Medical Products Liability Posts in March, 2013

Reporting Pediatric Medical Product Issues

In 2012, the FDA received almost 900,000 adverse event and medical error reports from consumers—but only 5 per cent of those reports concerned children less than 18 years of age. However, reporting adverse effects in pediatrics can help shed important light on these products, especially since most pediatric clinical trials only contain a small number of patients. In addition, a product may be studied in one age group and approved for widespread use but affect another age group in a different way....
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Wrong Medication Prompts Recall

The Food and Drug Administration (FDA) recently announced a recall for one Lot (# 12G468) of Ferrous Sulfate Tablets, 325 mg, because these tablets may actually contain Meclizine HCl 25 mg tablets. Meclizine HCl is given for the treatment of nausea and vomiting....
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Californian Drug and Dietary Supplement Manufacturer Closed

According to the FDA, a federal judge declared that a Californian company must stop manufacturing drugs and dietary supplements for domestic commerce—at least until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act. Titan Medical Enterprises, Inc. continuously failed to comply with Good Manufacturing Practice for drugs or Good Manufacturing Practice for dietary supplements. In addition, the company violated the Act by distributing unapproved new drugs....
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Trail Begins for Defective Hip Replacement Suit

At the end of January, according to beforeitsnews.com, Johnson & Johnson was facing a slew of claims regarding a hip replacement the company developed “that had several design defects.” The hip replacement, manufactured by Johnson & Johnson subsidiary DePuy Orthopedics, is suspected to have leaked toxic debris into patients’ bloodstreams....
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Recall of Fisher & Paykel Healthcare Reusable Breathing Circuit

Apnea in Greek means “without breath”. When a person has sleep apnea, their breathing involuntarily stops while they are sleeping. This stopping can happen hundreds of times throughout the night for up to a minute, or longer at a time. Most of the time the person is not aware of their breathing stopping, which means death is a quiet, inevitable occurrence when not treated. Statistics show that one out of fifteen people have some case of sleep apnea.  However, one out of fifty go undiagnosed....
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Scleral Plugs to Change FDA Classification

In January 2013, according to the Federal Register, Volume 78, the Food and Drug Administration proposed for the first time that the scleral plug should be classified as a Class II (special controls) medical device....
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  • Newland & Newland LLP, Attorneys, Arlington Heights, IL
  • Lawyer.com