Alabama Product Injury Lawyer Blog

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.

Posted by Craig P. Niedenthal | Permalink | Email This Post | Comments (0)

Posted In: Byetta , Drugs

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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.

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Posted In: Preemption

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I have written several earlier posts on the issue of preemption and how important it is for the average American to understand how significant this issue is to your right to have your day in court. This fall, the U.S. Supreme Court will be hearing and deciding the case of Levine v. Wyeth. The issue has caused such a stir that 47 our of 50 state attorney generals submitted "friend of the court" briefs to the Supreme Court about this issue supporting the right for people to continue to be able to sue about a product even thought a federal agency such as the FDA has approved the drug for sale. One of my favorite sites, Pharmalot, has a post on this and links to the various briefs that have been submitted to the Supreme Court on this issue. Boston Globe also has article discussing the filing of the 47 "friend of the court" briefs by the various state attorney generals.

What I find most interesting is that this is a "states rights" issue. That is, even if the federal government through its agencies approves a product for sale, states should still have the right, through its court system, to allow its citizens to seek redress if they are injured by these approved products. Historically, "states rights" and the concept of smaller federal government has been a big issue supported, at least in words, by the Republican party. However on this issue, as shown by George Bush's push to have various federal agencies include language in their rulings indicating the agencies rulings preempt state law, the Republicans have pushed hard to have preemption be the law of the land. Guess the support of big business and corporate America over the average consumer, wins out over "states rights". Why??? One word answer....$$$$.

Posted by Craig P. Niedenthal | Permalink | Email This Post

Posted In: Preemption

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Time for the weekly updates on recent recalls. Here's what is new and interesting:

1. Fisher-Price Learning Pots and Pans:The Learning Pots and Pans toy sets with stackable pots and pans has a lid and shape-sorting blocks. The model number is G6685 which number is located on the bottom of the blue pan that comes with the toy set. This toy pan is missing screws and the clear plastic cover can come off releasing small balls which can become a choking hazard to young children. These were sold in toy stores throughout the country between October 2007 and August 2008. If you have this toy, you should immediately check the bottom of the blue pan (see here) and if all six screws are not installed, you should contact Fisher-Price at (888) 521-0820 to address replacement of the pan.

2. Atico International Personal Blenders: These blenders, called Signature Gourmet and Crofton Personal Blenders, , are being recalled because when you place the cup on or off the bender, it can inadvertently turn on and activate the blade, creating a risk of serious laceration i.e. taking off a finger. Approximately 124,000 of these blenders were sold at Walgreen's (Signature Gourmet) from July 2006 through March 2008 and Aldi stores (Crofton Blenders) from May 2007 thought March 2008. You should stop using the blender immediately and call Atico, the manufacturer at (877) 546-4835 for return instructions and to obtain a full refund. For more information, see here.

3. Perfect Flame Gas Grill from Lowe's Stores: Perfect Flame Gas Grills sold at Loew's Home Centers between October 2007 and July 2008 are being recalled because the cooking chamber of the grill can ignite, posing risk of fire and burn injuries. The model affected is the GAC3615 four burner LP gas grills. The model number and serial number is printed on the label on right side cart frame panel. For the serial numbers involved in the recall see here. If you have one of these grills, you should stop using it immediately, disconnect the propane tank and return the grill to Loew's to receive a full refund.

4. Viapro 375mg tablets: Viapro supplement capsules are sold over the counter in retail outlets nationwide and were last sold in March 2008. A lab analysis was done on the product by the FDA and was found to contain a potentially harmful ingredient which is similar to the drugs contained in Viagra and Levitra type pills, medication for erectile dysfunction (ED). This can interact with nitrate related drugs like nitroglycerin and can lower blood pressure to dangerous levels. You should stop using this product immediately and call you physician if you think you had any reaction related to this pill. For more information, see the FDA's website here.

Actually a pretty slow week as recalls go. Maybe too many people watching the Olympics!? Have a great week. Be careful out there.

Posted by Craig P. Niedenthal | Permalink | Email This Post | Comments (0)

Posted In: FDA Recalls , Recalls , Recalls of the Week

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Everyone breathe a sigh of relief....I am back! Have to apologize for my lack of posting the last month and a half. I had some major issues going on in my life including the passing of my Dad and the passing....I mean leaving of my paralegal. In between all that, I attended a conference for lawyers who fight the good fight for the everyday folk so it has sent my life into a bit of turmoil. However, things are getting better everyday. A brand spanking new....and very competent and hardworking paralegal has started working with me this week (welcome Therese!), my older son Alec (the writer) is getting ready to leave to explore his life as a college student, my younger son Blake just returned from a summer at camp in Maine (tough life) and my wonderful and supportive wife is here by my side. So bottom line....I will start posting again on a regular basis and do my best to keep you aware of issues related to defective and dangerous products. Which brings me to this weeks catch up version (great segway) of Recalls of the Week. So here are the most recent one's of most significance:

1. DEWALT Cordless Brad Nailers: The DC608 Model of this DEWALT Cordless Brad Nailer is being recalled because it can still operate even with the safety in the locked position. This can cause the unexpected ejection of a nail which can cause serious injury to an unsuspecting consumer. The date codes, found on the underside of the handle once the battery pack is removed, are 200728 through 200821. In addition, "DC608" is located on the right side of the magazine. These Nailers were sold between October 2007 and May 2008. If you have one of these Nailers, you should stop using it immediately and contact DEWALT at (866) 220-1481 to get a free repair.

2. Sky Scrambler and Sharper Image Wireless Indoor Helicopters: Remote controlled helicopter toys sold as the "Sky Scrambler" and the "Sharper Image Wireless Indoor Helicopters" are being recalled due to potential for fire and burn hazards. About 685,000 of these toys were sold at various department stores, drug stores and retain stores throughout the country between June 2007 and May 2008 for about $20. The rechargeable lithium battery in these helicopters can overheat, catch fire and ignite, creating a potential for fire and burns. The toy helicopters have yellow, red or blue decals. "BH26047" is printed on the tail of the Sky Scrambler and "The Sharper Image" is printed on tail of the Sharper Image helicopter toys. You should stop using these helicopters immediately and contact the manufacturer Innovage at 866-672-2630 to obtain and full refund.

3. Santorini Chair Sold at Cost Plus and World Market: The Santorini chair, which is a outdoor black metal stacking type chair that has vertical bars on the seat back and horizontal bars across the seat part, was sold at Cost Plus and World Market Stores. The seat weld can fail which would allow the chair to collapse. The chairs were sold between January 2008 and April 2008 for about $50. If you have one of these chairs, you should stop using immediately and return to Cost Plus or World Market for a full refund. Only seats with weld joints on the side of the seat are included in the recall. Chairs with rear weld joints in the seat area are not included in this recall. For more information, go here.

4. Reebok Exercise Cycles: This is for all you fitness fanatics who head off to the local gym to work your body into exhaustion, of which some may say I am one. Reebok's Studio Exercise Cycles, the type you see in cycling classes at the gym are being recalled because the cranks on the cycles can break during use causing lacerations. The recalled bike is black with silver cranks. It has an internal belt drive. There is a Reebok logo on the side of the cycle that shows a person riding a bike. The bikes were sold to fitness centers between 1997 and 2000. If your gym is still using these bikes, have them contact Reebok at 800-382-9823 and they will recieve a discount on the current model. The gym should also remove the cycle from use immediately. Reebok's website has more information here.

5. Honda ATVs Recalled: The 2007-2008 TRX 420 Rancher Honda ATV, of which approximately 42,000 have been sold, have been recalled because if the rubber constant velocity (CV) boots get punctured or torn, the joint will become contaminated and could cause severe binding of the CV joints, resulting in sudden loss of steering. This model is also referred to as the Honda FourTrax Rancher 4x4. These are adult sized ATVs and designed to be used by riders 16 and older. The Honda name and wing logo are printed on the fuel tank. The model year is on a label located on the frame behind the left front wheel. The defective ATVs were sold at Honda ATV dealers between January 2007 and May 2008. If you have one of these ATVs, stop using it immediately and contact your Honda ATV dealer to make an appointment for a free repair. For more information, go to Honda's website.

Continue reading " RECALLS OF THE WEEK------RETURNS (and so do I) " »

Posted by Craig P. Niedenthal | Permalink | Email This Post

Posted In: Recalls of the Week

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