Regulatory Agencies and Products Safety

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.

class_actionOver 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/

 

Recall Issued for Symbios Pain Pumps

The recall was initiated on June 6, 2013 and distributed by B. Braun Medical Inc.

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

Unapproved Neptune Systems 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.

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 25th 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 12th.

This recall is an expansion on a June 5th 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.

DePuy Hip Recall Issued Due to Metallic Poisoning Danger

This testing will also show the presence of toxic metals in the bloodstream, which will need to be treated.

Johnson & Johnson subsidiary DePuy Orthopedics Inc. issued a recall of all ASR Hip Implant Systems. In May 2010 there were a reported 40,000 DePuy hip implants that were under review, according to the London Times, in Great Britain. This was due to physicians linking the hip replacements with metallic particles, they believed responsible for hip pain, muscle damage, soft tissue damage, vision loss and hearing loss.

In a report released by the National Joint Registry showed the replacement hip had a 13 percent failure rate in the first five years after surgery. It was estimated that one in eight of the hip replacement patients would need to undergo surgery a second time for a new hip replacement.

The National Health Institute of Health published a research report that the hip implant was a faulty device that was necessary to have removed and the patient should be treated for metallic poisoning.

Chromium and cobalt, the heavy metals in the hip replacement were found to enter the circulatory system through the lower part of the hip and acts as a way for toxic debris to enter the bloodstream.

Patients with a hip replacement are urged to visit the physician immediately for comprehensive diagnostic tests to determine if there is hip implant failure damage. This testing will also show the presence of toxic metals in the bloodstream, which will need to be treated.

If you a loved one has suffered from a defective hip replacement device, the hip recall attorneys of Ehline Law will be able to assist you in determining if you have a valid hip recall claim.

Consumer Product Safety Commission Bans Drop Side Cribs

Over the past five years there have been over 9 million drop side cribs recalled, according to New York Democratic Senator Kirstin Gillibran, who pushed the legislation to outlaw the drop side crib.

December 16, 2010 (by Horatio Algren) According to reports the drop side crib is to be outlawed in the United States.
According to a vote by the Consumer Product Safety Commission they have unanimously voted to ban the manufacture, sale and resale of the drop side crib. This is cribs that have side rails that move up and down to allow parents easy access to the infant.

Over the past decade there have been more than 30 deaths of infants and toddlers and millions of cribs recalled.
The new standard for cribs will require having a stationary side and will take effect in June 2011, this will include hotels and child care centers that will be required to purchase new cribs. According to the CPSC they will have a year to replace the cribs.

According to Inez Tenenbaum the CPSC chairman the new standards for cribs comes after the drop side cribs in recent years have caused a danger to infants and toddlers with malfunctioning hardware. Plastics and assembly problems can lead to the drop side rail becoming partially detached creating a V shaped between the mattress and side rail, which can allow the infant to be caught, suffocate or strangle.

Since 2000 there have been at least 32 deaths associated with drop side malfunctions and is suspected in at least 14 more infant fatalities. Over the past five years there have been over 9 million drop side cribs recalled, according to New York Democratic Senator Kirstin Gillibran, who pushed the legislation to outlaw the drop side crib.

Companies that have issued recalls for drop side cribs include Delta Enterprise Corp., Evenflo and Pottery Barn Kids. This has been a public service message from the personal injury lawyer in Los Angeles at Ehline Law Firm. Call now 213.596.9642.

Myer Trading Cast Iron Skillets Sold by QVC Recalled

Consumers should stop use of the skillets immediately. The ordered skillets from QVC have been mailed instructions how to obtain a refund and consumers that purchased the skillet at a QVC store should return it to the store for a full refund.

The U.S. Consumer Product Safety Commission and the Meyer Trading Company Limited, of Hong Kong China have announced a recall of about 7,500 enamel coated 8-inch cast iron skillets.

The cast iron skillets were sold through QVC televised shopping programs, QVC retail and employee stores, between August 2009 and September 2010.

The enamel coating can come off of the skillet when heated, which can be a burn hazard. The skillets sold between $28 and $35 and were manufactured in China and involves Technique brand 8-inch enamel coated cast iron skillets.

Consumers should stop use of the skillets immediately. The ordered skillets from QVC have been mailed instructions how to obtain a refund and consumers that purchased the skillet at a QVC store should return it to the store for a full refund. If you were injured as a result of defective, or bad utensils, contact a defective cooking utensil attorney at Ehline Law Firm at 213.596.9642.