Despite the addictions, injuries, and deaths, and despite reports of awful business practices by the makers of these prescription painkillers, defense lawyers have developed certain legal defenses to help these drug companies avoid liability. Let’s look at a few:

The FDA Approved the Drug, So It’s the Government’s Fault

This is a tough one. Essentially, the drug companies proclaim: the FDA approved the opioid product for manufacture and sale, so we can’t be liable for claims such as defective design. If opioids were a problem, they argue, the FDA should not have approved the drug for sale in the first place.

I have struggled with this defense for years. For one, the FDA is one government agency, and it is tasked with overseeing the review and approval of all new drugs, as well as monitoring practices among drug companies after approval. Plus, and although it shouldn’t be, the FDA inevitably becomes political, and depending on the administration, the policing efforts can range from effective to cozy with drug companies. In political climates with relaxed enforcement, problem drugs can reach the market.

The solution: the FDA must remain independent, and protected from political influence, and serious and competent people must run the operation. If that can happen, this defense would hold more weight.

The Learned Intermediary Doctrine, So It’s the Doctor’s Fault

A drug maker has a duty to warn patients about the risks of its drug. If the drug label is inadequate, leaving out vital information, the person injured by the drug can bring a claim for failure to warn. However, if the label lists all the risks (even if a key risk is buried deep in the package insert) the drug company can often rely on a defense known as the learned intermediary doctrine. This means a manufacturer is not liable for a high-risk prescription drug if the risk was placed on the label and technically made available to the patient’s doctor (the “learned intermediary”). In these cases, the duty to warn shifts away from the drug company and to the physician, who is supposed to give the patient a full explanation of the benefits and risks of the medication he prescribes.

The problem is this: in many cases general practitioners don’t know all the risks of a certain drug. And really, how could they? Doctors must stay current on all kinds of illnesses and conditions, and they can’t be expected to know granular detail of every drug on the market.

I’ve never liked this defense. Of course, I represent individuals injured by defective medical devices and drugs, so I guess it is predictable that I wouldn’t like it, as it can cause me and my clients certain difficulties. But aside from my potential professional bias, the learned intermediary doctrine is a flawed defense, mainly because it occasionally allows drug companies to escape truly negligent and harmful behavior.

The Patient Misused Opioids, So It’s the Victim’s Fault

This defense can be very effective, and in many ways it is galling. A drug company puts a highly addictive drug on the market, pushes the drug in marketing campaigns and in aggressive one-on-one meetings with doctors to push prescriptions, and then, when the patient becomes addicted and misuses the product, the drug company points to the bad behavior as an affirmative defense. And it often works. The alleged misuse can take many forms: taking the drug after recovery from the underlying injury is complete, or, after addiction has set in, attempting to procure opioids from different doctors or for made-up health reasons. Now granted, many people can and have abused these drugs. I get it. But it is a complicated matter when you are dealing with an addictive prescription medication like opioids.

The Statute of Limitations Has Run, So It’s the Calendar’s Fault

I have written about the statutes of limitations many times on this site. As a plaintiff’s lawyer, the statute of limitations haunts my dreams like The Lone Biker of the Apocalypse in Raising Arizona. The statute of limitations is a law limiting the time you may bring a lawsuit for personal injury. In each state you have a certain number of years from the injury, or the date of discovery of the injury, to file a complaint in court. In opioid cases, plaintiffs argue that the court should use the “discovery rule,” which states that the limitations period cannot begin to run until the plaintiff knows or should have known about the specific injury. As you can imagine, however, vicious fights occur in court about the start date for many statutes of limitation.

Now you be the lawyer: what arguments can you make to overcome these defenses? What weaknesses do you see in these defenses? Feel free to email me your thoughts. Or call me to discuss further.

Millions of Americans have stomach issues, many of which are related to heart burn and acid reflux. Thankfully, there are several medicines available over-the-counter and by prescription that prevent and relieve these discomforts. Some drugs that help with these stomach issues are called proton pump inhibitors.

A proton pump inhibitor (PPI) is a medicine that reduces stomach acid. People take PPIs for heart burn, acid reflux, stomach ulcers, and other related conditions. While many PPIs are available by prescription only, some are becoming more readily accessible over-the-counter; you may have seen or heard of Prilosec, Prilosec OTC, Prevacid, or Nexium. These are all well-known PPIs.

PPIs work by preventing stomach acid from being produced – they stop heart burn, indigestion, and acid reflux before it begins. Many people take them first thing in the morning or take them before meals.

While proton pump inhibitors help with heart burn, reflux, ulcers, and other conditions, they are causing other issues such as kidney disease, kidney injury, kidney failure, and interstitial nephritis (a type of kidney infection). Which begs the question – is preventing the occasional heart burn worth the risk of kidney failure? Or worse?

PPIs have been on the market since the 1980s and have been tolerated well by a majority of the population. In fact, some 15 million Americans take, or have taken, PPIs. Generally, these drugs cause few issues for the patient and cause minor side effects. For instance, Prilosec OTC states that its side effects are “mild” and are commonly headache and diarrhea. Prevacid’s side effects are listed as headache, nausea, diarrhea, constipation, and stomach pain.

However, long-term use of PPIs has caused some patients to experience more severe side effects. Recently PPIs have been associated with a risk of chronic kidney disease, also called renal disease. PPIs and their manufacturers do not warn against or provide information about this risk. Now there are lawsuits against PPIs such as Prilosec, Prevacid, Nexium, and their manufacturers due to these side effects, primarily involving injury or damage to the kidneys.

Lawsuits are being filed all over the country against pharmaceutical manufacturers like AstraZeneca, Proctor & Gamble, Takeda, and Pfizer. These law suits are being filed on behalf of patients who have ingested PPIs and later experienced various kidney injuries. For example, companies such as AstraZeneca are being sued because they failed to warn patients and doctors about the risk of kidney injury and instead continued to advertise PPIs as safe. A multi-district litigation site for PPIs has been designated in the federal court of New Jersey (MDL 2789), and injured people from all over the country are permitted to start a lawsuit in that court.

Proton pump inhibitors may reduce heartburn, prevent acid reflux, and help with stomach ulcers; but they may also cause kidney disease, kidney failure, and other issues. If you have taken a PPI and have experienced kidney problems – call me. Don’t let a medicine that was designed to cure stomach issues cause additional, more serious injuries.

If you have a specific type of leukemia—Philadelphia chromosome-positive chronic myeloid leukemia, or Ph+ CML—you may have been prescribed the chemotherapy drug Tasigna (nilotinib). Tasigna offers promise for some patients and may even be associated with remission of their disease—but it’s not without risks.

What’s more alarming, the drug’s manufacturer, Novartis Pharmaceuticals Corporation, may have known about those risks and failed to disclose them to you. People who have been harmed or lost loved ones due to Tasigna have sued Novartis. Here’s what you need to know.

What Is Tasigna?

Tasigna is a form of chemotherapy used to treat one specific genetically linked type of leukemia. In Ph+ CML, the bone marrow overproduces white blood cells. These extra white blood cells are abnormal and can overwhelm healthy cells, causing symptoms such as fatigue and anemia and eventually organ failure and premature death.

Tasigna is associated with a range of both “common” and “severe” side effects. On its website, Novartis warns that those side effects include, but aren’t limited to, the following:

• nausea;
• rash;
• headache;
• tiredness;
• itching;
• vomiting;
• diarrhea;
• cough;
• constipation;
• muscle and joint pain;
• runny or stuffy nose, sneezing, and sore throat;
• fever;
• night sweats;
• low blood count causing unexplained bleeding or weakness;
• liver damage;
• tumor lysis syndrome (TLS);
• QT prolongation, a heart problem that causes an irregular heartbeat;
• pancreas inflammation (pancreatitis);
• bleeding in the brain, which may cause confusion or loss of consciousness;
• fluid retention; and
• decreased blood flow to the leg, heart, or brain.

As if that were not enough, there’s another problem with Tasigna that Novartis isn’t talking about.

Tasigna and Atherosclerosis

Scientific studies have shown that Tasigna is also associated with atherosclerosis, where fatty deposits build up in arteries. These deposits narrow the blood vessels, eventually slowing and even stopping the flow of blood throughout the body. Because blood distributes oxygen to cells, a reduction in blood flow can lead to cells literally suffocating. Depending on what area of the body is deprived of blood and oxygen, atherosclerosis can cause heart problems and stroke and can lead to amputation of limbs. (Note that atherosclerosis is a specific type of arteriosclerosis, or hardening of the arteries. These terms are often used interchangeably, so don’t be confused if you see discussions of Tasigna causing arteriosclerosis.)

As early as 2013, Canada issued a governmental warning about Tasigna, indicating that its use was associated with “the possible risk of developing atherosclerosis-related conditions.” Canada published its warning after finding that Novartis’s own global safety database revealed 277 cases of atherosclerosis between 2005 and 2013.

But Novartis has not included atherosclerosis as a risk in the information it distributes about Tasigna in the United States. Now, some patients and their families are taking Novartis to court over it.

Tasigna Lawsuits

Dainis Lauris was prescribed Tasigna for leukemia, but he soon developed peripheral artery disease. His doctor read that the drug was linked to atherosclerosis, causing problems just like Lauris’s, and quickly changed him to a different medication. But the damage was done: Lauris died from atherosclerosis complications about six months later. He was 49 years old. Now, his family has filed a lawsuit in California federal court. They allege that Novartis knew about the drug’s risks and intentionally failed to warn American consumers or their doctors. So far, the court has denied Novartis’s motion to dismiss the lawsuit and its motion for summary judgment. The case is awaiting trial.

Have you or a loved one developed atherosclerosis after taking Tasigna? Call me for more information and to discuss your options: (919) 830-5602.

Note: This post was written from news reports and court filings. The allegations against Novartis have not yet been proven. I will provide updates as they occur. Photos are for illustrative purposes only.

The Attune Artificial Knee

The DePuy Synthes Attune artificial knee is marketed as an “innovative, comprehensive, integrated knee system” that provides stability, strength, and a greater range of motion post-surgery. This novel design was created to be a better approach to traditional knee replacements. But many people have experienced complete failure of their Attune knees shockingly soon after surgery.

To understand what goes wrong, let’s first consider how an artificial knee is supposed to work. The replacement joint has to sit right where the knee originally was, connecting the femur, or thigh bone, with the tibia, or shin bone. The new knee must be firmly attached to both bones or it won’t work. Imagine a single hinge holding a door onto a wall and allowing it to swing. If the hinge comes detached from either the wall or the door, the door will pull away from the wall and fall down as it swings.

Last year, a group of orthopedic surgeons reported in The Journal of Knee Surgery that this is exactly what happens with a disconcertingly large proportion of Attune artificial knees. While the replacement joint remains solidly cemented to the femur, the lower bond to the shin has a tendency to fail. The cement that should hold the knee to the tibia binds to the bone but not to the Attune device itself. Therefore, the detached joint floats, and just like the failed hinge that allows the door to fall, the replacement knee can’t hold any weight.

People with defective Attune knees experience significant knee pain, especially when they try to bear weight on the knee when standing or walking, as well as a restricted range of motion. The study revealed that these problems sometimes occurred within just a few months of the original knee replacement.

The only way to correct a failed Attune knee is to undergo a second or “revision” surgery. That second surgery—where the useless cement must be removed from the tibia and the solid femur connection must be broken—is more involved and more painful than the initial knee replacement procedure. To make matters worse, the surgeons’ report indicated that the separated knee generally doesn’t show up on X-rays; it can only be detected during the revision surgery. In other words, a doctor may not realize that the replaced knee has failed.

The Attune knee’s defects are further evident in the U.S. Food and Drug Administration’s Medical Device Adverse Events (MAUDE) database. Even though MAUDE is a self-reporting system, such that only the manufacturer, DePuy Synthes, can report its knees’ failures, there are dozens of recent reports. The Attune knee has been redesigned and may now be less prone to separation from the shin bone, but the original design has not been recalled, and the recipients of that faulty device have been left to fend for themselves.

Fortunately, DePuy Synthes is now being forced to answer for these defects in court.

The Attune Lawsuit(s)

Last September, a law firm filed the first lawsuit involving a defective Attune knee in Tuscaloosa County, Alabama. The case alleges that its client’s artificial knee failed prematurely, resulting in substantial pain, delayed recovery, and significant medical expenses. Expect to see more lawsuits in the future involving Attune knees. These cases are likely to involve not only damages for pain and suffering but also for the costs of the second replacement knee surgery and the accompanying physical therapy.

Have you had a knee replacement that ultimately failed or that caused more problems than it solved? We can advise you whether you may have a case against the manufacturer or another involved party. Please contact us to talk with a lawyer about your situation.

Have you been directly affected by the opioid epidemic in America? Millions of people have become addicted to these powerful drugs—and for many, that addiction started with a legally prescribed medication to treat legitimate pain. One report estimated that more than 59,000 people died from drug overdoses in 2016—and most of those were caused by opioids. The President has even declared opioid abuse a national public health emergency.

I’ve written before in this space about the opioid epidemic and the massive opioid litigation gearing up across America as well as the establishment of centralized multidistrict litigation. So far, these cases primarily involve state and local governments suing opioid manufacturers and distributors for their roles in the opioid crisis.

No doubt governments have suffered financial losses from the skyrocketing number of overdoses requiring emergency treatment. In North Carolina alone, the cost of opioid-related accidental overdose deaths was estimated at $1.3 billion in 2015.

But if you’re a victim of the opioid epidemic—either through your own addiction or that of a loved one—you may be wondering whether you’ll ever see any benefit from these government lawsuits or whether you can sue directly. After all, the government’s losses are secondary, while you may have lost your job, home, relationships, or loved one.

Will these government lawsuits affect your ability to file your own case? The answer depends both on who might be responsible for the harm and how you could hold them accountable.

Who’s Responsible?

The government cases have focused on drug manufacturers and distributors. They allege that these businesses overzealously marketed opiates for pain treatment, misrepresenting their risks and benefits.

Other lawsuits have gone after doctors, arguing that they negligently prescribed addictive drugs without fully explaining the risks. It’s easy to see why doctors are targets: The Centers for Disease Control and Prevention (CDC) reported that “In 2015, the amount of opioids prescribed was enough for every American to be medicated around the clock for 3 weeks.”

With that kind of rampant overproduction and overuse, and drugs that prove addictive to as many as one person in every four who receives an opioid prescription, this epidemic might have been unavoidable.

How Are These Drug Suppliers Responsible?

In product liability cases, there are three general ways to hold a manufacturer or seller responsible for the injuries to someone who is hurt using a product. That product might have:

• A defective (and dangerous) design. Think of tobacco, for example—if used as intended, it causes serious negative health effects.
• A manufacturing defect. A product that is otherwise safe might have been produced in a way that made it unsafe. For example, if a batch of ice cream is accidentally contaminated with salmonella as it is mixed, that is a manufacturing defect.
• A defect in warnings. A product might be unsafe in certain predictable situations, yet the manufacturer or distributor failed to warn customers about those risks. If a toxic household cleaner didn’t advise users to wear gloves that could qualify as a failure to warn.

The most likely avenue for opioid litigation by individuals is the third, a failure to warn patients of the risks of addiction. But one of the problems with opioid litigation is that each potentially responsible party can blame someone else. Manufacturers and distributors point the finger at doctors who over-prescribed drugs, while doctors argue that they didn’t understand the risks either, given the heavy promotion from pharmaceutical companies.

As an individual, this finger-pointing is especially problematic, because there will always be a finger pointing back at you.

Misuse of Narcotics

In most product liability cases, people are injured using a product in the way it was designed to be used. This is how the tobacco litigation unfolded: people were injured because they were smoking cigarettes, not because they were misusing cigarettes.

Unfortunately, the fallout from opioid abuse generally comes from off-label use, where people start using more of the medication than they were supposed to. Many people become so desperately addicted that they resort to street drugs like heroin to satisfy their physical cravings.

Manufacturers, distributors, and doctors can all argue that the addict is responsible for the destructive effects of opioids. If the patient had stuck to the prescribed dose, none of this would have happened! Governments avoid this problem, because they had no role in that off-label use.

But is it really your fault if you became addicted to opioids? If you’re like most people prescribed these potentially addictive narcotics, you weren’t an addict before you got that prescription. Addiction is a disease; the negative or even illegal behavior that follows is arguably caused by the addiction itself. When the addiction was a foreseeable consequence of the original prescription, are you solely responsible for that conduct?

That’s the question we’re interested in examining. At least some courts are trying to make sure that the government lawsuits don’t impede the right of affected people to sue individually. Expect to see more here about opioid litigation—both government and individual—in the future.

Many things in life involve a cost benefit analysis. We’re constantly taking risks that can cause harm, but choose to take on that risk because the benefits outweigh the dangers. A good example of this is driving a car. There is a risk of getting into an accident, but the benefit of having on-demand personal transportation is easily worth it.

Prescription medications are no different. Each one is intended to provide a benefit, although each will always have at least some side effects or adverse reactions. The question is never, “does the drug have a side effect or adverse reaction?” Rather, it’s “how many side effects and adverse reactions are there and how bad are they?”

It’s no surprise to learn that many medications on the market today have numerous side effects and adverse reactions, some of them deadly. Yet, they’re available for use not only because the benefits may outweigh the risks for a significant number of consumers, but also because the makers of the medication are required to inform consumers of these risks. So a pharmaceutical company that fails to properly warn consumers of the risks of its drugs can get into trouble. That’s exactly the issue with Actemra.more What Is Actemra?

Approved by the US Food and Drug Administration in 2010, Actemra, also known as tocilizumab, is a drug manufactured by Genentech (a subsidiary of Roche). It is used to treat rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and giant cell arteritis. Actemra is most commonly used to help individuals suffering from RA, which is an autoimmune disorder where the body’s own immune system attacks the joints, making them swollen and painful.

What’s the Problem with Actemra?

Actemra has a long list of side effects and adverse reactions that are recognized by the FDA and included in its warnings. Some of these adverse reactions and side effects are:

• Serious infections
• Gastrointestinal perforation
• Severe allergic reactions, including death
• Respiratory tract infections
• Headache
• Increased blood pressure

However, Actemra has recently been discovered to increase the risk of the following:

• Heart attack
• Heart failure
• Stroke
• Pancreatitis
• Interstitial lung disease

These are very serious problems, possibly linked to over 1,100 deaths of Actemra users, according to a recently published STAT investigation. The problem isn’t just that these serious problems exist, but that Actemra does not currently have the necessary strong warnings to inform consumers of the risks. Many similar immunosuppressive RA drugs already on the market, such as Humira (adalimumab), Remicade (infliximab) and Enbrel (etanercept), have similar risks, but unlike Actemra, they have warnings to bring these risks to consumers’ attention.

Actemra was actually marketed by Genentech as an RA treatment with similar effectiveness as Humira, Remicade and Enbrel, but with reduced serious health risks. STAT’s investigation calls this claim into question and raises the potential for a huge number of lawsuits. Essentially, the lawsuits would revolve around a failure-to-warn theory, where the drug maker would be legally liable for not properly warning consumers of a drug’s risks.

Are There Currently any Actemra Lawsuits?

Yes, although the litigation is still in the very early stages. All cases are individual lawsuits with few, if any, settlements or verdicts. Additionally, there is currently no multi-district litigation (MDL) as of yet.

However, this could quickly change as more users of Actemra with injuries come forward, the number of lawsuits rise and the potential legal liability of Genentech becomes clearer. When there are any new developments I’ll make sure to provide you with an update. And if you currently take Actemra, you may want to discuss these recent findings with your doctor. And if you have already suffered injury from Actemra, call me.

This post was written after review of several news sources.

Over the past few years, an opioid epidemic has caused horrific problems for many regions of the country. In 2015 alone, the US Department of Health and Human Services estimated that 12.5 million people misused prescription opioids, causing over 33,000 overdose deaths. In 2013, the opioid epidemic resulted in $78.5 billion in economic losses. In response to this tragic loss of life and the economic strain placed on many state and local governments, several lawsuits have begun.

What Exactly Are Opioids?

Opioids are synthetic or semi-synthetic forms of opiates (like morphine). Opiates are derived directly from the poppy plant while opioids are manufactured chemicals that are very similar to opiates.

Opioids are used as painkillers and prescribed to patients to treat a variety of medical conditions where moderate to severe pain is a concern. Commonly prescribed opioids include:

• Oxycodone (OxyContin)
• Hydrocodone (Vicodin)
• Fentanyl

Opioids are effective at relieving pain, but unfortunately, they are extremely addictive and often lead to overdoses and the use of stronger (and more dangerous) illicit drugs. The causes of the opioid epidemic are complex, but one approach to combating it is to seek relief in the courts by going directly after the opioid makers.

The Basis for Opioid Lawsuits

Both individuals and local governments have sued the pharmaceutical companies under a variety of legal theories, although they are often based on the idea that the makers of opioids downplayed the risks of opioids while exaggerating their benefits.

These lawsuits are in new legal territory, but parallel some of the earlier lawsuits where states sued Big Tobacco and firearms manufacturers for the number of deaths and the financial toll their products were taking on the general population and state budgets.

If the opioid lawsuits have the same ending as the lawsuits against cigarette companies, states and municipalities may be able to help pay for fighting and treating the opioid crisis. For example, when the lawsuit against Big Tobacco settled, it resulted in the largest civil settlement in history, amounting to tens of billions of dollars. Continued payments are made by cigarette companies forever to help states treat their sick citizens suffering from tobacco-related illness and disease.

However, the opioid lawsuits face potential challenges that may not guarantee victory. For example, the opioid crisis has many causes, not just the pharmaceutical companies allegedly marketing their opioid products incorrectly.

For example, opioid abuse is the result of doctors who are overprescribing opioids and (questionable) scientific studies incorrectly concluding opioids were non-addictive. In addition, many of the abused opioids are obtained illegally by users and prescription medication distributors often don’t halt suspicious orders for opioids. Despite these challenges, there have been early successes in the opioid litigation.

For example, in 2004, the state of West Virginia settled its lawsuit against Purdue Pharma, the makers of OxyContin, for $10 million. And in 2007, Purdue Pharma agreed to pay $130 million for future civil lawsuit settlements brought by private parties, such as patients who were prescribed OxyContin.

Current Status of Opioid Lawsuits

Recently, many of the opioid lawsuits have been brought by government plaintiffs, such as states, counties and cities. Several of these plaintiffs include:

• The state of Ohio
• Cherokee Nation
• The city of Everett, Washington
• Santa Clara and Orange counties in California
• Orange, Nassau, Broome, Erie and Suffolk counties in New York
• The city of Chicago, Illinois

Most of these lawsuits have been brought within the past few months, so we need more time to see the direction they will take. Regardless of the outcome of these cases, the mounting pressures from the opioid crisis is starting to make a difference in other ways.

For example, in June 2017, the U.S. Food and Drug Administration (FDA) asked Endo Pharmaceuticals to voluntarily pull one of its opioids, Opana ER (oxymorphone hydrochloride) from the market. The FDA made this recommendation on the basis that Opana ER was being abused in ways where the benefits from having the drug available in the market were outweighed by its risks. For example, Opana ER was being manipulated so that it could be injected. Besides the obvious addiction and overdose risks, this new method of abusing the drug created outbreaks of diseases, such as HIV and hepatitis C.

I suspect opioid lawsuits will increase dramatically over the next few years. With opioid litigation having only just begun, stay tuned to this blog for any additional updates.

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.

Hernia mesh is causing problems. People who have been implanted with hernia mesh have suffered adhesions (scar tissue that sticks together), inflammation, pain, allergic reactions, internal bleeding, infections, and many other injuries.

One of the hernia mesh products sold for years, Ethicon’s Physiomesh, has caused many of these health problems in patients. In revision or removal surgeries, the Physiomesh has been discovered to have shrunk, folded, or curled. Surgeons have found scar tissue surrounding the mesh. This scar tissue can cause severe pain and discomfort. In many cases, by the time the mesh is removed, the damage has been done and long-term problems remain.

What Is Hernia Mesh?

A hernia appears when an internal organ protrudes through a wall of tissue (often a muscle) into another area of the body where it does not belong. Depending on how bad the hernia is, surgery may be required to fix it. Because hernias involve a hole in a muscle or other tissue, additional reinforcement is thought to be needed to close the opening and keep it from reopening. This is where hernia mesh comes in. The mesh often takes the form of a plug or sheet of biological or synthetic mesh and is surgically implanted over the hole.

But not all hernia mesh is effective. And some don’t work.

Some Key Facts About Physiomesh

Physiomesh is a multi-layer mesh with layers of polypropylene and film. Ethicon hoped that the film layers would resist adhesions (scarring), permit mesh ingrowth into the abdominal wall, and maintain separation between the mesh and internal organs.

Physiomesh is a product intended to be used in laparoscopic surgeries. This is the less-invasive surgical technique using fiber-optic instruments and tubes. A laparoscopic surgical procedure is illustrated in the photograph to the left. In hernia repair operations, the tubes enter the abdominal wall and, using small cameras and other medical instruments, the surgeon is able to repair the hernia surgically, including in some cases implanting hernia mesh. Obviously laparoscopic procedures are less traumatic to the patient and easier from which to recover. That is, if the implanted devices are not defective.

Unfortunately, Physiomesh has been shown to cause scarring around the mesh, inflammation, implant folding and curling, and other serious complications. Physiomesh causes adhesions but does not permit adequate ingrowth into the abdominal wall.

Sadly, these results would have been available to Ethicon if it had done adequate premarket testing on the Physiomesh instead of rushing it to the market.

In April 2010 Physiomesh was approved to treat hernias in patients. It was approved by the FDA through the 510(k) process, which I have written about often on this site. The 510(k) process is a way around the more complex (and safer) premarket approval process. Under 510(k), the manufacturer notifies the FDA of its intent to market a device like hernia mesh and explains the device’s “substantial equivalence” to a device already on the market. The FDA may then approve the medical device for sale in the United States without extensive premarket testing. This is how Physiomesh made it to the market, in October 2010.

Physiomesh was on the market from October 2010 until the product was withdrawn in May 2016. This means that if you had surgery for hernia mesh repair between October 2010 and May 2016, and mesh was implanted, it could possibly be Ethicon’s Physiomesh.

Want to Learn More About Physiomesh?

There are studies you can access online which drills down on the subject of hernia meshes and the causes of hernia mesh failure:

Long-term evaluation of adhesion formation and foreign body response to three new meshes. Authors: Vogels RR, van Barneveld KW, Bosmans JW, Beets G, Gijbels MJ, Schreinemacher MH, Bouvy ND. Published in Surgical Endoscopy, 2015 August 29 (8):2251-9. Among other findings, this study concluded that “[f]ractioning of the Physiomesh(®) coating over time led to an increase in interfilamentary granuloma formation, leading to scar plate formation, but with only minimal to no abdominal wall adherence” and that Physiomesh is not “superior in all aspects required for effective and safe incisional hernia repair.”

Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial. Authors: Pawlak M, Hilgers RD, Bury K, Lehmann A, Owczuk R, Smietananski M. Published in Surgical Endoscopy, 2016 Mar 30 (3):1188-97. This study was stopped due to safety reasons, which is alarming. Conclusion: ” . . . the obtained results from the enrolled patients indicate that the [Physiomesh] system associated with significantly greater hernia recurrences and postoperative pain compared with the [Ventralight ST/SorbaFix] system.”

There are other studies out there, and plenty of other information on Physiomesh and the problems it has caused.

So What’s Next?

One estimate indicates that as many as 160,000 patients received the Physiomesh hernia mesh in the United States between October 2010 and May 2016. It is expected that hundreds of people will eventually file suit against Ethicon for injuries caused by Physiomesh.

On May 25, 2017, the Judicial Panel on Multidistrict Litigation (JPML) conducted a hearing on a motion brought by Physiomesh plaintiffs, who asked the JPML to create a new multidistrict litigation specifically for Physiomesh cases. I will let you know when a decision has been reached on that motion, though I suspect we will see a Physiomesh MDL.

In the meantime, if you have had any surgical mesh implanted in your body to treat a hernia, and particularly if you know you received a Physiomesh hernia repair product, you should speak with your doctor as soon as possible. This is important, even if you aren’t aware of any problems with the mesh. You may be fine, but you should monitor your situation carefully.

Diabetes is an awful disease. It is a chronic condition that affects the way the body metabolizes sugar. Diabetes is also a growing health problem in the United States, with over 29 million Americans currently suffering from the disease. Of the newly diagnosed cases of diabetes in adults, approximately 95% are for Type 2 diabetes (sometimes referred to as adult onset). It’s also expected that one out of every three people will develop diabetes in their lifetimes.

Type 1 diabetes occurs when the human body doesn’t produce enough insulin, a hormone used to help the body absorb glucose. Type 2 diabetes occurs when the human body produces enough insulin, but cannot use insulin properly. Both types of diabetes result in high blood sugar levels which can cause long-term health problems.

What does all this mean? From the perspective of pharmaceutical companies, it means there is a huge market for Type 2 diabetes drugs.

Invokana: Diabetes Drug

Invokana is the trade name for the medication canagliflozin. Canagliflozin is a subtype 2 sodium-glucose transport inhibitor marketed by Janssen, a subsidiary of Johnson & Johnson. Invokana works to lower the body’s blood sugar levels by stopping the kidneys from reabsorbing blood glucose. Instead of the blood glucose staying in the body, it is removed with the body’s urine.

Problems and Side Effects of Invokana

All drugs have side effects and Invokana is no different. However, many patients who took Invokana suffered many side effects that they did not anticipate because Janssen allegedly did not warn users adequately of these side effects. Injuries claimed as a result of Invokana include:

• Diabetic ketoacidosis
• Renal failure and acute kidney injuries, even in those without a history of kidney problems
• Stroke
• Urinary tract infections, resulting in either blood or kidney infections
• Increased risk of leg and foot amputations

After its approval and release in the United States, drugs containing canagliflozin, including Invokana, were the subject of several safety announcements and warning label updates.

For example, in May 2015, the FDA issued a Drug Safety Communication telling the general public that there was a risk of diabetic ketoacidosis.

In September 2015, the FDA issued another Drug Safety Communication declaring increased safety warnings concerning the risk of bone fractures due to decreased bone density.

In December 2015, the FDA released yet another Drug Safety Communication requiring that drugs containing canagliflozin have warning labels that listed diabetic ketoacidosis and urinary tract infections.

And in May 2017 there was another Drug Safety Communication released by the FDA confirming an increased risk of leg and food amputations in those taking medications containing canagliflozin. The FDA also required medications containing canagliflozin to have updated warning labels to reflect this risk. The FDA’s decision was based on two clinical studies which found that individuals taking medications containing canagliflozin had twice the risk of having a foot or leg amputated.

With all these newly discovered problems with a popular medication, it’s no wonder there is currently a flurry of lawsuits pending in the courts.

People Injured by Invokana Filing Suit

As of April 27, 2017, there were 295 Invokana product liability lawsuits in federal court. By the time you read this, that number is very likely to be higher.

Because of the varied side effects and problems with taking Invokana, the lawsuits set forth a variety of physical injuries, including stroke, diabetic ketoacidosis, urinary tract infections, kidney failure and death.

The most significant legal argument of the plaintiffs is that Janssen did not adequately warn them or their doctors of these and other risks associated with taking Invokana. Had they been warned about these risks, they could have chosen an alternative method of treating their Type 2 diabetes.

Invokana Litigation Status

The Invokana federal lawsuits have been placed into a multi-district litigation, or MDL. The purpose of this consolidation is to allow for a more efficient pre-trial litigation process and facilitate a potential settlement.

The cases are currently in the discovery phase, which will take many months to complete. The Judge overseeing the Invokana MDL hopes to have three bellwether trial cases selected by January 2018, with the first bellwether trial beginning in September of 2018.

What Happens Next?

The pretrial activities, such as discovery, will need to run their course and that can take a while. The discovery process occurs when both sides share information that may be used at trial. In large cases involving corporate defendants, the discovery process can be the most time consuming and expensive part of the lawsuit.

The FDA currently recommends patients taking Invokana and other medications containing canagliflozin to contact their doctor immediately if they’re experiencing any problems with the medication. The FDA has also told patients not to stop taking Invokana until they speak with their doctor first.

When there are additional updates to the Invokana litigation, I will post them on this blog.

We’ve previously blogged about Stryker LFIT V40 artificial hip problems, discussing a recall made back in August 2016 and how to tell if you have an artificial hip that’s part of that recall. Since those posts a lot has been going on in courthouses across the country, with dozens of lawsuits popping up from individuals who received affected artificial hips made by Striker Orthopaedics and its subsidiary, Howmedica Osteonics Corporation (HOC).

Just recently, approximately 33 pending lawsuits against HOC were consolidated into a multi-district litigation (MDL). In a way, you can think of this consolidation as a “things just got real” moment for HOC. But what’s the big deal about the Stryker LFIT V40 litigation now being in MDL status? Let’s begin by discussing the underlying lawsuits.

Why Are the Plaintiffs Suing?

Patients who received the Stryker LFIT V40 femoral head suffered from a variety of problems with their artificial hip, including extreme pain, cobalt/chromium poisoning, inflammation, joint instability, loss of movement and joint dislocation. These symptoms were the result of a taper lock failure.

The major claim made by plaintiffs is that the taper lock failure was caused by corrosion at the taper junction, which is the part of the hip implant where the LFIT V40 femoral head attaches to the hip stem. Plaintiffs also argue that not only were the LFIT V40 femoral heads defective, but Stryker and HOC knew of these problems and failed to properly warn the doctors who performed surgeries to implant these artificial hips.

Over time, the taper lock failure resulted in metallosis, a serious condition where metal debris builds up in soft tissue, as well as the LFIT V40 femoral head completely separating from the hip stem.

Why Did the Plaintiffs Want Their Lawsuits to Be Consolidated in One Court?

There are several possible reasons why the Stryker LFIT V40 plaintiffs wanted their cases consolidated.

First, it allows plaintiffs to pool their resources and coordinate their legal strategies. This means they can litigate more efficiently and save money.

Second, litigation can occur faster. This is usually good for the plaintiffs, because they can obtain compensation sooner. It also prevents defendants from dragging out a case.

Third, cases consolidated into an MDL get a lot of attention (even, I suppose, this article). The extra media attention can bring in even more plaintiffs. With more money at stake, plaintiffs have more leverage during settlement talks.

In this case, HOC was concerned about extra negative attention. As a result, HOC argued that the name “Stryker” should be removed from the MDL case name in the hopes that it would avoid some of the bad publicity for its parent company. HOC’s argument was not accepted by the Court and the Stryker name stayed in the MDL case name. It is now, “In re: Stryker LFIT V40 Femoral Head Products Liability Litigation.”

The Decision to Consolidate

The decision to transfer was made by the United States Judicial Panel on Multi-District Litigation (JPML). Plaintiffs argued that since all the cases involved one or more common questions of fact, consolidation into an MDL would promote judicial efficiency and be more convenient for the litigating parties.

HOC disagreed, arguing that there were only a “few” cases, so consolidation wasn’t necessary. HOC also argued that even though all the cases involved the same LFIT V40 femoral head, because there were a wide variety of hip stems used by different patients, it didn’t make sense to consolidate the cases. The JPML disagreed with HOC and consolidated all 33 cases into an MDL.

Next Steps

The 33 Stryker LFIT V40 lawsuits from 17 total federal districts will be transferred to the District of Massachusetts, and handled by Judge Indira Talwani, who is already hearing several Stryker LFIT V40 cases. However, Judge Talwani has never handled an MDL and has only been a federal judge since May 2014.

The cases will now advance to pre-trial matters, primarily discovery. In the meantime, additional cases may also be added to the MDL.

Once discovery is complete the cases will be transferred back to their original federal districts for trial. Before that happens, the Court will try to get the parties to settle the cases. One way to promote settlement is to have bellwether trials.

Bellwether trials are cases that represent the whole group. Bellwether cases will go to trial and be tried by a jury. How these cases turn out will provide insight to the parties as to whether a settlement is possible and if so, what the settlement terms should be.

The Viagra litigation is ramping up. Last April the U.S. Judicial Panel on Multidistrict Litigation (JPML) created a multidistrict litigation site in the Northern District of California for lawsuits alleging injury against Pfizer from the use of Viagra. Since then, the Viagra lawsuits have piled up in California federal court.

The U.S. Food and Drug Administration approved Viagra (sildenafil citrate) for sale in 1998. It set out to fix an intimate and unhappy problem: erectile dysfunction. One study indicated that thirty million men may suffer from erectile dysfunction. And it worked (I’ve heard). Millions of men standing on the sidelines were back in the game.

The reason I know it worked is because Viagra’s manufacturer, Pfizer, Inc., sold $1.8 billion dollars worth of the drug in 2013. Pfizer has self-reported that it has prescribed Viagra to 35 million men. All over the country and all over the world, those 30th wedding anniversary weekends were suddenly a lot more fun. And that’s a wonderful thing.

more

Unfortunately, some of these men developed skin cancer. Melanoma is the most aggressive and most dangerous form of skin cancer. Melanoma develops when damage to skin cells triggers mutations that lead the skin cells to multiply rapidly and form malignant tumors. Many 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 has been estimated to cause over 10,000 deaths in the United States each year.

The problem is, men taking Viagra seemed to be developing melanoma at a greater rate than the general population developed melanoma.

The Master Long Form Complaint in the Viagra Litigation

The Master Long Form Complaint in the Viagra MDL sets out the narrative of the claims of men who developed melanoma after taking Viagra. I will bullet-point some of the important allegations:

• The Plaintiffs allege that Pfizer knew or should have known about the connection between Viagra use and melanoma, even going back to the late 1990s.
• Several studies linked Viagra use and the increased risk for melanoma.
• A 2014 study indicated an 84% increase in the risk of developing melanoma after taking Viagra, or worsening the effects of existing skin cancer.
• A 2016 study from Northwestern University reported “’a significant association with melanoma’ for users of sildenafil and tadalafil. Significantly, the study found a doubling of the risk for sildenafil.” (I write more about the science behind the connection between Viagra use and melanoma here.)
• Despite these studies, Pfizer continued to market Viagra aggressively (and you would think this medication would sell itself, given what it cures).
• Pfizer has marketed Viagra to younger men.
• Through the years, and through increasingly aggressive marketing campaigns, Pfizer did not warn users about the increased risk of developing melanoma.
• The general public and doctors who prescribe Viagra would not have known of the risks of taking Viagra.
• Pfizer knew or should have known that the drug posed a significant health risk to the men taking Viagra.
• The health risks of taking Viagra outweighs the benefits of using the drug, but Pfizer kept selling it anyway. After all, erectile dysfunction, while unpleasant, does not pose any health risks to men.
• Pfizer aggressively marketed and sold Viagra, for decades, and made a lot of money selling it.
• As a result of all these sales, consumers of the drug were placed at increased health risks.
• Many men developed melanoma.
• These men were seriously injured by taking Viagra. Melanoma is a serious health issue.
• Pfizer downplayed the risks through the manufacture and sale of Viagra.
• Pfizer did not mention any potential risks for developing melanoma in the medication label or package inserts.
• Pfizer did not mention any potential risk for developing melanoma in its advertising materials.
• As a result of Pfizer’s actions, the plaintiffs were injured.
• If doctors would have known of the risks, they would not have prescribed the drug.
• If patients would have known of the risks, they would not have taken the drug.

The Plaintiffs’ Claims

From these allegations, plaintiffs bring many claims or “causes of action,” including:

1. Negligence 2. Unfair and Deceptive Trade Practices (Unfairness, Fraud, Unlawfulness) 3. Defective Design 4. Failure to Warn 5. Failure to Test 6. Breach of Express and Implied Warranties 7. Negligent Misrepresentation 8. Fraudulent Misrepresentation and Concealment 9. Fraud and Deceit; Willful, Wanton, and Malicious Conduct 10. Unjust Enrichment 11. Loss of Consortium 12. Survival 13. Wrongful Death 14. Punitive Damages

Pitched Court Battle Inevitable

Please remember: at this stage of the litigation, the allegations listed above are not yet proven. Pfizer has denied many of the allegations and will have the opportunity to defend itself, and intends to . . . vigorously. Pfizer is represented by Williams & Connolly, DLA Piper, and Kay Scholer, three of the most expensive defense law firms in the country. Look for a pitched court battle. Still, the scientific studies are mounting which point to a clear connection between Viagra use and the increased risk for melanoma. Please talk to your doctor if you are taking Viagra (or Cialis or Levitra); it may not be worth the risks.

I’ve written about Viagra and the Viagra litigation on this site. Check it out for more information.

Treating Hernias with Surgical Mesh

First off, let’s briefly explain what a hernia is. A hernia appears when an internal organ protrudes through a wall of tissue (often a muscle) into another area of the body where it doesn’t belong. Depending on how bad the hernia is, surgery may be required to fix it.

Because hernias involve a hole in a muscle or other tissue, additional reinforcement is usually needed to close the opening and keep it from reopening. This is where surgical mesh comes in. The mesh often takes the form of a plug or sheet of biological or synthetic mesh and is surgically implanted over the hole.

Clinical studies have shown that using surgical mesh to treat hernias reduces the chances of the hernia returning. Each year hundreds of thousands of hernia surgeries are performed. Given their proven effectiveness, it’s no wonder that many of these surgeries use a surgical mesh. Unfortunately, a significant number of the meshes have serious flaws.

more Problems in Patients with Hernia Surgical Mesh

Many patients who undergo surgery to have surgical mesh implanted for hernia treatment recover quickly and go on with their lives. However, some patients suffer from the following problems with their surgically implanted mesh:

– Allergic reactions – Adhesions (scar tissue that sticks together) – Perforation of organs – Return of the hernia – Severe pain – Bowel blockages – Uncomfortable or painful sex – Internal bleeding – Infection – Damage to nerves – Movement of the mesh within the body – Fluid buildup – Rejection of the implant (the body’s immune system attacks the mesh) – Fistulas (an abnormal connection between two hollow areas of the body, like the intestines)

Removal of the surgical mesh is often required, but by the time the mesh is removed, the damage has been done and long-term problems remain. As a result, many patients have sued the manufacturers of these surgical meshes.

Hernia Surgical Mesh Lawsuits

A few years ago, Bard Davol faced numerous lawsuits concerning its Kugel hernia mesh. These lawsuits have been mostly resolved by now, but they appear to represent just the tip of the iceberg.

Patients who have surgical meshes made by other companies are having problems too, and they are starting to line up at the courthouse steps for their day in court. Two major hernia mesh lawsuits involve the following products.

C-Qur

Atrium Medical Corporation manufactured the C-Qur hernia mesh, which is made of polypropylene and coated with Omega-3 fatty acid fish oil. The use of fish oil was intended to reduce the chance of adhesions occurring, but instead has caused many complications. These include allergic reactions to the fish oil, life threatening infections and the fish oil coating separating from the mesh once it is implanted inside the body.

In July of 2013, the Atrium Medical Corporation recalled the C-Qur mesh, with over 30,000 meshes taken off the market. There are currently about two dozen C-Qur mesh lawsuits pending in MDL. However, it’s expected the number of C-Qur lawsuits will grow.

Physiomesh

Ethicon is another company that manufactured a hernia mesh made out of polypropylene called Physiomesh. This mesh had a special coating which was also designed to prevent adhesions. However, the coating led to a complication: It also prevented the mesh from properly integrating into body tissue.

The Physiomesh implant had a larger number of problems that Ethicon did not anticipate, including fluid buildup, scar tissue formation and hemorrhaging. These have led to serious symptoms, such as chronic pain, bowel blockages and infections.

In May of 2016, Physiomesh was withdrawn from the market, although not officially recalled. Currently only a few lawsuits have commenced, although many more lawsuits are anticipated.

Why Did These Hernia Mesh Products Have Problems?

As you might expect, there is no simple answer to this question, but there are two major factors that likely contributed to the problems.

First, the hernia mesh was made out of polypropylene, which was originally considered to be completely inert within the human body. However, studies have shown the polypropylene degrades over time and can damage surrounding tissue.

In order to deal with the problems of polypropylene, medical device manufacturers covered the mesh in special coatings, like Omega-3 fish oil. But these coatings didn’t work very well. So why didn’t companies like Ethicon or Atrium Medical Corporation find a material other than polypropylene?

The answer to this question brings us to factor number two: getting FDA approval as quickly as possible. If a medical device company decided to use a completely different surgical mesh material, it would have taken longer and cost more money to get the product to market. This is because the mesh would have been considered a brand new medical device and therefore full clinical and safety studies and trials and would have been needed. By simply using a new coating, the device would be considered “substantially equivalent” to a medical device already approved by the FDA and therefore would be cheaper and much more readily available to use in patients.

One of the procedures medical device companies used to get their products to market faster was the 510(k) expedited approval process. I’ve written about the 510(k) procedure often on this site. Using this process, Physiomesh and C-Qur didn’t need to be tested in humans; animal tests were considered sufficient.

While there can be advantages of getting medical products to market sooner rather than later, hernia surgical mesh serves as another example of the dangers of not conducting proper tests to ensure a medical product’s safety and effectiveness. Unfortunately, it doesn’t appear these fast-track approval procedures are going anywhere anytime soon given the passage of the 21^st Century Cures Act.

Now What?

The hernia surgical mesh lawsuits are in their early stages with at least one trial set to start in early 2018. It shouldn’t be surprising that more plaintiffs will step forward before then, alleging problems with their hernia surgical mesh.

If you have had a surgical mesh implanted into your body to treat a hernia, especially a product from one of the above mentioned companies, you should speak with your doctor as soon as possible. This is important, even if you aren’t aware of any problems with the mesh.

The Washington Lawsuit

States can sue companies on behalf of their injured citizens. If the state’s attorney general decides that a “bad act” is harmful to enough citizens, her office can file a lawsuit on behalf of the state and the group of people who were injured. It is an important consumer protection function provided by the states. This is what happened in Washington and California a few days ago. The Washington Attorney General reported that 11,728 transvaginal mesh products were sold (and implanted) in women in the state. The attorneys general in those states filed suit against Johnson & Johnson and made a series of chilling allegations against the company for its marketing of transvaginal mesh.

Let’s look at some of the key allegations in the Washington State lawsuit. When I refer to “Defendants,” I mean Johnson & Johnson, Ethicon, Inc., and their related companies, who made and marketed several types of transvaginal mesh.

more Key Allegations:

1. Defendants misled consumers through informational and marketing materials that misrepresented the safety and effectiveness of transvaginal mesh. (Complaint, p. 7)
2. Defendants did not conduct human trials prior to the initial sale of transvaginal mesh. (p. 10)
3. Defendants destroyed the underlying data they claimed supported the safety and effectiveness of their original mesh products. (p. 11)
4. Defendants misrepresented the safety history of the transvaginal mesh to doctors. (p. 11)
5. Defendants made misrepresentations about the mesh directly to consumers through advertisements, brochures, and other marketing materials. (p. 11)
6. Defendants’ marketing materials failed to disclose the possible health complications from implantation of transvaginal mesh. These health problems include incontinence, defecatory dysfunction, dyspareunia (pain during sex), dysuria (pain while urinating), fistula, hematoma, hemorrhage, pain to partner during intercourse, permanent urinary dysfunction, recurrence, pain, UTI, urinary tract obstruction, vaginal scarring, and worsening incontinence. (p. 12)
7. Defendants knew about these mesh health problems but did not report this information. (p. 12-13)
8. Defendants’ Polypropylene Mesh Products present risk of chronic bacterial infection. These infections can occur years after the mesh was removed surgically. (p. 14)
9. Polypropylene mesh degrades and oxidizes in the body over time. This can cause a reaction in the body which can cause chronic inflammation. (p. 14)
10. The transvaginal mesh cannot be removed effectively when the medical device fails. (p. 15)
11. Transvaginal mesh implantation may also cause cancer in women. (p. 15)
12. Defendants knew about problems with sexual function and shrinkage at least as early September 2006, based on the discovery of a Johnson & Johnson internal document. (p. 15-16) Despite this knowledge, J&J sold thousands of mesh products after 2006.
13. Defendants falsely claimed that their transvaginal mesh products were “FDA Approved.” (p. 16) Rather, the mesh products were cleared under the 510(k) equivalency process. (p. 17) I have written about the 510(k) process several times in this blog.
14. Defendants failed to update informational and marketing materials. (p. 18)

Washington State’s Individual Claims Against J&J:

Washington State brought the following individual claims against Defendants:

1. Misrepresentation and Omissions Regarding Safety
2. Misrepresentations or Omissions Regarding Efficacy (the ability to produce a result)
3. Failure to Update Information Provided to Consumers

The State of Washington asked the court to “decree” (to determine, conclude) that Johnson & Johnson engaged in all the bad acts listed in the complaint. It also asked that the court find that J&J engaged in “unfair and/or deceptive acts” in violation of that state’s consumer protection laws. Washington then asked for a permanent injunction which would prohibit Johnson & Johnson from selling transvaginal mesh products in Washington. It also asked for civil penalties for every violation of state law. And finally, Washington asked for “restitution to consumers.”

The Complaint is captioned: State of Washington v. Johnson & Johnson, et al. (Wash. Super. Ct., King Cty.), and is worth reading if you have the time.

Meanwhile, in California

Kamala Harris, Attorney General for California, also filed suit on behalf of California on May 25, 2016. Attorney General Harris stated that Johnson & Johnson sold almost 800,000 pelvic mesh devices nationwide between 2008 and 2014. According to AG Harris, 42,000 mesh products were implanted in California women during this period. On behalf of the citizens of California, Harris sued Johnson & Johnson, alleging false advertising and deceptive marketing of its transvaginal mesh. The lawsuit alleges that J&J failed to inform patients and doctors of possible severe complications and misrepresented the frequency of these risks.

Johnson & Johnson’s Blanket Denial of Wrongdoing

Remarkably, despite more than a hundred thousand serious injuries, thousands of lawsuits, millions paid in jury verdicts and settlements, Johnson & Johnson still contends the mesh product is safe and is the preferred treatment for certain female health issues. According to the Wall Street Journal, Johnson & Johnson responded to the states’ lawsuit by stating, “the use of implantable mesh is often the preferred option to treat certain female pelvic conditions . . . .” As I’ve said before on this site, this blanket denial is a dangerous game for Johnson & Johnson to play, particularly when intentional misrepresentations are alleged.

The Takeaway

An injured person often feels powerless when facing a huge corporation like Johnson & Johnson. And rightly so. No individual, standing alone, can absorb a long legal fight in the same way that a multi-billion dollar corporation can. But when a state gets involved, the fight gets fair. California and Washington can bring the full power of the state to the legal fight against J&J. These lawsuits are therefore a huge step forward in protecting women against future pain and injury from transvaginal mesh. I will keep you posted on key developments in both cases.

Note: Again, I am no doctor. Please call your doctor if you have transvaginal mesh implanted in your body and you have concerns about your health. The information in this post comes mostly from the State of Washington’s lawsuit, which is a public document. I encourage you to review it carefully for further information.