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Blog Posts in July, 2013

  • Hazard Alert Regarding Medtronic's Consulta CRT-P Pacemaker

    Australia's Therapeutic Goods Administration (TGA) reports that Medtronic Australasia issued a hazard alert on July 15, 2013 regarding its Consulta Cardiac Resynchronization Therapy Pacemaker. This implantable medical device is used to treat heart failure. The alert warns of a manufacturing issue affecting a subset of Medtronic's particular pacemaker model (Consulta CRT-P C3TR01) made between ...
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  • First Bellwether Trial In Toyota Sudden Unintended Acceleration Cases

    A recent CBS News article reports on the first "bellwether" trial involving liability for the so-called "sudden unintended acceleration" affecting certain Toyota vehicles. The case deals with a 2006 Toyota Camry that plaintiffs allege unexpectedly and uncontrollably accelerated to speeds of up to 100 mph, which caused a collision that killed the driver. Plaintiffs claim that the sudden unintended ...
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  • Carcinogenic Potential Of Actos

    A news article published online on July 5, 2013 in The Lancet discusses the carcinogenic potential of Actos (pioglitazone), a drug used for the treatment of Type 2 diabetes. Specifically, the article summarizes the assessments made in a recent expert meeting at the International Agency for Research on Cancer (IARC). Based on evidence that Actos is associated with an increased risk of bladder ...
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  • Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: Class 1 Recall

    On April 17, 2013, Bryan Medical, Inc. recalled a single lot of its Tracoe Mini 3.0mm Tracheostomy Tube due to mislabeled packaging. The tube is used "to provide safe airway access and to remove discharge from the lungs... in neonatal and pediatric patients." The recalled lot consisted of longer pediatric tube mislabeled as shorter neonatal version. Use of an oversized tube in neonatal setting can ...
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  • Class Action Lawsuit Proposed Against MyFord Touch Systems

    The Center for Defensive Driving, a California nonprofit educator, filed a proposed consumer class action lawsuit against the Ford Motor Company in the U.S. District Court for the Central District of California. The lawsuit concerns Ford, Lincoln and Mercury vehicles equipped with MyFord Touch, MyLincoln Touch, or MyMercury Touch dashboard infotainment systems. The Center for Defensive Driving ...
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  • Recall Of Medtronic Minimed Paradigm Insulin Infusion Sets

    On June 7, 2013, Medtronic MiniMed recalled its medical devices known as the Paradigm Insulin Infusion Sets. The recall was prompted by "a potential safety issue" due to "too much or too little insulin being delivered resulting in hypoglycemia or hyperglycemia which can be severe and lead to serious illness." See http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm360618.htm for more ...
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  • Voluntary Recall Of Estarylla Tablets

    A recent posting by the FDA informs that Sandoz, a Division of the Novartis group, has issued a voluntary recall of a batch of Estarylla tablets. Estarylla (norgestimate and ethinyl estradiol) is a combination oral contraceptive. The recall was prompted by a packaging flaw. In particular, the affected lot had placebo tablets mixed with regular tablets containing the active ingredients. According ...
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  • Anti-Inflammatory Drug, Diclofenac, May Increase Risk Of Heart Attack

    A Committee of the European Medicines Agency recently concluded that diclofenac is associated with an increased risk of heart attacks compared to other non-steroidal anti-inflammatory drugs (NSAIDs). The conclusion, based on robust evidence, further states that increased vascular risks are particularly associated with high-dose or long-term use of the drug. Thus the Committee recommends that ...
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  • Taking SSRIS During Pregnancy Could Increase Risk Of Birth Defects

    A recent publication by BBC News reports that "SSRIs can double the risk of a child being born with a heart defect." According to Prof. Stephen Pilling, an expert adviser to UK's National Institute for Health and Care Excellence (NICE), the risk increases from 2 in 100 (in the general population) to 4 in 100 in cases where the mother took an SSRI during early pregnancy. Prof. Pilling further warns ...
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