Proton pump inhibitors can cause a number of medical issues in users. Unfortunately, manufacturers may not always advise patients about the drugs’ risks, and innocent patients have suffered as a result. Lawsuits can aid in recouping the significant medical and emotional costs from serious side effects linked to these drugs.
Doctors prescribe proton pump inhibitors (PPIs) to patients who suffer from gastroesophageal reflux disease (GERD) or erosive esophagitis (EE). These two conditions occur when gastric (stomach) acid is overproduced and makes its way out of the stomach and into other parts of the body, such as the throat. Proton pump inhibitors aim to reduce the production of gastric acid. This enables the user to experience relief from irritation, and the esophagus to heal from damage done by gastric acid.
These drugs are popular and bring in substantial revenue for their manufacturers. For example, in 2015, PPI manufacturer AstraZeneca reported revenue of $24.7 billion, and Takeda Pharmaceuticals reported $16.9 billion in sales.
Unfortunately, despite the fact that people have been taking PPIs for decades, new research shows that these medications can cause a number of severe side effects, such as heart attacks, bone fractures and dementia. Multiple bodies of peer-reviewed research released in 2016 linked PPI usage to severe kidney issues.
Evidence is mounting that certain PPI manufacturers might have been aware of some major risks associated with PPIs, but did not disclose those risks to doctors or users. People harmed by PPIs turn to the legal system for compensation to help them pay for the costs of treatment. They also hope to stop drug makers from harming future PPI users. Some plaintiffs experienced bone fractures while engaging in everyday activities and others suffered heart attacks.
In 2016, a plaintiff filed a lawsuit against AstraZeneca in U.S. District Court, after he claimed PPI use led to his kidney failure and lifesaving kidney transplant. The suit claims that AstraZeneca knew of the risks to Nexium users’ kidneys, yet continued to market the drug without warning of these dangers.
As researchers discover more PPI-related medical problems, attorneys expect more lawsuits against manufacturers who knew about these risks, yet put profits before people.
The Side Effects and Costs of Proton Pump Inhibitors
People taking drugs typically expect minor side effects — such as headache and nausea — to accompany most medications. For many people with GERD, PPIs might seem like a good choice to treat acid reflux and prevent damage to the esophagus. However, studies show that PPI users may suffer from severe medical complications linked to the drugs that can drastically alter their quality of life. These conditions incur physical and emotional costs for patients.
Kidney Injury and Interstitial Nephritis
In 2016, the Journal of the American Society of Nephrology reported that those who use PPIs on a long-term basis could be 95% more likely to experience kidney failure, also known as End Stage Renal Disease (ESRD). Additionally, long-term PPI users are 28% more likely to suffer from chronic kidney disease (CKD).
Interstitial nephritis or acute interstitial nephritis (AIN) is a kidney injury that causes the spaces in between kidney tubules to swell. Studies link AIN to PPIs. AIN can progress to permanent kidney damage and failure. Some doctors believe AIN is triggered by an immune reaction to these drugs or one of the metabolites. Prilosec (omeprazole) and Nexium (esomeprazole) were associated with the majority of cases in studies.
The annual per-patient costs of CKD treatment are about $20,000, and the annual per-patient costs of ESRD soar around $70,000. According to the Congressional Kidney Caucus, Medicare often pays much of these costs, and taxpayers are forced to pay tens of billions of dollars.
The Pharmaceutical Journal reported in 2016 that avoidance of PPIs may help prevent dementia. Researchers found that patients who regularly used PPIs were 44% more likely to develop this devastating disease.
Dementia is an incredibly costly disease, both emotionally and financially. Alzheimer’s Association reports that dementia costs the U.S. $236 billion each year. Taxpayer-funded Medicare contributes about $11 billion. In 2015, researchers found that the average cost of caring for a dementia patient over a course of five years was $287,038. Medicare only covered about half of those costs. In addition to the financial burden, family members often sacrifice major life goals — such as education and careers — in order to care for their loved one with dementia.
In 2015, the Stanford University School of Medicine completed a sizable project that linked PPI usage to heart attack risk. Researchers studied 1.8 million heartburn sufferers, and found a 16–21% increase in heart attack incidence among PPI users. Since 2006, multiple studies have found that long-term PPI use is associated with increased bone break events.
Cardiovascular disease can devastate multiple aspects of sufferers’ lives. It is also among the nation’s most expensive health problems, costing the U.S. around $320 billion each year.
In 2012, the BMJ, a peer-reviewed medical journal, found that PPI users were slightly more at risk for hip fractures than non-PPI users. Hip fractures are especially devastating, both financially and physically. Patients are usually confined to bed for weeks, and the financial setback can be enormous, as a hip fracture can cost upwards of $40,000 to an uninsured person in the U.S.
The costs associated with bone fractures vary widely based upon which bone is broken. However, most fractures tend to be quite expensive, incurring multiple thousands of dollars in costs.
Settlements and Claims
Proton pump inhibitors have been on the market for decades, beginning in the 1970s. Drug companies developed differing formulas over the years, but all the medications work by inhibiting proton pumps from secreting gastric acid. That said, most PPIs expose users to the same dangers.
Drug makers sometimes recognize risks of their medications but do not immediately disclose the risks to users or doctors. If these companies informed users of the dangers of PPI use, they might have chosen a different solution to their heartburn problem. Unfortunately, for those who have already taken PPIs without knowledge of the dangers, it is too late. In these situations, patients may turn to the legal system for help.
Nexium has garnered the most legal attention out of all the PPIs on the market. In addition to the first kidney damage lawsuit filed in 2016, plaintiffs filed multiple lawsuits against drug giant AstraZeneca, alleging the company failed to warn users about known risks of taking the medication.
In 2015, AstraZeneca was involved in a pay-for-delay scheme that aimed to keep cheaper Nexium alternatives off the shelves. AstraZeneca paid Israeli drug maker Teva Pharmaceuticals to delay the release of a generic version of Nexium in order to continue reaping the huge financial benefits of Nexium sales. AstraZeneca paid $20 million settlement for the case and Teva paid $24 million to the U.S. government.
Multiple individuals have filed lawsuits against AstraZeneca after experiencing fractures related to PPI usage. For example, in 2011, Ginny Begin of Toledo, Ohio filed a lawsuit against AstraZeneca, the manufacturer of Nexium. Begin had been taking the drug when she broke a bone in her leg during everyday activities. Two years later, the same bone broke — along with two others — as she was descending the stairs. Begin’s attorneys claim that the pharmaceutical company was aware of the risk of fractures but did not inform Nexium users. The case is still ongoing.
In 2015, Prilosec maker AstraZeneca paid $20 million when a class action lawsuit proved that the company had attempted to “evergreen” the drug. This means that AstraZeneca created a drug that was almost identical to Nexium, but started charging users way more for the new drug. Outraged users filed multiple lawsuits against the drug giant. The $20 million payout is just one outcome, and the remaining lawsuits are pending.
In 2012, David S. Tatum of Philadelphia, PA filed a lawsuit against Prevacid manufacturer Takeda Pharmaceuticals, claiming that the company failed to warn him about the drug’s ability to weaken his bone structure and cause fractures. Tatum’s bones weakened so much that he required a hip replacement. Because Tatum sued in Pennsylvania where punitive damages are not an independent cause of action, the drug giant has thus far been able to avoid paying Tatum. The trial is ongoing.
In 2013, Pfizer Inc. paid a $55 million settlement to the U.S. government, which alleged that the drug maker promoted the PPI Protonix for inappropriate uses. The lawsuit claimed that the maker’s sales force pushed the drug for use outside the realm of its approved uses. Sales reps were only supposed to market the drug to users with specific forms of GERD. However, the company trained its salespeople to push the drug to people with all forms of GERD.
As further PPI research emerges, people injured by these drugs may continue to file lawsuits. Future litigation will involve other PPIs, such as Aciphex and Dexilant. Since PPIs can cause a variety of medical problems, plaintiffs claimed an equally wide variety of damages in court.