PROTON PUMP INHIBITORS

If you or a loved one took a proton pump inhibitor (including Prilosec, Prevacid, Nexium, Dexilant, or Vimovo) and suffered kidney damage (especially acute interstitial nephritis), you may have a claim for damages.

What are Proton Pump inhibitors (PPIs)?

nexium-pill-400x320Proton pump inhibitors (PPIs) are a class of drugs used to treat gastrointestinal reflux disease (GERD), commonly known as heartburn. PPIs are also used for dyspepsia, acid petic disease, Zollinger-Ellison syndrome, acid reflux and peptic or stomach ulcers.

With 15 million Americans who have used or been prescribed a PPI, they are the most commonly prescribed drugs in the United States and worldwide.

Typically, they are only recommended for short-term use in people who have damage to their gastrointestinal tract as a result of a severe acid reflux condition. However, PPIS have been marketed for a broader group of patients who are suffering from simple heartburn. The problem is that this may result in a dependency—when you stop taking them, the heartburn comes back with a vengeance. So people who never needed to take them in the first place started on them and now cannot get off.

How do PPIs work?

PPIs work be inhibiting the secretion of stomach acid. In other words, they prevent the stomach from producing acid. They do this by binding with proton pumps, which are active mechanisms in the stomach that produce gastric acid. This prevents the gastric parietal cells from secreting gastric acid.

Unlike other heartburn or GERD drugs (H2 inhibitors like Zantac or Pepcid or antacids like Tums), PPIs do not work right away. Usually, they take at least a day, and up to four days, to start working.

Why are PPIs used?

PPIs are very effective in the short term at easing symptoms of GERD. However, PPIs are one of the most overprescribed drugs in the United States. Initially, many thought these drugs were safe and had no risks. As a result, 90% of these drugs are taken by people who do not truly need them.

What harms do PPIs cause?

PPIs have been linked to a number of different injuries to the kidneys. These can include acute interstitial nephritis, chronic kidney disease, renal or kidney failure, and acute kidney injury.

What is Acute Interstitial Nepritis?

Acute Interstitial Nephritis (AIN) consists of inflammation of the tubes and tissues of the kidneys. The most common symptoms of AIN are fatigue, nausea or weakness, but sometimes, there are no symptoms. When symptoms do occur, they can start as early as one week after beginning treatment with PPIs or as late as nine months out.

AIN is an unusual diagnosis, and is most typically caused by drugs, including PPIs, but also non-steroidal anti-inflammatories (NSAIDs) or antibiotics. When it results from PPI exposure, there may be specific signs of this in the liver biopsy.

However, it may present with no symptoms, or very generic symptoms, such as fatigue, nausea and weakness. If you are experiencing these symptoms after taking a PPI you should ask your doctor about the possibility of AIN. A liver biopsy can confirm whether you can this condition.

Why are PPIs still on the market?

Good question. Given the new research regarding the dangers of PPIs, as well as the presence of numerous alternatives, it is unclear why the FDA continues to permit PPIs to remain on the market. We believe it is only a matter of time before these kinds of drugs stop being sold altogether.
Big drug companies have a tremendous incentive to develop such drugs because acid reflux and GERD affect so many people. But they only get to keep exclusive control over the drugs while they are under a patent. Under current laws, drugs are typically covered for 20 years.

Prilosec (omeprazole) was first approved by the FDA in 1989. At the time, patent protection lasted 17 years. Even though it seemed to work fine, its manufacturer, AstraZeneca, developed Nexium (esomeprazole) and got it approved by the FDA in 2001, just a few years before the patent protection of Prilosec was due to expire. That way, they could pour their marketing budget into Nexium, and hang onto the exclusive rights for another 20 years.

Drug companies are extremely powerful. Despite the fact that the link between PPIs and kidney disease were established as early as 1992, no action was taken by the FDA to change the label until 2013. In 2011, a nonprofit group petitioned the FDA to change the label to include warnings including of kidney damage and AIN. In 2014, more than three years later, and only because it was facing litigation over the delay, the FDA finally agreed to change the label to include some information regarding the risk of AIN. Even so, this warning is in tiny type (not a “black box” warning) and does not appear at all on not on over-the-counter PPIs

What are the alternatives to PPIs?

There are numerous alternatives to PPIs that do not carry the same extreme risks of kidney disease. For example, people who suffer mild heartburn can simply avoid certain foods. If acid reflux at night is the problem, you can avoid eating or consuming alcohol within three hours of bedtime, or sleep with your head elevated. Sometimes, other drugs cause heartburn, such as aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs). Simply avoiding using the medications may solve the acid reflux issue.

If not, there are plenty of other alternatives that do not appear to cause kidney damage. Antacids such as Maalox or Tums belong to one category of safe alternatives to PPIs. Similarly, H2 blockers, such as Zantac, Pepcid and Tagamet, are an effective alternative to PPIs. H2 blockers work by partially preventing the production of stomach acid, and they work more quickly than PPIs.

What evidence is there of the harms of PPIs?

Several large scale studies conducted in 2016 provide very strong evidence that PPIs cause a high risk of kidney disease and kidney failures. One study was published in the Journal of the American Society of Nephrology, and conducted by physicians at Washington University in St. Louis and at the Veterans’ Affairs (VA) Clinical Epidemiology Center in St. Louis. The study found a statistically significant more than doubling of the risk of kidney damage.

The study also found that there was a greater effect the greater amount of PPIs the patient had taken. Another 2016 study also found PPI use associated with a high risk of chronic kidney disease (CKD). The study found a 50% increased risk of kidney disease from using PPIs, confirming other 2016 study.

What drugs are PPIs?

PPIs include Prilosec (omeprazole), Prevacid (lansoprazole), AcipHex (rabreprazole), Protonix (pantoprazole), Nexium (esomeprazole), Zegerid (omeprazole and sodium bicarbonate), Dexilant (dexlansoprazole), Vimovo (esomeprazole and naproxen). There are also over the counter PPIs including Pirlosec OTC, Prevacid 24 hour, Zegerid OTC and Nexium 24 hour.

PPIs do not include sodium bicarbonate or naproxen by itself. Antacids such as Tums, Rolaids, or Maalox are not PPIs. Similarly, H2 blockers such as Tagamet (cimetidine), Zantac (ranitidine), Pepcid (famotidine), Tazac or Axid (nizatidine) are not PPIs.

Did PPI manufacturers do something wrong?

As early as 1992, it was suspected that PPI use could cause acute interstitial nephritis (AIN). A case report published that year examined the case study of a 74-year old woman who had been admitted to the University of Arizona Health Sciences Center because of acute kidney failure. Two weeks before coming to the hospital, she was experiencing a general feeling of not being well, including fatigue and loss of appetite. But by the time she got the hospital she was in full blown renal failure.

The hospital ran tests of her urine protein and diagnosed her as having drug-induced AIN, caused by Prilosec (omeprazole). The case report pointed out that this could be a huge problem—accurately predicting that omeprazole would soon become a “mainstay in the treatment of acid peptic diseases.” Because of this, the author cautioned that physicians should be warned of the association between AIN and PPIs. The manufacturer did nothing: did not change to label, withdraw the drug, or warn anyone.
In 1997, additional research was done regarding the previously discovered connection between PPIs and AIN. The 1997 paper noted that the link had been documented in 1992 and this time the researchers tried giving withdrawing the omeprazole to see if the renal symptoms would go away. They did. They then started the omeprazole up again and the kidney dysfunction returned.

The authors noted that this result meant that extra caution and monitoring of kidney damage would be necessary for PPIs. Still, the manufacturer did nothing.

In 2004, another study found that AIN was caused by PPIs, and this time, concluded that (1) drugs are the most common cause of AIN and (2) the most common type of drugs to cause AIN is PPIs. This study found that in 24 cases of AIN that were studied, 14 of those were cause by drugs, and eight were caused by PPIs. Again, the manufacturers of these drugs did nothing to warn anyone.

As of 2006, it was “was well known” that PPIs could cause kidney damage, specifically AINs. For example, one study conducted in New Zealand in 2006 found that PPIs were the “most commonly identified cause” of AIN.

Another study that same year found that Prilosec (omeprazole), Nexium (esomeprazole) and AcipHez (rabreprazole) were associated with PPIs. But—you guessed it—the manufacturers once again put warning labels on not a single PPI.

Another similar study came out in 2009. Research articles continued to reference the known link between PPIs and kidney damage. Then, in 2011 a nonprofit petitioned the FDA to force the manufacturers to add this risk to the label. Nothing happened.

It was not until late 2014, under pressure from the FDA that some manufacturers changed their labels to include some mention of the risk of AIN. But even these labels make it sound like only certain “hypersensitive” individuals might get AIN. And these labels do not mention the risk of chronic kidney injury or renal impairment. And none of the OTC versions of these drugs contain any kidney damage warning at all.
In sum, the manufacturers of these drugs knew or should have known for more than two decades of the dangers, yet did not lift a finger to warn consumers. When they were eventually forced to add labels, they made them as cryptic as possible, and left them off of many of the most commonly used PPIs.

Do I have a claim?

If you took one or more PPIs and suffered kidney damage, you may have a claim for damages. Your claim will be especially strong if you have suffered acute interstitial nephrosis (AIN) confirmed by a kidney biopsy, and you have taken PPIs for a long time. However, if you have any diagnosed kidney issue after taking just one PPI, you may still have a claim. Call us today for a free consultation to determine whether you may have a claim.

Can I sue the manufacturer?

If you took a PPI and suffered kidney damage, including AIN, you may have a claim for damages. The specifics of who you may be able to sue and when will depend on the facts of your particular case. Contact Keane Law LLC today for a full, free case evaluation to determine whether you may have a claim.

Is there a class action against manufacturers of PPIs?

There is no current class action against PPI manufacturers. Instead, these cases are being pursued individually. Because kidney damage is a very severe condition that not every who takes these drugs will necessarily get, this makes sense.

Because of the fact that there is no class action, you must take action individually if you want to receive compensation. You will need to hire your own attorney to pursue an individual case. Call Keane Law LLC—our attorneys can help you assess, for free, whether or not this makes sense in your particular circumstance.

Can I sue my physician?

Depending on the particular facts, you may have a claim against your physician if he or she prescribed a PPI without warning you of the danger of kidney damage, or if the physician recommended a PPI despite knowing you had a history of kidney issues. We can help you assess whether a suit against a physician makes sense given your unique situation.

How do I file claim?

The mechanics of how to file a claim differ greatly depending on where you are. Currently, there is no multi-district litigiation (MDL) set up for PPIs, so most likely your claim will be filed in local state or federal court. You may be able to file on your own, but the best course of action is to hire a lawyer to file the claim for you. Pharmaceutical litigation becomes very complicated very quickly; an experienced attorney can help guide you through the process. Most pharmaceutical attorneys (including Keane Law LLC) will not charge you anything unless and until they recover a verdict or settlement or your behalf. In other words, you do not pay unless you win.

When will my claim expire?

When your claim expires depends on the local laws and rules that may be applicable to your claim. It is not simply a matter of where you live—when and where you purchased the applicable medication, when you were diagnosed with a kidney or other injury, and when first found out you might have a claim, when it was first prescribed, and other factors may impact the statute of limitations for your case. The best advice is to reach out to an experienced attorney to discuss your matter right away; the attorney can collect all the applicable facts and give you an idea when your claim is likely to expire.

What kind of compensation can I get for my PPI claim?

The compensation you get depends on the injuries. If a loved one passed away from using PPIs, you can expect that your claim is worth far more than if you experienced symptoms that completely resolved after you stopped taking PPIs.

Contact an attorney; we can help you assess the value of your claim based on an analysis of all the important facts in your case.

Why should I hire Keane Law LLC for my PPI claim?

The attorneys of Keane Law LLC have recovered millions of dollars on behalf of consumers injured by dangerous or defective products and fraudulent business practices. Our experienced attorneys are well-versed in this complicated area of law and have a track record of success. Our attorneys can maximize the value of your claim and earn you the compensation you deserve. Contact us now to get started.