Posts tagged with "illness"

Product recalled after 73 cases of illness

Manufacturers of products sold in this country have an obligation to their customers to make sure that what they sell doesn’t pose a safety risk. Sometimes, though, regulations can be lax or manufacturers don’t have a fool-proof process by which to test what they make, which can lead to dangerous and defective products. The results can often be severe injuries, illness or even death.

After cases of salmonella kept popping up around Canada and the United States, including one case in Massachusetts, investigators began looking into the claims. After interviewing 39 people, they were able to draw some conclusions. Thirty-seven of the 39 people reported having eaten sprouted seeds or sprouted powder of chia. While no deaths have yet been reported, Salmonella can be incredibly dangerous and can cause sickness that may require hospitalization.

As a result, the U.S. Food and Drug Administration and the Canadian Food Inspection Agency have recalled several products that contain chia powder or seeds that have sprouted.

If a civil case were to arise, it would be the job of an attorney to investigate the makers and determine if negligence played a part. Were any of the manufacturers of these chia seeds and powders aware of the potential dangers they could pose? What kinds of fail-safes were in place to prevent dangerous products from reaching the hands of consumers? If dangers were inherent, did the product’s labeling sufficiently and clearly spell them out?

Whether it’s a car part, a consumable or a defective toy, if you’ve been negatively affected by a faulty product, you and a Massachusetts attorney can sit down and discuss the possible options of receiving compensation.

Source: foodsafetynews.com, “U.S., Canada Salmonella Cases Linked to Sprouted Chia Seeds Rise to 73,” June 23, 2014

FDA analyzes increased trend in recall of faulty medical devices

The Food and Drug Administration is charged with monitoring and managing the recall of any food and drink products, supplements, drugs and medical devices that could potentially cause illness or injury. Nowhere is this more crucial than with life-saving medical equipment that, when faulty, can instead become life-threatening.

The FDA has just released a 10-year trend analysis of recalls of defective medical devices. Recalls have been affected by the ongoing work the FDA does with manufacturers, which in recent years has led to:

  • Improved self-regulation by medical equipment companies.
  • Increased awareness of performance safety.
  • Better classification of types of equipment that are frequently recalled.

The data trends are dramatic but also somewhat reassuring. Total recall events, with single events sometimes affecting multiple products, numbered 604 in 2003 and almost doubled to 1,190 in 2012.

Class 1 is the sub-group of devices that have the potential to cause death, or at least serious injury or illness, when they malfunction. Examples are ventilators and defibrillators. Recalls of Class 1 equipment have increased from a low of seven in 2003 to a high of 57 almost a decade later.

Class 1 recalls increased from about 1 percent of all recall events in 2003 to closer to 5 percent in 2012, and the increase may have to do with the reclassification of many products to be included in the Class 1 category.

A recent example of the scale of some recalls is one that happened in December 2013. Ventilators, manufactured by a firm with its U.S. headquarters in Massachusetts, were found to have errors in the software that put them at risk of ceasing to work at crucial times in the treatment of patients. More than 16,000 units had already been distributed in the U.S. If you include sales to other countries, the total number of units distributed globally was more than 56,000.

The FDA’s increased vigilance over medical device manufacturers can only help medical care to become safer. Still, when machinery does fail, companies are liable to face legal action by affected patients and their families.

Source: Boston Business Journal, “Life-threatening medical device recalls up eightfold since 2003,” Don Seiffert, March 21, 2014