Alabama Product Injury Lawyer Blog

Recalls of the Week

2008-11-20T16:20:15Z

Over the past week there have been several significant recalls. Let's jump right on into it.

1. Topical Acne Cream: A voluntary recall has been issued for all 1 ounce tubes of 10% Benzoyl Peroxide Acne Cream sold under the following names: DG Maximum Strength Acne Medicated Gel (sold at Dollar General), Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication (sold at Kroger) and Equate: Medicated Acne Gel (sold at Wal-Mart). It is being recalled because some samples of the product have been found to have a bacteria growing in them. Although the manufacturer CSI USA, Inc. has concluded the risk of illness is low, there is an increased risk of infections for individuals with cuts, scrapes or other compromised skin conditions or those with weakened immune systems. Obviously, those using this cream for acne would have a "compromised skin condition." You should stop using the product immediately and you can get a full refund by mailing the tube or proof of purchase to CSI USA, Inc, 170 Commerce Way, Gallatin, TN 37066, Attn: ACNE CREAM RECALL. For more information, see here.

2. GE Profile Monogram and Kenmore Wall Ovens: GE is recalling about 244,000 GE Profile Monogram and Kenmore Wall Ovens because extreme heat can escape during the self-clean cycle if the wall oven door is removed and incorrectly re-attached by the consumer or installer. This can create a fire and burn hazard to consumers. The wall ovens were sold in white, black, bisque and stainless steel. The affected ovens were sold to homebuilders between October 2002 and December 2004 for between $900 and $3600. For information regarding the models involved in this recall and photos of the ovens, see here. There is a test you can do to see if the oven door is attached properly which is shown at this site. If the door is incorrectly attached, do not use the self-clean feature and GE for a free repair. You can continue to use the normal baking and broiling function (i.e. no problem for cooking that Thanksgiving turkey...whew.) Consumer Reports addressed this recall here.

3. Mylicon Gas Relief Dye Free Drops: Although it has been awhile since I had a small child, I can still remember being told that my younger son suffered from "colic" i.e. he was always miserable and we really don't know why. In fact, my wife swears that when she discussed the issue with our then pediatrician after my son was one month old, the pediatrician told her "to put him in a closet till he's 4 months old and then take him out and he will be fine." Great solution. One thing we did use on a regular basis to try and help the situation was Mylicon drops. Well just last week a voluntary recall of about 12,000 units of Mylicon Gas Relief Dye Free drops sold in 1 oz. plastic bottles distributed after October 5th of this year was issued. Some bottles could have metal fragments in them generated during the producing of the drops. If you have given this drops to your infant and are concerned, you are instructed to take your child to your health care provider immediately. To see a description of the specific lots involved in this recall, see the FDA's website and Consumer Reports discussion of this recall. If you have one of the recalled bottles, you should immediately stop using them and call the company at 1-800-222-9435 or see their website at www.mylicon.com regarding how to dispose of the product and get replacement or refund. As an aside, if your child has been given Mylicon out of one of these bottles, I would take him to see your doctor and DO NOT dispose of the bottle until you confirm nothing is wrong with the child as a result. Should a problem have occurred as a result of having one of these bottles, you will need to keep the bottle and the medicine in it as potential evidence. In fact, it is your best evidence and should not be discarded and even given to the manufacturer. If you need some advice on this issue, feel free to contact me using the contact form or calling me. Please note the recall DOES NOT include Original Mylicon Gas Relief or the Mylicon Gas Relief Dye Free 1/2 oz. size.

4. Roman Blinds sold at IKEA: Just today a recall has been announced for IRIS and ALVINE Roman Blinds sold at IKEA Home Furnishings. Approximately 670,000 of these blinds have been sold. Back in April of this year, a 1 year old girl became entangled in the inner cord and strangled. (Question: Why did it take over 6 months to announce the recall???) The recall includes all sizes of these blinds and they are white. At the top edge of the blind, there is a sewn in label with the IKEA logo, and a 5 digit number, either 19799 or 21369. These blinds were sold from July 2005 though June 2008. You should immediately stop using these blinds and return them to IKEA for a full refund. For more information see the CPSC's website or IKEA's website.

That's it for this week of recalls. Be careful out there. And if you need any help or advice regarding an injury due to a product, please contact me.

Recalls of the Week

2008-11-11T18:27:01Z

Fortunately, not alot of significant recalls this week. Maybe its the post-election hangover or the gear up for the holidays. Here is a couple recalls of note:

1. Claire's Recalls Children's Metal Necklaces: Claire's Boutiques is recalling their "Best Friends Yin Yang Necklace Sets" because the necklaces contain high levels of lead. About 67,000 of these necklaces have been sold. It is a set of two necklaces that have silver colored metal bead type chain. See here for a picture of the chains. If you have one or both of these necklaces, you should immediately take away from any children and return to Claire's for a full refund.

2. Ethex Corporation Recalls Five Generic Drugs Due to Potential for Oversized Tablets: There has been several problems lately with drug manufacturers distributing pills that are double the size they are suppose to be, leading to a patient taking more of the medication than they should. Digitek has been one such drug which was recalled earlier this year for this problem and which i wrote about here and here. Now Ethex Corporation is voluntarily recalling several of the generic medications it distributes because of a concern they are oversized and contain more of the active ingredient than intended. The drugs include Propafenone, Isosorbide Mononitrate, Morphine Sulfate, Dextroamphetamine. Overdoses of these drugs can cause serious complications including irregular heartbeat, low blood pressure, difficulty breathing or rapid heart beat. For a detailed description of this recall and the drugs involved, see here. The lots of these drugs were shipped before May 22, 2008. If you take one of these drugs, call your physician, pharmacist or other health care provider immediately. If you think you have had any adverse reactions as a result of taking one of these problematic drugs, contact the FDA at www.fda.gov/medwatch.

Well believe it or not, that's all we have this week of interest. Please contact me should you have any questions or concerns regarding these recalls or any other issues relating to injuries caused by products. Until next week, be careful out there.

FDA Issues Recall of Syringes Used by Diabetics

2008-11-06T21:17:30Z

Today the FDA issued a recall of Insulin syringes referred to as ReliOn. These are single-use, disposable, hypodermic syringes used by patients with insulin dependent diabetes. The syringe is mislabeled and may result in the patient overdosing by as much as 2.5 times the intended dose. This can lead to serious health consequences, including death. The syringes were sold by Wal-Mart and Sam's Club pharmacies. The recall only applies to lot number 813900. The product was distributed from August through October 8th of this year. You should check your syringe packaging carefully and do not use this product and return to the pharmacy for a replacement. For more information regarding this recall, see here.

Recalls of the Week

2008-11-06T16:27:49Z

Its the dawn of a new day. Like everyone else, I have been caught up in the presidential election hoopla. I honestly believe our country has turned a significant corner and the opportunity to "build a more perfect union" is upon us. But we cannot expect government to give us all the answers. It is our responsibility as citizens of this great nation to participate in this process. Not by sitting on the sidelines and taking pop-shots at those in office, but really participating in the governing process. If this election has shown us anything, its that we can make a difference and change the direction and course of our country, if we just participate.

Enough of my political moment, here is some information on the latest significant recalls of products:

1. Laptop Batteries Causing Fire: The lithium-ion batteries used in HP, Toshiba and Dell Notebooks pose a potential for fire and burning. There have been 19 reports of the batteries overheating, including 17 reports of flames/fire. The majority of these batteries were sold with HP laptops (about 32,000 of the total of 35,000 defective ones out there). For a listing of the models of laptops involved see here. On the HPs, the recalled batteries will have a bar code label starting with A0, L0, L1 or GC. The batteries were sold both with the laptops and separately. For HPs, the batteries were sold between December 2004 and June 2006; for Toshiba, April 2005 and October 2005, and for Dell they were shipped between November 2004 and November 2005. If you have one of these batteries, you are instructed to immediately remove it from the notebook and contact your computer manufacturer. If you have one of the recalled batteries, you will receive a free replacement. Consumer Reports also has a story about this recall here.

2. Krylon "Outdoor Spaces" UV Fabric Protector: Sherwin-Williams is recalling the Krylon "Outdoor Spaces" UV Fabric Protector because overexposure to fumes, vapors or the spray mist can cause serious respiratory and breathing problems. This is an aerosol coating used to protect fabric. It has been sold at Wal-Mart, Ace Hardware and other retail stores between January 2006 and September 2008. If you have this product, stop using it and return it to the place you purchased it from for a full refund. For more information on this recall, see here.

3. Firestone Tires: Bridgestone/Firestone is recalling over 135,000 Firestone FR380 tires, size P235/75R15 manufactured between June 4, 2006 and September 8, 2007, as well as almost 27,000 LEMANS Champion SE Tires of the same size due to being produced with insufficient tread base gauge. If you continue to use these tires, it can lead to vibration and groove cracking and may ultimately lead to tread separation which is very dangerous. Bridgestone will be letting owners know that the affected tires can be replaced free of charge and the replacement tires will be mounted and balanced free of charge. For more information regarding this recall and who to contact with questions, see here.

4. Cybex Treadmills: Being a fitness enthusiast myself (and yes I HATE treadmills....or should i say running in general) I thought I would pass this recall along. Cybex is recalling about 20,000 treadmills because the treadmills can speed up unexpectedly, posing a potential for users to fall. Yeah, like if the treadmill suddenly jumped up to 10mph i know I'd go flying off the treadmill and it would not be pretty. The recall only involves the 115V treadmills and not the 220V treadmills. For the models involved, see here. These treadmills were sold by Cybex and Cybex dealers between January 2001 and September 2008. If you have one of these treadmills, unplug it and stop using it immediately. Contact Cybex to obtain a free replacement fuse and if you ask, they will send a tech out to install it.

5. Serta Zipper-Covered Foam Core Mattresses: Over 6,000 Serta Zipper-Covered Foam Core Mattresses are being recalled because the mattresses fail to meet the federal open flame standard for mattresses and therefore pose a risk of fire to the consumer. The mattresses were sold in twin, full, queen, king and California king sizes. They were manufactured between November 30, 2007 and May 20, 2008. For information regarding models involved, see here. If you have one of these mattresses, you should contact Serta immediately and if your mattress is included in the recall, a free replacement mattress cover will be provided.

That's it for this week. Please stay safe and remember to be careful out there.

FDA Issues Public Health Notification of Serious Problems With Surgical Mesh Used to Treat Pelvic Organ Prolapse and Urinary Incontinence in Women

2008-10-22T21:07:29Z

Surgical mesh products are medical devices used to fix everything from hernias to prolapse of pelvic organs (uterus) to urinary incontinence seen in women sometimes after they have had several childbirths. These products can be rejected from the body and cause alot of complications sometimes making the original problem look minor compared to the ultimate problems caused by use of the mesh product. Yesterday, the FDA issued a public health notification to both physicians and consumers of the potential risks that can arise from use of these mesh products to repair some of these problems.

Specifically with regard to women who choose to have surgical mesh to address prolapse of their uterus or urinary incontinence, the FDA reports complications with the placement of this mesh including erosion through the vagina, infection, pain, including pain during sexual intercourse and recurrence of the prolapse or incontinence. In fact, a second surgery may be required to address removal of the mesh that has eroded into the vagina.

The FDA recommends many questions which need to be asked of your doctor if you need to have Pelvic Organ Prolapse or Stress Urinary Incontinence surgery. For a list of these questions, see the FDA's Consumer Information on this here.

As a consumer and potential patient, you must be aware of these potential problems and you must discuss them with your doctor to make the right decision for you. If your doctor is not willing to address your concerns or blows them off as not important, you need to find yourself a new doctor. As I said, with use of these mesh products, sometimes the repair and the ultimate results can be much worse than the original problem. Rule number one when dealing with doctors prescribing medications and recommending surgeries; ask questions and demand clear, understandable answers. It is ultimately your life and you need all the necessary and relevant information to make the right decision for you.

Recalls of the Week

2008-10-22T16:13:24Z

The past week has been a little crazy with my son in college home for "fall break" (not sure why he needed the break since he has only been in school for about a month) and then a quick trip to South Florida for a family celebration. Back this week to keep fighting the good fight. There have been several significant recalls of products this past week and so here we go...

1. Delta Enterprise Drop Side Cribs: Over 1.5 million cribs manufactured by Delta Enterprise are being recalled because they are missing safety pegs which can cause entrapment and suffocation. If you have been following my Recalls of the Week for the last several weeks, there have been a significant number of cribs/bassinets recalled over the past month or two. This is one of the largest so far. The recalled cribs have date codes between 1995 through December 2005 and one model was made in 2007. The cribs were sold at Wal-Mart, Kmart and Target.com. Parents are being told to stop using the cribs that are missing a safety peg on any leg of the crib and contact Delta to receive a free repair kit. For more information on this recall see here and here. Additionally, the Wall Street Journal wrote a news report addressing this recall and Consumer Reports has also issued a report. Consumer Reports also recommends that if you are in the market presently to by a crib, it is safest to choose one with sides that don't go down. It also requests that the Consumer Product Safety Commission work on issuing stronger standards regarding crib durability.

2. Rage Wireless Guitars for Wii Video Gaming System: This recall was just issued today and given the significant interest in Guitar Hero and similar video games, I felt this was important to pass along. The Rage Wireless Guitar is designed to be used on the Nintendo Wii gaming system. The guitar is blue or white and contains battery operated LED- lighted fret buttons on the guitar neck. It is reported there is a circuit board defect which can cause the AA batteries used in the guitar to leak if the batteries are installed incorrectly which can cause chemical burns. Consumers are instructed to stop using the guitars immediately and return them to where it was purchased for a full refund. Sorry kids, maybe you should try playing a real guitar.

3. General Power Products Portable Generators: With winter just around the corner, thought this recall of portable generators would be important to publicize. This recall involves the General Power Products 6000 Watt portable generator and the Poulan Pro 6000 Watt portable generator with serial number 060400483 through 060600725. These generators were sold in hardware and home improvement stores in Illinois, Indiana, Louisiana, Ohio and Texas between June 2008 and September 2008. The problem is the generator's fuel valve can be damaged by the cover plate during shipment and cause a fuel leak during use. This creates the potential for fire. If you have one of these generators, you should stop using it immediately and call General Power Products to find out if the generator's fuel valve is damaged and if so, obtain a free repair kit. For more information, see here.

4. Gen Netcom's GN9120 Wireless Headset: Approximately 525,000 of these wireless headsets typically used in office settings, are being recalled because there is an internal short circuit which can cause the batteries to overheat, leading to a risk of fire. Imagine talking on the phone through the head set and all of a sudden your hair is on fire...OUCH. There have been 10 reports of overheating, including 3 reports of open flames. These headsets were sold nationwide between January 2005 and September 2008 for between $150 and $350. You are instructed to stop using and unplug this head set immediately and call the manufacturer to obtain a replacement battery. For more information, see here.

5. Dextroamphetamine Sulfate 5mg Tablets: ETHEX Corporation is recalling 3 lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5mg tablets due to the potential that some of the tablets may be oversized and contain as much as twice the amount of medication you should be receiving. These lots were distributed between January 2007 and May 2008 and the pill is an orange round tablet with "ETHEX" on one side and "311" on the other side. If you take more than the expected dose, it can lead to rapid heart beat, high blood pressure, tremors, decreased appetite, headache, dizziness, blurred vision and stomach upset. There are several manufacturers of this product so check to see that, if you are taking this medication, it is the one manufactured by ETHEX. You should not use any of these tablets which appear oversized. For more information, you can contact ETHEX at 1-800-321-1705. You might want to consider contacting your pharmacist and try and determine if the medication you have is part of the lots that are included in this recall. For more information, see here.

Well that's it for this week of recalls. Remember to be careful out there and have a safe and happy rest of your week.

Genentech and FDA Announce New Black Box Warning for Raptiva

2008-10-18T15:53:20Z

It was announced yesterday that Raptiva, a drug used to address psoriasis, has received a black box warning (the highest warning a drug can get) that taking of the drug increases the risk for certain viral and bacterial conditions. The new warning highlights increased risk for sepsis, viral meningitis, and other potential serious infections.

According to the FDA's press release regarding this label change:

Patients taking Raptiva should be educated about recognizing the signs and symptoms of infection, PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia (dizziness upon standing, weakness or jaundice), thrombocytopenia (bruising, bleeding gums, pin-point sized red or purple dots under the skin), or the worsening of their psoriasis or arthritis. Signs of a nervous system disorder include sudden onset of numbness, tingling or weakness in the arms, legs or face.

For further discussion of this new warning and the reasons for it, see Pharmalot's discussion of this label change.

Preemption - Wall Street Jounal Reports How Bush Trying to Take Away Right to Sue for Unsafe Products in His Final Days

2008-10-15T23:34:47Z

As you are aware if you have followed my blog over time, the issue of preemption and how our right to access to the courts to address injuries caused by unsafe products is being taken away under our unsuspecting noses, has been a continuous crusade of mine. My previous discussions of this issue and what it means to the everyday consumer of products can be found here.

Well, the Wall Street Journal reports today how the Bush Administration, even in its last days, as the country's economy slowly burns to the ground, is doing everything it can to continue to block consumers' access to the court system when they are injured by defective products. The Bush administration couldn't do it the upfront way by bringing it to Congress and let it be debated in front of the American public. Instead he did it the quiet, back door way by having the various federal agencies involved in regulating products; the FDA (drugs and medical devices), NHTSA (cars and trucks) and CPSC (all other consumer products) create rules that incorporate provisions that indicate a consumer injured by a defective product which the applicable agency approved to be marketed cannot seek redress for his or her injuries in a court. Sorry, if the agency says the product is ok, that's good enough.

The American Association for Justice (AAJ) has issued a press statement and a significant paper entitled "Get Out of Jail Free -- How the Bush Administration Helps Corporations Escape Accountability" explaining in detail what the Bush administration has done over the last 8 years to take away our rights as consumers to seek redress in our courts for injuries caused by defective and unsafe products. What the Wall Street Journal article points out is that even with a new administration in power who does not agree with this underhanded method of cutting off our right to access to the court system, it could take several years to change the regulations issued by these agencies under Bush. Maybe if the Bush Administration spent more time over the last 8 years studying the economy and properly regulating the banking industry instead of figuring out ways to take away our right to access to the court system to address our injuries, we might not be waking up every morning now hearing the words "recession", "depression" and "crash".

Recalls of the Week

2008-10-14T16:34:16Z

That time again friends to explore what has been going wrong in the products world while the rest of our world is completely off its axis. I seem to be spending most of my free time watching the economic and political pundits go on and on about the potential for a depression, our government investing in private enterprise ( can we say "conservatives" promoting socialism???) and whether the ethics of a candidate running for the second highest office in the U.S. really matter. One thing I have always prided myself on and which I use to evaluate people passing through my own life is "are they a good person" . Isn't that what ethics is all about? Doing the "right thing". I will now get off my soapbox and onto the issue at hand; what products do you need to be concerned about this week.

1. Nerf N-Strike Recon Blasters: About 330,000 of these Nerf bazooka type toys are being recalled because the Blasters' plunger can pull the user's skin when it is fired which can cause injury to the face, neck or chest. Already 46 reports of injuries have been received involving children between the ages of 4 and 12. These Blasters were sold at the usual; Wal-Mart, Target and Toys "R" Us between November 2007 and August 2008. The recall instructs parents to take the Blaster away from the child immediately and contact Hasbro at 1-800-245-0910 for a cover to prevent injuries. For more information, including how to identify if you have one of the problematic Blasters, see here.

2. General Electric Toasters: GE Toasters sold at Wal-Mart between September 2007 and July 2008 are being recalled because of an electrical short issue, which can cause a fire or electrical shock. Wal-mart has received 140 reports of fires and sparks coming from the toasters. (Yes, but was the toast burnt???) The recalled toasters have a chrome body, black plastic base and are either 2 or 4 slice toasters. The model numbers involved are 169115 and 169116. If you have one of these toasters, you should stop using it immediately and return it to your local Wal-Mart for a full refund or replacement. See here for more information regarding this recall.

3. Rack Room's Girls' Sandals: Now here is a new one on me...recall of shoes!! Rack Room Shoe Stores, between February 2008 and June 2008 sold sandals for little girls with attached leather flowers. The shoes were sold under the brand name "Kids Feet". The sandals are white or white with pink soles. The ornamental leather flowers can detach and create a potential choking hazard for little kids. If your child has these shoes, you should take them away immediately and return them to the store where you purchased them for a refund or store credit. For more information regarding this recall and a photo of the shoes involved, see here.

4. Pottery Barn Wooden Hammock: Pottery Barn is recalling Wooden Hammock Stands, which, when use outdoors (where else would you put a hammock???) can deteriorate and break over time posing risk of falls and lacerations to users of the hammock. These Hammock Stands have been sold via the Pottery Barn catalog and website between March 2003 and July 2008. If you own this product, you are instructed to remove the two top side brackets of the hammock stand and dispose of the remaining parts of the stand. Contact Pottery Barn to receive a free pickup of the brackets (I guess proof you had the stands) and receive a merchandise credit. Just an aside: the hammock stands are made of wood. Did they not realize from the start that these would deteriorate over time when being used outside, as they knew they would, and break? That, in the products liability world, is called "foreseeability" which you much show to hold a manufacturer responsible for a defect in a product. For more information on this recall, see here.

That is all I have for you this week on recalls. Please remember to be careful out there, and if you need any further assistance regarding a recalled product or a product you have been injured by, please contact us either by calling the number shown above or filling out the "contact" form above.

Recalls of the Week

2008-09-28T21:49:47Z

That time once again to catch up on the significant products which have been recalled within the past week.

1. MacGregor and Mitre Folding Soccer Goals: I think every young child this day and age is introduced to the sport of soccer. I remember my kids when they were as young as 3 being out on the soccer field kicking a ball....and then picking their nose. Needless to say, neither of my sons pursued soccer. But i digress. The point is that many kids are exposed to soccer and thus this recall is of significance. These two soccer goals, distributed by Regent Sports, have a foldable white frame with a white net attached. These nets are being recalled in large part because a 20 month old child was strangled to death when his neck and arm got tangled in the net. The recalled nets, which were sold at Wal-Mart, Ace Hardware and sports and toy stores across the country between May 2002 through May 2008, have squares measuring 5 inches on each side. The MacGregor soccer goal has model number 97236 and the Mitre soccer goal has model number 89186. Bottom line, the openings in the netting are too large creating the potential hazard of children getting their head and body parts caught in the net. Look here for the CPSC information regarding this recall and for a more in depth report of the concerns related to soccer goals, including these, read this report from Consumer Reports. If you have one of these nets, take it down immediately and contact Regent Sports.

2. Simplicity Cribs: I have had two previous posts about recalls of Simplicity bassinets here and here. Now its the cribs. The CPSC has recalled 600,000...yes you read that correctly 600,000 cribs distributed by Simplicity at places like Babies "R" Us, Target and Wal-Mart. These cribs were sold between January 2005 and August 2008. It is reported that the drop side of the crib can come off the tracks and if it does, it can lead to entrapment and suffocation of the infant. For a complete description of those models affected, see here. As with the bassinet recalls, since Simplicity is out of business, you need to bring the crib back to where you purchased for a full refund. Consumer Reports has a complete discussion of this recall here.

3. Harry Potter Bookends: Some 36,000 of these Harry Potter bookends were sold through elementary school fundraising programs, as well as through various dollar stores between June 2004 and January 2006. The paint on the bookends contain excessive levels of lead. I guess being a wizard does not exclude you from being effected by the problems of lead paint. If you have these bookends, you are to return them to Giftco, the importer for a full refund. Go here for more information on who to contact regarding this recall.

4. Razor Powerwing 3-Wheeled Scooter: The Razor Scooters are still very popular, including one's that are now electrically powered. The Powerwing version of the Razor Scooters is a 3-wheeled version which was sold in black or silver. The undersides of the foot platforms can have sharp edges that can cut and lacerate kids riding the scooters. There have been 10 reports of Achilles tendon and ankle lacerations, some of which required surgery. If you child has one of these scooters (go here to see the specific models involved) you should have them stop using it immediately and contact Razor for a set of free replacement foot platforms.

Those are some of the more significant recalls over the past week. Remember, be careful out there. If you have any questions regarding any of these recalls, or any other products, you are welcome to contact me for further assistance.

New York Times Reports on Study Indicating Older Antipsychotics Better for Children

2008-09-16T17:35:50Z

The New York Times today is reporting about a study funded by the National Institute of Mental Health and reported in The American Journal of Psychiatry that drugs which are most often prescribed today to children suffering from schizophrenia, Zyprexa and Risperdal, are no more effective than the older, less expensive drugs used to treat this condition. More significantly, these newer drugs have been shown to be more likely to cause harmful side effects like rapid weight gain. In fact, it is reported that the children receiving Zyprexa gained so much weight that the government oversight panel monitoring safety during the study ordered that the children be taken off Zyprexa. The older drug used for comparison purposes was molindone. On average, those taking Risperdal gained about 9 pounds and those on Zyprexa gained 13 pounds. Both these groups also saw increases in cholesterol and insulin levels which are risk factors for diabetes. In contrast, those taking the older medication molindone gained less than a pound on average and had little changes in cholesterol and insulin levels. One 18 year old who was given Risperdal for several months gained 35 pounds.

The lead researcher on the study, Dr. Linmarie Sikich concluded that the guidelines for treating schizophrenia have to be changed so some of the older, more traditional medications are considered first line treatment. What is important to note is that more than 80 percent of prescriptions written for Zyprexa and Risperdal are not for schizophrenia, but for autism- related aggression, bipolar disorder or ADD issues which are not approved indications for uses of those drugs.

There are a few thoughts to take away from the results of this study. First, I have always believed that when taking medications, generally go for the one that has been on the market the longest because there has been time to really evaluate the potential adverse effects of the drug. It usually takes about 5 years or so for a drug to be on the market before the greater majority of the significant side effects can be seen. This is mainly because the amount of people involved in clinical studies used to get approval of the drug for sale is so small and selective that they can not truly evaluate problems with the drug in the general population. The other thing to be aware of is that many drugs are used "off-label" as is discussed above. In other words, doctors will prescribe the drug for conditions which have not been approved of by the FDA. You should question your doctor when he is prescribing medication about whether the condition for which he is prescribing it for is an "indicated" use or a use approved of by the FDA and addressed in the label for the drug. You shouldn't necessarily refuse to take the drug if it is being given for a "non-indicated" use, but find out from your doctor the basis upon which he relies on prescribing the medication for the condition he is seeking to treat. Yes, trust your doctor, but don't do it blindly. You need to ask questions and do your best to inform yourself about the medications he is prescribing for you and your family.

Recalls of the Week

2008-09-15T16:21:46Z

Its that time again to catch up on what significant items have been recalled over this past week. I try and pick items which have been sold to alot of people and/or the potential danger for which the product has been recalled is significant. So, here we go:

1. Graco and Simplicity Bassinets: I posted last week about the recall of Simplicity Bassinets, however further information has been developed regarding this very important and wide ranging recall. Some of the bassinets recalled include ones which have the "Graco" logo or the "Winnie the Pooh" motif on them. The one's with the Graco logo on them were sold between 2001 and 2004. The one's with "Winnie the Pooh" on them were sold between 2002 and as recent as 2008! As mentioned last week, Simplicity has sold its business and the company who now owns Simplicity is refusing to participate in this recall. However, most of the major retailers who sold these bassinets will provide a refund or store credit if you return the bassinet where you purchased it. These include Wal-mart, Toys "R" Us, Kmart, Target and many others. See here for a complete listing of those retailers who are participating in this recall. For a Consumer Reports article updating the problems with this bassinet, see here.

2. Zebra Rug sold at J.C. Penney: Animal rugs are the hit of decorators everywhere...or so my wife tells me. Well, a faux (fake for us non-decorator types) Zebra Rug sold at J.C. Penney is being recalled due to the fact they do not meet federal flammability standards. The rug measures 30"x54" and was sold through Penney's website and catalogue from December 2007-July 2008 for between $50-$70. You can either get a full refund or if you like it too much, you can get a warning label to put on the back side of the rug. For more information, go here.

3. "Protocol" Remote-Controlled Mini Helicopter Toys: About 78,000 of these remote control helicopters have been sold and are now being recalled because the rechargeable battery inside the helicopter can overheat which can result in the helicopter melting....yuck...and can lead to risk of fire and burns. The remote control mini helicopter toys have a model number starting with 1442 and were sold in retail stores all over the country between October 2007 and December 2007...that's right, just in time for this past Christmas. For a more specific description of the helicopter toys in question, read this warning from the CPSC here. You are instructed to take the toys away from your children immediately and contact the company to get a replacement helicopter.

The good news is, that is about all that was interesting in recalls this past week. The bad news is don't have anything more to write in this post for you. As always, remember to PLEASE be careful out there.

Recalls of the Week

2008-09-08T18:35:19Z

Back with the weekly post (okay, it hasn't been so "weekly" lately) addressing the most significant recalls of products over this past week. Let's see what we have to be concerned with now:

1. Sony VAIO Notebook TZ-series: Sony is recalling 73.000 of the TZ-series notebooks because the units can overheat and create burning hazards. One reported customer has actually indicated they received a minor burn. The CPSC reports that some wires near the computer's hinge or a dislodged screw is causing short circuit and overheating. Not all units of this series are affected and if you have one, you should contact SONY (888-526-6219) to see if your unit is part of the recall. If your unit is involved, SONY will provide an inspection and on-site repair at your home or office. Gives new meaning to the phrase "burning up the keys."

2. Simplicity Bassinets: In an unusual move, the CPSC issued a warning to parents (not an official recall) to stop using convertible "close-sleeper/bedside sleeper" bassinets manufactured by Simplicity due to two strangulations of infants trapped in the bassinets the CPSC learned about within the last year. One involved a 5 month old who just last month was strangled to death when she became entrapped between the bassinet's metal bars. The CPSC issued the safety alert instead of a formal recall because the company which purchased Simplicity is refusing to cooperate and recall the product. The bassinet has metal bars and the infants head can become entrapped in the bars and suffocate. If you have an infant that goes to a day care center or the like, you need to check to make sure they are not using this type of bassinet. Fortunately, many major stores which sold this product have voluntarily agreed to recall the product and provide a full refund or store credit to those customers who return the product to the store where purchased. These include Wal-Mart, Toys "R" Us, Kmart, Target, Big Lots and J.C. Penney. See this additional press release from the CPSC addressing return of these bassinets. Consumer Reports has two articles (see here and here) addressing this significant problem. Even the Wall Street Journal has gotten involved addressing the problem that there may be no company to hold "liable" for this problem, since the manufacturer of the bassinet, Simplicity, sold its assets to a company known as SFCA Inc. when it went out of business in April of this year. For now, the most important issue to get these defective bassinets off the market to insure other infants are not killed.

3. Sears Kenmore and Kenmore Elite Coffee Makers: Approximately 145,000 of the Kenmore and Kenmore Elite Coffee Makers sold at Sears and Kmart are being recalled because the wiring can overheat and create burn and fire hazards. You don't want to start up your morning cup of Joe in the morning to then come out of the shower and find your kitchen on fire. If you have one of these coffeemakers you should stop using it immediately. The recall includes the 12-cup Kenmore coffeemaker sold in black, white and red and the 12 cup Kenmore Elite coffeemakers with the thermal carafe and the 14 cup Kenmore Elite coffeemaker. These coffeemakers were sold at Sears and Kmart stores and online stores from August 2007-April 2008. Stop using the coffeemaker immediately and take it back to Sears or Kmart to obtain a free replacement. See here for more information.

4. Wolf Appliance Gas Ranges:Lots of fire potential going around. The Wolf Appliance 48-inch gas ranges with model numbers P48, PS48 and R48, which are stainless steel and have a double oven, are being recalled because a delayed ignition in the 18 -inch oven can cause a flash of flames to project out at the user when the oven door is open. These are very expensive models running anywhere from $5000-$9000. If you have this oven, you should stop using the 18-inch oven and call the manufacturer at 866-643-6408 to schedule a free, in-home repair. More specific information and pictures can be found here.

Those are the most significant recalls this past week. Keep your eyes open for new product hazards being found. If you come across something in your own daily life, feel free to contact me to discuss. Remember, be safe out there.

FDA Issues Further Warning on Diabetes Drug Byetta

2008-08-19T16:58:25Z

Yesterday, the FDA issued additional warnings regarding the drug Byetta, which is an injectable drug used twice a day to help patients who have type 2 diabetes. This was reported in both the New York Times and by ABC News. Back in October of last year, the FDA issued its first Information to Healthcare Professionals alerting physicians to the concern that patients taking this drug were reported to come down with acute pancreatitis, which is a very painful and potentially deadly infection of the pancreas. At that time, the FDA had received 30 reports of patients taking Byetta contracting acute pancreatitis.

Since then the FDA has received another 6 reports of acute hemorrhagic or necrotizing pancreatitis in patients taking Byetta. All of these patients had to be hospitalized and 2 died. The FDA has warned that if patients taking this drug come down with symptoms of unexplained and continuous severe stomach pain, nausea and vomiting, the use of Byetta should be stopped immediately. If you are taking this drug and do have any of these symptoms, contact your treating doctor immediately. At this time, the FDA is working with the maker of Byetta to add stronger and more prominent warnings.

Our firm assists individuals who have been injured by drugs or medical devices. If you need assistance, please feel free to contact us. I will continue to keep you up to date on further information provided regarding Byetta.

Wall Street Journal Reports New England Journal of Medicine Sides with Plaintiffs on Preemption

2008-08-18T18:21:45Z

As a follow up to my post at the end of this last week about preemption ( and yes, this is a really big issue as I see it so I post about it ALOT!), the Wall Street Journal reports that the New England Journal of Medicine (NEJM), the most respected medical journal in the world, filed a "friend of the court" brief with the U.S. Supreme Court in the Wyeth v. Levine case, supporting the position that preemption should not apply in pharmaceutical cases. Moreover, the NEJM argues that such lawsuits by injured plaintiffs are a "needed check to protect consumers from dangerous medicine." So even the doctors who prescribe medicines believe injured consumers should be permitted to sue pharmaceutical manufacturers even though the drug was approved for sale by the FDA. According to the Wall Street Journal, the NEJM signers say " its the first time that the full roster of current and former editors of the journal has come together on a court brief." The article goes on to discuss some interesting details regarding the brief filed on behalf of the NEJM:

The NEJM posse points to a string of problems with drugs as evidence that second-guessing the FDA is good public policy. In particular, they cite 23 drugs withdrawn from the market since 1997, including Merck’s Vioxx, Wyeth’s Redux and Pfizer’s Rezulin. “These examples demonstrate that the FDA alone cannot be the guarantor of drug safety,” the brief says. Click on the PDF icon to read the document.

In a particularly interesting twist, former NEJM editor Marcia Angell, for years the bane of trial lawyers, signed the NEJM brief supporting the rights of plaintiffs to press their cases. Angell had famously denounced junk science invoked in liability suits over breast implants in a book called “Science on Trial.” Though, we have to point out she more recently wrote a book blasting drugmakers: “The Truth About the Drug Companies: How They Deceive Us And What To Do About It.”

Lawsuits, she told the Health Blog, are now the only deterrent against misbehavior by drug companies because the FDA isn’t a reliable gatekeeper. “The FDA has been given over to the industry it regulates,” Angell said. Companies are “putting drugs on the market with insufficient evidence of safety, and keeping them there even where clear evidence of risk emerges — and the FDA has not take decisive or fast action.”

Here's hoping the Supreme Court gives due consideration to the thoughts of a highly respected and valued member of the medical community. When the one's who prescribe the medications are concerned about the power of the pharmaceutical industry over the FDA, it is indeed time to take note and do all that can be done to protect the injured consumer.