Why Are People Suing the Makers of Invokana?

Michael GrossmanMarch 02, 2018 15 minutes

I'm sure we've all seen or heard ads with a stern-voiced lawyerly looking actor telling us about the dangers of a particular drug. They're pretty standard fare on mid-afternoon and late-night television. In recent months, a slew of ads targeting the drug Invokana, a diabetes medication, aired on stations around the country. These commercials usually say that if you've suffered certain side effects, such as an amputation, heart attack, or stroke, then you should call immediately to talk to an attorney.

It's not a stretch to believe that a fair number of people roll their eyes and assume this is just some scam that attorneys concocted to shake down a drug company. Others might view the same commercial and conclude that an evil pharmaceutical company concocted a dangerous drug cocktail that is now inflicting misery, all in the name of chasing the almighty dollar. Since these commercials offer very limited information on the Invokana controversy and there's next to nothing in the press, people are left to fall back on their own biases when forming their opinion.

This is a controversy that impacts people regardless of whether or not they take Invokana, so it's important that people have the facts about Invokana lawsuits, in order to form an opinion based upon more than just a cocktail of commercials and prejudices.

What Is Invokana?

If someone doesn't suffer from type 2 diabetes, or have a loved one who does, it's quite likely that they've never even heard of Invokana outside of lawyer ads on television and radio. Invokana is the brand name for canagliflozin, a diabetes drug that helps regulate blood sugar levels. Jansen Pharmaceuticals, part of Johnson & Johnson, devloped the drug and manufactures it. According to financial documents from 2017 (the most recent year), sales of Invokana topped $1 billion.

Invokana works by altering a process in the kidneys that reabsorbs filtered blood sugar. For those who don't know, kidneys function in our bodies a bit like an oil filter does in a car. Just as oil filters work by removing impurities that build up in the oil of our cars that comes from normal use, kidneys filter out the gunk that builds up in our bloodstream and releases it as urine.

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Of course, in filtering out the bad stuff, kidneys keep the good, like nutrients and of particular relevance to this discussion, sugars. Since sugars are the primary fuel that powers our bodies, if the kidneys filtered out all of the sugars found in our blood, we would starve to death. The reason that we don't starve to death is because our kidneys have a process that helps to reabsorb the sugar that the kidneys filter.

Invokana modifies this process. For many diabetics, there are issues with too much sugar in the blood, which is responsible for a good portion of diabetic weight gain. Their bodies retain more sugar than is necessary to survive. Enter Invokana. It modifies the process in the kidneys related to sugar absorption. So instead of reabsorbing all of the sugar in the bloodstream, the kidneys retain a much smaller amount of sugar and treat the rest as waste. It stays in the urine the kidneys produce and is later expelled from the body.

In a lot of ways, Invokana functions like a more controllable intestinal parasite, like a tapeworm. Whereas a tapeworm is a separate organism that steals nutrients from the body, Invokana alters how the kidneys work to get the body to do this without the assistance of an outside organism, in a more regular, controllable way. As a result of the lowered blood sugar, patients on Invokana see far less diabetic weight gain than patients on other treatments.

What Are the Side Effects of Invokana?

In addition to blocking the reabsorption of sugar, Invokana is also a diuretic. This means that Invokana increases the frequency and urgency to urinate. Other documented side effects include increased risk for kidney damage, low blood sugar, yeast infections (in both women and men), bone fractures, and recently, increased risk of limb amputations found its way on to the list of known side effects.

A large portion of the present controversy and many of the court cases involving Invokana stem from that last side effect. Some folks may wonder, "Don't diabetics already run an increased risk of amputation? Why do the makers of Invokana have to warn about something that already is a side effect of the disease?" Well, recent studies indicate that Invokana doubles the risk of amputation in patients. Sure, diabetics run the risk of amputations just by having the disease, but that risk is even greater for patients on Invokana, which is a bit of information that almost any patient would want before deciding whether or not to take the drug.

There are also reports that Invokana increases the risk of strokes, blood clots, and heart attacks. Unfortunately, the only sources that I can track down for that information are attorney web sites, which means that I take those claims with a giant grain of salt. Unlike studies that demonstrate the increased risk of amputations, which stood up to FDA scrutiny and led to stronger warning labels, the lack of independent data for the cardiovascular maladies allegedly associated with Invokana means that any judgment is little more than poorly informed guess.

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Does this mean that these side effects don't exist? Of course not. What it does mean is that context matters. The fact that the FDA ordered an update to include amputation risks on the Invokana warning label, but has yet to do so for heart and circulatory ailments suggests that data connecting Invokana and amputations is more thoroughly vetted than evidence that the drug causes heart problems and strokes.

Of course, even the most aggressive attorney isn't going to file hundreds of lawsuits without some evidence to back up their claims, which is why we shouldn't dismiss potential claims about increased heart attacks and strokes from using Invokana until we are in a position to see the evidence for ourselves.

Why Are People Suing the Makers of Invokana?

I realize that when discussing a lawsuit, most people bring a lot of pre-conceived notions to the table. As I mentioned before, some people view lawsuits against businesses as nothing more than a way for lawyers to get rich off of technicalities and shakedown deep-pocketed businesses. The opposite of that bias are people who believe that businesses profit off of human misery and lawsuits are just the best means for class-based score settling. The truth is a little different.

The reason we have laws, isn't so that lawyers can exploit "loopholes" or to "bring the capitalist swine to their knees," but to provide predictable, general principles that guide citizens' behavior. In medicine, this takes the form of the doctrine of informed consent.

Imagine for a second that in order for a doctor to prescribed a drug, or recommend a surgery, the doctor had to be 100% certain that nothing bad would happen. What would the result be? There wouldn't be modern medicine. Even telling a patient to take two aspirin and call in the morning carries the risk of something going seriously wrong. In order to get around this problem and enjoy the benefits of modern medicine, we've decided that doctors can do procedures and prescribe drugs that carry really serious risks, as long as patients know those risks going in.

For instance, suppose that there was a surgery that could cure quadriplegics 50% of the time, while killing the patient when it didn't work out. Would that surgery be illegal? Not necessarily, given the way our laws currently work. For some people, the risk of death might be worth it, if there's a chance that they can move their limbs again. For others, they'd likely not take the chance that things could get any worse. The general rule is that as long as the doctor makes clear what the risks of the surgery are, they're free to perform it.

Where our hypothetical surgeon could get into trouble is if they only told patients about the 50% success rate and left out the 50% mortality rate. Who wouldn't sign up for a surgery that works half the time, with seemingly no downside? Probably everyone. I think most of us would agree that when people started dying, under this scenario, the doctor would shoulder a large share of the blame for not revealing all the risks. People could credibly argue that their loved one would have never signed up for the surgery if they knew there was such a high risk of dying.

The same logic applies to drugs. Once the FDA determines that a drug actually does what it claims to do, without unnecessarily high risks to patients, the drug is approved, with the caveat that the manufacturer has to reveal all of the side effects of taking the drugs. Some drugs have absolutely horrific side effects, including death, but since they work for the vast majority of people, they're on the market, and appropriately labeled.

As it concerns Invokana, the current evidence is pretty clear that one of the side effects of the drug is that it increases the risk of amputation. Based upon this knowledge, the FDA ordered Johnson & Johnson to update the drug's label, in order to warn patients of these risks. However, between the time the drug hit the market and when the FDA ordered the update to the warning label, countless people took the drug without knowing about the increased risk of amputations. It's not far-fetched to believe that a fair number of these people wouldn't have chosen to take Invokana had they known about the elevated amputation risk.

At it's most basic level, a large portion of Invokana lawsuits center on the question, "Did Johnson & Johnson fulfill its duty to warn patients of all of the side effects of Invokana?" Some people might see a slew of lawsuits over a warning label omission as another example of lawyers making a big deal out of "technicalities," but that misses the point that the entire doctrine of informed consent is based on accurately reporting all side effects. Informed consent is a doctrine of technicalities. As long as a doctor or manufacturer reveals to the patient every bad thing that could go wrong, they're not on the hook when something bad happens.

Another class of allegations concern whether or not Invokana increases patients' risk of strokes, heart attacks, and blood clots. As previously discussed, I can't track down any publicly available studies that connect increased risks of cardiovascular ailments with Invokana's use. If you can't look at the evidence, it's impossible for someone observing the lawsuit from the outside to know just how strong it actually is.

One thing that the folks who suffered these maladies have going for them is that the Invokana warning label doesn't say anything about increased risks for strokes and other cardiovascular ailments. The only warning that comes remotely close is one advising patients that hypotension, or low blood pressure is possible. Since there's a world of difference between a stroke, a heart attack, and low blood pressure, this warning doesn't cover what the injured patients allege happened.

So if those who suffered heart attacks, strokes, etc., can show that Invokana increased their risk for those maladies, then it's likely that they have a very strong case. If no connection exists, then it's likely Johnson & Johnson will prevail in those cases.

In short, you can boil down Invokana lawsuits to two questions:

  1. Does Invokana cause X side effect?
  2. Did the makers of Invokana fail to warn patients of the potential for X malady?

If the answer to both of those questions is yes, then injured patients will prevail. However, if the answer to either question is 'no,' then Johnson & Johnson will win in court.

The Current State of Invokana Lawsuits

As of February of 2018, there are a little over 1000 pending lawsuits against Johnson & Johnson, relating to injuries that Invokana allegedly causes. While some people believe that anytime there are a large number of claims, the matter is a class action lawsuit, that is not true for Invokana lawsuits. Instead, these cases comprise what is known as multi-district litigation. The distinction between multi-district litigation and class action lawsuits is more than just legal semantics. These types of legal action function quite differently from each other.

In a class action lawsuit, many people suffer the exact same harm from the exact same cause. Then, rather than having everyone pursue their case individually, courts bundle the lawsuits together into a single case. For instance, suppose a drug manufacturer sold their a drug, Pain Away, at a list price of $1 per bottle. People want Pain Away and decide to purchase it at that price. But when these folks get their credit card statements, instead of $1 per bottle, they find out that the company charged them $10 per bottle. When the customers contact the company to request their $9 back, they're told that the $9 is a handling fee, which they were not told about ahead of time.

When it becomes clear that the company isn't going to refund any of their money, people will probably start filing lawsuits. As courts notice that thousands of people are suing over the exact same issue, instead of having thousands of individual trials, they'll lump them together into one big trial. That's a class action.

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Now suppose instead of charging too much money, people took Pain Away and then started to experience all sorts of side effects. Some folks claim that they had debilitating hives, while other said their eyeballs began to spontaneously melt. Unlike the scenario where the company overcharged its customers and those customers all suffered the same damage, in this hypothetical, each person has their own individual damages, which may not necessarily be the same.

Tracking back to the Invokana cases for a moment, even among the group of people who underwent amputations, the severity of the amputations varies wildly. I'm not saying that it's ever easy to have a part of your body surgically removed, but there's a world of difference between losing a toe and having an entire leg removed. Consequently, an attempt to do right by the victim has to take into account the severity of the injury, in order to be just. Class actions cannot provide invidually tailored justice, but multi-district litigation can.

Individual cases all have discovery, a formal, court supervised evidence gathering process, which can be both time-consuming and expensive. If there were just a thousand individual lawsuits, then in each case the injured person and the drug company would have to go through the discovery process from scratch. While the circumstances surrounding each reported injury might be different, the main evidence used to determine whether or not the drug causes these issues is going to be the same. So rather than force everyone to go through the time and expense of producing the same evidence in each individual case, a court can combine the cases into multi-district litigation, an MDL.

In an MDL, the court appoints a small number of attorneys to conduct discovery on behalf of all the injured people. The court then makes this information available to all of the attorneys who represent injured clients for use when those individual cases go to trial. The costs are then shared equally by all of the plaintiffs. In a lot of ways, this functions a lot like procuring equipment for a big football game. Everyone could go through the process of ordering their own cleats, pads, and helmets, or since they'll all end up on the same field, they can pool their resources, have one person place the order for everyone, then collect their equipment before the game, or in this case, the trial.

Upon completion of discovery, the court that overseas the MDL selects a number of cases that address the thorniest fact issues in the dispute. These cases then go to court and juries have their say. Such cases are known as bellwether trials. Whatever decision juries reach, it informs the other parties of the MDL how juries view the evidence and the controversy. If we go back to our hypothetical for a moment, let's suppose that the court decides that a handful of debilitating hive cases are to be tried first. In those cases, the jury rules against the injured people, because in their minds the evidence doesn't link the drug with hives outbreaks. Everyone else who is suing because they've experienced awful hives then knows that it's probably a waste of time to pursue their case. In that case, most of the remaining hive lawsuits would likely be dropped.

While the hive cases were at trial, the court likely selected a group of eye-melting cases to trial in order to allow juries to weigh in on that controversy. Unlike the hive cases, our juries in the hypothetical eye-melting cases decide that the drug does cause eye-melting, the manufacturer didn't properly label the drug, and orders the drug-maker to pay damages to the melted eye victims. These juries provided valuable information to help resolve the controversy. First, they established that the manufacturer was liable for any eye-melting injuries. Then they also set a price on the manufacturer's bad behavior, since you can't just go on Amazon and look up a price for lost sight.

This sets the stage for a negotiated settlement in the dispute. If it can be avoided, injured people don't want to wait years to hold someone accountable for their injuries, and businesses don't want to go through the time and expense of trying thousands of cases, when it's obvious they're going to lose. Now that they know that a jury will hold them accountable and how much a typical jury will make them pay, there's a huge incentive for the drug-maker to settle the remaining claims against them. They'll likely offer the hive folks nothing, since they never won a case, while making reasonable offers to the eye-melting crowd, in order to avoid a jury making them pay far more.

Currently, more than 1000 Invokana cases are part of an MDL overseen by a federal District Court in New Jersey. Invokana claims currently come in two varieties, those who suffered amputations and those who experienced heart attacks, strokes, blood clots, or other cardiovascular ailments. Discovery in both groups is pretty far along, and the court already scheduled bellwether trials for a small portion of both types of Inovkana claim. Group A bellwether cases are going to court in order to see how the amputation cases play out before a jury, while Group B cases address the cardiovascular ailments.

Since bellwether cases impact all of the other cases in the MDL, a common mistake that people make is to assume that they're practice cases and the courts are only asking juries to weigh in, as a means of resolving the other cases. That is not what's happening. The trials are very real and their outcomes binding. It's just that plaintiffs and the drug-maker decided that these cases cover the range of legal and fact issues present in these lawsuits, so they decided to push them to the front of the line.

Until these trials conclude, the rest of the Invokana cases will likely remain in a holding pattern. That doesn't mean that the attorneys for those individuals sit around and do nothing, instead they keep one eye on the bellwether cases, while crafting the best arguments for their clients' unique circumstances. Depending on how the bellwether cases go, these cases will eventually go to trial, settle, or be dropped.

Do People Who Believe They've Suffered an Invokana-Related Injury Hire Their Own Attorney?

Perhaps some of the confusion from these types of ads comes about because there are two different forms of mass legal actions that work in similar, but different ways. They are class actions and mult-district litigation (MDLs).

In a class action, there is one legal action and potentially a single trial. In these cases, the court appoints a single attorney, or group of attorneys, to represent all of the victims. This makes sense in a class action, because the damages do not vary from person to person. Like my earlier example with the overcharged drugs, everyone was overcharged the same amount.

Maybe the easiest way to understand how this works is to think of a lawsuit as a test. An attorney has to master all of the material for this test, which in the case of lawsuits, are all the relevant facts on both sides of the controversy. In a class action, there's a single lawsuit and a single test. Therefore, it's possible for a single person, or a small group of people to understand everything they need to know, in order to pass the test on behalf of their clients.

MDLs are quite different. Since every injured person has their own unique story and the cases have their own trials, it's akin to an attorney having to take a test on behalf of each and every injured person. In an MDL like the one involving Invokana, there are literally 1000 tests. It's simply not possible for any small group of attorneys to master that tremendous amount of information. Even the largest law firms in the country would have to devote almost all of their resources to passing that test.

That's the main practical reason that those who believe that they were injured by taking Inovkana hire their own attorneys. While the shared discovery process means that a large portion of the evidence will be the same from case to case, the individualized nature of the injuries means that a person is best served by having an attorney they trust to master the facts of their case, while looking out for the injured person's interest.

In a class action, a court says here's the attorney for everyone, sign up with him or go find your own attorney and start a whole new lawsuit, whereas in an MDL people seek out their own attorneys, who then join in the MDL on their client's behalf.

Invokana Side Effects Are a Legitimate Controversy

So now that we're all roughly on the same page with regard to what's happening, it's fair to ask, "Are Invokana lawsuits just a money-grab by greedy attorneys or do they represent a greedy corporation 'putting profits ahead of people?'" Truthfully, these lawsuits are probably neither and just how we resolve a major, far-reaching controversy in our society.

If we're to believe that 1000 lawsuits are all a giant conspiracy to enrich lawyers, we have to convince ourselves that a group of attorneys rounded up a bunch of injured people, convinced them that Invokana caused these injuries, then tracked down doctors to falsify research to back up their claims about Invokana. They also tricked the FDA into adding side effects to the drugs' warning label. Does that seem like just a bit of a stretch? It's even less likely when you consider that these nefarious lawyers would have to concoct this whole scheme and then execute it without leaving a paper trailer that Johnson & Johnson could uncover.

At the same time, extreme business-bashers rallying around the flag of corporate greed are likely just as wrong. Their premise is that Johnson & Johnson developed a potentially dangerous drug like Invokana and decided to sell it, just to pad their bottom line. While there is certainly money-making potential in dangerous drugs, guess what makes even more money--safe drugs. If those greedy executives at Johnson & Johnson really wanted to make money, they would have developed a drug that didn't allegedly hurt people. Such a drug would sell more than a dangerous drug and it would save the company a ton of money in legal fees and potential damages.

Even if you think that corporations are inherently evil and greedy, you still have to gloss over that these evil geniuses could have avoided this entire controversy by properly labeling Invokana in the first place. If people had proper warning about the amputation risks and took the medicine anyway, then any injuries would be on them.

I'm not trying to sit on the fence and not pick a side in these cases, but having an opinion doesn't really contribute anything to resolving the controversies over whether Invokana caused people to suffer various ailments, and if so, what should be done to make them whole. It would be a bit hypocritical to consistently advise people to wait until all of the evidence comes in before forming an opinion about what happened in an 18-wheeler accident and then firmly declare for one camp or another about a controversy that is orders of magnitude more complex, like the Invokana controversy.

This isn't to say that I don't have sympathy for people who've lost a limb or a loved one and believe it was due to Invokana. Given the seriousness of what those people have endured and the limited information that has come to light, the very least these folks deserve is their day in a fair and impartial court. It's almost like that's why we have the civil justice system in the first place.