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Category: Defective Medical Devices

The Transvaginal Mesh Litigation

06/1/2015
Defective Medical Devices
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Multidistrict litigation (MDL) is a consolidation of civil cases transferred from different jurisdictions around the country to a single U.S. District Court to achieve certain pre-trial efficiencies. All transferred cases must be marked by common fact questions, and are overseen by a federal judge. The aim of this consolidation is to preserve […]

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What is Transvaginal Mesh?

06/1/2015
Defective Medical Devices
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Transvaginal mesh is a medical device implanted to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women. Transvaginal mesh is a semi-permeable barrier implanted into a woman as a reinforcing structure to keep her internal organs in place. The device is known as vaginal mesh because it is now […]

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The Coloplast Mesh Litigation

06/1/2015
Defective Medical Devices
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  In 2010, doctors in the United States inserted more than 70,000 mesh devices in patients, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs or to treat incontinence, according to court filings. Sometimes the failure of these devices is masked by other symptoms, […]

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Permanent Injunction Against Medtronic

05/29/2015
Defective Medical Devices
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The Food and Drug Administration (FDA) first approved the Synchromed II Implantable Infusion Pump System manufactured Medtronic, Inc. in 2004. The pump infuses pain medication, Baclofen, through a catheter into a patient’s spine. This medical device is used to treat primary or metastatic cancer, chronic pain and severe spasticity. There […]

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Essure and Bayer Under Fire

05/6/2015
Articles
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The FDA recently announced that it is investigating allegations of improprieties in conjunction with clinical trials that were conducted by Bayer and Conceptus with regard to the Essure device, which is utilized in sterilization procedures. Bayer Corporation, a German pharmaceutical giant, purchased Conceptus, the original designer of the Essure device, […]

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Power Morcellator – A Deadly Twist

04/13/2015
Defective Medical Devices
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The power morcellator, a surgical device used to mince large masses of tissue inside the body so the material can be extracted through small incisions, has been the center of a debate in the medical community since the Food and Drug Administration (“FDA”) discouraged its use in April, 2014. The FDA discouraged the use […]

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Lengthy Clinical Trial Process Gets Overhaul by FDA

03/10/2015
Articles
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Safeguarding, streamlining, strengthening the clinical trial process is one of three of the Food and Drug Administration’s primary goals for 2015. So states an 11-page document titled 2014 – 2015 Strategic Priorities. The other two goals focus on 1) striking a better balance between data collection requirements and the time […]

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