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

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

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

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

1. Background

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

2. Interaction with Attorney Clay Hodges

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

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

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

3. Outcome and assessment

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

[Former Client]
November 16, 2025

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

The 3M Settlement

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

Under the settlement’s terms, the money would be paid out over 13 years and could amount to more than $12 billion if additional public water systems detect PFAS in their water.

Over the course of less than two months, the PFAS litigation has resulted in more than $11 billion in tentative settlements. Yet this is probably just the start of what’s to come.

The Potential Breadth of PFAS Litigation

PFAS are sometimes called “forever chemicals” because it’s difficult for PFAS to break down in the human body and in nature. PFAS easily dissolves in water, so PFAS spreads around the world through rain, rivers, and ocean currents. Some studies have found possible links between PFAS and cancer.

Then there’s the fact that PFAS was widely used in the consumer and commercial contexts. For example, it was used to make non-stick cookware, stain-resistant carpets, cardboard food packaging, cosmetics, and firefighting foams.

As a result, PFAS can be found almost everywhere. The Environmental Working Group reports that more than 200 million people in the United States could have PFAS in their drinking water. As if that’s not bad enough, a study found that 97% of Americans tested had PFAS in their blood.

So we have two major AFFF/PFAS settlements amounting to more than $11 billion. But those settlements largely concern public water suppliers, not individuals. Therefore, it doesn’t take much of an imagination to see how much more money and litigation are probably still forthcoming. It wouldn’t be surprising if PFAS litigation verdicts and settlements rival those from the asbestos and tobacco civil suits.

Individual PFAS Lawsuits

There are a lot of PFAS lawsuits involving individual plaintiffs, but many of them haven’t been resolved. The AFFF MDL also has a lot of cases featuring individuals as plaintiffs.

In May 2023, the judge in the AFFF MDL issued Case Management Order Number 26, which began the process of litigating many of the cases involving personal injuries. This process consists of two steps.

In step one, the court and parties will identify a group of cases involving personal injury plaintiffs where additional discovery will take place.

Step two requires the court and parties to examine the list of cases from step one, then further narrow down this list to find cases that will undergo even more discovery and prepare for bellwether trials. According to the case management order, the parties have until July 28, 2023 to identify cases for step one.

While this timeline can easily change over the next few months, it reveals that resolving PFAS lawsuits involving individual plaintiffs in the AFFF MDL will take a bit more time.

It should be noted that not all PFAS cases involving personal injuries are part of the AFFF MDL. For instance, a 2020 case in Ohio federal court resulted in a $40 million verdict for the plaintiff who alleged PFAS caused his cancer. The verdict was upheld on appeal, although now the defendant is appealing the case to the U.S. Supreme Court.

This Ohio case was one of more than 3,500 cases that were a part of the In Re: E. I. du Pont de Nemours and Company C-8 Personal Injury Litigation MDL No. 2433. (C-8 MDL). These lawsuits stemmed from the alleged discharge of a chemical called C-8 by DuPont in West Virginia. C-8 is also known as perfluorooctoanoic acid (PFOA), which is part of the same family of chemicals as PFAS.

Many of the cases in the C-8 MDL settled, likely with favorable terms for the plaintiffs. This is because the settlements came after two bellwether trials and one post-bellwether trial all went against DuPont. However, not all C-8 MDL cases were part of that settlement.

The C-8 MDL results don’t necessarily predict what will happen in the AFFF MDL or any other PFAS-related lawsuits. But it shows what’s possible. It also hints at how many more PFAS-related lawsuits are likely for the foreseeable future.

If you have any questions about the AFFF MDL or PFAS exposure in general, please give me a call at (919) 830-5602. I’ll do my best to answer your questions.

What’s Wrong With the Foam?

These machines use polyester-based polyurethane (PE-PUR) foam that can break down into little bits and enter a user’s airway. The foam can also break down by off-gassing harmful chemicals that the user inhales. These can potentially cause health problems for users, such as:

• Cancer
• Dizziness/headaches
• Asthma
• Nausea
• Vomiting
• Cough
• Sinus infections
• Organ damage
• Irritation to the respiratory tract, skin and/or eyes

As you might expect, a lot of people who use these CPAP machines have filed lawsuits. There are so many cases that the courts have set up multi-district litigation, or MDL to handle many of them.

What’s Multi-District Litigation?

An MDL is a consolidation of many related lawsuits so the court can more efficiently handle the cases and encourage the parties to settle. MDL usually takes place in federal court, although a state may have its own version of MDL litigation where cases from various counties are consolidated.

MDLs are not the same as class-action lawsuits, though. Class-action litigation involves multiple plaintiffs in a single case. In contrast, an MDL consists of many individual cases that get their pre-trial matters (like discovery) handled by a single court.

MDLs are also sometimes more likely than class action lawsuits to settle, especially after several bellwether cases go to trial.

There are a variety of logistical and legal reasons why cases might end up in a class action lawsuit instead of an MDL or vice versa. The important thing to know concerning the Philips CPAP, ventilator and BiPAP recall litigation is that many (if not most) of the cases have been consolidated into an MDL.

The Philips CPAP, BiPAP and Ventilator MDL

The bulk of the CPAP, BiPAP and ventilator litigation against Philips is part of “MDL 3014 In Re: Philips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation” (MDL 3014). The Honorable Joy Flowers Conti from the U.S. District Court for the Western District of Pennsylvania is the presiding judge in this case.

The MDL is still in the very early stages, with plaintiffs still joining MDL 3014 and filing their complaints. The cases will progress with parties exchanging information through discovery and the court making decisions about discovery disputes.

Eventually, the court will schedule a few bellwether cases for trial. After the bellwether trials, the parties will see if a global settlement is possible. Depending on how these bellwether cases go, it could give the plaintiffs or defendants a major advantage during settlement talks.

If a global settlement isn’t possible, many of the cases could get sent back to their respective federal district courts where they were originally brought. The litigants can proceed with their lawsuits and settle or go to trial.

How Can I Find Out If Something Important Happens in MDL 3014?

There are three ways to learn about recent developments. First, you can use an online search engine such as Google to look for any news stories, blog posts or articles about the case.

This is the easiest and quickest approach, but the problem is that unless there’s a big development in the MDL, such as a global settlement, you’re not likely to find much.

Second, you can go to the MDL 3014 court website, which is free and readily available to anyone with an Internet connection. Here, you’ll find court orders from the case. A court order usually reflects something “official” the court does, such as transferring a case, deciding a motion or scheduling a bellwether trial.

The drawback of going to the MDL 3014 website is that it only contains a small fraction of what’s going on in the case. This means it’s sometimes hard to understand the meaning or importance of a particular order.

For example, let’s say you see an order that indicates a judge has granted a plaintiff’s motion for sanctions against the defendant for not providing the requested discovery. But you don’t see each side’s legal briefs or memos arguing their legal positions. You also won’t see any other related motions that the court has yet to rule on.

In a way, seeing a court order all by itself is like being told the current score of a football game, but you aren’t told what quarter it is.

The third option for keeping up with MDL 3014 (or any other federal case) is to review the federal dockets. Dockets consist of a list of pretty much everything that happens in a case, organized by date. The docket will reflect pleadings, motions, an attorney’s entrance of appearance or a jury’s verdict after the trial.

If you want to know all the relevant updates to a particular case or MDL, looking at the dockets is the best approach. That being said, it’s not always the easiest way to learn about recent developments. This is because it can be difficult to understand the various bits of legal and court-specific jargon and codes that appear.

Another problem is that they’re not easily accessible by the public. Yes, anyone with access to the Internet can access federal court dockets, but they need to make a free PACER (Public Access to Court Electronic Records) account.

What’s not always free is using PACER. Information you get from PACER can cost 10 cents per page, although there’s a cap of $3.00 when reviewing a particular document. This is handy when you want to look at a particular court document that’s 500 pages and only have to pay $3.00 instead of $50.00.

If your PACER fees are less than $30.00 for a calendar quarter (three months), the fees are waived. This $30.00 threshold gets reset every quarter, so as long as you’re only using PACER sparingly, you can use it all year and not have to pay anything. But the worst part about PACER is that it’s not the most user-friendly website.

If you want more information about the CPAP litigation, or are thinking about joining MDL 3014, feel free to reach out to me at (919) 830-5602.

Exactech Inc. (Exactech) has been having some legal troubles lately involving its hip, knee, and ankle implants. Some patients receiving these implants have suffered complications from the implant they allege are the fault of Exactech. There have been recalls for the affected products, but this hasn’t been enough to fully compensate the affected patients.

As you might expect, many of these patients have sued Exactech. Because there are a lot of cases with similar facts and issues (and they are also in the early stages of litigation), many of these cases have been consolidated into a multi-district litigation, or MDL.

One of the more recent updates in this litigation involves transferring many cases to a single federal district to centralize the legal proceedings. To better explain what this means, let’s first review what an MDL is.

An Overview of Multi-District Litigation

MDLs are a way federal courts try to streamline the legal process when there are many similar lawsuits filed all over the country. For example, a defendant company might have thousands of products that have affected thousands of customers. These customers are located all over the country and file suit in federal courts that are also located all over the country.

Because of the similarities between the cases, it’s possible to consolidate part of the litigation process (such as discovery) into a single federal court. This can improve the efficiency of the litigation, reduce conflicting court decisions dealing with the same issues and make it easier for the cases to settle

The Exactech MDL Transfer Order

Issued by the Judicial Panel on Multidistrict Litigation (JPML), the transfer order centralizes the Exactech MDL cases to one federal district court. Specifically, the cases will be sent to the Eastern District of New York (EDNY) and assigned to Judge Nicholas G. Garaufis. Many of the plaintiffs supported transferring the MDL cases to the EDNY. However, some also suggested the Eastern District of Pennsylvania and the Southern District of New York.

Exactech expressed a preference for transferring the cases to the Northern District of Florida, the District of South Carolina and the Eastern District of Louisiana. There are several potential explanations as to these preferences, but one commonality among most of them is that the plaintiffs’ choices tend to have juries and judges that are more likely to be plaintiff-friendly while Exactech’s preferences are more likely to be defendant-friendly.

Why Did the JPML Choose the Eastern District of New York?

In explaining its decision in the transfer order, the JPML choose the EDNY because:

• Many MDL cases were already located there.
• The EDNY isn’t as busy as many other federal district courts.
• Several important witnesses are located in or around the EDNY.
• Judge Garaufis has plenty of experience handling MDL cases.

Why Do Litigants and Defendants Have Preferences for Courts that Handle MDL Cases?

In addition to choosing a district that’s more likely to have a judge or jury panel that’s sympathetic to a particular side, other reasons to select one federal district over another include:

• More plaintiffs and/or key witnesses are located in the district, so there’s less of a travel burden placed on them.
• Important evidence is located in that district.
• How busy the district is and how quickly either side wants to get through the litigation.
• Prior legal decisions from the district favoring one side over the other.

Do You Have Additional Questions Concerning the Exactech MDL Transfer Order?

If you’ve decided to sue Exactech and this transfer order affects your case, you pretty much have no choice but to go along with it. If you’re thinking about suing Exactech for an allegedly defective implant, there’s a reasonable chance this transfer order could affect you.

To learn more about what’s going on, you should get a consultation with a product liability lawyer. If you have one in mind, give them a call. If you’re not sure whom to contact, don’t hesitate to call me at (919) 830-5602 and I’ll see how I can help. Good luck.

If you follow my blog, you’ve probably heard about paraquat. If you’re unfamiliar with paraquat, it’s a highly toxic herbicide that may cause Parkinson’s disease. As you might imagine, this potential link is alarming and has led to quite a few lawsuits. Let’s take a look at the current status of these paraquat cases.

Paraquat Lawsuits Begin

It’s undisputed as to the harm paraquat can cause when humans are exposed to it in large amounts over a short period of time. But much of the current litigation concerns plaintiffs who were exposed to paraquat for extended periods, such as when using it often while working on a farm. Due to this long-term exposure, plaintiffs are claiming that paraquat caused their Parkinson’s disease.

The first major lawsuit alleging a link between paraquat and Parkinson’s disease was filed in 2017. Since then, hundreds of plaintiffs have sued the makers and distributors of paraquat (such as Chevron and Syngenta) claiming paraquat caused their Parkinson’s disease.

Paraquat Lawsuits Get Consolidated

In June 2021, several paraquat lawsuits were combined into the In re: Paraquat Products Liability Litigation. This is a type of multi-district litigation (MDL), where many of the pre-trial litigation matters in the participating cases get handled together. Even though each case stands on its own and can still have its own trial, a single court will oversee pre-trial matters such as motions and discovery. These pre-trial rulings will apply to all of the cases. This makes it possible to save a lot of time and effort by avoiding repetitive court proceedings and decisions.

Major Events in the Paraquat MDL So Far

The Paraquat MDL is progressing, with several notable events during the litigation process. However, none of these events have significantly altered the potential outcome of the MDL.

In October 2021, the defendants filed several motions to dismiss and cited various reasons, such as the passing of the statute of limitations deadline.

On December 3, 2021, the court instructed both sides to choose 16 cases to proceed with limited discovery. Limited discovery meant the parties were restricted in what documents they could request and the number of depositions they could take.

In March 2022, the MDL court decided the motions to dismiss and gave each side a partial victory. The court sided with the plaintiffs by concluding that the cases were not filed too late in violation of the applicable statute of limitations or statute of repose (which is not the same thing as a statute of limitations but works in a similar way to time-bar a lawsuit).

Nevertheless, the court ruled in favor of the defendants by agreeing to dismiss several causes of action concerning public nuisance and consumer protection. Yet having these causes of action thrown out wasn’t a major blow to the plaintiffs because they could still proceed with their other claims.

On April 13, 2022, the court issued an order choosing six cases to proceed with expanded discovery. This discovery is to conclude by September 2022, with bellwether cases to begin a few months later in November.

What’s Next for the Paraquat MDL

In compliance with the April 13, 2022 order, both sides will resume discovery, which will include a lot of documents being exchanged and individuals being deposed. Then the bellwether trials start in the fall.

The outcomes of the bellwether cases do not apply to the other cases in the MDL. However, they’re important because they can help predict how future cases in the MDL will turn out if they get to trial or settle.

How the bellwether cases turn out won’t guarantee any future result. But imagine if six paraquat bellwether cases result in five verdicts for the plaintiff and one hung jury. It’ll mean that during settlement negotiations, the plaintiffs will have a lot of leverage. And any global settlement will be far greater than if the defendants won at least a few of those six bellwether cases. It could also mean the plaintiffs are more willing to take certain cases to trial.

Have You Been Exposed to Paraquat and Now Suffer from Parkinson’s Disease?

If you’re reading this right now, I sincerely hope your answer to this question is “no.” But if it’s a “yes” or “maybe,” then you should think about the possibility of joining the paraquat MDL to help pay for your medical care and to compensate you for your serious health issues. If you have any questions about paraquat, don’t hesitate to give me a call at my firm Harris Sarratt & Hodges (919.830.5602).

In any product liability litigation, the injured person must ultimately prove that the injury was caused by the defective product (legal causation). A relatively easy example is when a lamp explodes and burns an individual, and in the post-explosion investigation the plaintiff discovers the lamp’s wiring was faulty and unreasonably dangerous. In the Zantac (ranitidine) multi-district litigation (MDL), thousands of plaintiffs have come forward alleging that use of the heartburn medication caused their various cancers. I discussed how Zantac is alleged to cause cancer in previous posts. You can start here if interested. In a nutshell, however, studies have shown that Zantac may contain potentially dangerous levels of NDMA (N-Nitrosodimethylamine), which is a likely carcinogen in humans.

There are several ways that NDMA is thought to be present in Zantac medication, which you can read about here. The larger point is simple: you do not want to ingest NDMA, and you certainly do not want to ingest large amounts of NDMA, especially for months or years. Remember, millions of people have taken Zantac or the generic ranitidine, some for many years, so the potential consumer-health risk is widespread. Zantac has been recalled.

Because these studies link Zantac to NDMA, plaintiffs who used Zantac and later developed one of several cancers (reasonably) came forward and filed lawsuits against the manufacturers of Zantac. The original Master Complaint listed at least sixteen different cancers, with indications that the list was not exhaustive.

Zantac Plaintiffs Have Filed Expert Reports on Five Cancers

On January 25, 2022, however, the Plaintiffs’ Leadership in the Zantac MDL filed disclosures with the Court indicating that the plaintiffs would provide general causation expert reports focused on five cancers: bladder, esophageal, gastric, liver, and pancreatic. Remember, the plaintiffs must have credible expert opinions on the link between a medication like Zantac and its likelihood of causing certain cancers. At this point it appears the plaintiffs’ experts will be able to make a viable connection between the use of Zantac and the onset of the above five cancers. If you have one of these cancers and you also took Zantac for a period of time prior to your cancer diagnosis, you should call me immediately ((919) 830-5602) to discuss your legal options.

The next step in the litigation is for both sides to take depositions of all experts providing reports in the litigation, and following that, the Court will hold hearings on the science supporting the expert reports (known as Daubert hearings). If the Court upholds the scientific viability of the plaintiffs’ experts, the cases will move closer to jury trials.

But What if I Have Been Diagnosed with a Different Cancer?

It’s a good question. At this point you will not be able to pursue your claim against the makers of Zantac in the Zantac MDL. Plaintiffs’ lawyers are still investigating the link between Zantac-use and other cancers, as well as looking for other possible venues to bring claims for those who suffered a different cancer than those five listed above. However, it bears repeating that an expert opinion is required for any successful product liability lawsuit.

If you have taken Zantac for a period of time and were subsequently diagnosed with bladder cancer, esophageal cancer, gastric cancer, liver cancer, or pancreatic cancer, it’s possible that your cancer was the result of your taking Zantac. Call me to discuss, and either way, good luck.

Note: The information contained in this post was developed from publicly available information, including court filings and media reports.

Although talcum powder studies are ongoing, it has been established that some products that use talcum powder may contain small amounts of asbestos. And there’s a well-known link between asbestos and cancer (especially mesothelioma).

So where does Johnson & Johnson come in? Well, they’ve been one of the more prominent defendants in these talcum powder/asbestos cancer lawsuits. Let’s take a quick look at the baby powder litigation and then examine how Johnson & Johnson is planning to use something called “Project Plato” to deal with their recent legal and financial losses.

A Brief History of Johnson & Johnson’s Baby Powder Litigation

In 2018, Reuters published a story claiming that Johnson & Johnson (J&J) knew its baby powder products used talc that contained asbestos. In 2019, J&J voluntarily recalled some of its baby powder being sold in the United States.

A lot of people sued J&J and/or related entities claiming the products they used containing talc (such as baby powder) caused their cancer. Many of these cases are currently in the Johnson & Johnson Talcum Powder Litigation MDL, or multidistrict litigation, which is currently in New Jersey federal court.

A few of the cases against J&J have resolved, resulting in massive verdicts in favor of the plaintiffs. One of the most notable was a case from St. Louis where 22 women successfully sued J&J in 2018 and were awarded more than $4 billion in damages. On appeal, this amount was reduced to about $2 billion. Still, a remarkable amount.

As of 2021, J&J faced approximately $3.5 billion in legal settlements and judgments relating to its baby powder. This was bad enough, but it was just the beginning for J&J, with tens of thousands of cases still remaining. Seeing the writing on the wall, J&J allegedly thought of a new strategy to handle these lawsuits and gave it the code name Project Plato.

How Project Plato Works

Project Plato is a very clever strategy that takes advantage of federal bankruptcy and state corporate laws. The goal is to pay off baby powder cancer litigants for pennies on the dollar and prevent J&J from having to worry about future plaintiffs. The plan is still ongoing and it’s unclear if it’ll work as J&J plans, but here’s a rough overview of the process.

For step one, J&J shifted its headquarters to Texas. The reason would be to take advantage of one of Texas’ corporate laws that allows a corporation to divide itself into two or more companies through a process called a “divisive merger.”

In step two, J&J created a subsidiary called LTL Management. This would take on J&J’s legal liabilities relating to the baby powder asbestos litigation. However, it would have a relatively small number of assets to pay any legal awards or settlements. The rest of J&J would continue operating as the second company, yet it would no longer have to worry about any lawsuits from the talcum powder litigation.

The third step required LTL Management to file Chapter 11 bankruptcy, which it did almost immediately after being created.

Project Plato is currently in step four, which involves getting the automatic stay to temporarily halt the talcum powder litigation against J&J. It’s also during step four that J&J hopes the bankruptcy judge will approve LTL Management’s Chapter 11 bankruptcy reorganization plan which has a few special terms.

Namely, all baby powder cancer plaintiffs against J&J would have to make their case in bankruptcy court (instead of regular court) and fight for their share of $2 billion that J&J would give LTL Management to compensate the almost 40,000 current plaintiffs.

J&J would also get a non-debtor release, which would immunize it from getting sued by any future plaintiffs claiming they got cancer from using J&J’s baby powder or talcum-based products. So the $2 billion wouldn’t just be split among the almost 40,000 in current plaintiffs, but it would also be all that’s available for future plaintiffs, too.

J&J reasons that this plan makes it more likely that plaintiffs who go to court for financial compensation for their injuries will get at least something. J&J contends that getting an almost guaranteed small amount of money is better for plaintiffs because they can avoid the risk of losing at trial. It would also give J&J finality to its baby powder legal woes. If successful, Project Plato would allow J&J to move on without constantly worrying about another talcum powder lawsuit decades from now.

Project Plato is a slight variation of something called the Texas Two Step, which has been successfully used by several companies (like Georgia-Pacific) looking to reduce and offload their mass tort legal claims.

Will J&J’s Plan Work?

No one knows for sure. Right now, the case isn’t going as well as J&J would have hoped. When LTL Management filed Chapter 11 bankruptcy, it chose to do so in North Carolina. Why? Because of that state’s history of favorable judicial rulings involving the Texas Two Step strategy. However, the North Carolina judge transferred the case to New Jersey.

As you can imagine, the plaintiffs aren’t happy about Project Plato and are doing everything they can to stop it. The New Jersey bankruptcy judge has scheduled a hearing for February 14, 2022 to listen to arguments from the plaintiffs (who are technically creditors in this bankruptcy proceeding) as to why the court should dismiss LTL Management’s request for bankruptcy.

Their primary argument would be that LTL Management filed Chapter 11 bankruptcy in bad faith. Specifically, that it was done as a way for J&J to avoid paying out the massive legal settlements and court judgments that have already been handed down, and with many more anticipated in the future.

A possible good omen for plaintiffs in the J&J litigation is what’s been happening with Purdue Pharma’s litigation involving its alleged role in the opioid epidemic. Late last year, a judge rejected Purdue Pharma’s proposed settlement and bankruptcy reorganization plan. The settlement and reorganization plan involved non-debtor releases that would have protected key individual defendants from personal liability. While Purdue Pharma’s strategy wasn’t the same as Project Plato, it was similar in that it tried to use the Bankruptcy Code to limit its legal liability in its civil lawsuits.

What Happens Next?

Over the next few months, we’ll see if Project Plato works for J&J. If it does, it would create a blueprint for any other company that faces mass tort lawsuits. This would make it much harder for plaintiffs to obtain compensation for their injuries. There’s even a proposed law in Congress to ban what J&J is trying to do.

In the meantime, if you have any questions as to whether you can receive compensation for injuries potentially related to using baby powder or other talc-based products, don’t hesitate to get in touch with me. And I’ll let you know if there are any major developments in J&J’s Project Plato.

There are as many as four million machines affected by the CPAP recall. The Philips CEO has stated that it may take a year or longer to fully repair or replace the affected machines. When he says repair he’s talking about replacing that problematic foam or replacing the entire machine for a brand new machine, so it’s going to take a while. And that’s one of the problems that a lot of the people that are calling my office are saying, and that is, that they use this machine to sleep and some of them are worried that they will have to use the recalled machine to sleep. So they’re in a tough position. Again, I’m not a doctor and I don’t give medical advice, but I would say if you can find a replacement machine quickly, set aside your recalled CPAP machine and don’t use it and beyond that, you just have to talk to your doctor about what’s going on and what you should do next.

Potential Injuries from the Recalled CPAP Machines

What are the potential injuries from the recalled CPAP machines? These injuries would include somewhat modest problems like irritation to the eyes or skin, a cough, headache or dizziness. These are not unimportant issues, they can be serious problems, and they run from the gamut from headaches and nausea to sinus infection. More serious injuries include organ damage, asthma and even cancers. The medical community is looking at this aggressively and quickly and trying to figure out all the many problems that can result from inhaling these particulate foam pieces from the CPAP machines or getting exposed to the off-gassing.

The FDA has classified the CPAP recall as Type 1, the most serious one they have, and they’re taking it very seriously. So there is a constellation of symptoms that could result from a breakdown in these CPAP and BiPAP and ventilator machines. Just be very aware of your health and any changes in your health and if you’re feeling a new and suspicious cough or an infection of the sinus, headaches, vomiting, nausea, anything like that, you need to take it and have a doctor to check you out.

CPAP Lawsuits

As you might imagine lawsuits have begun to be filed around the CPAP recall. Millions of these devices have been used for years by millions of patients. Now they’ve been recalled and and they have caused injuries. They suffered through no fault of their own. This litigation is very new and it’s emerging but a multi-district litigation (MDL) site was established in October 2021, in the US District Court for the Western District of Pennsylvania. The judge that is going to be overseeing the MDL for the CPAP device is Judge Conti. If you think you have a case, you can certainly call me ((919) 830-5602) and we can discuss further.

What Should You Do Next?

If you believe you may have a recalled CPAP machine and you have injuries that are flowing from this defective machine, you should not discard the machine. Don’t throw it away and don’t send it back to Philips. Hold on to it. I would encourage you to get a replacement machine if you need one to sleep with, but in any event, the existing machine that is subject to recall, you need to keep all of it and that includes the hoses, pieces and accessories. You want to keep it all because it may end up being evidence in your case.

The very next thing that I would do if I were in your position is to contact your doctor, schedule a visit and explain everything. Explain the kind of machine you have and that it has been recalled, that you are aware of at least two ways for the recalled machine to have caused injury and that you want to be checked out. The third thing I would do is to take inventory, take stock of what’s happened to you in the last few months, the last few years, whether there’s been a new onset of symptoms that you didn’t recognize but you just kind of wrote off because you know, you just thought it was the normal process of aging. I would also write down every detail you can think of that might help your case down the road, which includes when you started using the device, when you stopped using the device, how many nights a week you used it, how many hours per night. You can even note the pressure settings. If you know that how the device was cleaned, how you cleaned the device, and the products used to clean the device. Any time you keep kind of a journal of the basic facts of any case, it’s going to help out your attorney, it’s going to help out your case and it’s going to be useful for you down the road. These facts can be lost to memory and time if you don’t stay on top of it.

So that’s where we are at the moment in this defective product area. The MDL site has been created in Pennsylvania. Dozens of cases are already filed. There are going to be thousands of cases filed in the next year. If you are a user of the Philips CPAP, BiPAP or any ventilator machine that was subject to recall, and you also have symptoms, you need to be well aware of it and keep checking this site as I try to keep people up-to-date. Call me if you want to discuss your case further. But either way, good luck and good health

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.

There are many reasons to become educated on the herbicide Paraquat: it’s very dangerous, very toxic, and unfortunately studies are starting to indicate that it can cause serious disease if you’re exposed to it in any length of time.

What is Paraquat? / Why is it used?

Paraquat is a toxic chemical that is widely used in this country, particularly in the eastern half of the United States where there’s a lot of farmland, orchards, agricultural areas. It is used as an herbicide, a plant killer primarily for weed and grass control.

It’s also used as a drying agent for certain crops; the technical term for that is desiccant. It is also used as a defoliant. So again, its main use is to control weeds and grasses that grow in an agricultural setting when you’re trying to grow some kind of crop. It’s also used as a drying agent for certain crops, like cotton, prior to harvest.

The good news is that Paraquat is not something you can obtain easily. It’s not something you can buy over the counter; you can’t get it at Lowe’s or Home Depot, or you certainly shouldn’t be able to get it there. And it’s not to be used for home landscaping, weed control on your lawns, nothing like that. In fact, it’s a restricted use pesticide (RUP). And so what that means is you must have a license to buy the product Paraquat. You must be a licensed applicator, to buy Paraquat to mix it up and to apply it to farmland.

Unfortunately it is common that these restricted use pesticide licenses are used by people who then allow some of their workers to apply the Paraquat to crops and other environments for weed control. And so it’s not just those people with licenses that may end up being vulnerable to injury and disease. But it’s any worker that handles this product.

One article I read suggested that Paraquat has gotten more popular in the United States partly because some weeds and grasses have become resistant to glyphosate, which is the active chemical in Roundup and because of that, they need a more effective weed killer and that’s where Paraquat comes in. So even though it’s highly toxic, highly dangerous, it’s become more popular over the last 20 years.

Now, as I wrote in an article a few months ago on my website, www.northcarolinaproductliabilitylawyer.com, I was introducing my readers to some of the basics of Paraquat. And one thing I noted is that it is highly toxic and even poisonous and that I’ve read that even a thimble-full of it, if you ingest it, it could be fatal and so, it’s a horrible chemical for safety reasons, even while it is highly effective at weed control and drying out crops like, hay, cotton, things like that.

Some of the brand names that you might find Paraquat out there is Firestorm, Cyclone, Helmquat, Parazone, Parashot, and Gramaxone. So, those are some of the brand names but Paraquat is the name of this chemical that we’re dealing with and that I’ll continue to use today.

Who Uses Paraquat?

Obviously, agricultural workers might have access to Paraquat and might be asked to put it on crops, whether they’re spraying it by hand, after they mix it up with water or if they are driving a tractor and covering larger amounts of farmland. Farmworkers, crop dusters, pesticide applicators, tanker workers, pretty much anyone who works in the agricultural industry or works with orchards or even vineyards, might have access to Paraquat. Again, there has to be the RUP license, the restricted use pesticides license to buy it but I do think people who work with people who have the license may be asked to apply it. Anybody who works in this industry or any of these industries needs to be aware that it’s out there and it could be possibly dangerous for you.

Let me say that if you work in agriculture or in a vineyard or an orchard, you probably know what you’re doing and you probably know if Paraquat is involved in the day’s work. So for those people, you got to be very vigilant and you probably need to listen to the rest of this podcast because there’s some important health information.

So, I’ve talked about all the places that Paraquat might be used as a weed control chemical or as a drying agent—desiccant. The primary crops that it’s used to fight off weeds and is often used in relation to the growing of soybeans, cotton, corn, rice, tobacco. It’s used extensively in the eastern half of the United States. And that’s pretty obvious because there’s a lot of farmland in the eastern half of the United States. It is a very common in my home, North Carolina, because there are many farms in this state and throughout the east coast. If you live in this part of the country you’re probably not far away from a farm that has used Paraquat in the last year or more recently.

Paraquat and Parkinson’s Disease

Studies have started to indicate a significant and alarming connection between the exposure to Paraquat, the use of Paraquat, and the development of Parkinson’s disease. Now, Parkinson’s disease is a brain disorder that can lead to trembling, shaking, stiffness in the body, difficulty with balance, coordination, walking. As with most diseases, these symptoms usually come on gradually and maybe imperceptibly for months or years. But as the disease progresses, people have more trouble with the trembling, more trouble with walking and balance, and it can become a debilitating disease.

I won’t go into too much detail about the science behind the studies that show how exposure to Paraquat can lead to Parkinson’s disease. But I just want to do some high-level discussion of why it happens and why epidemiologists and scientists believe there is a significant connection between exposure Paraquat and Parkinson’s.

The main issue seems to be this concept of oxidative stress. It’s essentially an imbalance between the production and accumulation of oxygen reactive species and cells and the antioxidant defenses that are able to neutralize these oxygen reactive species. There are a lot of environmental factors that can lead to harmful levels of oxidative stress in the body and that it can include non-Paraquat conditions or triggers like obesity, exposure to radiation, smoking cigarettes, pollution, that kind of thing. But what scientists are increasingly finding in the studies is that exposure to toxic pesticides and specifically Paraquat can cause this extreme oxidative stress. It can cause it at such a level that it can damage areas of the brain that are otherwise able to function properly and cause injury and acute damage, such that Parkinson’s disease can develop in the brain. So obviously there’s more to the story of the science connecting Paraquat to a higher risk for developing Parkinson’s disease, but that gives you a thumbnail of why they think this is occurring and how it can damage one specific part of the brain that can lead to Parkinson’s disease. For more information there are studies out there that you can read and learn more about specifically, if you’re an individual who spent the last few years (or even less time) working in a farm-like setting.

Paraquat Regulations

At least with respect to the United States, there has not been a ban on Paraquat and the EPA, as recently as October 2020, reapproved Paraquat for use in the United States. Now, let me re-emphasize that not everybody can buy this product. I cannot purchase Paraquat. You probably may not be able too. You must have a Restricted Use Pesticide license to even purchase the chemical. There are serious warning labels on the bottles of Paraquat that talk about how poisonous it can be. But I think it’s really important and I need to emphasize that the EPA takes the position that the connection between Paraquat and Parkinson’s disease is not strong enough to justify a ban. So even while there might be a strong warning on the Paraquat bottle that it’s toxic and even fatal if swallowed (and it certainly can kill you if you drink any amount of it), the EPA is not yet willing to warn the consuming public about the growing science showing a connection between Paraquat and Parkinson’s disease.

Now even though the EPA hasn’t banned Paraquat in the U.S., the chemical has been banned in 32 countries. Many countries in Europe banned Paraquat for use in the 1980s and 1990s. The United States will not follow suit and that’s I think unfortunate. And sadly, I think it must be mentioned that the EPA’s refusal to ban such a dangerous chemical in the United States may very likely have something to do with the way the United States always seems bow down to large corporate interests and profit-making opportunities and Paraquat is certainly a profitable chemical that is sold by Syngenta and (for a period of time) Chevron, who will turn out to be the key defendants in the litigation that is emerging over Paraquat.

If you want to hear more about the connection between health care and the overwhelming obsessions with profit in this country, I invite you to listen to a podcast I did a few months ago with my good friend Dr. Jerome Hoffman. It’s called “Excessive Testing, Diagnosis and Treatment: A Conversation with Dr. Jerome Hoffman.” And in that podcast we talked a lot about how the profit motive in this country leads to some very unhappy results in medicine, health care, and all of corporate America.

Paraquat Litigation: Do You Have a Case?

Paraquat litigation is on the rise. It’s no secret that because Paraquat has been shown to increase the risk and perhaps cause the development of Parkinson’s disease, lawsuits have been filed against the manufacturers of Paraquat. The two key defendants in this operation are Syngenta and Chevron USA (for the period of time when Paraquat was sold by Chevron). So do you have a possible case? The answer is, you must check some serious boxes to be eligible for a lawsuit here. First you have to be able to confirm exposure to Paraquat. All detail is important in any litigation, but certainly this one you want to be able to establish that you worked in an agricultural setting, worked on a farm, an orchard, a vineyard; you need to be able to establish that you used Paraquat, applied it to crops, applied it to the fields. Dates are very important, as are receipts. If you’re one of the people who have the license to purchase Paraquat, all those receipts are vitally important. How often did you apply the Paraquat and how often were you exposed to it? Any details like that are very helpful.

There may be other opportunities for people who lived near farmland, perhaps right beside a farm where crop-dusting took place regularly or tractors applied Paraquat over a period of months or years. Proximity might be another way you can be exposed. Also, scientists believe airborne drift may lead to unhealthy exposure. If you live within five or ten miles of a farm where Paraquat is regularly used and then as the years pass, you develop Parkinson’s disease, then you may be in line to pursue litigation against these big Paraquat defendants.

Second, you need to have a diagnosis of Parkinson’s disease. If not a diagnosis you need to exhibit many of the symptoms that are associated with Parkinson’s. But let me be very clear: if you have been exposed to Paraquat and you are having symptoms of trembling or shaking, difficulty walking, difficulty with balance but you don’t have a diagnosis of Parkinson’s disease, I’m afraid you need to get to a doctor and get diagnosed and find out what’s wrong. You need to do that regardless of what you choose to do with any litigation.

There are also some other serious ailments and diseases that may develop that you need to be aware of. If you have been exposed to Paraquat and while you don’t yet have a Parkinson’s disease diagnosis, you’ve got kidney disease or renal failure or certain symptoms consistent with Parkinson’s disease, then you may well have a claim in the Paraquat litigation.

This litigation is very new, and a multidistrict litigation site has recently been established in June 2021, in federal court in the Southern District of Illinois. As of last week there were 60 cases filed, but obviously there’s going to be dozens more cases filed soon. The studies are increasing that show a real connection between this seriously toxic chemical and the development of a horrible and debilitating disease: Parkinson’s.

That’s the story of Paraquat for today. It’s not a happy story and I hope you were never exposed to the chemical at work. If you were exposed, and you’ve developed this disease, you may want to look into your whether you should be involved in the litigation. You can always reach out to me at my firm Harris Sarratt & Hodges in North Carolina. My number is (919) 830-5602.

Again, stay healthy, be well, and good luck.

Clay: What are some of the brand names for a TAF tenofovir drug?

Whitney: So the first TAF drug that was approved was called Genvoya, and it was approved in late 2015. And then Odefsey is another TAF drug that was approved in 2016. And then one that maybe is the most well-known is called Descovy, and that was also introduced into the market in the US in 2016. Truvada was perhaps one of the most well-known of the TDF drugs. Descovy is exactly the same as Truvada except it has TAF instead of TDF. So then it has also been approved by the FDA for PrEP. So, for prophylactic treatment of patients who are currently HIV-negative and as a preventative measure. So Descovy is one of the biggest TAF drugs on the market right now.

Clay: So Descovy may be seen as the medication that’s really replacing Truvada. And hopefully informed doctors will now be making that transition to Descovy. Is that right?

Whitney: Yeah. So I think what we’ve seen is that a lot of folks and the biggest chunk of the market has moved to the TAF iteration, and there are certainly a large number of patients who have been switched over to Descovy. And I think prescribers are using that more widely now.

Clay: So speaking of doctors and how they’re informed, it’s my understanding that Gilead promoted these TDF medications for years and often told doctors in the United States that there were no toxicities or very few, and let me say, based on what I read, they gave more dire warnings in Europe than they did in United States. Is that your understanding?

Whitney: We talked a lot about the warning labels that accompany prescription medications. And one of the things that we’ve seen is that for years, the warning labels in Canada and the European Union countries were much much stronger. They disclosed a much more closer relationship, basically between the TDF medication and then nephrotoxicity, and even some bone issues which we haven’t touched on a lot today but is another one of the injuries that we believe the TDF class of drugs could cause. So yes, you’re exactly right, Clay. There were stronger labels in other parts of the world, and not in the US. So a patient in EU country might receive Truvada and they might get a lot more information about the possible side effects, whereas a patient in the US wouldn’t have been given those same kind of warnings. And that’s really the crux of a lot of this, right? I mean, years ago, direct to consumer advertising in pharmaceuticals wasn’t a thing. That’s been in the last 20 or 30 years. So, it’s my view that if pharmaceutical companies are going to be able to market directly and advertise directly to patients, then they should disclose all of the risks that could happen and they should disclose the risks that are more likely to happen. It’s not the laundry list of X, Y, and Z. If there’s a significant or an increased risk of something as serious as kidney failure happening, then a patient needs that information so that they can decide with their doctor if it’s worth the risk.

Clay: I think that’s exactly right. That’s maybe the best point of all. The tragedy, especially when a patient is dealing with such a scary diagnosis as HIV, is that he and his doctor might not know the full extent of the side effects and the potential long-term problem that’s outside of HIV or AIDS.

Whitney: That’s absolutely right.

Clay: So we’ve talking about TDF and Tenofovir and the potential injuries that it can cause patients, and we’ve talked about how the studies indicate that it can be toxic to kidneys and damage kidneys and cause kidney failure. You mentioned the bones, so tell me about what you know about bone injuries.

Whitney: It’s interesting and it’s something we’re still learning a lot about. But another one of these issues or side effects we’ve seen from TDF/tenofovir is causing stress fractures or fractures in various parts of the body. So rib fractures from non-traumatic events, femoral fracture, so somebody might get a fracture in the portion of their leg that’s above their knee, and again, not falling down, not getting in a tragic event. It’s an overall decrease in their bone mineral density that then can lead to osteoporosis or osteopenia and then make them more likely for some of these fractures to occur.

Clay: So we’ve got this tenofovir drug, it’s been out there for a while, and even though it’s cycling out of the marketplace for 15 years, thousands of people took the drug, and now we’ve got people that are injured. Kidney damage, kidney failure, bone injuries. So litigation has followed.

Whitney: We represent a couple thousand individual plaintiffs in tenofovir lawsuits that have been filed in Federal Court in the Northern District of California. That’s where Gilead’s home office in the US is located.

Clay: So is that at the multidistrict litigation site?

Whitney: Yeah. So technically, it’s not been designated MDL yet, but it’s a consolidated litigation. That’s in federal court. We’re working that up. We represent a bunch of individual plaintiffs who have had these injuries occur. And then we’re moving forward with those cases. There’s also a consolidated litigation in state court in California. That’s kind of referred to as the JCCP litigation. So that’s in state court in California as well. And those cases are being worked up against Gilead, kind of on a different schedule, but the same general idea as what we’re doing.

Clay: And just so everybody understands, you’re not representing folks in a class action? These are consolidated individual cases with individual claims.

Whitney: That’s absolutely right, Clay. We’re representing individuals. What often happens is, I’m sure folks know from listening to you, is where you have a bunch of people who have been injured by a medication instead of trying to recreate the wheel two thousand times in different venues across the country, it makes sense to have all those folks consolidated in front of one judge so that your discovery rulings, getting document production, getting evidentiary rulings, all of that can be consistent. And then also each plaintiff isn’t having to take on the burden of fighting against a corporate behemoth like Gilead Sciences. So, this way is the best of both worlds. You get the efficiency of the consistent pre-trial rulings and evidentiary rulings, but it’s still everyone’s individual lawsuit and they’re not bound with other folks who may have different injuries and different claims. The individual folks who have been injured by the medications are still in charge of their own cases, but we’re working them up together for at least some of this initial stuff.

Clay: Got you. Well, I appreciate you explaining that because a lot of times I get calls, and I’m sure you do too, they talk about class actions and they sometimes worry about that. They don’t want to be just another widget in a massive class action. And that’s not the case in this litigation or in most product cases, most product liability cases. It’s never a class action. It’s individuals fighting the big company for fair compensation. Well, Whitney, this has been fantastic. Those are the questions I have. I really appreciate you spending some time with us.

Whitney: Thanks for having me, Clay.

If you have taken a tenofovir drug like Truvada and suffered kidney damage or bone injuries, please call me at (919) 830-5602 to discuss your possible case against Gilead Sciences. Good luck.

Today, we’re going to talk about the HIV medication, Tenofovir. This was a medication sold for years to delay the progression of HIV. As studies are beginning to show, there were problems with the medication causing toxicity to kidneys, bone loss and bone injury. Whitney Butcher is an attorney with Hilliard Martinez and Gonzales, and today we’re going to talk about Tenofovir, the brand name medications that derive from this compound, the problems that were discovered and the litigation that has inevitably followed all this.

Let’s start at the beginning. Most people know that HIV is the virus that causes AIDS, what is an antiretroviral drug?

Whitney Butcher: So, those were one of the first class of drugs that were basically brought to market to help stop and slow the spread of HIV. Once a person contracts HIV, the goal of these medications is to target the cells and prevent them from replicating so that an HIV diagnosis doesn’t progress into full-blown AIDS which can of course be life-threatening and very dangerous.

Clay: What is Tenofovir?

Whitney: Tenofovir is a compound that’s in a class of nucleotides, and it’s very effective at preventing the replication of HIV, but it can be nephrotoxic meaning that it can harm patients’ kidneys. Tenofovir is the active compound that’s in a number of different antiretroviral medications. Truvada is one that a lot of folks have heard of.

Clay: In reading about this medication, when they were formulating it, around 20 years ago, it was only meant to be administered in an intravenous form, and the company, Gilead Sciences, was trying to make it into a pill form. Can you talk a little bit about that and kind of the downside and upside of that?

Whitney: So while Tenofovir is effective, it can’t be taken orally, which, as you just said Clay, means that you can’t put it by itself in a pill and have somebody take it. It just doesn’t work that way. So, what happens is, these delivery agents are added to the compound Tenofovir. The first drug involving Tenofovir was the class of medications that I’ll call TDF, that’s Tenofovir Disoproxil Fumarate, or TDF. The very first TDF medication that came on the market was called Viread, and that was approved in 2001. So, TDF is Tenofovir, the drug that will prevent the cells or slow the cells replicating the virus, and then the DF, the Disoproxil Fumarate, that’s the delivery agent. That’s what allows the patient to take Tenofovir orally in pill form and then allows the medication to get to the cells to do the work that it’s supposed to. So I kind of make a joke that the Tenofovir is the Amazon package that you’ve ordered, and the DF is the Amazon Delivery Agent, that’s going to deliver it to your front door. So, you’re not going to get the package unless you’ve got the DF. Tenofovir is not getting into cells without the delivery agent, the DF, that accompanies it.

Clay: Let’s move from talking about Tenofovir and going to TDF. What are some of the brand names that were out there under that TDF umbrella.

Whitney: Absolutely. The first one was Viread. That was approved in 2001. The next name brand TDF drug and, perhaps the biggest, was Truvada, and that was approved in 2004 by the FDA. And so, Truvada features TDF plus another component. So, with Viread, even though it was effective, patients would have to take lots of other medications. In the early days, HIV patients would talk about having to take like 10 different pills per day. So Truvada was the first to combine TDF plus an additional medication. The other interesting thing about Truvada is it was actually the first medication that was approved for PrEP, so what that means is for patients who might be at a higher risk of contracting HIV but are currently negative. The FDA approved Truvada to be used by those, overall, very healthy people as a preventative measure. Some other TDF medications, Atripla was a big one. Atripla, as the name suggests, kind of speaks to triple. So there’s three different compounds that make up Atripla. Another one, Complera, and then the last in the TDF class was Stribild, which had four different components to it, again, including TDF. And Stribild came out in 2012.

Clay: TDF is considered toxic to kidneys. Is that correct?

Whitney: Yes. As we’ve gotten more information and as we’ve had a chance to talk to patients who took TDF oftentimes years and years, what we’ve learned is that…so the TDF drugs, again, the Tenofovir is trying to get into the cells to prevent the replication. It’s less stable of a compound. And so, what happens is the changeover. So you take it as an oral pro-drug, right? Your body starts converting it into Tenofovir before it reaches the target cells, meaning that you get a greater systemic exposure. So, Tenofovir, at its core, is nephrotoxic, meaning that it can harm your kidneys. It can do positive things, but it can also harm your kidneys. And so by allowing for this greater systemic exposure, what we’ve seen is that TDF medications do have a higher likelihood of causing problems with people’s kidneys. And in the worst cases causing end-stage kidney failure that requires them to be on dialysis, which is really an awful thing for anyone to go through.

Clay: It’s just a shame because these are individuals, these are patients with a terrible illness in a lot of cases. It’s an awful choice they have to make. Obviously, they didn’t know for years that this medication was potentially that harmful, and yet, when they’re facing the prospect of AIDS, the development of AIDS, it’s horrendous choice they have to make. In my reading, it seems like the company that developed TDF knew even prior to 2001, when the first class of these drugs came out, that TDF was toxic to the kidneys and quite potentially harmful to the human body. Isn’t that correct?

Whitney: That’s certainly what we believe. We’re still in the early stages of discovery. So we’re working through a lot of that. But yes, Tenofovir was nephrotoxic. Everybody knew it was nephrotoxic. We believe that the company knew that TDF had a greater likelihood to cause kidney damage in patients before it was approved.

Clay: An excellent point you’re making. And let’s stop for a second and say we’re both attorneys, and some of the things we’re talking about today are allegations made in complaints against the company. And the job of the plaintiffs is to go out there and prove it, so Gilead is going to certainly deny a lot of the allegations that we talked about today. Speaking of allegations and things we’ve discovered, along the way, at some point, Gilead came up or developed a safer alternative to TDF. Isn’t that true?

Whitney: So this is important. I don’t mean to sound like I’m correcting you because you’re the boss Clay, but it wasn’t at some point down the line. It was initially, I mean, we believe that they had these two drugs in the hopper at about the same time. So TDF and then its safer alternative, TAF, were kind of in existence at the same time. And Gilead, we believe, made the choice to shelve TAF, which ultimately proved to be a safer alternative, meaning it was as effective, if not more so, at preventing the spread of HIV, but it didn’t have the side effects of kidney failure and then ultimately bone mineral density issues and other fractures that we saw with the TDF drug. So it wasn’t that they got TDF on the market and they stumble on TAF at some time later. We believe that it was there to be seen and developed instead of TDF from the beginning.

Clay: I appreciate that distinction. And that actually gets to the heart of this thing and makes it a little more sinister if the plaintiffs are able to prove that it’s true. Tell me how TAF is noticeably safer than the TDF.

Whitney: So again, the active drug in TDF or in TAF is Tenofovir. And so, TAF stands for Tenofovir Alafenamide Fumarate. So the AF are the delivery agents and they’re more stable. What that means is when you take the oral medication, that is TAF, it stays in that encapsulated form longer and doesn’t begin the conversion process to Tenofovir until it actually reaches the target cells. So, it’s not causing all this systemic exposure because the switch over to TAF or Tenofovir isn’t happening while it’s in the body. It’s more stable. It’s a more stable compound, and so, it maintains its integrity until it gets in the target cells and then switches over to Tenofovir, which makes it more effective, we believe. But then also, it’s not causing the systemic exposure and being processed through the patient’s kidneys which can then cause a lot of the kidney issues that we’ve seen with folks who took Truvada and other TDF medications.

Clay: So to say it back to you: with both medications, TDF and TAF, their usefulness is because of the Tenofovir that’s present and it’s effective in slowing down HIV progression. But that said, the study shows that TAF is markedly safer than the TDF. Now, Gilead had both around the same time, we believe, chose to keep selling the TDF branded medications. Do you have a theory why?

Whitney: The theory would be to maximize profits. I hate to say it as bluntly as that, but with both on the market, you’re competing for the same population of patients. So, if you have one, that’s the only option on the market. You can extend the patent life of the drugs. Everybody’s heard of generic medications, right? So there’s a period of time, seven or ten years, when a drug gets approved. It’s the only game in town, if you will. And so, we believe, to maximize profits, Gilead wanted TDF drugs to be the only game in town, the only option with Tenofovir for prescribers so as to maximize their profits. Then, when they were approaching the end of patent life of the TDF medications, they would roll out the TAF drugs because they wouldn’t have the protection from generic competitors for TDF, so let’s try to switch everybody over to TAF because those are newly approved, we’re the only game in town now with the TAF drugs.

Clay: The implications are horrifying, if this is true, that for twelve, fifteen years, Gilead was making sure that TDF was front and center, and then they slow-waltzed the TAF medications which they knew to be safer. And again, some of these are allegations that must be proven. But I did read that the TDF drugs were the major part of the sales figures for Gilead in the early part of the 2000s, like as much as 68% of all Gilead sales in 2003. Is that your understanding?

Whitney: I’m not familiar with that number, but I have no reason to doubt it; it sounds right.

Clay: I talk a lot on my site about the profit motive that drives a lot of these corporations. We all know every corporation has a profit motive, but the extent to which the profit motive can drive devastating decisions for public health is just [horrifying]. I stumble on a new example of it every week it seems. So, in 2015, the TDF drugs were getting closer to the expiration of the patent, and Gilead started to move toward TAF medications. Is that right?

Whitney: Yes.

In Part 2, Clay and Whitney discuss the injuries that Tenofovir can cause, and the emerging litigation against Gilead.

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.

¿Qué es el paraquat?

Es un químico tóxico que se usa ampliamente en este país, particularmente en la mitad este de los Estados Unidos, donde hay muchas tierras de cultivo, huertos y áreas agrícolas. Se utiliza como herbicida, un asesino de plantas principalmente para el control de malezas y pastos.

También se utiliza como agente secante para ciertos cultivos; el término técnico para eso es desecante. También se utiliza como defoliante. Una vez más, su uso principal es controlar las malezas y pastos que crecen en un entorno agrícola cuando se intenta cultivar algún tipo de cultivo. También se usa como agente de secado para ciertos cultivos, como el algodón, antes de la cosecha.

La buena noticia es que el paraquat no es algo que se pueda obtener fácilmente. No es algo que pueda comprar sin receta; no puede conseguirlo en Lowe’s o Home Depot, o ciertamente no debería poder conseguirlo allí. Y no debe usarse para jardinería doméstica, control de malezas en su césped, nada de eso. De hecho, es un pesticida de uso restringido (RUP). Entonces, lo que eso significa es que debe tener una licencia para comprar el producto Paraquat. Debe ser un aplicador con licencia para comprar Paraquat para mezclarlo y aplicarlo en tierras de cultivo.

Desafortunadamente, es común que estas licencias de pesticidas de uso restringido sean utilizadas por personas que luego permiten que algunos de sus trabajadores apliquen el Paraquat en cultivos y otros entornos para el control de malezas. Por lo tanto, no son solo las personas con licencias las que pueden terminar siendo vulnerables a lesiones y enfermedades. Pero es cualquier trabajador el que manipula este producto.

Un artículo que leí sugirió que el paraquat se ha vuelto más popular en los Estados Unidos en parte porque algunas malezas y pastos se han vuelto resistentes al glifosato, que es el químico activo en Roundup y debido a eso, necesitan un herbicida más efectivo y ahí es donde el paraquat entra. Entonces, aunque es altamente tóxico, altamente peligroso, se ha vuelto más popular en los últimos 20 años.

Ahora, como escribí en un artículo hace unos meses en mi sitio web, www.northcarolinaproductliabilitylawyer.com, estaba presentando a mis lectores algunos de los conceptos básicos del Paraquat. Y una cosa que noté es que es altamente tóxico e incluso venenoso y que he leído que incluso un dedal lleno, si lo ingieres, podría ser fatal y, por lo tanto, es un químico horrible por razones de seguridad, incluso mientras que es muy eficaz para el control de malezas y el secado de cultivos como heno, algodón, cosas por el estilo.

Algunas de las marcas que puede encontrar Paraquat son Firestorm, Cyclone, Helmquat, Parazone, Parashot y Gramaxone. Entonces, esos son algunos de los nombres de marca, pero Paraquat es el nombre de este químico con el que estamos tratando y que continuaré usando hoy.

¿Quién usa paraquat?

Obviamente, los trabajadores agrícolas pueden tener acceso al paraquat y se les puede pedir que lo pongan en los cultivos, ya sea que lo estén rociando a mano, después de mezclarlo con agua o si están conduciendo un tractor y cubriendo grandes cantidades de tierra de cultivo. Los trabajadores agrícolas, fumigadores, aplicadores de pesticidas, trabajadores de camiones cisterna, casi cualquier persona que trabaje en la industria agrícola o trabaje con huertos o incluso viñedos, podría tener acceso al Paraquat. Una vez más, tiene que haber una licencia RUP, la licencia de pesticidas de uso restringido para comprarlo, pero creo que a las personas que trabajan con personas que tienen la licencia se les puede pedir que la apliquen. Cualquiera que trabaje en esta industria o en cualquiera de estas industrias debe ser consciente de que está ahí fuera y que podría ser peligroso para usted.

Déjeme decirle que si trabaja en la agricultura o en un viñedo o un huerto, probablemente sepa lo que está haciendo y probablemente sepa si el Paraquat está involucrado en el trabajo del día. Entonces, para esas personas, deben estar muy atentos y probablemente necesiten escuchar el resto de este podcast porque hay información de salud importante.

Entonces, he hablado de todos los lugares en los que el paraquat podría usarse como químico para el control de malezas o como agente secante: desecante. Los cultivos primarios que se utiliza para combatir las malas hierbas y se utiliza a menudo en relación con el cultivo de soja, algodón, maíz, arroz, tabaco. Se usa ampliamente en la mitad oriental de los Estados Unidos. Y eso es bastante obvio porque hay muchas tierras agrícolas en la mitad este de los Estados Unidos. Es muy común en mi casa, Carolina del Norte, porque hay muchas granjas en este estado y en toda la costa este. Si vive en esta parte del país, probablemente no esté lejos de una granja que haya utilizado Paraquat en el último año o más recientemente.

Paraquat y enfermedad de Parkinson

Los estudios han comenzado a indicar una conexión significativa y alarmante entre la exposición al Paraquat, el uso de Paraquat y el desarrollo de la enfermedad de Parkinson. Ahora, la enfermedad de Parkinson es un trastorno cerebral que puede provocar temblores, temblores, rigidez en el cuerpo, dificultad para mantener el equilibrio, la coordinación y caminar. Como ocurre con la mayoría de las enfermedades, estos síntomas suelen aparecer de forma gradual y quizás imperceptible durante meses o años. Pero a medida que la enfermedad progresa, las personas tienen más problemas con el temblor, más problemas para caminar y mantener el equilibrio, y puede convertirse en una enfermedad debilitante.

No entraré en demasiados detalles sobre la ciencia detrás de los estudios que muestran cómo la exposición al paraquat puede conducir a la enfermedad de Parkinson. Pero solo quiero hacer una discusión de alto nivel sobre por qué sucede y por qué los epidemiólogos y científicos creen que existe una conexión significativa entre la exposición al paraquat y la enfermedad de Parkinson.

El principal problema parece ser este concepto de estrés oxidativo. Es esencialmente un desequilibrio entre la producción y acumulación de especies y células reactivas al oxígeno y las defensas antioxidantes que pueden neutralizar estas especies reactivas al oxígeno. Hay muchos factores ambientales que pueden conducir a niveles dañinos de estrés oxidativo en el cuerpo y que pueden incluir condiciones no relacionadas con el paraquat o desencadenantes como obesidad, exposición a la radiación, fumar cigarrillos, contaminación, ese tipo de cosas. Pero lo que los científicos encuentran cada vez más en los estudios es que la exposición a pesticidas tóxicos y específicamente al Paraquat puede causar este estrés oxidativo extremo. Puede causarlo a un nivel tal que puede dañar áreas del cerebro que de otra manera podrían funcionar correctamente y causar lesiones y daños agudos, de modo que la enfermedad de Parkinson puede desarrollarse en el cerebro. Entonces, obviamente, hay más en la historia de la ciencia que conecta al paraquat con un mayor riesgo de desarrollar la enfermedad de Parkinson, pero eso le da una idea de por qué creen que esto está ocurriendo y cómo puede dañar una parte específica del cerebro que puede conducir a la enfermedad de Parkinson. enfermedad. Para obtener más información, existen estudios que puede leer y aprender más específicamente, si es una persona que pasó los últimos años (o incluso menos tiempo) trabajando en un entorno similar a una granja.

Regulaciones de paraquat

Al menos con respecto a los Estados Unidos, no ha habido una prohibición del Paraquat y la EPA, en octubre de 2020, volvió a aprobar el Paraquat para su uso en los Estados Unidos. Ahora, permítanme volver a enfatizar que no todos pueden comprar este producto. No puedo comprar Paraquat. Probablemente usted no pueda también. Debe tener una licencia de pesticidas de uso restringido para incluso comprar el químico. Hay etiquetas de advertencia serias en las botellas de Paraquat que hablan de lo venenoso que puede ser. Pero creo que es realmente importante y necesito enfatizar que la EPA toma la posición de que la conexión entre el paraquat y la enfermedad de Parkinson no es lo suficientemente fuerte como para justificar una prohibición. Entonces, aunque puede haber una fuerte advertencia en la botella de paraquat de que es tóxico e incluso fatal si se ingiere (y ciertamente puede matarlo si bebe cualquier cantidad), la EPA aún no está dispuesta a advertir al público consumidor sobre el ciencia creciente que muestra una conexión entre el paraquat y la enfermedad de Parkinson.

Ahora, aunque la EPA no ha prohibido el paraquat en los EE. UU., El químico ha sido prohibido en 32 países. Muchos países de Europa prohibieron el uso de paraquat en las décadas de 1980 y 1990. Estados Unidos no hará lo mismo y creo que eso es lamentable. Y, lamentablemente, creo que debe mencionarse que la negativa de la EPA a prohibir una sustancia química tan peligrosa en los Estados Unidos probablemente tenga algo que ver con la forma en que Estados Unidos siempre parece inclinarse ante los grandes intereses corporativos y las oportunidades de lucro y El paraquat es sin duda un producto químico rentable vendido por Syngenta y (durante un tiempo) Chevron, quienes resultarán ser los principales demandados en el litigio que está surgiendo sobre el paraquat.

Si quieres saber más sobre la conexión entre el cuidado de la salud y las abrumadoras obsesiones con las ganancias en este país, te invito a escuchar un podcast que hice hace unos meses con mi buen amigo el Dr. Jerome Hoffman. Se llama “Exceso de pruebas, diagnóstico y tratamiento: una conversación con el Dr. Jerome Hoffman”. Y en ese podcast hablamos mucho sobre cómo el afán de lucro en este país conduce a resultados muy infelices en la medicina, el cuidado de la salud y en toda la América corporativa.

Litigio de Paraquat: ¿Tiene un caso?

Los litigios relacionados con el paraquat van en aumento. No es ningún secreto que debido a que se ha demostrado que el paraquat aumenta el riesgo y quizás causa el desarrollo de la enfermedad de Parkinson, se han presentado demandas contra los fabricantes de Paraquat. Los dos acusados ​​clave en esta operación son Syngenta y Chevron USA (durante el período en que Chevron vendió Paraquat). Entonces, ¿tienes un caso posible? La respuesta es que debe marcar algunas casillas serias para ser elegible para una demanda aquí. Primero debe poder confirmar la exposición al paraquat. Todos los detalles son importantes en cualquier litigio, pero seguro que en este quieres poder establecer que trabajaste en un entorno agrícola, trabajaste en una finca, un huerto, un viñedo; debe poder establecer que usó Paraquat, lo aplicó a los cultivos, lo aplicó a los campos. Las fechas son muy importantes, al igual que los recibos. Si usted es una de las personas que tiene la licencia para comprar Paraquat, todos esos recibos son de vital importancia. ¿Con qué frecuencia aplicó el Paraquat y con qué frecuencia estuvo expuesto a él? Cualquier detalle como ese es muy útil.

Puede haber otras oportunidades para las personas que vivían cerca de las tierras de cultivo, tal vez justo al lado de una granja donde se realizaba regularmente el desempolvado de los cultivos o donde los tractores aplicaban Paraquat durante un período de meses o años. La proximidad puede ser otra forma de exponerse. Además, los científicos creen que la deriva en el aire puede provocar una exposición poco saludable. Si vive a cinco o diez millas de una granja donde se usa regularmente Paraquat y luego, a medida que pasan los años, desarrolla la enfermedad de Parkinson, entonces puede estar en línea para iniciar un litigio contra estos grandes acusados ​​de Paraquat.

En segundo lugar, debe tener un diagnóstico de enfermedad de Parkinson. Si no es un diagnóstico, debe presentar muchos de los síntomas asociados con la enfermedad de Parkinson. Pero déjeme ser muy claro: si ha estado expuesto al paraquat y tiene síntomas de temblores o temblores, dificultad para caminar, dificultad para mantener el equilibrio pero no tiene un diagnóstico de la enfermedad de Parkinson, me temo que debe obtener a un médico y obtener un diagnóstico y averiguar qué está mal. Debe hacerlo independientemente de lo que elija hacer con cualquier litigio.

También existen otras dolencias y enfermedades graves que pueden desarrollarse y que debe conocer. Si ha estado expuesto al paraquat y, aunque aún no tiene un diagnóstico de enfermedad de Parkinson, tiene enfermedad renal o insuficiencia renal o ciertos síntomas compatibles con la enfermedad de Parkinson, es posible que tenga un reclamo en el litigio de Paraquat.

Este litigio es muy nuevo, y recientemente se estableció un sitio de litigio multidistrital en junio de 2021, en un tribunal federal en el Distrito Sur de Illinois. Hasta la semana pasada, se presentaron 60 casos, pero obviamente pronto se presentarán docenas de casos más. Están aumentando los estudios que muestran una conexión real entre esta sustancia química seriamente tóxica y el desarrollo de una enfermedad horrible y debilitante: el Parkinson.

Esa es la historia del Paraquat de hoy. No es una historia feliz y espero que nunca haya estado expuesto a la sustancia química en el trabajo. Si estuvo expuesto y ha desarrollado esta enfermedad, es posible que desee investigar si debe participar en el litigio. Siempre puede comunicarse conmigo en mi firma Harris Sarratt & Hodges en Carolina del Norte. Mi número es (919) 830-5602.

Nuevamente, manténgase saludable, esté bien y buena suerte.

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.

After news broke that Zantac (the brand name for ranitidine) was linked to cancer, a large wave of lawsuits started making their way into state and federal courts. Many of these cases have been consolidated into the Zantac multi-district litigation, or MDL 2924.

The Zantac MDL is still in the early stages of litigation, but the court just handed down two major decisions that could dramatically undermine a majority of the cases and claims.

We’ll go over these two decisions, but before we do, we need to provide a little context. We’ll start with outlining the defendants and claims in the Zantac MDL, then discuss a legal concept called “preemption.”

The Defendants in the Zantac MDL

There are five main groups of defendants in the Zantac MDL:

• Brand-Name Manufacturers of Zantac
• Generic Manufacturers of Ranitidine
• Distributors of Ranitidine Products
• Retailers of Ranitidine Products
• Repackagers of Ranitidine Products

To learn more about each of these defendants, you can check out my blog post, Zantac Litigation Master Complaint Key Points, Part 1: The Parties Involved.

The Allegations in the Zantac MDL

The plaintiffs in the Zantac MDL set out their allegations in the following three master complaints:

• Master Personal Injury Complaint (MPIC)
• Consolidated Consumer Class Action Complaint (CCCAC)
• Consolidated Third Party Payor Class Complaint (CTPPCC)

There is a fair amount of overlap concerning the overall gist of the allegations in these complaints. Causes of action among the complaints include various strict products liability claims, as well as claims relating to negligence, breach of warranties, violations of consumer-protection laws, violation of the Magnuson-Moss Warranty Act, and derivative claims (like loss of consortium and wrongful death).

The MPIC and CCCAC include both the generic manufacturers and repackagers of ranitidine as defendants. The CTPPCC includes generic manufacturers of ranitidine as defendants, but not repackagers of ranitidine.

After these complaints were filed, the generic manufacturer and repackager defendants (collectively, Generic Defendants) filed a motion to dismiss and the retailer and distributor defendants (collectively, Retailer Defendants) filed two motions to dismiss.

On December 31, 2020, the Zantac MDL court granted the Generic and Retailer Defendants’ motions to dismiss based largely on preemption grounds. These rulings have the potential to undermine and even end a majority of the Zantac MDL plaintiffs’ claims. But what is preemption and why does it matter?

Preemption and Why It’s Kind of a Big Deal in the Zantac MDL

Preemption is the legal principle that says federal law is the supreme law of the land. In other words, when federal law conflicts with state law, federal law wins (or “controls”). Preemption sometimes comes into play when plaintiffs sue generic drug makers (and related parties, like repackagers) for injuries from their products.

Most medicines and drugs sold in the United States are subject to regulation by the U.S. Food and Drug Administration (FDA). This includes rules about labeling, safety, effectiveness, when a drug can be sold as a generic and so on. But many personal injury claims involving pharmaceuticals arise from state law.

The FDA has established very specific rules about how generic drug manufacturers can sell a name-brand drug as a generic. After a name-brand drug is approved by the FDA (including how it’s labeled) generic drug companies who want to sell that name-brand drug are limited in what changes they can make to the drug. Without getting into the nitty-gritty, a generic drug company cannot substantially alter the drug or its label, including warnings placed on the packaging.

So let’s say a plaintiff uses state law to bring a personal injury lawsuit against a generic drug company claiming it didn’t properly warn patients of the risks when taking the drug. This puts the generic drug company in an unfair situation.

The generic drug company is being sued under state law for not changing the warning label of the drug. But federal law prohibits the generic drug company from making that label change. This is a conflict between state and federal law, so preemption comes into play and dismisses the failure to warn claims based on state law.

This means that the plaintiff’s legal case against the generic drug company is often effectively over because federal law overrides state law, leaving the plaintiff with few legal options to pursue a meaningful recovery.

This is largely what happened concerning the Generic and Retailer Defendants’ motions to dismiss. Now we can take a look at each motion more closely.

The Generic Defendants’ Motion to Dismiss

In its motion to dismiss, the Generic Defendants made the majority of their arguments relying on the theory of preemption. These arguments applied, at least in part, to the following plaintiffs’ claims:

• The generic drugs had labeling and product defects.
• The Generic Defendants should have conducted more testing of their generic drugs.
• The Generic Defendants should have adjusted the expiration date of the generic drugs.
• Ranitidine should have been stored and transported differently.
• The Generic Defendants should have warned the FDA about ranitidine’s cancer risk.
• The generic drugs had a manufacturing defect.
• The Generic Defendants violated the Magnuson-Moss Warranty Act
• The Generic Defendants have absolute liability for the harm plaintiffs suffered from taking ranitidine.
• Generic Defendant’s liability has led to derivative claims, including wrongful death and loss of consortium.

In deciding the motion to dismiss, the court sided with the Generic Defendants on every single point, largely relying on preemption. But that’s not the worst part for the plaintiffs.

The worst part is that not only did the court agree to dismiss all the claims, but it agreed that many of them should be dismissed “with prejudice.” That means that those claims cannot be rewritten and refiled and are lost forever.

Often, courts will grant a motion to dismiss, but give plaintiffs an opportunity to revise and adjust their legal arguments. This is called dismissing the claims “without prejudice.”

In this scenario, a court is telling plaintiffs that their arguments will not succeed as currently presented, but the plaintiffs might be successful if they replead the same legal arguments differently in an amended complaint.

In this Zantac MDL, the court only granted this “do-over” opportunity with the following plaintiffs’ claims:

• Expiration dates
• Testing
• Storage and transportation methods
• Warning the FDA
• Manufacturing defects
• Magnuson-Moss Warranty Act
• Derivative claims

Notice what’s missing: claims concerning product and labeling defects and absolute liability. These are among the strongest claims being made by the plaintiffs in the Zantac MDL.

The Retailer Defendants’ Motions to Dismiss

There were two motions to dismiss that were decided by the court.

In the first motion to dismiss, Retailer Defendants’ arguments were very similar to the Generic Defendants. Basically, Retailer Defendants argued that preemption required the court to dismiss the bulk of plaintiffs’ claims, including:

• Absolute liability
• Misbranding of products containing ranitidine
• General negligence
• Violations of the Magnuson-Moss Warranty Act
• Derivative claims, including wrongful death and loss of consortium

Just like with the Generic Defendants’ motion to dismiss, the court largely relied on preemption to dismiss every single one of the plaintiffs’ counts against the Retailer Defendants.

The court also allowed the counts to be dismissed with prejudice, except the plaintiffs’ claims for general negligence (to the extent they do not include arguments relating to the adequacy of the ranitidine label or the design of ranitidine), derivative claims and violations of the Magnuson-Moss Warranty Act. The plaintiffs were granted leave to amend their complaints to replead these claims.

Regarding the Retailer Defendants’ second motion to dismiss, the court denied it as moot, as it was based on arguments made in the first motion to dismiss.

Now What Happens in the Zantac MDL?

The court will soon release its decision concerning the Zantac brand-name manufacturers’ motion to dismiss. This is another very important court ruling that could have major implications on the Zantac MDL moving forward.

Plaintiffs will then have 30 days after the court releases that pending decision to file their amended complaints concerning the Generic and Retailer Defendants.

But the Zantac brand-name manufacturers’ motion to dismiss also relies heavily on preemption arguments. We still believe many viable and important claims will survive against the makers of Zantac, but recent court decisions have not been kind to certain plaintiffs in the Zantac litigation.

If you believe you have been harmed by Zantac, call me: (919) 830-5602.

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.

Health care is an industry that, for the most part, is pretty quick to make the most of new technology. One such area is medical records.

With the increased capabilities and reduced costs of computers, networks and electronic storage, electronic health records (EHR) are primed to take full advantage of what information technology has to offer the medical field. These advantages can include better cost efficiency and improved patient care.

That’s one reason why Congress passed the Health Information Technology for Economic and Clinical Health Act (HITECH Act). This law set out to promote the use and adoption of EHR and medical information technology.

One of the things the HITECH Act did was establish rules concerning access to patient EHR, including who can access them and how much it costs to obtain a copy of these records. But a court case just made it more expensive for attorneys acting on behalf of patients to obtain these records. This could have a notable impact on a plaintiff’s ability to recover for injuries caused by a negligent company or individual.

Access to Medical Records: An Overview

After the passage of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the U.S. Department of Health and Human Services (HHS) created regulations that outlined a patient’s right to his or her medical information.

Specifically, 45 CFR § 164.524 set out how someone could review or obtain copies of his or her health care records. These regulations also set out how much a medical provider could charge individuals for obtaining copies of their records.

Basically, this regulation said that a medical provider could only charge patients a reasonable, cost-based fee (Patient Rate). This meant that the fee could only include actual production costs, such as labor, materials, and postage for producing and sending the documents to the patient.

When passed in 2009, the HITECH Act made a few changes. It not only streamlined a third party’s ability to get a copy of a patient’s EHR (with the patient’s permission, of course), but it further limited the fee that the medical provider could charge patients.

In 2013, HHS released new regulations relating to access to EHR. One of the things these regulations did was allow a patient to get a medical provider to send any of his or her medical records to a third party, even if it wasn’t an EHR.

Then a big change came in 2016, when the HHS release its Guidance titled “Individuals’ Right under HIPAA to Access their Health Information 45 C.F.R. § 164.524.” This provided additional information on how to calculate the Patient Rate, including the option for a flat rate of $6.50. But most importantly, the 2016 Guidance allowed third parties to pay the Patient Rate only as long as they were getting the documents at the request of the patient.

But a court case from January 2020 changed all this.

Ciox Health, LLC v. Alex Azar

Ciox Health, LLC (Ciox) is in the business of processing patient medical information on behalf of health care providers. Ciox’s pricing model relied on the understanding that the Patient Rate only applied to individuals who were asking for copies of their own medical records. But when patients asked that their records go to a law firm or insurance company, Ciox could charge a fee that far exceeded the Patient Rate.

But thanks to HHS’ 2016 Guidance, third parties only had to pay the Patient Rate, which was sometimes just $6.50. This was a problem for Ciox because it meant a significant loss in revenue.

So what did Ciox do? It did what almost any other business might do when the government makes a law or rule that cut into their profits – it sued.

Ciox won its case when the U.S. District Court for the District of Columbia concluded that HHS was not allowed to apply the Patient Rate to third parties and that patients could only ask for their EHR to be sent to a third party (as opposed to any medical records, regardless of format).

What the Ciox Case Means for Plaintiffs

This case means that injured plaintiffs will now have the added burden of not just requesting their medical information, but once receiving it, forwarding it to their attorney. Or if plaintiffs want the information sent directly to their attorneys, there will be a much higher fee, often in the hundreds of dollars.

Many attorneys will probably be the ones to advance this large hard-cost expense. But in the end, everyone will pay.

The plaintiff will be expected to pay litigation hard-costs from the proceeds of any settlement or trial verdict. If the case is lost, the attorney usually pays these litigation costs, which could make attorneys less likely to take on winnable but risky cases in the future. If it’s just one case, it’s not a big deal. But many injury law firms could have dozens or hundreds of cases where they have this new expense. Now we’re talking tens if not hundreds of thousands of dollars in hard cost expenses.

The defendant will also eventually pay, because these added costs for obtaining medical records will indirectly factor into any verdict or settlement.

Congress or HHS should make changes that make it more affordable for patients to get copies of their complete medical records to their lawyers, insurance companies or other third parties. Until then, plaintiffs and defendants can expect the litigation process to get even more expensive.