FDA calls for Adverse Reporting of Heparin

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Posted on 25th March 2008 by gjohnson in Uncategorized

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The FDA website today has these words on it:

Please report all adverse events associated with heparin to MedWatch with then a link to this page:

http://www.fda.gov/medwatch/how.htm


If you or your loved one has had what you believe to be an adverse reaction to Heparin, at a minimum you should take these forms to your doctor and begin the investigation process. Remember, that problems with Heparin did not begin in late December as earlier reported, but may go back as far as the beginning of September, based on what we know now. But in fact, these problems could go back even further.

But don’t just rely on your doctor, on Baxter, on the FDA to get to the bottom of your case. Call a lawyer, tell your story to us and let us guide you thru this process. In our experience, if you trust your case to those who have an interest in minimizing the economic and political impact of what is occurring in this disaster, your injuries may be dismissed, shuffled aside and justice denied.


Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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Is Heparin Epidemic Understated?

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Posted on 23rd March 2008 by gjohnson in Uncategorized

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The FDA recall of Baxter Heparin identified a few fatalities and hundreds of adverse reactions to heparin, beginning in late December. However, a detailed examination of the timeline of problems with this drug clearly shows that it may have started as early as early November, and perhaps even earlier.

The problem with identifying the full scope of this problem, is that any adverse reaction or death that occurred before the FDA announced the recall on January 17, 2008, may not have been properly investigated. For example, the first identified problems in terms of the current announced investigation occurred on Nov. 19, 2007 Doctors at St. Louis Children’s Hospital. For Chicago Tribune story on timeline, click here. This was the first time a problem was identified, but the troublesome Heparin was packaged as early as September. If these lots had the contaminants, how do we know that there were countless adverse reactions and deaths associated with these batches?

Moreover, as the investigation has spread, it is clear that the contamination effected considerably more than the batches of the drug that were first identified as being toxic. While most American’s have a false confidence in the diagnostic infallibility of their doctors, we encounter cases every day, where even the most logical diagnostic conclusions are never considered. But with a secret contaminant in a drug with a long track record, it is highly likely that any death or adverse reaction that was caused by Heparin prior to the end of January, might have slipped by without further thought or investigation. How many people died of heparin contamination prior to the FDA announcement where no autopsy was performed?

Making the misdiagnosis even more probable is that the bulk of the people getting the tainted Heparin were people who were frail and at risk for sickness and death. The more frail the victim, the less likely the doctors are going to probe an adverse reaction, choosing the obvious (but likely incorrect conclusion) that the adverse reaction or death is a subset of the disease for which the Heparin is diagnosed. But the reality, the more frail the patient, the more likely that the contaminants will kill.

It is time for the FDA investigation, and for conscientious doctors, to take a second look at any serious health problem a Heparin recipient may have had, between September 1 and January 31. If the contamination is as widespread as it appears, then the investigation must not just grab onto the obvious cases, but dig deep to see if the adverse reactions started earlier. These frail patients are the canary in the coal mine. There adverse reactions may point us to the full scope of the epidemic of greed.


Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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FDA Intercepting Heparin Before Entering US

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Posted on 18th March 2008 by gjohnson in Uncategorized

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Step one, get FDA inspectors into China to inspect Heparin while it is being processed. Step two, inspect Heparin at the border. Friday, the FDA announced that all shipments of the active ingredients which make up the blood thinner sold by Baxter, would be tested at the border for signs of impurity. See the story on this development from Dow Jones at http://money.cnn.com/news/newsfeeds/articles/djf500/200803141503DOWJONESDJONLINE000954_FORTUNE5.htm

In an interesting example of how much more seriously the FDA is now taking the Heparin issue, at http://fda.gov they explain the current process as follows:

“COLLECT SAMPLES
FDA samples identified lots of heparin Active Pharmaceutical Ingredient (API) and finished heparin for laboratory testing.
“TEST FOR CONTAMINATION
Results from new state-of-the art chemical methods developed by FDA reveal contaminant in heparin API that conventional testing could not detect.
“TEST FOR ALLERGIC REACTION
FDA and industry are developing animal testing to determine if human adverse reactions are based on allergic reactions and to determine if there is a link to the contaminant.
“CROSS CHECK LOTS
FDA is working to identify lots linked to adverse reactions in humans with any corresponding contaminated lots. “
For a full diagram of this process, go to:http://www.fda.gov/cder/drug/infopage/heparin/analyzing.pdf


Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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FDA Moving Forward on Improved Chinese Heparin Monitoring

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Posted on 17th March 2008 by gjohnson in Uncategorized

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In the category of finally, or “its about time”, the FDA has announced plans to have permanent full time positions to monitor Chinese imports, such as the ingredients for Heparin. This comes in the wake of an increasing scandal related to Baxter’s recall of Heparin following reports of deaths and hundreds of adverse reactions.

The FDA’s press release is below.

Attorney Gordon Johnson

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FDA Takes Next Step in Establishing Overseas Presence
Agency on path to establish offices in China
In an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People’s Republic of China, pending authorization from the Chinese government.

This is an important step forward in the FDA’s plans to hire and place FDA staff in China over the next 18 months. In addition, the FDA will be hiring a total of five local Chinese nationals to work with the new FDA staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou.

“In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters,” said Murray M. Lumpkin, M.D., deputy commissioner for International and Special Programs, FDA. “Along with the important Memoranda of Agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market.”

Building the FDA’s capacity outside of the United States supports the agency’s “Beyond our Borders” initiative. The initiative facilitates the building of stronger cooperative relationships with the FDA’s counterpart agencies around the world and enhanced technical cooperation with foreign regulators. The permanent overseas offices in China will also allow greater access for inspections and greater interactions with manufacturers to help assure that products that are shipped to the United States meet U.S. standards for safety and manufacturing quality.

For additional information on the FDA’s international programs, please visit: http://www.fda.gov/oia/overview.html. For more information on the historic Memoranda of Agreement signed in December 2007, between the United States and The People’s Republic of China, please visit: http://www.hhs.gov/news/press/2007pres/12/pr20071211a.html.


Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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German Heparin Also Contaminated

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Posted on 7th March 2008 by gjohnson in Uncategorized

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With word that the FDA has disclosed that the Chinese contamination in a medicine similar to Heparin has been discovered in Germany, it is time to demand a full accounting of both U.S. drug companies and international pharmaceuticals as to why the production of these biological ingredients should be entrusted to Chinese companies. For today’s developments, see the Chicago Tribune story at http://www.chicagotribune.com/business/chi-baxter-bax-heparin-german-mar6,0,5116778.story

This latest development comes almost upon the anniversary date of the FDA’s notification of the Chinese Pet food disaster of last year. Last year the FDA announced:

“On March 15, 2007, FDA learned that certain pet foods were sickening and killing cats and dogs. FDA found contaminants in vegetable proteins imported into the United States from China and used as ingredients in pet food.”See http://www.fda.gov/oc/opacom/hottopics/petfood.html

Then there was the continuing problem with lead paint in children’s clothing. We have been warning about the dangers of lead paint in American homes for nearly a decade, but at least US companies stopped using lead paint in the early 70’s. We will still deal with the poisoning of our children for decades to come, but how can the US government tolerate such poor quality control on our imports that such deadly paint should show up on children’s toys?

At least the possibility of such issues with imports are getting to be a political issue, with both Democratic candidates advocating for tougher health and labor standards under NAFTA. But NAFTA reform only impacts the Mexican and Canadian imports. While protectionism seems to be an economically deadening concept, is there really adequate reasons for us to be importing agricultural products that we cannot monitor? Perhaps it is my Wisconsin and Illinois roots, but what possible reason can U.S. companies have to import pork products from overseas? And it it must come from overseas, why China, a country with such a poor track record on purity of their products?


Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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FDA Identifies Contaminant in Heparin

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Posted on 6th March 2008 by gjohnson in Uncategorized

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The FDA, at a press conference yesterday indicated that the FDA has identified the contaminant in the suspect Heparin injections, amid speculation that the such contamination could have been intentional.
In a news story on that Press Conference, the Chicago Tribune states:
“The mysterious substance, which has a chemical makeup similar to heparin, comprises as much as 20 percent of the active ingredient in nine suspect lots produced by Baxter since September, the FDA said Wednesday. The suspect lots are connected to at least four deaths reported nationwide since Baxter noted a spike in adverse reactions to the drug in late December.”
Click here for the Chicago Tribune story.
The FDA attributed this Heparin to as 19 deaths and 785 serious illnesses since Jan. 1, 2007.
According to the Tribune story the Heparin deaths and illnesses are suspected to extend further back in time than the original September of 2007 timeframe which was originally identified.
The Tribune quoted the FDA spokesman as follows:
“We don’t know whether the introduction of the contaminant was accidental, as part of the biological process, or if it was deliberate,” said Dr. Janet Woodcock, acting director of the FDA’s center for drug evaluation and research.
Areas of inquiry and controversy that are now swirling around this tragedy include suspicions of a Chinese pig epidemic being passed thru to the drug, concerns about the possibility of the contaminant being used because the active ingredient was in short supply and the possibility of other wrongdoing.
As I have asked before on this blog: Why are we risking the safety of our medicines, given to our frailest of citizens, on products that come from Chinese pigs? Only greater profits, in an industry that is taxing the American economy as greatly as the oil industry, can justify not getting such product from Illinois or midwestern pork. We fight so hard to keep animal diseases out of this country, then import them into products for human medicines, because we have no effective control or accountability on the foreign suppliers of such products.


Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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Heparin Recall Timeline

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Posted on 4th March 2008 by gjohnson in Uncategorized

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The Chicago Tribune published on Sunday a timeline of the progression of the Baxter problems with Heparin, which resulted in deaths and hundreds of adverse reactions. It is clear from this documentation that Baxter had lots of warning that things could go bad. Click here for the story.

One of my first reactions to this story is why nothing was done when the first reactions occured at Children’s Hospital in November. Children and sometimes older people can be like the canary in a coal mine. There getting sick will warn others of the danger. But from Nov. 19 when the first children got sick in St. Louis, until January 7, when dialysis patients had a series of reactions at the same hospital, Baxter didn’t show any public awareness of what might be going on. A full 10 days later, the first recall was done.

One of the constants throughout my experience as an attorney representing those injured by the wrongful conduct of others, is that it is the most vulnerable individuals who have the worst results. I spent all of yesterday in a deposition, where my entire point with the doctor, which after hours, he eventually admitted, that it is the people with the most vulnerabilities before hand that are most likely to be impaired by wrongful conduct.

The defense experts seem to think that if they can find enough wrong with the plaintiff before the bad conduct of those they are hired by, it will excuse the defendant. But the reality is, that the more vulnerable a person, the more severe the wrong doing.

We know that with children we have a greater risk of harm. That is why we put kids in car seats. And no defense attorney would have the guts to claim that bad conduct is excused because the same conduct wouldn’t injure an adult. Yet, just because a young jock wouldn’t be injured by bad conduct, doesn’t mean that an older adult, who has a troubled medical history, can’t be injured thereby.

With respect to Heparin, Baxter should have known that when children were getting sick, it might mean that something was wrong. They were the canaries… someone should have heard the warning. Baxter should have heard the warning, especially when producing a product for consumption by the already compromised. In this case, children and the kidney patients who make up such a substantial percentage of the early cases were the ones who fell ill first. I wonder if the Chinese workers were sick even earlier?


Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney