The FDA held a panel this week to decide on whether Avandia, a diabetes drug effective in lowering blood sugar levels, should be restricted or taken off the market entirely due to risks to heart health. The maker of Avandia, GlaxoSmithKlein, claims Avandia is safe and that evidence of the risks has been exaggerated pointing to its own RECORD study for support. However, many now say that the RECORD study was fundamentally flawed and would never have held water in the drug’s initial approval process. An FDA study indicates that seniors taking Avandia compared to seniors taking Actos (a comparable and competing drug) had significantly higher risks of heart attack, stroke, and fatality.
12 members of the panel voted to discontinue the distribution of Avandia, 10 voted that it should be distributed but its use curtailed with additional label warnings and possible sale restrictions, 7 voted for more label warnings alone, and 3 voted to continue sales with no changes. The FDA does not have to follow the recommendations of the panel and will reach a final decision in the near future.
1.8 million toy dart guns have been recalled after the death of two boys. The Consumer Product Safety Commission (CPSC) said a 9-year-old from Chicago and a 10-year-old from Milwaukee died from asphyxiation after the suction-cup darts became lodged in their throats.
The CPSC stepped in after the toy’s manufacturer, Henry Gordy International, refused to comply with a recall. The “Autofire” toy dart set was sold at Family Dollar stores from September 2005 to January 2009 for around $1.50.
“Gordy Toy” and “Ages 8+” are printed on the toy’s packaging.
The toy guns should be disposed of immediately. Family Dollar has agreed to provide a refund which can be received by calling (800) 547-0359.
Baxter International Inc., a manufacturer and marketer of medical products, has been ordered to “recall and destroy” 200,000 of its Colleague brand pumps by the U.S. Food and Drug Administration (FDA). Baxter’s Colleague brand pump is a type of infusion pump found in hospitals.
Infusion pumps are used to automatically deliver medicine, fluids, and nutrients into a patient’s system. The defective pumps either delayed or interrupted the infusions.
Baxter ceased selling the pump in 2005 due to problems with design flaws, battery failures, and software errors, but the previously sold pumps remained in use. Since then there have been 56,000 reports of malfunctioning infusion pumps of all brands resulting in over 500 deaths and an untold numbers of injuries. Baxter wanted to leave its remaining pumps on the market until 2013 but the FDA rejected this plan citing the “persistent safety problems.”
Baxter’s chairman and CEO Bob Parkinson told his company’s shareholders that the situation “languished far beyond what it should have.” While Parkinson’s admission is warranted, the question should be why the pumps weren’t taken off the market earlier. According to the FDA’s news release, Baxter was working with the FDA to try to correct the defects since 1999. Partial recalls were intermittently issued. Yet, the pumps weren’t completely recalled until over 10 years later. Prompted by the Baxter recall, Baxter’s comptetitor Hospira voluntarily ceased sales of one of its infusion pump brands as well, raising questions of the extent of infusion pump safety issues.
Johnson & Johnson has recalled over 40 of its children’s Tylenol, Motrin, Zyrtec, and Benadryl brands. Other medicines contained either the wrong amounts of active ingredients while the inactive ingredients didn’t meet quality control standards. Over 40 customers had reported finding black “specks” in some medicines, but there is no information on what the black specks were. An investigation from the Food and Drug Administration (FDA) found bacteria in some of the raw ingredients used at the Philadelphia manufacturing plant.
No serious health risks have been linked to the recalled medicines. The FDA advises parents to stop giving these medicines to their children as a precaution and replace them with a generic brand alternative. Generic brands have been unaffected by the recall.
On April 29, 2010, the U.S. Consumer Product Safety Commission issued recalls on two baby crib brands, Simplicity and Graco, due to defective parts. Parents or guardians with cribs in their homes should check their crib’s brand and model number to see if this recall applies to them. These cribs pose a possible risk of falling, suffocation, or strangulation to babies.
All Simplicity full-size cribs with tubular metal mattress-support frames have been recalled. There have been reports that the frame can bend or detach, creating a space where a child can become trapped. A one-year-old child from Massachusetts suffocated after falling between the crib mattress and the crib frame. There have been 13 other reports of the crib bending that did not result in injury, and one child who suffered minor cuts. Simplicity cribs were sold at Walmart, Target, Babies R Us, and other retailers for between $150 and $300. More detailed information on the Simplicity crib recall can be found here.
About 217,000 Graco-branded drop side cribs manufactured by LaJobi have been recalled as a result of 99 reports of broken hardware and detached drops sides, including two incidents of children becoming trapped in the gap created by the detached drop side. Neither was injured. There were six other reports of children falling out of the crib, with one suffering a minor concussion. These cribs were sold from February 2007 to March 2010 for between $140 and $200. For further descriptions and pictures of the recalled models, go here.
Owners of these cribs should stop using them immediately and not attempt to make any repairs. If your baby has been injured from either a Simplicity or Graco brand crib, you may have a claim that could result in compensation. Contact an attorney at Gary D. McCallister & Associates, LLC for more information.
On Tuesday January 26, 2010, Toyota announced that not only was it recalling certain vehicles related to safety concerns regarding the acceleration of the vehicle, but now Toyota is halting production and sales of many of its most popular vehicles. Toyota initially claimed the floor mats could make a driver unable to stop the car. Now Toyota is claiming a sticking accelerator is causing the safety problems.
The seriousness of this recall can be seen in the changes Toyota made this passed Tuesday. Rarely does a car manufacturer halt production and sales of its vehicles, especially multiple top selling vehicles, unless there are serious safety concerns. There may very well be more to this tale than Toyota is currently sharing with the public.
There have already been several complaints and injuries related to uncontrollable accelerating vehicles. People injured as a result of these faulty cars have a right to seek answers from Toyota, and Toyota should be held responsible for the injuries suffered to these people through no fault of their own. The vehicles affected by the recall include: 2009-2010 Rav 4, 2009-2010 Corolla, 2009-2010 Matrix, 2005-2010 Avalon, 2007-2010 Camry, 2010 Highlander, 2007-2010 Tundra, 2008-2010 Sequoia.
If you or someone you know has been injured as a result of the recalled Toyota vehicles, contact Gary D. McCallister & Associates, LLC. You may be entitled to money damages.
Recently Toyota announced the floor mats in several Toyota and Lexus vehicles have the potential to become trapped causing unexpected acceleration of the vehicle, which may lead to serious injuries or death. The recall effects the following vehicles, the 2007 – 2010 Camry, 2005-2010 Avalon, 2004-2009 Prius, 2005-2010 Tacoma, 2007-2010 Tundra, 2007-2010 ES350, 2006-2010 IS250 and the 2006-2010 IS350.
Owners of these vehicles should contact a local dealer to have the problem corrected, however, it is likely the problem will not be fixed until parts are available and mechanics are properly trained, which will likely be in early 2010. In the interim, owners should remove the floor mats from the driver’s side to avoid any potential harm.
If you have been involved in a collision as a result of unexpected acceleration in one of these vehicles, you may be entitled to compensation. Contact an attorney at Gary D. McCallister & Associates, LLC for more information.
The investigation at the Burr Oak Cemetery has been going on for almost three weeks now and still many families are left without answers. Many are left with questions about how this could happen, but no one ready to answer. Family members took upon the difficult task that we all must take on one day of making funeral arrangements and burying loved ones, many who died all too soon, many who were only children. After going through this process and learning to be at peace with the fate of their family members, these families are now forced to relive the most difficult time in many people’s lives.
Families entrusted their loved ones final resting place to the Burr Oak Cemetery. They paid money and signed contracts to ensure their families members would be eternally safe at the cemetery, only now to find out that the bodies may have been moved and/or discarded in a mass grave. It is unfathomable that people would stoop so low as to disturb the dead to put a few extra dollars in their pockets, but the reality is that it has happened, and now these families have a right to be compensated.
Families whose loved ones final resting place was disturbed at the Burr Oak Cemetery should be compensated by those involved. The cemetery workers, owners and others who knew about this disgraceful scam to resell occupied plots should not be able to walk away without answering to the families who have been harmed. If you believe you may have a claim against the Burr Oak Cemetery, contact Gary D. McCallister & Associates to learn more about your legal rights.
As the seriousness of the offenses of the owners and workers of Burr Oak Cemetery continue to come to light, the State is taking steps to protect the families of the loved ones buried at Burr Oak Cemetery. On Monday, Dan Hynes, Illinois Comptroller, moved to freeze almost $6 million in funds that are under the control of the company that owns the cemetery. This is one of many steps Illinois is taking to protect the rights of the families. The State is also taking steps to create better oversight of cemeteries. Currently no one is overseeing how the cemeteries are being run and whether bodies are actually being properly and respectfully buried.
Family members have a right to know that they can return to the site where loved ones were buried and know that upon their return the gravesite will be as they left it on the day the person was buried. The fact that cemetery workers and owners could have such disregard for the remains of so many people is disgraceful and these people should be held accountable. Family members have a right to know that their loved ones’ gravesites are being taken care of properly and are not being disturbed. If you believe your loved ones burial site may have been disturbed, contact Gary D. McCallister & Associates to discuss what your legal rights are against the cemetery.
An investigation is being conducted at the Burr Oak Cemetery in Alsip, Illinois after it was revealed workers were digging up the remains of people and moving them to a mass grave so the burial plots could be resold. At this time it is believed at least 300 bodies were removed, but the number is likely to rise as there are over 100,000 bodies buried at the cemetery.
Some families went to the cemetery, after hearing the news about the reselling of the plots, to find their loved ones only to realize the headstones were missing or not where the family member was buried. Currently, authorities are not allowing families into the cemetery as they try to determine the location of the over 100,000 bodies. Family members, however, are able to go to the cemetery to give authorities information regarding family members burial information.
Some workers from the cemetery have been charged criminally, but the cemetery also is responsible for damages to the families. If you believe your loved one’s body may have been moved, contact an attorney to find out what type of claims you may be able to bring against the cemetery.