Articles Posted in Product Liability

Drug manufacturers are liable for the safety of their products. Mostly for profit reason some trial results may be overlooked and drugs may be launched on the market with dangerous side effects. A recent study published in the New England Journal of Medicine showed that patients with diabetes using the drug saxagliptin had an increased risk to be hospitalized for heart failure.
For this reason The FDA just published a safety announcement that it requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure.

Read the Safety Announcement from the FDA

A class I product recall has been issued by the FDA for the Puritan Bennett 840 Series Ventilator manufactured by Covidien. A software problem may cause the Ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own. This medical device is usually used on critically ill patients who may not be able to breathe without the ventilator. Therefore if the ventilator inadvertently stops the patient may suffer serious personal injury or death.

Read the complete FDA safety Alert

Some companies recently advertised the Nipple Aspirate Test as a method for breast cancer screening. The Nipple AspirateTest consists of using a breast pump to collect fluid from a woman’s nipple to screen for breast cancer. According the the FDA there is absolutely no clinical evidence to support these claims. So far the mammogram, even though it is uncomfortable for women, is the only way to screen for breast cancer.

The company that is promoting this false advertising is Atossa Genetics. Atossa Genetics was issued a warning by the FDA that their test test was misbranded in that its labeling was false or misleading and asking them to address the violation. Atossa Genetics voluntary recalled the ForeCYTE Breast Health Test from the market in October 2013.

In its advertising Atossa Genetics falsely claimed that the test was “literally a Pap smear for breast cancer.”

Toy testing, toy recalls, toy related injuries and toy shopping will be the subject of the first Google+ Hangout hosted by the CSPC. John Massale, A CSPC engineer, will describe the toy testing process and spokeswoman Nikki Fleming will there to answer all your questions.

You can post your questions on Twitter using #AskCPSC hashtag or on CPSC’s G+ Hangout event page.

Some defective Personal Emergency Reporting System (PERS) Transmitters are being recalled by Linear because the battery clips in the transmitters can corrode causing the transmitters to operate intermittently or not at all, without generating a warning.

The recalled Linear PERS transmitters allow users to push a button on the transmitter to summon assistance. Models recalled are:

• The DXS-LRC, a gray plastic pendants with a black circle in the center and can be worn as a pendant around the neck or on a wristband.
• The DXS-LRP, a white pendant with a green swirl design on the front.
• The DXS-LRW a solid black wristband with a black plastic face and black button in the center.

A defective electrical component in Philips HeartStart defibrillators may fail to deliver a needed shock in case of emergency, warned the FDA yesterday. This safety alert by the FDA follows the recall by Philips of three models of its HeartStart devices in September 2012 due to an internal electrical malfunction.

The recall affects about 700,000 defibrillators sold between 2005 and 2012. The FDA recommends Customers who have received the affected devices contact Philips at 1-800-263-3342 to receive a replacement.