Alabama Product Injury Lawyer Blog

My weekly installment of the recalls that hit last week on consumer products. Let's get right to it:
1. MUNCHKIN DELUXE BOTTLE AND FOOD WARMER: When we were new parents with our first born, 17 years ago, the big craze was "wipe warmers". You would put your baby wipes in there and it would keep them nice and warm so at night when you had to change your kid, they wouldn't freak out from the cold wipe on their bottom. Well, Munchkin Inc., a company based out of California, makes a Deluxe Bottle and Food Warmer, which allows you to warm food and bottles of various sizes. (Guess the microwave ain't good enough or fast enough anymore.) Lot number TP-1487 (shown on the bottom of the warmer) is being recalled because it can overheat, leading fire. There were sold between June 07 and April 08. If you have one, call them at 866-619-8673 or see their website, www.munchkin.com.
2. 2008 HONDA TRX500 ATVs: This is a bad one. Many moons ago, as a young lawyer learning to defend auto manufacturers, I got heavily involved in defending various manufacturers of ATVs in cases in which the plaintiff was claiming ATVs were unstable and leading to the death and maiming of individuals, many of them young kids. They were very tough cases to handle as a young lawyer as the plaintiff's lawyers were very aggressive and it was hard to defend a product which was killing young kids who had no idea how dangerous these products could be. However, I always had a hard time understanding how a parent could allow a child to drive a machine which could go anywhere from 35-50mph or more and think they would be just fine with no supervision. I had a hard time letting my 15 year old get behind the wheel of a car, how could a parent allow a 10 or 12 year old child take off on a motorcycle type vehicle, with little or no training or no supervision. Dumbfounded me. Anyway, the 2008 Honda Model TRX500 4 wheeler is being recalled because apparently the electric power steering shaft can break, resulting in the rider losing control. This is BAD. Driving 40 or 50 miles and hour, in an open vehicle, the drive shaft breaks, you lose control and all that can happen is only bad. As Honda represents, "this poses a risk of injury or death to the riders." The problematic models were sold at Honda dealers between October 2007 through March 2008. If you have one of these models, STOP USING IT IMMEDIATELY!! Contact your Honda ATV dealer to get an appointment for a free repair. If you in fact had a problem with one of these ATVs and need some advice, you are welcome to call me for assistance.
3. PLAYWORLD SWINGSETS: Anytime I see problems with products meant for children, I will try and get the word out there to all of you. Children are the innocents (generally that is, don't forget, I do have teenagers). They don't know about "warnings" and "reading directions" and when it comes to taking risks, generally they will do it because of their lack of fear and feelings that they will live forever. A Playground Swing Set manufactured by Playworld Systems out of Pennsylvania, is being recalled becuase a part known as a "clevis bearing" can wear out and the swing can then detach and off the kid will go...or fly. This part appears to be the part that attaches the chain of the swing to the set itself. These sets...worst of all...were generally sold by dealers to daycares and children learning centers between January 2007 and February 2008. Therefore, if the daycare where you send your child got a new swing set in the last year or so, you may want to ask them to check it out and see if its one of these recalled swing sets. The part numbers for the swing sets that have this problem can be found here. Please check it out if you have any concerns. Like they say, better safe than sorry.

That raps up this past weeks significant consumer product recalls. Remember, be careful out there.

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

Posted In: Recalls , Recalls of the Week

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Have to give a shout out to this Blawg (didn't spell it wrong; blogs dedicated to legal issues are referred to as "blawgs") which is an absolute MUST read for any lawyer, plaintiff or defendant, doing pharmaceutical litigation. Drug and Device Law, which is a blawg written by two lawyers involved in the defense of the pharmaceutical industry, provides in depth analysis to legal issues facing the pharmaceutical lawyer these days in a smart, insightful, and yeah, many times witty manner. No doubt, these guys are not fans of plaintiff's litigation against the pharmaceutical industry and are huge proponents of preemption in this area of the law.....which strikes at my heart as you know from my previous postings on the subject.....but they are brilliant representations of what is good about the defense side of the business. I just wish sometime they might budge an inch or so .....maybe even just a millimeter....and throw a bone to us good and honest and hardworking lawyers on the plaintiff's side who are truly committed to what they are doing in the same vein that they are. You MUST put it a required reading every week if you are going to venture into this world of pharmaceutical litigation. By the way, these guys haven't paid me anything to say this. Just need to give props where it is due. (Got that word "props" from my 17 year old son.)

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Baxter International, the manufacturer of Heparin, the blood thinner recently pulled off the market because of alleged tampering of the product which was made in China, reported that it has not felt much legal ramifications from the problem. This is despite the fact there has been a reported 80 deaths and 1000 adverse reactions due to the problem.

What I find interesting is how Baxter is trying their hardest to paint this as a tampering issue. Essentially, they have told the FDA and the FDA has bought it that someone had intentionally tampered with the manufacturing process to cause this problem. Makes me start to wonder if Baxter is trying to lay the ground work for its defense in these potential cases. It would be a lot easier to argue to a jury that someone intentionally was trying to sabotage our drug, then having to explain that they had not undertaken the proper inspection of the chinese facility and as a result, something mistakenly got into the drug.

There are several of these cases I am looking at where individuals were given heparin and they had an adverse reaction. Since this issue only came to pass over the last several months, the number of lawsuits Baxter may have to contend with as a result of this "mistake" remains to be seen.

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The second installment of Recalls of the Week. A few interesting items have shown up this week.

1. BROIL KING GAS GRILLS: These gas grills, which were sold at various independent retailers throughout the country, are being recalled because the cook box where the burners are can melt or crack and cause a grease fire. There are about 4800 of these grills and include the Signet, Sovereign and Sovereign XL series. You should stop using the grill immediately and contact the manufacturer, Onward Manufacturing for a free repair kit. You can find more information at www.broilkingbbq.com or call 886-434-7455. You can also go to the CPSC's website here for more information.

2. CHILDREN'S STORAGE BINS (LOWE'S STORES): Another lead paint issue from China. These are wooden bins with scalloped edges that were painted pink or green. It is requested you take these bins away from children and return to Lowe's for a full refund. For more information, go here.

3. QVC SPACE HEATERS: If you were up late one night with nothing to do and turned on QVC and found the urge to order that bargain of a space heater to keep you warm, you better pack it up and send it back. The SoleusAir Space Heathers can overheat and potentially cause a fire. They were sold through QVC between December 2007 and March 2008. If you bought the heater through QVC.com or the TV program, you should receive something in the mail about how to get your refund. You can look here for more information. Oh yeah, forgot to mention, made in China again.

4. CARDINAL HEALTH MOUTHWASH: Hydrox Labs, who manufactures Cardinal Health alcohol-free mouthwash is recalling the mouthwash because it apparently contains a bacteria which is known to cause infections in patients in the hospital. It is especially serious in consumers who have Cystic Fibrosis. It is the 4 oz. size that is at issue with lot number 26228. The FDA has issued a statement about this recall which can be reviewed here. It's interesting to note that apparently this mouthwash is placed in Personal Hygiene Hospital Admissions Kits and this same mouthwash, if you decide to use it in the hospital, may in fact make you a lot sicker than when you got there. Not a good thing.

Until next week, please be careful out there. Also, if you do need any help or guidance on any of these recalls, please feel free to contact me.

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Since early February the FDA has been dealing with contaminated Heparin that was causing patients to have allergic reactions including problems breathing, nausea, vomiting, and rapid drop in blood pressure which can lead to life threatening shock. The type of Heparin at issue is typically given to dialysis patients during the dialysis procedure. At this point, the FDA is aware of approximately 131 reports of death related to being given heparin between January 07 and April 08. The significant jumps in death reports started in Nov 07 through end of February 08 when 81 of those 131 deaths occurred, prompting the FDA to call for ending the use of Heparin. As fate would have it, the problematic doses of heparin were manufactured by a company in, yup, good 'ole China.
Congress has been having hearings for several weeks now trying to get to the bottom of this problem, specifically addressing the failure of the FDA to properly and timely inspect the facilities in China who were manufacturing this product. In order to avoid this happening in the future, Congress has been trying to get the FDA to tell it how much money it needs to properly and timely inspect these foreign manufacturers and have been stonewalled by the FDA officials regarding its needs to properly undertake these inspections.

Just this past Tuesday, Jane Woodcock, director of the FDA's drug center, indicated that the FDA is now working on the hypothesis that this contamination of heparin was INTENTIONAL!!! They believe that someone(s) purposely contaminated this drug to cause people to get ill. Some are saying this is the most significant case of poisoning since the contamination of Tylenol back in 1982 when someone laced Tylenol with cyanide.

One of the Congressional investigators told Congress that this all could have been avoided if there was some oversight of this plant. Apparently, the distributor of the drug, Baxter, has purchased ingredients for heparin from the Chines plant in question between 2004 and 2008, but only visited the plant once, in September 2007. It is reported Baxter sent one person for one day to look at the plant at that time. However, 5 months later when the FDA went to the same plant after this problem came to the surface they found tons of problems. The congressional investigator, David Nelson's thoughts on this apparent 5 month "change" in the plant from fine when Baxter looked at it to horribly out of compliance when the FDA looked at: "It really is impossible for a plant to have fallen that far out of compliance in five months." So what was the Baxter official doing during that inspection...enjoying some good Chinese food????

This continues to be an interesting story as it develops. Another drug company caught with egg on its face and not spending the money to properly address safety of its products. I am in the process of evaluating several cases where patients appeared to be injured as a result of being given heparin during dialysis treatment. If you or someone you know may have been a victim of this tragic situation, you are welcome to call me to discuss.

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Posted In: Drugs , Heparin

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Today is officially my one month "blogging" anniversary. What, no candles??? I have decided in honor of this significant event that I am going to begin a new weekly feature. You guessed it.....RECALLS OF THE WEEK. My plan is to provide short blurbs about various recalls that have occurred in the past week in the world of drugs, medical devices and general consumer products, providing a link to where you can obtain more information regarding these recalls. It will not be all inclusive, but I will do what I can to provide you some information on recalls which may impact your daily life. So, without further adieu (or something like that), here is the first installment of RECALLS OF THE WEEK:

1. LAWNBOTT LAWN MOWERS: The Consumer Products Safety Commission (CPSC) and the manufacturer, Kyodo America are recalling these lawn mowers because the blades continue to rotate when the mower is lifted from the ground and there is enough space on the side of the mower that your foot could get caught and struck by the blades....ouch. These mowers were sold between Jan. 2006 and Dec. 2007. Here is the link to the CPSC's page regarding this recall and Kyodo America's web page.

2. ELECTRIC SIMMER POTS: CPSC and Waxcessories, Inc recall electric simmer pots which are used to melt scented wax in a ceramic cup. The pots have wire connections that can become loose, potentially causing shock or a fire. These were sold at gift and novelty shops between 2002 and April 2008. Yup, made in China. This is the CPSC link to this recall and here is Waxcessories link.

3. BECO BUTTERFLY INFANT CARRIERS: CPSC and Beco Baby Carrier, Inc. issued a recall of the Baby Butterfly Carriers. They are infant carriers used to hold a baby like a back pack, but the baby is on the front of your body. The buckles on the shoulder straps can lose tension, potentially allowing the baby to hit the ground. These were sold between January 2008 and February 2008. The CPSC link to this recall is here and the Beco Baby Carrier's website is here.

4. 2006-2008 HYUNDAI SONATA: Hyundai is recalling these vehicles because of a significant problems with its advanced air bag system. In the right front seat, the vehicle features what is known as an Occupant Classification System (OCS) which is suppose to determine when there is a small child sitting in the front seat and if so detected, automatically disable the right front airbag. This is because an airbag can do more harm than good to a small child or infant in a car seat. Apparently, the system is misclassifying a small adult as a small child and disabling the front air bag. This is not good. The recall is to begin in about a month. You can contact Hyundai at 1-800-633-5151. The information provided does not indicate what you should do in the meantime i.e. until you have the recall fix performed. You might want to consider not having small adults sit in the front passenger seat. The link to the National Highway Traffic Safety Administrations' discussion of this recall is here.

5. DIGITEK (DIGOXIN TABLETS): A recall has been announced of the generic drug Digitek, all strengths, which is the drug known as Digoxin. This is a drug used to treat heart failure and abnormal heart rhythms. It is reported that double the appropriate thickness of the pill has been released which means the patient will essentially get twice the dose they should be getting. This poses a risk for patients taking this drug who are in kidney failure. It can cause nausea, vomiting, dizziness, low blood pressure and cardiac instability. Death can also occur from taking too much of this drug. The information regarding this recall from the FDA can be found here, and the manufacturer's information regarding this recall can be found here.

That's the most significant recalls I could find for the past week. If you have been effected by any of these recalls and need legal advice, I am available for a free consultation. Be careful out there.

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

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For those of us lawyers who have been fighting Big Pharma over the last many years, the issue of drug companies "ghostwriting" studies about their drugs and then having doctors sign on to the studies to give them credence, has been one actively pursued. Last week, one of the most prestigious medical journals, Journal of the American Medical Association (JAMA) took this issue head on in addressing documents which have been uncovered during the litigation that has transpired regarding Vioxx and its manufacturer Merck. The article discussed how Merck drafted dozens of research studies regarding Vioxx and then paid prestigious doctors to put their name on the study to make it look like the study was done by "independent" doctors. Literally, with "ghostwriting", the drug companies hire marketing companies to help them write up the results of the study and to give the study the most positive spin. The drug companies then hire doctors who were not even involved in running the study and have never reviewed the detailed information regarding the results of the study, to sign off on the publication so it can be submitted to a medical journal and have some credibility.

As the New York Times reported, the JAMA article discussed one study by Merck on Vioxx which indicated Merck was still looking for a "big-name researcher" to sign on to the study. The draft of the study identified the lead author as "External author?" indicating Merck was still trying to find a doctor who would vouch for the study. The lead author of the report in JAMA, Dr. Joseph Ross indicated "It almost calls into question all legitimate research that's been conducted by the pharmaceutical industry with the academic physician."

The real problem with these type of studies that are done and drafted by the drug company and a "spin doctor" they hire, is that it is an attempt to "pollute" or manipulate the information out in the public domain on these drugs. Once these positive studies are published, the drug companies will use them to promote their product to doctors, with the doctors having no idea the information has been manipulated in such a manner as to give the most positive spin on the information developed from the study. Additionally, if there is ultimately litigation involving the drug, the lawyers for the drug companies will use all these slanted studies to show the court that there is no problem with the drug.

This information came to light just at the right time. The FDA is in the process of considering a proposal which would allow drug companies to use articles printed in medical journals to promote the use of the drug for "off-label" use or for uses not approved by the FDA. As an example, with hormone therapy which was approved to give to woman who were experiencing symptoms of "the changes" such as hot flashes, etc..., it has been found the the pharmaceutical companies making these drugs were promoting these drugs to also help woman with their heart, which was not approved by the FDA. This article that has been published in JAMA now calls into question these articles the drug companies would use to promote these off label uses since they the studies are being "ghostwritten" by some for-profit company and the drug companies then search out doctors to sign off on the studies. Several groups have now objected to this FDA proposal including the New York State's health commissioner and the Blue Cross Blue Shield Association , a trade association made up of 39 major health insurance plans.

I don't have problems with off label uses of drugs and doctors always have the ability to prescribe drugs for uses that have not been approved by the FDA. But if drug companies are allowed to use studies which they have bought and paid for to promote off label use with the doctors who are prescribing the medications, doctors may not be provided with all the necessary information needed to determine whether the potential benefits outweigh the risks of taking the drug. Experience has shown that in studies published by "ghostwriters" on behalf of drug companies, the risks are always downplayed and deemphasized, if mentioned at all, opening the door to problems on an unsuspecting doctor and his patient.

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Posted In: Drugs

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You remember back in 2001 or so, all the publicity about Ford Explorers rolling over and a big fight between Ford and its tire supplier about who was at fault; bad manufactured tires or a poorly designed vehicle. Well a class action was also filed at that time in California claiming that all that bad publicity reduced the resale value of the Explorers. After 7 years, Ford has settled these lawsuits which involve people in California, Connecticut, Illinois and Texas with Explorers of model years 1991-2001. Its one of those deals where the plaintiff's lawyers made a lot of money....reported to be $25 million...and all the consumers received were $500 vouchers to buy a new Explorer. Thanks, but in times of gas being almost $4.00 /gallon, what the heck do I want with another of your poorly designed vehicles which suck down gas. Even being a plaintiff's attorney, I have to say I'm not sure this is the best deal for the consumer. The judge indicated "It's not perfect...but its likely that a lot of people would have gotten nothing." The plaintiff's lawyer added that it also helped to contribute to safer vehicles.

Having done automobile products liability work for 18 years representing the car manufacturers
before I became a plaintiff's lawyer, I feel very confident that to the extent Ford has improved the design of its SUVs including the Explorer, it has been related to the countless number of lawsuits related to the severe injuries and death caused by a vehicle which was unreasonably unstable with a significant potential to rollover on dry smooth pavement. I'm not sure this action really would have had much effect on Ford changing the design of its vehicles. I have to agree on this one that the plaintiff's lawyers.....and the defense lawyers charging Ford very high hourly rates, were the real winners in this matter.

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Sorry its been almost a week since I've posted, but been running around looking at colleges with my oldest son who is a senior in high school and graduating in about a month. Amazing the way these almost 18 years have flown by. All I can tell you is no matter what you save for your child's college education, it will never be enough. The college financial system is broke and needs to change soon or it will all come crashing down.

Anyway, saw this little blurb that I just had to comment on. The fake "Hillbilly Teeth" have been recalled because the paint used has too much lead in it. When we first moved to Alabama almost 11 years ago, I think I bought a pair of these and wore them to my old law firm's main office in Florida. Since I knew what some at my old firm thought of those in Alabama, thought I'd show them I fit in now that I lived there. What they have never figured out is Alabama is the best kept secret. Figured this would help keep them away and leave all the great things we have here to those of us who know how truly amazing this place is. Of course, that was before the days of everything made in China and the lead paint they love to use over in China. Well guess what??? The "Hillbilly Teeth" are made in China and they continue to use lead paint. Guess if you wear these fake teeth long enough you won't need them because your real teeth...what you have left....would look just like the fake ones.

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The Associated Press reported yesterday that most of the Big Pharmaceutical companies have decided to begin to disclose information regarding the members of the medical community they pay to do presentations at educational conferences. What you may not know is that virtually all the major pharmaceutical companies pay doctors throughout the country to travel to exotic locations i.e. Paris, Rome, the Virgin Islands to name a few, and to give presentations at "educational conferences" that other doctors attend. In the medical world these are known as CMEs (continuing medical education). In the past, the drug companies did not have to disclose who the doctors were they were paying to do these CME's and what perks they were being provided i.e. free trips, gifts, money and the like. The concern is that this could effect medical care because these doctors would tend to promote the drugs for the companies that provide them all these "favors."

Having friends of mine who are Drs. that have been taking part in this ritual, I have to admit that there is a part of me that's jealous. The best I've received from different groups who have requested me to give seminars on trying pharmaceutical cases or addressing legal issues like production of electronic evidence (alot of good stuff is kept on company computers as you can imagine), has been an umbrella. Now granted, it was the biggest umbrella that I have ever seen and there are days in Alabama when I am truly happy I have it. But I have yet to receive an offer for an all expense paid trip to some exotic location, as well as payment for my time, just for me to speak about an issue I know alot about. My mom always did want me to be a doctor.

I digress. Anyway, Congress has been looking out for us and are in the process of trying to pass legislation that will require drug and medical device makers to disclose anything of value given to physicians. When told this was coming, most of the major pharmaceutical companies agreed that they would proceed to begin to provide such information. Just to get an idea of how big this issue is, Eli Lilly, who voluntarily started reporting this type of information last year (thank you Eli Lilly), gave almost $19 million in one quarter of 2007 for these "grants" as they refer to them. Over a year, that could come to almost $80 million dollars....and that's just from one company!!! Knew I should have listened to my mother! (Good thing she doesn't use the internet!)

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Posted In: Drugs , Pharmaceutical Companies

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Continuing on with some other points made by the Reader's Digest Article regarding the problems with the FDA, the following issues of concern were raised:

3. Safety of New Drugs: The studies used by the drug industry to obtain approval from the FDA are so small and for such a short period of time, that the true safety of the drug cannot be determined before it is approved for marketing. As the article points out, typically, the studies used to obtain FDA approval only involve between 600-3,000 people and often only go on for a couple months. The studies also focus on specific type of people and often keep out people with any other problems other than the problem the drug is seeking to address. Therefore, once it gets on the market and used by the greater population who may have many other ailments other than the one which the drug addresses and be on many other medications at the same time which interact with the new drug, we all of a sudden see many other problems the drug can cause. As an example, this is one of the problems that arose with the drug Baycol which was ultimately withdrawn from the market. Baycol was a statin/anti-cholesterol drug, like Lipitor and Zocor, which was marketed to lower your cholesterol. People with cholesterol problems may also have a problem with their triglycerides. Historically, doctors will also prescribe a drug known as Lopid or gemfibrozil with the statin drug to also address the triglycerides. Even though this happens on a regular basis, when Bayer did its pre-marketing testing of Baycol, it never addressed Baycol's usage with Lopid. Ultimately when it obtained approval and Baycol began to be sold, it was found that people who took Baycol and Lopid together had a signficant increased risk of developing the condition of rhabdomyolisis which I discussed in one of my previous posts. Bayer never addressed using its drug Baycol with a drug which is commonly prescribed with a statin type drug, therefore no one knew how patients would react until it was on the market. The question arises, shouldn't the drug manufacturer be required to evaluate use of its drug with the types of drugs it is expected to be co-prescribed with? This is not required by the FDA and typically is never done. Moreover, many drugs are approved subject to the drug company performing additional testing. However, as the article points out, the FDA can't enforce this agreement to do further studies and 65% of the studies that have been promised in recent years have not even been started.

There have been some recent changes instituted by Congress which should help this. More money has been provided to the FDA to improve drug safety. Also, FDA can now require companies to follow the long term effects of their drugs or face fines of up to $10 million. Also, companies can no longer cherry pick the tests and studies they publish and deep six the bad ones. All clinical studies have to be published within one year of completion. But, according to the article, companies can wait 3 years to publish summaries written for the general public to understand. It is definitely a step in the right direction.

4. The article goes on to discuss other problems at the FDA such as shutting up FDA employees who have something bad to say about a drug or FDA advisory boards which provide the FDA with recommendations of what to do about a particular drug, with over half their members being paid by the drug companies in some form or fashion. The question then becomes, are you going to bite the hand the feeds you???? (Yeah, my own dog has done that, but only when I was taking a bone full of meat out of her mouth.) There have been attempts by Congress to remedy some of these problems, but we still have a long way to go till we have a properly funded and fully independent FDA who can really do the job it has been given to do....protect us from unsafe drugs and food.

Which brings this all around to that nasty issue of preemption. If the argument goes that we should leave it to the FDA to decide what drugs are safe and what are not, and what warnings should be given for these drugs, and not to our court system and individuals who cannot understand the difficult scientific and medical issues which need to be balanced when addressing the sale and marketing of a drug, the argument assumes we truly have an agency who has all the tools to make those decisions in a proper and unbiased manner. What this article points out in so many ways is that at this point at least, we do not have such an agency. Yes, things are being done to improve the process and to give the FDA more autonomy from the drug industry in making these important decisions. However, much work remains before we can all feel confident that the pill we are putting in our mouth won't do something to us that we don't know about, and that Big Pharma forgot to tell us about. Thus it is important that the right remain to the court system and the jury system to determine if the public...and the FDA....was given all the information necessary to make a decision whether the drug at issue is safe.

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Posted In: Drugs , Pharmaceutical Companies , Preemption

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In some of my earlier posts I have made comments about how, when there is bad news about a drug, for some reason there is a delay in getting this "bad" information out to the public. With the recent release of the ENHANCE study indicating Vytorin really didn't do any better than the old anti-cholesterol standbys like Lipitor and Zocor, questions have been raised about why Merck, the manufacturer, delayed letting this information out for several months. In Pharmalot, one of my favorite blogs addressing information about the drug industry, this issue is addressed head on in a quote by Joel Haye, professor of pharmaceutical economics at USC, who, addressing Merck's actions with regard to disclosing the results of the ENHANCE study said:

"The longer they could keep sales up, the more tens or hundreds of millions of dollars they’d bring in. It took them two years to release the clinical trial results. That gave them huge additional dollars of revenue. In the case of Merck you really have to wonder. This isn’t their first situation along these lines. It’s really starting to hurt their reputation. They seem to get into a stonewalling mode, which is not in the best interests of the company. It needs to promote science above all else.”

When will they get the message that such gamesmanship only hurts their reputation and more importantly, potentially affects the health and welfare of the public.

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Posted In: Drugs , Vytorin

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