On July 24, 2008 Zimmer Holdings announced that it was voluntarily suspending United States sales of its Durom © Acetabular Component (Durom Cup) used in total hip replacement surgeries. The device was first approved for use in the U.S in 2006 and has been implanted in an estimated 12,000 patients. In a press release issued by Zimmer, the largest manufacturer of implantable orthopedic devices, the company said
“Zimmer Holdings, Inc (NYSE and SWX: ZMH) is temporarily suspending marketing and distribution of the Durom®Acetabular Component (Durom Cup) in the United States,
while the Company updates labeling to provide more detailed surgical technique
instructions to surgeons and implements its surgical training program in the U.S. The
Durom Cup will continue to be marketed without interruption outside the U.S.”
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Gadolinium is a paramagnetic metal ion which is injected into the blood as an intravenous radiocontrast agent to enhance images in Magnetic Resonance Imaging (MRIs) and other imaging. The FDA has requested that the manufacturers of Gadolinium-based contrast agents (GBCA’s) help define the risk of disease. The FDA ordered a black box warning in May 2007. (more…)
Much of American commerce is carried by big trucks on our highways, but far too many major accidents occur involving negligence or even reckless indifference by truckers and trucking companies. Truckers are governed by the Federal Motor Carrier Safety Regulations which contain many requirements from checking the safety equipment on trucks before a truck leaves the yard, to hours of operation, to loading safety.
Now a new United States safety study which was obtained by the Associated Press has found that many drivers are violating the rules by driving while sick. This is sometimes done with the complicity of medical doctors who approve long term conditions such as those that cause periodic black outs, or with the consent of the trucking company that allows a sick driver to go out on the road. See the full story here.
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Digitek® is the brand-name of one of the cardiac glycosides, a group of drugs having specific effects on the myocardium of the heart. Digitek® is widely prescribed and used by a great number of residents of New Jersey, Pennsylvania, New York, and elsewhere to treat various heart conditions, including atrial flutter and congestive heart failure. On August 15, 2006, the FDA issued a letter warning about failing to file periodic safety reports. The FDA’s August 2006 Warning Letter also warned about not developing procedures for the surveillance, receipt, evaluation and report of adverse events. On February 1, 2007, the FDA issued a revised Warning Letter citing “significant deviations from the current Good Manufacturing Practice regulations.” According to the FDA’s Revised Warning Letter:
Significant deficiencies were found in the operations of your firm’s quality control unit, and as a result there is no assurance that many drug products manufactured and released into interstate commerce by your firm have the identity, strength, quality and purity that they purport to possess.
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