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Product Liablity

FDA’s Plan to Significantly Change the 510(k) Process

The Food and Drug Administration (FDA) is taking steps to significantly alter its process for clearing most medical devices for marketing in the United States. As part of the change, the agency intends to reduce the emphasis it has previously placed on utilizing comparisons with older medical devices and products. The FDA’s dependence on these…

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Cadillac Recalls More Than 50,000 Cars For Seat Heater Fire Risk

General Motors recently notified the National Highway Traffic Safety Administration (NHTSA) of a recall on their 2014-2016 Cadillac CTS sedans due to a malfunctioning seat heater that could potentially cause a fire. An NHTSA release from September 7 stated that damaged seat heating elements can put out excessive heat. Seat heaters in the affected vehicles…

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Spontaneous Fires Affecting Numerous Kia and Hyundai Vehicles

An investigation conducted by WESH 2 News concerning vehicle fires has resulted in the National Highway Traffic Safety Administration (NHTSA) revealing some 400 complaints of fires in vehicles manufactured by Kia and its sister company, Hyundai. According to the U.S. Department of Transportation, it has hundreds of fire incident reports connected with multiple Kia vehicles…

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Lawsuit Alleges NutriBullet Blenders Explode Without Warning

Capital Brands, manufacturer of the high-speed blender the NutriBullet, is facing a lawsuit that alleges they failed to warn consumers that the appliance has the potential to explode without warning. The suit claims these explosions can cause severe injuries to NutriBullet users, including skin and facial injuries, severe burns, and even broken bones. The class…

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Takata Bankruptcy Has Far-Reaching Implications

Facing billions of dollars in debt, automobile airbag manufacturer Takata has filed bankruptcy, asserting their financial inability to pay their creditors. This latest development comes after years of litigation and will have far-reaching implications for the automobile industry, as well as individual victims impacted by horrific accidents involving the company’s defective airbags. Takata filed for…

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These Sorin 3T Heater-Coolers Pose a Serious Risk

Lawyers are the first to tell you that you don’t always need to go to trial; for every valid claim that makes it to trial, there are dozens that never see the light of day. Just as there are provisions, edicts, and even laws that prevent frivolous lawsuits from going to trial, there are provisions…

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Product liability, medical negligence focus: medical scope alarms

Duodenoscopes. Gastroscopes. Colonoscopes. Bronchoscopes. What do all these medical devices — used for internal looks and treatment of patients’ body parts and organs, such as lungs, stomachs, bladders and colons — have in common? According to emerging research, these medical devices are often impervious to truly effective post-use cleaning protocols. The result: Many of the…

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Concerns regarding Medtronic’s device royalty scheme, Part 2

We noted in our earlier blog post of this week that Medtronic, which describes itself online as “the world’s premier medical technology and services company,” is front and center in a recent media expose that denotes it as “a flash point in a national debate about the role of money in medicine.” In a nutshell,…

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