13,000 Kidney Patients Await Trial Over Deadly Proton Pump Inhibitors

The invidious aspect of heartburn medicines called “proton pump inhibitors” (PPIs) is that there are no specific symptoms of the kidney damage that they cause.

Victims take the medicine for years and suffer general symptoms such as decreased urine output, tiredness, difficulty concentrating, problems sleeping, loss of appetite and dry, itchy skin. Only when they visit their doctor do they discover – to their shock — that they have deadly kidney disease.

The patients unwittingly took PPIs for acid reflux, GERD, dyspepsia, and peptic or stomach ulcers. Little did they know that the “little purple pill” and other PPIs were giving them chronic kidney disease, acute kidney failure, acute interstitial nephritis, and end-stage renal disease.

Now they faced agonizing dialysis, a kidney transplant or death.

“You can treat and hopefully cure infections. Fractures can heal, though they can be catastrophic events for older people, but chronic kidney disease doesn’t go away,” Dr. Adam Schoenfeld, an internal medicine resident at the University of California, San Francisco, told The New York Times in 2016.

The patients charge in 13,338 federal lawsuits that multiple drug makers knew that PPIs caused kidney damage but they failed to warn doctors and patients. The cases are consolidated in MDL 2789 before US District Judge Claire C. Cecchi in Newark, New Jersey, IN RE: Proton-Pump Inhibitor Products Liability Litigation (No. II).

More than 15 million Americans are taking PPIs, including the biggest PPI brand names in the U.S. market:

  • Nexium (esomeprazole)
  • Prilosec (omeprazole)
  • Prevacid (lansoprazole)
  • Protonix (pantoprazole)
  • Dexilant (dexlansoprazole)
  • Zegerid (omeprazole and sodium bicarbonate)
  • AcipHex (rabeprazole)
  • Vimovo (esomeprazole and naproxen)

Reducing stomach acid

Stomach acid is essential for proper digestion, but it’s also highly corrosive. It’s as powerful as battery acid and potent enough to dissolve metal or to eat a hole through wood.

When your body produces too much gastric acid, it can eat through the protective stomach lining. This leads to a painful ulcer. If the valve that keeps the stomach acid from rising up from the stomach and into your esophagus doesn’t work, that acid can damage your esophagus.

Stomach acid is produced by glands — proton pumps — in the stomach’s lining. PPIs inhibit the amount of acid they produce.

The root of the litigation started in 1989 when the FDA approved Prilosec (Omeprazole) as a heartburn drug, sold in prescription-strength capsules and over the counter forms. Quickly, many PPI’s were approved for the market, and total sales skyrocketed to $14 billion by 2016.

However, researchers began documenting problems with PPIs shortly after the first drug hit the market. Patients had no idea there was a connection between their heartburn medication and kidney failure.

In 1992, just three years after Prilosec got FDA approval, an article appeared in The American Journal of Medicine detailing the first case of acute interstitial nephritis caused by a PPI.

Some Prilosec lawsuits allege that AstraZeneca knew of the risk of kidney damage since 2004 before warning the public.

  • In 2004, researchers writing in the journal Nephrology, Dialysis, and Transplantation concluded Prilosec and Prevacid are the “drugs most commonly associated with interstitial nephritis.”
  • In 2007, other researchers writing in Clinical Nephrology identified an “ever-increasing number of cases of acute interstitial nephritis associated with PPI therapy” and that “all PPIs have been documented to cause AIN [acute interstitial nephritis].”

Despite numerous studies finding a connection between drugs and acute interstitial nephritis, the FDA did not require manufacturers to add acute interstitial nephritis warnings to labels until December 2014.

In 2015, a study in CMAJ Open found that those who started PPI therapy had an increased risk of acute kidney injury and acute interstitial nephritis.

A 2016 study in the Journal of American Nephrology found long-term users were 28 percent more likely to suffer from chronic kidney disease. They were also 95 percent more likely to experience kidney failure. This is also called end-stage renal disease.

A different 2016 study in the journal JAMA Internal Medicine associated long-term use with a 20 to 50 percent higher chance for developing chronic kidney disease.

Litigation begins

The first PPI lawsuit was filed against AstraZeneca’s Nexium in May 2016 in federal court in Tennessee. According to the complaint, Charles Bowers took Nexium from 2003 to 2008, when he was diagnosed with acute interstitial nephritis. As a result of his condition, Mr. Bowers was forced to undergo dialysis three times a week and is awaiting a kidney transplant.

In February 2017, the Judicial Panel of Multidistrict Litigation denied a motion to combine 39 PPI cases into centralized proceedings, because it said the cases were too different. By the summer of 2017, there were more than 160 lawsuits filed against five PPI manufacturers.

Due to the huge number of similar cases, MDL 2789 was finally approved on August 2, 2017 to streamline proceedings for more than 60 early lawsuits. A “science day” was held in May 2018, where the parties made presentations about their cases.

The first bellwether trial is scheduled for November 15, 2020.

People who took these drugs and got kidney disease have filed lawsuits against a who’s who of 26 corporate defendants:

  1. Abbott Laboratories
  2. AstraZeneca Pharmaceuticals LP
  3. AstraZeneca LP
  4. GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  5. GlaxoSmithKline Consumer Healthcare LP
  6. GlaxoSmithKline Consumer Healthcare Holdings (US) IP LLC
  7. Merck & Co. Inc. d/b/a Merck, Sharp & Dohme Corporation
  8. Novartis Corporation
  9. Novartis Pharmaceutical Corporation
  10. Novartis Vaccines and Diagnostics, Inc.
  11. Novartis Institutes for Biomedical Research, Inc.
  12. Novartis Consumer Health, Inc.
  13. Pfizer, Inc.
  14. The Procter & Gamble Company
  15. Procter & Gamble Manufacturing Company
  16. Takeda Pharmaceuticals USA, Inc.
  17. Takeda Pharmaceuticals America, Inc.
  18. Takeda Pharmaceuticals LLC
  19. Takeda Pharmaceuticals International, Inc.
  20. Takeda California, Inc.
  21. Takeda Development Center Americas, Inc. f/k/a Takeda Global Research & Development Center, Inc.
  22. Takeda Pharmaceutical Company Limited
  23. TAP Pharmaceutical Products, Inc. f/k/a TAP Holdings Inc.
  24. Wyeth Pharmaceuticals, Inc.
  25. Wyeth-Ayerst Laboratories
  26. Wyeth LLC

Penelope Costamagna of California suffered kidney failure and required a kidney transplant after taking Prilosec for “multiple years.” She sued Procter & Gamble and AstraZeneca in February 2017.

Costamagna stopped taking the medication in November 2016, when doctors discovered she had a kidney injury. Her complaint said she was unaware of any risk to her kidney health until doctors diagnosed her injury.

“It is statistically likely that Plaintiff Penelope Costamagna will require another kidney transplant in her lifetime, or will die as a result of not having such a transplant available,” her complaint said.

The court-approved plaintiff’s short-form complaint allows the following claims:

  • Strict Product Liability
  • Strict Product Liability – Design Defect
  • Strict Product Liability – Failure to Warn
  • Negligence
  • Negligence Per Se
  • Breach of Express Warranty
  • Breach of Implied Warranty
  • Negligent Misrepresentation
  • Fraud and Fraudulent Misrepresentation
  • Fraudulent Concealment
  • Violation of State Consumer Protection Laws
  • Loss of Consortium
  • Wrongful Death
  • Survival Action

AstraZeneca is the worst defendant

By far the worst corporate actor is AstraZeneca, headquartered in Gaithersburg, MD. In 2015 the company paid millions in fines and settlements over illegal kickbacks, a “pay for delay” scheme, shortchanging Medicaid and ripping off consumers.

In 2015, AstraZeneca agreed to pay the U.S. government $7.9 million to resolve kickback allegations involving Nexium. The government charged AstraZeneca worked with another company to boost sales.

AstraZeneca had paid pharmacy-benefit manager Medco Health Solutions to maintain Nexium’s “sole and exclusive” status on certain Medco lists. AstraZeneca provided the payment to Medco through price concessions on drugs including Prilosec, Toprol XL, and Plendil.

“Hidden financial agreements between drug manufacturers and pharmacy benefit managers can improperly influence which drugs are available to patients and the price paid for drugs,” Joyce R. Branda, the Acting Assistant Attorney General, said at the time.

In 2015, AstraZeneca was accused in a class action of participating in a pay-for-delay scheme, which is when a pharmaceutical company pays another drug manufacturer to hold off on selling a generic version of a particular drug.

The Nexium class-action lawsuit claimed the company paid off Teva Pharmaceuticals to delay its release of a generic version of Nexium. Teva paid a $24 million settlement to the U.S. government, freeing itself from the case.

Also, in 2015, AstraZeneca agreed to pay the U.S. government and several states $26.7 million to settle claims that its underpaid rebates owed under the Medicaid Drug Rebate Program.
In February 2015, AstraZeneca agreed to pay $20 million to consumers in a Prilosec and Nexium class-action lawsuit that had lasted for 10 years.

The class action claimed the company spent $260 million on an advertising campaign to mislead consumers into buying more expensive medicine. It accused AstraZeneca of attempting to keep market share as a patent expired.

According to the lawsuit, AstraZeneca’s patent on Prilosec was about to expire, so the company pushed Nexium to replace it. The two drugs were almost chemically identical, but Nexium was far more expensive than Prilosec.

In separate heartburn litigation involving Zantac, US District Judge Robin L. Rosenberg in West Palm Beach, FL, is presiding over the new MDL No. 2924. Some 126 lawsuits over a cancer-causing impurity in the heartburn medication Zantac before the federal court. Plaintiffs in all the actions allege that Zantac—and its active ingredient ranitidine—breaks down to form a carcinogen known as N-Nitrosodimethylamine (NDMA).

The Plaintiffs have cancer of the bladder, kidney, colon, and stomach, and they charge that the manufacturers, sellers, and distributors of Zantac and other Ranitidine medications knew or should have known that these medications exposed consumers to NDMA, and that defendants concealed the NDMA-associated dangers posed to consumers.

The defendants include Boehringer Ingelheim Pharmaceuticals, Inc.; GlaxoSmithKline LLC; Pfizer Inc.; Sanofi-Aventis U.S. LLC; Sanofi US Services Inc.; and Chattem, Inc.

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