The history, issues and litigation surrounding proton pump inhibitors
Heartburn. Everyone’s experienced it at some point to a varying degree. That uncomfortable pressure and pain in your chest, the acid burning up your esophagus, the sensation of food coming back up your throat... It isn’t pleasant.
In those instances, it makes sense to swing by the pharmacy and pick up some heartburn medication. Maybe the problem can be solved with a short course of Tums or Mylanta. Many individuals who experience heartburn at least twice a week usually need a low dose of these proton pump inhibitors, or PPIs like Prilosec, on a daily basis to control the reflux of stomach acid. (Those who do experience these symptoms on a routine basis might have GERD, or gastroesophageal reflux disease.)
PPIs used to be available only by prescription. Now, however, they – along with their generic counterparts – can be found at any pharmacy. According to researchers, the heartburn industry is supposed to reach $4.34 billion by 2025. It is insanely lucrative, and who really needs working kidneys, anyway?
Don’t worry. We’ll get into that later in the article.
Who needs a PPI medication like Prilosec?
Proton pump inhibitors are intended for patients who experience heartburn, GERD or other reflux disorders. Stomach acid splashes up into the esophagus, which can cause symptoms like chest pain, nausea and food regurgitation. Many patients on multiple medications take Prilosec, Nexium, Prevacid or the like to control the sensations caused by taking so many drugs at once.
The following are the scientific names of available PPI medications:
According to Consumer Reports, up to 70% of people who take PPIs could potentially find relief in less potent remedies. When a patient uses a PPI, it is recommended that it be used for the shortest period of time possible in order to reduce the chance of rebound symptoms (AKA symptoms that worsen in intensity following the cessation of medication).
How does a PPI medication work?
Put simply, proton pump inhibitors work on the cells in your stomach lining and reduce the amount of acid in your stomach. Stomach acid is so corrosive that the tissue lining must protect itself with a mucus membrane. When that membrane breaks down because of too much acid, it can harm the tissue and create an ulcer. A PPI reduces the stomach acid as well as “inhibiting” the proton pump, which is a colloquial name for the hydrogen-potassium adenosine triphosphatase enzyme system. They also assist in healing ulcers caused by acid erosion in the esophagus and part of the stomach called the duodenum.
Other treated conditions are for the eradication of H. pylori, a bacteria that can cause stomach ulcers. It is also used in the prevention of ulcers caused by NSAIDs (e.g., ibuprofen) and in the treatment of a rare condition called Zollinger-Ellison syndrome (AKA the overproduction of stomach acid).
Omeprazole, the first PPI medication available by prescription, was introduced to the market in 1979 and was approved for over the counter use in 2003. Doctors were told of the wonders of this gastric acid secretion inhibitor that saved patients from the discomfort of heartburn. A variety of human and animal trials began, and it was not until 1992 that the first reports of kidney failure started surfacing.
Omeprazole was discovered to be a possible cause of acute interstitial cystitis, a serious side effect that can damage kidney function. This can cause the following symptoms:
- Blood in urine
- Mental changes ranging from drowsiness to a coma
- Increased or decreased urine output
- Water retention
Other PPI medications such as pantoprazole, lansoprazole and rabeprazole were the next to be linked to this condition.
PPI use was linked to an increase in the bacteria known as C. difficile diarrhea in 2003, which can cause conditions like diarrhea or even a life-threatening inflammation of the colon. In 2006, scientists reported that hypomagnesemia (low magnesium levels) was also a potential side effect, as well as vitamin B12 deficiency. In 2009, it was linked to an increased risk of community-acquired pneumonia. In 2009, it was linked to recurrent heart attacks. The Food and Drug Administration was also called on to include a bone fracture warning on PPIs, though they have so far declined to do so, as bone fractures are linked to long-term use of PPIs. Most individuals complete a short-term regimen, which lessens the likelihood of any fractures by a significant amount. A litany of other health issues – strokes, artery damage, increased risk of death, and even the development of food allergies – have cropped up during studies.
Two JAMA Internal Medicine studies linked PPIs to renal failure in 2013, an increased risk of dementia in 2016, and increased risks of heart attack, renal failure and dementia that same year.
Litigation for proton pump inhibitors (PPIs)
Over the last decade, more than 15,000 PPI lawsuits have been filed against manufacturers of prescription and over-the-counter PPIs.
The chief complaints among plaintiffs in PPI lawsuits are that:
- PPIs caused extensive kidney damage (such as end-stage renal failure, chronic kidney disease, and acute kidney injury)
- Drugmakers failed to give users adequate warning about the dangers of PPIs
On January 5, 2017, Jeanette filed a lawsuit against AstraZeneca Pharmaceuticals, the maker of Nexium. The lawsuit alleged that the drug manufacturer failed to warn Jeanette about the risk of kidney disease. The lawsuit further alleged that had Jeanette been warned, she would not have taken Nexium and would not have developed chronic kidney disease.
The lawsuit is currently pending.
In 2017, a judicial panel consolidated most federal PPI lawsuits into a multi-district litigation (MDL).
MDL is a legal proceeding intended to reduce the burden on federal districts. In short, when civil actions in different district courts involve common questions of fact, they may be temporarily consolidated and transferred to a single district court (in this case, the district court of New Jersey) for pretrial proceedings, even though they remain separate cases.
While the results of these early trials do not bind the results of other PPI claims in the MDL, they will gauge how juries may respond to evidence and testimony brought up repeatedly in these claims.
A previous PPI-related MDL in California combined 47 bone fracture cases in 2012. While this MDL grew to more than 1,000 individual lawsuits, the judge decided in favor of AstraZeneca in 2014. Takeda Pharmaceuticals, also included in the MDL, decided to settle with plaintiffs for an unknown sum that same year, and that particular MDL was concluded.
Keep in mind that just because an MDL exists doesn’t mean a plaintiff has to participate in the MDL. Many plaintiffs choose to go through state court instead of federal court, or have not been ordered to join the MDL.
Which companies are currently facing PPI lawsuits?
The following companies are currently facing PPI lawsuits:
- AstraZeneca: Nexium and Prilosec
- Procter & Gamble: Prilosec over-the-counter
- Takeda Pharmaceuticals: Prevacid
- Pfizer: Protonix
When it comes to PPI litigation, the largest challenge plaintiffs typically face is proving that the PPI drug they took caused their medical condition.
Although the research isn’t conclusive, a number of studies have found a link between PPI drugs and kidney problems. Most notably, a 2017 study looked at 125,000 PPI users and found that PPI drugs may increase the risk of kidney problems.
“Our results indicate kidney problems can develop silently and gradually over time, eroding kidney function and leading to long-term kidney damage or even renal failure,” said Dr. Ziyad Al-Aly, the study’s senior author. “Patients should be cautioned to tell their doctors if they’re taking PPIs and only use the drugs when necessary.”
On the other hand, a 2019 study published by Gastroenterology followed 17,000 adults for 3 years and found no link between PPI use and increased rates of pneumonia, fractures, type 2 diabetes, chronic kidney disease, dementia, chronic obstructive pulmonary disease, or cancer.
FDA actions regarding PPIs
The FDA has not issued any recalls, though some of the companies have issued their own (Omeprazole, for instance, has had 11 recalls over the years). The FDA has, however, done their own work on PPI labels so that risks are more comprehensive and detailed:
- A 2010 update added information about the risk of bone fractures in the hip, spine and wrist. Muscle spasms, irregular heartbeat and low magnesium levels were added the following year.
- Intestinal warnings came in 2012.
- In 2014, they stated that if a patient takes a PPI for more than three years, it can lead to low levels of vitamin B12 and memory loss.
- That same year, the FDA also debuted the acute interstitial cystitis warning.
- In 2016, the label was updated to reflect the possibility of lupus erythematosus, an autoimmune condition in which immune cells attack other cells or even entire organs in the body.
- While not an FDA action (yet), as of 2017 there is now a link to gastric cancer, a risk that doubles for patients who previously suffered from an H. pylori infection.
What to do if your PPI medication is causing issues
First, talk with your doctor to see if you can fix the problem with little intervention. Perhaps you can try ceasing the medication for a time or changing to one linked to fewer side effects. Do not stop any medication regimen without speaking to a health professional, as well as weighing the benefits against the risks. Every medication has potential side effects, and your doctor knew this when prescribing it. The majority of people can take a PPI without side effects, so there might be another issue at play.
Second, talk to an attorney. Each state has a statute of limitations (AKA the time window in which to file your legal claim). Once you are past that window of time, you can no longer file. Some states only offer one year for cases, so do this sooner rather than later. A lawyer will be able to preserve your claim.
Keep in mind, however, that pharmaceutical cases take forever to complete. It might be a decade before you see any money, if any money at all. Make sure to keep this in mind and temper your expectations.
For a case like this, you will need a lawyer with many years of experience and who knows how to coordinate work with other attorneys. If you have not met with a lawyer, consider looking through the Enjuris directory for someone in your state who can help.
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