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Nexium, Prilosec, & Other PPI Lawsuits

Proton pump inhibitors (PPIs) such as Prilosec, Prevacid and Nexium are blamed in hundreds of lawsuits for causing kidney damage or injuries.

*Please seek the advice of a medical professional before discontinuing the use of this drug.

If you took a Proton Pump Inhibitor (PPI) like Nexium or Prilosec and suffered one of the following side effects, you may be entitled to compensation.

  • Kidney Disease
  • Kidney Injury
  • Kidney Failure
  • Interstitial Nephritis
Are you suffering kidney complications from a Proton Pump Inhibitor?

Number of Lawsuits Hundreds of active lawsuits

Plaintiff Injuries Kidney injury; bone injury; low magnesium levels; food poisoning

Defendants AstraZeneca Pharmaceuticals LP; Takeda Pharmaceuticals USA Inc.; Pfizer Inc.; Proctor & Gamble

Litigation Status Active

Class-Action Status Inactive

Top Settlement $55 million

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Written by , on May 10, 2016

Edited on November 15, 2017

Fast Facts

  • People are suing PPI manufacturers after suffering kidney complications
  • PPI manufacturers have paid more than $100 million to settle lawsuits
  • Studies link the popular heartburn drugs with other serious side effects

Heartburn sufferers spend $10 billion a year on PPIs. Originally sold by prescription only, many PPIs are now available over-the-counter (OTC) and in generic or store-brand versions. The popular heartburn drugs are among the most widely consumed medications in the U.S.

Multiple studies since PPIs first hit the market have associated the heartburn medications with an increased risk of serious kidney problems. Despite mounting scientific evidence of potential side effects leading to kidney disease or damage, PPIs were widely sold for 18 years before their labels were forced to carry a warning of the risks.

Status of PPI Lawsuits

Since 2016, people have filed hundreds of lawsuits claiming PPIs caused kidney disease, damage or injuries and that manufacturers have failed to warn people about the risk for years.

FACT

The American Journal of Medicine published the first case study linking PPI use to kidney injuries in 1992

More than 270 of kidney complication lawsuits have been combined in a federal multidistrict litigation (MDL) in New Jersey. MDLs allow several similar cases to move more quickly and efficiently through the legal process. Lawyers expect thousands of cases may eventually be included in the proton pump inhibitor MDL.

Timeline of PPI Kidney Complication Issues

  • May 2016

    First Nexium kidney damage lawsuits are filed against AstraZeneca

  • February 2017

    U.S. Judicial Panel on Multidistrict Litigation (JPML) denies motion to combine 39 federal lawsuits against various PPI manufacturers into a single MDL

  • July 2017

    JPML reconsiders request to combine 163 lawsuits against five PPI manufacturers into an MDL

  • August 2017

    JPML centralizes 161 PPI cases into one action in a New Jersey federal court

  • October 2017

    Total number of cases in MDL grows to 273

Why People Are Suing PPI Manufacturers

The lawsuits being added to the multidistrict litigation (MDL) in New Jersey claim Prilosec, Nexium and other PPIs caused kidney-related complications. People suing PPI manufacturers claim they “suffered and continue to suffer” from serious kidney injuries or damage.

People claim in lawsuits that PPIs caused:

  • Kidney disease
  • Kidney injury
  • Kidney failure
  • Acute interstitial nephritis (a condition that can lead to permanent kidney damage or failure)

Some of the lawsuits were filed by people who developed kidney complications themselves after taking PPIs. Other lawsuits were filed by family members after an immediate relative died from kidney problems after taking the drugs.

Rebecca Montrone discusses the problems associated with proton pump inhibitors, many of which have led to legal action

Accusations in Lawsuits Against PPI Manufacturers

Lawsuits over kidney-related complications claim that AstraZeneca knew of possible kidney risks as early as 2004, but never warned patients about the danger. PPI labels did not warn of AIN risks until the FDA required that labels include it starting in 2014.

PPI MANUFACTURERS ARE ACCUSED OF:

  • Negligence
  • Misbranding
  • Deceptive advertising
  • Negligent misrepresentation
  • Fraud
  • Failure to warn of PPI side effects
  • Accepting kickbacks
  • Designing, manufacturing and selling defective products

Heartburn Drug Brands Facing Lawsuits

The proton pump inhibitor MDL involves four manufacturers and five specific brands of heartburn medications.

PPIs Named in Lawsuits & Manufacturers Being Sued

Drug Name Manufacturer
Nexium AstraZeneca
Prilosec AstraZeneca
Prilosec OTC Proctor & Gamble
Prevacid Takeda Pharmaceuticals
Protonix Pfizer

Verdicts and Settlements against PPI Manufacturers

The current proton pump inhibitor MDL is still in the very early stages, so there have been no verdicts or settlements yet. But past PPI lawsuits for other causes have included a $55 million settlement. Most settlements so far have resulted from lawsuits brought by the government over PPI manufacturers’ business practices.

Past PPI Lawsuit Settlements

  • 2012

    $55 million

    Pfizer agrees to settlement with U.S. government for promoting Protonix for unapproved uses

  • 2014

    Undisclosed

    Takeda Pharmaceuticals settles a lawsuit claiming Prevacid was responsible for bone fractures

  • 2015

    $20 million

    AstraZeneca agrees to a settlement in a consumer class action lawsuit involving its marketing of Prilosec and Nexium

  • 2015

    $7.9 million

    AstraZeneca agrees to settlement with U.S. government over alleged kickback scheme involving Nexium

  • 2015

    $24 million

    Generic drug maker Teva Pharmaceuticals settles lawsuit claiming it took money from AstraZeneca to keep generic Nexium off the market

Prilosec and Nexium Class Action Lawsuit

AstraZeneca paid $20 million in 2015 to settle a class action lawsuit involving two PPIs the company manufactured – Nexium and Prilosec.

AstraZenca Infographic stat

The class action lawsuit accused AstraZeneca of attempting to “evergreen” the drugs. It claims that as AstraZeneca’s patent on Prilosec was running out, the company created Nexium — a new, nearly identical drug that was much more expensive — to replace it.

Fact

Nexium and Prilosec are almost chemically identical

In the class action lawsuit, consumers claimed the company’s $260 million marketing campaign tricked people into buying the more expensive Nexium rather than Prilosec, even though the drugs had the same effect.

FDA Actions, Studies Raise Concerns over PPI Side Effects

Scientific studies and federal safety warnings have highlighted the possibilities of other serious side effects related to PPIs.

2010

FDA requires bone fracture risk added to PPI labels

The first wave of individual lawsuits over the heartburn drugs claimed PPIs such as Nexium had caused or contributed to bone fractures and other bone conditions.

Timeline of PPI Bone Fracture Lawsuits

  • 2011

    First Nexium lawsuit is filed against AstraZeneca, claiming it led to a woman’s bone fractures

  • 2012

    The U.S. Judicial Panel on Multidistrict Litigation (JPML) combines 47 Nexium lawsuits in a single multidistrict litigation (MDL) in a California federal court

  • 2012

    MDL grows to more than 1,000 lawsuits against AstraZeneca

  • 2014

    The MDL judge closes the MDL in favor of AstraZeneca

  • 2014

    Takeda Pharmaceuticals settles bone fracture lawsuit naming Prevacid for an undisclosed amount

More recently, research has indicated PPIs increase the risk of serious kidney damage or injury. In December 2014, the FDA required PPI manufacturers to add warnings to their product labels about the risk of acute interstitial nephritis.

Timeline of FDA Actions on PPI Labels:

  • 2010

    FDA revises labels for PPIs to include safety information about a possible increased risk of fractures of the hip, wrist and spine

  • 2011

    FDA safety communication warns of possible low magnesium levels for people taking PPIs for a year or longer – risking muscle spasms and irregular heartbeat

  • 2012

    FDA warns that PPI use can lead to Clostridium difficile-associated diarrhea, which can lead to more serious intestinal conditions

  • 2014

    The agency warns that taking PPIs for three years or longer can lead to Vitamin B12 deficiency, associated with memory loss

  • 2014

    FDA requires warning of increased risk of acute interstitial nephritis be added to PPI labels

  • 2016

    FDA approves PPI label changes to include risk of lupus erythematosus – a condition in which the body’s immune cells attack other cells or organs in the body

Studies Point to Potential for Future PPI Lawsuits

Though current lawsuits target kidney-related injuries and past suits were about bone fractures, recent studies suggest PPIs may be responsible for other serious complications.

Recent studies have linked PPI use to an increased risk of stroke, heart attack and gastric cancer in certain patients.

Side Effect Investigated Date of the Study What Researchers Found About PPI Users
Heart Attack June 2015 Heart attack rate increased from 16 to 21 percent
Stroke November 2016 21 percenter increased stroke risk
Gastric Cancer September 2017 Risk of gastric cancer doubled for patients with previous Helicobacter pylori infections

No lawsuits have been filed over these side effects yet, but as more PPI research emerges, attorneys say more people injured by these drugs may seek compensation through the courts.

Author

Terry Turner is an Emmy-winning, former television journalist. He is an associate member of the American Bar Association, the ABA’s Health Law group and a member of the Alliance of Professional Health Advocates. He holds six certificates in Health Literacy for Healthcare Professionals from the Centers for Disease Control and Prevention. As a Washington-based investigative reporter, he routinely reported on health and medical policy issues before Congress, the FDA and other federal agencies. Terry received his B.A. in Media Arts from Lyon College.


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Did you use a heartburn drug and suffer from kidney problems?
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