Proton Pump Inhibitor (PPI) Lawyer
A proton-pump inhibitor (PPI) lawsuit demands compensation for injuries caused by these dangerous drugs. Patients who have taken PPIs and suffered harm have the right to file a claim for damages. Several cases have already been filed in the United States. PPIs are being investigated for their links to chronic kidney or renal disease, and acute kidney or renal disease.
If you or someone you care about have used a proton-pump inhibitor and been diagnosed with chronic kidney disease, acute kidney disease, or other serious side effects, you may be eligible to file a lawsuit. Our dangerous drug lawyers can help you demand justice.
Proton-pump inhibitors, or PPIs, are a specific type of medication used to relieve symptoms of acid reflux, heartburn, and gastroesophageal reflux disease (GERD). They work by reducing the amount of stomach acid produced by the glands in the stomach. The first PPI, omeprazole, was released in the United States in 1990 and sold under the brand name Prilosec. Along with its European counterpart Losec, omeprazole quickly became one of the world’s best-selling drugs.
- Types of Proton-Pump Inhibitor Medications
- What Are Side Effects of PPIs?
- Are There PPI Alternatives?
- Are There Proton-Pump Inhibitor Lawsuits?
- Should I Hire a Proton-Pump Inhibitor Attorney?
What Do Proton-Pump Inhibitors Do?
Proton-pump inhibitors are prescribed to treat conditions such as:
- Gastroesophageal Reflux Disease
- Acid Peptic Disease
- Zollinger-Ellison Syndrome
- Peptic or Stomach Ulcers
- Acid Reflux
What Causes Gastroesophageal Reflux Disease (GERD)?
The development of acid reflux in a healthy individual should not be seen as an indication of a greater health risk as the condition can develop in otherwise healthy individuals ranging from infants to adults. The condition can be triggered in many ways but typically only occurs in brief spurts without the development of any debilitating or bothersome symptoms.
One of the common causes of GERD is a stomach abnormality called hiatal hernia, which can develop within a wide range of healthy individuals.
The most common cause of acid reflux disease is a problem developing with the lower esophageal sphincter (LES) muscle. The LES muscle acts as an impregnable barrier between the stomach and esophagus and prevents stomach acid from seeping into the esophagus. The muscle loosens and opens as food passes through the esophagus but tightly closes, creating the barrier, once food has reached the stomach.
If something is preventing the LES muscle from closing as it is designed to do, stomach acid and other substances will flow into the esophagus causing pain and discomfort.
In addition to pain and discomfort, sufferers report pain in the upper abdomen and chest, nausea, and indigestion among other symptoms. Most reports of GERD do not involve severe pain but in the cases that they do, time after meals is typically the peak of symptom activity.
What Causes Heartburn?
When humans eat, the body increases the production of stomach acid to fuel the digestive system. Some foods and beverages can cause more severe heartburn than others. Foods like meats, fruits, vegetables, and foods containing dairy affect the ability of the esophagus to keep acid down. Beverages such as coffee, tea, and alcoholic drinks can also be troublesome. Although, food and beverage triggers can vary from person to person.
Eating large portions can also increase acid indigestion. The more full the stomach becomes, the more pressure is applied to the LES. This can lead to the LES allowing stomach acid to move up through the esophagus, causing heartburn.
Even the worst chronic heartburn can be managed by eating a healthy and proper diet. Acid reflux is also linked to obesity, and symptoms can be minimized by losing weight.
Types of Proton-Pump Inhibitor Medications
After 13 years on the market as a prescription medication, the FDA approved an over-the-counter version of Prilosec in 2003. With the advent of additional OTC proton-pump inhibitors, these drugs have consistently ranked in the top-grossing medications in the country for years. In fact, approximately 15 million Americans use and/or are prescribed PPIs, making it the most commonly prescribed type of drug in the United States.
The chart below contains information about many of the current PPIs in use today:
|Rabeprazole||AcipHex||2002||EISAI, Co., Ltd.|
|Omeprazole/Sodium Bicarbonate||Zegerid||2006||Salix Pharmaceuticals|
One of the major drugs constituting the proton-pump inhibitor class, it was developed to treat symptoms of frequent heartburn caused by acid reflux. It does so by preventing the backup of stomach acid and/or bile into the esophagus which in serious cases can lead to extensive damage.
AcipHex is manufactured by the Japanese pharmaceutical company, Eisai Co., Ltd. and was approved by the U.S. Food and Drug Administration in 2002. Since approval, the anti-ulcer drug has become one of the most popular proton-pump inhibitor drugs on the market and is regularly a top 100 yearly selling drug.
The drug – which is in the same pharmacologic class of drug as omeprazole – allows the esophagus to heal from the effects of acid reflux by decreasing the stomach’s ability to make acid. If taken early enough, the drug can prevent the development of ulcers (sores in stomach or esophagus lining) and nonsteroidal anti-inflammatory drug-induced ulcers.
The drug can be prescribed in two forms, a delayed-release tablet or a delayed-released capsule referred to as “AcipHex Sprinkle.” Delayed-release tablets are swallowed whole as a standard pill while AcipHex Sprinkle is administered by sprinkling the opened capsule over food or liquid to be consumed.
In addition to being prescribed to combat symptoms of heartburn and acid reflux, it can be used to treat symptoms similar to Zollinger-Ellison syndrome in which the stomach produces too much acid.
The anti-ulcer drug can be administered through two primary methods, delayed-release tablets or delayed-release oral suspension. While tablets are swallowed, the delayed-released oral suspension dosage is administered through disintegration in a consumed portion of apple juice or applesauce.
Developed by Pfizer Inc. subsidiary Wyeth, a New York-based pharmaceutical company, Protonix was initially approved by the U.S. Food and Drug Administration (FDA) in February 2000 for 8-week treatments. Two additional FDA approvals followed the initial approval date with the final approval being announced in April 2002 for long-term treatment to combat health complications, including Zollinger-Ellison Syndrome.
Protonix (pantoprazole) is categorized in the same pharmacologic class as popular medication Prilosec (omeprazole), sharing a wide range of characteristics with the drug and other PPI medications. The drugs allow the esophagus to heal from exposure to stomach acid by decreasing the amount of acid the stomach produces. With stomach acid withdrawing from the esophagus, ulcers (sores in the stomach or intestine lining) and non-steroidal anti-inflammatory drug-induced ulcers can be prevented.
Zegerid is one of the major drugs that constitute the proton-pump inhibitor (PPI) drug class designed to combat frequent heartburn symptoms caused by the flow of stomach acid into the esophagus – acid reflux.
The drug is available to consumers as a standard capsule and a powder for oral suspension, each taken by mouth. The chemical makeup of both methods works by decreasing the amount of acid the stomach can produce, giving the esophagus time to heal from previous acid damage. This healing time allows the body to prevent or halt ulcers – sores in the stomach or intestine lining.
Developed by pharmaceutical giant Bayer AG, Zegerid was first approved by the U.S. Food and Drug Administration in 2004 for both methods of use. While being approved primarily to combat the symptoms of acid reflux, the drug is also approved for use for conditions in which the stomach produces too much acid – Zollinger-Ellison syndrome.
What are the Side Effects of Proton-Pump Inhibitors?
Like most medications, PPIs have a range of normal side effects that can affect the user. It is also important to note that stomach acid is responsible for fighting dangerous bacteria in the stomach. Because PPIs reduce the production of this acid, the user can become more susceptible to bacterial infections. However, these occurrences are rare. Below are some common side effects associated with most proton-pump inhibitors:
- Abdominal Pain
Unfortunately, there has been concern over additional dangerous side effects that may be associated with the use of proton-pump inhibitors and can be the basis of a lawsuit with the help of the right lawyer. Research conducted over the last decade has brought about concern regarding PPIs and the effect they have on the heart, kidneys, and mental health. Below are some of the most serious complications believed to be associated with proton-pump inhibitors:
Dementia is a category of degenerative brain disease with a wide range of symptoms ranging from memory distortions to serious behavioral and psychological symptoms. There is currently no cure for these conditions. Approximately 36 million people are affected by different types of dementia globally. It is believed as the average lifespan for humans continues to increase, so does the rate of dementia. Nearly half of all people over 85 years and older will suffer from dementia.
A prominent German study published in February 2016 associated PPIs with dementia. The research found that there was a 44 percent increased risk of dementia in users of PPI medication compared to those who were not taking the drug.
Chronic Kidney Disease
The concern over serious complications associated with proton-pump inhibitors has been brought on by a series of studies and reports that have been conducted on these drugs. A 2016 study published in the Journal of the American Society of Nephrology concluded that taking PPIs may dramatically increase the risk of kidney failure and kidney disease. The study looked at data from over 170,000 patients who were currently using PPIs and compared those results to a control group of over 20,000 individuals who were using a proton-pump inhibitor alternative. The study determined there was a significant difference in the rates of acute kidney injury and acute interstitial nephritis in patients who took PPIs compared to those who did not — the risk of end-stage renal disease was 96% higher in those who took PPIs.
Other reports have produced similar findings. In January 2016, the Journal of the American Medical Association published a study that found those taking PPIs once daily had a 15% increased risk of chronic kidney disease, and twice-daily users were 46% more likely to develop chronic kidney disease. The study also found that those who took PPIs had a 39% higher risk of kidney disease than patients who took H2 blockers, a different type of drug used to treat heartburn and acid reflux.
Another study on proton-pump inhibitors in The Journal of the American Medical Association published in early 2016 suggested an association between PPI medications and CKD. Two groups were studied over a ten-year period consisting of self-reported PPI users. One group contained over 10,000 Americans taking part in a national study on arteriosclerosis, while the other group was part of almost 250,000 patients of a Pennsylvania health care system. Researchers determined that an increased risk of CKD was associated with PPI use in both groups.
In their report, researchers identified a 15% increased risk of chronic kidney disease in PPI users who took the medication once a day. Alarmingly, they also reported a staggering 46% increased risk of the condition in patients who took PPIs more than once per day.
The Journal of the American Medical Association published a study in February 2016 identifying a link between the drug and kidney disease. Over 10,000 participants were studied from a period ranging from 1996 to 2011. According to their findings, the use of proton-pump inhibitors was associated with a higher risk of incident chronic kidney disease (CKD).
The following symptoms can be applied to any type of kidney disease including prerenal, intrinsic, and postrenal kidney failure, and may vary depending on the severity of the disease.
- Urine output
- The gradual diminution of urine can indicate urethral stricture
- Nausea, vomiting
Oliguria or anuria is the failure to produce a normal amount of urine and is usually accompanied by an AKI, however, polyuria, the opposite of oliguria and anuria occur due to reduced fluid reabsorption by damaged renal tubules.
Acute Kidney Injury (AKI)
Acute renal failure or acute kidney injury occurs when a reduction in blood flow to the kidney causes a loss of kidney function. This is one of the most common types of acute kidney injury, as it can be a complication of almost any disease, condition, or medicine that decreases the normal amount of blood and fluid in the body.
Acute Kidney Injury (AKI) is a condition that results in decreased kidney function or kidney damage within only hours or days. In some cases, acute kidney injury can lead to more serious complications such as chronic kidney disease or complete kidney failure (End-Stage Kidney Disease).
The Canadian Medical Association Journal published a study in 2015 identifying a link between proton-pump inhibitors and acute kidney injury. The nine-year study looked at Canadian residents 66 years of age or older who regularly took PPI drugs like Nexium. About 300,000 people were compared to an equal-sized control group who did not regularly take PPI medication. The study concluded that PPI users were three times as likely to develop ACI complications than the control group.
This same study also measured the rate of interstitial nephritis that occurred in PPI users. Interstitial nephritis is a condition that causes inflammation of the kidneys and can lead to more serious kidney complications such as acute kidney injury. Although the occurrence of interstitial nephritis was much less common in the study, the results still showed a three times higher rate of the condition in users of proton-pump inhibitors.
Proton-Pump Inhibitor Alternatives
Individuals who suffer from chronic acid reflux do have treatment options other than proton-pump inhibitors. Before prescribing PPIs, doctors often recommend a patient try using antacids, a type of medication that neutralizes stomach acid and reduces the amount of acid that is refluxed into the esophagus. However, for patients who suffer from chronic heartburn, also known as gastroesophageal reflux disease (GERD), antacids may not be enough to combat their condition.
Another type of medication commonly used to treat acid indigestion is Histamine H2 receptor antagonists, commonly known as H2 blockers. These medications work to reduce the production of stomach acid, as well as make stomach juices less acidic so that the esophagus becomes less irritated. Doctors will usually prescribe H2 blockers to patients who suffer from chronic heartburn that is not controlled by antacids. Popular H2 blockers include Pepcid and Zantac.
Proton-Pump Inhibitor Lawsuits
There have been more than 15,000 lawsuits filed against the manufacturers of PPIs. These lawsuits allege that manufacturers didn’t do enough to warn health care providers and patients about the possible risks. Some Prilosec lawsuits allege that AstraZeneca knew of the kidney risk for at least a decade before warning the general public.
As of January 2020, more than 13,400 PPI lawsuits are pending in federal court.
In the last few years, multiple lawsuits against PPI manufacturers have been settled for large amounts. In 2013, Nexium manufacturer AstraZeneca settled a lawsuit that alleged deceptive marketing tactics were used in promoting the product. The class-action lawsuit settled for $20 million.
Then, in February 2015, AstraZeneca settled another lawsuit for $7.9 million against the United States Government alleging that the company engaged in a kickback scheme that violated the False Claims Act.
Another PPI manufacturer, Teva Pharmaceuticals, settled a class-action lawsuit for $24 million in June 2015. This lawsuit alleged that Teva intentionally withheld a generic version of Nexium off the market after it was found that they were paid off by AstraZeneca.
Should I Hire a Proton-Pump Inhibitor Attorney?
Drug Lawsuit Source is currently investigating PPI-induced Acute Interstitial Nephritis (AIN), which is a condition where the spaces between the tubules of the kidney cells become inflamed. The injury appears to be more profound in individuals older than 60.
While individuals who suffer from AIN can recover, most will suffer from some level of permanent kidney function loss. In rare cases, individuals suffering from PPI-induced AIN will require a kidney transplant.
Studies and reports on PPI complications coupled with the recent history of lawsuits against these companies have prompted attorneys to investigate cases for patients who have been harmed by these drugs. If you believe a PPI medication is responsible for complications you or your loved one has suffered, you may be eligible to file a lawsuit and recover compensation.
To file a proton-pump inhibitor lawsuit with the help of our proton-pump inhibitor lawyers, the following criteria must be met:
- The patient took one of the following PPIs by prescription or over-the-counter for at least one year:
- The patient was diagnosed with a new-onset of one of the following while taking the PPI:
- Acute kidney/renal failure
- Chronic kidney/renal disease
- Acute interstitial nephritis
Contact us today for your free case review. Our legal team will review your medical records to determine if you have a case. If you do qualify for a claim, we will start your case immediately. We charge no fees unless we win.