2. When did the Heparin return to being Safe?
Officially, all of the contaminated heparin should have been off the shelves by April of last year. However, recalling millions of vials of contaminated heparin is an enormously complex process, especially in hospital settings where different supplies of heparin may have been commingled. If the your loved ones death or catastrophic reaction after heparin fits the resembles an alergic reaction to a bee sting type, call us regardless of how recently the adverse event occurred.
3. How severe of a reaction should we have before calling a lawyer?
All cases of death should be investigated especially those after January 1, 2007 until the present day as I write this in March of 2009. Further, all cases of “severe consequences” should also be investigated. “Severe consequences” means adverse reactions involving significant additional medical care, hospitalization or damage to any body organ or limb.
For example, if heart damage occurred, you should call. If the heart stopped and the body was deprived of oxygen or blood flow for a documented period of time, you should call. If there was gangrene or injury to any limb, you should call. There may even be cases of amputation resulting from contaminated heparin. All such cases should be identified.
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
Heparin – Frequently Asked Questions Part I
Heparin FAQ’s
The Heparin Catastrophe has left thousands of people with questions. We have heard most of them we over and over, and have done our best to answer those we could. Many answers are still unknown. In those thousands of heparin conversations, we have been asked tens of thousands of questions. Below and the series of blogs to follow are our answers to the most frequently asked questions.
1. When did the Heparin contamination begin?
Baxter claims it started shipping contaminated Heparin on September 13, 2007, but we believe there is at least circumstances that make us believe that it may have started sooner. This September 13, 2007 start date means that any death or severe consequences occurred in the administration of heparin after that date, requires an investigation. Baxter claims to have tested all heparin shipped from China, even going back years and has alleged that the OSCS contaminant began on that date. But the conditions that allowed for this contaminant and didn’t properly test for it, leaves doubts as the purity of Heparin even before that date.
While at one time we felt fairly comfortable turning down cases that occurred before that time, we are no longer doing so just based on that September date. As additional disclosures have trickled in, we are seeing more and more evidence that clearly suggests some contaminated heparin was in the supply chain earlier in 2007, especially in hospital settings, such as in cardiac surgery. If you know of a death or severe consequence following heparin administration at any time in 2007, call us and we will investigate.
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
The Heparin Catastrophe has left thousands of people with questions. We have heard most of them we over and over, and have done our best to answer those we could. Many answers are still unknown. In those thousands of heparin conversations, we have been asked tens of thousands of questions. Below and the series of blogs to follow are our answers to the most frequently asked questions.
1. When did the Heparin contamination begin?
Baxter claims it started shipping contaminated Heparin on September 13, 2007, but we believe there is at least circumstances that make us believe that it may have started sooner. This September 13, 2007 start date means that any death or severe consequences occurred in the administration of heparin after that date, requires an investigation. Baxter claims to have tested all heparin shipped from China, even going back years and has alleged that the OSCS contaminant began on that date. But the conditions that allowed for this contaminant and didn’t properly test for it, leaves doubts as the purity of Heparin even before that date.
While at one time we felt fairly comfortable turning down cases that occurred before that time, we are no longer doing so just based on that September date. As additional disclosures have trickled in, we are seeing more and more evidence that clearly suggests some contaminated heparin was in the supply chain earlier in 2007, especially in hospital settings, such as in cardiac surgery. If you know of a death or severe consequence following heparin administration at any time in 2007, call us and we will investigate.
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
FDA and Heparin Inspections
Yesterday, I railed against the FDA’s increasing inability to assure that our drug supply is pure. Earlier this week, our blogs quoted a familiar name, Janet Woodcock, about some of those same failings. Woodcock should be a familiar name to those who have followed the Heparin Catastrophe. It was Woodcock who last year testified to Congress about foreign inspections, the in wake of first reports of Heparin deaths.
Last year, Woodcock explained the new and improved approach of the FDA to Congress as follows:
FDA conducted more foreign inspections in Fiscal Year (FY) 2007 than any other in the Agency’s history. For example, in FY 2007, FDA conducted 332 inspections of foreign drug manufacturers, compared to 260 in FY 2004, 266 in FY 2005, and 212 in FY 2006. We plan to conduct 500 in FY 2009. While, inspections are an important component of the Agency’s systematic approach to ensuring the safety of imported medical products, they alone cannot fully address these challenges.
Well, the Heparin Catastrophe demonstrates how flawed the FDA’s approach has been. Eight American inspectors for all of China? The goal is to increase inspections from 300 to 500? That is like having 500 auditors for the entire IRS. And I wonder how many of those eight people will speak Chinese?
The Congressional hearings told about the horrors of Chinese drug facilities, just in terms of basic things like cleanliness, not even to mention sterility. Hopefully, massive increases in inspections will at least address those concerns. What good is it for doctors to wash their hands if the drugs they give aren’t sterile?
But the biggest problem the FDA faces is purity. While that sounds like the same thing, I refer to the sterility issue as assuring that bacteria or viruses don’t contaminate drugs. By purity, I mean that the drugs are diluted by a substance that is put in there to dilute the drug, by using cutting agents that are being cleverly disguised to look like the real thing, such as with OSCS and Heparin. The problem with the cutting agents that are disguised to look like the real thing is that these compounds are not innocuous like sugar,. They are in fact complex organic compounds that may have very complex and poorly understood consequences.
But just imagine that the cutting agent was as innocuous as sugar. Well, that would be fine if you weren’t giving it to a diabetic. The problem with any cutting agent is you don’t know who will be hypersensitive to it. The FDA can impose all of the stringent trial and research requirements it wants before approving a drug, but if what is actually sold under that label, isn’t pure, it is a disaster.
You are not going to catch clever counterfeiters with inspections. This type of misconduct can only be detected by rigorous and ever more vigilant testing for purity. It may never be practical to catch each new and progressively more clever attempt to dilute the purity of drugs. Which is why we should not allow any drug to be imported. But if that is too protectionist for the free marketers, and our global trading partners, then at a minimum we must ban the importation of drugs used for intravenous or other sterile administration.
As all Baxter does, according to its Chairman Robert Parkinson is, “manufacture products that are injected or infused or inhaled by patients who need them to stay alive,” Baxter should never have imported any part of what it sells. Baxter should begin its reparations for poisoning Americans by leading the U.S. drug industry towards this type of protectionism – protecting the American patient.
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
Last year, Woodcock explained the new and improved approach of the FDA to Congress as follows:
FDA conducted more foreign inspections in Fiscal Year (FY) 2007 than any other in the Agency’s history. For example, in FY 2007, FDA conducted 332 inspections of foreign drug manufacturers, compared to 260 in FY 2004, 266 in FY 2005, and 212 in FY 2006. We plan to conduct 500 in FY 2009. While, inspections are an important component of the Agency’s systematic approach to ensuring the safety of imported medical products, they alone cannot fully address these challenges.
Beyond Our Borders Initiative. The FDA Beyond Our Borders Initiative is a multi-pronged approach to promote and verify compliance of imported food, cosmetics, and medical products with FDA requirements. This Initiative includes increased FDA presence in China, increased FDA inspections, greater sharing and use of foreign competent authority inspection reports and other information, use of third party certification, and increased capacity building with countries that have less developed regulatory systems to ensure product safety.
Foreign Presence. China is one of the largest exporters of drug products for the U.S. market. Recently, FDA and HHS leadership, the Department of State, and the U.S. Ambassador to China committed to establishing an FDA office in China this year. On March 8, 2008, the Department of State approved FDA to place 13 total staff in China (eight FDA personnel and five Foreign Nationals). This staff will be responsible for building closer working relationships with our Chinese counterparts, carrying out inspections, and working with Chinese inspectors to provide training. FDA is in the process of making the necessary arrangements and preparing to hire staff. This effort builds on two recently-signed Memoranda of Agreements (MOA) with two Chinese FDA counterpart agencies that facilitate broader access to Chinese production facilities on an expedited basis. This is a significant step toward ensuring the safety and efficacy of medical products produced for the U.S. market.
FDA’s efforts will build stronger cooperative relationships with counterpart agencies in China, enhance technical cooperation with these agencies, and foster the flow of information between regulatory systems. Having an overseas presence in China will improve our ability to inspect facilities in China and, very importantly, foster greater interactions between FDA staff and Chinese manufacturers to help ensure that products shipped to the U.S. meet FDA standards for safety and manufacturing quality. In addition, FDA is working to establish beneficial collaborations with India, another large exporter of drug products to the U.S.
Well, the Heparin Catastrophe demonstrates how flawed the FDA’s approach has been. Eight American inspectors for all of China? The goal is to increase inspections from 300 to 500? That is like having 500 auditors for the entire IRS. And I wonder how many of those eight people will speak Chinese?
The Congressional hearings told about the horrors of Chinese drug facilities, just in terms of basic things like cleanliness, not even to mention sterility. Hopefully, massive increases in inspections will at least address those concerns. What good is it for doctors to wash their hands if the drugs they give aren’t sterile?
But the biggest problem the FDA faces is purity. While that sounds like the same thing, I refer to the sterility issue as assuring that bacteria or viruses don’t contaminate drugs. By purity, I mean that the drugs are diluted by a substance that is put in there to dilute the drug, by using cutting agents that are being cleverly disguised to look like the real thing, such as with OSCS and Heparin. The problem with the cutting agents that are disguised to look like the real thing is that these compounds are not innocuous like sugar,. They are in fact complex organic compounds that may have very complex and poorly understood consequences.
But just imagine that the cutting agent was as innocuous as sugar. Well, that would be fine if you weren’t giving it to a diabetic. The problem with any cutting agent is you don’t know who will be hypersensitive to it. The FDA can impose all of the stringent trial and research requirements it wants before approving a drug, but if what is actually sold under that label, isn’t pure, it is a disaster.
You are not going to catch clever counterfeiters with inspections. This type of misconduct can only be detected by rigorous and ever more vigilant testing for purity. It may never be practical to catch each new and progressively more clever attempt to dilute the purity of drugs. Which is why we should not allow any drug to be imported. But if that is too protectionist for the free marketers, and our global trading partners, then at a minimum we must ban the importation of drugs used for intravenous or other sterile administration.
As all Baxter does, according to its Chairman Robert Parkinson is, “manufacture products that are injected or infused or inhaled by patients who need them to stay alive,” Baxter should never have imported any part of what it sells. Baxter should begin its reparations for poisoning Americans by leading the U.S. drug industry towards this type of protectionism – protecting the American patient.
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
Counterfeiting not an Unforeseeable Problem in Imported Heparin
The issue of counterfeiting imported drugs is neither new or unique to the Heparin disaster. In fact, this may be one of the biggest problems facing the pharmaceutical industry, worldwide. The FDA has devoted considerable resources to this issue for some time, including an entire portion of the FDA website, http://fda.gov to the issue of counterfeiting. See http://www.fda.gov/importeddrugs/
For example, at http://www.fda.gov/importeddrugs/chart071304.html the FDA reports its findings on three of the leading selling drugs that are being brought in from Canada: Ambien, Lipitor and Viagra. On all three of these drugs, the concentration level or purity (the same issues as with Heparin) are problems. For example, the above page says this about the safety of Viagra, a drug taken orally:
Clearly, both Baxter and SPL should have been on notice of the risk factors of contaminants and counterfeit in the raw material imported from China. With a drug intended for the human blood stream, that notice should have required the absolute utmost care.
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
For example, at http://www.fda.gov/importeddrugs/chart071304.html the FDA reports its findings on three of the leading selling drugs that are being brought in from Canada: Ambien, Lipitor and Viagra. On all three of these drugs, the concentration level or purity (the same issues as with Heparin) are problems. For example, the above page says this about the safety of Viagra, a drug taken orally:
The sample tablets may be less clinically effective because of their reduced potency and poorer dissolution profile.
The sample tablets may also be less safe due to the elevated impurities.This comment was made about a drug with only .7% impurities, unlike the up to 20% impurities in the contaminated heparin.
Clearly, both Baxter and SPL should have been on notice of the risk factors of contaminants and counterfeit in the raw material imported from China. With a drug intended for the human blood stream, that notice should have required the absolute utmost care.
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