In our previous blogs, we discussed the filing of more than 150 Heparin wrongful death cases against Baxter in Cook County, Illinois. The Court has had many case management conferences including one where the first trial dates are set to begin in January of 2011. That is now little more than a year away.
The cases in Cook County, Illinois are supervised by the Honorable Judge Duncan-Brice. The judge has approved various pre-trial orders including a protective order designating documents produced during discovery as “confidential,” He has also allowed plaintiffs’ counsel to act as personal representatives of potential clients, solely for the purpose of obtaining relevant medical and pharmaceutical records. He has further ordered the defendants to disclose to plaintiff’s lead counsel all ongoing medical and scientific studies and identification of contaminated lots.
Despite the entry of the foregoing orders, there are still numerous items that the court and all parties have to consider, such as the litigation calendar for the consolidated cases, and the manner by which these cases will be tried. To date, the judge has not set a deadline for discovery, nor has the court ruled if exemplar plaintiff cases will be designated. These matters will be addressed in future court dates. Nevertheless, a trial date has been scheduled for January 17, 2011.
Cases involving the Heparin contamination have in addition been filed in the Federal District Court in Ohio (MDL Litigation). Discovery in both proceedings is being coordinated for efficiency. With over a million documents to review, that is a necessity. The Nolan Law Group was appointed lead counsel for plaintiffs in the consolidated state court cases and likewise serves as a member of the Plaintiff’s Executive Committee in the MDL litigation.
As a member of the Plaintiff’s Executive Committee, the Nolan Law Group is in charge of all document reviews relating to product distribution and identification. One responsibility of the said product identification subcommittee deals with the identification of Heparin product lots which are suspected of being contaminated, but have not been publicly acknowledged by Baxter. If proven, these newly identified contaminated products may not only extend the time frame of the contamination back to a much earlier date, but also expand the categories of contaminants in the tainted Heparin. These developments will surely make the plot even thicker!
More on these “product identification” issues in our coming blogs.
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 Warns Qingdao Heparin Company, conclusion
The FDA warning letter to Qingdao Jiulong Biopharmaceuticals Co. Ltd. concluded as follows:
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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Please also address in your response to this letter the following issues:Maybe you should write the FDA and tell them what you think about importing dangerous drugs from China?
During the inspection, the investigators were informed that your firm does not distribute heparin sodium directly to the U.S. and that the product manufactured was shipped to Shanghai. During an inspection conducted at a U.S. facility, we found purchase orders and information indicating that since 2005, heparin sodium manufactured at your facility was being shipped into the U.S. Please clarify whether you shipped drugs directly to the U.S. and provide a list of all lots of heparin sodium (intended for experimental or commercial use) shipped to the U.S. since your firm started to manufacture heparin sodium. Please also identify whether you shipped drugs that you understood were ordered by or ultimately destined for the U.S., even if you did not ship them directly to the U.S. yourself. Also include a list of any other customers to whom you have supplied heparin sodium or other substances intended for the U.S. market. Include the amounts shipped and dates of all shipments.
Please also explain the relationship between your firm and (b)(4). Please provide information regarding any lots of heparin sodium that were shipped by (b)(4) on your firm’s behalf, including lot numbers, dates of shipments and amounts.
In light of the above and the fact that your predecessor (Qingdao Kangyuan) was never inspected by FDA and apparently no longer manufactures heparin sodium, we expect you to address the reliability of any information generated regarding the manufacture, processing, testing, packaging, and labeling of heparin sodium shipped to the U.S. and used to support your DMF 22222.
One way you can do this is by employing a third party auditor to conduct a validity assessment of the information you have provided or intend to provide to support your DMF regarding the production of heparin sodium. Conducting such an audit could expedite the process of re-qualifying your facility.
The listed deficiencies are not to be considered an all inclusive list of deficiencies at your facility. FDA inspections are audits, which are not intended to address all deviations from CGMP or all violations which may exist at a firm. If you wish to ship your products to the U.S., you are responsible for ensuring compliance with all U.S. standards for CGMP and all other applicable U.S. laws and regulations.
Until FDA has confirmed corrections of the deficiencies and compliance with CGMP, this office may recommend withholding approval of any new applications listing your firm as the drug manufacturer. In addition, shipments of articles manufactured at Qingdao Jiulong Biopharmaceutical Co., Ltd located at Jiulong Indusrial Garden Jiaozhou, Qingdao, Shangdon Providence 266319, People’s Republic of China facility and shipped into the U.S. are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C; Act [21 U.S.C. 381(a)(3)], in that, the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of Section 501(a)(2)(B) of the FD&C; Act [21 U.S.C. 351(a)(2)(B)].
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice. Please respond to this letter within 30 days of receipt. Please identify your response with FEI 3006745882. If you have any questions concerning this letter, you may contact Carmelo Rosa, Compliance Officer at the address and telephone numbers shown below.
U.S. Food & Drug Administration Center for Drug Evaluation and Research Division of Manufacturing and Product Quality International Compliance Team White Oak Building 5110903 New Hampshire Avenue Silver Spring, Maryland 20993 Tel: (301) 796-3667 Fax: (301) 301-847-8741
Sincerely,
/s/
Richard L. Friedman Director Division of Manufacturing and Product Quality Office of Compliance Center for Drug Evaluation and Research Office of Compliance
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 Contamination Can do More than Kill
It seemed so obvious, but a brain damage expert I know felt the need to say it twice: That which can kill can do a lot of damage to those who survive. The body is a closed vessel, that is designed to very closely monitor that which comes in and out, especially the things that get into the blood stream.
All organs are extremely susceptible to a disruption in what is supposed to be in the blood supply. That susceptibility applies not only to a poison that shouldn’t be there, but also if there isn’t enough of what should be there: i.e. fuel to make the body work (glucose) and oxygen to make the fuel burn. Further, if the blood isn’t circulating properly, the waste products from this biological fire will not be carried away. In a very similar way to how people will succumb to carbon monoxide poisoning, the body’s cells and organs will be injured or killed by failure to properly ventilate (via the veins) the waste products created by keeping the body running.
When you put contaminated heparin intravenously into a human body, you bypass all of the body’s filters. The blood stream directly circulates that contaminant to every cell and organ. So what happens when a toxin runs amuck in our bodies? Almost anything that can go wrong, could go wrong.
Today I will talk about just the articulated theory from the CDC and the FDA of “acute allergic-type reaction has been defined as an episode of anaphylactic or anaphylactoid reaction”. See http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5705a4.htm What can happen with anaphylactic shock? The body goes into shock. See http://en.wikipedia.org/wiki/Anaphylactic_shock and more specifically with respect to shock: http://en.wikipedia.org/wiki/Shock_%28medical%29
Some highlights from Wikipedia:
We know that reduced blood flow is one of the common symptoms of the Heparin contamination cases, because of the hypotension (low blood pressure) reported in most of these cases. Some highlights from Wikipedia about the risk of brain damage from Hypoxia:
Symptoms of hypoxia? Cognitive problems similar to what might be expected with a concussion. Amnesia, confusion, difficulty doing complex tasks, responding to unexpected processing demands. While there is some controversy about how much hypoxia can occur without long term damage, we believe this is the most important issue to evaluate in any Heparin contamination case.
So far no one at the CDC or FDA has announced any inquiry into whether hypoxic damage to the brain or other organs has occurred. While the brain is the most susceptible to permanent damage in a healthy person, since the recipients of this contaminant were those with compromised organs (hemodialysis patients for example), other organ damage may have occurred before the evidence of cerebral hypoxia showed up. Further, as vital organs like the kidneys and liver started to malfunction, other toxins could have been circulated into the blood stream.
It is time to insist the inquiry in this matter is no longer ruled by the presumption that those who survived the allergic reaction will have no long term damage. It is unimaginable that something toxic enough to have killed 62 people while affecting as many as 5,000 others, didn’t leave some permanent damage behind.
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
All organs are extremely susceptible to a disruption in what is supposed to be in the blood supply. That susceptibility applies not only to a poison that shouldn’t be there, but also if there isn’t enough of what should be there: i.e. fuel to make the body work (glucose) and oxygen to make the fuel burn. Further, if the blood isn’t circulating properly, the waste products from this biological fire will not be carried away. In a very similar way to how people will succumb to carbon monoxide poisoning, the body’s cells and organs will be injured or killed by failure to properly ventilate (via the veins) the waste products created by keeping the body running.
When you put contaminated heparin intravenously into a human body, you bypass all of the body’s filters. The blood stream directly circulates that contaminant to every cell and organ. So what happens when a toxin runs amuck in our bodies? Almost anything that can go wrong, could go wrong.
Today I will talk about just the articulated theory from the CDC and the FDA of “acute allergic-type reaction has been defined as an episode of anaphylactic or anaphylactoid reaction”. See http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5705a4.htm What can happen with anaphylactic shock? The body goes into shock. See http://en.wikipedia.org/wiki/Anaphylactic_shock and more specifically with respect to shock: http://en.wikipedia.org/wiki/Shock_%28medical%29
Some highlights from Wikipedia:
Shock is a serious, life-threatening medical condition where insufficient blood flow reaches the body tissues. As the blood carries oxygen and nutrients around the body, reduced flow hinders the delivery of these components to the tissues, and can stop the tissues from functioning properly.And guess what can happen when the tissue stops functioning properly – brain damage and other organ damage, from a condition called hypoxia. See :http://en.wikipedia.org/wiki/Hypoxic_encephalopathy
We know that reduced blood flow is one of the common symptoms of the Heparin contamination cases, because of the hypotension (low blood pressure) reported in most of these cases. Some highlights from Wikipedia about the risk of brain damage from Hypoxia:
Cerebral hypoxia refers to deprivation of oxygen supply to brain tissue. … Extended periods of cerebral hypoxia can lead to brain death or permanent brain damage. … The effects of certain kinds of severe generalized hypoxias may take time to develop. For example, the long term effects of serious carbon monoxide poisoning usually may take several weeks to appear. Recent research suggests this may be due to an autoimmune response caused by CO induced changes in the myelin sheath surrounding neurons.
Symptoms of hypoxia? Cognitive problems similar to what might be expected with a concussion. Amnesia, confusion, difficulty doing complex tasks, responding to unexpected processing demands. While there is some controversy about how much hypoxia can occur without long term damage, we believe this is the most important issue to evaluate in any Heparin contamination case.
So far no one at the CDC or FDA has announced any inquiry into whether hypoxic damage to the brain or other organs has occurred. While the brain is the most susceptible to permanent damage in a healthy person, since the recipients of this contaminant were those with compromised organs (hemodialysis patients for example), other organ damage may have occurred before the evidence of cerebral hypoxia showed up. Further, as vital organs like the kidneys and liver started to malfunction, other toxins could have been circulated into the blood stream.
It is time to insist the inquiry in this matter is no longer ruled by the presumption that those who survived the allergic reaction will have no long term damage. It is unimaginable that something toxic enough to have killed 62 people while affecting as many as 5,000 others, didn’t leave some permanent damage behind.
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 Spider Web of Heparin Clues
When the FDA announced the recall of Baxter’s Heparin in January, it was limited to nine lots. The FDA’s recent statements make it clear this contamination is much broader. The number of suspected deaths has risen to 62. Below are portions of the FDA’s release on Heparin on April 8, 2008:
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
Information on Adverse Event Reports and Heparin
The chart below shows numbers of deaths reported after heparin administration that occurred and were submitted to FDA over the last fifteen months (i.e., from January 1, 2007 through March 31, 2008).
The reports are sorted according to the date of the medical event in the report, indicated in the first column. This date may be different than the date of death.
The second column indicates the number of deaths reported after heparin administration, regardless of cause.
The third column indicates the number of death reports that included one or more allergic symptom(s) or symptoms of hypotension (low blood pressure). These are the events that prompted a series of heparin recalls.
There have been 103 reports of death since January 1, 2007; 91 were reported to FDA on or after January 1, 2008.
Of the 62 reports of death that included one or more allergic symptom(s) or symptoms of hypotension, 56 were reported to FDA on or after January 1, 2008.
The fact that allergic symptoms or hypotension was reported does not mean that these were the cause of death in all cases.
FDA received reports of 41 patients who died without mention of allergy or hypotension. These patients died of a variety of causes.
Number of Deaths of Patients Receiving Heparin Reported to FDA,
January 1, 2007 through March 31, 2008
Click here to see this chart.
FDA continues to receive reports of adverse events occurring after heparin administration.
FDA will analyze these and all other reports of adverse events after heparin administration.
FDA will update the data on this website on a periodic basis.
Reports have to be analyzed to see if there is a plausible causal association between the drug and the medical event.
It is often not possible to tell in an individual case if there is a causal relationship between the drug and the medical event or death.
62 deaths. That is a lot, yet probably only a portion of the problem. The FDA implies that the number is higher than is truly related, because of the serious conditions that could have caused the reported problems. But for the same reason, we believe that the amount is severely under-reported. Because this group of people was otherwise ill, the typical doctor may have had no reason to suspect that what appeared to be a normal consequence of the illness, is in fact an allergic reaction. We believe that is entirely possible that the reason the number of reported deaths and reactions went up so dramatically after the first warning was flagged late in 2007, was that someone actually started to look for the pattern.
Many patients have other serious conditions that could have caused the reported problem.
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 Lawsuits Provide Chance for Deep Probe Into Tough Questions
We at the Nolan Law Group have brought the first case against Baxter for the Heparin debacle in Baxter’s home state of Illinois. Click here for more on that lawsuit. As the lawsuits explode on the scene of against Baxter, here are some issues that need to be addressed:
1. How do we know that this catastrophe began with September of 2007 produced product, and not much earlier? Doctors, medical examiners and pathologists had no basis to suspect heparin in any deaths prior to January of 2008. Unfortunately, as most of those receiving heparin were already very sick, a suspicious death or reaction might just have been attributed to the already comprised health of the person receiving heparin. Will the FDA, Baxter, the CDC go back and do additional surveillance of all deaths in dialysis patients in the period prior to the fall of 2007, to see if there is a pattern that was previously missed?
2. What is the precise method of death and morbidity caused by this contaminant in the heparin? Is it strictly a anaphylactic or anaphylactoid reaction, or is there something more complex going on.
3. If it is anaphylactic or anaphylactoid reaction, has the patient been sensitized to the contaminant because of earlier treatments (such as with a prior bee sting) and then has the anaphylactic reaction upon the later treatment (the second bee sting)?
4. What health risks/disabilities do those with adverse reactions who survived faced? Are they at greater risk of anaphylactic or anaphylactoid reaction in the future? Do they need to carry precautionary warnings, medications with them?
5. What about the thousands of those exposed to this toxin, who did not have an adverse reaction? If the issue is anaphylactic or anaphylactoid reaction, are they at greater risk of anaphylactic or anaphylactoid reaction in the future because they have now had the equivalent to the first bee sting?
6. In the survivors, is there any risk of organ damage or brain damage as a result of the cardiac or hypotensive events that occurred?
7. If the pathology is broader than an anaphylactic or anaphylactoid reaction what other damage did it do to the bodies of those who survived?
8. What diagnostic tests should be being performed on the survivors? MRI of the brain, EKG’s. Clearly, it would seem imperative to do kidney function tests, on the hemodialysis survivors.
9. What about all of those exposed to the toxins, without a clinically significant acute reaction? This exposure presumably went on for weeks and even months. Could they have chronic damage with a more subtle manifestation?
The lawsuits provide the best mechanism to get to the bottom of these issues, but we hope that Baxter, its joint venture participants, the CDC, the FDA and other government agencies will be pondering these issues and looking for the truth, not just pointing fingers.
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
1. How do we know that this catastrophe began with September of 2007 produced product, and not much earlier? Doctors, medical examiners and pathologists had no basis to suspect heparin in any deaths prior to January of 2008. Unfortunately, as most of those receiving heparin were already very sick, a suspicious death or reaction might just have been attributed to the already comprised health of the person receiving heparin. Will the FDA, Baxter, the CDC go back and do additional surveillance of all deaths in dialysis patients in the period prior to the fall of 2007, to see if there is a pattern that was previously missed?
2. What is the precise method of death and morbidity caused by this contaminant in the heparin? Is it strictly a anaphylactic or anaphylactoid reaction, or is there something more complex going on.
3. If it is anaphylactic or anaphylactoid reaction, has the patient been sensitized to the contaminant because of earlier treatments (such as with a prior bee sting) and then has the anaphylactic reaction upon the later treatment (the second bee sting)?
4. What health risks/disabilities do those with adverse reactions who survived faced? Are they at greater risk of anaphylactic or anaphylactoid reaction in the future? Do they need to carry precautionary warnings, medications with them?
5. What about the thousands of those exposed to this toxin, who did not have an adverse reaction? If the issue is anaphylactic or anaphylactoid reaction, are they at greater risk of anaphylactic or anaphylactoid reaction in the future because they have now had the equivalent to the first bee sting?
6. In the survivors, is there any risk of organ damage or brain damage as a result of the cardiac or hypotensive events that occurred?
7. If the pathology is broader than an anaphylactic or anaphylactoid reaction what other damage did it do to the bodies of those who survived?
8. What diagnostic tests should be being performed on the survivors? MRI of the brain, EKG’s. Clearly, it would seem imperative to do kidney function tests, on the hemodialysis survivors.
9. What about all of those exposed to the toxins, without a clinically significant acute reaction? This exposure presumably went on for weeks and even months. Could they have chronic damage with a more subtle manifestation?
The lawsuits provide the best mechanism to get to the bottom of these issues, but we hope that Baxter, its joint venture participants, the CDC, the FDA and other government agencies will be pondering these issues and looking for the truth, not just pointing fingers.
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