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Organizations Urge FDA to Reverse its Approval of Prescription Painkiller Zohydro ER

A recent article published in the British Medical Journal on March 3, 2014 reports that over 40 consumer groups, addiction treatment organizations, and healthcare agencies have called on the United States Food and Drug Administration (FDA) to reverse its recent approval of a potent oral opioid drug they say threatens to worsen a widespread addiction […]

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Transvaginal Mesh Product Manufacturer Coloplast Agrees to $16 Million Settlement

Bloomberg News reports that Colplast A/S, the manufacturer of, has agreed to pay approximately $16 million to settle lawsuits alleging that its vaginal mesh products have injured women. The article details that Coloplast officials agreed in January to resolve approximately 400 lawsuits, although the official was not identified as they were not authorized to publicly […]

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Playtex Announces Voluntary Recall of AC/DC Power Adapters for Electric Breast Pump Due to Risk of Electric Shock

On March 18, 2014, Playtex Manufacturing, Inc. issued a press release announcing a voluntary nationwide recall of certain AC/DC power adapters used with the Playtex® Nurser Deluxe Double Electric Breast Pump. The Playtex® Nurser Deluxe Double Electric Breast Pump has been sold across the nation and is available online and with specialty retailers. Playtex urges […]

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New Study Reports that Infant “Sleep Machines” May Actually Harm Hearing

The New York Times reported on a recent study that supports that “sleep machines” used for infants can be loud enough at maximum volume to damage a baby’s hearing. The devices use a constant sound, such as “white noise” or calming nature sounds, to help infants fall asleep and stay asleep. These machines, often embedded […]

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Pradaxa® MDL Lawsuit Update (MDL 2385): First Pradaxa® Trial Now Set to Begin September 2014

The first trial in the Pradaxa® Multidistrict Litigation entitled In re: Pradaxa® (Dabigatran Etexilate) Products Liability Litigation (MDL 2385, Case No. 12-md-2385) is set to begin this fall in the United States District Court for the Southern District of Illinois. According to a recent Case Management Order issued by The Honorable Chief Judge David R. […]

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NuvaRing® MDL Lawsuit Update (MDL 1964): NuvaRing® Settlement Opt-In Deadline Extended Until March 25

On February 7, 2014, United States District Court Judge Rodney W. Sippel approved a $100 Million settlement in the NuvaRing® Multidistrict Litigation In re: NuvaRing® Products Liability Litigation (MDL No. 1964, Case No. 08-md-1964). The terms of the settlement require that at least 95% of eligible claimants opt into the settlement program. “The deadline for […]

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FDA Issues Class I Recall for GE Healthcare Resuscitation Systems

On February 28, 2014, the FDA issued a Class I Recall for GE Healthcare Resuscitation Systems with the issue being that “the oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.” The FDA warned that “[t]hese recalled products may interfere with oxygen delivery, resulting in inaccurate […]

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Testosterone Drugs Cause Heart Attacks, Strokes, and Blood Clots, New Lawsuits Claim

According to five lawsuits recently filed in the United States District Court for the Northern District of Illinois, the Testosterone replacement drug, AndroGel, is allegedly linked to causing serious medical problems, including life threatening heart attacks, strokes, and blood clots. The cases are Aurecchia v. AbbVie, Case No. 14-cv-00772; Benn v. AbbVie, Case No. 14-cv-00774; […]

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Safety Advisory Issued by Thoratec Corporation for HeartMate II LVAS Pocket System Controller After 4 Patient Deaths

On March 5, 2014, the FDA reported that “Thoratec Corporation issued a safety advisory because some patients and caregivers have experienced difficulties with the process of changing from a primary system controller to their backup system controller. These difficulties have resulted in four deaths and five reports of loss of consciousness or other symptoms of […]

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Recent Study Concludes that Users of Testosterone Supplements at Increased Risk of Heart Attack or Stroke

ABC News reported on a study published by the Journal of the American Medical Association (JAMA), which followed more than 8,000 male veterans with low testosterone. After comparing cardiovascular events in males taking a testosterone supplement with those who were not taking such supplements, the study concluded that men who used a supplement were 29% […]

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