Timeline Shows PPI Approval, Complications, and Lawsuits

ppi_lawsuitsProton pump inhibitor (PPI) medications like Prilosec® (omeprazole), Prevacid® (lansoprazole), and Nexium® (esomeprazole) block the gastric proton pump enzyme in the stomach lining, reducing the production of gastric acid that causes heartburn and other peptic-acid disorders.

The U.S. Food and Drug Administration (FDA) approved the first PPI—Prilosec—in 1989. In the years since, PPIs have become one of the most widely-used classes of medications in the country.

PPIs were approved to prevent and treat chronic heartburn, as well as gastroesophageal reflux disease (GERD), gastropathy caused by nonsteroidal anti-inflammatory drugs, and peptic ulcer disease (PUD). Nearly 20 percent of Americans suffer from these conditions.

Despite their widespread popularity, PPIs have been linked to a number of concerning side effects and complications, including bone fractures, osteoporosis, arterial damage, cardiovascular disease, kidney damage, chronic kidney disease, and renal failure. As a result, hundreds of patients have filed lawsuits against PPI manufacturers, alleging the companies failed to warn them of the risks associated with the use of the drugs. Because many of the lawsuits were filed in response to recently published data on PPI risks, some experts expect the number of lawsuit filed against PPI manufacturers to increase significantly in coming months and years.

If you were prescribed a PPI medication or experienced serious side effects while taking a PPI, here's what you need to know:

PPI Complications and Lawsuits Timeline

1989: The FDA approves AstraZeneca's Prilosec.

1995: The FDA approves Takeda Pharmaceuticals' Prevacid.

1999: The FDA approves Eisai Inc. and Janssen Pharmaceutical's AcipHex (rabeprazole)®.

2000: The FDA approves Pfizer's Protonix® (pantoprazole).

2001: The FDA approves AstraZeneca's Nexium.

2004: The FDA approves Santarus, Inc.'s Zegerid® (omeprazole and sodium bicarbonate).

2006: The Journal of the American M+dcal Association publishes a study linking long-term PPI use to an increased risk of hip fracture in patients older than 50.

2009: The FDA approves Takeda Pharmaceuticals' Dexilant® (dexlansoprazole).

2010: The FDA requires PPI manufacturers to update their warning labels to include information about link to bone fractures.

2011: A Nexium patient files a lawsuit against AstraZeneca for PPI-related bone fractures.

2011: The FDA issues a safety communication for prescription PPIs, warning that long-term use may cause low magnesium levels.

2012: A Prevacid patient files a lawsuit against Takeda Pharmaceuticals, claiming that the company failed to warn doctors and patients of the potential for bone fracture side effects.

2012: The FDA releases a safety announcement warning of the link between PPI use and life-threatening C. difficile infections, which causes severe intestinal problems.

2013: Pfizer pays the U.S. Government $55 million to resolve an allegation that the company marketed Protonix for unapproved uses.

2013: The Circulation medical journal publishes research linking popular PPI heartburn drugs to an increased risk for cardiovascular problems.

2016: The Journal of the American Society of Nephrology publishes a study linking PPI medications to an increased risk of kidney injury, chronic kidney disease and renal failure.

2016: A Nexium patient files a lawsuit against AstraZeneca for PPI-related kidney damage.

2016: JAMA Neurology publishes a study warning that long-term use of PPIs may increase dementia risks by up to 44 percent.

2016: The International Journal of Rheumatic Diseases publishes research showing that PPIs may increase bone loss and osteoporosis risks.

Will PPI Lawsuits Become an MDL?

When a large number of similar lawsuits are filed, the U.S. Judicial Panel on Multidistrict Litigation may decide to merge them into multidistrict litigation (MDL). If this happens, PPI cases from all across the country will be consolidated into a single court and move through the pre-trial process together, allowing attorneys to share information and evidence.

Are You Considering Filing a PPI Lawsuit?

If you suffered from bone fractures, kidney issues, or cardiovascular problems related to long-term PPI use, you may be able to seek compensation from the drug's manufacturer for damages, including medical bills. Contact McGartland Law today to schedule a free initial consultation to discuss the details of your potential PPI complications lawsuit.