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.
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
Sen. Grassley Asks FDA For Update On Foreign Drug Inspection Improvements Since Heparin-Contamination Deaths
At least one lawmaker hasn’t forgotten the 2008 heparin-contamination tragedy, which resulted in untold numbers of people dying. Sen. Chuck Grassley (R-Iowa) has renewed his quest to hold the U.S. Food and Drug Administration accountable for improving foreign drug inspections so deadly incidents like the blood-thinner debacle doesn’t happen again.
Earlier this week Grassley, who since 2007 has twice filed legislation seeking to “beef up” the FDA’s foreign inspection operation, sent a letter to the federal agency seeking a progress report on improvements to inspections.
Here is the senator’s press release on the matter, and the full text of his letter.
http://www.iowapolitics.com/index.iml?Article=185684
In seeking a follow-up, Grassley is essentially trying to hold the FDA’s feet to the fire for commitments it made when Baxter International temporarily suspended production of its blood thinner heparin in 2008 because of adverse reactions.
“My letter today follows up on oversight I did at that time because requirements the FDA already had in place then were not met by the FDA, and the drug company itself didn’t have a system to check the quality of upstream providers of the drug components,” Grassley said in statement. “In fact, pharmaceutical companies aren’t required to have those checks in place.”
That is terrifying information for anyone who takes medication in this country.
“I will continue asking the FDA for information and working to hold the federal agency accountable in its work to protect the safety of the drugs in our medicine cabinets,” Grassley said.
His proposed legislation calls for the enhanced enforcement for quality and safety violations. But the bills, which Grassley had introduced with the late Sen. Ted Kennedy (D-Mass), hasn’t been passed by Congress.
Grassley’s press release noted that China is one of the largest exporters of pharmaceutical products to the United States. Following questions raised by him others in 2007 and 2008 about the inadequate foreign inspections, the FDA has opened an office in China to facilitate inspections.
Dow Jones wrote a story on Grassley’s call for answers and an update from the FDA.
http://www.nasdaq.com/aspx/stock-market-news-story.aspx?storyid=201002161801dowjonesdjonline000426&title;=sengrassley-asks-fda-about-monitoring-of-drugs-made-abroad
That article says that 80 deaths were blamed on contaminated heparin, a blood thinner, from China. Based on the number of wrongful death claims that have been filed against Baxter, that number may be seriously understated. The contaminant, oversulfated chondroitin sulfate, OSCS, was in the heparin that Baxter received from is supplier Chanzghou SPL. Chanzghou SPL is a subsidiary of a Wisconsin company, SPL.
Grassley wants the FDA to answer his letter by March 2.
Don’t expect too much. While Grassley’s position is laudable, more should be done by Congress to get a full accounting of just how many people Baxter and SPL killed.
Congress should be publicly asking these questions of all of the heparin players, not just the FDA:
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
Earlier this week Grassley, who since 2007 has twice filed legislation seeking to “beef up” the FDA’s foreign inspection operation, sent a letter to the federal agency seeking a progress report on improvements to inspections.
Here is the senator’s press release on the matter, and the full text of his letter.
http://www.iowapolitics.com/index.iml?Article=185684
In seeking a follow-up, Grassley is essentially trying to hold the FDA’s feet to the fire for commitments it made when Baxter International temporarily suspended production of its blood thinner heparin in 2008 because of adverse reactions.
“My letter today follows up on oversight I did at that time because requirements the FDA already had in place then were not met by the FDA, and the drug company itself didn’t have a system to check the quality of upstream providers of the drug components,” Grassley said in statement. “In fact, pharmaceutical companies aren’t required to have those checks in place.”
That is terrifying information for anyone who takes medication in this country.
“I will continue asking the FDA for information and working to hold the federal agency accountable in its work to protect the safety of the drugs in our medicine cabinets,” Grassley said.
His proposed legislation calls for the enhanced enforcement for quality and safety violations. But the bills, which Grassley had introduced with the late Sen. Ted Kennedy (D-Mass), hasn’t been passed by Congress.
As many of our readers will know, Grassley is one of the chief Republican obstacles to the passage of health care reform. The irony of that contrasted against his outrage with Heparin is a bit much.
Grassley’s press release noted that China is one of the largest exporters of pharmaceutical products to the United States. Following questions raised by him others in 2007 and 2008 about the inadequate foreign inspections, the FDA has opened an office in China to facilitate inspections.
Dow Jones wrote a story on Grassley’s call for answers and an update from the FDA.
http://www.nasdaq.com/aspx/stock-market-news-story.aspx?storyid=201002161801dowjonesdjonline000426&title;=sengrassley-asks-fda-about-monitoring-of-drugs-made-abroad
That article says that 80 deaths were blamed on contaminated heparin, a blood thinner, from China. Based on the number of wrongful death claims that have been filed against Baxter, that number may be seriously understated. The contaminant, oversulfated chondroitin sulfate, OSCS, was in the heparin that Baxter received from is supplier Chanzghou SPL. Chanzghou SPL is a subsidiary of a Wisconsin company, SPL.
Grassley wants the FDA to answer his letter by March 2.
Don’t expect too much. While Grassley’s position is laudable, more should be done by Congress to get a full accounting of just how many people Baxter and SPL killed.
Congress should be publicly asking these questions of all of the heparin players, not just the FDA:
- How many wrongful death claims has Baxter received?
- How many doses of the contaminated heparin were actually given to people?
- Why didn’t Baxter react more quickly when it learned of the deaths?
- Why didn’t Baxter have some type of tracking system on its products so that when it learned of the contamination, it could quickly pull all of the tainted product from its shelf?
- Why wasn’t the FDA and Baxter more concerned about the risk of counterfeiting drugs?
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 Starts Targeting High-Risk Drug Imports
Why did it take a complete catastrophe for the FDA to practice what it preached with respect to the safety of foreign drugs. For years the FDA has cautioned that the number one risk to the safety of our drug supply was counterfeit and contaminated drugs from overseas. Yet it is now – two years after the infamous recall of heparin – that the FDA is implementing modern technological methods to help detect problems. Still, this problem isn’t going to be solved by software. Entirely new policies about under what circumstances we will import drugs from overseas must be made. This is too little, too late.
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.
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 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.
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
Baxter Heparin Debacle from a Financial Perspective
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:
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:
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?
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
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.”See A New Paradigm to Address the High Cost of Vendor Qualification
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.
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?
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
America Exporting our Well Being to China – From Heparin to Green Tech
China exports what American’s want. Not because they do it better, but because they do it cheaper. Baxter’s Heparin debacle is the perfect example. Anyone who lives in the Midwest knows that we grow all the corn necessary to domestically raise all the pigs we need. The raw material for Heparin comes from the small intestines of pigs.
Yet Baxter and its supplier SPL went off to China to get Heparin. The reason of course was to save pennies on each dose. Somehow, someone at Baxter decided that maintaining manufacturing and quality control over this most dangerous of products wasn’t as important as those pennies per dose.
The problem for American society is that China, despite its communist political system, always seems to be motivated by the “green” in greed equation. The irony of that now is that even though China is seen as the world’s worst polluter, they appear to be poised to receive the green, for Going Green.
On Point, the NPR program/podcast did an excellent piece on China’s Going Green, “Green China & the Clean-Tech Race”. To get the Podcast from September 30th go to http://www.onpointradio.org/2009/09/green-china-and-the-clean-tech-race
The program listing begins with this teaser:
The Heparin Catastrophe is not just a crisis about the safety of American pharmaceuticals. It is also a crisis about American jobs, technology and economic growth. If the greed equation results in the U.S. corporations exporting the manufacturer and development of this next tech explosion to China, our prosperity made be forever compromised.
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
Yet Baxter and its supplier SPL went off to China to get Heparin. The reason of course was to save pennies on each dose. Somehow, someone at Baxter decided that maintaining manufacturing and quality control over this most dangerous of products wasn’t as important as those pennies per dose.
The problem for American society is that China, despite its communist political system, always seems to be motivated by the “green” in greed equation. The irony of that now is that even though China is seen as the world’s worst polluter, they appear to be poised to receive the green, for Going Green.
On Point, the NPR program/podcast did an excellent piece on China’s Going Green, “Green China & the Clean-Tech Race”. To get the Podcast from September 30th go to http://www.onpointradio.org/2009/09/green-china-and-the-clean-tech-race
The program listing begins with this teaser:
“On Capitol Hill today, the Senate introduces a bill meant to slow global warming. Meanwhile, back on the wind farm, American entrepreneurs are taking the problem seriously — as an environmental threat but also as the next great economic prize.
“In China, the government says it’s determined to become a green superpower — or risk drowning in its own pollution.
“Some say the next great global race is on — the clean-tech race — and that China’s entry is a “Sputnik moment.”
“Has America heard the wake-up call? Is there a clean-energy race to be won or lost? This hour, On Point: China, the U.S., and the clean-energy future.”One of the guests in this podcast is Michael Splinter, whose American based firm, Applied Materials, is about to open the world’s largest privately funded solar research facility — in Xian, China. For more on Splinter and his company go to http://www.appliedmaterials.com/about/bio_michael_splinter.html
The Heparin Catastrophe is not just a crisis about the safety of American pharmaceuticals. It is also a crisis about American jobs, technology and economic growth. If the greed equation results in the U.S. corporations exporting the manufacturer and development of this next tech explosion to China, our prosperity made be forever compromised.
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 Purity – Heparin Potency – Heparin Adverse Reactions
What is the true scope of the Baxter’s legacy when it comes to Heparin? Is it the relatively small number of deaths reported by the FDA last summer, or is it a number of deaths that could reach into the thousands?
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.
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
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.
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 Wrongful Death Trials Start in January of 2011
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
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
Heparin Deaths – The March Towards Justice
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 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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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 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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Baxter – Heparin: A Funny Way to Apply Expertise
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
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?
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
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?
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 – FDA’s SPL Inspection – No One in Charge
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:
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
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?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.
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.
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