Archive for September 2010
FISHER-PRICE RECALL OF TRICYCLES, TOY CARS, HIGH CHAIRS & INFLATABLE BALLS | Dallas, Texas Personal Injury Attorney Blog
Fisher-Price and the U.S. Consumer Product Safety Commission have announced a voluntary recall of millions of tricycles, toy cars, high chairs and inflatable ball toys due to reports of injuries – including genital bleeding.
The products involved in the recall include:
- Fisher-Price Tough Trikes toddler tricycles. So far, 10 injuries in 2- to 3-year-old girls have been reported to Fisher-Price and the CPSC, and six of those required medical attention. The girls were injured by falling on the disc-shaped or D-shaped plastic key that protrudes from the seat by at least 5/8 of an inch, and is located 3 inches in front of the seat. Approximately 7 million of the tricycles were sold in the United States between January 1997 and September. The tricycles involved in the recall have a manufacture run number higher than 1670Q2; the run number can be found under the seat below the model number. Fisher-Price Trikes and Tough Trikes toddler tricycles were recalled in the United States, as well as some in Canada, because of a protruding, plastic “ignition” key that could result in injury and even genital bleeding if a child fell on it.
- Approximately 100,000 Little People Wheelies Stand ‘n Play Rampway toys in the United States and Canada. The toy is sold with small cars that have wheels which may detach and pose a choking hazard. The cars at issue are the purple and green cars marked with the word “MEXICO” and don’t have a yellow dot on the bottom.
- Nearly 1 million Fisher-Price Healthy Care, Easy Clean and Close to Me High Chairs were recalled in the United States and Canada, because children can fall on the rear pegs, used for high-chair storage, and suffer injury or laceration. All three high chairs have a folding frame and reclining seat. Families can find the manufacture date by looking at the date code on the back of the seat — if the fourth digit in the date code is 6 or less, it’s included in the recall.
- Nearly 3 million Fisher-Price infant toys with inflatable balls were recalled because they may pose a choking hazard . Forty-six incidents in which the valve came off the ball were reported, and in 14 reports, children put the valves in their mouths. In three reports, a child had begun to choke. This recall includes the following Fisher-Price products:
A. All Baby Playzone Crawl & Cruise Playground,
- B. Baby Playzone Crawl & Slide Arcade,
- C. Baby Gymtastics Play Wall
- D. Bat & Score Goal
- E. Ocean Wonders Kick & Crawl Aquarium The date code for the Ocean Wonders toy is located on the back of the fabric tag on the quilt, if the fourth digit of the date code is 7 or lower, the product has been recalled.
- F. 1-2-3 Tetherball toys manufactured before 2008. The date code for the Tetherball toy is located on the bottom of the base. If the fourth digit of the date code is 7 or lower, the product has been recalled.
Some of the toys have been marketed by Fisher-Price for 10 years. The Fisher Price spokesperson Juliette Reashor said it took the company several years to agree to and to announce these recalls “because it’s important for the company to find repetition in injury reports, to determine if incidents are isolated or if there’s a pattern related to the toy.”
Families can contact Fisher-Price at 800-432-5437 or www.service.mattel.com for free replacements or fixes for the recalled toys. The company recommends all families to remove all recalled items from their children’s reach.
Montes Law Group, P.C.
Rachel Montes
1121 Kinwest Parkway, Suite 100
Irving, Texas 75063
Telephone (214) 522-9401
Facebook @ Montes Herald Law Group, L.L.P.
AVANDIA WARNING | Dallas, Texas Personal Injury Attorney Blog
The US Food & Drug Administration (FDA) issues a consumer warning for persons who use any of the following products
• Avandia – (generic name – rosiglitazone maleate)
• Avandamet – Contains Avandia combined with metformin
• Avandaryl – Contains Avandia combined with glimepiride
• Actos – (pioglitazone HCl) is a type of oral diabetes agents called thiazolidinediones
Glaxo SmithKline manufactures the Avandia drugs and sells them under various generic names including Rosiglitazone Maleate. The drug is currently on the market and is used to treat Type II diabetes. The drugs may cause serious and deadly side effects that the manufacturer failed to warn patients or doctors of including:
• Death
• Heart Attacks
• Congestive Heart Failure
• PPH – Primary Pulmonary Hypertension
• Bone Fractures
• Hepatitis
These dangerous drugs have been on the market since 1999. Even though Glaxo knew of the problems, they failed to provide sufficient warning to the public or to the doctors that prescribed the medication. Avandia can cause heart attacks, Primary Pulmonary Hypertension (PPH), and Congestive Heart Failure in patients taking the drug.
If you have taken Avandia to help treat diabetes and have suffered one or more heart attacks or had symptoms of Pulmonary Hypertension or Congestive Heart Failure, or if you have been diagnosed with either of these serious conditions, call us today. There is a good chance you have been injured by Avandia. You need to get expert medical care and legal advice as soon as possible regarding your claim.
Avandia is sometimes combined with other diabetic medications into a single pill:
When your doctor prescribes one of these two combinations, the medication will have a different label but still contain Avandia.
If you have taken Actos, Avandia, Avandamet or Avandaryl and experienced one or more heart attacks, symptoms of Pulmonary Hypertension, or Congestive Heart Failure, or if your doctor has already diagnosed you with any of these conditions then call us today. Acting now could help save your life.
The diabetes drug Avandia has been associated with a significantly higher incidence of heart attacks and death, according to a major research analysis. The findings were the result of an analysis of 42 studies involving 15,560 patients who took Avandia and 12,283 who took other drugs or were given a placebo. The study was conducted by doctors at the renowned Cleveland Clinic and reported May 21, 2007 in The New England Journal of Medicine.
One of those who conducted the latest study, Steven Nissen, chairman of cardiology at the Cleveland Clinic, said it raised “serious concerns about the cardiovascular safety” of Avandia. (He advised that patients first consult with their doctor before discontinuing use of the medication.) Following release of the study, termed a “meta-analysis,” the U.S. Food and Drug Administration issued the following warning: “Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.” The FDA said its own analysis of the drug was ongoing.
Avandia, prescribed in pill form, is the most widely used oral diabetes treatment, with 2006 sales in excess of $3 billion. The FDA approved it for use in 1999 for the treatment of Type 2 diabetes, the most common form of diabetes. Since that time more than six million people worldwide have taken Avandia.
Montes Herald Law Group, L.L.P.
Rachel Montes and Tom Herald
1121 Kinwest Parkway, Suite 100
Irving, Texas 75063
Telephone (214) 522-9401
Toll Free (877) 529-8899
Facebook @ Montes Law Group, P.C.
AVANDIA LINKED TO INCREASED RISK OF HEART ATTACK AND DEATH | Dallas, Texas Personal Injury Attorney Blog
On September 23, 2010, the U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
According to the New York Times, experts claim that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia was linked to 304 deaths during the third quarter of 2009 alone.
Janet Woodcock, M.D., the current Director for the Center for Drug Evaluation and Research at the FDA, FDA issued her memorandum finding:
- The drug manufacturer had not met the FDA’s guidelines for 95% confidence for the risk ratio (test drug versus comparators) for Major Adverse Cardiovascular Events (MACE).
- Pioglitazone, the only other drug in this same class of drugs as Avandia does not have similar signals as Avandia.
- There is a concern by some experts that Avandia may increase the risk of heart attacks by as much as 80% as compared to other therapies.
As a result, the FDA is restricting access to rosiglitazone (Avandia) until more substantial evidence of its safety becomes available.
Avandia, a drug manufactured by GlaxoSmithKline’s (GSK), has been widely prescribed drug used to treat type 2 diabetes, has been shown to increase users’ risk of heart attack by 43 percent and cardiac-related death by 64 percent, according to the 2007 study published in the New England Journal of Medicine.
LEGAL RIGHTS OF PATIENTS INJURED BY AVANDIA
The law in most states provides several personal injury claims for persons who have been seriously injured by a prescription drug with excessive and dangerous side effects. These claims include strict liability for a defective product, breach of warranty, negligence, and misrepresentation. Damages sought against pharmaceutical companies for dangerous drug side effects and injuries include at least the following types of damages:
- Physical pain and suffering, mental anguish and physical impairment; and
- Medical expenses associated with efforts to remedy the injuries as a result of the original surgery; and
- Loss of earnings and/or earning capacity; and
- In the case of a patient’s death, the family of the victim may file a wrongful death action and seek damages.
Montes Law Group, P.C.
1121 Kinwest Parkway, Suite 100
Irving, Texas 75063
Telephone (214) 522-9401
Fax: (214) 522-9428
Facebook @ Montes Law Group, P.C.
A LOOK BACK AT FDA ACTIONS CONCERNING AVANDIA | Dallas, Texas Personal Injury Attorney Blog
2007 NEW ENGLAND JOURNAL OF MEDICINE ARTICLE
After a 2007 study published in the New England Journal of Medicine showed a link between Avandia and an increased risk in heart attacks, on May 21, 2007, the Food and Drug Administration (FDA) issued a safety alert on May 21, 2007. However, the FDA did not ban the drug at that time or recommend that physicians take their patients off Avandia at that time, but instead promised a further investigation into the medication.
The study was conducted by two doctors at the Cleveland Clinic who evaluated 42 studies that compared patients taking Avandia with those who were not. The overall study involved 28,000 patients, 15,560 of whom were taking Avandia.
Of those patients taking Avandia,
- 86 suffered heart attacks compared to 72 among patients not on the drug;
- Another 39 patients died from cardiovascular causes compared to 22 patients who were not taking Avandia.
2007 BLACK BOX WARNING REQUIRED
In 2007, Seven Galson, the physician director of the FDA’s Center for Drug Evaluation and Research, announced that the FDA would analyze the information it has on the Avandia risk as soon as possible and make the results available. The FDA would also present the issue of Avandia’s potential heart attack side effect and the need for an Avandia warning or other action to an advisory committee as soon as one can be convened. Eventually, the FDA required a “black box warning,” the FDA’s most serious level of warning, for the increased risk of coronary problems in patients taking Avandia. In July of, 2007, the FDA announced that the manufacturer of Avandia (rosiglitazone) has agreed to add new information about potential increased risk for heart attacks to the existing boxed warning.
CONGRESSIONAL INVESTIGATIONS
Members of Congress have also expressed concern about the FDA handling of Avandia. Both houses of Congress are currently debating funding bills for the FDA that contain certain requirements for reform of the methods used by the FDA to monitor drug safety. Representatives John Dongell and Bart Stupac, both Democrats from Michigan, have vowed to investigate further whether GSK revealed the dangers of Avandia to the public. The House Oversight Committee held a hearing on the FDA’s handling of Avandia.
OTHER CONCERNS REGARDING AVANDIA
Another 2007 study raised additional concerns about Avandia side effects. The study found that Avandia increases the risks of fractures of the upper arm, hand, and foot of women taking it and two other drugs manufactured by GSK, Avandamet and Avandaryl. Since millions of people take this drug, bone deteriorization could have a major health impact.
SEPTEMBER 23, 2010: FDA ANNOUNCES SIGNIFICANT RESTRICTIONS
On September 22, 2010, Janet Woodcock, M.D., the current Director for the Center for Drug Evaluation and Research at the FDA issued her memorandum finding that the drug manufacturer had not met the FDA’s guidelines for 95% confidence for the risk ratio (test drug versus comparators) for Major Adverse Cardiovascular Events (MACE). The FDA noted that pioglitazone, the only other drug in this same class of drugs as Avandia does not have similar signals as Avandia. The FDA also noted that there is even a concern by some experts that Avandia may increase the risk of heart attacks by as much as 80% as compared to other therapies. As a result, the FDA is restricting access to rosiglitazone (Avandia) until more substantial evidence of its safety becomes available.
On September 23, 2010, the U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
LEGAL RIGHTS OF PATIENTS INJURED BY AVANDIA
The law in most states provides several personal injury claims for persons who have been seriously injured by a prescription drug with excessive and dangerous side effects. These claims include strict liability for a defective product, breach of warranty, negligence, and misrepresentation. Damages sought against pharmaceutical companies for dangerous drug side effects and injuries include at least the following types of damages:
- Physical pain and suffering, mental anguish and physical impairment;
- Medical expenses associated with efforts to remedy the injuries as a result of the original surgery; and
- Loss of earnings and/or earning capacity; and
- In the case of a patient’s death, the family of the victim may file a wrongful death action and seek damages.
Montes Herald Law Group, L.L.P.
Rachel Montes
1121 Kinwest Parkway, Suite 100
Irving, Texas 75063
Telephone (214) 522-9401
Toll Free (877) 529-8899
Facebook @ Montes Law Group, P.C.
SEPTEMBER 23, 2010: FDA REPORT RESTRICTING ACCESS TO AVANDIA | Dallas, Texas Personal Injury Attorney Blog
Attached is a copy of the Memorandum written by Janet Woodcock, M.D., the current Director for the Center for Drug Evaluation and Research at the FDA, FDA concerning Avandai
(rosiglitazone) in which the FDA finds:
- the drug manufacturer had not met the FDA’s guidelines for 95% confidence for the risk ratio (test drug versus comparators) for Major Adverse Cardiovascular Events (MACE).
- Pioglitazone, the only other drug in this same class of drugs as Avandia does not have similar signals as Avandia.
- There is a concern by some experts that Avandia may increase the risk of heart attacks by as much as 80% as compared to other therapies.
As a result, the FDA is restricting access to rosiglitazone (Avandia) until more substantial evidence of its safety becomes available.
LEGAL RIGHTS OF PATIENTS INJURED BY AVANDIA
The law in most states provides several personal injury claims for persons who have been seriously injured by a prescription drug with excessive and dangerous side effects. These claims include strict liability for a defective product, breach of warranty, negligence, and misrepresentation. Damages sought against pharmaceutical companies for dangerous drug side effects and injuries include at least the following types of damages:
- Physical pain and suffering, mental anguish and physical impairment;
- Medical expenses associated with efforts to remedy the injuries as a result of the original surgery; and
- Loss of earnings and/or earning capacity.
- In the case of a patient’s death, the family of the victim may file a wrongful death action and seek damages.
Montes Herald Law Group, L.L.P.
Rachel Montes
1121 Kinwest Parkway, Suite 100
Irving, Texas 75063
Telephone (214) 522-9401
Toll Free (877) 529-8899
Facebook @ Montes Law Group, P.C.
2007 NEW ENGLAND JOURNAL OF MEDICINE ARTICLE | Dallas, Texas Personal Injury Attorney Blog
Click on the link below to view a copy of the 2007 study published in the New England Journal of Medicine which showed a link between Avandia and an increased risk in heart attacks.
The study was conducted by two doctors at the Cleveland Clinic who evaluated 42 studies that compared patients taking Avandia with those who were not. The overall study involved 28,000 patients, 15,560 of whom were taking Avandia.
Of those patients taking Avandia,
- 86 suffered heart attacks compared to 72 among patients not on the drug.
- Another 39 patients died from cardiovascular causes compared to 22 patients who were not taking Avandia.
LEGAL RIGHTS OF PATIENTS INJURED BY AVANDIA
The law in most states provides several personal injury claims for persons who have been seriously injured by a prescription drug with excessive and dangerous side effects. These claims include strict liability for a defective product, breach of warranty, negligence, and misrepresentation. Damages sought against pharmaceutical companies for dangerous drug side effects and injuries include at least the following types of damages:
- Physical pain and suffering, mental anguish and physical impairment;
- Medical expenses associated with efforts to remedy the injuries as a result of the original surgery; and
- Loss of earnings and/or earning capacity.
- In the case of a patient’s death, the family of the victim may file a wrongful death action and seek damages.
LEGAL RIGHTS OF PATIENTS INJURED BY AVANDIA
The law in most states provides several personal injury claims for persons who have been seriously injured by a prescription drug with excessive and dangerous side effects. These claims include strict liability for a defective product, breach of warranty, negligence, and misrepresentation. Damages sought against pharmaceutical companies for dangerous drug side effects and injuries include at least the following types of damages:
- Physical pain and suffering, mental anguish and physical impairment;
- Medical expenses associated with efforts to remedy the injuries as a result of the original surgery; and
- Loss of earnings and/or earning capacity.
- In the case of a patient’s death, the family of the victim may file a wrongful death action and seek damages.
Montes Law Group, P.C.
Rachel Montes and Tom Herald
1121 Kinwest Parkway, Suite 100
Irving, Texas 75063
Telephone (214) 522-9401
Toll Free (877) 529-8899
Facebook @ Montes Law Group, P.C.