Heparin Deaths » FDA recall of Heparin

Heparin Deaths » FDA recall of Heparin http://heparin-law.com/blog Wed, 01 Sep 2010 16:41:13 +0000 en hourly 1 http://wordpress.org/?v=3.0.1 FDA Starts Targeting High-Risk Drug Imports http://heparin-law.com/blog/2010/02/fda-starts-targeting-high-risk-drug-imports.html http://heparin-law.com/blog/2010/02/fda-starts-targeting-high-risk-drug-imports.html#comments Mon, 08 Feb 2010 11:20:00 +0000 gjohnson http://heparin-law.com/blog/2010/02/fda-starts-targeting-high-risk-drug-imports.html
The initiative involving new procedures for U.S. border inspectors comes in the wake of the contaminated blood thinner, heparin. The heparin came from China and had a deadly contaminant in it that caused what is a still unknown number of U.S. deaths in 2007 and 2008. See http://heparin-law.com Toothpaste, pet food and other goods imported from China have also been found to have been dangerous.

For more on the FDA’s new computer process see http://www.reuters.com/article/idUSTRE6135S720100205

Some 20 million shipments of food, medicine and cosmetics will go through ports in the states this year, up 6 million from 10 years ago.

The new program, called “Predict,” uses a computer database to assign a risk score for a product. That score is based on whether a manufacturer has had previous recalls and whether a product has a history of prior contamination.

Goods that score high are pulled out for additional inspection.

“Predict” has been tested in Los Angeles and is being installed in New York. The FDA says the system will be rolled out nationally and in use by the early summer.

Still, with the FDA having a 30 year backlog on inspecting new facilities and a facility able to go online before inspection, this is a system still ripe for a disastor. It is time to stop delegating the manufacture of goods this dangerous to those we cannot control.]]> http://heparin-law.com/blog/2010/02/fda-starts-targeting-high-risk-drug-imports.html/feed 0 Heparin Purity – Heparin Potency – Heparin Adverse Reactions http://heparin-law.com/blog/2009/10/heparin-purity-heparin-potency-heparin-adverse-reactions.html http://heparin-law.com/blog/2009/10/heparin-purity-heparin-potency-heparin-adverse-reactions.html#comments Mon, 05 Oct 2009 14:56:00 +0000 gjohnson http://heparin-law.com/blog/2009/10/heparin-purity-heparin-potency-heparin-adverse-reactions.html
By now it must be known just how many doses of contaminated Heparin Baxter produced and distributed. Both Baxter and the FDA have to know at least that much, right? The FDA first started by recalling nine lots, then additional lots and then pulled all of the Chinese heparin. But just how broad of a problem does “nine lots” represent? Would anyone in the public or even the news media know?

I am still waiting for proof that that number didn’t reach into the millions of contaminated doses. Heparin is administered to millions of people each year. If all of the Heparin for even the shortened time period from the Fall 2007 thru the Spring of 2008 was contaminated, doesn’t that mean millions were poisoned? Why is the FDA not telling us more. I can understand when it is a Republican FDA, but why are the Democrats not doing better?

Now we learn from the FDA that getting the dosing right on Heparin requires intense monitoring. See our last blog. So doesn’t that mean that what the FDA and Baxter hasn’t told us includes that failure to control potency could have killed many more?

When dealing with an intravenous drug that is given to our sickest patients (like kidney dialysis patients) there must be a duty not just to make the drug perfect, but also to tell everyone who got the less than perfect drug, of what happened to them.]]> http://heparin-law.com/blog/2009/10/heparin-purity-heparin-potency-heparin-adverse-reactions.html/feed 1 Heparin Wrongful Death Trials Start in January of 2011 http://heparin-law.com/blog/2009/09/heparin-wrongful-death-trials-start-in-january-of-2011.html http://heparin-law.com/blog/2009/09/heparin-wrongful-death-trials-start-in-january-of-2011.html#comments Fri, 11 Sep 2009 06:50:00 +0000 gjohnson http://heparin-law.com/blog/2009/09/heparin-wrongful-death-trials-start-in-january-of-2011.html
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.]]> http://heparin-law.com/blog/2009/09/heparin-wrongful-death-trials-start-in-january-of-2011.html/feed 0 FDA Drug Chief Woodcock Accused of Conflict of Interest http://heparin-law.com/blog/2009/09/fda-drug-chief-woodcock-accused-of-conflict-of-interest.html http://heparin-law.com/blog/2009/09/fda-drug-chief-woodcock-accused-of-conflict-of-interest.html#comments Fri, 04 Sep 2009 07:49:00 +0000 gjohnson http://heparin-law.com/blog/2009/09/fda-drug-chief-woodcock-accused-of-conflict-of-interest.html
It was clear in those hearings that the Congressmen and Dr. Woodcock were well acquainted, with many references to her previous testimony. It now appears that Dr. Woodcock was the pure Washington insider, well acquainted not only with those who were in charge of oversight of her job, but also with those who she was supposed to be regulating.

The Wall Street Journal reported last month that Dr. Woodcock has been accused of conflict of interest, not just on any old drug, but with a heparin based blood thinner, Lovenox. http://online.wsj.com/article/SB125003545637224263.html

According to the Wall Street Journal:

“The investigation of Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, stems from an ethics complaint filed by Amphastar Pharmaceuticals Inc., a California company that says it has been delayed in its six-year effort to win approval for a generic version of Lovenox, a multi-billion-dollar blood thinner.

“In its complaint, Amphastar alleges that its competitor had special access to Dr. Woodcock at critical times in the prolonged approval process, which is ongoing. Amphastar points out that Dr. Woodcock co-authored a scientific paper with scientists at Momenta Pharmaceuticals Inc. while both companies were battling to win FDA approval of their generic blood thinners.”

It is an old cliché, but it may be time to throw out those bums. Change we can believe in must come to Washington. The debate over healthcare reform has shown just how deep the health industries ties are to our government. If we can’t return our government to the people, not corporate lobbyists, government for the people, by the people, may perish.]]> http://heparin-law.com/blog/2009/09/fda-drug-chief-woodcock-accused-of-conflict-of-interest.html/feed 0 Wyeth shareholders vote to be acquired by Pfizer http://heparin-law.com/blog/2009/07/wyeth-shareholders-vote-to-be-acquired-by-pfizer.html http://heparin-law.com/blog/2009/07/wyeth-shareholders-vote-to-be-acquired-by-pfizer.html#comments Mon, 20 Jul 2009 07:40:00 +0000 gjohnson http://heparin-law.com/blog/2009/07/wyeth-shareholders-vote-to-be-acquired-by-pfizer.html
Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com

Date: 7/20/2009 10:15 AM

MADISON, N.J. (AP) — Shareholders of drugmaker Wyeth have voted overwhelmingly to be acquired by industry giant Pfizer Inc.

More than 98 percent of Wyeth stockholders voted to approve the $68 billion acquisition. The deal will solidify Pfizer’s position as the top-selling drug maker in the world.

For Pfizer, it transforms the company overnight from being primarily a maker of the blockbuster pills to a one-stop shop for medical treatments. That’s because Wyeth brings multibillion-dollar products and substantial expertise in researching and manufacturing biologic drugs, vaccines, nonprescription medicines and animal health products.

Wyeth’s shareholders cast their votes while gathered at their annual meeting at the company headquarters in Madison, N.J.

Copyright 2009 The Associated Press.]]> http://heparin-law.com/blog/2009/07/wyeth-shareholders-vote-to-be-acquired-by-pfizer.html/feed 0 Rep. Barton Demands Answers about Heparin Contamination http://heparin-law.com/blog/2009/05/rep-barton-demands-answers-about-heparin-contamination.html http://heparin-law.com/blog/2009/05/rep-barton-demands-answers-about-heparin-contamination.html#comments Thu, 07 May 2009 16:56:00 +0000 gjohnson http://heparin-law.com/blog/2009/05/rep-barton-demands-answers-about-heparin-contamination.html
According to the Dow Jones Newswire, Rep. Joe Barton, R.-Texas, “is pressuring the U.S. Food and Drug Administration for more information about contaminated heparin from China amid concerns that the agency doesn’t know what caused U.S. patients to get sick or die while taking the blood thinner last year.”

Barton is a member of the House Energy and Commerce Committee which held hearings last year. He has written a letter to the FDA demanding the agency turnover databases on the Heparin contamination. According to Dow Jones:

Barton is trying to determine whether anyone in China has been held responsible for contaminating heparin that ultimately sickened and killed U.S. citizens.

“We don’t seem to be any further along a year later from understanding” this issue, said an Republican staffer for the committee, who asked not to be named. “What are they doing about it? Is this an acceptable practice in China?”

It is time that the FDA went public with all it knows about the Heparin Catastrophe. Freedom of Information Requests have been pending before the agency for more than a year now. What does the FDA know? Why are they not telling the American public about the full breadth of this poisoning?]]> http://heparin-law.com/blog/2009/05/rep-barton-demands-answers-about-heparin-contamination.html/feed 0 Baxter’s Heparin Contamination – More on SPL Inspection http://heparin-law.com/blog/2009/03/baxters-heparin-contamination-more-on-spl-inspection.html http://heparin-law.com/blog/2009/03/baxters-heparin-contamination-more-on-spl-inspection.html#comments Sun, 29 Mar 2009 17:02:00 +0000 gjohnson http://heparin-law.com/blog/2009/03/baxters-heparin-contamination-more-on-spl-inspection.html
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.]]> http://heparin-law.com/blog/2009/03/baxters-heparin-contamination-more-on-spl-inspection.html/feed 0 Heparin Frequently Asked Questions Continued http://heparin-law.com/blog/2009/03/heparin-frequently-asked-questions-continued.html http://heparin-law.com/blog/2009/03/heparin-frequently-asked-questions-continued.html#comments Sun, 22 Mar 2009 10:15:00 +0000 gjohnson http://heparin-law.com/blog/2009/03/heparin-frequently-asked-questions-continued.html
8. What if there was a death or a serious injury consequence from HIT?

HIT is short for heparin induced thrombocytopenia. See http://en.wikipedia.org/wiki/Heparin-induced_thrombocytopenia HIT is a condition where the body reacts to heparin causing the blood to clot. This clotting can result in death, serious injury such as gangrene and may leave survivors with severe consequences, such as amputations. The evidence is beginning to mount that OSCS may cause or exaggerate a HIT response or reaction. Thus, all cases of HIT after 2007. and up to this date, should be investigated.

We also are concerned that OSCS may cause a cumulative sensitization phenomenon, similar to what often happens with a bee sting. Most people experience little more than local pain and brief swelling with repeated stings by bees. Some people, however, become increasingly more sensitive until the person reaches the point of a severe allergic reaction or even death. In the case of OSCS, a second or later exposure may cause the catastrophic consequence. Thus, we are not ruling out a case where heparin was given during the presumptive contamination period – September 13, 2007 through April 30, 2008 – and then a catastrophic reaction to heparin occurred, even if the second dosage of heparin was not contaminated.]]> http://heparin-law.com/blog/2009/03/heparin-frequently-asked-questions-continued.html/feed 0 More Heparin Frequently Asked Questions: http://heparin-law.com/blog/2009/03/more-heparin-frequently-asked-questions.html http://heparin-law.com/blog/2009/03/more-heparin-frequently-asked-questions.html#comments Fri, 20 Mar 2009 17:58:00 +0000 gjohnson http://heparin-law.com/blog/2009/03/more-heparin-frequently-asked-questions.html
7. What if severe reaction occurred days or weeks after the getting Heparin?

As more is learned about the deadliness of the contaminant in heparin – OSCS – it is becoming clear that this poison could do more than cause immediate adverse reactions.

The first published research was taken from adverse reaction reports that were specifically limited to adverse reactions within 30 minutes of administration. This was done as an artificial research distinction despite the anecdotal reports of deaths from secondary adverse reactions. Thus, from the beginning we have not ruled out potential wrongful death cases where the reaction occurred later than this 30 minute cutoff. If death or serious consequences occurred after being given heparin or after the cessation of heparin therapy, call us to investigate. We believe that there are perhaps thousands of more cases. A doctor finding a seemingly natural cause of death when that doctor did not consider Heparin poisoning as a part of the differential diagnosis, does not rule out Baxter culpability.

When a manufacturer contaminates the drug supply all consequences must be reevaluated with that potential cause in mind.]]> http://heparin-law.com/blog/2009/03/more-heparin-frequently-asked-questions.html/feed 0 Heparin Frequently Asked Questions Part III http://heparin-law.com/blog/2009/03/heparin-frequently-asked-questions-part-iii.html http://heparin-law.com/blog/2009/03/heparin-frequently-asked-questions-part-iii.html#comments Sun, 15 Mar 2009 20:30:00 +0000 gjohnson http://heparin-law.com/blog/2009/03/heparin-frequently-asked-questions-part-iii.html

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?

Today, we continue with:

4. What Happens when I Call?

All Heparin calls are answered by my paralegal, Jayne Zabrowski, jayne@tbilaw.com If Jayne misses your call she will call you back if you leave a message. Jayne carefully listens to the details of how the death or serious injury occurred and will ask appropriate follow-up questions. Jayne cares and will sincerely listen to those who can benefit by our representation. If you have the type of case that we handle, you will then hear from the nurse paralegal who will assist in obtaining medical records and additional information.

Jayne has talked to every potential Heparin client, since our first client told us about a Heparin death in February of 2008. Melissa Scott had a severe reaction and died shortly after being administered Heparin during home dialysis. Jayne’s hours of talking to victims makes her uniquely qualified to understand the pain that this poison has caused and is experienced at prioritizing the cases for investigation.

Jayne is one of the country’s best paralegals and comes to the Heparin claims after a decade of work with the debilitating complexities of representing brain injured people in the bulk of the Johnson Law Office’s case load. She annually attends the national trial lawyers convention (AAJ) each year and is very knowledgeable and experienced in forensic medical issues.

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