Petition Denied for DePuy MDL Appeal

Posted in DePuy Pinnacle

The 5th District court in Texas recently denied a petition by defendants, Johnson & Johnson and DePuy Orthopedics, Inc., to grant an expedited appeal and to halt the next round of bellwether trials in the Pinnacle multidistrict litigation (MDL), which are currently scheduled to begin in early September 2016. The defendants filed the petition after losing the last bellwether trial earlier this year and getting hit with a jury award of $498 million dollars for five plaintiffs, who were injured from their metal-on-metal Pinnacle implants. The award was later reduced to $150 million dollars to meet the punitive damage caps in Texas.

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The BARD IVC Court’s Utilization of Case Management Plans and Case Management Orders to Guide and Control the Multidistrict Litigation

Posted in Inferior Vena Cava (IVC), Medical Devices

On August 17, 2015, the United States Judicial Panel on Multidistrict Litigation (“JPML”) consolidated the Bard IVC lawsuits, as part of a Multidistrict Litigation (“MDL”), in the United States District Court for the District of Arizona. Case Management Plans and Case Management Orders for this MDL are described below.

On October 30, 2015, the MDL court issued Case Management Order #1, appointing leadership council, including Lead/Liaison and Steering Committee, and designating their duties and responsibilities for Case Management. According to the Order, the “Lead/Liaison will be (a) the only attorneys permitted to file in the Master Docket as to all actions, and (b) the only attorneys receiving Notices of Electronic Filing for pleadings and orders filed in the Master Docket for all actions.“

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Initial Xarelto Trials Scheduled for 2017

Posted in Defective Drugs, Xarelto

Over the course of many months, counsel for Plaintiffs and Defendants worked tirelessly to identify 20 cases to be selected for the Xarelto bellwether pool. Each side was permitted to choose 10 cases for the pool, while the Court added another 20 cases that were randomly selected based on certain eligibility requirements. (See December 17, 2015, Case Management Order for eligibility requirements)

Courts often use the bellwether approach when a large number of plaintiffs are pursuing the same general theory of liability. Otherwise, it would be impossible for the various courts to handle the massive caseload. In essence, the bellwether cases act as a representative for the remaining cases in hopes of eventually reaching a global settlement.

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The Cook IVC Court’s Utilization of Case Management Plans and Case Management Orders to Guide and Control the Multidistrict Litigation

Posted in Inferior Vena Cava (IVC), Medical Devices

On October 15, 2014, the United States Judicial Panel on Multidistrict Litigation (“JPML”) designated the Cook IVC Multidistrict Litigation (“MDL”) in the United States District Court for the Southern District of Indiana. That Court has issued multiple Case Management Plans and Case Management Orders to guide and control the MDL.

On November 25, 2014, the MDL Court issued a comprehensive Case Management Plan, which designated Plaintiffs’ leadership structure (including lead counsel, liaison counsel, Plaintiffs’ Executive Committee, and Plaintiffs’ Steering Committee) and Defendants’ counsel. The MDL Court further set forth a description of the claims and defenses at issue and procedures for: pretrial pleadings and disclosures, general case discovery, bellwether selection criteria, case-specific discovery, motion practice and trial. Shortly thereafter, a form of Master Consolidated Complaint and a form of Short-Form Complaint were agreed upon and issued.

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Xarelto Court Enters New Case Management Orders

Posted in Defective Drugs, Xarelto

Xarelto (rivaroxaban) is a blood thinner that was approved by the U.S. Food & Drug Administration (FDA) in July 2011 to prevent strokes in patients who received hip and knee replacements. In November 2011, the approval was expanded to any patients with atrial fibrillation (irregular heartbeat). Xarelto has been widely prescribed, with millions of people taking the medication since it entered the market.

The number of lawsuits alleging injuries associated with ingestion of Xarelto continues to grow in the United States. Many of the pending lawsuits are centralized in federal court before the Honorable Eldon E. Fallon, in the Eastern District of Louisiana (“EDLA”), as part of MDL 2592. As we have previously reported, Judge Fallon has entered a series of Case Management Orders that continue to maximize the efficient management of the litigation.

On November 20, 2015, the EDLA issued Case Management Order #3, setting forth the general criteria for selecting the 40 discovery pool plaintiffs. These plaintiffs are jointly selected by the plaintiffs and defendants’ attorneys, for purposes of trial preparation.

On December 17, 2015, the EDLA issue Case Management Order #4, which provided more detailed instruction on the selection of the 40 discovery pool plaintiffs. The Order provides for

  • The selection of discovery pool plaintiffs;
  • The eligibility criteria of discovery pool plaintiffs; and,
  • The categories of discovery pool plaintiffs.

For example, to be eligible for the discovery pool, a plaintiff must satisfy the criteria in one of the following categories: a) plaintiff, between the ages of 50 and 90, must have taken Xarelto to reduce the risk of stroke and systemic embolism due to nonvalvular atrial fibrillation and allege a gastrointestinal bleed or death; or b) plaintiff, between the ages of 40 and 80, must have taken Xarelto to treat deep vein thrombosis or pulmonary embolism and allege a gastrointestinal bleed or death; or c) plaintiff, between the ages of 50 and 90, must have taken Xarelto to reduce the risk of stroke and systemic embolism due to nonvalvular atrial fibrillation and allege rectal bleeding or death; or d) plaintiff, between the ages of 40 and 80, must have taken Xarelto to treat deep vein thrombosis or pulmonary embolism and allege rectal bleeding or death; or e) plaintiff, between the ages of 50 and 90, must have taken Xarelto to reduce the risk of stroke and systemic embolism due to nonvalvular atrial fibrillation and allege a brain bleed/hemorrhagic stroke or death; or f) plaintiff, between the ages of 40 and 80, must have taken Xarelto to treat deep vein thrombosis or pulmonary embolism and allege a brain bleed/hemorrhagic stroke or death.

Xarelto Litigation

The attorneys at Stark & Stark continue to pursue all legal redress available in the federal action, as well as state actions in Pennsylvania and New Jersey, for the benefit of its clients that have suffered injuries resulting from their use of Xarelto.

If you feel you have experienced any side-effects from taking Xarelto, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the manufacturers of Xarelto.

Stark & Stark Attorneys Published in New Jersey Law Journal

Posted in Publications

Stark & Stark attorneys Martin P. Schrama and Stefanie Colella-Walsh, members of the Litigation and Mass Torts Groups, co-authored the article Monitoring Medical Surveillance Claims in New Jersey, which was published in the New Jersey Law Journal on December 9, 2015.

The article better explains the concept of medical monitoring, which is sometimes better known as “medical surveillance.” This theory is that plaintiffs who had been exposed to harmful chemicals but had yet to develop any bodily injuries could benefit from a program of specialized medical examinations. With that kind of program in place, patients would theoretically receive the earliest possible diagnosis of their chemically induced illness, which in turn would improve their prospects for treating, curing, and prolonging their lifespan.

New Jersey was one of the first states to identify this concept in 1987, when the New Jersey Supreme Court declined to “recognize increased risk of harm, absent bodily injury, as a tenable cause of action,” but did introduce “the independent claim of medical monitoring for plaintiffs who had not yet exhibited compensable bodily injuries was firmly established and defined.”

Additionally, in order for any plaintiffs to make a case for medical monitoring, they must “essentially demonstrate, through reliable expert testimony, significant and extensive exposure to chemicals, the toxicity of the chemicals, the serious diseases for which the plaintiff is at risk, the relative increase in the chance of the onset of those diseases in the exposed plaintiff, and the value of early diagnosis through medical monitoring.”

To read the full article, please click here.

Zofran Birth Defect Cases Consolidated in Boston, Massachusetts

Posted in Defective Drugs, Zofran

The United States Judicial Panel on Multi-District Litigation (JPML) recently assembled to determine whether the cases known as In Re: Zofran (ondansetron) Products Liability Litigation should be given Multi-District Litigation (MDL) treatment, and if so, where the litigation should be consolidated. Granting MDL treatment consolidates all federal lawsuits filed across the United States into one centralized district. This consolidation streamlines the pretrial discovery process, allowing the parties to avoid duplicative discovery and inconsistent rulings from different judges.

Plaintiffs in the Zofran litigation allege that GlaxoSmithKline (GSK), the manufacturer of Zofran, fraudulently misrepresented the safety of its anti-nausea drug for pregnant women to prescribing doctors, resulting in unsuspecting pregnant women ingesting the drug and unknowingly harming their unborn babies. The most common birth defects include cleft palate, spina bifida and heart defects. It is further alleged that GSK marketed Zofran to pregnant women without FDA approval, as the FDA only approved the drug to treat post-operative surgery patients and certain patients undergoing cancer treatments.

On October 13, 2015, the JMPL agreed with the parties that the cases should be consolidated for discovery purposes and ordered all federal cases to be transferred to the District of Massachusetts before US District Judge F. Dennis Saylor. There are currently about 60 cases before Judge Saylor, but with the establishment of MDL No. 2657, additional cases are expected to be filed shortly.

Anyone affected should seek legal counsel immediately.

The Xarelto Court’s Utilization of Pretrial Orders and Case Management Orders to Guide and Control the Multidistrict Litigation

Posted in Defective Drugs, Xarelto

Since the United States Judicial Panel on Multidistrict Litigation (“JPML”) designated the Multidistrict Litigation (“MDL”) on December 17, 2014, the United States District Court for the Eastern District of Louisiana (“EDLA”) has issued numerous Pretrial Orders and Case Management Orders to guide and control the MDL.

On December 17, 2014, the EDLA issued Pretrial Order #1, which set the initial pretrial conference before Judge Eldon E. Fallon, U.S.D.J., and solicited nominations for Liaison Counsel and Plaintiffs’ Steering Committee (“PSC”).

On January 16, 2015, the EDLA issued Pretrial Orders #2 and #3, which appointed Gerald E. Meunier and Leonard A. Davis as Co-Plaintiffs’ Liaison Counsel, and James B. Irwin as Defendants’ Liaison Counsel.

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Specific Details at Issue in Zimmer Persona Knee Implant Claims

Posted in Zimmer Persona

Recently, the Zimmer Persona Knee Implant came under fire after many people filed personal injury claims. As a result, Zimmer has begun to issue a recall of this implant.

For those unaware, the primary medical device, or portion of the device, at issue in potential claims is the Persona Trabecular Metal Porous-Coated Tibial Tray that is uncemented and any size other than A or B. The device was marketed and distributed in numerous states (including AK, AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA and WI) and virtually all of the potential claimants should have received recall letters at this time.

The implantation timeframe at issue is roughly the beginning of November 2012, to the recall in the middle of March 2015. Essentially, the complications at issue are aseptic (i.e. not from infection) loosening, lucency and/or radiolucent lines.

If you or a loved one has suffered injuries from the use of a Zimmer Persona Personalized Knee Replacement System, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any potential claims.

Recalled Zimmer Persona TM Tibia Knee Implant Claims Expected to be on the Rise

Posted in Medical Devices, Zimmer Persona

In 2012, Zimmer introduced its Persona Personalized Knee Replacement System. When components in the system were called into question for loosening, Zimmer issued a recall of more than 11,500 porous coated, uncemented Zimmer Persona Trabecular Metal Tibial Plates, as well as the Zimmer Persona Tibial Articular Surface Provisional (TASP) Shim tool, in March 2015.

Zimmer Inc.’s voluntary recall is the latest in a number of publicized medical device recalls. For instance, Zimmer issued a voluntary recall of its metal-on-metal hip device (Durom Cup) in 2008, and another recall for its other knee implant (NexGen) in 2010. Recipients of the Durom Cup and NexGen devices have brought various claims against Zimmer, which resulted in pending Multidistrict Litigations (“MDLs”) in New Jersey and Illinois, respectively.

An MDL has not yet been established for the recalled Zimmer Persona TM Tibia claims.

If you or a loved one has suffered injuries from the use of a Zimmer Persona Personalized Knee Replacement System, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any potential claims.