Tag Archives: FDA

Skin Antiseptic Chlorhexidine: Defense against Infection Comes with Risk

Chlorhexidine is a disinfectant and topical anti-infective agent with a novel mechanism of action that makes it highly unlikely that microbes will develop resistance to it. Its unique antimicrobial capabilities make chlorhexidine an important line of defense against nosocomial infections. … Continue reading

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Medical Device Cybersecurity: From Esoterica to Headlines

Some weeks, the FDA does not publish much new information. June 2013 was a week like that. It seemed like I was scraping the bottom of the barrel when I came across an FDA Safety Communication on cybersecurity for medical … Continue reading

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FDA’s Database Makes Proving Causation in Foodborne Illness Cases Much Easier

The FDA promotes its Genome Trakr database as a food safety compliance tool. The Genome Trakr network, established by the FDA in late 2012, is comprised of FDA, state, federal and international food safety laboratories sharing whole genome sequencing (WGS) … Continue reading

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Alzheimer’s Disease Presents an Array of Legal Issues

Few medical conditions raise as wide a variety of legal issues as Alzheimer’s disease, an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks and respond to the … Continue reading

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Hospital’s Policies, Procedures Not Discoverable in Vicarious Liability Suit

In most medical malpractice cases related to treatment in a hospital setting, a fairly standard interrogatory posed by plaintiffs to hospitals is a request for the production of any internal policies and procedures in effect at the time of the … Continue reading

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Hospital Can Be Liable for Employee Following Instructions from Non-Employee, Private Attending Physician

In New York, there are two situations where a hospital may be held liable for the acts of a hospital employee who was following instructions given by a private attending physician who is not a hospital employee: (1) the hospital … Continue reading

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Failure to Diagnose Cancer Claims Face Hurdles, Especially in New York

People who are diagnosed with cancer bring lawsuits for medical malpractice and negligence just as patients with other types of medical injury do. Failure to diagnose claims are brought by people who eventually are diagnosed with a disease, including cancer. … Continue reading

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Jury Instruction in Product Liability Case That Violation of the FDCA is Negligence Per Se; Preemption Considerations

Diverging from other courts’ decisions in 2014, the Ninth Circuit in 2015 held that a state law failure to warn claim was not preempted by the Medical Device Amendments of 1976 (MDA) to the Food, Drug & Cosmetics Act (FDCA) … Continue reading

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Patients Injected with Unsterile Training IV Solution Injured

As of February 3, 2015, the CDC was aware of more than 40 patients who had received infusions of Wallcur simulated saline solution. These products are not sterile and should not be injected in humans or animals. Some patients experienced … Continue reading

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