01

What are Proton Pump Inhibitors?

Proton pump inhibitors are a category of drugs designed to regulate the stomach’s production of acid. Proton pump inhibitors are available in both prescription and over-the-counter versions. They’re commonly sold under brand names Nexium, Prilosec, Prevacid, Protonix, and Dexilant.

Proton pump inhibitors are often used to treat occasional heartburn, gastroesophageal reflux disease (GERD), esophageal inflammation, and ulcers in the small intestine and stomach. Proton pump inhibitors can also be used in the treatment of a rare condition called Zollinger-Ellison syndrome. This condition is caused by a bacteria found in the stomach called Helicobacter pylori that can cause tumors in the pancreas or the upper part of the small intestine.

Due to its range of uses, proton pump inhibitors are a popular medication—about 15 million Americans currently take proton pump inhibitors. The popularity of drugs like Nexium, Prilosec, Prevacid, Protonix, and Dexilant can also be traced to drugmakers’ multibillion-dollar marketing spend advertising to consumers. Some experts have also expressed concern that PPI usage statistics are artificially high due to misuse for non-chronic heartburn problems.

 

02

How do Proton Pump Inhibitors Work?

Proton pump inhibitors function by blocking certain stomach enzymes from excreting acid. Specifically, the drug inhibits the gastric proton pump at the tail end of the enzyme’s acid production process, giving proton pump inhibitors their name. This blockage of acid production is irreversible and proton pump inhibitors can prevent stomach acid secretion by as much as 99%. The irreversible nature of PPIs also makes them a much more effective option than a different popular heartburn medication type: H2 receptor antagonists.

This is an important distinction, since a highly popular H2 drug, Zantac, is also the target of ongoing litigation. Zantac, however, is under fire for contamination with a human carcinogen, NDMA. It was recalled by the FDA in April 2020 and related class action suits are in the works.

03

Link Between Proton Pump Inhibitors, Kidney Damage, & Kidney Failure

Over the years, a number of studies have linked proton pump inhibitor usage to an array of medical risks. These risks include bone fractures, pneumonia, cardiovascular disease, esophageal cancer, dementia, and diarrhea. Proton pump inhibitors have even been connected to low levels of vitamin B12, magnesium, and calcium. The primary side effects at the center of ongoing proton pump inhibitors lawsuits are kidney damage.

A 2016 study published in the Journal of the American Medical Association found proton pump inhibitor usage is associated with a 20–50% higher chance of chronic kidney disease. In March 2019, a University at Buffalo study found similar results. The study revealed that proton pump inhibitor medications increase the risk of kidney disease by 20% in people older than 15. The researchers also found that people who use proton pump inhibitors are four times more likely to suffer from kidney failure than individuals not exposed to proton pump inhibitors. This risk of proton pump inhibitor kidney failure is highest for people 65+ years of age.

That same month, The British Medical Journal published a study of U.S. veterans that concluded proton pump inhibitors were associated with a “small excess of cause specific to mortality including death due to cardiovascular disease, chronic kidney disease, and upper gastrointestinal cancer.” The study’s researchers urged proton pump inhibitor users to be extremely vigilant should they continue to take the drug.

The National Kidney Organization, however, maintains there is no definitive proof that proton pump inhibitors increase the risk of chronic kidney damage. The organization explains, “It has not been proven that proton pump inhibitor use causes chronic kidney disease, but some studies suggest there is an increased risk in individuals who have normal kidney function before using a PPI. This does not mean that everyone who uses PPIs will get chronic kidney disease, but it is important to know that there may be a risk.”

04

No FDA Proton Pump Inhibitors Recall to Date

Despite all the indications that proton pump inhibitors and chronic kidney disease are linked, the FDA has not recalled proton pump inhibitors from the market. In 2011, a consumer group demanded that the FDA require proton pump inhibitor manufacturers to include a black box label. A black box label is a warning on a prescription label that draws attention to serious or life-threatening risks. When the FDA resisted, the group sued.

Soon afterward, in 2014, the FDA mandated label changes, but fell short of the requirements for black box labeling. Instead, the manufacturers of Nexium, Prilosec, Protonix, Prevacid, Dexilant, Zegerid, Aciphex, and their generic counterparts were required to include only certain categories of warnings. This included information regarding risk of C. difficile-associated diarrhea, certain drug interactions, vitamin B12 deficiency, and acute interstitial nephritis (AIN). The FDA declined to require proton pump inhibitors to have specific warnings for chronic kidney disease, kidney failure, and other kidney injuries when it issued the new labeling warnings order.

Expert insights have never been more important.

05

Proton Pump Inhibitor Class Action Lawsuit Terms

The majority of cases filed have been consolidated into a proton pump inhibitor class action lawsuit before Judge Claire C. Cecchi in the District Court of New Jersey. The purpose of the proton pump inhibitor lawsuit centralization is to streamline the thousands of complaints containing similar fact statements and allegations against the common proton pump inhibitor-maker defendants. The proton pump inhibitor lawsuits will share pretrial proceedings to eliminate duplicative discovery and to promote consistent rulings across jurisdictions. Part of the judicial process also involves whittling the cases down to around six bellwether cases.

The plaintiffs in the proton pump inhibitor class action lawsuit claim the drugs caused their kidney damage, kidney failure, and chronic kidney disease, among other adverse side effects. Allegations also include claims that warning labels on the class of medication were insufficient. The plaintiffs have demanded compensatory damages for their medical expenses, pain and suffering, and other losses.

06

Proton Pump Inhibitor Lawsuits

Though the proton pump inhibitor MDL is made up of thousands of claims, these represent a sampling of the individual complaints filed.

Costamagna et al v. Procter & Gamble Company et al

Plaintiff Penelope Costamagna’s 2017 lawsuit against AstraZeneca and Proctor & Gamble alleges that after taking Prilosec for multiple years her kidneys failed, requiring a kidney transplant. The complaint also claims that it is statistically likely that Ms. Costamagna, a Californian, will require another kidney transplant to avoid death.

Stockton v. AstraZeneca Pharmaceuticals Lp et al

AstraZeneca also faces a Nexium lawsuit brought by Jeanette Stockton of Louisiana. This plaintiff claimed she took Nexium from 2002–2012 and learned she had chronic kidney disease in 2012. Unaware of Nexium’s chronic kidney disease risks, she continued taking the drug until 2016. The plaintiff claims she was not told of the kidney risks of Nexium and warnings from the company were inaccurate and ambiguous.

Koon v. AstraZeneca Pharmaceuticals Lp et al

Plaintiff Jackie Koon of Kansas claimed she used Prilosec from 2010–2013 and as a result, developed end-stage renal disease that will require lifelong dialysis or a transplant. She sought $10 million for physical pain and mental anguish, loss of enjoyment of life, and expenses for lifelong medical treatment, monitoring, and medications.

Vertrees et al v. Takeda Pharmaceutical Company Limited et al

Karen Vertrees of Tennessee claimed Takeda Pharmaceutical’s Dexilant and Prevacid PPIs caused her acute and chronic kidney injury. She took the drugs between 2001–2014, unaware of the kidney risks associated with proton pump inhibitors. She also claimed the company had not properly warned her of the risks associated with the PPIs.

07

Proton Pump Inhibitor Bellwether Schedule & Important Dates

The proton pump inhibitor MDL bellwether trials will act as a test balloon for parties to see how jurors perceive the evidence and testimony linking proton pump inhibitors to kidney disease and kidney failure. Proton pump inhibitor lawsuits that don’t settle after these stages will be sent back to their home federal district courts for trial.

The Bellwether Schedule

Judge Cecchi ordered both sides of the proton pump inhibitor class action lawsuit to select 20 representative cases for a discovery pool. This pool will be whittled down to six bellwether trials. Case Management Order No. 36 lays out the bellwether case schedule, culminating in the first trial start date of November 15, 2021.

Bellwether Case Selection and Discovery

The six bellwether cases will be selected on October 28, 2020, and will begin to prepare for trial. This includes any additional act discovery, expert discovery, and dispositive or trial-related motion practice. Fact discovery must be complete by January 12, 2021. The generic corporate discovery completion deadline is September 15, 2020.

Bellwether Trial Case Expert Schedule

Here are the key dates and requirements Judge Cecchi established related to bellwether case experts in Order No. 36.

  • The plaintiffs’ general and case-specific expert reports for bellwether trial cases are due on or before February 9, 2021.
  • The defendants’ general and case-specific expert reports for bellwether trial cases are due on or before March 23, 2021.
  • Any plaintiff rebuttal expert witness reports must be submitted by April 23, 2021.
  • The defendants’ depositions of that rebuttal witness must be completed within two weeks of May 28, 2021.
  • Expert witness disclosures must include at least 2 dates when the expert is available for a deposition.
  • All expert witness depositions must be completed by May 28, 2021, unless there is a party agreement or a leave of the court.
  • The plaintiffs’ expert depositions must be completed before the defendants’ expert in the same discipline.
  • Parties may attempt to schedule a plaintiff expert deposition prior to April 13, 2021, if that expert is not serving a rebuttal report.
  • Any Daubert challenges to expert testimony must be filed on or before July 2, 2021.

Summary Judgment Motions in Bellwether Trial Cases

Attorneys or interested parties will want to track the summary judgment motions in these cases.

Here are the key dates to be aware of:

  • Summary judgment motions or partial summary judgment motions must be filed on or before June 25, 2021.
  • Motions to challenge expert testimony pursuant to Daubert must be filed on or before July 2, 2021.
  • Responses to summary judgment motions must be filed on or before July 26, 2021.
  • Responses to motions seeking to challenge expert testimony pursuant to Daubert must be filed on or before August 5, 2021.
  • Reply briefs in further support of summary judgment motions must be filed before August 17, 2021.
  • Reply briefs in further support of motions seeking to challenge expert testimony pursuant to Daubert must be filed on or before August 27, 2021.
  • If the court determines that a hearing or oral argument on summary judgment and/or Daubert motions, is necessary, the court will schedule this hearing.

08

What Attorneys Need to Know About Pursuing Proton Pump Inhibitor Lawsuits

A major challenge up against these pending PPI lawsuits is that, overall, proton pump inhibitors are generally safe. Though multiple studies have indicated kidney health risks related to PPI usage, there are sources that indicate the opposite. A study published by Harvard Health Publishing in June 2020 found no links between proton pump inhibitor usage and increased rates of kidney disease in older adults. Even the U.S. National Library of Medicine’s MedlinePlus says proton pump inhibitor side effects are rare. MedlinePlus makes no mention of kidney damage associated with the drugs. This contrary information, coupled with a lack of an FDA recall, will likely be capitalized on by the defense counsel and will likely pose the greatest burden of proof for plaintiffs.

Experts for Proton Pump Inhibitor Lawsuits

Attorneys leading proton pump inhibitor lawsuits will want highly-qualified, respected, and experienced experts to consult on their cases. Given the scope of the MDL, attorneys will need to be prepared to present their expert opinions, stand up to cross examination, and refute rebuttals by the defense.

PPI cases will also require a fleet of medical experts with knowledge of kidney diseases, kidney transplants, dialysis, and long-term treatments and care costs. Experts in the stomach, acid production, and drug interactions with these systems will also be a priority. Pharmacology experts should also be consulted to speak to uses, effects, and modes of action of PPI drugs. An FDA expert will also be key for understanding the labeling changes to PPIs and why there was never a recall. Pharmacists might also be considered for consultations or testimony on what warnings or risk factors the defendant drugmakers gave them or mentioned in passing. Attorneys might also rely on pharmacy experts to report on what kinds of PPI risk questions patients were asking during pharmacy consults over the years.

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