St. Jude Medical, Inc. is a global company that designs and manufactures health management solutions, including heart devices. On October 11, 2016, the company issued a field advisory to physicians, patients and caregivers warning that the company’s Implantable Cardioverter Defibrillator, ICD, and Cardiac Resynchronization Therapy Defibrillator, CRT-D, device batteries may prematurely fail, and a recall
General Motors, GM, has asked for a one year delay in Takata airbag recalls related to GM vehicles so that a research firm, Obital ATK, can complete a study of the airbags. The research is aimed at determining the service life of the inflators, and is scheduled for completion in August 2017. GM claims that
In August, 2016, the Centers for Disease Control and Prevention, CDC, announced that a Hepatitis A outbreak linked to Tropical Smoothie Café seemed to be under control. The culprit was frozen strawberries that were imported from Egypt. Hepatitis A is a very contagious disease that can be spread to others when an infected person does
A class action lawsuit was filed in the First Circuit Court in Hawaii on August 23, 2016, against Genki Sushi, Koha Foods and Sea Port Products Corp. The action is a result of Hepatitis A exposure at Genki Sushi after patrons consumed raw, imported scallops. The class action is being filed by those that did
In June, 2016, the Inspector General, Daniel R. Levinson, notified Robert M. Califf, M.D., Commissioner of Food and Drugs, Food and Drug Administration, FDA, that, as a result of an ongoing audit his office was conducting, it was found that the method that the FDA used to initiate a food recall was inefficient and ineffective.
Imagine replacing your car seats with lawn chairs. Or cardboard. How safe would those changes be if you were in a rear-end crash? Safe enough according to the federal government! Rear Seat Danger Ignored by NHTSA.
Clarence Ditlow, executive director for the Center for Auto Safety said,”The damage to Volkswagen is going to last for years. This was so clearly a deliberate act by executives at Volkswagen that there needs to be criminal penalties.”
Tangible damage has already begun on a grand scale for the company since the announcement, as its stock has plunged over 35 percent by midday trading on Tuesday, including closing down 18 percent on Monday, already dropping the company’s value by nearly $17 billion even before Tuesday’s announcement. The scandal and costs associated with EPA-ordered recall will likely cost the company at least that much factoring in federal penalties from the U.S. as well as in other nations. In addition, the amount of civil liability and class-action lawsuits could also range in the billions.
The company faces a potential $37,500 fine by the EPA for each Clean Air Act violation. That could lead to the automaker facing as much as $18 billion in federal penalties in total. To put that in comparison, General Motors just agreed to a $900 million federal penalty on Thursday after a Justice Department criminal investigation over its ignition-switch defect that led to at least 124 deaths, and Toyota agreed to a $1.2 billion penalty last year after several deaths were attributed to an acceleration defect.
The FDA cited various reasons for the violations in its press release. As an example, the agency cited that the filter on the Camel Crush Bold cigarettes contain a capsule that when crushed, releases additional menthol flavoring. The agency found that the feature creates a significant difference from products that existed prior to the law. The Campaign for Tobacco-Free Kids president Matthew Myers praised the decision, believing that the Camel Crush cigarettes “deliver menthol differently and at higher levels, have added sugars and other sweeteners, new filters, and tested differently for harmful and potentially harmful constituents.” According to Myers, Camel is the most popular cigarette brand among young smokers.