Now, as reported at Pharmalot, one of my favorite websites for information on the drug industry, Alison Bass, a reporter at the Boston Globe in the 1990s, has written a book to be published this week entitled "Side Effects: A Prosecutor, A Whistleblower and A Best-Selling Antidepressant on Trial". Pharmalot's post includes a great interview with Ms. Bass. Among other things, when asked about what she learned from investigating the suicide issue and the SSRI Paxil, she had these thoughts:

"There has to be full disclosure of clinical trial data. And doctors have to acknowledge when they have conflicts of interest. Major academic centers should have requirements that doctors aren’t allowed to earn more than ‘X’ amount from a drug company. As I wrote in my blog recently, Marty Keller, the principal Paxil investigator at Brown University for the 329 study, acknowledged receiving consulting fees from Glaxo, but never reported them on his tax return. Researchers who are getting lucrative personal payments should be prohibited from studying these drugs if they’re making more than whatever minimum is established by the institution. But you know, these studies are a great source of income for these institutions."

As Ms. Bass explains and what is most concerning is that this is not a problem with just Paxil and SSRI's. It is a much deeper and more widespread issue across the pharmaceutical industry as a whole, as we have continued to see with drugs such as Vioxx, Vytorin and Trasylol. We as consumers, must continue to press our legislators and these corporations to incorporate protections and practices which will allow the consuming public to feel that all that is known about the drug at issue, including all potential safety issues, have been disclosed

1. Ski-Doo Snowmobiles: Over 400 of these snowmobiles imported to the U.S. by BRP U.S. Inc. have been recalled due to friction between the fuel hose and cylinder head cover which can cause the hose to pierce. As a result, fuel can leak out and cause a fire. The recall includes 2007 and 2008 Expedition TUV V800 in Deep Red/Black and the 2007 and 2008 Skandic SWT V-800 in Yellow/Black. If you have one of these snowmobiles, you should stop using it immediately and contact a Ski-Doo dealer to get a free repair. For more information, go here. Considering global warming and how hot it is already, guess now is a good time to get that snowmobile fixed up anyway.

2. Playsafe Spinning Quad Merry-Go-Rounds: Last week, I reported on a swing set that was being recalled and this week its a Merry-Go-Round. Of all things, products made for children's use must be manufactured with all do care. However, often it seems its all about the money. According to the Consumer Product Safety Commission, about 15,000 of these Merry-Go-Rounds were sold at Toys R Us between January and March 2008. A bearing on the merry-go-round can fail, causing the seat assembly to break off and fall to the ground. Clear hazard to those children riding the merry-go-round. Consumers are instructed to immediately take the merry-go-round away from children (that will be fun) and return to Toys R Us for a full refund. Go here for more information.

3. Children's Overalls by Sara Lynn Togs: This is one hitting close to home. All you Auburn and Alabama fans play close attention. If you purchased for your child or your friend's child some overalls with the Auburn or Alabama emblem on them and they were made by Sara Lynn Togs, you need to get those overalls back to the store for a refund. The buttons on the shoulder straps can detach and children can then choke on them. Go here, to see what the overalls looked like. The specific overalls/shortalls are in gingham or flannel. Sizes included in the recall are 6/9 months, 12 month, 18 month, 2T, 3T and 4T. These overalls were sold at college bookstores, fan stores, children's boutiques and gift shops from March 2007 through February 2008. You need to return them to Sara Lynn Togs for a full refund. Roll Tide/War Eagle!

4. Sauna by Airwall: Ever lay there in a nice hot sauna and think to yourself...."what would I do if I got locked in here and the heat never went off"...at the least claustrophobia hits in. Well, Sauna by Airwall, Inc. distributes the Infra-Red Sauna Rooms which were sold by Sauna By Airwall dealers nationwide between November 2006 and April 2008 which can have a failure of the heating unit and fuse, leading to overheating of the saunas. These saunas are made of wood and include model numbers IC I, IC II, IC III, IC IV and IC V. If you have one of the saunas, you should immediately stop using it and disconnect it from the power source and call collect to 562-630-2283 to get a full refund. Go here for more information and to see photos of the saunas in question.

5. Morphine Sulfate Extended Release Tablets: This is an expanded recall of this drug. More lots of 30 mg and 60mg morphine sulfate extended release tablets are being recalled due to the possibility of the tablets being oversized and therefore giving the patient more of the drug then was intended. The oversized tablets could contain as much as twice the labeled amount. The lots in question were distributed by ETHEX Corporation between June 2006 and May 2008. Go the the FDA website regarding the recall for the specific lot numbers involved. The risks involved in taking these potentially double dose tablets include difficulty or lack of breathing, low blood pressure and apnea. The 60mg tablet is white, oval, with "60" on one side and "E" on the reverse side. The 30mg tablet is pink, oval and "30" on one side and "E" on the reverse side. You can contact ETHEX at 1-800-321-1705.

Busy week in recalls. Remember, be careful out there. Until next time....

1. Children's Place Camouflage P.J.s: When I first saw this, I assumed it had something to do with flammability issues as are most recalls on P.J.s But no, its the hot topic of the last several months...LEAD. The screen print on the shirt of the P.J.s, which says "Athletics 90", contains excess levels of lead. There have been about 28,000 of these sold and involves both long and short sleeved versions. They were sold at Children's Place between December 2006 and January 2008. You are directed to stop using them immediately and take them back to Children's Place for a full refund. For more information, go here.

2. Crate and Barrel Shag Rugs Catch Fire: And I don't mean in a good way. The Remy Shag Rugs which have been sold at Crate and Barrel in Red and White between January 2007 and April 2008, through catalogue and in-store are being recalled. These rugs can catch fire too easily. Not something you want laying near the fireplace. You should stop using the rugs and call Crate and Barrel and they will pick up the larger rugs and give you a refund and with the smaller rugs, you can return for refund or just get a label put on it telling you its flammable. Apparently, smaller rugs can be flammable, you just have to warn about it. Not sure this makes alot of sense. Here is the complete information on this recall.

3. Backyard Leisure Swing Set : Those really nice wooden swing sets, sold as Adventure Playsets brand at Walmart and Create N Adventure brand at Toys "R" Us and sold between January 2008 and May 2008 are being recalled. The hangers holding the chains for the gliders can break and the child can fall and get injured. 114 reports have been received thus far regarding this problem and there have been about 11,000 of these swing sets sold. You need to remove the gliders from the swing set immediately and contact Backyard Leisure (866-546-7902) for replacements. Go here for more information.

4. Tomatoes: You say tomato, I say....DON'T EAT IT! This is a killer for me because I try and eat alot of tomatoes given how healthy they are and especially for men and the ole' prostate. However, the FDA is warning consumers nationwide that certain raw red plum, red Roma, red round tomatoes have been linked to salmonella. You CAN continue to eat cherry tomatoes, grape tomatoes and tomatoes sold with the vine still on them. Take a look at the FDA's website on this for more important information. Guess I better stick to some berries right now.

That's the biggies for the week. If you know of any others I and others should be aware of, please leave a comment. Remember, be careful out there.

Recently Susan asked me to write an article for her website discussing how I came to the decision to go solo. Her website has periodic pieces called "Going Solo; Confessions and Inspirations". Last week she printed my article entitled "Defying Gravity". Yes, for those familiar with Broadway, it is taken from the recent Broadway hit, "Wicked". When you read the piece, you will understand the significance of these words and that play in my life and the decision to go solo.

My hats off to Susan Carter Liebel. Not only for discovering my abilities as a writer (well probably not that) but for her hard work and efforts into making this world of solo practice a little easier to forge into. Susan is also starting a new project entitled "Solo University". It will really bring the world of solo practice to a new level and offer great educational information for those venturing out on their own. Thanks Susan for your commitment and support. It is invaluable.

1. Chicco Child Seats: This is an important one because it involves protecting our small innocent infants and children. Chicco is recalling the following infant child seats: Cortina Travel Systems, Keyfit and Keyfit 30. There are about 18,000 of these infant seats out there that are effected by this recall. They involve the bases for these infant seats and the problematic ones were manufactured between February 26 and March 17, 2008. There is a defect in the base that can prevent the base from being tightly secured to the vehicle when the lower latch attachments are used to secure the base to the vehicle. Bottom line, in a crashes, the base could move more than it should and cause worse injury to your child. Chicco is notifying owners of the problematic bases. The recall is to begin June 2nd. Go here for more information.

2. Polycom Wireless Conference Phone: Hello....anyone home....oops, what's that fire starting in my phone. Polycom is recalling the SoundStation2W Wireless Conference Phone. It affects phones sold between December 1, 2007 and May 2, 2008. The rechargeable Li-ion battery pack can overheat and catch fire. If you have one of these, remove the battery back immediately and contact Polycom for a free replacement. For more information, go here.

3. Simmons Kids Crib Mattresses: Again, a serious issue for the children. The Simmons Kids Mattresses manufactured between July 1, 2006 and March 23, 2008 may measure smaller than the width requirement for cribs, thereby creating a gap between the mattress and crib side rails where babies can get caught. The recalled mattresses have a color label attached at the top or side of the mattress and has the following names on it: Pottery Barn Kids by Simmons Kids Lullaby, Simmons Kids Slumber Time Evening Star Luxury Firm, Simmons Kids Baby Mattress Series 400 and Simmons Kids Baby Mattress 234 Coil Count. Simmons asks that you measure the width of your mattress using a tape measure as described here. They will give you a free replacement if it does not measure correctly.

4. Polaris ATVs: Polaris has already recalled 95.000 of its ATVs due to defective Electronic Control Modules (ECMs) that can overheat and burn or cause fire. Now they are recalling another 700 of these ATVs for the same reason. Go here for the model numbers involved in this newest expansion of the recall.

5. QVC Tomato Planters: For those of you staying up late at night buying those bargains off of QVC, there may be a problem with that Tomato Planter you bought between March and April 2008. The Topsy-Turvy Deluxe Tomato Planter with Stand, can collapse and can injure those near by. Go here to find out what to do, which includes how to get a refund.

6. Viril-ity Power Tablets: Good one to end on. Something that is sold over the counter to help in the bedroom department, like Viagra and friends. Well apparently this "supplement" may have a drug in it similar to the active ingredient in Viagra, which you know requires a prescription. When combined with other drugs, it might cause blood pressure to drop to life threatening levels. You are advised to stop taking it. Here is the press release regarding this recall. Moral of this story is even though its sold over the counter, it can still be dangerous and effect your heath in a negative manner. As I have said before....be careful out there.

Well, first thing this morning my wife emails me a link...to the Observer...and there it is....picture and all.....an article and interview with my son trying to figure out who this kid from Alabama, of all places, was and what caused him to challenge the literary publishing word. Yes, I am a proud Dad. Of course, his comment in his interview that "Neither of my parents are big readers at all" struck me. Reading briefs, memos, case opinions, legal periodicals, blawgs.....and the list goes on, doesn't count. Thanks son. Guess he doesn't really have a good understanding of what I do all day long. I'll forgive him...for now....because he deserves to glow.

Now I know its not good for a blog to get off topic...and this is way off topic of products liability issues, but it is such an important part of my life and of who I am, I just need to yell it out. A little background will help. My oldest son has always had the gift of writing. He has always written pieces of work which were well beyond his calender years. If he had any weakness in this area, as with most kids his age and going through teenage angst, he has never really believed in himself and his abilities as a writer as much as his Mom and Dad have. You can tell your kids all you want how talented they are, but they have to feel it deep down inside before they can truly begin to blossom.

I think he really began to understand and believe in his talent last summer when he learned he received a 5 on the AP English Exam. For those who are not familiar with AP Exams, 5 is the highest score you can achieve and its a college level exam. When he learned his score, you could see the look in his eyes change. The self recognition that "Hey, I can do this."

Throughout this past school year, as he applied to schools known and recognized for their focus on writing, and began to recieve acceptance after acceptance, I could continue to see that light in his eyes grow even stronger. About a month and a half ago we went to one of the schools he was accepted to in order to make that final decision of where to go. Getting into this school, nationally recognized for focusing on writing and putting out amazing young writers, was a huge feather in his cap. When we met with one of the admission's counselors, she just went on and on how amazing his essay was that he wrote for his application and they gave it the highest score they give for essays. I could sense his pride...and belief in himself just flowing. As usual, he played down his abilities and was polite in thanking the Counselor for her thoughts, but I could see it was all coming together for him.

Which leads me to the New York Times Book Review. No, we don't live in New York, but every Sunday for at least the last year or two, I pick up the Sunday New York Times and my wife and I enjoy just taking Sunday morning to catch up on the world. My older son as well, would read certain sections, but always first attacked the New York Times Book Review section. You see, besides being a gifted writer, he is a voracious reader and always is looking for new books to jump into.

Then it happened. He told his Mom and I about a week ago that he had written a letter to the editor of the New York Times Book Review and they contacted him and said they were going to publish it. If you don't know, typically, very few, such letters are ever published, and they are usually from some scholastic, professor or other writer commenting on a review. My son expressed how this was the crowning achievement in his eyes to his first 17 years....Then the topper of it all came.

Yesterday, as his Mom and I come home from an afternoon at the gym, he was standing outside with just this amazing smile on his face. Apparently an editor of a major publisher read an advance copy of his letter and was interested in reading his writings. What??? Could this be true??? Well, yes apparently it is. As a parent, I couldn't be more proud of him. But most importantly, he finally gets it. He finally understands and believes in his talent and now I know.....the skies the limit! Fly son, its your time!

This particular story caught my eye because evaluating and handling rollover accidents has been a large part of my legal career. As a defense lawyer, handling rollover cases on behalf of car companies became one of my specialties. In fact, for about the last 8 years of my practice as a defense lawyer, I was Regional Counsel for the southeast United States for all rollover lawsuits for one of the major car manufacturers. As a plaintiff's lawyer, I continue to handle these cases on behalf of those injured and killed in rollover accidents.

Rollover cases are very complicated to handle and evaluate. You must have an understanding of what vehicles should be able to do in certain situations and at what point is there nothing that a reasonably designed vehicle could have done differently under the circumstances of the accident. With current technology, many rollover accidents can be avoided. Most car manufacturers have developed ESC or electronic stability control systems which assist the driver in controlling the vehicle when performing emergency avoidance maneuvers and the like. Some manufacturers still make such ESC systems optional equipment in SUV type vehicles. I suggest that if you are considering purchasing any current model SUV, you inquire into whether it is equipped with an ESC type system or traction control. Every manufacturer has given the ESC system it has developed a different name. However, its important you ask about it and insist on having one equipped in your SUV if you are purchasing a current year model.

If you or a loved one have been injured or killed in a rollover accident, feel free to contact me to discuss whether there might be a potential claim against the car manufacturer with regard to either causing of the rollover, or not properly protecting the passengers in the vehicle during the rollover itself. Both are important issues to look at when determining whether the car manufacturer has responsibility for injuries sustained in a rollover accident.

1. Shindaiwa Corp. Backpack Blowers: About 23,000 of these blowers have been sold between September 2005 and January 2007. The reported problem leading to the recall is that the blower's fan can separate from its base and then break apart, causing some plastic pieces to blow out of the machine. These pieces can cut and do worse if they hit someone as they come flying out. Apparently these same blowers have been previously recalled due to a fire hazard. It involves Models EB8510 and EB8510RT. There have been 13 incidents reported. The manufacturer, Shindaiwa asks that you immediately stop using the blower and contact Shindaiwa at 800-521-7333. For more information, see here.

2. FireX Branded 10000 Series Carbon Monoxide Alarms and 12000 Series CO/Smoke Combo Alarms: The FireX Carbon Monoxide and CO/Smoke Combo Alarms are being recalled because the alarms can sound a "double chirp"/fault alarm in the presence of CO, before going into full alarm mode. The Owner's Manual advises that if you hear this double chirp, you should take the alarm out of service. Problem is, if you follow that instruction, you may never hear the alarm go off telling you there is CO present in house. CO (carbon monoxide) is the odorless deadly killer. You may never know there is a CO leak without the alarm going off. But if you hear this double chirp and follow the instructions, you will never hear the alarm tell you there is a deadly amount of CO in the air. These alarms are made by a company called Maple Chase Company. There are about 280,000 out there, many of which are installed by contractors in new homes. For more information, see the CPSC's site here. They do instruct you not to stop using your old alarms until you call the company and receive a replacement. If you have moved into a home built in the last year or two, you may want to check out your CO or CO/fire alarms installed in your home and see if it is a FireX Brand.

3. Tumble Tower Infant Rattles: A baby's rattle made by the Manhattan Group is being recalled because the ends can break off and the baby can choke on the parts of the rattle. There have been about 7,000 of these rattles sold through gift and specialty stores around the country, as well as on the internet from September 2007 through April 2008. If you have one of these rattles, you should take it away from the baby and return it to the store where you purchased it or contact Manhattan Group at 800-541-1345. To see a picture of the rattle and for more information, go here.

4. Solodyn Tablets: Just this past Friday, the FDA issued a press release indicating that certain lot numbers of the antibiotic Solodyn, 90 mg tablets, are being recalled because one of the bottles in the lot was found with a completely different medication, Azasan, which is an immuno-suppressive agent used in transplant cases to prevent kidney rejection and for treatment of rheumatoid arthritis. If you take Azasan and not Solodyn, it can decrease your number or red and white cells, cause infection, bleeding, chills, nausea and vomiting. The two lots at issue were manufactured in February 2008 and are lot numbers B080037 and B080038. Call 888-656-6381 with any questions or see the FDA's website for more particulars.

That's all for this weeks concerns. As always, be careful out there. If you have any questions regarding any of the above, do not hesitate to contact me and I will try and assist you in any way I can.

It was a two year bitter battle. It included Bayer withholding its own study on the drug during a FDA hearing about the drug, which study only came to light after its author disclosed its existence after the hearing when he couldn't understand why Bayer did not tell the FDA about the study at the hearing itself. At the end of 2007, another FDA hearing was held on the drug which I attended by webinar. Dr. Mangano himself spoke to the FDA panel defending the work he had done. Bayer did all it could do to discredit Mangano's work and hired statisticians to completely confuse the issue. During that hearing, Bayer talked about a study being done in Canada, called the BART study, which was using Trasylol and comparing it to two generic drugs which do the same thing and cost a lot less, in high risk open heart surgeries, the types of surgeries which Trasylol was originally approved for. Bayer indicated to the panel that they hoped this clinical study would provide a lot of answers and show what a great drug Trasylol was.

Within about 2 months of that meeting, the walls caved in. An unexpected announcement came that the BART study was being closed down because too many people were dying that were being given Trasylol. As a result, the FDA and Bayer put a "temporary halt" on use of the drug, except in extreme situations, pending evaluation of the information which could be obtained from this BART study.

Well, now its out in black and white. Essentially, the study found that Trasylol did not do that much better a job than its generic competitors and Trasylol cost $1400 per surgery versus $4 per surgery for the generics. Yes, you read that right $4 (four dollars). More importantly, those patients being given the Trasylol were dying at a higher rate within 30 days of the surgery then those given the generics. Thus, even using the drug for the limited purpose for which it was originally approved i.e. high risk surgeries, more people died who were given the drug within 30 days than who were given the much cheaper alternative which performed comparably. As the editorial in the NEJM said it"...in all likelihood, this is the end of the aprotinin (trasylol) story." It appears today it is and way overdue.

What has always been so insidious about the use of this drug is that patients never know they were given the drug as it is given during the anesthesia process for surgery. Thus, when things later go wrong, whether it be kidney failure or death, the patient and the family would never know it may have been the drug Trasylol which caused the problem. Now at least, the drug will be kept out of the surgery room and away from the unsuspecting patient.

If you feel you or a family member may have been given this drug during open heart surgery and have ended up in kidney failure or died unexpectedly, you are welcome to contact me to discuss whether you may have a potential case regarding Trasylol.

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

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.

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.