Defective medical devices play a huge role in personal injury incidents in the United States. Every year, medical device manufacturers create and sell defective medical devices that cause injuries to patients that end up using them. Although there are times when the medical device manufacturers are unaware of the dangerous aspects of their product, there…
As is common with many defective drugs or devices that are later recalled, the Alere INRatio Monitors and Testing Strips gained their FDA approval through the FDA’s controversial 510(k) program. The program, which has been around for more than 35 years, allows medical device manufacturers like Alere to get their products approved quickly if they…
Although Alere INRatio devices and Testing Strips were recalled in 2014, Alere had knowledge of the dangerous inaccuracies of their devices for more than 10 years. In 2005 and 2006, the FDA issued warning letters to Hemosense, the manufacturer of the INRatio device at that time. In their warning letters, the FDA noted that Hemosense…
Alere INRatio Monitors and Test Strips were recalled in December of 2014 for producing inaccurate test results when compared to laboratory testing. Patients taking blood thinners such as warfarin need to constantly monitor their blood clotting to make sure they do not suffer a serious bleed. Inaccurate readings caused by Alere INRatio products could cause…
In fall of 2015, Bayer and Johnson and Johnson notified the FDA that the device used in the clinical trials for their drug Xarelto (a blood thinner and direct competitor to warfarin) was recalled for giving inaccurate results. The device in question? The Alere INRatio. The clinical trial for the blockbuster blood thinner Xarelto (called…
On December 5th, 2014, medical device manufacturer Alere issued a voluntary recall of their Alere INRatio, INRatio 2PT/INR System and INRatio Test Strips because they can give a false (low) reading. INRatio products are used by people on blood thinners, who must constantly monitor their anti-coagulation levels. If a person who is on blood thinners…
Every year in the United States, more than 120,000 children are born with a birth defect. The Centers for Disease Control has found that birth defects are the leading cause of death in infants, with 1 out of 5 infant deaths being caused by a birth defect. While some birth defect causes are known and…
Every year, an estimated 33,000 accidents and 500 motorist deaths are caused by defective tires. Unfortunately, many of those accidents could have been prevented if the drivers had known that the tires they were relying on were defective. Unfortunately, even in 2016, there is no way to reliably know if your tires are recalled unless…
Propecia, manufactured by Merck & Co., has been used for almost 2 decades to help treat men with male pattern baldness. Originally, a similar drug called Proscar was used to treat men with enlarged prostates, but during the trials it was discovered that the drug caused men’s hair to grow. After this was discovered, Merck…
Levaquin, a popular antibiotic manufactured by Johnson and Johnson subsidiary Janssen Pharmaceuticals, has been recently linked to some very serious side effects. One of the side effects Levaquin has been linked to is peripheral neuropathy. Peripheral neuropathy occurs when there is damage to the peripheral nervous system, leading to symptoms such as tingling and numbness,…
