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) .
Posted on 11th September 2009 by gjohnson in Uncategorized
Baxter Heparin Wrongful Death case Illinois, Baxter recall of heparin, CDC investigation heparin, FDA recall of Heparin, heparin, heparin attorney, Heparin deaths
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 JohnsonChair 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
Posted on 10th September 2009 by gjohnson in Uncategorized
Baxter Heparin Wrongful Death case Illinois, heparin, heparin adverse reactions, heparin attorney, Heparin deaths, heparin lawyer
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.
Attorney Gordon JohnsonChair 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
Posted on 9th September 2009 by gjohnson in Uncategorized
Baxter Heparin Wrongful Death case Illinois, Baxter recall of heparin, heparin, heparin attorney, Heparin deaths, Scientific Protein Laboratories
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.
Attorney Gordon JohnsonChair 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
Posted on 4th September 2009 by gjohnson in Uncategorized
FDA recall of Heparin, heparin and punitive damages, heparin attorney, Heparin deaths, heparin fraud, heparin syringes, Janet Woodcock
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.htmlAccording 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.
Attorney Gordon JohnsonChair 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
