Makers of Tysabri Warn of Serious Liver Damage
February 28, 2008
Biogen Idec and Elan have informed healthcare professionals of reports of “clinically significant” liver injuries among patients treated with TYSABRI (natalizumab), a drug used for treatment of multiple sclerosis (MS).
Medical Device Litigation 101
February 25, 2008
Medical Device Litigation History and Primer
1976 through Reigel v. Medtronic
Guest post provided by Denver personal injury attorney Beth Klein
Background of the Act
The Food & Drug Administration (“FDA”) governs medical devices for use and sale in the United States. The FDA was given power over medical devices in the 1976 Medical Device Amendments to the Food, Drug, & Cosmetic Act, 21 U.S.C. section 360c et seq. (AMDA@). The purpose of the MDA was to provide reasonable assurance of safety and effectiveness for all medical devices.
Rinnai Wall Furnaces Recalled
February 24, 2008
Rinnai America Corporation of Peachtree City, GA is recalling their Direct-Vent Wall Furnace models RHFE 431 and RHFE 556 due to a carbon monoxide poisoning hazard.
This recall involves about 52,000 Direct Vent Wall Furnaces that were sold to contractors nationwide for the last seven years and were made in Japan.
Chanitx and Suicide
February 21, 2008
More reports of erratic behavior and suicide have been associated with the use of Chantix, a drug that was designed to help people stop smoking and was approved by the Food and Drug Administration just under two years ago. In November 2007, the FDA issued a statement that they are reviewing the possible Chantix suicide side effects and that there have been over 100 reports received of suicidal thoughts and severe behavioral changes within just a few weeks of taking the drug.
Supreme Court Grants Immunity to Medical Device Manufacturers
February 21, 2008
(Editorial Content)
The Supreme Court finally gave medical device makers their one true wish – Immunity from Lawsuits. Companies that produce medical devices like breast implants and implantable defibrillators now have federal protection against lawsuits arising from deaths or injuries associated with their products as long as the product has been approved for use by the FDA.
143 Million Pounds of Beef Recalled by USDA in Largest Beef Recall in History
February 18, 2008
The United States Department of Agriculture (USDA) today ordered the recall of 143 million pounds of frozen beef – the largest beef recall in US history.
The recalled beef cam from a Chino, California slaughterhouse called the Westland Hallmark Meat Company. This slaughterhouse is the subject of an animal abuse investigation and provided meat to schools across the country.
See the horrific video footage taken on this farm:
FDA Drops The Ball Again – Chinese Drug Maker Not Inspected
February 16, 2008
The tainted blood thinner heparin, which was recalled in January, has been linked to four deaths in the US and about 350 other “complications”.
A recent report by Walt Bodanich and Jake Hooker of the New York Times reveals that the active ingredient in this blood thinner marketed by Baxter International was produced by a factory in China. No big surprise there.
Bracelets Recalled Due to Violation of Lead Paint Standard
February 15, 2008
The United States Consumer Product Safety Commission, along with Mission City Press of Franklin, Tennessee, has announced a voluntary recall of A Life of Faith Charm Bracelet Sets. Approximately 11,00 of these bracelets have been recalled due to the following hazard: Surface paint on the pearl white beads of the bracelet contains excessive levels of lead, violating the federal paint standard.
Huge ATV Recall by Polaris – Sportsman and Scrambler
February 15, 2008
Polaris is recalling 95,000 ATVs due to defective electronic control modules (ECMs) that may overheat, causing a fire and burn hazard to riders. If you own one of the four wheeler / ATV models below, contact your closest Polaris dealer for information on how to schedule a free repair. In the meantime, consumers are advised to disconnect the negative (black) battery cable from the battery.
Potentially Dangerous Chemicals Under Your Kitchen Sink
February 13, 2008
I was reading about yoga poses today on one of my favorite websites when I came across an article about hazardous household cleaning products.
Some of these are seriously toxic substances that cause kidney, liver and brain damage, but they can be found in ordinary household cleaners that we use every day:
- Chlorinated phenols can be found in toilet bowl cleaners and are toxic to respiratory and circulatory systems.
- Diethylene glycol found is found in window cleaners and depresses the nervous system.
- Phenols can be found in disinfectants are toxic to respiratory and circulatory systems.
- Nonylphenol ethoxylate can be found in laundry detergents and all-purpose cleaners. It is banned in Europe and could biodegrade slowly into even more toxic compounds.
- Formaldehyde is often found in spray and wick deodorizers and could cause cancer.
Pain Medication Patches Recalled
February 13, 2008
Fentanyl pain medication patches have been recalled this week due to a flaw that allows the very potent opiod medication to come in direct contact with the patient using the patch, proving to be potentially deadly.
The patches have been sold in the United States under the brand name Duragesic and sold generically as fentanyl by Sandoz, Inc. The recall actually includes all 25-microgram-per-hour patches with expiration dates on or before December 2009.
FDA Issues Statement About Dangers of Botox and Botulinum Toxin Products
February 8, 2008
The US Food and Drug Administration (FDA) has received several reports of side effects, including respiratory problems and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved use.
FDA Gives Makers of Unapproved Deadly Gout Medicine 30 Days to Stop Selling Product
February 7, 2008
There have been at least 50 reports of adverse events (side effects) associated with the use of intravenous colchicine, which includes at least 23 deaths. Colchicine is an unapproved injectable drug used to treat gout.
The harmful and potentially deadly effects of the drug include low blood cell counts, organ failure and cardiac arrest. The FDA stresses that the difference between an effective dose of colchicine and a potentially fatal dose is a very small margin.
Evenflo Announces Recall/Revision of Discovery Infant Car Seat
February 6, 2008
On February 1, Evenflo announced a voluntary recall/revision of its Discovery infant car seats, Models 390, 391, 534, and 552. Recent laboratory tests conducted by Evenflo and the National Highway Traffic Safety Administration (NHTSA) showed that the seats could become detached from their bases in high impact side collisions.
Medtronic SynchroMed EL Implantable Infusion Pumps Recalled
February 4, 2008
In a Class 1 Recall yesterday, the U.S. Food and Drug Administration has recalled all SynchroMed El pumps with motors manufactured after September 1999.
Air Compressors Recalled
February 4, 2008
&The United States Consumer Product Safety Commission, along with Campbell Hausfeld, has announced a voluntary recall of approximately 233,000 Campbell Hausfeld and Husky Air Compressors because the protective covers on the compressor’s motor are not made from proper flame retardant material and can ignite, posing a fire hazard.
Ford Re-Recalling Hundreds of Thousands of Vehicles
February 3, 2008
Ford Motor Co. said yesterday that they are recalling about 225,000 vehicles, including 185,000 E-Series vans, that were already repaired as part of an earlier recall to address concerns about a cruise control deactivation switch.
Yet Another Way to Stay Informed on Product Recalls
February 1, 2008
&tUS Recall News offers several widgets and feeds that you can subscribe to, including this blog. We also have a monthly newsletter that we send out. However, the monthly newsletter only highlights the biggest or most dangerous recalls, and you may miss out on being informed of a recall on any number of products you own.
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