Alabama Product Injury Lawyer Blog

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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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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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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Let me start off by saying that NO, I am not a regular or avid reader of Reader's Digest. Have to say, I always considered it a publication for my Mom and Dad to read. Of course, now at the ripe old age of 48, I guess I have now become my Mom and Dad and the world has come full circle. Anyway, I digress. In the April Edition of Reader's Digest, a very insightful article has been published entitled What's Ailing the FDA? In it the author discusses the overworked and underfunded FDA and how it is not able to do the job it is assigned to do, protect the public from dangerous food and drugs. A couple key points in the article bear mentioning:

1. The funding provided for this agency to do its job of regulating food, drugs, vaccines, medical devices, cell phones, dietary supplements and biotechnology is equivalent to what a county school system in Virginia is provided. The FDA's own advisory Science Board commissioned a report which led one of the members of that Board to say, "We were shocked at the appalling state of science at the FDA." The Institute of Medicine has labeled the drug branch of the FDA "dysfunctional", indicating it quiets those at the FDA who disagree, inadequately monitors drug safety and relies too much on the financial support of the drug companies, who it is given the job to regulate.

2. Pressure of the Drug Industry: Big Pharma pressures the FDA to speed up decisions on drugs so it can get the drugs to the market and make money, and to soft-pedal problems with the drugs. The article points out that Big Pharma now pays for over half of the budget of the FDA for drug review. This money comes from Big Pharma through user fees the drug companies pay the FDA to speed the drug review process. As the article suggests, it may save taxpayers money, but it calls into question the independence of the FDA when making decisions.

Moreover, there has been a big push by the drug companies for faster approval of drugs i.e. get on the market quicker so the money comes in quicker. We can all agree that getting important lifesaving drugs on the market quicker is important. Who can dispute that pushing through the approval of a drug that can cure a certain type of cancer is not important. However, when this same pressure is used to push through approval of a "life style" drug, like something to help with "restless leg syndrome" ( a condition the drug companies came up with so it could have a disease for its drug to treat), the FDA is not able to fulfill its role of really addressing the potential safety issues with these drugs. The FDA denies the overriding influence of the pharmaceutical industry in making its decisions, but the truth lies in the results. Think Vioxx, Ortho Evra, Baycol, Singulair, Chantix...and the list goes on and on. All these situations have shown that the FDA was not given complete information about a drug, or the drug company failed to disclose all the information it had. Instead the drug companies pushed like hell to get its drug to market for the almighty dollar.

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Posted In: Drugs , Pharmaceutical Companies , Preemption

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Well even the mainstream media is really catching on to the problems I discussed last week about preemption. Both the New York Times and Reader's Digest have just recently printed articles taking on the issue of preemption and how the problems at the FDA make this issue one of significant importance. In the New York Times article, which appeared on the front page of Sunday's edition, it explains how the issue of preemption may significantly effect ongoing litigation involving the Ortho Evra birth control patch (the Patch). As background, the Patch was touted by its manufacturer, Johnson & Johnson (J&J), as an easy alternative to the Pill. Instead of having to take a pill every day, the Patch was applied weekly. J&J told the FDA that this patch would actually supply less estrogen to women than the Pill, but yet still provide protection from pregnancy. The amount of estrogen that goes into a woman's body is important because, as addressed in the article, it has been known for a long time that high doses of estrogen raise the risks of blood clots which can lead to heart attacks and strokes.

The New York Times article goes on to explain how a study was done for J&J on the Patch and it found in 1999 that in fact the Patch released significantly more estrogen into the body than the Pill, Moreover, the amount of estrogen being put into the body by the patch was at a dangerous level and beyond the level of estrogen which the FDA had determined 11 years earlier, could not be sold in the Pill. The interesting fact was that the author of this J&J study, who has since retired from J&J, applied what has come to be known as a "correction factor" to this study such that he played with the numbers and showed that the Patch released alot less estrogen into the body than the study actually showed, Apparently when this study was provided to the FDA so it could evaluate the Patch, it only mentioned this "correction factor" ONCE in 435 pages of the report, and that mention was only when discussing a complicated math formula. J&J did what they could to obscure the fact that this "correction factor" was applied to the results so that the levels of estrogen being released into the body looked OK, when in fact they were at dangerous levels.

Ultimately the FDA relied on this study to make its decisions regarding approval of the drug and the warning to place on the drug. J&J had two other studies, one in 1999 and one in 2003 which both showed that the Patch released more estrogen than the Pill, but guess what???? J&J delayed giving this information to the FDA.

J&J has now filed a motion with the Court requesting it find preemption and that the lawsuits regarding this drug not be permitted to continue. The argument goes that the FDA is in the best position to decide issues regarding whether the warnings are good and since the FDA approved the warnings regarding the Patch, a court cannot now say the FDA was wrong. Problem with this argument is that the FDA's decision is only as good as the information provided to it by the manufacturer when it makes these decisions. The FDA does not do its own testing on these drugs. It relies on the manufacturers to be forthright and provide it with all the information it has learned about the drug.....good AND bad. It appears J&J hid this problematic information from the FDA when it made its decisions about permitting the marketing of the Patch and the warnings that should go with the Patch.

This is one of the main reasons for the problematic nature of preemption, especially in the context of the FDA. The drug manufacturers argue that the FDA should have the last word about warnings on a drug. But this assumes the FDA is provided ALL the necessary information to make the right decisions, and clearly in the case of the Patch, that was not the case.

As mentioned at the beginning of this post, Reader's Digest published an article recently addressing the problems with the FDA which also relates to this issue of preemption. Stay tuned for part II of this post where I will address this article and how it points out problems at the FDA which impact on this argument of preemption.

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Posted In: Drugs , Pharmaceutical Companies , Preemption

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As a fitting follow-up to my previous post in which I questioned whether the highly touted ending of a study on the anti-cholesterol drug Crestor because the results were too good was due to the fact that the people who were the "guinea pigs" (sorry, but that's what they are) were too perfect to show a problem, the Washington Post reported on a study issued by Chronic Disease Prevention & Control Research Center at Baylor College of Medicine which indicates that testing on new drugs has excluded alot of important potential patient populations such as women, older people and minorities. Daniel Goldberg, the chief policy advisor for the report is quoted as saying "We've got a big problem, and it is extremely urgent that we fix it. Because we're trying to figure out how to streamline health care and make people healthy, of course. And the fact that we have under-representation in clinical trials undermines both of these goals and undermines the quality of the evidence we come up with."

This echoes the point I made in my previous post. These drugs, in the clinical trials the drug companies do to see if the drug works, must be tested on the type of population that it is expected will use the drug. Otherwise, in the clinical trials we will not see the REAL benefit of the drug and potentially what adverse reactions there might be when used in the population that will actually use the drug in the real world. As an example, if you are developing a drug to reduce cholesterol, you need to test it on people who have significant cholesterol issues. Additionally, you know that such drugs are more likely than not going to be used in the elderly and senior population, so you have to include seniors in your testing of the drug to see how they react. Unfortunately what you find when you read the details of many (not all) studies done by drug companies on drugs they are evaluating is that they try and pick the "perfect" patient with no significant medical issues other than maybe the one particular one which they are trying to address.

I understand that you need to exclude certain individuals because they may have a condition which may confuse your results i.e. you won't know if its the drug that's helping the individual or the other condition they may have, but there must be some consideration given to testing these drugs on the type of patient who will really be taking the drug once it gets out to the general population. In fact, part of the reason, in my view, that so many new drugs are running into problems once they get on the market is because of the failure to really evaluate the drug in the patient population which will actually be using the drug.

On a personal note, one thing I have learned after spending time learning about the pharmaceutical world and how it works is that I try not to take a drug the doctor prescribes for me unless its been on the market for at least 5-7 years. That way there has been time for the drug to be used in the "real" population and all the potential problems and issues addressed.

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Posted In: Drugs , Pharmaceutical Companies

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Now this is something you don't often see. A study on a drug, in this case Crestor, an anti-cholesterol drug, is ended early because the results were just too good. What is even more interesting is that this same drug had a hard time getting approved for marketing by the FDA several years back because it appeared to have a high incidence of rhabdomyolosis (rhabdo). Rhabdo, as its come to be known, is a condition where the muscle tissue breaks down and releases a substance known as myoglobin into your bloodstream and ultimately it can clog up your kidneys and lead to kidney failure. I became very familiar with this condition back in 2001 when I became involved in representing many consumers who took the anti-cholesterol drug Baycol and developed this condition. Baycol was ultimately taken off the market and Bayer, the drug manufacturer, settled thousands of claims of consumers who took this drug and developed rhabdo. Now it is known that these types of anti-cholesterol drugs, which would include Lipitor and Zocor, known as statins, can cause this condition, but Baycol caused it at a statisically higher rate than the other similar type drugs like Lipitor and Zocor. It was, as it is referred to, "an outlayer" in these class of drugs.

This brings us around to Crestor. As mentioned, when Crestor was going through the approval process, which was during the time Baycol and its problems with rhabdo were front page news, there were concerns raised that it too had a high rate of rhabdo. However, the drug was ultimately approved by the FDA and Astra Zeneca has been highly touting and marketing the drug ever since. Clearly, this is great news for Astra Zeneca, especially considering the concerns now being raised with other anti-cholesterol drugs Zetia and Vytorin. But honestly, I am just waiting for the other shoe to drop. I expect in this study they also looked at adverse events. When the information is ultimately published on this study, I will be interested to see what, if any information is disclosed about adverse events reported in the study.

One other interesting tidbit. It is reported byAstra Zeneca that the study participants, of which there are over 15,000, had no existing evidence of cardiovascular disease and the end point (what they were looking at in these patients given Crestor vs. a placebo) was if the drug would reduce major cardiovascular events. Well, you picked people to be in the study who had no prior history of heart problems, so how do you know your drug helped them vs. the fact that they were individuals with no evidence of heart disease to start with. Now the participants did have elevated C reactive protein which is an indication of inflammation and associated (not cause) with a higher risk of cardiovascular events. We will now see Astra Zeneca telling everybody Crestor protects people from heart attacks based on this study, when in fact they give it to a population at a lower risk for heart attacks and in fact that may be the reason why there was such a reduced incidence of cardiovascular events. Such is the way of big pharma and its manipulation of data. This will be an interesting drug to continue to follow.

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Posted In: Drugs

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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.

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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????"

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Posted In: Drugs , SSRI/Anti-Depressants , Singulair

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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.

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

Posted In: Drugs , Trasylol

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