PPI litigation is of a group of mass tort lawsuits against the major pharmaceutical companies that make and sell acid reflux pills known as proton pump inhibitors, or PPIs. These PPIs, including Prilosec and Nexium, have serious and potentially fatal side effects, including bone fractures and severe kidney problems. Nevertheless, the companies that make PPIs have failed to warn doctors and patients about these dangers, putting them in harm’s way.
In this article, our defective drug lawyers look at proton pump inhibitors and how they work. Then we will discuss the side effects that they can cause. We will then show how the pharmaceutical companies that make PPIs fail to adequately warn people about the dangers of their pills and the lawsuits that this has caused. Finally, we will explain the compensation that victims can recover in a lawsuit and how you can invoke your rights.
- 1. How proton pump inhibitors work
- 2. Serious side effects of PPIs
- 3. PPI litigation for failure to warn
- 4. Compensation for victims of PPIs
- 5. What you can do if you have suffered after taking a PPI
1. How proton pump inhibitors work
As the name implies, proton pump inhibitors work by slowing down a patient’s proton pump. This proton pump is found in the gastric parietal cells in the stomach lining. They are the last step in the process that produces hydrochloric acid, also known as stomach acid. PPIs work by irreversibly blocking one of the enzymes necessary to produce stomach acid.
Blocking the proton pump and reducing the amount of stomach acid in someone’s stomach can help to treat:
- Acid reflux disease, also known as gastroesophageal reflux disease (GERD) and heartburn,
- Peptic ulcers,
- Zollinger-Ellison syndrome, a medical condition that leads to peptic ulcers,
- Gastric ulcers, including those associated with Chron’s disease, and
- Esophagus erosion.
Some of these conditions are incredibly common, making PPIs some of the most used drugs on the market.
Some of the most common PPIs include the following pills:
- Prilosec,
- Nexium,
- Prevacid,
- Aciphex,
- Dexilant, and
- Protonix.
2. Serious side effects of PPIs
There are numerous side effects of proton pump inhibitors. The most common include:
- Headache,
- Fever,
- Dizziness,
- Cough,
- Upper respiratory tract infections, including laryngitis and sinus infections,
- Sore throat,
- Dry mouth,
- Abdominal pain,
- Nausea,
- Constipation,
- Decreased appetite,
- Diarrhea,
- Vomiting,
- Regurgitation of stomach acid,
- Gas,
- Back pain, and
- Fatigue.
However, proton pump inhibitors are also linked to far more severe side effects, including:
- An increase in the risk for suffering a hip fracture,1
- Pneumonia,2
- An increase in the risk of coronary artery disease for people who are also taking blood-thinning medication,3
- Acute interstitial nephritis, or swelling of the kidney,4 and
- Chronic kidney disease and renal failure.5
The increased risks for kidney disease and renal failure that come with proton pump inhibitors is startling. Studies have indicated that people who take PPIs were up to 50% more likely to develop chronic kidney disease than those who did not.6
Another study found that the increased risk for developing chronic kidney disease and renal failure grows, over time. People who took a PPI for more than 90 days more than doubled their odds of developing chronic kidney disease or renal failure as those who did not take a PPI.7
The risks that come with taking proton pump inhibitors over the long term are why PPIs were never intended to be used as more than a short-term treatment. However, the companies that sell PPIs rarely mention the increased risks for kidney damage or the other side effects associated with their drugs. Instead, they insist that it is a risk-free cure-all for stomach acid problems, acid reflux disease, and heartburn.
3. PPI litigation for failure to warn
Because the drug companies did not warn consumers and doctors about the serious side effects of proton pump inhibitors, products liability lawsuits have been filed against them by the victims who have suffered the consequences. These lawsuits claim that the failure to disclose the side effects associated with PPIs amounted to a defective warning that put people at risk.
Legally, drug companies have an obligation to take reasonable steps to find the potential harm that their drugs can do, and then disclose those side effects. Doctors rely on these warnings to protect their patients from drugs that could be especially harmful to them. Patients rely on these warnings to make informed health decisions about whether taking a drug is worth the risks. However, drug companies try to hide the risks as much as possible to boost sales of the drug and increase the company’s profit.
When that decision not to disclose the dangers of a drug creates an unreasonable risk for people to get hurt, the drug company can be held liable for the injuries that it has caused. Victims can file product liability claims based on the company’s failure to warn them of the danger, and can recover compensation.
Because these lawsuits stem from a single act – the choice not to disclose the dangers associated with a drug – and involve lots of victims from across the U.S. who have been hurt in nearly identical ways, they are often consolidated into multidistrict litigation, or MDL. Claims against PPI companies for injuries caused by the side effects of PPI medication have been consolidated into an MDL in the District Court of New Jersey.8
4. Compensation for victims of PPIs
The people who have gotten hurt from the poorly disclosed side effects of a proton pump inhibitor deserve to be compensated for their losses. After all, they were kept in the dark about the dangers associated with PPIs, and could not make an informed decision about whether it was wise to take one or not.
This compensation should not just cover the costs of a victim’s out-of-pocket medical expenses. Instead, it should include all of the ways that a victim has suffered, including:
- Foreseeable medical costs in the future,
- Professional setbacks associated with the PPI’s side effects, like lost wages and a diminished ability to earn a living in the future,
- Physical pain, and
- Emotional and mental anguish and suffering.
5. What you can do if you have suffered after taking a PPI
If you have taken a proton pump inhibitor like Prilosec or Nexium and you suspect that you are suffering from its side effects, you should see a doctor promptly. There may be things that can be done to minimize the damage of the PPI.
If it becomes clear that your symptoms are a result of taking a PPI, you should consider seeing a lawyer. By invoking your legal rights and filing a products liability lawsuit against the PPI maker and claiming that they violated their duty to warn you of the dangers of their drugs, you can fight for the compensation that you need and deserve. You can also work to hold a huge drug company accountable for its profiteering conduct that puts you and thousands of others at risk.
Talking to a lawyer soon is important, though. There are statutes of limitations that can force you to file your claim quickly – often within two years of your injuries.
Legal References:
- Yang YX, Lewis JD, Epstein S, Metz DC, “Long-term proton pump inhibitor therapy and risk of hip fracture,” JAMA 296(24):2947-53 (December 27, 2006).
- Herzig SJ, Howell MD, Ngo LH, Marcantonio ER, “Acid-suppressive medication use and the risk for hospital-acquired pneumonia,” JAMA 301(20):2120-8 (May 27, 2009).
- Niu Q, Wang Z, Zhang Y, Wang J, Zhang P, Wang C, Yin X, Hou Y, “Combination Use of Clopidogrel and Proton Pump Inhibitors Increases Major Adverse Cardiovascular Events in Patients With Coronary Artery Disease: A Meta-Analysis,” Journal of Cardiovascular Pharmacology and Therapeutics 22(2):142-52 (March 22, 2017).
- Härmark L, van der Wiel H, de Groot M, van Grootheest AC, “Proton pump inhibitor-induced acute interstitial nephritis,” British Journal of Clinical Pharmacology 64(6):819-23 (December 2007) and Ruffenach SJ, Siskind MS, Lien YH, “Acute interstitial nephritis due to omeprazole,” American Journal of Medicine 93(4):472-3 (October 1992).
- Lazarus B, Chen Y, Wilson F, Sang Y, Chang A, Coresh J, Grams M, “Proton Pump Inhibitor Use and Risk of Chronic Kidney Disease,” JAMA Internal Medicine 176(2):238-46 (February 1, 2016).
- Id.
- Xie Y, Bowe B, Li T, Xian H, Balasubramanian S, Al-Aly Z, “Proton Pump Inhibitors and Risk of Incident CKD and Progression to ESRD,” Journal of the American Society of Nephrology, 27(10):3153-63 (October 2016).
- MDL 2789, In Re: Proton-Pump Inhibitor Products Liability Litigation.