Nexium, or esomeprazole, is a drug that is used to treat heartburn and excessive amounts of acid in the stomach. Specifically, it is used to treat duodenal and gastric ulcers, esophagitis, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. Nexium is a proton pump inhibitor (PPI) that decreases the amount of acid produced in the stomach. Other drugs that are in the same class as Nexium include Prevacid and Prilosec. Approximately 15 million Americans use PPIs that are sold both as prescription and over-the-counter. Nexium sales exceed $3 billion a year.
Nexium Class Action Lawsuit Updates
March 2023: The bellwether trial in the Nexium PPI litigation that was supposed to get started this month has now been postponed to June 5, 2023. Two additional bellwether trials will follow in July and September. No explanation for the postponement was given, but many believe that was done because the parties are close to a settlement.
August 2022: Defendants in the PPI MDL had moved to dismiss all failure to warn claims in the PPI class action lawsuit because they are preempted. The argument, and it is a weak one, is that because the FDA (a federal agency) approved the warning labels, state law claims cannot be brought.
Our lawyers talked about this in the last update in June – this motion is crucial because the crux of this class action lawsuit is that you knew of this problem with kidney injuries yet you did not change their product, instructions, guidelines, or, most importantly, warn doctors of the risk.
The Special Master in the MDL likely put this issue to bed in the Prilosec-Nexium class action lawsuit. issued a report to the MDL Judge recommending that this argument be rejected because the defendants cannot show that the FDA would have rejected proposals for stronger warnings about kidney damage. The first bellwether trial in the MDL is set for November.
June 2022: The defendants in the Nexium-Prilosec PPI class action MDL have filed motions for summary judgment in the upcoming bellwether test trials. The primary legal argument in this motion is based on a doctrine called federal preemption. The preemption doctrine holds that victims are blocked from bring tort lawsuits under state law if there is a federal law that protects the defendants from liability. The Special Master in the MDL recently allowed both parties to submit additional briefing to address how a recently decided case on the preemption issue (In re Fosamax Alendronate Prod. Liab. Lit.) could potentially impact the issues in the Nexium-Prilosec cases. Our lawyers have read the Fosamax case (which rules in favor of defendants on a preemption argument) and in our opinion it is not applicable to the issues in the PPI cases.
April 2022: There are around 13,500 lawsuits pending in the Nexium-Prilosec PPI class action MDL. The first trial will be in October. The hope is that a few trials will set settlement amounts for Nexium kidney lawsuits. But many class action lawsuits – at least lately – have had trials and the parties still could not agree to a settlement amount for the victims. So the judge, in this case, wants to keep the pressure on the lawyers. So if a global settlement is not reached, the MDL Judge has identified a group of 200 cases that the parties will be preparing for trial over the next 16 months.
- These drugs have had a troubled history. Zantac, which was long considered a great and safe drug, has now been associated with cancer.
Problems with Nexium
Nexium is a controversial drug. At one point, bone fracture lawsuits were all the rage because there was data suggesting Nexium, particularly the long-term use of Nexium, would cause bone fractures and breaks. Our lawyers believed many of these lawsuits were meritorious. But the litigation did not get very far.
One reason those lawsuits did not go further is that product liability lawyers turned their attention to the kidney problems Nexium may cause. There have been literally hundreds of reports of injury reported to the FDA in association with PPIs like Nexium and other PPIs.
As early as 1989, the FDA began getting reports of kidney problems with PPIs like Nexium. Recent studies suggest the possibility that prolonged use of PPIs is associated with a 20% to 50% higher risk of incident chronic kidney disease.
If you have serious kidney disease after taking Nexium for an extended period, you may be eligible for a lawsuit to recover money damages. Call us today at 888-322-3010 and find out if you may qualify. You can also get a free online case review to find out whether you may be eligible for financial compensation.
History of Nexium
Nexium is a proton pump inhibitor (PPI) that is used to treat gastroesophageal reflux disease (GERD), peptic ulcer disease, and other related conditions. It was first approved by the FDA in 2001, and it quickly became a popular drug in the United States, with millions of people using it to treat acid reflux and heartburn.
When PPIs were initially approved in the 1980s, they were thought to be safe. However, as more and more people began using Nexium, concerns started to arise about its safety and effectiveness. In particular, there were concerns about its potential to cause serious side effects, such as kidney damage, bone fractures, and increased risk of infections.
These concerns led to a number of lawsuits being filed against AstraZeneca, the manufacturer of Nexium, alleging that the company had failed to adequately warn patients about the risks associated with the drug. The lawsuits claimed that AstraZeneca had engaged in false and misleading marketing practices to promote Nexium, and that the company had concealed information about the drug’s potential side effects from doctors and patients.
In 2012, the FDA issued a warning about the potential risks associated with long-term use of PPIs, including Nexium. The agency advised doctors to prescribe the lowest possible dose of the drug for the shortest possible period of time, and to consider alternative treatments for patients who did not respond to PPIs. Other side effects include allergic reactions including itching or hives, swelling in the face or hands, chest tightness, difficulty breathing, blistering, rapid heartbeat, fever, joint pain, weight gain, seizures, dizziness, muscle cramps, stomach pain, nausea, vomiting, weight loss, and bloody or black stools.
In 2015, AstraZeneca settled a lawsuit with the U.S. Department of Justice for $7.9 million, resolving allegations that the company had paid kickbacks to doctors to prescribe Nexium and other drugs. The settlement also resolved allegations that AstraZeneca had engaged in false and misleading marketing practices to promote the drug.
Kidney Disease
PPIs have also been linked to an inflammatory kidney disease known as acute interstitial nephritis (AIN), which leads to swelling of spaces inside the kidney and causes fever, rash, blood in the urine, and decreased urine output. Recently, there have been reports that Nexium is associated with chronic kidney disease (CKD), a kidney disorder to eventually leads to renal failure.
CKD is a tough disease that causes a gradual loss of kidney function. One real problem with CKD is the lack of warning. CKD is often diagnosed by testing creatinine blood levels. But creatinine levels are often normal in the early stages of CKD. So often by the time the disease is diagnosed, it is too late to prevent permanent damage.
A study published in February 2016 in JAMA Internal Medicine investigated a potential association between the use of PPIs and CKD. In this study, 10,482 participants were followed from an initial visit between 1996-1999 to 2011 who used PPIs. The participants who used PPI were compared with participants who did not use a drug, as well as participants who used another class of acid-reducing drugs, histamine2 (H2) receptor antagonists that include Zantac, Tagamet, and Pepcid. The study found that PPI use was associated with a 20% to 50% higher rate of CKD. In comparison, the use of H2-receptor antagonists was not associated with any kidney problems. Also, using a PPI twice daily was associated with a higher rate of CKD than using it once daily. The study also tested the association of PPIs and CKD in a separate group of 250,000 patients, where it also noted the association. Thus, this study established an association of PPIs, including Nexium, with CKD.
Another study conducted by the Johns Hopkins University and the Royal Brisbane and Women’s Hospital in Australis followed 10,000 adults with normal kidney function from 1996 to 2011. They found that in participants who used PPIs, there was a 50% greater likelihood of development of CKD than in participants who did not use PPIs.
Moreover, a study conducted by the SUNY Buffalo School of Medicine tested 24,000 patients between 2001 and 2008 who developed CKD. The study found that one out of four patients were treated with a PPI. The study also found that in patients who took PPIs, the risk of dying prematurely had doubled.
One doctor at the University of California, San Francisco recommended that people should not take PPIs as initial therapy to relieve heartburn. He noted that doctors initially saw the benefits of PPI and started using them immediately, as they were expected to be safe. In fact, they come with several side effects. He recommends that people should initially change their lifestyle, including diet, termination of smoking, or reduction of alcohol consumption, and only take PPIs if lifestyle changes do not improve their symptoms.
Nexium Kidney Lawsuits Allegations
When lawyers file a lawsuit, they bring a lot of claims. Lawsuits have been filed arguing that Nexium is poorly designed and manufactured. Those claims are a sideshow to what will be the core issue in these cases: the failure to warn. Drugs come with risks. We all get that. But the core allegation in these lawsuits is that Nexium’s manufacturer had a duty to warn the plaintiff and her doctors of the risks to let them make an informed choice. Few people are clamoring for a Nexium recall. For some, the risk may be worth the benefits. But doctors should have all the information to help patients make the right call.