FDA loophole leads to approval of defective products
If you are like most New York consumers, you probably assume that a Food and Drug Administration-approved product has been properly tested and is now considered safe. Unfortunately, that is not always the case. For example, about 90 percent of the medical products and devices that are on the market have been approved by the FDA through the agency’s 510(k) process.
But under a loophole in that process, a product that is ‘substantially equivalent’ to one that has previously been approved by the FDA must also be approved, automatically, no questions asked. Because this is the case even when that earlier product has been recalled or has otherwise been shown to be harmful, the loophole results in many defective products making their way to the market. To remedy this dangerous situation, a number of federal lawmakers are currently working to pass a law which would effectively close that loophole. Continue reading
Electric cigarette manufacturer could face product liability suit
Manufacturers of dangerous or defective products are responsible for the injuries caused when the product malfunctions. Such injuries include those caused by a fire or a chemical explosion.
Electric cigarettes are plastic imitation cigarettes, designed to generate a nicotine mist when inhaled, much like a real cigarette. These devices are widely used among as many as 2.5 million Americans in New York City and around the country. Continue reading
Mix-up at pill plant could impact health of New York consumers
A pharmaceutical company has become concerned about potential product liability that may result from the mix-up of several of its prescription pain pills and over-the counter medicines. This story is worth paying attention to because the underlying facts could affect the healths of New York residents.
Novartis, the Swiss pharmaceutical company, operates a drug manufacturing plant in Nebraska. That plant was shut down last week as a result of numerous complaints that mistakes had been made with respect to several of the products made at the facility. Continue reading
Specific Build-A-Bears may not be so snuggly, declared a hazard
The U.S. Consumer Product Safety Commission is a governmental agency that helps to protect the public from the unreasonable risk of injury or death that could result from dangerous products released into the stream of commerce.
The Build-A-Bear experience has become very popular amongst young children who love the brightly lit store filled with sensory stimulating bold colors and soft and snuggly stuffed bears. Children in New York and across the nation especially love the part of the experience where they can design and create their own bear. Some of those bears may not be as comforting as originally thought after a recall of the Colorful Hears Teddy Bears line was announced. Continue reading
Risk of bacterial infection prompts tampon recall
New York personal injury attorneys familiar with product liability cases took note recently that certain types of Kotex tampons have been recalled as an “unsafe product” because there may be danger to users from bacteria that may be contained in some of the plastic tubing used for packaging the tampons.
Persons with compromised health and immune system problems — such as HIV positive women — may be at higher risk of a dangerous infection from using those tampons. The recall clearly illustrates the efforts of Kimberly-Clark to mitigate possible repercussions from that product defect. Continue reading
Chantix may increase risk of suicide in New York smokers trying to quit
Giving up cigarette smoking is one of the hardest things a person can do. Smokers will try just about anything that may help them break the nicotine addiction, but only 3 percent manage to quit for six months or more. Unfortunately, one smoking cessation aid may be more harmful to a smoker’s health than smoking, and some New York physicians have suggested that a cessation pharmaceutical may be adangerous product.
One research study has shown that the smoking cessation drug Chantix raises the risk of suicide and depression eight times higher than products such as the nicotine patch. Researchers recommended that smokers only try Chantix when it is clear that other treatments had failed. Even then, only 10 percent of smokers who take Chantix quit smoking for at least a year. Continue reading
Pharmaceutical settlement shows how great injury costs can be
A recent agreement made by GlaxoSmithKline illustrates the depth of damages that can arise from personal injury lawsuits over defective products and failure to warn consumers. According to the New York Times, this agreement stipulates that the company will pay $3 billion to settle allegations of illegal drug marketing and fraud against Medicaid.
This is the largest pharmaceutical settlement to date, breaking previous records of $2.3 billion and $1.4 million settlements. The product that was the focus of this lawsuit is the drug Avandia and the company’s methods of marketing it to doctors. Also under legal scrutiny by the U.S. Justice Department were the company’s alleged manipulation of research. Continue reading
Impala owners sue GM in New York over faulty suspension
Three owners of model 2007-08 Chevrolet Impala sedans are suing General Motors Corp. for failing to repair rear-end suspension problems that the company fixed for the version of the Impala used by law enforcement agencies. The suit, filed in U.S. Bankruptcy Court for the Southern District of New York in New York City, is the second filed by owners of that Impala model. GM, now known as General Motors Co., said it is not the manufacturer’s responsibility because the current incarnation of the company was created after General Motors Corp., now known as Motors Liquidation Corp., filed for bankruptcy in 2009 as a condition for receiving federal bailout funds and cannot be held liable for “old” GM’s design issues. The Impala owners said the repairs on the police Impalas were equal to a “silent recall.” The lawsuit states that the rear-end suspension problems leads to drivers burning through tires, a dangerous safety issue, and wants faulty suspension rods replaced. Continue reading
Defective Honda seatbelts could cause injury, recall announced
We all know the process for product development: an inventor has an idea, they design the product, someone produces it, someone distributes it and another person sells it. Although products are fairly heavily tested for safety in this day and age, any mistake during the process could lead to serious injury for a consumer.
When a car is manufactured, it is especially important that there are no errors in production. Even one defective motor vehicle part could lead to serious personal injury or even death. Honda announced this month that they would be recalling approximately 310,773 Honda Pilots beginning on October 3, 2011 due to a defective seatbelt. Continue reading