The National Highway Traffic Safety Administration released a series of reports involving Takata’s defective air bag inflators, around 100 million of which have been declared defective worldwide, with nearly 70 million inflators in the U.S. alone. In the report, Takata also holds its U.S. arm, not the parent company, responsible for designing, testing and producing defective air bag inflators.
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The vehicles are legal to be sold since the U.S. National Highway Traffic Safety Administration has declared they will not become potentially unsafe until exposed to high humidity for a prolonged period.
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Posted by Buck Daniel
February 25, 2013 – On February 23rd, Affymax and Takeda instituted a recall of OMONTYS following serious adverse reactions, including life threatening and fatal events. Omontys is used to treat anemia associated with chronic kidney disease for patients on dialysis. Anemia, in which the body is unable to produce enough red blood cells to deliver oxygen to the body’s organs, is often found in kidney dialysis patients. The condition causes fatigue and sometimes heart attacks.
Omontys was produced as an alternative to Epogen, which has been a staple of kidney-dialysis treatment since 1989. However, despite having knowledge that the safety endpoint of cardiovascular events and death was worse for Omontys than for its alternative Affymax kept Omontys on the market. It was further proven, through two randomized controlled trials published in 2013, that Omontys was no more effective than its alternative despite having far greater risks.
About five patients were reported to have died after receiving Omontys, according to the figures provided by Affymax, and around 17 had severe allergic reactions requiring immediate medical help and, in some cases, hospitalization. The reactions could occur within 30 minutes of the first dose.
June 6, 2012 – Johnson and Johnson has announced that its Ethicon unit will end sales of most of its vaginal mesh implants which are the subject of hundreds of lawsuits claiming the implants are defective and dangerous. It is expected that it will take several months for the products to come off the market and the company has asked the FDA for 120 days to end sales. In addition, Johnson and Johnson says Ethicon will also discontinue or revise, as appropriate, all marketing materials during this time. These marketing materials form the basis of claims that patients and physicians were not appropriately warned of the risks of vaginal mesh implants. Ethicons agreement to change or stop using the marketing materials is an important victory for the lawyers and clients pushing for changes in how these implants are made and sold.