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Blog Posts in 2015

  • Dennis Canty Appointed to Power Morcellator Litigation MDL Plaintiff's Steering Committee

    Kaiser Gornick partner Dennis J. Canty has been appointed to the Plaintiff’s Steering Committee by Judge Kathryn H. Vratil of the District of Kansas in the Multi-District Litigation against Ethicon, Inc. (a subsidiary of Johnson & Johnson), a manufacturer of power morcellator devices. Ethicon, Inc. is a subsidiary of Johnson & Johnson and was the largest distributor of power morcellators in the US ...
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  • First Ever Women Majority In Power Morcellator Litigation MDL PSC

    On November 19, 2015, The National Law Journal published an article on the composition of the Plaintiff’s Steering Committee in Ethicon’s power morcellator MDL . According to the publication, Judge Kathryn H. Vratil from the U.S. District Court of Kansas “approved a committee of 20 members, 11 of whom are women.” This historic appointment would mark the first time a plaintiff’s steering committee ...
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  • FDA ISSUES RECALL NOTICE ABOUT QUEST MEDICAL'S MPS DELIVERY SETS

    The FDA recently warned healthcare professionals of a recall of MPS Delivery Sets by Quest Medical, Inc. The Sets are used to deliver solutions to the heart during cardiopulmonary bypass surgeries. Quest Medical has recalled certain lots of these defective medical devices that were distributed between June 2015 and September 2015. The reason for the nationwide recall is a "seal failure along the ...
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  • MDL formation

    On October 15, 2015, a panel of judges centralized all federal lawsuits involving Ethicon’s power morcellators in the U.S. District Court of Kansas under Senior Judge Kathryn H. Vratil. As of January 21, 2016, 33 lawsuits have been consolidated under this multidistrict litigation , or MDL. An MDL is a legal procedure designed to expedite the handling of complex litigations where many individual ...
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  • FDA ISSUES RECALL NOTICE ABOUT SYNCARDIA'S FREEDOM DRIVER SYSTEM

    The FDA recently warned healthcare professionals of a recall of Freedom Driver System by SynCardia Systems. The Freedom Driver System operates and monitors SynCardia's Total Artificial Heart, which serves as a temporary "mechanical replacement for a patient's heart." SynCardia Systems has recalled certain lots of these defective medical devices that were distributed between November 2014 and July ...
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  • FDA ISSUES RECALL NOTICE ABOUT TELEFLEX MEDICAL'S ENDOBRONCHIAL TUBES

    The FDA recently warned healthcare professionals of a recall of Hudson RCI Endobronchial Tube by Teleflex Medical. These tubes are inserted through the mouth into the bronchi of the lungs and are "used during a medical procedure that determines how well a lung is working." In the US alone, Teleflex Medical has recalled over 62,000 of these defective medical devices that were distributed between ...
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  • FDA ISSUES RECALL NOTICE ABOUT COOK MEDICAL'S ANGIOGRAPHIC CATHETERS

    By Kaiser Gornick LLP posted in Defective Medical Devices on Monday, August 17, 2015 The FDA recently warned healthcare professionals of a recall of Beacon Tip Angiographic Catheters by Cook Medical. These angiographic catheters "are used to inject contrast dye into blood vessels in the heart to prepare it for a type of X-ray used to diagnose heart conditions." In the US alone, Cook Medical has ...
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  • FDA ISSUES RECALL NOTICE ABOUT TIGERPAW SYSTEM II

    The FDA recently warned healthcare professionals of a recall of TigerPaw System II by Maquet Medical Systems. The TigerPaw System II "is a surgical staple used to close tissue in the left atrial appendage," a muscular ear-shaped pouch in the heart. Maquet Medical Systems has recalled all lots of these medical devices that were distributed between April 2013 and March 2015. The reason for the ...
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  • FBI Investigation

    FBI Investigates Cancer Spread with Power Morcellators and What their Largest Distributor Knew On May 27, 2015, the Wall Street Journal reported that the FBI was investigating power morcellators that were “found to spread cancer in women” and “what the largest manufacturer of [power morcellators], Johnson & Johnson, knew about [morcellation] hazards before pulling [its devices] off the market.” ...
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  • FDA ISSUES RECALL NOTICE ABOUT MYLAN INJECTABLE PRODUCTS

    The FDA recently warned healthcare professionals of a recall of various injectable medications by Mylan N.V. These pharmaceuticals include gemcitabine, carboplatin, methotrexate, and cytarabine, which are mostly used to treat various types of cancer. Mylan has recalled certain lots of these injectable products that were distributed in 2014. The reason for the nationwide recall is "the presence of ...
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  • FDA ISSUES RECALL NOTICE ABOUT HOSPIRA INFUSION PUMPS

    The FDA recently warned healthcare professionals of a recall of Plum A+ and Plum A+3 Infusion Systems by Hospira. These devices are used to deliver fluids, including "critical intravenous medication... into a patient's body in controlled amounts." Hospira has recalled infusion pumps manufactures and distributed between July 2012 and May 2014. The reason for the recall is faulty alarms that may ...
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  • FDA ISSUES RECALL NOTICE ABOUT TELEFLEX MEDICAL MAQUET SERVO HUMIDIFIER

    The FDA recently warned healthcare professionals of a recall of MAQUET Servo Humidifier 163 by Teleflex Medical. These devices are "placed over a surgically-created opening in the throat or a tube inserted into the trachea to warm and moisten gases breathed in by a patient." Teleflex Medical has recalled certain lots of the humidifiers distributed between June 2013 and November 2014. The reason ...
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  • FDA ISSUES SAFETY ALERT ABOUT INFECTION RISKS WITH DUODENOSCOPES

    The FDA recently issued a safety communication about potentially serious health risks associated with the use of ERCP endoscopes (also called duodenoscopes). These medical devices are "flexible, lighted tubes that are threaded through the mouth, throat, stomach, [in order to reach] the small intestine [or duodenum]." Their use "allows the injection of contrast dye [for imaging] or the insertion of ...
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  • Study in JAMA Urges Caution In Patients Over 50

    On February 19, 2015, the Journal of the American Medical Association Oncology published an investigation on the use of power morcellators and the prevalence of hidden uterine cancer in women who undergo myomectomy. The lead researcher, Dr. Jason Wright, is the Division Chief of Gynecologic Oncology at Columbia University, New York City, and an internationally recognized expert in gynecologic ...
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  • FDA STRENGTHENS MARKETING REQUIREMENTS FOR DEFIBRILLATORS AFTER NUMEROUS DEVICE FAILURES

    The FDA recently issued a final order requiring "more rigorous review" of automated external defibrillators (AEDs) in order to improve the safety and reliability of such medical devices on the market. AEDs are portable devices used to "provid[e] a rapid response to victims of cardiac arrest" by "automatically analyz[ing] the heart rhythm... and deliver[ing] an electrical shock to the heart to ...
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