Medical Products Liability Posts in April, 2015

FDA Consent Decree Halts Most Sales of Infusion Pump

The United States Food and Drug Administration (FDA) announced this week that the agency has filed a consent decree against a medical device manufacturer for repeatedly failing to correct identified violations related to an implantable drug infusion pump. A consent decree is a type of legal settlement in which the manufacturer agrees to follow the court-ordered directives without acknowledgement of fault or guilt....
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FDA Launches Home-Use Medical Device Pilot Program

Every year, more than 7 million patients receive home health medical care under the direction of their medical providers. Many such cases require the use of medical devices in the home to treat or maintain a wide variety of conditions. The devices are put to use by the patient directly, or with the help of a caregiver or family member....
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Ice Cream Maker Expands Listeria-Related Recall

The maker of a popular brand of ice cream announced yesterday that it is conducting a voluntary recall of all its products due to concerns of listeria contamination. Blue Bell Ice Cream, a Texas based manufacturer of frozen dessert products, issued the recall for products made at all of its facilities as the company works to find the source of contamination and implements new product testing protocols....
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Insurance Carriers Push for Stronger Regulations on Medical Devices

An influential health insurer trade group has called for more stringent rules related to the approval and tracking of medical devices. The request follows revelations of gaps or loopholes in the federal regulatory procedures which allow potentially dangerous medical devices to be put on the market with minimal safety and performance testing....
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Egg Company Executives to Serve Prison Time for Salmonella Outbreak

Maintaining food safety can be challenging, of course. It requires constant attention to detail, meticulously following proper procedures, and, sometimes, being willing to take losses when products may be compromised. Unfortunately, many food producers are too focused on the their bottom line, instead risking consumer safety and food poisoning outbreaks to save a few dollars in preventive losses....
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Nationwide Recall for Compounded Drugs from North Carolina Pharmacy

A state inspection of a pharmacy in Fayetteville, North Carolina, has led to the recall of more than 600 drugs in a variety of dosages and formulations, officials announced in late March. The U.S. Food and Drug Administration (FDA) and the North Carolina Board of Pharmacy (NCBOP) have issued a warning to medical professionals and patients regarding all compounded drugs made or distributed by the Prescription Center pharmacy, which has been since shut down. Compounded Drug Recall...
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Understanding Medical Device and Drug Recalls

When discussing the safety of medical devices or prescription drugs, it is not uncommon to hear about various recalls and safety alerts being issued. The announcement of a safety recall by manufacturers or government regulators may seem extremely ominous, but it is important to understand that a recall does not necessarily mean a product cannot be used at all....
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Holes in FDA Testing Process Lead to Flawed Designs

There has been substantial media attention and reaction from affected patients regarding metal-on-metal hip implants over the last decade or so. Of course, one of the most famous examples is the articular surface replacement, or ASR, implant which was manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. Tens of thousands of the devices were implanted in patients before injuries, immobility, and even metal poisoning led to their recall in 2010....
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  • Newland & Newland LLP, Attorneys, Arlington Heights, IL
  • Lawyer.com