Heparin Recall | Heparin Deaths

FDA Criticized For Role In Heparin Contamination Case

Posted on 30th April 2010 by gjohnson in Uncategorized

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A congressional probe has faulted the Food and Drug Administration for failing to identify the companies responsible for contaminated heparin being imported from China to the United States, where it was linked to hundreds of deaths, according to a story in The Wall Street Journal Friday. http://online.wsj.com/article/SB10001424052748703572504575214420823549694.html?mod=WSJ_hpp_sections_news

That should come as no surprise to anyone with knowledge of that nightmarish heparin disaster. It’s rather obvious that the FDA was not doing its job, and still may not be doing its job in this regard, namely properly policing imported medicines and drugs.

Rep. Joe Barton, R-Texas, and Rep. Mike Burgess, R-Texas, in a letter to the FDA this week outlined the details of their investigation into the deadly heparin case. They told the agency that it had failed to follow up on several “specific and credible leads” that could have identified who was responsible for the contaminated blood thinner, The Journal reported.

Between 2007 and 2008 the contaminated imported heparin was tied to more than 80 deaths, and to hundreds of incidents where people fell sick.

Barton, the top Republican on the House Energy and Commerce Committee, has been spearheading the probe, and a vocal critic, of how the FDA handled the tainted heparin situation.

The letter to the FDA asserted that the federal agency hasn’t done any follow-up with the Chinese government on issues related to some Chinese companies, according to The Journal.

The investigation also found that the FDA didn’t investigation leads it received from foreign officials. For example, one November 2008 FDA memo said that a respectable foreign government agency had shared “a significant finding” that a Chinese business was manufacturing counterfeit heparin with plans to ship it to the United States under another company’s name, The Journal reported.

China is the source of much of the world’s crude heparin, as that country processes pigs intestines as an ingredient for that drug.

Back in March 2008, the FDA announced that it had identified the heparin contaminant. It was chondroitin suflate, which was mixed into the raw heparin in China “to stretch the supply,” according to The Journal.

The FDA never announced who it thought was responsible for the contamination. But there seemed to be several obvious culprits.

The letter cited the case of Chongqing Imperial Bio-Chem in China, which supplied pharmaceutical ingredients. An FDA document from April 2008 said that some of the crude heparin that Chongqing sent to an Ohio company was tainted, The Journal reported.

The FDA in March 2009 did ban pharmaceutical ingredients from Chongqing from coming to the states. But Barton and Burgress maintained that the agency should have probed further, in terms of Chonqging’s actual name and its place in the drug supply chain, according to The Journal.

The congressmen’s letter also pointed out that the FDA will have to overcome legal and language hurdles to conduct probes of drugs overseas

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Toddler Dies After Heparin Overdose At Nebraska Hospital

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Posted on 5th April 2010 by gjohnson in Uncategorized

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In a case that mirrors the near-tragedy that happened to actor Dennis Quaid’s twins, a toddler has died from an overdose of the blood thinner heparin at an Omaha, Neb., hospital. http://www.emaxhealth.com/1506/24/texas-toddler-dies-nebraska-hospital-after-heparin-overdose.html

Almariah Duque, 23 months old, of Dallas, Texas, was at Nebraska Medical Center to receive organ transplants when was given the allegedly fatal dose of heparin. The hospital is investigating the child’s death.

An estimated 100,000 people die each year in hospitals as a result of medical mistakes, and heparin is typically high on the list of drugs involved in medication errors, according to an online story on eMaxHealth.com.

There’s a reason for that: Pediatric and adult doses of heparin used to come in bottles that had the same size and shape, with just a slight difference in their blue color. Heparin’s manufacturer, Baxter International, redesigned the bottle’s labels to try to prevent future mistakes with the medication. There is now a red caution label on the vials that must be removed before they can be opened.

But the drug maker didn’t recall the old heparin bottles.

Quaid and his wife Kimberly made preventable medical errors their cause celebre after an incident in 2007 when their twins were accidentally given 1,000 times the common dosage of heparin at Cedars-Sinai Medical Center in Los Angeles.

The babies began bleeding, and had to be given protamine sulfate to counteract the heparin’s effect. The twins were hospitalized for 12 days.

On the CBS show “60 Minutes,” Quaid said he had learned that accidental heparin overdoses often happened. He and his wife have created the Quaid Foundation to raise awareness about medical mistakes that are fatal.

FDA Soon To Issue Guides On Tracking/Tracing Drugs

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Posted on 13th March 2010 by gjohnson in Uncategorized

FDA Issue Guides for Tracking drugs, FDA recall heparin, FDA recalls, heparin attorney, heparin recall

It may have taken three years since the heparin-contamination tragedy, but the Food and Drug Administration is apparently close to issuing its guidance for the tracking and tracing of medicines. http://www.securingpharma.com/40/articles/403.php

Joshua Sharfstein, FDA deputy commissioner, said Thursday that the guidance will set “a standard for unique identification for prescription drug packages, which ultimately will help in identifying the whereabouts and authenticity of drug packages and distinguish them from counterfeits.”

He made his remarks before a House Energy and Commerce health subcommittee meeting, which was called “Drug Safety: An Update From The FDA.”

Coming up with a better system of tracking drugs is crucial, especially when about 80 percent of all active pharmaceutical ingredients used by U.S. drug makers come from overseas, according to a 1998 U.S. General Accounting Office study.

During his testimony, Sharfstein claimed that the FDA has made great progress beefing up the oversight of foreign-made drug ingredients that are coming into the United States, For example, it has opened offices in several countries and now has information-sharing deals with foreign regulatory agencies.

Sharfstein also cited the calamity involving Chinese-made heparin, which he said caused the deaths at least 80 Americans, during his comments to the subcommittee.

Heparin Debacle Lead To A Decline in Chinese Drug Exports

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Posted on 23rd February 2010 by gjohnson in Uncategorized

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China’s sometimes deadly quality control issues cut into the demand for its active pharmaceutical ingredients (API)s last year, but that will change this year, according to outsourcing consultant JZ Med.

The bean counter statistical analysis of this is really quite remarkable. From our perspective the decline should have been catastrophic, not single digits. It just goes to show how little this huge debacle for America’s most ill patients, has stayed out of the news cycle. By point of comparison, I wonder what the drop in Chinese dog food and drywall has been?

If the public had truly understood the magnitude of this disaster, the result might have been to ban all foreign manufacture of drugs. Perhaps when the full extent of the disaster is known because of the hundreds and hundreds of wrongful death cases still pending, the experts such as JZ Med will have to redo their numbers. We can only hope that the Civil Justice System can do more to protect us than Wall Street and the FDA has done.

The market for APIs from China last year dipped 3 percent, to be worth $31 billion, said FiercePharma, based on the report from JZ Med. http://www.fiercepharma.com/story/chinas-api-exports-hurt-quality-issues/2010-02-22

Chinese API exports declined by 8 percent, to about $16 billion last year. JZ Med believes these numbers declined because of quality control disasters like the 2008 recall of the blood thinner heparin from China, which was contaminated and was blamed four countless deaths. The world’s economic woes have also cut the demand for Chinese APIs. See http://heparin-law.com

JZ Med argues, and we are not necessarily buying into this, that drip in demand has made some API manufacturers to improve their quality control to be more in line with the standards in place in the United States and Europe.

This year the market for APIs will increase 5 percent to 8 percent, according to JZ Med, to $33 billion. Following that, the API growth should see larger annual increases, to 15 percent, or $65 billion, by 2015, the consultant said.

Please, Big Pharma: If I am sick and need something put directly into my veins so that I don’t die during a procedure, can you please make sure it comes from a facility that the FDA has inspected? The only way to really make sure is to have that facility to be directly under the FDA’s jurisdiction. In other words, in the USA.

Baxter Heparin Debacle from a Financial Perspective

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Posted on 24th December 2009 by gjohnson in Uncategorized

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Criticism of the greed based decision making of exporting the manufacture of Heparin to China came from an interesting direction yesterday. The source: Norm Howe, Senior Partner at Validation and Compliance Institute, consultants for FDA regulated industries. Mr. Howe had this to say:

When FDA inspected a Heparin supplier, Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd., they thought they were seeing the real plant. It turned out that it was only a show facility. The real plant was a shadow plant located somewhere else. The US-FDA Warning Letter later stated, “The inspection revealed that the facility was not manufacturing, and did not appear to have ever manufactured, Heparin Sodium USP (or heparin sodium) for the U.S. market.”

This case is similar to Baxter Pharmaceutical’s experience with their Heparin supplier in 2008. The result of that deception was that hundreds of patients suffered life-threatening reactions like severe hypotension, low blood pressure and over 80 people died.

See A New Paradigm to Address the High Cost of Vendor Qualification
http://www.costa-classified-ads.com/manag/3515/a-new-paradigm-to-address-the-high-cost-of-vendor-qualification/ In this article, Mr. Howe went on to point out that saving a few dollars on Chinese imports, may end up costing your company exponentially more.

He continued:

Any pharmaceutical or medical device plant is a very complex place. Unless you plan to take up residence at the vendor you have no chance to understand the true nature of these operations. And what company in today’s cost-cutting climate has the resources to do that? Keep in mind that an audit costs more than what you pay for your auditors to investigate the vendor. The vendor has to spend their time escorting the auditors around, digging out records, and following up on action items. Guess who has to cover that cost. The assumption today is that a BETTER audit means a LONGER audit. There has to be another way.

What’s needed is a new paradigm for vendor qualification; a tool that can drill deeply into the vendor’s operation at low cost; something that can provide a more lasting measure of the vendor’s performance than simply an audit.

Isn’t there a simpler solution? Manufacture drugs in the United States where the company whose name is on the product, can control what goes in them?

Heparin – FDA’s SPL Inspection – No One in Charge

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Posted on 6th April 2009 by gjohnson in Uncategorized

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Today we discuss what has to be the most staggering aspect of the manufacturing situation at the Changzhou SPL plant in China, Baxter’s source of the API which made up the contaminated Heparin: No one with specialized knowledge of Heparin, was working for SPL in China.

These quotes are taken from the April 29, 2008 hearings before the House Subcommittee on Oversight and Investigations hearings, see: The Heparin Disaster: Chinese Counterfeits and American Failures
For more, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml

Regina Brown of the FDA was questioned in those hearings by U.S. Representative, Jan Schakowsky:

Question by Schakowsky: There was no person with special knowledge of Heparin at the firm to guide decisions made by the quality unit. So Ms. Brown, I would assume that if a plant was making Heparin API, it would want to have a person with “special knowledge” of that product, in case deviations from any manufacturing process were observed, wouldn’t you agree?

Answer by Brown: They had a quality unit there, which consisted of four people, they were trying to track what was going on with the firm. The person with the special knowledge I mentioned, because when I arrived, management was aware that there were Baxter recalls, and that there were adverse drug events and deaths in the United States. It was middle of February, the general manager of the firm, Mr. Wong, was the one who described the process to me and how he thought that impure materials were removed from the crude heparin to make it into the heparin API and he said he wasn’t a heparin expert. And so, he was really the person who gave me my fullest extent of knowledge during the inspection.

Q: So, neither he nor the others had any special knowledge, he had the most knowledge?

A: I believe so, yes.

Unbelievable. SPL is manufacturing a drug that is going to be put in to the veins of our sickest people and they don’t have anyone on site with specialized knowledge as to how to make Heparin? How could Baxter have allowed this? Any superficial investigation would have determined that Changzhou SPL didn’t know what it was doing. Such a breakdown in the process of making an intravenous pharmaceutical is outrageous and is an institutional catastrophe.

Baxter’s Heparin Contamination – More on SPL Inspection

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Posted on 29th March 2009 by gjohnson in Uncategorized

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In our previous blogs, we discussed the first of the four essential problems with the manufacture of Heparin API at the Changzhou SPL plant in China. Today, we discuss the second, which is non-sterile equipment found during the FDA’s inspection of Changzhou SPL plant in China. Changzhou SPL was the supplier of the contaminated Heparin to Baxter.

Again, these quotes are from the April 29, 2008, House Subcommittee on Oversight and Investigations hearings, see: The Heparin Disaster: Chinese Counterfeits and American Failures
For more, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml

Regina T. Brown, FDA Consumer Safety Officer was the FDA Officer at the Changzhou SPL plant. U.S. Representative, Jan Schakowsky’s, questioning of Brown included the following with respect to the substandard equipment:

Question by Rep. Schakowsky: You found that the equipment SPL used to manufacture heparin may not have been suitable for its intended use, isn’t that correct?

Answer by Brown: Yes.

Q: And how was it unsuitable and why is this important?

A. There were three different pieces of equipment that I found unsuitable for use.

The first was these big polyethylene tanks that they dissolved heparin up in, just prior to the last manufacturing step, which was a liofolization, a freeze drying step. And these PE tanks were scratched on the bottom, very scratched, as if somebody had been chopping stuff out of them with plastic. I ran my fingernail along it and it was like playing an accordion. And there also was stuff adhering to the bottom of these tanks.

Q: This was inside?

A: On the inside of the tanks where crude heparin would be right before it became heparin API. So I scratched stuff off the inside of the tank. And this was tank that was marked clean.

A second PE tank I turned over and liquid fell out of the handle, the molded, PE comes from a mold polyethylene, and stuff, a liquid fell out of the handles into the bottom of the tank. And it was marked cleaned. So it wasn’t a clean tank.

Q: Stuff. Do we know what stuff was in there?

A: The stuff I scratched off? No I don’t know what it was. It was a little gray colored, it wasn’t white. That is all I know.

If Brown was describing the conditions of a commercial kitchen, this would be a serious area of concern. But that such non-sterile conditions could occur in the manufacture of an intravenous medicine to be given to ill people, is simply outrageous. Baxter claims to have inspected this plant in the months before word of this calamity reached the U.S. market. It is hard to imagine how an honest inspection could have been done by Baxter, in light of what the FDA inspection showed.

Heparin Frequently Asked Questions Part V

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Posted on 19th March 2009 by gjohnson in Uncategorized

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Our recent blogs have been addressing Frequently Asked Questions. We have addressed:
1. When did the Baxter Heparin contamination begin?
2. When did Heparin return to being Safe?
3. How severe of a reaction should we have before calling?
4. What is the process should when I call the Johnson Law Office?
5. Will this Involve a Class Action?
Today, we continue with:

6. Are these Federal or State Court Actions?

Each plaintiff has a choice as to whether to file a non-class action case in Federal or State Court. The class action cases (non-severe consequences) are being handled in Federal Court. The Johnson Law Office, as well as our affiliated firm, The Nolan Law Group, are licensed in Illinois, the state where Baxter has its home office. Baxter has agreed to allow our claimants to bring these cases in Cook County, Illinois. Our litigation affiliate, The Nolan Law Group of Chicago, has a long track record of excellent results in Cook County, Illinois, including the Air Philippines case which was settled in 2007 for $165 million.

FDA: Information on Adverse Event Reports and Heparin

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Posted on 18th November 2008 by gjohnson in Uncategorized

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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 from January 1, 2007 through May 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 246 reports of death reported to FDA since January 1, 2007; 238 were reported to FDA on or after January 1, 2008.

Of the 149 reports that included one or more allergic symptom(s) or symptoms of hypotension and death, 146 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 97 patients who died without mention of allergy or hypotension. These patients died of a variety of causes.

In the majority of reports with a death outcome, there was not enough clinical information to assess the relationship between death and the use of heparin.

The recent internet posting from the Center for Devices and Radiological Health (CDRH) (http://www.fda.gov/cdrh/safety/heparin-qanda.html) states that CDRH has received reports of 11 deaths associated with heparin-containing devices. The CDRH reporting system is separate from the Adverse Event Reporting System (AERS) used to capture the reports counted below. It is possible that reports of one death were sent to both systems, and could potentially be counted twice.

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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.

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FDA Criticized For Role In Heparin Contamination Case

Toddler Dies After Heparin Overdose At Nebraska Hospital

FDA Soon To Issue Guides On Tracking/Tracing Drugs

Heparin Debacle Lead To A Decline in Chinese Drug Exports

Baxter Heparin Debacle from a Financial Perspective

Heparin – FDA’s SPL Inspection – No One in Charge

Baxter’s Heparin Contamination – More on SPL Inspection

Heparin Frequently Asked Questions Part V

FDA: Information on Adverse Event Reports and Heparin

FDA calls for Adverse Reporting of Heparin

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