The stomach-acid drugs called proton pump inhibitors (PPIs) carry serious risks, and manufacturers have been accused of not always alerting consumers of all the possible dangerous health complications.
As a result, patients who have experienced adverse health effects with PPI use have filed lawsuits against manufactures, seeking compensation for their pain, emotional distress and medical expenses. 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; others were consolidated under a multidistrict litigation (MDL).
Popular PPIs and manufacturers named in litigation include:
|AstraZeneca||Nexium (esomeprazole magnesium)|
|Proctor & Gamble||Prilosec OTC (omeprazole magnesium)|
|Takeda Pharmaceuticals||Prevacid (lansoprazole)|
|Pfizer Inc.||Protonix (pantoprazole sodium)|
Kidney Injury Multidistrict Litigation
In 2016, PPI users who filed six lawsuits against the drugs’ manufacturers asked a federal judicial panel to consolidate all federal PPI kidney injury cases into a single multidistrict litigation (MDL). This centralization process is intended “to avoid duplication of discovery, to prevent inconsistent pretrial rulings and to conserve the resources of the parties, their counsel and the judiciary,” according to the U.S. Judicial Panel on Multidistrict Litigation. Such action is taken when civil lawsuits pending in different federal districts involve one or more common questions of fact.
When plaintiffs requested the MDL transfer in October 2016, 15 actions asserting similar claims regarding PPIs were pending in 12 district courts. By February 2017, the number of related federal actions had more than doubled, reaching 39 actions. 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” as a result of using PPIs, according to the motion.
They further alleged that AstraZeneca Pharmaceuticals LP, Takeda Pharmaceuticals USA Inc. and Pfizer Inc., 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 recognizes the actions all arise from plaintiffs’ allegations that taking PPIs may result in various types of kidney injury, but the named defendants vary from action to action and are competitors. AstraZeneca is sued in most of the actions (37 actions), but Proctor & Gamble is 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 FDA approval times and the fact some are available over-the-counter while others require a prescription.
Nexium and Prilosec Lawsuits
AstraZeneca has paid tens of millions of dollars to resolve lawsuits filed over its PPIs Nexium and Prilosec. In fact, the company paid $20 million in 2015 to settle one class action lawsuit involving both drugs.
In February 2015, AstraZeneca was found liable for promoting Nexium as more effective in treating acid reflux than its cheaper and nearly identical sister drug, Prilosec. The litigation for this claim lasted ten years and came to an end with the $20 million settlement. The class action lawsuit proved AstraZeneca had attempted to “evergreen” the drug. This means that AstraZeneca allowed its patent on Prilosec to run out and then created Nexium — a new, nearly identical drug that was much more expensive — to replace it.
AstraZeneca spent $260 million marketing Nexium to American consumers, who in turn launched several lawsuits against AstraZeneca when it was discovered the two drugs were almost chemically identical. In that class action lawsuit, 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.
Today, AstraZeneca continues to fight claims over Prilosec and Nexium brought by federal and state governments and by consumers.
Nexium Kick-Backs, Pay-for-Delay and Underpaid Rebates
In 2015, AstraZeneca said it would pay the U.S. government $7.9 million to resolve kickback allegations involving Nexium. 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,” then-Deputy Assistant Attorney General Joyce R. Branda said in a U.S. Justice Department press release.
“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, Former Deputy Assistant Attorney General
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 Nexium.
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.
Class-Action Nexium Marketing Lawsuits
Class action lawsuits over Nexium accuse AstraZeneca of using billions of dollars in advertising, promotions and other marketing to persuade consumers to choose Nexium over much cheaper options like generic drugs and Prilosec. Complainants allege the company wrongfully and deceptively presented Nexium as more effective in treating acid reflux. In one example of a class action lawsuit, 512 people from across the U.S. filed a case against AstraZeneca in U.S. District Court in 2012.
The case makes several claims against the pharmaceutical company, including:
AstraZeneca did not use “ordinary care” when manufacturing and selling Nexium, which caused the plaintiffs’ injuries. The lawsuit states AstraZeneca failed to carry out health and safety inspections, adequately warn future users of harmful side effects, use care when labeling and selling the product, and advise future users how to properly use the drug.
AstraZeneca did not disclose the harmful side effects of Nexium, therefore misrepresenting its product as safe. According to the suit, the company failed to disclose the harmful side effects, explain protocol for taking Nexium, and disclose to medical professionals Nexium’s clinical evidence and product safety profiles.
AstraZeneca financially benefited from intentional misrepresentation of its product by making unsubstantiated claims to persuade the plaintiffs to buy Nexium.
AstraZeneca “defectively designed, manufactured, and marketed Nexium,” and because of these defects the plaintiffs suffered.
Nexium Bone Injury Lawsuits
Hundreds of consumers have 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. According to the complaint, Begin had been taking Nexium 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. Begin’s attorneys claim that the pharmaceutical company was aware of the risk of fractures but did not inform Nexium users.
Attorneys claim that AstraZeneca was aware of the risk of bone fractures but did not inform Nexium users.
Also in 2011, more than 30 Texans filed a Nexium bone fracture lawsuit. Several plaintiffs shared their story with the local 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 has since led to the development of a chronic pain condition that requires 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
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. 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 plaintiff’s cannot 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 assert Nexium caused bone injury appealed the dismissal of their claims to the California Second Appellate Division, which also affirmed the district court’s judgment. The MDL, known as MDL-2404 IN RE: Nexium (Esomeprazole) Products Liability Litigation, officially closed on January 4, 2017, according to the U.S. Judicial Panel on Multidistrict Litigation website.
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.
Nexium Kidney Injury Lawsuits
A Nexium patient who developed chronic kidney disease and received a kidney transplant filed the first federal kidney disease case against AstraZeneca in May 2016. The suit alleges 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.
Harry Mason from Madison County, Illinois, filed the lawsuit against AstraZeneca in the U.S. District Court, Southern District of Illinois. Mason claimed that he began taking Nexium 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.
Prilosec OTC Class Action Lawsuit
Thomas Mitchell began taking Prilosec OTC in July 2008 at the advice of his physician. On October 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 class action complaint filed, “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.”
In May 2009, Mitchell initiated a class action against Proctor & Gamble and AstraZeneca PLC 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.
The district court dismissed the case without prejudice in March 2010 to allow Mitchell to plead his claims under the Ohio Product Liability Act.
Nexium is not the only PPI named in bone-injury lawsuits. In 2012, David S. Tatum of Philadelphia, Pennsylvania, sued Prevacid manufacturer Takeda Pharmaceuticals, 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.
Pfizer Inc. agreed to pay a $55 million settlement plus interest to the U.S. government, which alleged that the drug maker misbranded its PPI, Protonix. The government says Pfizer’s sales force promoted Protonix to physicians for unapproved uses. Sales reps were only supposed to market the drug for specific forms of GERD. However, the company trained its salespeople to push Protonix for treatment of all forms of the condition, according to the U.S. Justice Department. The Justice Department announced the settlement Dec. 12, 2012.
Potential for Future Litigation
In addition to bone injury, kidney injury and low magnesium levels, PPIs have been linked to an increased risk of dementia, stroke and heart attack. Researchers found patients who regularly used PPIs were 44 percent more likely to develop dementia and 21 percent more likely to have a stroke. They also found a 16 to 20 percent increase in heart attack incidence among PPI users. As further PPI research emerges, attorneys say more people injured by these drugs may file lawsuits. Recent PPI Side Effect Studies
|Study Date||Investigated Side Effect||Findings Among PPI Users|
|April 2015||Acute Kidney Injury||rate of acute kidney injury more than doubled|
|June 2015||Heart Attack||heart attack rate increased 16 to 21 percent|
|February 2016||Chronic Kidney Disease||20-50 percent higher chronic kidney disease risk|
|February 2016||Dementia||44 percent increased dementia risk|
|November 2016||Stroke||21 percent increased stroke risk|