Pharmaceutical Lawsuit and Recall Information
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Cybersecurity vulnerabilities for medical devices and hospital networks has become a focus for the FDA The Food and Drug Administration has been working with medical device manufacturers, and federal agencies to recognize vulnerabilities that could directly impact medical devices. The FDA is recommending medical device manufacturers, and health care facilities, take steps to assure safeguards [...]
A class 1 recall has been issued for 157,000 surgical devices The “Medial Tools” being recalled are the Proximate PPH hemorrhoidal circular stapler and accessories, the Proximate HCS hemorrhoidal circular stapler and accessories, and the Transtar circular stapler procedure set. According to the FDA (Food and Drug Administration) the Johnson & Johnson surgical stapler devices [...]
A bill is pending in the House of Representatives regarding the FDA, Medical Devices and Information in the Public Safety Database A bill remains pending in the House of Representatives that would allow the FDA (Food and Drug Administration) to reject an application for a new medical device, if it is modeled after an earlier device [...]
Heart Device Wires by St. Jude’s Found Faulty St. Jude’s recalled Riata wires, the wires used to connect life saving defibrillators, because they have been found to short circuit and melt conductors. These defects may not be as dangerous as actually removing the wires. The American College of Cardiology reports that the wires put off a [...]
Regulatory System for Medical Devices Is Weak CQ (2/18, Bristol, Subscription Publication) reported, “While the Food and Drug Administration takes heat from members of Congress over slow approval for medical devices, Public Citizen argues the regulatory system is too weak and that new proposals could endanger patients. ” Public Citizen “objects in particular to bills introduced [...]
Defective Medical Devices Recalled Too Slowly Bloomberg News (2/15, Cortez) reports, “St. Jude Medical Inc. (STJ)’s Riata, a cable used in heart defibrillators, is the latest example of a defective medical device that wasn’t spotted quickly enough because US surveillance systems are lacking,” according to an article published in the New England Journal of Medicine. “St. [...]
Medical Devices Have No Uniform Labeling System The Politico reports, the Food and Drug Administration “has been coordinating with device regulators around the world in a push to develop a uniform code that would be a regulatory relief for an increasingly globalized industry.” The FDA sent a proposal last July to the Office of [...]
