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.

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

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

How Is AFFF Potentially Harmful?

AFFF contains a variety of chemicals, but two of the most relevant here are perfluorooctane sulfonate (PFOS) and perfluorooctane acid (PFOA). These chemicals are also used in other consumer products, like nonstick surfaces and stain-repellant coatings. They also belong to a family of chemicals called perfluoroalkyl and polyfluoroalkyl substances (PFAS).

When PFAS enters the human body, whether it’s ingested, inhaled or absorbed through the skin, it starts to accumulate. It doesn’t get metabolized or processed by the human body and it doesn’t get filtered out either. Over time, the amount of PFAS can build up in the human body and potentially cause health issues. Some of these problems may include:

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

The relationship between PFAS and cancer isn’t definitive, but studies suggest a possible link. Given the potential health risks from PFAS, many companies no longer use or make these chemicals.

Individuals may have been harmed by the AFFF through exposure during their jobs or from PFAS from the AFFF finding its way into their drinking water.

Pending PFAS Litigation

The primary focus of much of the litigation concerning AFFF, PFOA, PFOS and PFAS lies with the Aqueous Film-Forming Foams Products Liability Litigation MDL No. 2873 (AFFF MDL). This MDL (multi-district litigation) is before Judge Richard Gergel in the U.S. District Court for the District of South Carolina and he’s overseeing more than 4,000 lawsuits.

The plaintiffs include individuals and state and local government entities while the defendants include chemical companies like 3M, Tyco Fire Products, DuPont De Nemours (DuPont), Corteva and the Chemours Company (Chemours). Also included as a defendant is the U.S. government.

After litigation began, one of the major defenses that the chemical company defendants relied on was the government contractor defense. This was because much of the AFFF was used by firefighters working on military bases or on behalf of the federal government.

The government contractor defense basically says that a company doing business with the government can avoid legal liability in certain situations because they can sometimes share in the government’s legal immunity from lawsuits. However, Judge Gergel denied the motion for summary judgment that the defendants filed in August 2022 which relied heavily on this defense. This didn’t mean the defense wouldn’t work, but the defendants would have to wait until trial to present this defense.

Possible Settlements

On June 2, 2023, three defendants in the AFFF MDL announced a tentative settlement agreement amongst themselves. The defendants subject to this agreement included Chemours, DuPont and Corteva. The settlement would only apply to certain plaintiffs, largely municipal public water systems.

The three defendants will contribute $1.185 billion to a settlement fund. DuPont would provide about $400 million, Corteva approximately $193 million and Chemours contributing the bulk of the settlement money of roughly $592 million.

What’s Next?

These three defendants hope to finalize the settlement agreement over the next month or so, although there are two potential hurdles before the settlement becomes official.

First, Judge Gergel has to approve the settlement. Second, assuming the judge approves the settlement, enough plaintiffs must consent to the settlement and opt into it. If too many plaintiffs decline the settlement, then Chemours, DuPont and Corteva reserve the right to cancel the settlement and proceed to trial.

Another thing to keep in mind is that even if this settlement gets approved and enough plaintiffs accept it, there will still be many plaintiffs and defendants in the AFFF MDL that still have pending cases that could go to trial or get settled at a later time. For example, 3M, another prominent defendant in the AFFF MDL is rumored to have agreed to a settlement of at least $10 billion.

If you’d like to learn more about this litigation or think you might have been affected by AFFF, don’t hesitate to contact me (direct line) at (919) 830-5602. And if you’re curious about whether AFFF has potentially contaminated your drinking water, you can check out the Environmental Working Group’s PFAS Contamination in the U.S. map.

To most people, Johnson & Johnson (J&J) is a respected company and the maker of popular consumer products. However, J&J has taken quite a hit lately with both its reputation and finances.

Specifically, J&J has been accused of causing cancer in thousands of individuals due to the alleged presence of asbestos in its baby powder products. As a result, tens of thousands of plaintiffs have sued J&J, with notable results amounting to billions of dollars.

Even though J&J has successfully survived or settled many of these cases, it only takes a handful of plaintiff wins to cause serious financial damage to the company. Because of this, J&J employed a sneaky and ambitious plan called Project Plato.

What Is Project Plato?

Project Plato worked by allowing J&J to create a new company (officially known as LTL Management) that would take on J&J’s talcum powder legal liabilities. LTL Management would then declare bankruptcy and treat any potential plaintiffs relating to the asbestos talcum powder lawsuits as creditors. This maneuver has been referred to as the Texas Two-Step.

Because LTL Management would have a relatively small amount of assets, these plaintiffs/creditors would likely receive less money than if they sued J&J directly. As for J&J itself, it would be free of the legal and financial risks from these talcum powder lawsuits.

It’s an ingenious plan, and you can read more about it in an earlier blog post I wrote. Yet the cleverness of the plan doesn’t stop it from being very unfair to potential asbestos baby powder victims. As you might imagine, plaintiffs weren’t happy about Project Plato and opposed its use.

Legal Opposition to Project Plato

LTL Management filed Chapter 11 bankruptcy in North Carolina, given the success of earlier schemes similar to Project Plato that were filed there. At the time of the filing, there were more than 38,000 lawsuits against J&J alleging its baby powder products contained asbestos which caused the plaintiffs’ ovarian cancers.

Fortunately for the plaintiffs, the North Carolina bankruptcy court moved the case to a bankruptcy court in New Jersey. Once the case got to bankruptcy court in New Jersey, the plaintiffs asked the court to dismiss LTL Management’s bankruptcy petition claiming it was not filed in good faith.

Turns out the “good faith” bankruptcy test that the New Jersey bankruptcy court would use was more generous to the plaintiffs than the equivalent test used by the North Carolina bankruptcy court. Coincidence? Probably not.

Despite this more lenient standard, the New Jersey bankruptcy court refused to dismiss LTL Management’s bankruptcy petition. The plaintiffs appealed the decision to the U.S. Court of Appeals for the Third Circuit (Circuit Court), which ruled in their favor and dismissed LTL Management’s bankruptcy petition.

Why the Circuit Court Struck Down Project Plato

If you’d like to get into the weeds and read about the nuanced legal arguments, feel free to take a look at the Circuit Court’s opinion. But in essence, the Circuit Court concluded that LTL Management did not file its bankruptcy petition in good faith because it was not in “financial distress.”

The Circuit Court recognized that a company can be in financial distress even though it wasn’t yet insolvent. By way of (strained) analogy, you didn’t have to be on the verge of death before you were allowed to go see a doctor.

But how much financial trouble did a company need to be in before it could file for bankruptcy in good faith? Answering that question was tricky, and in finding that LTL Management wasn’t in financial distress, the Circuit Court noted the key fact that despite LTL Management’s legal liabilities, it had access to $61.5 billion from J&J.

In other words, J&J was like a super-rich co-signer on a debt that LTL Management had to pay. So even though LTL Management’s creditors might not be able to get much from LTL Management, they could still recover money from J&J.

There was also the fact that despite a few notable legal losses, J&J handled many of the asbestos baby powder lawsuits against it. For example, J&J settled about 6,800 claims for a little less than $1 billion.

To put this in perspective, the $4.69 billion (later reduced to $2.1 billion) that ovarian cancer plaintiffs won against J&J was divided among 22 women. So while J&J was spending a lot of money to resolve the talcum powder lawsuits against it (J&J’s legal costs totaled between $10 million and $20 million per month), it wasn’t nearly as bad as J&J wanted the bankruptcy court to think.

What Happens Next?

J&J indicated that it would appeal, although it’s not clear if it will appeal to the U.S. Supreme Court or for an en banc review of the decision by the full Third Circuit Court of Appeals. Either way, J&J will face an uphill battle.

Assuming J&J’s appeal is unsuccessful, the dismissal of LTL Management’s bankruptcy petition is a major win for mass tort plaintiffs. However, things may not be over just yet.

For instance, despite ruling against the use of Project Plato, the Circuit Court left open the possibility of defendants in mass tort lawsuits using a variation of Project Plato. Any new approach would need to strike a delicate balance between giving the debtor company enough assets to avoid a fraudulent transfer claim, but not too much where it’s deemed to not be in financial stress.

Finally, we need to keep in mind that the Circuit Court’s decision, assuming it stands, only applies to federal cases in New Jersey, Delaware and Pennsylvania. Despite this limitation, the decision should still have some influence in other courts across the country.

For now, claims against J&J for alleged injuries caused by its baby powder products will likely continue. If you have any questions about bringing your own claim for injuries due to talc-based products containing asbestos, feel free to reach out to me.

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.

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.

Earlier this year I wrote a blog post that discussed the recent revelation that Zantac might cause cancer. Scientists found a link between N-Nitrosodimethylamine (NDMA), a likely cancer-causing substance, and ranitidine, the key ingredient in Zantac.

A few things have changed since that blog post, such as the U.S. Food and Drug Administration (FDA) asking all manufacturers to immediately recall drugs containing ranitidine from the market.

Why Did the FDA Ask for a Recall?

The FDA based this decision on its findings that the levels of NDMA could increase over time when stored at higher than room temperatures. The FDA’s new testing found that “NDMA levels increase in ranitidine even under normal storage conditions.” The FDA also discovered that “the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA.”

There is debate on how the NDMA makes its way into medications such as Zantac. The FDA sometimes seems to take the approach that the NDMA is an impurity found in medications with ranitidine. However, the major theory is that as ranitidine breaks down in the human body, it creates very high levels of NDMA.

One study from 2016 supports this theory. Ten adults each took just 150mg of ranitidine (the recommended dose is 150mg, twice a day) with scientists analyzing their urine for 24 hours. They found that NDMA levels in the urine increased by a factor of 400.

Despite this massive increase, it’s still a conservative number. That’s because the human body will metabolize some of the NDMA before it can be removed through urine.

Regardless of how the NDMA finds its way into the human body, it’s clear that NDMA is something that people should avoid, especially for its increased cancer risks.

How Does NDMA Cause Cancer in Humans?

The World Health Organization explains that NDMA causes cancer when a particular enzyme converts NDMA into a methyldiazonium ion. This ion then leads to DNA damage, which can turn healthy cells into cancerous cells.

The U.S. Environmental Protection Agency (EPA) classifies NDMA as a “B2 (probable human) carcinogen.” This is based on studies that have found cancer in the liver, kidney and lungs of several different types of laboratory animals. Other studies have potentially linked NDMA to other cancers, such as pancreatic cancer, stomach cancer and bladder cancer.

Currently, there is the fear that Zantac and other medications containing ranitidine can lead to many types of cancers, including:

• Small intestine cancer
• Colorectal cancer
• Esophageal cancer
• Throat cancer
• Nasal cancer
• Thyroid cancer
• Liver cancer
• Brain cancer
• Colorectal cancer
• Kidney cancer
• Breast cancer
• Lung cancer
• Ovarian cancer
• Prostate cancer
• Testicular cancer
• Uterine cancer
• Multiple myeloma
• Non-Hodgkin lymphoma

It’s thought that this cancer risk is cumulative, which means the more someone takes ranitidine, the higher that person’s risk of developing cancer. The problem is that until last year, the widespread view by medical professionals was that ranitidine was an extremely safe drug. This means potentially millions of people were taking ranitidine non-stop for years and even decades.

Currently, more research is underway to better understand the links between NDMA and cancer, including exactly what types of cancers are the result of medications containing ranitidine.

If you have taken Zantac or any other drug with ranitidine for an extended period of time and have been diagnosed with any of the above cancers, it’s possible that your cancer was the result of you taking ranitidine.

As scientists complete their research and learn more, I’ll be sure to provide additional updates and information. In the meantime, feel free to call me at (919) 830-5602 if you have any questions, and if you took Zantac for an extended period and later developed cancer, call me to discuss your potential case against the pharmaceutical company Sanofi.

With the rise of Type 2 diabetes in the United States, drug makers have attempted to meet the demand for treatments to lower blood sugar levels in patients. A variety of drugs such as saxagliptin, alogliptin, linagliptin, sitagliptin, exenatide and liraglutide were developed to help patients treat their Type 2 diabetes. Several of these drugs have resulted in unexpected problems. One specific drug in particular is saxagliptin, which goes by the trade name “Onglyza.”

What Is Onglyza?

Onglyza was co-developed by Bristol-Meyers Squibb and AstraZeneca and is a DPP-4 inhibitor. It works by increasing the levels of incretin (a type of hormone) in the body. Incretins lower blood glucose levels by reducing the amount of sugar the liver makes and increasing the amount of insulin released by the pancreas.

In conjunction with diet and exercise, Onglyza is supposed to help adults with Type 2 diabetes control their blood sugar levels and avoid long-term health issues, such as nerve damage, blindness, kidney damage and heart problems. Ironically, it ended up increasing the risk of suffering from some of these ailments.

Are There Health Problems?

In a small number of drug users, there is an increased risk of headache, upper respiratory tract infection, urinary tract infection, severe joint pain and hypoglycemia (low blood sugar).

More serious problems include an increased risk of heart failure and a potential link to pancreatitis and pancreatic cancer. A 2013 study found a 27% increased risk of hospitalization due to heart failure. As a result of this data, the US Food and Drug Administration’s (FDA) set up a special panel to review Onglyza. Out of the 15 panel members who voted, 14 of them voted to update the drug’s warning label to reflect this heart failure risk. The lone holdout? That panelist voted to remove Onglyza from the US market entirely.

There were also studies involving DPP-4 inhibitors that found an increased risk of pancreatitis (inflammation of the pancreas) and pancreatic cancer. To be fair, the connection between the DPP-4 inhibitor family of drugs and pancreatitis and pancreatic cancer is not conclusive. However, precancerous cells and benign tumors (called adenomas) have been found in the pancreases of patients who had been taking DPP-4 inhibitors.

Are There Any Lawsuits Involving Onglyza?

Currently, there are a few lawsuits in the court system, but this number will increase. Most industry watchers expect an increase because of post-release studies involving Onglyza.

During clinical testing, Onglyza met the FDA cardiovascular safety requirements, but barely. So the FDA wasn’t fully convinced that the drug was safe for the heart and ordered the drug makers to conduct additional testing once Onglyza was approved for sale to the general public.

A test of over 16,000 individuals over approximately two years revealed the 27% increased risk of hospitalization due to heart failure. This means that there are a lot of patients who took Onglyza before updated heart failure warnings were ordered by the FDA.

Additionally, there is much more extensive litigation of other, related drugs. Drugs with brand names such as Victoza, Januvia, Byetta and Janumet are already in multi-district litigation, or MDL. Given the similarities between these drugs and Onglyza with respect to how they work and problems associated with taking them, it’s probable that the makers of Onglyza will see themselves in a comparable legal fight.

The Future of Onglyza

Determining whether Onglza and its makers face large scale litigation is impossible to predict with certainty, but it is anticipated. If there are any significant developments, I’ll be sure to provide an update.

Cancer is rough. It is a disease that has caused massive suffering, and virtually every family will be affected by it at some point. Doctors and scientists have tried to treat or cure cancer in patients ever since humans have existed as a species. In fact the name of this disease originates from ancient doctors who treated cancer and observed how a tumor’s appearance reminded them of crabs (cancer is Latin for crab).

Despite these efforts at fighting cancer over thousands of years, there is no complete cure and many current treatments, such as chemotherapy, have severe side effects.

Because of chemotherapy’s significant side effects and a general inability to completely cure the patient, a cost benefit analysis has always been important for cancer patients. Many cancer patients have to ask themselves if going through several weeks or months of misery is worth adding months or years to their lives. It’s an awful choice to make.

In making these decisions, cancer patients must rely on information from cancer drug companies, as well as their own doctors, to understand a chemotherapy drug’s effectiveness and side effects. Unfortunately, it appears one particular cancer drug maker, Sonafi SA, may have covered up the truth about its chemotherapy drug Taxotere in order to boost profits, regardless of what harm the drug may have caused to patients taking it.

What Is Taxotere?

Taxotere is the brand name for the cancer drug Docetaxel. It works by damaging the physical structure of cells so that cells cannot divide and reproduce. Taxotere has been used largely to treat breast cancer, but it has also been used to treat:

• Lung cancer
• Stomach cancer
• Neck and head cancer
• Prostate cancer

Like other chemotherapy drugs, Taxotere attacks both “good” and cancerous cells. This often leads to notable side effects, including:

• Fatigue
• Nausea and vomiting
• Diarrhea
• Muscle and joint pain
• Fingernail and toenail damage
• Shortness of breath
• Mouth sores
• Swollen hands and feet
• Loss of appetite
• Hair loss, both temporary and permanent

The side effect of hair loss is not initially notable because it’s one of the most common chemotherapy drug side effects. What is notable is that the hair loss can sometimes be permanent, despite Sonafi SA’s assertions to the contrary.

What Sonafi SA Did Wrong?

The alleged wrongs of Sonafi SA revolve around misinforming cancer patients in two primary ways. First, it is alleged that Sonafi SA covered up data from studies that showed that Taxotere not only caused permanent hair loss, but did so at a rate much higher than comparable chemotherapy drugs.

Second, it is also alleged that Sonafi SA falsely marketed Taxotere as being more effective than other chemotherapy drugs. Basically, similar chemotherapy drugs worked just as well as Taxotere, but they also did so with a smaller likelihood of permanent hair loss. Sonafi SA allegedly went to great lengths to prevent cancer patients from learning this fact.

Taxotere Litigation

As a result of the above allegations, thousands of cancer patients have sued Sonafi SA and its affiliated business entities. Currently, there are over 1,000 lawsuits involving Taxotere in the multi-district litigation or MDL located in the Eastern District of Louisiana. This number is expected to rise because the MDL consolidation effort will also include cases that involve generic versions of Taxotere.

The Taxotere MDL is currently in the early stages of litigation, although it has been reported that Judge Kurt D. Engelhardt overseeing the MDL has pushed the attorneys involved to focus on settling the cases and less on preparing for trial. We will see how that takes shape.

If the Taxotere MDL cases settle, it may take a while, but Judge Englehardt has a reputation of making settlements happen. I will let you know if there are any significant developments.

According to the American Society of Plastic Surgeons almost 280,000 breast augmentation procedures took place in the United States in 2015. Given the popularity of breast implants, a wide range of breast implant products have been released in the United States and the rest of the world. One such product is the textured breast implant.

Why Are Breast Implants Textured?

The purpose of adding texturing to the breast implant surface is to help the body keep the implant in place and avoid it from shifting. Another reason is to prevent a complication called capsular contracture, which occurs when the scar tissue that forms around the implant become painful and hard.

Despite these logical reasons for using textured breast implants, the Food and Drug Administration (FDA) has concluded there is a clear link between textured breast implants and Anaplastic Large Cell Lymphoma.

What is Anaplastic Large Cell Lymphoma?

Anaplastic Large Cell Lymphoma, or ALCL, is a rare type of non-Hodgkin’s lymphoma, or cancer of the blood. In ALCL, the white blood cells grow uncontrollably and can spread to the lymph nodes and skin, in addition to the breast itself. ALCL is not breast cancer and if found early it can be effectively treated, although it can be fatal if not treated soon enough.

One of the common forms of treatment involves removing the breast implant along with the scar tissue capsule surrounding it in a procedure called capsulectomy. About 70% of the time, this is the only treatment needed to be cured of ALCL, although radiation and chemotherapy may also be required.

Common symptoms of ALCL include:

• Ongoing pain in the area surrounding the breast implant (this is the most common symptom)
• Fluid buildup, lumps or hardening masses surrounding the breast implant
• Fever
• Backache
• Fatigue
• Swelling of the lymph nodes

The Connection Between Textured Breast Implants and ALCL

In 2011, the FDA noted a possible connection between textured breast implants and ALCL. However, in March of this year, the FDA officially recognized the link between textured breast implants and ALCL.

Of the 231 medical device reports the FDA received where individuals who had ALCL also indicated the type of breast implant they received, 203 of the ALCL patients had textured breast implants while only 28 had smooth surface breast implants. This is a troubling statistic, and more study is needed.

Ideally, more data would be available for analysis, but unfortunately, it’s been somewhat sparse. For example, even though there were 231 ALCL medical device reports the FDA received identifying the breast implant type, 128 of the reports made no mention of the breast implant surface type. Currently, there is no comprehensive database of breast implant recipients and ALCL sufferers although efforts are being made to create one. It is critical that we get more information.

How Does the Textured Surface Cause ALCL?

This is likely the multi-billion dollar question because right now, no one seems to know for sure why textured breast implants result in a much higher rate of ALCL.

One reason for this lack of clarity is that multiple companies offer textured breast implants and the implants have different types of texturing and there are different ways of manufacturing the textured surface. However, there is one predominant theory to explain the link between a textured surface and ALCL.

This explanation is that ALCL is caused by a bacterial infection in the textured surface that starts an inflammatory response in the body. It has been established that certain types of lymphoma can be caused by chronic infections.

Does This Mean I Can Sue if I Have a Textured Breast Implant?

We are still early in the process. The FDA recognized the link just a few months ago. But if you suffer from ALCL after getting textured breast implants, it’s important (1) to get medical treatment immediately and (2) to keep detailed records of your pain, your medical care, medical bills, and any other vital information relating to your ALCL.

These companies manufacture textured breast implants, and it is important for them to study the issue immediately and thoroughly as we move forward:

• Allergan
• Sientra
• Mentor
• Ideal Implant, Inc.

So What Now?

Basically, we wait-and-see. The FDA does not recommend patients have their breast implants removed unless they have symptoms of ALCL or other adverse reactions to the textured breast implants. If you suffer any problems with your textured breast implants, you should see your doctor as soon as you can.

I will update this information as I receive more news, so keep checking back with me.

As if erectile dysfunction were not harrowing enough. In March 2016 a published study concluded that the use of the drug sildenafil (Viagra), vardenafil (Levitra), and tadalafil (Cialis) “could promote melanoma in humans.”

As you probably know, melanoma is the most aggressive and most dangerous form of skin cancer. Melanoma develops when damage to skin cells (usually caused by ultraviolet radiation from sunshine or tanning beds) triggers mutations that lead the skin cells to multiply rapidly and form malignant tumors. Most people think of melanoma as dark, asymmetrical moles, and in fact melanoma can develop from existing moles, but melanoma can also form directly on the skin. Melanoma is often caused by intense, sustained exposure to ultraviolet light, the kind which causes suntans and sunburns. Melanoma has been estimated to cause over 10,000 deaths in the United States each year.

The Latest Study

A team of researchers recently published findings from a study of the potential connection between the increased risk of melanoma in humans who take erectile dysfunction drugs like Viagra. The study is titled Sildenafil Potentiates a cGMP-Dependent Pathway to Promote Melanoma Growth, which you can access here. This study identified a pathway in the cells of the human body which can permit the growth of melanoma. The science behind the study is complex and technical, but let’s give it try:

Sildenafil (Viagra) is a phosphodiesterase 5 inhibitor (PDE5). When PDE5 is inhibited, a man has the enhanced ability to gain an erection. And that’s a good thing. Unfortunately, according to the study, the inhibition of PDE5 in the human body also increases the level of “cyclic guanosine-3′, 5′-monophosphate” (cGMP), which is described as “a signaling molecule,” and increased levels of cGMP in the body promotes “mitogen-activated protein kinase” (MAPK), which is a pathway in the molecules associated with the increased growth of melanoma cells. When PDE5 is not inhibited, there are low cGMP levels and less active melanoma growth. But when sildenafil or other drugs inhibit PDE5, it causes a molecular reaction which promotes the malignant growth of melanoma cells. So the inhibition of PDE5 increases cGMP levels, which promotes MAPK, which encourages melanoma cell growth. Got it?

Vardenafil (Levitra) and tadalafil (Cialis) are also PDE5 inhibitors. The study states that Levitra and Cialis would also operate like Viagra to promote melanoma cell growth through similar molecular reactions.

Other studies have linked the use of Viagra to an increased risk of melanoma, including one from the Journal of American Medical Association (JAMA) in 2014.

Viagra Maker Denies Increased Melanoma Risk

Pfizer is the manufacturer of Viagra, the first and most popular of the drugs used to treat erectile dysfunction. Pfizer has denied any increased melanoma risk, stating that Viagra has been studied in 136 clinical trials and that “there is no reliable scientific evidence that the medicine causes melanoma.” It is important to listen to the denial, as Pfizer states there is no reliable scientific evidence, which recognizes that there is scientific evidence; Pfizer thus discounts the existing scientific evidence as “unreliable.” Pfizer has stated that it stands behind “this important medicine” and intends to “vigorously defend these lawsuits.”

I also read one article which suggested that the Viagra lifestyle was the cause of the increased incidence of melanoma (and not the Viagra itself). The “Viagra lifestyle” was suggested to be a world where men would take their romantic partners to places like the Caribbean or on a boat, places where exposure to the sun’s damaging rays was higher. I would advise skepticism for this theory. I have not seen any evidence that men who use Viagra had better sun tans than those men who did not take Viagra, except on all the commercials.

The Lawsuits Are Mounting

In April, the U.S. Judicial Panel on Multidistrict Litigation created a MDL site in the Northern District of California for lawsuits from those alleging injury against Pfizer from the use of Viagra. Judge Richard Seeborg of San Francisco has been assigned to preside over the Viagra MDL. The central allegations are that (1) sildenafil increases the risk of developing melanoma and that (2) Pfizer failed to warn consumers and medical care providers of the risk. Originally fourteen cases were transferred to the Viagra MDL, but more are being filed each week.

Pfizer first sold Viagra in 1998. And to no one’s surprise, it became hugely popular and very profitable. In 2013 alone Pfizer made $1.8 billion dollars from the sale of Viagra worldwide. All this to say that many millions of men have taken Viagra over the past eighteen years. If the studies are accurate, this is an army of men more vulnerable to the onset of life-threatening skin cancers.

The Takeaway

Let’s face it, compromised conditions of aging, like bad knees or erectile dysfunction, can dramatically reduce a person’s quality of life. For years medications like Viagra seemed like a great way to extend an aging man’s ability to engage in sexual intercourse (which is a great thing to engage in). However, the most recent study of Viagra, coming as it does after other studies concluding that Viagra may increase the risk of melanoma, suggests that the use of erectile dysfunction drugs may not be worth it. Talk at length to your doctor about the risks of taking Viagra or Levitra or Cialis. Of course avoid excessive sun exposure and always wear sunscreen. Above all, keep a careful watch about any news reports of new studies linking Viagra and similar drugs to the onset of melanoma.