Proton Pump Inhibitor (PPI) Lawsuits
Proton pump inhibitor (PPI) lawsuits claim that the drugs used to treat heartburn and acid reflux caused serious kidney problems in people who took them. Thousands of people have filed PPI lawsuits against the manufacturers of Nexium, Prilosec and other proton pump inhibitors in what is one of the largest mass litigations in the United States.
PPI lawsuits blame the heartburn drugs for causing four specific types of kidney damage: kidney disease, kidney injury, kidney failure and acute interstitial nephritis (AIN). Several PPI brands are named in the lawsuits. They include the prescription versions of Nexium, Prilosec, Prevacid, Protonix and Dexilant — as well as over-the-counter Prilosec OTC, Nexium 24HR and Prevacid 24HR.
The lawsuits also argue that manufacturers failed to warn people of the drugs’ dangers. Lawsuits involving Prilosec, for example, claim AstraZeneca knew of kidney risks as early as 2004, but the company did not warn patients about them for another 10 years.
As of August 2019, there were 13,061 proton pump inhibitor lawsuits pending in federal court — out of a total of 14,248 that had been filed. A judicial panel combined the cases into a multidistrict litigation (MDL) in August 2017.
The number of lawsuits grew quickly, tripling during the first three months of 2019 alone. By mid-2019, it had become the second-largest mass litigation in the United States. Attorneys expect the MDL could include thousands more cases. The judge overseeing the litigation has scheduled the first bellwether trial for Sept. 21, 2020.
|Drug Name (Generic Name)||Manufacturer|
|Dexilant (dexlansoprazole)||Takeda Pharmaceuticals|
|Prilosec OTC (omeprazole)||Proctor & Gamble|
|Prevacid (lansoprazole)||Takeda Pharmaceuticals|
All cases in the MDL claim the drugs, used to control stomach acid, caused serious side effects that damaged kidneys. Lawsuits involving Prilosec, for example, claim AstraZeneca knew of kidney risks as early as 2004, but the company did not warn patients about the risks for 10 years.
- Kidney disease
- Kidney injury
- Kidney failure
- Acute interstitial nephritis (AIN)
Kidney Injury Lawsuits Consolidated
In October 2016, PPI users who filed six lawsuits against the drugs’ manufacturers asked a federal judicial panel to consolidate all federal kidney injury cases into a single multidistrict litigation.
At the time, 15 cases asserting similar claims were pending in 12 district courts. By February 2017, the number of related federal lawsuits had more than doubled, reaching 39. Complainants alleged they “suffered and continue to suffer from kidney injuries including but not limited to, acute interstitial nephritis, chronic kidney disease or renal failure known as end-stage renal disease, and acute kidney injuries,” according to the motion.
They further alleged that AstraZeneca, Takeda and Pfizer, along with others involved in the manufacturing of the drugs, failed to adequately warn about the risk of kidney injuries related to the use of Prilosec, Nexium, Prevacid and other PPIs.
“Given the widespread use of PPIs and their defective nature, it is likely that additional claimants will be harmed by the medications and additional similar actions will be filed in or removed to federal courts in the future,” Paul J. Pennock, Esq., of Weitz & Luxenberg, P.C., said in the plaintiffs’ motion.
The U.S. Judicial Panel on Multidistrict Litigation denied the MDL request in February 2017. In its order denying transfer, the panel said it recognized the lawsuits all arose from plaintiffs’ allegations that taking PPIs may result in various types of kidney injury, but the named defendants varied from action to action and are competitors. AstraZeneca was sued in most of the actions (37 actions), but Proctor & Gamble was sued in only eight, Takeda in four, and Pfizer in two.
The panel also took issue with the variety of kidney injuries alleged and the differences among the drugs, including the different U.S. Food and Drug Administration approval times and the fact some are available over-the-counter while others require a prescription.
However, on Aug. 2, 2017, the judicial panel ordered the cases centralized in the District of New Jersey. Plaintiffs in 24 lawsuits had asked for the MDL the second time. There were 161 lawsuits pending – 60 in the District of New Jersey, which is more than in any other district. The panel also knew of 34 additional cases involving related issues. It assigned U.S. District Judge Claire C. Cecchi to oversee the proceedings.
- Harry Mason
- Harry Mason from Madison County, Illinois, filed the first federal kidney disease lawsuit against AstraZeneca in the U.S. District Court, Southern District of Illinois, in May 2016.
The suit alleged the pharmaceutical company received complaints about Nexium’s link to kidney injury as early as 2004 yet continued to market the drug aggressively without adjusting its warning label.
Mason claimed that he began taking the medication in 2006, which led to chronic kidney disease and kidney failure. He was able to survive only after undergoing a kidney transplant.
His complaint stated that he was seeking actual and compensatory damages and punitive or exemplary damages. Mason voluntarily dismissed his lawsuit in March 2017, court records show.
- Jackie Koon
- In August 2016, Jackie Koon of Segwick County, Kansas, sued AstraZeneca over permanent kidney injuries she blamed on Prilosec.
Koon began using the medication in 2010 and continued taking it through 2013. She developed end stage renal disease (ESRD). People with ESRD will die unless they have a kidney transplant or regular dialysis treatment for the rest of their lives.
Koon sought $10 million in her original complaint. She claimed the kidney damage cause her “physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.”
- Penelope Costamagna
- 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.
In November 2016, Costamagna stopped taking the medication 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.
- Jeannette Stockton
- In January 2017, Jeannette Stockton of Louisiana filed suit against AstraZeneca blaming the company’s Nexium for her kidney injuries.
Stockton’s complaint said she began taking the drug regularly in 2002. She was diagnosed with chronic kidney disease in September 2012. Stockton was unaware of any kidney damage risks from the drugs and continued taking the medication until May 2016.
“The warnings that were given by [AstraZeneca] were not accurate, clear, and/or were ambiguous,” Stockton’s complaint said.
Previous Bone Fracture Lawsuits and Settlements
Hundreds of consumers filed lawsuits against AstraZeneca, alleging Nexium caused bone deterioration, loss of bone density and bone fractures.
In 2011, Ginny Begin of Toledo, Ohio, filed a lawsuit against AstraZeneca that claimed the pharmaceutical company was aware of the risk of fractures but did not inform Nexium users.
According to the complaint, Begin had been taking the drug when she broke a bone in her leg during everyday activities. Two years later, the same bone broke — along with two others — as she was descending the stairs.
Also in 2011, more than 30 Texans filed a Nexium bone-fracture lawsuit. Several plaintiffs shared their story with NBC TV news station Local 2. The lead plaintiff, then-49-year-old Natalie Stempfer, said she fractured a bone in the middle of her foot while walking in the mall. She told the news outlet her doctors had never seen that type of fracture before, and it led to the development of a chronic pain condition that required her to wear a boot.
Another plaintiff in the case, then-47-year-old Cindy Davidson, said she broke her leg when roller skating with her daughter. According to court documents, the only male injured in the case — then-9-year-old Cole Williams — fractured his right hand after taking Nexium for a year and a half. The plaintiffs charged AstraZeneca with negligence. They alleged the company failed to warn users of side effects, misrepresented the drug, committed fraud and produced a defective product.
Nexium Bone Injury MDL Ends in Favor of AstraZeneca and McKesson Corporations
In December 2012, the U.S. Judicial Panel on Multidistrict Litigation created an MDL in the Central District of California to merge Nexium bone-injury lawsuits representing more than 1,000 plaintiffs.
But in October 2014, U.S. District Judge Dale S. Fischer granted a defense motion to exclude plaintiff’s general causation expert and granted summary judgment. The court said it questioned the reliability of the expert testimony and said without it, the plaintiffs could not establish their cases.
The court then entered judgment in favor of defendants AstraZeneca and McKesson Corporations and against all plaintiffs. In its order, the court said the plaintiffs shall recover nothing and the defendants shall recover their costs of suit.
The federal plaintiffs appealed the judgment, and the Ninth Circuit affirmed the dismissal of about 270 claims. About 40 plaintiffs who asserted Nexium caused bone injury appealed the dismissal of their claims to California’s Second District Court of Appeal, which also affirmed the district court’s judgment.
The consolidated action, known as MDL-2404 IN RE: Nexium (Esomeprazole) Products Liability Litigation, officially closed on Jan. 4, 2017, according to the U.S. Judicial Panel on Multidistrict Litigation website.
First Nexium lawsuit filed against AstraZeneca. It claimed the drug led to a woman’s bone fractures.
A federal court panel combined 47 lawsuits. It centralized the multidistrict litigation in a California federal court.
The MDL panel identified more than 1,000 lawsuits.
The judge closed the MDL in favor of AstraZeneca.
Stricter Warnings & Undisclosed Settlement
Still, many plaintiffs found success in these cases, including a class action suit from 2014 that forced the FDA to require stricter warnings on the labels of Nexium and other proton pump inhibitors. Because of this case, Nexium labels now clearly state reduced bone density and risk of bone fractures is a possible severe side effect.
Also in 2014, Takeda Pharmaceuticals reached a settlement in lawsuits that claimed a link between Prevacid and bone fractures. But the amount remains undisclosed.
One of the settled cases was filed by David S. Tatum of Philadelphia, Pennsylvania. He sued Takeda in 2012, claiming that the company failed to warn him about the drug’s ability to weaken his bone structure and cause fractures. As a result of taking Prevacid, Tatum’s bones weakened so much that he required a hip replacement, according to the complaint. A judge dismissed the case in March 2014, stating the issues between the parties had been settled.
Misbranding, Deceptive Advertising and Kickbacks
PPI manufacturers also have faced lawsuits over complaints such as misbranding, deceptive advertising and kickbacks. Some of the complaints were brought forth as class action lawsuits.
AstraZeneca Pays More Than $34 Million to Resolve Nexium Allegations
In 2015, AstraZeneca said it would pay the U.S. government $7.9 million to resolve kickback allegations involving Nexium. The government claimed AstraZeneca worked with another company to boost sales.
The federal government alleged AstraZeneca agreed to pay pharmacy-benefit manager Medco Health Solutions in exchange for Medco maintaining Nexium’s “sole and exclusive” status on certain Medco lists that give details of medicines that may be prescribed. The government further alleged that AstraZeneca provided some or all of 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.”
In addition to kickbacks, AstraZeneca is accused 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.
AstraZeneca was the focus of a class action lawsuit that claimed the company essentially 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. In January 2015, Teva announced that the FDA had approved its generic equivalent of the drug.
Also in 2015, AstraZeneca agreed to pay the U.S. government and several states $26.7 million plus interest to settle claims that the pharmaceutical company underpaid rebates owed under the Medicaid Drug Rebate Program, according to the U.S. Justice Department.
Pfizer Agrees to Two Protonix Settlements Totaling $839 Million
In 2016, Pfizer agreed to a $784 million settlement with the U.S. government. The government had accused Pfizer’s Wyeth unit of overcharging Medicaid for Protonix.
In 2012, Pfizer agreed to pay $55 million plus interest to resolve allegations by the government that the company misbranded the drug. The government said Pfizer’s sales force promoted the medication to physicians for unapproved uses.
Sales reps were only supposed to market it for specific forms of GERD. However, the company trained its salespeople to push it for treatment of all forms of the condition, according to the U.S. Justice Department. It announced the settlement on Dec. 12, 2012.
AstraZeneca Pays $20 Million in Nexium and Prilosec Class Action
In February 2015, AstraZeneca agreed to pay $20 million to consumers in a Nexium and Prilosec 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 “evergreen” the medicines. That is, the company tried 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.
Consumers alleged the company’s marketing campaign tricked consumers into buying the more expensive Nexium rather than Prilosec, even though the drugs have the same effect.
In 2008, the pharmaceutical company won a similar case over the Prilosec and Nexium marketing in which pharmacies like Walgreens and Rite Aid sued it for violating antitrust laws. The U.S. District Court for the District of Columbia dismissed the complaints and ruled that the pharmacies did not show that AstraZeneca violated antitrust laws by how it marketed Nexium. “The court said AstraZeneca was within its rights to market Nexium to the detriment of Prilosec,” according to a Reuters report.
AstraZeneca also has faced several lawsuits claiming the company did not warn its customers against all of the possible side effects and produced a defective product. Patients who developed bone fractures and low magnesium levels joined class action lawsuits against the pharmaceutical company, many of which resulted in updated warning labels.
Prilosec OTC Class Action Lawsuit
In May 2009, Thomas Mitchell initiated a class action against Proctor & Gamble and AstraZeneca in the U.S. District Court for the Southern District of Ohio. The class action alleged that the manufacturers failed to warn consumers that Prilosec OTC can increase the chances of contracting food poisoning.
Mitchell began taking the over-the-counter medicine in July 2008 at the advice of his physician, according to the complaint. On Oct. 1, 2008, Mitchell attended a buffet-style dinner party after which he became ill. The next day, Mitchell visited his physician with complaints of diarrhea, night sweats and fever. Mitchell’s physician prescribed an antibiotic.
According to the complaint, “Defendants marketed and sold Prilosec OTC but failed to adequately warn users of certain dangers which defendants knew or should have known were the result of using Prilosec OTC.”
The district court dismissed the case without prejudice in March 2010 to allow Mitchell to plead his claims under the Ohio Product Liability Act.
Please seek the advice of a medical professional before making health care decisions.