If it is somebody who basically just wants to be able to grocery shop and, be able to get their groceries in and out of their car independently and walk with a normal gait, unless they are profoundly weak when we start, it is not going to be too long. So, I know that is a ridiculously vague answer.

Clay: No, everybody’s different.

Amy: But fundamentally, everybody’s different with what they bring into the operating room and everybody’s different with their expectations following. So, the way I rehab a 35 year old, and the expectations and the demands that 35 year old is going to place on that new hip is going to be profoundly different than my 82 year old.

In Part 2, Amy and I discuss recovering from hip replacement surgery, returning to activity and even sports after hip surgery, and the importance of getting active and staying active.