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FDA Asks Hip Implant Manufacturers for Data on Blood Metal Levels

Friday, May 13, 2011

The Food and Drug Administration has been concerned enough about the numbers of people with hip implants who have suffered metal poisoning, to ask manufacturers of these implants to study the effects of metal levels in the body.

Earlier this month, the Food and Drug Administration sent a letter to at least 20 implant manufacturers, including Johnson & Johnson, Zimmer Holdings Inc., Biomet Inc. and Stryker Corporation, asking them to test the levels of metals, including cobalt and chromium, in patients for at least eight years after implantation of these devices.

Manufacturers of metal hip implant devices have been under increased scrutiny over the past couple of years.  Johnson & Johnson, in particular, faces a number of hip implant lawsuits related to the high risk of revision surgeries from its two best selling hip implants manufactured by Johnson & Johnson’s subsidiary, DePuy Orthopedics.  Approximately 9 months ago, DePuy announced the recall of the hip implant devices after these had been implanted in more than 90,000 patients across the globe.  During the recall, DePuy admitted that a study conducted in the United Kingdom had revealed a high risk of revision surgeries in patients that have been implanted with these devices.  In some cases, the risk of the implants failing, leading to revision surgeries was as high as 12%.  Other than Johnson & Johnson, Stryker and Zimmer are two of the biggest implant manufacturers in the industry.

California pharmaceutical liability attorneys have seen some signs that the Food and Drug Administration is beginning to take the health risks from these implant devices more seriously.  Earlier this year, the agency dedicated a section on its website to explain the health risks of these devices.  Among the health concerns that the agency mentions on its website is that some of the patients who have been implanted with these devices have been diagnosed with high levels of metal ions in the bloodstream, possibly leading to complications of the heart, nervous system and thyroid gland.

NTSB Probes Plane Wing Clipping Incident at JFK Airport

Monday, April 18, 2011

An aviation safety incident last week at New York's JFK airport has left California plane crash lawyers and passengers asking questions about the role of air traffic controller/pilot error, super-sized jumbo jets and a host of other aviation safety issues.  The National Transportation Safety Board has already begun an investigation into the incident in which an Airbus struck a smaller plane as it taxied passed the plane.

The Airbus A380 was taxing down the runway at John F. Kennedy International Airport, when the plane struck the left horizontal stabilizer of a Comair plane.  The impact sent the smaller Bombardier CRJ -700 spinning, and left the rudder, the horizontal tail and vertical fin of the smaller aircraft damaged.  There were a total of 52 passengers and four crewmembers on board Comair flight 293, and 485 passengers and 25 crewmembers on board the Airbus.  Fortunately, none of the passengers reported any injuries.

According to the passengers of the Comair flight, they suddenly felt the plane shuddering violently, and spinning around.  All passengers were then instructed to evacuate the plane immediately.  The National Transportation Safety Board and the Federal Aviation Administration have both begun investigations into the incident.  The full-scale investigations will include interviews with both the pilots of the plane and air traffic controllers as well as ground crew at the airport.

Investigators are specifically looking at whether there was a communication problem between the pilots and air traffic controllers.  Besides, investigators are also likely to focus on whether the size of the Airbus jumbo jet was an issue here.  Most airports around the country don't allow the Airbus A380 because the aircraft doesn't fit into the airport. 

American Airlines Violated FAA Rules in Runway Incident Inquiry

Thursday, March 24, 2011

This is not the first time that California aviation accident lawyers have found American Airlines in violation of FAA rules. This time, the carrier is in more trouble after federal officials found that the airline had downloaded information from the plane’s flight recorder after a runway incident.

The National Transportation Safety Board had been investigating the incident, which occurred at Wyoming's Jackson Hole Airport. A Boeing 757 landed on the runway at the airport in snowy weather conditions, and came to rest about 350 feet beyond the runway. There were 181 passengers and crewmembers on the plane. Fortunately, no one aboard the plane was injured.

It was what happened after the incident that concerns California plane crash lawyers. The National Transportation Safety Board found that technicians from American Airlines downloaded information from the plane's digital flight data recorder before handing the data recorder over to the federal agency. In such instances, the National Transportation Safety Board requires airlines to hand over the digital flight data recorder in its entirety to the federal agency without downloading any of the information. According to the NTSB, the downloaded information was a breach of protocol and violated federal standards.

American Airlines has now been barred from further participation in the inquiry because of this violation. American Airlines has defended its downloading of information as part of its normal investigation into the incident. However, aviation experts find it odd that American Airlines, which has been in the airline industry for years wasn't aware of basic NTSB protocols during runway incidents.

California Injury Lawyers Warn about Possibly Contaminated Alcohol Prep Pads

Monday, February 07, 2011

The Food and Drug Administration and California pharmaceutical liability lawyers are once again drawing attention to a recall of alcohol prep pads that was announced last month. The recall involves alcohol prep pads, or swabs, that were included in convenience kits manufactured by Triad Group. The recall was linked to possible contamination of these prep pads with the potentially deadly Bacillus cereus organism. This infection can lead to serious, and even life-threatening, infections.

According to Triad Group, the company has received at least one report of an infection that was contracted from using these alcohol prep pads. However, the infection, in this case a skin infection, was not life-threatening.  Watson Pharmaceuticals, the company that announced the recall, has rushed to assure consumers that none of the other products in the convenience kits are contaminated. The convenience kit also contains drugs and injection kits, and these are not contaminated.

This week, the Food and Drug Administration once again reminded consumers about the possible contamination of the non-sterile prep pads. The products have already been removed from the market, but it's important for people to know that not all pads are safe for use before procedures. For instance, non-sterile pads are not meant to be used before performing procedures that require strict and high degrees of sterility. For example, non-sterile pads are not meant for use before a catheter is inserted. They are also not meant to be used on patients who suffer from a weak immune system. Patients who have just had surgery or have just recovered from a long illness, may have a weakened immune system. These patients may be much more likely to contract infections from contaminated alcohol prep pads.

The products that have been included in this recall are marked with a label that mentions Triad Group. The Food and Drug Administration is insisting that these pads not be used to disinfect and sterilize the skin even before an injection. The FDA also wants consumers to know that the pads should not be used on IV ports and other medical devices and equipment.

More Pharmaceutical Recalls from Johnson & Johnson

Friday, February 04, 2011

For California pharmaceutical products liability attorneys, 2011 is turning out to be a repeat of 2010 as far as Johnson & Johnson recalls is concerned. The pharmaceutical giant has announced another recall of some of its most popular products, including Tylenol and Benadryl because of yet more quality control issues.

In January, the company announced a massive recall of close to 50 million bottles and packages of some of its most popular drugs, including Benadryl, Tylenol and Sudafed. According to the company, some 43 million units of the products have been recalled because of inadequate equipment cleaning procedures at the company’s Fort Washington, Pennsylvania plant. It's the same plant involved in several earlier recalls by Johnson & Johnson in 2010. The Pennsylvania plant has since been shut down. Apart from these 43 million units, approximately 4 million Rolaids have been recalled because of labeling irregularities. Johnson & Johnson has assured consumers that the recalled medications do not have any quality-control problems, and will not harm anybody.

Johnson & Johnson's recall last year involved a number of its most popular blockbuster medications, including a number of widely-used children's medications like Tylenol, Motrin, Zyrtec and Benadryl for children. Some of these recalls were linked to the presence of particulate matter in some of the bottles, while other recalls were linked to a higher concentration of the active ingredient in the medications than required. Other recalls were linked to the presence of a moldy odor in the packaging, due to chemicals that leached from the packaging. Besides, the company is under scrutiny over a phantom recall, in which the company pulled off several bottles of medications from store shelves, without giving any reason.

FAA Proposes Fines against SkyWest for Airline Safety Violations

Monday, January 24, 2011

The Federal Aviation Administration is proposing fines totaling more than $350,000 against SkyWest Airlines for civil violations that increased the risk of a plane crash. The violations disclosed by the Federal Aviation Administration occurred between July 2009 and July 2010.

The largest fine of $220,000 is for the airline’s failure to document heavy checked bags, and heavy shipments carried in cargo. Because of this, the airline operated aircraft with incorrect weight and balance data. The FAA is also proposing a civil penalty of $70,500 for the airline's failure to follow a continuous airworthiness maintenance program. According to the FAA, SkyWest operated an aircraft that had not been properly maintained on at least five revenue passenger flights.

The agency is also proposing a fine of $60,500 because of allegations that the airline operated noncomplying, Bombardier jets on at least eight revenue passenger flights between May 30th and June 1, 2010. In this case, the agency says that the airline mechanics failed to follow the carrier’s continuous airworthiness maintenance program while replacing an air-conditioning pack valve.

SkyWest Airlines insists that the safety of its flights was not compromised. The company has 30 days in which to appeal the fines.

These are not the only allegations against SkyWest that California plane crash lawyers have been monitoring. The airline is currently the focus of six ongoing investigations by the National Transportation Safety Board. These investigations involving everything from cabin door maintenance deferral procedures to landing gear problems.

These actions by the Federal Aviation Administration indicate that the agency is taking noncompliance with aviation safety regulations by carriers very seriously indeed. The agency has come under much criticism from California plane crash attorneys over the past couple of years, including its failure to rein in carriers.

Feds Seek to Prevent Runway Accident at Burbank's Bob Hope Airport

Monday, January 17, 2011

The close proximity of the passenger terminal to the runway at Burbank's Bob Hope Airport has not gone unnoticed by the thousands of passengers who use the airport every year and California plane crash lawyers. However, after yet another recent aviation safety scare at the airport, the Federal Aviation Administration has once again raised concerns about the proximity of the terminal to the runway.

The FAA has long been concerned about the location of the terminal, which is far too close to the runway. In 1986, the FAA was so concerned about this proximity that it actually prohibited planes at the airport from taking off to the east. However, in April, there was yet another adverse incident involving the runway that once again raised concerns. In April, two planes came dangerously close to each other just above the airfield. An investigation later revealed that the incident was due to air traffic controller error, but the federal report held that poor design that located the passenger terminal too close to the airport runway, presented “significant risks” and violated airport design safety standards.

The airport is now taking small steps towards safety. Officials with the Burbank-Glendale-Pasadena Airport Authority now confirm that Burbank Airport in the process of making the small minor adjustments that the Federal Aviation Administration is asking for. These include the relocation of a weather sensor near the runways. The airport authority is also working together with a private property owner to remove a nearby windmill, which is a possible aviation safety hazard. According to the FDA's regulations, the airport is also likely to enhance the “blast walls” that are meant to redirect exhaust from the aircraft.

FDA Could Soon Have Powers to Issue Mandatory Drug Recalls

Monday, January 03, 2011

The Food and Drug Administration could soon have the authority to issue mandatory drug recalls when it has reason to believe that a particular pharmaceutical drug has the potential to cause serious or deadly injuries to patients.

On December 17th, a bill aimed at expanding the agency's authority to announce recalls on its own was introduced in the House of Representatives. The bill was introduced by Reps. John Dingell, Henry Waxman, Frank Pallone, and Bart Stupak. The bill, HR 6543, aims to provide the agency with a number of authoritative powers, including the power to announce recalls.  The FDA’s limited power to recall defective or dangerous drugs and devices has been a source of criticism by California pharmaceutical products liability lawyers.

Specifically, the bill would:

  • Provide for the creation of an updated registry of all drug manufacturing facilities, not just on American soil, but also overseas
  • Provide for increased funding for Good Manufacturing Practices inspections
  • Prohibit entry of drugs into the country from facilities that delay or deny inspections
  • Prohibit entry of drugs into the country from facilities that lack documentation safety
  • Bans misleading or false reports made to the FDA
  • Mandatory recall authority for the FDA
  • Provision of increased civil and criminal penalties
  • Provision of powers that will allow the FDA to subpoena records related to possible violations
  • Provision of unique verification numbers for other companies to allow the FDA to quickly identify parties that are involved in a violation
  • Providing for greater uniformity between domestic and foreign drug manufacturing plant inspections

In December, Congress also passed a massive food safety bill, that would give the Food and Drug Administration increased powers to move proactively to announce food recalls on its own. HR 6543 would give the agency the same kind of drug safety powers too. Currently, the FDA has extremely limited powers to initiate a recall, and is forced to depend on drug manufacturers to come forward with information about possible safety hazards before it can act.

New Radiation Errors Traced to Pinpoint Beam Device

Sunday, January 02, 2011

The New York Times is continuing with its series exposing radiation errors in hospitals. In its latest exposé, the newspaper is chronicling a number of errors around the country that occur with a new radiation-emitting device that is designed to target pinpoint, high-intensity radiation on specific parts of the body. In some horrible examples of the errors that have occurred, the apparatus that was supposed to guide the pinpoint radiation to the specific body part was misaligned causing radiation exposure to other areas of the body.

Some of those errors have now resulted in doctors around the country being warned about the possibility of deadly errors from misusing these devices. The device is being used in a procedure called stereotactic radiosurgery (SRS), which happens to be one of the fastest growing radiation therapies. SRS is specially designed to target tiny tumors, especially in the brain and the spinal cord. The device helps target radiation to a pinpointed spot of the brain or the spinal cord, leaving the rest of the body unaffected.

However, since the area that is being targeted is so minute, the amount of radiation used must be precise. It is very important that the concentration level be perfectly accurate. However, in at least one of the errors that the New York Times has profiled, the SRS unit did not come with safety features that would have prevented an overdose.

These are not just random instances of errors. SRS units manufactured by a company called Varian Medical Systems as well as its German partner BrainLab have been linked to a number of such errors. Many of them occurred because the systems did not come with adequate safeguards, while others were traced to operator error. Much of the problem emanates from the fact that these complicated devices are comprised of components from different manufacturers.

Feds Voice Concern over Increasing Number of Laser Incidents

Friday, December 31, 2010

This isn’t a safety risk that California plane crash lawyers or aviation safety experts have given much thought to in the past. However, the Federal Aviation Administration is now beginning to take this threat very seriously indeed. According to the agency, the numbers of people who point lasers at aircraft cockpits, thereby temporarily blinding pilots, is actually increasing. According to the agency, there has been a substantial increase in the number of people who engage in such practices. In fact, the numbers of such incidents have been serious enough for the Federal Aviation Administration chief Randy Babbitt to call the problem “serious.”

Even with all the automation in a cockpit, a pilot still needs to have his attention focused 100% on flying, and when someone is pointing a laser to his face, it can be hard to do that. The FAA has documented more than 2,000 reports of such laser incidents in 2010. That is an increase from 2005, when less than 300 such laser incidents were reported. California saw some of the highest such laser incidents in 2009.  Pilots flying over Florida and Texas also had a lot of trouble with laser incidents last year.

What exactly are these lasers that are being used? Most of them are used for commercial purposes, and have ranges that are more than 30,000 feet. They are extremely powerful, and emit a bright light. These are not things that you would find a child playing with.  There have been a lot of amateur hobbyists traced to many of these laser incidents.

A laser beamed into a pilot's cockpit, can temporally blind pilots. Consider that some of these pilots could be piloting massive aircraft with hundreds of passengers, around some of the world's busiest airspace, and you understand the risks involved. In fact, some of these laser incidents have been so serious that pilots have been forced to stop flying and hand over control of the plane to the copilot. In some cases, pilots were forced to abort landings because of such incidents.

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