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.

Inferior Vena Cava (IVC) Claims Are on the Rise

Posted in Inferior Vena Cava (IVC), Medical Devices

Essentially, an Inferior Vena Cava (IVC) filter is a small device implanted into a patient’s circulatory system in order to prevent blood clots from reaching the lungs and turning into pulmonary embolisms.

Unfortunately, there is a very high failure rate with this process; with parts of the filter breaking off and perforating the patients’ veins, or migrating to the heart, lungs and other vital organs and causing serious injury or death. In 2010, the FDA issued a warning about the risk of IVC filter devices, indicating it had received hundreds of adverse event reports since 2005. The types of adverse events and product problems reported by the FDA include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC and difficulty removing the device.

In 2012 and 2013, reliable published studies demonstrated the high rate of failure and injury from the devices was coupled with a lack of effectiveness. In May 2014, the FDA strengthened its warning and recommended that doctors remove IVC filters as soon as the risk of pulmonary embolism has passed.

Similar to TVM, there are various IVC filter manufacturers—ALN, Braun, Boston Scientific, Cordis, Crux, Rafael, etc. The two largest manufacturers appear to be Cook and Bard. The Cook lawsuits were consolidated in a Multidistrict Litigation (“MDL”) in mid-2014, and are currently pending before Judge Richard Young in the Southern District of Illinois. Just this August, the Bard lawsuits were consolidated in an MDL, and are currently pending before Judge David G. Campbell in the District of Arizona.

If you or a loved one has suffered injuries from the use of an IVC filter, it is recommended that you speak with experienced legal counsel who can help assess any potential claims.

Attention Volkswagen or Audi Owners: You May Be Entitled to Compensation Due to the Recent Recall!

Posted in Recalls

Stark & Stark attorneys are currently seeking owners of Volkswagen or Audi automobiles affected by the recent emissions testing scandal uncovered in recent weeks. Volkswagen executives have admitted to designing cars with 2.0 liter diesel engines that emit lower levels of harmful emissions during mandatory inspections than they do when operating on the road. As a result, these cars must be recalled to address emissions levels that are 10 to 40 times greater than the law allows.

What This Means for You
By fraudulently marketing these cars as “Clean Diesel,” Volkswagen was able to charge consumers premium prices of $1,000 to $6,855 more than the price of gasoline-powered cars. In addition, the engine adjustment required to fix the problem will result in decreased fuel efficiency, poorer performance and a drop in resale value.

If you are the owner or purchaser of a diesel powered Volkswagen or Audi, you may be entitled to compensation. Stark & Stark attorneys have the experience and knowledge to help you recover damages caused by this scandal. For more than 20 years, attorneys at Stark & Stark have successfully represented consumers injured by the deceptive marketing practices of auto manufacturers and other large corporations.

Our No-Fee Guaranty
Our lawyers work on a contingent fee basis and will review your case at no cost or obligation to you. Once we accept your case, if you don’t get paid, we don’t get paid.

Affected Automobiles
The Environmental Protection Agency’s mandatory recall affects the seven diesel powered car models pictured below:

Volkswagen Cars Graphic

If you purchased one of the above-mentioned automobiles, you may be entitled to receive compensation for damages caused by Volkswagen’s deceptive marketing and promotion. Don’t wait until it’s too late. Your claim may be barred if you fail to act quickly, so please contact us today at 1-800-53-LEGAL (1-800-535-3425) or VWrecall@stark-stark.com.

Januvia Linked to Severe Joint Pain

Posted in Byetta, Januvia/Janumet and Victoza

The U.S. Food and Drug Administration (FDA) warned that Type 2 diabetes drugs in the Dipeptidyl peptidase-4 (DPP-4) inhibitors class may cause severe joint pain. Januvia/Janumet (Sitagliptin) was developed and marketed by Merck & Co. as an oral anti-hyperglycemic beginning in 2006. It was the first approved medication in the DPP-4 class to hit the market. Januvia is widely prescribed and is expected to exceed sales of over $7 billion per year by 2018.

The FDA safety report warns that ingestion of DPP-4 inhibitors may cause severe and disabling joint pain. The FDA said it identified cases of severe joint pain associated with the use of DPP-4 inhibitors in a review of medical literature and adverse events reported to the FDA. Patients started having symptoms from one day to years after they started taking DPP-4 inhibitors like Januvia/Janumet. Incretin mimetic medications, including Januvia/Janumet have already been connected to serious injuries including pancreatitis and pancreatic cancer.

If you or a loved one have suffered from pancreatitis or pancreatic cancer after taking Januvia/Janumet, Byetta or Victoza, 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.