Proton Pump Inhibitor (PPI) Lawsuits Related to Nexium and Prilosec
Proton pump inhibitors are a class of heartburn medication that is intended to treat the illness by reducing excessive stomach acid. These are among the most popular drugs on the markets, and they are used even more now that medications like Zantac have been recalled.
However, PPI users have experienced problems of their own as these are dangerous drugs, far worse than the manufacturer would have you believe. Proton pump inhibitor usage can cause serious problems, such as chronic kidney damage.
As a result, the pharmaceutical companies behind these products (such as Priolec and nexium) are facing thousands of lawsuits filed by injured consumers. If you or a loved one have been injured by a proton pump inhibitor, contact an attorney to learn more about filing a product liability lawsuit.
Treating Excess Stomach Acid
There are several pharmaceutical ways to reduce gastric acid production. Each of these methods works a different way. Here are some of the types of heartburn drugs on the market:
- Antacids - These are available over the counter, and they are the simplest way to reduce stomach acid. These include Mylanta, Rolaids and Tums.
- H2 Receptor Blockers - These act on specific receptors in the stomach that release acid, and they inhibit certain reactions in these cells to reduce the amount of acid that they produce. These medications include Pepcid and Tagamet.
- Proton Pump Inhibitors - These are even stronger acid blockers, such as nexium/prilosec, that keep acid from being produced and promote healing in the esophagus.
- Ranitidine - this was another way to treat stomach acid, but all of these drugs (including the market leader Zantac) were recalled from the market because they were tainted with a carcinogen.
In general, proton pump inhibitors are thought to be stronger than H2 receptor blockers, and they are known to work better.
Purposes of a Proton Pump Inhibitor
Stomach acid is the major cause of heartburn. Acid reflux is also known as gastroesophageal reflux disease. This is when food or liquid travels up from the stomach to the esophagus.
It creates a constant burning sensation and continuous discomfort for the patient. In addition, heartburn can also raise the long-term risks of esophageal cancer.
A proton pump inhibitor is meant to reduce the amount of stomach acid that is produced. It is intended to treat gastroesophageal reflux disease. Less stomach acid means that it cannot travel up the esophagus to cause discomfort. We will describe the exact way that these medications work below.
How Proton Pump Inhibitors Work
The goal of proton pump inhibitors is to reduce stomach acid. This way, it will not travel up to the esophagus. The end result is that a PPI medication will block the stomach from producing acid.
Proton pump inhibitors get their name because they keep the stomach cells from making acid and pumping it into the stomach. Patients are supposed to take them a short time before a meal.
Specifically, the gastric parietal cells have an enzyme system that makes the acid. This is also known as a proton pump. PPIs help block this system from producing too much acid, hence the name "proton pump inhibitor."
These medications are used to treat the following stomach acid related conditions:
- Acid reflux and heartburn
- Gastroesophageal reflux disease (GERD)
- Peptic ulcers (stomach ulcers)
- Zollinger Ellison Syndrome
PPIs may also be used to treat stomach infections.
History of Proton Pump Inhibitors for Acid Reflux
The first proton pump inhibitor came to market in 1988. The first version of the drug was called omeprazole. This is also known as Prilosec. Initially, this was a prescription medication, but over-the-counter versions of the drug were also introduced.
Eventually, related categories of proton pump inhibitor drugs were introduced. These drugs have grown in popularity over the years
Proton Pump Inhibitors on the Market
You are undoubtedly familiar with a number of companies that make PPIs and the brands that they sell. For example, you are likely inundated with ads for Prilosec OTC every time you turn on a football game or any other major television event.
Other proton pump inhibitors on the market include:
- Nexium (made by Astra Zeneca)
- Prevacid (made by Takeda Pharmaceutical Company Limited)
- Protonix (made by Pfizer)
- Prilosec (Astra Zeneca)
Right now, the total market size for PPIs is around $3 billion. This is a fast-growing segment of the drug market, especially without competition from drugs like Zantac, which treated heartburn and reflux in a different way. Millions of people use these products each year.
These Are Over the Counter Medications
PPIs are a popular heartburn medication, in part, because they are so easy to get. You do not need a doctor's prescription for many of these medications. You can simply go to your local drugstore and pick them up.
Most of the popular brands have an over the counter version along with one that comes in prescription strength. Patients may even buy these drugs without consulting with their doctors (which is something that they should not do).
Proton Pump Inhibitor Drugs Are Heavily Sold to the Public
These are among the more heavily advertised drugs on the market. Of course, the makers of these drugs would have you believe that they are completely safe.
Almost two decades ago, the makers of Prilosec launched a $100 million ad campaign to boost sales. It is hard to turn on the television without seeing an ad for one of the PPI drugs.
One study revealed that Nexium had a monthly budget of $1.7 million spread across the four broadcast news networks and spent roughly the same amount on cable networks. This figure does not account for digital and print advertisements.
These drugmakers do not tell you that their products could permanently damage your kidneys. This lack of a warning is one of the problems at issue in the lawsuit.
The FDA Drug Safety Communications
The Food and Drug Administration has issued a number of safety communications about Nexium/Prilosec and other proton pump inhibitors. Some of these FDA warnings include:
Bone fractures - This FDA drug safety communication warned of an increased possibility of hip, wrist and spine fractures from the use of proton pump inhibitors. However, the FDA drug safety communication indicated that a boxed warning label was not necessary.
Low magnesium levels - Again, while warning the public, the FDA downplayed the risk, and said that this risk was only present with prescribed medication and not with OTC versions of proton pump inhibitors.
In 2014, the FDA required the warning label on proton pump inhibitors to include a caution about the risk of acute interstitial nephritis. This came after three years of pressure on the FDA to take such a step.
Finally, the public became aware of the possibility of chronic kidney disease, after the manufacturers knew it for years.
Research About the Safety of Proton Pump Inhibitors
The main problem with proton pump inhibitors (ppis) is that they can impair kidney function. This can range from more minor and manageable problems to acute renal failure.
Although reports of kidney injuries showed up in the FDA database for years (See below), some of the more extensive research was undertaken in the middle of the last decade.
Some of the first reports of kidney damage from proton pump inhibitors came in 1992, when researchers recognized PPIs as a cause of acute interstitial nephritis (AIN). This is a serious kidney disease.
One large study in New Zealand looked at nearly 600,000 patients who had taken PPIs. These patients did not have any prior history of AIN. The research found that patients taking proton pump inhibitors had five times the chance of developing AIN.
The publication from JAMA Internal Medicine also included a study about PPIs and kidney injuries. This journal studied 250,000 patients taking proton pump inhibitors, and it found that they were 20-50% more likely to develop chronic kidney disease than patients who were not taking these drugs.
Another study from the Atherosclerosis Risk in Communities Study found that patients using PPIs had an approximately 35% higher chance of developing chronic kidney disease. There have been many further studies recently that have continued to develop the statistical correlation between PPIs and kidney injuries.
Even if proton pump inhibitors only measurably increase the chances of kidney injuries, the tens of millions of people who have taken this drug means that there will still be a large number of patients who have suffered kidney damage.
Another paper was published by the Houston Methodist Research Institute in 2015. While this did not touch on kidney disease, the Houston Methodist Research Institute did find that long-term usage of proton pump inhibitors can increase the risk of a heart attack.
How Proton Pump Inhibitors Damage the Kidneys
Much attention has also been devoted to figuring out the kidney risks from PPIs. The first study to detail a connection between kidney damage and PPIs found that this could occur from a hypersensitivity immune reaction to the drug. Many patients will have an allergic reaction to the drug that causes kidney damage.
Researchers are still trying to document the exact connection and how medications like Prilosec OTC cause kidney disease. For now, the statistical connections seem pretty compelling.
Food and Drug Administration Adverse Event Reports
As of this writing, the FDA is currently evaluating the need for regulatory action for another potential problem related to proton pump inhibitors.
There have been some adverse event reports about a condition called rhabdomyolysis that may be connected with PPIs. This is a potentially fatal condition when damaged muscle tissue releases proteins and electrolytes into the blood.
One research study data mined the FDA adverse events reporting system to find reports about kidney injury associating with proton pump inhibitors. Of course, as has recently emerged, not every single report in this system is available to the public.
For years, there was a secret reporting system that allowed serious complications to escape public notice. Thus, the number of reported events is likely far lower than the number of people who have suffered serious kidney damage from using Nexium/Prilosec.
Nonetheless, between 2004 to 2019, this study identified 3,187 cases of acute kidney injury and 3,457 cases of chronic kidney disease associated with proton pump inhibitors. Based on the adverse event reports, the study found that PPI users suffered acute kidney injury in an average of 23 days after beginning use of the proton pump inhibitor. It took an average of 177 days for patients to develop chronic kidney injury.
Side Effects of Chronic Kidney Disease
Kidney diseases will have an immeasurable impact on the patient's ability to live a normal life. This involves a gradual loss of kidney function. Over time, it will grow far worse.
The problem is that many people will not realize that they are sick at first, costing them valuable treatment time. Eventually, the kidneys will filter less and less waste from the blood.
Some symptoms of chronic kidney disease are:
- Loss of appetite
- Loss of mental acuity
- Changes in urination
- High blood pressure
- Shortness of breath
The progression of chronic kidney disease depends on the patient. It can worsen over the period of years. Eventually, the patient may need dialysis or a kidney transplant. In some cases, they will reach end stage renal failure.
Chronic kidney disease ranges from stage 1-5. Stage 1 chronic kidney disease is more mild damage. Over time, it can worsen to become stage 5, which is complete kidney failure.
Acute Kidney Injury
As opposed to a chronic kidney condition, acute kidney injury happens relatively suddenly. Here, there is very little warning, and the kidneys will stop working with short notice.
This is a life-threatening condition that often requires intensive care treatment. Here, proton pump inhibitors will do sudden damage to the kidneys in a short period of time.
Treating Chronic Kidney Disease
The treatment for kidney injuries caused by proton pump inhibitors depends on the severity of the injury. With chronic kidney conditions, the key is in managing the progression of the disease.
These conditions may not be curable, but doctors can help control symptoms. Over time, chronic kidney disease may eventually stop the organ's functions.
Chronic kidney disease is managed, but it is incurable. Patients can make diet and lifestyle changes that can help slow the progression of the disease.
Treating Acute Kidney Injuries
Acute kidney injuries are treatable in some cases. Doctors can treat the symptoms, helping the body to maintain functions while the kidneys recover as much as they can.
This could include dialysis to remove waste from the blood and medication to control blood potassium and restore calcium levels. However, even if a patient can recover from an acute kidney injury, the damage to the kidneys is done, and the patient will be more likely to develop further kidney conditions in the future.
The Costs of Kidney Injuries
Long-term kidney injuries will impose a number of costs on the patients who are suffering from them. These are injuries that could require expensive surgical procedures (such as a kidney transplant) or daily treatment.
The medical bills alone can add up to hundreds of thousands of dollars or more. Patients will need lifelong medical treatment to manage a condition that will not get better.
In addition, those who suffer from serious kidney injuries can sustain the following damages:
- Lost wages from the time that they miss from work or a reduction in their earnings capacity (people with kidney disease on dialysis may not be able to work at all)
- Pain and suffering - renal failure can be a painful condition, as the body cannot effectively remove the toxins. In addition, kidney failure is a debilitating disease that causes both physical and mental discomfort.
- Loss of enjoyment of life - being hooked up to dialysis machines several times per week can keep people from the hobbies that they enjoyed beforehand. In addition, constant reliance on dialysis degrades the quality of life.
Wrongful Death From Kidney Failure
In some cases, kidney failure patients cannot obtain a transplant in time to save their life. Kidney failure is a condition that will eventually become fatal without a transplant. Patients can only live for so long on dialysis with kidney problems.
One study in the respected medical journal BMJ compared the number of deaths among people taking PPIs to those taking other types of heartburn drugs, and the statistics that they found were alarming.
Wrongful Death Damages From Proton Pump Inhibitor Medications Lawsuits
Families who have lost a loved one to end stage renal disease have the ability to file a wrongful death lawsuit against the maker of the drug that their loved one took.
If you win your wrongful death lawsuit or receive a settlement, you may be able to get the following damages:
- The lost wages that your loved one would have earned over the course of their lifetime
- Payment for the grief that the family went through from losing their loved one
- Compensation for the loss of your loved one's physical support
- Loss of consortium damages
In addition, end stage renal failure can often be a difficult and drawn out death. The estate can also bring a survival action to recover for the damages that the family member suffered before they died.
Increased Risk of Ischemic Stroke From PPIs
Much of the publicity about side effects from proton pump inhibitor use discusses chronic kidney damage. However, another major complication is that proton pump inhibitors increase ischemic stroke risk, according to some researchers.
This is still a matter where there is disagreement among researchers. One study found that, while the risk of stroke was higher in patients taking PPIs, it was not measurably higher after adjusting for lifestyle and other risk factors.
Nonetheless, there is at least some correlation between strokes and PPI usage.
Proton Pump Inhibitor Litigation
PPI lawsuits began to be filed in 2016-2017. By 2017, there were over 200 cases filed. At that point, they were consolidated into multidistrict litigation.
The number of cases continues to grow. We expect there to be more litigation in the future, as millions of people have taken these drugs.
Legal Grounds for Prilosec Lawsuits
Even though the manufacturer will market Nexium as a safe drug, the reports and statistics say something different. A drug that was long thought to be safe may be anything but.
Here are some common grounds in PPI lawsuits:
- The design of the drug was unreasonably dangerous because it caused kidney damage
- The makers of these products knew that they were dangerous and failed to warn the public of the dangers
- The makers of these drugs were negligent in both designing and manufacturing PPI drugs
- The product makers fraudulently concealed defects with the drugs
- The makers breached both express and implied warranties that the product was safe and for use
There are numerous additional counts to these complaints, including state law claims.
Where the Proton Pump Inhibitor MDL Currently Stands
The Proton Pump Inhibitor lawsuits have been granted multidistrict lawsuit status. All of the cases against the PPI manufacturers have been consolidated into one legal action (although this is not a class action lawsuit) The MDL is No. 2789.
The case is currently in the United States District Court for the District of New Jersey. As of this writing, there are nearly 13,500 lawsuits pending as part of the MDL.
The first bellwether trials in the multidistrict litigation have been scheduled for this case in early 2022. They were originally supposed to happen in 2021, but they were delayed because of the pandemic.
After the verdicts are issued in the bellwether trial, the defendants will assess their legal risk. Usually, if they lose the first cases, they will look more closely at a global settlement agreement.
The case has been assigned to District Court Judge Clair C. Cecchi. Currently, the case is at the stage where the parties are challenging each other's expert witnesses (as they always do).
Filing a Proton Pump Inhibitor Lawsuit
If you or a loved one have been injured after taking Prilosec, or any other proton pump inhibitor, you may be able to file a lawsuit.
The law firm of Rosenfeld Injury Lawyers has a strong track record of helping injured clients take legal action against the individual or company whose careless or reckless actions harm them.
Call us today for a free case evaluation and to learn more about your legal options.