JPML Approves Proton Pump Inhibitor MDL 2757 Assigned to US District Court New Jersey, Judge Claire C. Cecchi on August 2, 2017

JPML Approves Proton Pump Inhibitor MDL 2757 Assigned to US District Court New Jersey, Judge Claire C. Cecchi on August 2, 2017

 The Judicial Panel on Multidistrict Litigation (JPML) has entered an order consolidating the Proton Pump Inhibitor (PPI) MDL 2757 (Nexium, Prevacid, et al) on August 2, 2017 see JPML Consolidation Order of August 2, 2017, assigning PPI MDL 2757 to Judge Claire C. Cecchi, US District Court of New Jersey based on the July 27, 2017 consolidation hearings at the Los Angeles Federal Courthouse. The case is In Re: Proton-Pump Inhibitor Products Liability Litigation [No. II], MDL Docket No. 2757, JPML, where the case filings have significantly 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 related defense issues with so many co-defendants. The JPML ultimately denied the MDL 10 days later to the view that consolidation would be to cumbersome, however due to the large numbers of new suits and the refiling of a Motion to Consolidate, the July 27th Los Angeles hearings have had a different outcome.

The drugs at issue include Prilosec, Nexium, Protonix and Dexilant as well as potential the numerous generic manufacturers. The hearing order lists over 163 cases in 28 federal district courts and a decision will likely come in mid-August. Nevertheless, the judges may try to come up with ways to split up the cases into structures that might be simpler and more efficient or combine all parties. Ideas 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 its attorney said is currently named in 100 cases.

 Kidney injuries

In their May 31 motion, Motion to Consolidate Re: PPI Hearing Los Angeles July 27, 2017, the moving plaintiffs seek centralization before U.S. Judge David R. Herndon of the Southern District of Illinois.

The plaintiffs allege that PPIs cause kidney injuries including acute interstitial nephritis, chronic kidney disease and end-stage renal disease. Concerns that these drugs have harmful side effects for users’ kidneys were brought to the U.S. Food and Drug Administration by consumer advocacy group Public Citizen in 2011, and the agency required warnings about risks of acute interstitial nephritis on labels in 2014, according to the patients’ MDL brief.

More recent research led to stronger findings of a connection, including a scientific study published in January 2016 that said PPI use was independently 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, more than 5,000 PPI cases are under investigation by Plaintiff’s counsel, and more could be added to that number as awareness of the association between PPI use and kidney damage continues to increase. While the drug class first received FDA approval in 1989, serious side effects prompted the FDA in 2014 to require all PPIs to display a warning label that called out the connection to acute interstitial nephritis. The Plaintiff’s brief also mentions several studies that have made a correlation 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 John Hopkins published in the Journal of the American Medical Association (JAMA).

The plaintiffs note that in January, the JPML denied centralization of PPI cases, but say later significant developments “warrant a second look at consolidation.”

The defendants are AstraZeneca Pharmaceuticals LP, Proctor & Gamble Co., McKesson Corp., Takeda Pharmaceuticals USA Inc., Novartis Pharmaceuticals Corp., Pfizer Inc. and Pfizer subsidiary Wyeth.  The defendants’ responses are due June 27.

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JPML Takes a Second Look at Proton Pump Inhibitor MDL 2757 at July 27, 2017 Hearings in Los Angeles

JPML Takes a Second Look at Proton Pump Inhibitor MDL 2757 at July 27, 2017 Hearings in Los Angeles

 The Judicial Panel on Multidistrict Litigation (JPML) has decided to revisit a possible Proton Pump Inhibitor (PPI) MDL consolidation (Nexium, Prevacid, et al) and will hear arguments July 27, 2017 at the Los Angeles Federal court on a new motion to centralize (PPI) drugs in a multidistrict litigation. The case is In Re: Proton-Pump Inhibitor Products Liability Litigation [No. II], MDL Docket No. 2757, JPML, where the case filings have significantly increased since the initial JPML hearing 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 related defense issues with so many co-defendants. The JPML ultimately denied the MDL 10 days later to the view that consolidation would be to cumbersome, however due to the large numbers of new suits and the refiling of a Motion to Consolidate, the Los Angeles hearings may have a different outcome.

The drugs at issue include Prilosec, Nexium, Protonix and Dexilant as well as potential the numerous generic manufacturers. The hearing order lists over 163 cases in 28 federal district courts and a decision will likely come in mid-August. Nevertheless, the judges may try to come up with ways to split up the cases into structures that might be simpler and more efficient or combine all parties. Ideas 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 its attorney said is currently named in 100 cases.

Kidney injuries

In their May 31 motion, Motion to Consolidate Re: PPI Hearing Los Angeles July 27, 2017, the moving plaintiffs seek centralization before U.S. Judge David R. Herndon of the Southern District of Illinois.

The plaintiffs allege that PPIs cause kidney injuries including acute interstitial nephritis, chronic kidney disease and end-stage renal disease. Concerns that these drugs have harmful side effects for users’ kidneys were brought to the U.S. Food and Drug Administration by consumer advocacy group Public Citizen in 2011, and the agency required warnings about risks of acute interstitial nephritis on labels in 2014, according to the patients’ MDL brief.

More recent research led to stronger findings of a connection, including a scientific study published in January 2016 that said PPI use was independently 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, more than 5,000 PPI cases are under investigation by Plaintiff’s counsel, and more could be added to that number as awareness of the association between PPI use and kidney damage continues to increase. While the drug class first received FDA approval in 1989, serious side effects prompted the FDA in 2014 to require all PPIs to display a warning label that called out the connection to acute interstitial nephritis. The Plaintiff’s brief also mentions several studies that have made a correlation 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 John Hopkins published in the Journal of the American Medical Association (JAMA).

The plaintiffs note that in January, the JPML denied centralization of PPI cases, but say later significant developments “warrant a second look at consolidation.”

The defendants are AstraZeneca Pharmaceuticals LP, Proctor & Gamble Co., McKesson Corp., Takeda Pharmaceuticals USA Inc., Novartis Pharmaceuticals Corp., Pfizer Inc. and Pfizer subsidiary Wyeth.  The defendants’ responses are due June 27.

The plaintiff attorneys are Christopher A. Seeger and Jeffrey Grand of Seeger Weiss in New York.

 

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JPMDL to Reconsider Proton Pump Inhibitor MDL at July 27 Hearing

nexium-b-1The Judicial Panel on Multidistrict Litigation (JPMDL) will hear arguments at a July 27 hearing on a new motion to centralize proton pump inhibitor (PPI) drugs in a multidistrict litigation. The case is In Re:  Proton-Pump Inhibitor Products Liability Litigation [No. II], MDL Docket No. 2789, JPMDL.

The drugs at issues include Prilosec, Nexium Protonix and Dexilant. The hearing order lists 163 cases in 28 federal district courts and a decision will likely come in mid-August.

Kidney injuries

In their May 31 motion, the moving plaintiffs seek centralization before U.S. Judge David R. Herndon of the Southern District of Illinois.

The plaintiffs allege that PPIs cause kidney injuries including acute interstitial nephritis, chronic kidney disease and end-stage renal disease.

The plaintiffs note that in January, the JPMDL denied centralization of PPI cases, but say later significant developments “warrant a second look at consolidation.”

The defendants are AstraZeneca Pharmaceuticals LP, Proctor & Gamble Co., McKesson Corp., Takeda Pharmaceuticals USA Inc., Novartis Pharmaceuticals Corp., Pfizer Inc. and Pfizer subsidiary Wyeth.  The defendants’ responses are due June 27.

The plaintiff attorneys are Christopher A. Seeger and Jeffrey Grand of Seeger Weiss in New York.

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JPMDL Denies Consolidation of Proton-Pump Inhibitor Litigation

nexium-b-1The US Judicial Panel on Multidistrict Litigation (JPMDL) cited four reasons to refuse the creation of a multi-district litigation docket for plaintiffs in nationwide proton pump inhibitor lawsuits, charging that the heartburn medicines cause kidney damage.

Six plaintiffs who suffered kidney damage had filed a motion for the JPML to create a new MDL 2757 in Louisiana to consolidate 15 lawsuits filed against manufacturers of proton pump inhibitor (PPI) medicines in federal court in California, Illinois, Kansas, Louisiana, Missouri, New Jersey, New York, Ohio, Tennessee, and West Virginia.

The cases arise from allegations that taking proton pump inhibitors (PPIs) may result in various types of kidney injury, including acute interstitial nephritis (AIN), chronic kidney disease, end-stage renal disease, and kidney failure.

First, the defendants vary from action to action. Although AstraZeneca is sued in most of the actions (14 constituent actions and 23 tag-alongs), P&G is sued in only eight, Takeda in four, and Pfizer in two. “Centralization thus appears unlikely to serve the convenience of most, if not all, defendants and their witnesses,” the court said.

Second, the various defendants are competitors. We are “typically hesitant to centralize litigation against multiple, competing defendants which marketed, manufactured and sold similar products,” the court said. Centralizing competing defendants in the same MDL likely would complicate case management due to the need to protect trade secret and confidential information.

Third, a significant amount of the discovery in these actions appears almost certain to be defendant-specific. Although all the subject drugs are PPIs, they are not identical. Some are available by prescription only, but others are sold over-the-counter. Each has a unique development, testing, and marketing history, and each was approved by the FDA at different times.

For example, Prilosec (omeprazole) and Prevacid (lansoprazole) have been on the market since 1989 and 1995, respectively, whereas Nexium (esomeprazole magnesium) was approved by the FDA in 2001. “Further, the variety of kidney injuries alleged, combined with these differences among the drugs, significantly undermines any efficiency gains to be achieved from centralization,” the court said.

Fourth, although plaintiffs almost guarantee that the number of involved actions will increase by the hundreds if not thousands, the Section 1407 motion presently encompasses just 15 cases and 24 tag-alongs. “The Panel previously has been disinclined to take into account the mere possibility of future filings in [its] centralization calculus,” the court said. “Such caution is warranted here, given that the first PPI came to market more than two decades ago and the drugs have been taken by millions of Americans.”

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Plaintiff’s Expert Excluded a Second Time in California Nexium Litigation

doctors-Bal_Bhajanjit
Dr. Bhajanjit Sonny Bal, MD, JD, MBA, a Professor of Orthopaedic Surgery

Plaintiff’s expert witness Dr. Sonny Bal will not testify in litigation that Nexium causes bone fractures, according to a ruling by the California Court of Appeal. He had also been excluded in 2014 in simultaneous federal litigation involving Nexium by other plaintiffs.

However, Dr. Bal has been successfully admitted as a plaintiff’s expert witness in Zimmer NexGen Knee Implant Products Liability Litigation in federal court in Illinois (see below).

While he is an orthopedic surgeon specializing in hip and knee replacements, Dr. Bal lacked any special expertise in epidemiology and the metabolism of proton pump inhibitors (PPI) like Nexium, according to the California court. Jolena Wilson v. McKesson Corp, No. B266990, California Court of Appeal, Second Appellate District, Divison Three.

Summary judgment upheld

The ruling affirmed summary judgment for the defense in the case of 204 plaintiffs who sued AstraZeneca Pharmaceuticals and McKesson Corporations for negligence, fraud and products liability. The plaintiffs alleged that ingestion of Nexium causes bone deterioration, osteoporosis, or bone fractures.

Dr. Bal was the sole expert on causation for the plaintiffs. Dr. Bhajanjit Sonny Bal, MD, JD, MBA, is a Professor of Orthopaedic Surgery at the University of Missouri School of Medicine in Columbia, MO. He regularly treats bone fractures but does not have a specialty in epidemiology, bone biology, bone biology, endocrinology, gastroenterology, vitamin and mineral metabolism and how PPIs might compromise calcium intake.

“Dr. Bal never prescribed Nexium or any other PPIs, nor did he study the impact of PPIs on bones. Dr. Bal admitted he did not understand how proton pump inhibitors compromised calcium intake, and did not know how they were metabolized. When asked about the particulars regarding how PPIs could cause bone deterioration, Dr. Bal conceded at least 10 times that he would defer to “experts,” specifically a gastroenterologist, an epidemiologist, or an endocrinologist,” the court says.

“In short, Dr. Bal simply read epidemiological studies in preparation for this litigation and summarized what he thought such studies said.”

nexium-b-1Multidistrict litigation

Meanwhile,  plaintiffs who suffered kidney damage have filed a motion for the Judicial Panel on Multidistrict Litigation (JPML) to create a new MDL 2757 in Louisiana to consolidate dozens of lawsuits nationwide filed against manufacturers of PPI heartburn medicines.

They allege that as a result of ingesting a PPI for gastric acid-related conditions, they have been diagnosed with kidney injuries including acute interstitial nephritis (AIN), chronic kidney disease (CKD), and renal failure, also known as end-stage renal disease (ESRD).

Plaintiffs’ counsel have more than 5,000 Proton-Pump Inhibitor cases under investigation, with nearly 100 PPI cases will be filed in the coming weeks, according to plaintiff’s attorney Paul J. Pennock of Weitz & Luxenberg, P.C. in New York, NY.

Defendants include Takeda Pharmaceuticals USA, AstraZeneca Pharmaceuticals LP, Pfizer, Inc., and The Procter & Gamble Company. The products in question include Nexium, Prilosec, Protonix, Prevacid and Dexilant.

Zimmer Knee Implants

A federal judge overseeing the Zimmer NexGen Knee Implant Products Liability Litigation admitted Dr. Bal as a plaintiff’s causation expert whose opinion is that the company’s warning labels and instructions failed to warn adequately about the risk of failure for obese patients.

US District Judge Rebecca R. Pallmeyer rebuffed a defense motion under Rule 702 to exclude Dr. Bal in Beverly Goldin v. Zimmer Inc., Docket No. 11 C 5468.

There are 500 lawsuits filed against Zimmer in MDL No. 2272 in the Northern District of Illinois. Separately, Zimmer is facing 463 lawsuits in IN RE: Zimmer Durom Hip Cup Products Liability Litigation in MDL 2158 before U.S. District Judge Susan D. Wigenton in the District of New Jersey.

“Dr. Bal is sufficiently qualified to offer his opinions in this case and that those opinions are not so unreliable that the jury should not consider them,” the court said. “There are disputed issues of material fact concerning the adequacy of Defendant’s warnings and their role in causing Plaintiff’s injury. Those issues should be resolved by a jury.”

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Pharma Companies Argue the Proton Pump Litigation Too Complex for an MDL

nexium-b-1Vehemently opposing a motion to create a new MDL for proton-pump inhibitor litigation (PPI), pharmaceutical companies argue that there are too many disparate issues involving drugs, companies and plaintiffs to centralize the cases.

So far, plaintiffs have filed 27 cases in federal court. They requested that the Judicial Panel on Multidistrict Litigation create a new MDL 2757 in Louisiana to consolidate all the cases.

They allege that as a result of ingesting a PPI for gastric acid-related conditions, they have been diagnosed with kidney injuries including acute interstitial nephritis (AIN), chronic kidney disease (CKD), and renal failure, also known as end-stage renal disease (ESRD).

Hodge-podge

But the primary defendant AstraZeneca Pharmaceuticals LP asserts, “Movants seek to create an unwieldy MDL with a hodge-podge of divergent defendants, medications (prescription and OTC), and alleged injuries.  More than 40 companies manufacturing and/or selling nearly 30 different PPIs (brand and generic) spanning nearly three decades may be implicated.”

The three primary drugs are Prilosec, Nexium, and Prevacid. The primary defendants are AstraZeneca, Takeda, and McKesson. But the defense says this is making things too simple.

“More than 40 companies manufacturing and/or selling nearly 30 different PPIs (brand and generic) spanning nearly three decades may be implicated,” AstraZeneca argues.

With so many different products, parties, and alleged injuries, individualized issues will eclipse any purported common ones, and MDL efficiency tools, such as a Master Complaint and bellwether trials, will be, at best, cumbersome and, at worst, unfeasible, and in all likelihood ineffective at efficiently narrowing claims and issues.”

AstraZeneca argues that the injuries cited are common among aging Americans and that the complaints focus on one of the most commonly prescribed classes of medications.

However if the JPMDL does create an MDL, AstraZeneca requested US District Judge Dale S. Fisher of the Central District of California. He presided over Nexium product liability litigation in 2012.

Enzyme Inhibitor

PPIs are a group of drugs containing Omeprazole that are intended to act as hydrogen potassium ATPase (“H+/K+ ATPase”) enzyme inhibitor to block the production of gastric acid. The FDA approved PPIs in 1989 and on Oct. 31, 2014 required PPIs to carry a warning label:

Acute interstitial nephritis has been observed in patients taking PPIs including [Brand]. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue [Brand] if acute interstitial nephritis develops.

The plaintiff’s brief cites several studied supporting their arguments:

  • In October 1992, researchers from the University of Arizona Health Sciences Center led by Stephen Ruffenach published the first article associating PPI usage with kidney injuries in The American Journal of Medicine.
  • In 2006, researchers at the Yale School of Medicine conducted a case series published in the International Society of Nephrology’s Kidney International finding that PPI use, by way of AIN, left most patients “with some level of chronic kidney disease.”
  • On August 23, 2011, Public Citizen, a consumer advocacy group, filed a petition with the FDA to add black box warnings and other safety information about several risks associated with PPIs including AIN.
  • In January 2016, a study published in the Journal of the American Medical Association found that PPI use was independently associated with a 20 – 50% higher risk of CKD.

The plaintiffs recommended the MDL be created in the federal Middle District of Louisiana in Baton Rouge before Chief Judge Brian A. Jackson, Judge Shelly D. Dick, Judge John W. deGravelles or Senior Judge James Joseph Brady.

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Plaintiffs in Proton-Pump Litigation Seek MDL in Louisiana

nexium-b-1The Judicial Panel on Multidistrict Litigation will decide at a hearing on Jan. 26 in Miami whether to create a new MDL 2757 in Louisiana to consolidate dozens of lawsuits nationwide filed against manufacturers of proton pump inhibitor (PPI) heartburn medicines.

15 actions are pending in 12 different United States District Courts. Plaintiffs’ counsel have over 5,000 Proton-Pump Inhibitor possible cases under investigation and expect to file nearly 100 new lawsuits in the coming weeks.

PPIs are a group of drugs intended to act as hydrogen potassium ATPase (“H+/K+ ATPase”) enzyme inhibitor to block the production of gastric acid. The plaintiffs were prescribed a PPI by a physician and were later diagnosed with kidney injuries including acute interstitial nephritis (AIN), chronic kidney disease (CKD), and renal failure, also known as end-stage renal disease (ESRD). The complaints charge negligence, design defect, failure to warn, fraudulent concealment, warranty claims, and loss of consortium.

The defendants include:

  • AstraZeneca Pharmaceuticals LP
  • AstraZeneca LP
  • AstraZeneca PLC
  • Pfizer, Inc.
  • Procter & Gamble Manufacturing Company
  • The Procter & Gamble Company
  • Takeda Pharmaceuticals USA, Inc.
  • Takeda Pharmaceuticals America, Inc.
  • Takeda Pharmaceuticals International, Inc.
  • Takeda Development Center Americas, Inc.
  • Takeda Pharmaceutical Company Limited

Initial symptoms can be non-specific, such as fatigue, nausea and weakness. However, failure to treat interstitial nephritis (AIN) can lead to kidney death, dialysis, a kidney transplant or death.

The plaintiffs recommended the MDL be created in the federal Middle District of Louisiana in Baton Rouge before Chief Judge Brian A. Jackson, Judge Shelly D. Dick, Judge John W. deGravelles or Senior Judge James Joseph Brady. Alternatively, they would accept venues including the District of New Jersey, Southern District of Illinois, the District of Kansas or the Western District of Louisiana.

The motion was filed by Paul J. Pennock of Weitz & Luxenberg in New York.

 

 

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Kidney Damage Plaintiffs Seek MDL for Proton Pump Inhibitor Lawsuits

nexium-b-1Six plaintiffs who suffered kidney damage have filed a motion for the Judicial Panel on Multidistrict Litigation (JPML) to create a new MDL 2757 in Louisiana to consolidate dozens of lawsuits nationwide filed against manufacturers of proton pump inhibitor (PPI) heartburn medicines.

The cases are among 15 actions  filed in federal court in California, Illinois, Kansas, Louisiana, Missouri, New Jersey, New York, Ohio, Tennessee, and West Virginia.

They allege that as a result of ingesting a PPI for gastric acid-related conditions, they have been diagnosed with kidney injuries including acute interstitial nephritis (AIN), chronic kidney disease (CKD), and renal failure, also known as end-stage renal disease (ESRD).

5,000 potential cases

Plaintiffs’ counsel have more than 5,000 Proton-Pump Inhibitor cases under investigation, with nearly 100 PPI cases will be filed in the coming weeks, according to plaintiff’s attorney Paul J. Pennock of Weitz & Luxenberg, P.C. in New York, NY.

Defendants include Takeda Pharmaceuticals USA, AstraZeneca Pharmaceuticals LP, Pfizer, Inc., and The Procter & Gamble Company. The products in question include Nexium, Prilosec, Protonix, Prevacid and Dexilant.

PPIs are a group of drugs containing Omeprazole that are intended to act as hydrogen potassium ATPase (“H+/K+ ATPase”) enzyme inhibitor to block the production of gastric acid. The FDA approved PPIs in 1989 and on Oct. 31, 2014 required PPIs to carry a warning label:

Acute interstitial nephritis has been observed in patients taking PPIs including [Brand]. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue [Brand] if acute interstitial nephritis develops.

The plaintiff’s brief cites several studied supporting their arguments:

  • In October 1992, researchers from the University of Arizona Health Sciences Center led by Stephen Ruffenach published the first article associating PPI usage with kidney injuries in The American Journal of Medicine.
  • In 2006, researchers at the Yale School of Medicine conducted a case series published in the International Society of Nephrology’s Kidney International finding that PPI use, by way of AIN, left most patients “with some level of chronic kidney disease.”
  • On August 23, 2011, Public Citizen, a consumer advocacy group, filed a petition with the FDA to add black box warnings and other safety information about several risks associated with PPIs including AIN.
  • In January 2016, a study published in the Journal of the American Medical Association found that PPI use was independently associated with a 20 – 50% higher risk of CKD.

Initial symptoms can be non-specific, such as fatigue, nausea and weakness. However, failure to treat interstitial nephritis (AIN) can lead to kidney death, dialysis, a kidney transplant or death.

The plaintiffs recommended the MDL be created in the federal Middle District of Louisiana in Baton Rouge before Chief Judge Brian A. Jackson, Judge Shelly D. Dick, Judge John W. deGravelles or Senior Judge James Joseph Brady. Alternatively, they would accepts venues including the District of New Jersey, Southern District of Illinois, the District of Kansas or the Western District of Louisiana.

 

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Proton Pump Inhibitor Litigation Reaching Critical Mass


Litigation against the makers of powerful antacids, know as proton pump inhibitors, is mounting as plaintiffs charge that the key ingredient causes kidney damage and disease.

Daniel Thornburgh, an attorney with Aylstock, Witkin, Kreis & Overholtz, PLLC in Pensacola, FL, said that defendants include AstraZeneca, Pfizer, Procter and Gamble and Takeda. He spoke at the recent Mass Torts Nexus course in Ft. Lauderdale, FL.

The products in question are Nexium, Prevacid and Prilosec — the “purple pill” that is the third most-prescribed drug which produces $6.3 billion in annual sales. Omeprazole is the ingredient that blocks histamines in the stomach lining from creating acid.

Acute interstitial nephritis (AIN)

“You’re not supposed to take proton-pump inhibitors for more than two weeks,” he said. “If you take it more than eight weeks and stop, you will get a bad acid reflux rebound and become dependent on it.” Long term use causes acute interstitial nephritis (AIN), acute kidney injury, chronic kidney disease and kidney failure, according to Thornburgh.

“It’s been known since 2006 that PPIs causes interstitial nephritis, an inflammatory response that swells the kidney. To cure it, you must immediately remove the drug, stop taking it and get rounds of steroids,” he said. There was no warning on the label about interstitial nephritis until 2014.

The litigation is in the emerging stage, with individual lawsuits filed in New York, New Jersey, Kansas and Tennessee. No multidistrict litigation docket has been organized yet.

The product his heavily advertised, with TV commercials featuring Larry the Cable Guy saying. The voiceover says, “One pill, each morning, 24 hours, zero heartburn.”

The drug is prescribed for Gastroesophageal reflux disease (GERD), Dyspepsia, Acid peptic disease, Zollinger-Ellison syndrome, Acid reflux, and Peptic or stomach ulcers.

Federal case in NY

A case filed in US District Court for the Eastern District of New York is George Mullen V. Astrazeneca Pharmaceuticals LP and Astrazeneca LP, Case 1:16-cv-04801-NGG-CLP.

It states that the risk of AIN among PPI users was first raised in 1992. By 2011, the World Health organization adverse drug reaction report included nearly 500 cases of AIN as of July 2011.

Between 2004 and 2007 at least three additional studies confirmed AIN related to PPI usage. More recent studies indicate that those using PPIs such as Nexium are at a three times greater risk than the general population to suffer AIN.

On October 30, 2014, the FDA notified Defendants that the FDA determined that PPIs pose additional risks not previously disclosed. On December 19, 2014, the labeling for PPIs was updated to include a warning about AIN. The new label added a (never-before-included) section about AIN that read, in the relevant part, that AIN “may occur at any point during PPI therapy.”

Among others, the following medical studies support the fact that there is an association between PPIs, including Nexium, and AIN:

  • Ruffenach, Stephen J., Mark S. Siskind, and Yeong-Hau H. Lien, Acute interstitial nephritis due to omeprazole. The American journal of medicine 93, no. 4 (1992): 472-473.
  • Badov, David, Greg Perry, John Lambert, and John Dowling, Acute interstitial nephritis secondary to omeprazole, Nephrology Dialysis Transplantation 12, no. 11 (1997): 2414-2416, available at http://ndt.oxfordjournals.org/content/12/11/2414.short
  • Torpey, Nicholas, Tim Barker, and Calum Ross, Drug-induced tubulointerstitial nephritis secondary to proton pump inhibitors: experience from a single UK renal unit, Nephrology Dialysis Transplantation 19, no. 6 (2004): 1441-1446, available at http://ndt.oxfordjournals.org/content/19/6/1441.short
  • Geevasinga, Nimeshan et al., Proton Pump Inhibitors and Acute Interstitial Nephritis, Clinical Gastroenterology and Hepatology , Volume 4 , Issue 5 , 597 – 604, available at http://www.cghjournal.org/article/S1542-3565(05)01092- X/abstract?cc=y=.
  • Harmark, Linda, Hans E. Van Der Wiel, Mark C. H. De Groot, and A. C. Van Grootheest, 2007, Proton Pump Inhibitor‐Induced Acute Interstitial Nephritis, British Journal Of Clinical Pharmacology 64 (6): 819-823, available at http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2125.2007.02927.x/full.
  • K. Sampathkumar, A. Abraham. 2013, Acute Interstitial Nephritis Due To Proton Pump Inhibitors, Indian Journal Of Nephrology 23 (4): 304, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3741979/.

“Even the current warning of AIN is far from complete, lacking the necessary force to give patients and theaters the proper information needed to make an informed decision about whether to start a drug regimen with such potential dire consequences,” the complaint states.

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