Proton Pump Inhibitor MDL. The Judicial Panel on Multidistrict Litigation (JPML) has entered an order consolidating the Proton Pump Inhibitor (PPI) MDL (multidistrict litigation) on August 2, 2017. The MDL was assigned to Judge Claire C. Cecchi, U.S. District Court of New Jersey, based on the July 27, 2017 consolidation hearings at the Los Angeles Federal Courthouse.
The drugs in question include Prilosec, Nexium, Protonix, and Dexlant, as well as potential numerous generic manufacturers. The hearing order has over 163 cases in 28 federal district courts and a decision will probably come in mid-August. However, the judges may attempt to come up with ways to split up the cases into structures that might be simpler and more manageable or combine all parties. Suggestions included single-product or single-defendant MDLs, separating out prescription-only users, or separating out patients who had only used products made and sold by AstraZeneca, which is currently named in 100 cases.
PPI Products Liability Litigation
The Proton-Pump Inhibitor Products Liability Litigation is where the case filing substantially increased since the initial JPML hearing on January 26, 2017 in Miami when U.S. District Judge Sarah Vance said at one point during the oral arguments “It just seems to me to be nightmarishly complex” as the primary defense counsel raised concern over the generic makers and raised concern over the generic makers and related defense issues with so many co-defendants. The JPML eventually denied the MDL 10 days later to the view that consolidation would be too cumbersome, however due to the large number of new lawsuits and the refiling of a Motion to Consolidate, the July 27th Los Angeles Hearings have had a different outcome.
An MDL is created to consolidate cases with similar complaints to be tried in one court before one judge to streamline the process, allowing a faster outcome, lower court costs, and is generally more efficient.
National law firm Parker Waichman LLP has extensive experience and success representing clients in drug injury litigation. Our lawyers are actively reviewing potential lawsuits on behalf of individuals and are available to answer questions for anyone seeking information for a potential lawsuit.
FDA and Kidney Damage Warning
Kidney injuries including acute interstitial nephritis (a kidney disorder that happens when the kidneys are unable to filter waste and fluid properly), chronic kidney disease, and end-stage renal disease have been named by plaintiffs as potential dangers of PPI use. In 2011, concerns that these medications have harmful side effects for users’ kidneys were brought to the U.S. Food and Drug Administration (FDA) by consumer advocacy group Public Citizen. As a result, the agency required warnings about risks of acute interstitial nephritis on labels in 2014, according to the patients’ MDL brief.
Scientific Study Confirming Adverse Side Effects
Recent studies have found that the use of proton pump inhibitors significantly increased the risk of kidney problems. Both Nexium and Prilosec, two of the most popular medications for indigestion and heart burn, have been associated with kidney problems.
One of the most noteworthy studies was published in the Journal of the American Society of Nephrology which found that proton pump inhibitors had a higher risk of kidney problems compared to other heart burn medications.
The study revealed a 96 percent increased risk of kidney failure when patients took PPIs, along with a 28 percent increased risk of chronic kidney disease. The risk when compared with H2 receptor blockers was comparatively higher.
In January 2016, a scientific study published recent research on independent findings of a connection between PPI use that was linked to a 20 to 50 percent higher risk of chronic kidney disease. Plaintiffs have also brought allegations of renal failure being caused by the drugs. To date, over 5,000 PPI cases are under investigation by plaintiff’s counsel, and more could be added to that number as awareness of the link between PPI use and kidney damage continues to increase.
Although the drug class first received FDA approval in 1989, it was not until serious side effects prompted the FDA in 2014 to require all PPIs to place a warning label that identified the connection of the drug to acute interstitial nephritis. The plaintiff’s brief also mentions several studies that have made a connection between PPI use and kidney damage during the past 25 years, including a 1992 study by the University of Arizona Health Sciences Center, a 2006 study conducted at the Yale School of Medicine, and a 2016 study from Johns Hopkins published in the Journal of the American Medical Association (JAMA).
In January, the plaintiffs note that the JPML denied centralization of PPI cases, but say later significant developments “warrant a second look at consolidation.”
The defendants include AstraZeneca Pharmaceuticals LP, Proctor & Gamble Co., McKesson Corp., Takeda Pharmaceuticals USA Inc., Novartis Pharmaceuticals Corp., Pfizer Inc., and Pfizer subsidiary Wyeth.
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