Category: Defective Products

Over past decades defective and dangerous product injuries and deaths have declined, with the credit for this being a combination of regulatory agencies and tort law litigation. One of the largest problems now is with the regulatory agencies that have inadequate funding and other issues, including limited access to pertinent information of manufacturer. These lacks of information is because of political pressures and then add the fact that these agencies use their power to access information very limited.

Then there are trade secrets and confidential information that creates even more problems in product safety and defective products, plus the regulatory agencies being lenient. All of this often results in the regulatory agency reacting after there are problems in the form of voluntary recalls by manufacturers instead of preventing problems by using a preventive strategy.

The inefficiency of these agencies has been seen time after time, once an issue becomes clear instead of being on top of issues like one problem causing danger to children in the past. This was when children were being harmed by disposable lighters and nothing was done until there was a substantial numbers of injuries. Then the regulations made manufactures change the way these lighters were made, but it was a mandatory minimum standard for manufacturers.

Manufacturers and importers standard falls under the state common law liability, which means that when their products are dangerous or defective tort law litigation can result in holding them responsible for injury or death related directly to their product. Another of these prominent issues was with specific motor vehicles and this resulted in the Federal Motor Vehicle Safety Standard (FMVSS) 216, which regulates roof structure of vehicles, crashworthiness in most motor vehicles, and severe roof collapse.

These are to protect consumers and passengers in crashes as much as possible from impact, rollovers and roof crush, which result in severe injuries such as head, neck and spinal cord injuries. This was added too with FMVSS207, which is the standard for passenger vehicle seatbacks. This requires that folding forward brackets locks on seats must withstand 20 times the weight of the entire seat. This is below the force that can occur during a rear end collision and it is said that many lawn chairs pass the standards.

There are some auto manufacturers that have internal standards that are much more stringent than the seatback lock standards, while others have seats that collapse toward the back during a rear end collision and when this happens the driver or passenger can be ejected from the vehicle, suffering severe or fatal injuries in what could have been a collision that is survivable.

When regulations are weak then it reflects in the product safety monitoring and if it results in injuries or harm then it falls into the category of defective product liability. Manufacturers that experience suits for dangerous products using tort law often begin their own product safety regulations within the company for product quality assurance and optimal safety.

Citations:

Consumer Products Safety Commission- Regulations, Laws & Standards: https://www.cpsc.gov/en/Regulations-Laws–Standards/

 

There has been a manufacturer’s recall issued due to a malfunction that may result in anesthetic toxicity in patients. The Symbios Medical Products LLC is the manufacturer, who has issued the recall for disposable pain pumps.

The disposable pain pumps that are involved in the recall are local anesthesia infusion pumps GoPump and GoBlock. They work using an elastomeric balloon type reservoir and the lot that is included in the recall may have an unpredictable high flow rate, which may deliver more anesthetic than is planned. The balloon is inflated with a local anesthetic medication that is delivered slowly through tubes from the balloon to the surgical site of the patient.

The patients most at risk are the elderly and patients with low body masses for the adverse effects that may occur with the high flow rate.

The product recall by the Symbios Medical Products LLC manufacturer includes the GoPumps in Rapid Recovery System Kits and the GoBlock Kits, which have flow control components. The kits would have a manufacture date prior to July 2012 and distributed between April 27, 2011 and April 30, 2013. The recall was initiated on June 6, 2013 and distributed by B. Braun Medical Inc.

http://www.outpatientsurgery.net/news/2013/06/11-Symbios-Pain-Pumps-Recalled

According to Ehline Law Firm PC – The distribution of the Neptune Systems have been halted and are being recalled by Stryker. The FDA advisory stated that they never cleared or approved the Neptune 1 Silver and Neptune 2 Ultra (120v and 230v) fluid waste management systems for sale in the U.S.

Neptune 1 Gold was approved, though the others have not been and the FDA said the safety and effectiveness is basically untested.

The FDA in a recall notice on September 25^th advised owners of both the Neptune 1 and the Neptune 2 Ultra systems to stop use or do not use them, unless they have no fluid waste disposal alternative. They said that continued use of the devices, could have risks and users should weigh the risks and benefits associated with the device. The owners of these devices were told to submit a certificated of medical necessity to Stryker by October 12^th.

This recall is an expansion on a June 5^th recall, when the company issued a recall on the instructions for these two models, the Neptune 1 Gold and the Neptune 1 Bronze. This recall was issued after there were 2 reports of improper use resulting in tissue damage in surgical patients.

The first reported incident was of a Neptune 2 system that was used improperly as a passive chest drainage tube, with fatal results. The instructions had no warning to this effect.

The company is sending revised instructions and warning labels for staff education on the Neptune 1 Gold and the Neptune 1 Bronze users. They will also send this information for the Neptune 1 Silver and the Neptune 2 Ultra users who submit certificates of medical necessity.