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Author: Brenda Fulmer

The FDA’s MoM Panel

02/20/2014
Articles
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Two years ago, the Food and Drug Association (FDA) was still uncertain about how to address growing concerns over the effects of metal-on-metal (MoM) hip implants. So, on June 27, 2012, the FDA’s Orthopaedic and Rehabilitation Devices Panel convened an Advisory Committee in order to hear experts and the public […]

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NuvaRing Settlement Announced

02/10/2014
Announcement
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The NuvaRing New Jersey court has just announced today that a settlement agreement has been reached between Plaintiffs’ counsel and Merck for a sum of $100 million. NuvaRing is a popular contraceptive among women that increases the risk for fatal blood clots. The device is produced by Merck and its […]

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Biomet Settlement Announced

02/10/2014
Announcement
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The start of 2014 has seen some very significant developments in the national Biomet metal-on-metal hip implant litigation. Perhaps the most significant development though is Biomet’s offering, and the court’s acceptance, of a settlement for claimants who have undergone revision surgeries. On February 3, 2014, Judge Miller entered an order […]

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FDA Eyes Pradaxa Again

02/6/2014
Articles
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Despite all the company assurances that the anticoagulant Pradaxa is a superior alternative to warfarin, the Food and Drug Administration (FDA) plans to once again compare the two. Pradaxa was approved in 2010 but has since then brought a high complication rate to its users  – including dangerous and uncontrolled bleeding […]

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FDA Fails in Many Drug and Device Reviews

01/29/2014
Defective Drugs
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A trio of studies published in the Journal of the American Medical Association (JAMA) finds that just because a drug or medical device makes it to market does not necessarily mean it’s been tested and is safe and effective beyond all doubt. According to three published reviews, the same standards […]

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