Medical Products Liability Posts in April, 2013

FDA Issues Strongest Warning about Prescribing Codeine to Children

The U.S. Food and Drug Administration (FDA) recently issued an update to a prior warning they issued regarding the administration of codeine to children. In August 2012, the FDA warned that there were some children that shouldn’t be prescribed codeine after a tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome because it could lead to rare, but life-threatening adverse events or death....
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Knee Implant Device Recall

As if Johnson & Johnson didn’t have enough problems with their hip implant device Articular Surface Replacement (ASR), now the U.S. Food and Drug Administration (FDA) has announced a Class I recall for another orthopedic device made by the manufacturer – LPS Diaphyseal Sleeve. The device is used in reconstructive knee surgeries and is being recalled because of the potential for fractures that the device poses....
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Coloplast Transvaginal Mesh Implant is Defective and Dangerous

According to a recent article, Parker Waichman LLP filed a lawsuit on behalf of a New York woman. The woman was implanted with the Aris-Transobturator Sling System, which is a transvaginal mesh device intended to correct pelvic organ prolapse and stress urinary incontinence. It has been claimed that the device is defective and only caused more injuries. The Plaintiff is suing for pain and suffering, emotional distress, and economic loss....
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New Surgery Robot under Scrutiny by FDA

A new trend in operating rooms across the United States and the world is a robot named Da Vinci.  This expensive multi-armed machine was approved by the FDA nearly four years ago to assist with highly dangerous surgeries like prostate removal, heart valve replacement and the transplantation of organs.  In fact, nearly 400,000 surgeries have been performed with da Vinci across the United States, wh...
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Anti-Seizure Medication Depakote Tied to Birth Defects

In 1983, the FDA approved Depakote to treat certain issues with the central nervous system.  It has successfully treated or controlled such disorders as epileptic seizures and episodes of manic or bipolar behavior.  This medicine can also be prescribed for migraine headaches.  It is primarily used as a mood stabilizer and anti-convulsant, which has also provided relief for certain off label conditions....
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Off-Label Prescriptions of Medications Prompts Caution

Modafinil is a medication that was created to treat shift work sleep disorder, narcolepsy and excessive sleepiness during the day as created by sleep apnea.  This drug is only approved by the FDA to treat those symptoms.   It works in a similar manner as a stimulant but because its effects on the human bodies are different, it is often referred to as a “wakefulness promoting agent”....
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OTC Diet Supplement may have Hidden Dangers

People take over the counter pills for many ailments like headaches, colds and allergies.  With summer coming up just around the corner, people also take dietary supplements to assist in weight loss to look better in their swimsuits.  Also wedding season is beginning soon, when brides try desperately hard to look good in their dresses on the best nights of their lives.  The bad news is that some defective drugs are on the shelves while they are being checked by the FDA....
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  • Newland & Newland LLP, Attorneys, Arlington Heights, IL