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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Stryker Must Pay $7.6M for Defective Knee Replacements

Unicompartmental knee prosthesis
Unicompartmental knee prosthesis

Stryker Corporation, notorious for its defective hip implants, must also pay a $7.6 million product liability settlement for its artificial knee joint called the Duracon Unicompartmental Knee (or “Uni-Knee”) according to the Sixth US Circuit Court of Appeals.

The ruling ended 15 years of litigation in which Stryker tried to get its excess liability insurance carrier, TIG Insurance Company, to pay for the settlement of 70 product-liability claims dating back to 2000. Stryker v. National Union Fire Insurance Company of Pittsburgh, PA and TIG Insurance Company, Nos. 15-1657/1664 (decided Nov. 18, 2016).

Stryker currently faces 1,772 product liability cases consolidated into MDL 2441 before US District Judge Donovan W. Frank concerning its Rejuvenate and ABG II Hip Implant Products.

Also, a second wave of plaintiffs for hip implant cases is emerging for injuries related to the LVIT v40 Femoral Head component recall. Stryker issued  an urgent medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Head commonly used with the Stryker Accolade Hip replacement system as well as other models and brands of hip replacement products.

Defective knee replacements

There are 719,000 total knee replacements and 332,000 hip replacements performed annually in the U.S. (data from the Centers for Disease Control and Prevention (CDC). This number will grow exponentially with a more active and aging population.)

  • More than 7 million people in the U.S. have had a knee or hip replacement surgery
  • Hip and knee devices account for more than 85% of the joint reconstruction and replacement market
  • Joint registries demonstrate up to a 50% reduction in revision rates after registry initiation and identification of best practices

In the late 1990s, Stryker purchased a subsidiary of Pfizer, Inc. that made and sold the Duracon Unicompartmental Knee, which turned out to be defective. They were sterilized using gamma rays, which caused ultra-high molecular-weight polyethylene in the artificial knees to degrade and, if implanted past their five-year shelf life, potentially fail. Due to an inventory oversight, a number of expired Uni-Knees were sold to hospitals and implanted in patients.

Two policies, effective during the year 2000, were relevant: a “commercial umbrella” policy, issued by XL, and an “excess liability” policy, issued by TIG. The umbrella policy covered any “batch” of losses that Stryker became “legally obligated to pay by reason of liability imposed by law or assumed by the [i]nsured . . . because of [b]odily [i]njury.” That policy was limited to $15 million, after a $2 million self-insured retention.

The TIG excess liability policy kicked in after the umbrella policy was fully “exhausted,” and extended to Stryker’s “ultimate net loss . . . in excess of all underlying insurance” up to $25 million.

XL covered Stryker’s losses, but did so in non-chronological order: XL paid out the larger Pfizer judgment first, exhausted the limits of its coverage, and left Stryker’s individual product-liability claims on the table.

No written consent

Stryker sued TIG in the Western District of Michigan in 2013, seeking to recover the remaining $7.6 million paid to settle its direct product-liability claims. TIG disputed its coverage obligation, raising a defense that was “unique to [its] policy.” Stryker, 681 F.3d at 825 & n.4. In TIG’s view, the direct Uni-Knee claims did not constitute “ultimate net loss” because Stryker failed to obtain “written consent” at the time the settlements were made.

Stryker claimed that the policy, as applied to the idiosyncratic facts of this case, was latently ambiguous: because XL satisfied the Pfizer judgment first (and exhausted its policy), Stryker was forced to present its direct settlements to TIG years after they were made. Relying on the testimony of TIG’s former claims adjusters and underwriters, Stryker argued that the excess-liability policy did not actually require “consent to the Uni-Knee settlements when they were made.”

The Sixth Circuit disagreed, saying “Because Stryker did not satisfy the consent requirement, its direct settlements cannot constitute ultimate net loss, and there is no coverage under the policy.”

 

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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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