Heparin Deaths

Baxter Having Issues Passing New Heparin-Potency Test

Posted on 15th March 2010 by gjohnson in Uncategorized

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Baxter International, the maker of the blood thinner heparin, says it’s encountering problems having its drug pass a stricter drug-potency test, according to the magazine Modern Healthcare. http://www.modernhealthcare.com/article/20100315/NEWS/303159895

The update that has Baxter troubled has been devised by U.S. Pharmacopeia (USP), and provides potency reading for heparin that are 10 percent greater than the old test.

“It’s taking us a bit longer than anticipated to meet the requirements of the new test,” Baxter spokeswoman Kellie Hotz told Modern Healthcare.

She added that Baxter has been talking to the Food and Drug Administration about way it can meet the new USP standard.

The heparin that is currently being testing is pre-mixed product, not the concentrated vial product that was investigated by the FDA last year, Hotz told Modern Healthcare.

Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
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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?

Oversulfated chondroitin sulfate (OSCS) in Heparin Kills

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Posted on 12th September 2009 by gjohnson in Uncategorized

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What is OSCS? Frankly, it is poison. It politely is called a “contaminant.” It is part of what was in the Heparin (that Baxter and Scientific Protein Labs distributed) that killed people. Almost all of the controversy in the Heparin litigation has swirled around OSCS. OSCS is oversulfated chondroitin sulfate. Here is some of what the FDA has said about OSCS at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm112606.htm:

13. What is the contaminant? (new question and answer added 6/18/2008)
Oversulfated chondroitin sulfate (OSCS), a substance that mimics the biological activity of heparin, was identified as the contaminant.

14. Where is the contaminant found? (new question and answer added 6/18/2008)
The contaminant was found in samples of heparin crude materials, heparin active pharmaceutical ingredients (API), and finished heparin drug products.

15. Is oversulfated chondroitin sulfate unsafe by itself or in combination with heparin? (new question and answer added 6/18/2008)

The adverse events were reported in patients who received heparin contaminated with oversulfated chondroitin sulfate. The lab studies suggest that when oversulfated chondroitin sulfate is given alone or in combination to animals, similar adverse events occur (N Engl J Med 358;23 June 5, 2008 p2457) .

For a catastrophe the potential magnitude of the swine flu, that is pretty polite language. What the FDA doesn’t say about OSCS above is that OSCS got in Heparin by the intentional actions of some Chinese individuals trying to make an extra profit by cutting Heparin, like a street drug might be cut with sugar. OSCS was used to cut the drug because it chemically looked enough like Heparin that it would pass the crude testing that Baxter and SPL were doing to determine the purity of this drug.

What the FDA also doesn’t say is that OSCS got into Heparin because some American corporate executives also were motivated by greed. More on that tomorrow.

Heparin Wrongful Death Trials Start in January of 2011

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Posted on 11th September 2009 by gjohnson in Uncategorized

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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.

Heparin Deaths – Moving the Case Towards Trial

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Posted on 10th September 2009 by gjohnson in Uncategorized

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In our previous blog, we discussed the filing of more than 150 wrongful death cases against Baxter with respect to their sale and distribution of contaminated heparin in Cook County, Illinois. Today, we begin our discussion of the process those cases are going thru prior to trial. When a lawsuit is filed, it typically takes more than a year before it can be tried. Both sides have a right to put together their case and both sides have the right to find out what the other parties case is about. Deadlines are created for each side to name the expert witnesses upon which they will rely and to provide evidence to rebut the claims of the other side.

In addition, normally from very early on in the litigation, witnesses who have factual information about the events of what happened will be deposed. When the litigation is a complex as Baxter Heparin wrongful death litigation, things move slower than in an automobile accident case. The process of taking depositions and finding out what the other side is claiming, is called “discovery.”

The Illinois cases are currently in the stage of “discovery” after the court granted plaintiffs’ motion to strike all affirmative defenses alleged in their Answer by defendants Baxter International, Inc. and Baxter Healthcare Corporation (collectively “Baxter”). An affirmative defense is a claim by a defendant that even if all of the allegations against them are true, they still don’t have any responsibility for any number of technical reasons. The Court found that none of these technical claims protected Baxter from accountability here.

Plaintiffs have submitted to Baxter’s counsel their individual Plaintiff’s Fact Sheets in accordance with the judge’s orders, and defendants have been ordered to submit their own fact sheets in response to each case which has been filed against them. In addition, requests for production to and from the defendants (a form of written request that a party turn over documents) have been served and received. More than one million documents having been produced by defendants. Subpoenas for records have likewise been issued for all major Heparin drug distributors in order to establish the contaminated product’s chain of custody.

Oral depositions on key Baxter personnel are currently underway. On April 2, 2009, plaintiffs’ counsel took the deposition of Marie Keeley, Baxter’s Vice President for Business Operations, in order to gain a deeper understanding of Baxter’s existing sales and product distribution system. Other depositions scheduled involve Amy Gierytich and Tom Progar, Baxter employees who have been directly involved in handling Baxter’s first and second recall of Heparin products in January and February 2008, from recall strategy formulation and implementation to dealings with the Federal Food and Drug Authority and the Centers for Disease Control and Prevention. Baxter’s Vice President for Global Medical and Clinical Affairs, Francois Lebel, will also be deposed as well as Baxter’s designee of the person with greatest knowledge on causation.

In our next blog, we will discuss timing and future trial dates.

Heparin Deaths – The March Towards Justice

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Posted on 9th September 2009 by gjohnson in Uncategorized

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In February of 2008, Attorney Donald J. Nolan and I began our advocacy with respect to the absolutely outrageous actions of Baxter and SPL with respect to the importation without quality controls of the intravenous drug Heparin. The FDA had just recalled nine lots of heparin because it appeared to be killing people. Over time the recall grew and our advocacy spread to representing dozens of the families of those that had died as a result of this catastrophe. Our advocacy at http://heparin-law.com spawned the first wrongful death claim against Baxter filed in its home state of Illinois, the case of plaintiff, Mark Scott, against Baxter International, Inc., et. al., That first Cook County case has grown in size and scope.

To date, more than 150 plaintiffs have sued in Cook County, Illinois, for damages arising from personal injury and strict product liability caused by the administration of contaminated Heparin. In addition to Baxter, other Heparin drug manufacturers have been named as defendants in these actions, such as Medefil Inc., Covidien, Inc. and B. Braun Medical, Inc., just to name a few. All of these cases have been consolidated with the Honorable Judge Jennifer Duncan-Brice, who attorney Nolan as lead counsel for the consolidated state court cases.

I remember the first conversation between Attorney Nolan and myself. He had sent me a newspaper clipping from the Chicago Tribune talking about the initial recall. I knew very little about heparin, but it was clear from the beginning that Baxter was involved in something serious and severe. When I began to dig, it became clear that rarely had American Justice seen such a clear cut case of product liability. Despite knowing that heparin would be put in the veins of our sickest people, Baxter delegated the manufacture of this drug to a Chinese manufacturer who knew nothing about the drug and cared even less about its purity.

With this continued advocacy on behalf of those harmed by this reckless quality control of heparin, we hope that ultimately justice will be done for those harmed. We also hope that Corporate America, make that Corporate World, will learn that safety must come first. The lesson that should never have been learned? If you are talking about a pharmaceutical – sterility and purity is an absolute.

In our next blog, we will discuss some of the procedural issues in the pending Cook County actions.

FDA Drug Chief Woodcock Accused of Conflict of Interest

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Posted on 4th September 2009 by gjohnson in Uncategorized

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The name Janet Woodcock, M.D. is one that anyone who has followed the Heparin Catastrophe is familiar with. It was Dr. Woodcock who stood in front of Congress in 2008, trying to explain how the FDA could possibly have allowed the import of drugs into the United States from facilities that the FDA would not get around to inspecting for nearly 30 years.

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.

FDA clears Eli Lilly’s blood thinner Effient

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Posted on 13th July 2009 by gjohnson in Uncategorized

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The FDA is back in the news today, with the story another blood thinner, but not Heparin this time, but Effient. Let us hope that the FDA’s oversight of such new drug will not just be limited to its approval, but also how it is made and where it is made. Approving a drug is one thing. Making sure it is that drug that is administered to the sick, is another.

Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com

Date: 7/10/2009 6:08 PM

MATTHEW PERRONE,AP Business Writer

WASHINGTON (AP) — The Food and Drug Administration on Friday approved a highly anticipated blood thinner from Eli Lilly, though the drug must carry the agency’s sternest warning because of its bleeding risks.

The approval makes Lilly’s Effient the first real competition to the blood thinner Plavix, the world’s second-best selling medication made by Sanofi-Aventis and Bristol-Myers Squibb.

The FDA delayed its decision on Effient multiple times during an 18-month review, as agency staffers weighed the drug’s benefits versus its risks.

A study of over 13,000 patients conducted by Lilly found that Effient prevents more heart attacks than Plavix, but also causes more internal bleeding.

The FDA said Effient will carry a boxed warning to alert physicians to the risks of “significant, sometimes fatal, bleeding.” The boxed warning is reserved for issues that can cause serious injury or death.

The drug should not be taken by patients with a history of bleeding, stroke or who are undergoing surgery, the FDA said.

“Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug,” said Dr. John Jenkins, FDA’s director of new drugs.

The drug offers an alternative treatment for preventing dangerous blood clots that can lead to heart attack or stroke, Jenkins said.

The boxed safety warning could curb sales, but not to a large extent, according to Miller Tabak & Co. analyst Les Funtleyder.

“The FDA has been a lot more liberal with black box warnings than it was in the past, and in a way the black box has lost some of the meaning it had when it was rare,” said Funtleyder. “But it still has the ability to somewhat limit sales.”

Company studies showed 7 percent of patients taking Effient experienced nonfatal heart attacks, compared with 9.1 percent of patients taking Plavix. Despite lower rates of certain heart attacks, the actual rates of death were similar for both drugs.

Indianapolis-based Lilly developed Effient, known chemically as prasugrel, with Japanese drugmaker Daiichi Sankyo Co. The two companies will share revenue.

“After more than a decade of research and testing, we are proud to provide this new treatment option to patients with acute coronary syndrome,” Daiichi President Takashi Shoda said in a statement.

Wall Street analysts say Effient sales could reach an estimated $1 billion annually, compared with the $4.9 billion racked up by Plavix last year.

Like Plavix, Effient prevents blood platelets from sticking together and forming potentially dangerous clots. But where Plavix is approved for use in a wide range of patients, Effient is only approved for those undergoing angioplasty, a procedure in which an inflatable balloon is used to clear arteries clogged with plaque, which are often propped open with a stent.

Approval of Effient was considered crucial for Lilly because patents protecting its four best-selling drugs expire by 2013.

But even if the drug reaches the $1 billion mark, it will have trouble replacing the revenue of Lilly’s best-selling product, the anti-psychotic Zyprexa, which garnered $4.7 billion in sales last year.

Copyright 2009 The Associated Press.

Rep. Barton Demands Answers about Heparin Contamination

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Posted on 7th May 2009 by gjohnson in Uncategorized

Chinese toxic imports, FDA recall of Heparin, heparin attorney, Heparin deaths, heparin lawyer

Finally someone in Washington has remembered that there are still consequences to what they called a “catastrophe” last year.

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?

Baxter – Heparin: A Funny Way to Apply Expertise

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Posted on 7th April 2009 by gjohnson in Uncategorized

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Yesterday we ended our series of the four serious problems that the FDA found with the Changzhou SPL plant in China with the statement that Baxter’s failure to control what SPL was doing in China was outrageous. Today, I discovered this quote on Baxter’s website, http://www.baxter.com/about_baxter/news_room/news_releases/2009/03_05_09_world_kidney_day.html

Baxter International Inc. (NYSE:BAX) develops, manufactures and markets products that save and sustain the lives of people living with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

If Baxter’s mission is to apply a unique combination of expertise, how could they have delegated the critical steps in making an intravenous pharmaceutical to a company who didn’t have anyone on site who understood what he was doing? Poor quality control of the manufacture of Heparin API at Changzhou SPL, meant poor quality control of Baxter Heparin. If the stuff which Heparin is made from isn’t pure, the Heparin can’t be.

Baxter claims they inspected Changzhou SPL but how could such inspection done within six months of the FDA inspection, not have uncovered such blatant systemic problems? That failed inspection may have been responsible for thousands of deaths. Isn’t it time for justice for those casualties?

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Baxter Having Issues Passing New Heparin-Potency Test

Baxter Heparin Debacle from a Financial Perspective

Oversulfated chondroitin sulfate (OSCS) in Heparin Kills

Heparin Wrongful Death Trials Start in January of 2011

Heparin Deaths – Moving the Case Towards Trial

Heparin Deaths – The March Towards Justice

FDA Drug Chief Woodcock Accused of Conflict of Interest

FDA clears Eli Lilly’s blood thinner Effient

Rep. Barton Demands Answers about Heparin Contamination

Baxter – Heparin: A Funny Way to Apply Expertise

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