Posted On: March 31, 2008

Business Week Magazine Addresses Federal Preemption Concern

Following up on my comments last week about the issue of federal preemption and how our right to jury trial is up for grabs, an article appeared in Business Week yesterday addressing these same concerns. An interesting take Business Week has on this issue is from Attorney Generals (AGs) from 26 states who wrote a letter to the National Highway Transportation Safety Administration (NHTSA), the federal governing body for cars, requesting NHTSA drop the lawsuit protection (preemption) from the new rules for rollover protection that manufacturers have to comply with when designing cars. In the letter the AGs stated "State governments and the federal government will have to cover millions of dollars in healthcare costs which they will pass along to taxpayers, costs that, by all rights, should be the responsibility of the manufacturers." Basically, the only ones who win in this battle is Corporate America. There is something wrong in our system when those responsible do not have to step up to the plate and pay for their wrongdoing. Our governmental system is one of checks and balances and this is one check we can not afford to let pass.

Posted On: March 28, 2008

New York Times Addresses Preemption Concerns Led to Alaska Settlement of Zyprexa Claim

Just a quick follow up to the previous post on preemption. The New York Times today had an article about the recent settlement by the State of Alaska regarding its suit against Eli Lilly on the drug Zyprexa and how the preemption concern is one of the main reasons Alaska decided to settle during the trial. This is a real issue with significant potential for affecting the future of our jury system of justice. When the federal government, regulatory agencies and corporate America are free to pursue their own selfish goals, we as Americans can only be on one side....the losing side.

Posted On: March 28, 2008

Preemption and the Supreme Court: Our Rights Are Being Taken Away And Nobody Knows

The San Francisco Chronicle had an Editorial piece in todays paper addressing the upcoming argument before the Supreme Court regarding the issue of federal preemption. It is a legal concept which is not so easily understood unless you are mired in the works of the justice system. Essentially federal preemption, as is explained in the editorial, is the argument that federal law or regulation preempts any state law to the contrary. As an example, if there is a federal law making it illegal to possess video games (both my sons would have to leave the country), a state could not make a law which makes it legal to possess video games.

In the litigation world, when a state court jury makes a determination that a corporation is liable for putting a defective product in the market, that is considered the state making law. In the particular case going before the Supreme Court, a state court jury found a drug manufacturer liable to a plaintiff who lost who arm when the drug Phenergan was given to her intravenously. The jury found that Wyeth, the manufacturer of the drug, knew about this potential problem, but didn't warn about it in the label for the drug.

Wyeth is now arguing that federal regulations, i.e. those instituted by the FDA, preempt state law. Therefore,the argument goes, since the FDA approved of the warning, a state court jury cannot come back and say...well even if the FDA thought the warning was OK, we the jury do not and you need to pay for the damages that has caused. The theory behind this concept is that the regulatory agencies are protecting the public and they are better educated about these issues and the agency should be the final decider (a "George Bushism") regarding whether a warning is sufficient or not.

That is all well and good if the agency is given all the information it needs to properly make those decisions. However, at least when it comes to the FDA, we know that is not the case. The rules of the FDA generally only require the manufacturer to provide proof that drug does what the manufacturer said it does (what is termed the efficacy of the drug), and only advise of any significant safety issues that were learned during the pre-market testing of the drug. Specifically, the drug company is not required to provide the FDA with ALL the testing it has done on the drug; only the testing that proves it works as proposed needs to be provided to the FDA. So if during pre-market testing some of the studies done don't come out as the manufacturer likes, they can just be "deep sixed" as they say. Bottom line, the concept of preemption might work if the agency had ALL the necessary information needed to make an educated decision. However, that is not the reality.

Because this is a technical legal argument, the average man or woman on the street is not really paying attention. However, if the Supreme Court finds under the circumstances of this upcoming case that there is federal preemption, the next time that average man or woman goes to his or her attorney describing how their child took their own life due to a drug, the only response they will hear is ..."Sorry you don't have a case." Your right to legal redress in a court of law before a jury of your peers no longer exists. The federal government, and the courts have taken that away. By that time unfortunately it may be too late.

Posted On: March 28, 2008

FDA Reviewing Potential Cancer Risk from Regranx, an Ulcer Drug

The FDA was very busy yesterday. I already mentioned about the investigation into the potential link between Singulair and suicide. Now there has been a concern raised regarding a potential risk of cancer from a topical medication used to treat ulcers on feet and legs. The drug, Regranex, is used by diabetics to address ulcers on their feet and legs. For diabetics, such ulcers are serious because if not properly cared for, they could ultimately result in amputation. However, apparently there are several studies using a health insurance database which indicate that for those who were given 3 or more prescriptions of this medication, the deaths from cancer were higher than those who were had less than 3. No particular type of cancer has been identified at this time. The FDA, along with Johnson and Johnson are going to work together to see if there is an actual link.

Look, all medications have risks. All medications have potential adverse reactions. The issue has always been whether the benefits of the drug outweigh the risks. Clearly, assuming this drug does work, the benefit i.e. saving a diabetic from losing a limb, is significant. But depending how significant the potential is to develop cancer if you use that drug, the benefit may clearly be outweighed by the risk. Again, I am happy to see the FDA being very proactive in getting the word out there. Although it appears the first study which indicated this relationship with cancer was completed in 2001.....Yes, 7 years ago. Now the FDA does indicate it is looking at additional data through June 2003 and it does take sometime to gather and evaluate data, but again, that data is almost 5 years old. When you are dealing with the potential of a drug causing cancer, you'd think the FDA and more importantly, the manufacturer of the drug would move a little quicker.

Posted On: March 27, 2008

FDA Warns About Suicidality with use of Singulair

Today the FDA published an "early communication" regarding the drug Singulair which is used to treat asthma and allergies. According to the FDA, there is indication that taking of this drug might lead to suicidal thinking and behavior, otherwise known as "suicidality". Here is a drug meant for asthma and allergies and it is causing people to think about killing themselves?!? This is out of control.

I have handled several cases over the last many years involving children and adolescents who have been prescribed anti-depressants such as Paxil and Prozac and killed themselves. I have to tell you, there is no more difficult case to deal with on a personal level than a client who's young innocent child has decided to take their own life. The usual defense raised by the phamaceutical companies is that it was the disease i.e. depression, not the drug which lead the child to kill him or herself. In the cases I handled I was able to successfully show to the pharmaceutical companies that these children were never diagnosed clinically depressed, but instead were prescribed the medication by the family physician because the child was "going through a rough patch" i.e. adolescents. The doctors were lead to believe by the pharmaceutical companies that these anti-depressants were "safe" and promoted the drugs to be used to help those who are feeling "down in the dumps". This was despite the fact the drug was approved by the FDA to be prescribed for diagnosed depression. Thus, I was able to show that there was nothing else which could have caused the child to take the desperate act of suicide but the drug itself.


With Singulair, a drug prescribed for allergies and asthma, Merck, the manufacturer cannot claim the disease called the patient to take his own life. Should be interesting to see how Merck explains this one. Clearly, a patient taking a drug for allergies isn't expecting to feel suicidal. One thing I would say is it appears the FDA is trying to get information out there to the public on safety concerns alot quicker. I have to commend them for that. According to the FDA's website, Merck changed the adverse events on the package insert (what you generally get from the pharmacy when you pick up your prescription) on this drug in October 2007 to include suicidality concerns. They are working with Merck to figure out how to publicize this to the public and to doctors. It has been almost 6 months since they changed the package insert on this drug and they are still trying to figure out how to publicize this to doctors????? Something as significant as potential for suicide ??? Things that make you go "Hmmmm????"

Posted On: March 27, 2008

General Motors Settles Class Action regarding Dex-Cool Coolant

It took almost 5 years of litigation, but GM has finally decided to pay up for a significant problem it created in its cars. GM used an engine coolant in about 30 models of its cars which caused significant engine problems in these vehicles. As a result, owners were having to pay for repairs which were caused by a product GM choose to put in these cars. It started with model year 1995 and includes popular models Olds Cutlass and Chevy Impala. It is reported by the plaintiff's attorneys representing the class that each consumer will recieve back about 50% of the cost of the repair due to the problematic engine coolant.

My only thought on this is why did this have to take so long? Almost 5 years of litigation when surely GM knew early on it had a problem it had to fix. And yes, it is reported that the plaintiff's lawyers involved in this litigation will receive a fee that will be split among many lawyers and law firms of up to $16.5 million. But I promise you, the firms involved in defending GM, billing by the hour, at an hourly rate of at least $250 per hour, made gobs and gobs of money off this litigation. So don't let that old standard line about the only winners in this litigation is the plaintiff's attorneys fool you. The lawyers representing GM and the corporate world, with tens, if not hundreds of lawyers working for them on just this litigation, make out like bandits. And behind closed doors they will tell you they rely on litigation like this to make the huge incomes necessary to keep the lawyers for GM going.

Posted On: March 24, 2008

FDA Still Sitting on the Trasylol Issue

Yes I know 60 Minutes did a huge story on Trasylol a little over a month ago where, among other things, the leading researcher on this drug, Dr. Mangano, who has been fighting an up hill battle for over 2 years on this drug, indicated that the FDA could have saved 22,000 lives if it would have pulled this drug off the market when Mangano's first study on Trasylol was published in the New England Journal of Medicine (NEJM) back in January 2006. Since that report on 60 Minutes, many plaintiff's law firms have been searching far and wide for potential cases regarding this drug. However, like Dr. Mangano, I also have been fighting the good fight on this drug since his study first appeared in the NEJM.in late January 2006.

When I first read the study, I was convinced that this was a drug with significant problems and issues. I immediately addressed the issue with the partners in my old firm and convinced them we needed to help people who had been significantly injured by this drug. One of the biggest injuries caused by Trasylol, as addressed in Mangano's first study, was that the drug, given most often during heart bypass surgery to assist in reducing bleeding, had a significant potential to cause permanent kidney failure. Those patients unfortunate enough to have had this reaction are resigned to a life of 3 days of dialysis every day for the rest of their lives.

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This was personal to me. My own father, after open heart surgery over 8 years ago, ended up in kidney failure and has been tied to a dialysis machine ever since. Here was a man, who worked hard his whole life so that he and my mother could spend their retirement years enjoying the fruits of their labors, but instead they have spent the past 8 years running to doctors, hospitals, and dialysis centers. My dad for the past 3 years has essentially become an invalid and my mother his round the clock caregiver. Thus, when I saw clear, medically and scientifically validated information indicating a drug, which people don't even know they are given and thus have the chance to refuse, can cause a person to spend the rest of their lives tied to a machine just to keep them alive, I knew I had to do something to help.

As a result, I was the first lawyer in the United States to file a case in court claiming that a patient was given this drug and as a result, their kidneys failed, requiring them to have dialysis the rest of their lives. I was interviewed by an independent reporter from Germany who was doing a "60 Minutes" type report on Trasylol which was shown in Germany almost 6 months before the 60 Minutes report appeared. For those who don't know, Trasylol is a drug manufactured by Bayer Corporation which has its international headquarters in Germany.

What has been learned over these past two years of fighting the good fight is more evidence of corporate greed and decisions made by Bayer to expand the use of Trasylol to other surgeries and hide all the bad evidence indicating the drug had a significant potential to cause kidney failure. This included a scandal where Bayer representatives appeared before a FDA committee investigating Trasylol where they steadfastly took the position that there was nothing wrong with the drug, when Bayer knew that it had paid for its own study on Trasylol which confirmed the findings of Dr. Mangano, and hid that information from the FDA. To follow that up, even after Bayer decided to TEMPORARILY stop selling Trasylol in the U.S., it hired doctors to trump up to other doctors, the benefits of Trasylol. There is even indication now that Bayer knew back many many years ago when Trasylol was first put out on the German market that a concern was raised about increased risk of kidney failure from use of Trasylol. It appears that concern was pushed aside, and instead Bayer continued to aggressively pursue the sale and use of Trasylol.

I am continuing the fight I started on this drug over two years ago when I read the first study by Dr. Mangano. If you had open heart surgery and after the surgery ended up on dialysis for the rest of your life, you may have been given Trasylol during your surgery which may have lead to your kidney problems. It is a terrible cost to have to pay. You may want a lawyer to evaluate whether you might have a case against Bayer. My only suggestion in choosing a lawyer to assist you in this process is to make sure you choose one who understands the problems with this drug and can properly evaluate whether Trasylol caused your kidneys to fail. I will continue to provide information about this drug as I learn more because it is important for the public to be aware of what can happen when the drive to make money overrides the concern for patient safety.

Posted On: March 22, 2008

Products Liability Lawyer Begins His Push Into The Blogging World

And so I begin. As I started to think about developing my own legal blog focusing in on the area of products liability lawsuits, I thought of naming this blog "From Both Sides Now". I know, really catchy and in a minute you will understand the meaning behind it. However, my trusty educator on blogging informed me I had to come up with a name which would describe what my blog was about. Thus, the somewhat mundane name of Alabama Product Injury Lawyer Blog.

Now the meaning behind my concept of "From Both Sides Now". For the first 18 years of my practice I was a defense lawyer for a mid-size firm based out of Florida who focused on automotive products liability cases. This included not only cars, but ATVs, motorcycles and even SeaDoos. I represented numerous car manufacturers over the years in cases filed throughout the country. During the last years of my practice as a defense lawyer, I was southeast regional counsel for a major Japanese car manufacturer. At one point, the firm I worked for asked me to move up to Birmingham, Alabama and open and manage a satellite office of that firm in Alabama. Although my wife, a Pennsylvania girl born and raised, had some hesitation about moving to the heart of Dixie, it has proven to be the best move of our lives. Both professionally and personally, I and my family have blossomed.

After spending five years running the office for the defense firm in Birmingham, I decided it was time for a change. I had been doing defense work for 18 years and needed something to change things up a bit. That brings me to the meaning behind the catch phrase.....I became a lawyer representing individuals who have been injured. For the past six years I worked at an established and nationally known firm here in Birmingham who fought for the rights of the injured and wronged. Not only have I found my calling, but I never knew the practice of law could be so life changing. The ability to fight for someone who has had significant tragedy in their life and be able to provide them some hope for the future has been an incredible gift of this journey. I have had the privilege of representing parents who lost their child due to suicide caused by an anti-depressants, husbands and children who lost their mother due to the taking of a "bad drug", and in one case, an entire family who lost 3 family members and were left with 2 family members severely brain damaged all in one car crash due to the complete lack of care shown by a corporation in accepting responsiblilty for dangerous conditions it was causing to the roadway. No, I cannot bring back the so dearly loved family members or repair the significant injuries to my clients, but I can fight to give them something back so they begin to heal and repair their torn lives.

However, I bring a different perspective to cases because I have handled cases from "the other side". I know how they view cases, what strategies they may try, and how they evaluate cases. It permits me to anticipate how they will react to certain claims and know the potential moves before they even happen. This experience on both sides also provides me with different thoughts on issues than other attorneys representing the injured and wronged because for the first 18 years of my practice, the "defense perspective" was drummed into my brain.

That is the difference I hope to bring to this blog and the blogging world in general. Yes, I am a plaintiff's lawyer and fight for the rights of individuals who have been wronged. However, I understand the position of my defense bretheren and sometimes even agree with their views on legal issues. (As long as it doesn't somehow hurt my clients:))

Final thing and then I will sign off for now. Several months ago I left the firm from where I learned to practice as plaintiff's lawyer and have started my own firm. I handle cases of any type where people have been physically injured or killed, as well as contractual disputes. However, I continue to focus on cases involving products liability or products which have injured individuals. I have specialties in the areas of cars, drugs and medical devices that cause injuries to people. In this blog I will be addressing issues relating to lawsuits involving these types of products, as well as products liability cases in general. I hope you will take this ride with me and enjoy the journey. That's it....BLOG #1.