Bair Hugger Lawsuit MDL Judge Issues Bellwether Trial Order

Posted in Bair Hugger Lawsuit, Medical Devices

A Multidistrict Litigation (“MDL”) against 3M and Arizant Healthcare, alleging the manufacturers’ Bair Hugger surgical warming blankets were the cause of deadly post-surgical infections, has progressed to the bellwether pretrial stage. The more than 800 cases were recently consolidated in Minnesota under the purview of the Honorable Joan N. Ericksen. Bellwether case selection will begin on December 23, 2016, with final case selection to be completed on or before March 8, 2017.

The Bair Hugger forced air blankets are used to keep patients warm during surgery. The Master Complaint adopted by the Plaintiffs in the pending MDL alleges that “scientific studies have shown that as the warmed air rises against the downward airflow in the operating room, it deposits bacteria from the non-sterile portions of the operating theater to the surgical site.” The Master Complaint further alleges that “scientific studies have also shown that the inadequate air filtration system of the Bair Hugger allows pathogenic-carrying cells, including but not limited to isolates of S aureus, coagulase-negative staphylococci (“CoNS”), and methicillin-resistant staphylococcus aureus (“MRSA”), to penetrate the intake filter of the device and colonize inside the device.” Accordingly, it is alleged that without an adequate filtration system at the distal hose outlet, the device releases contaminants into the operating theater and directly onto the surgical site itself. Plaintiffs contend that Defendants have known, for over two decades, that “the Bair Hugger emits significant levels of internally generated airborne contaminants into the operating theater and that the exhaust generated thereby creates convective airflow patterns that disrupt the unidirectional airflow of the operating theater, dramatically increasing the risk of infection for patients undergoing lengthy surgeries, especially hip and knee replacement surgeries.”

If you or someone you love has been affected by the use of a Bair Hugger warming blanket and/or has suffered from a serious infection after surgery, you should consult an attorney with experience in litigation involving mass tort injuries related to medical devices and associated products. The attorneys at Stark & Stark are currently accepting clients with cases against 3M and Arizant Healthcare and can provide you with a free consultation to help ascertain if you are eligible for assistance.

Missouri Court Awards $70 Million in Johnson & Johnson Talcum Powder Lawsuit

Posted in Defective Drugs

Another talcum powder lawsuit has seen favorable results in Missouri. Unlike in New Jersey, where Multicounty Litigation (MCL) Judge Nelson C. Johnson rejected the science linking talc to ovarian cancer claims, a Missouri court again ruled in favor of the plaintiff—this time to the tune of $70 million. The plaintiff, Deborah Giannecchini of Modesto, California was diagnosed with ovarian cancer in 2012. In April and May of 2016, a Missouri court awarded $72 million and $55 million, respectively, for claims against Johnson & Johnson for ovarian cancer linked to its talcum powder products.

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Class I Recall of Alere INRatio and INRatio2 PT/INR Monitoring Systems Due to Incorrect Test Results

Posted in Alere INRatio2, Medical Devices, Recalls

There has been a Class I recall of Alere INRatio and INRatio2 PT/INR monitoring devices manufactured by Alere Inc. These devices are used to monitor blood clotting time as measured by PT/INR values in people taking blood thinning medication, including warfarin (also known as Coumadin). A Class I recall, the most serious type of recall, is issued when the continued use of the recalled devices may cause serious injuries or death.

Essentially, the monitoring devices have been found to generate incorrect readings in certain circumstances. Such incorrect readings can result in improper anticoagulation dosing, which can lead to the risk of major or fatal bleeding.

Alere has been unable to develop an adequate modification to ensure the safety and effectiveness of their PT/INR monitoring devices, and the following Alere INRatio devices are subject to the recall:

  • INRatio2 PT/INR Professional Monitoring System (55128A)
  • INRatio2 PT/INR Home Monitoring System (0200432)
  • INRatio2 Replacement Monitor (Home) (0200457)
  • INRatio2 PT/INR Professional Testing System (0200431)
  • INRatio/INRatio2 PT/INR Test Strips (99007EU, 99007G1, 99007G3,99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5,99008G7)
  • INRatio PT/INR System Professional (0100004)
  • INRatio Prothrombin Time (PT) Monitoring System (0100007)
  • INRatio Replacement Monitor (0100137)
  • INRatio PT/INR Test Strips (0100071, 0100139)

(The recalled devices and test strips were distributed from April 1, 2008 to the middle of this year.)

If you or a loved one has suffered a bleeding injury from the use of one of these recalled Aledevices, 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.

Sparks Fly in DePuy Pinnacle 3rd Bellwether Trial

Posted in DePuy Pinnacle, Medical Devices

The third DePuy Pinnacle bellwether trial got off to a roaring start this week as Hon. Ed Kinkeade, District Judge for the United States District Court, Northern District of Texas, took control of his courtroom to set the tone for the trial. According to reports, he flatly denied both a continuance and a motion for a mistrial delivered by defendant, Johnson & Johnson, in the first few minutes of the proceedings. After lunch, Judge Kinkeade penalized both sides for wasting time over a witness objection. Later, Judge Kinkeade called a break with a warning to Johnson & Johnson’s lawyer that if he did not stand while objecting, he would be chastised in front of the jury.

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Third DePuy Bellwether Trial Goes Forward

Posted in DePuy Pinnacle, Medical Devices

The third bellwether trial in the DePuy Orthopedics Pinnacle Hip Implant Multidistrict Litigation (MDL) is set to commence in the United States District Court, Northern District of Texas. The last multiple plaintiff bellwether case resulted in $150 million dollar verdict, which was later reduced due to punitive damage caps in Texas. The DePuy Pinnacle lawsuits involve claims for toxic metal poisoning called metallosis, tissue inflammation, and bone damage, all alleged to be attributable to faulty prosthetic hip components. There are roughly eight thousand plaintiffs in the matter, seven of which are included in this pending bellwether trial. Remaining MDL plaintiffs are represented by approximately thirty law firms including Stark & Stark of Lawrenceville, New Jersey.

Additional information on the MDL case can be found at: In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation.

If you or someone you know has suffered injuries from the Pinnacle prosthetic, or similar hip or knee replacement systems, you should contact an experienced Mass Tort/Pharmaceutical Litigation attorney involved in the MDL to help assess any claims for you. Most attorneys, including Stark & Stark, offer consultation services free of charge.

Talcum Powder Ovarian Cancer Claims Take a Hit in NJ

Posted in Defective Drugs

In April and May 2016, a Missouri court awarded $72 million and $55 million, respectively, for claims against Johnson & Johnson for ovarian cancer linked to its talcum powder products. At that time, over 100 other cases were pending in Missouri, along with a growing number of cases in other states. The New Jersey Supreme Court had already ruled that the cases should be consolidated in a Multicounty Litigation (MCL), under Judge Nelson C. Johnson. However, unlike the judge in Missouri, who sent the cases to the jury, Judge Johnson disqualified the same expert witnesses used in those winning cases, ruling that, although the experts were “eminently qualified” to give testimony, the evidence was not grounded in “objective science.”

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NJ’s Evolving Expert Opinion Standard and its Effect on Multicounty Mass Tort Litigation

Posted in Defective Drugs

On September 2, 2016, New Jersey Superior Court Judge Nelson Johnson issued an Order and Opinion barring Plaintiffs’ experts in the ongoing litigation involving claims against Johnson & Johnson, alleging ovarian cancer caused by the drug maker’s talc products. For those that follow Mass Tort litigation in New Jersey, that decision was significant, but not particularly surprising.

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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

IVC filter lawsuits are on the rise. 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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