America Exporting our Well Being to China – From Heparin to Green Tech

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Posted on 6th October 2009 by gjohnson in Uncategorized

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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:

“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

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.


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: 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?


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

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Posted on 6th April 2009 by gjohnson in Uncategorized

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

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

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

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

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

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

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


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

INSIDE WASHINGTON: Is the FDA a broken agency?

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Posted on 3rd March 2009 by gjohnson in Uncategorized

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Date: 3/3/2009

EDITOR’S NOTE — An occasional look at how Washington works — or doesn’t.
By RICARDO ALONSO-ZALDIVAR and MIKE BAKER
Associated Press Writers

WASHINGTON (AP) — Tainted peanuts. Unsterilized syringes. Salmonella in Mexican chili peppers. A contaminated blood thinner from China that sent patients into life-threatening shock.

Every few months, the Food and Drug Administration goes into fire-brigade mode, rushing to get control over another safety crisis. The agency that regulates products worth 25 cents of every dollar spent by U.S. consumers seems overwhelmed by its own mission.

Some say the FDA is broken, and others want to break it up — by moving food safety to a new office.

“You’ve got an agency that quite frankly is either non-functional, or dysfunctional, or maybe all of the above,” said Rep. John Dingell, D-Mich., who as the longest serving member of Congress has investigated many agencies, including the FDA.

“Bet yourself a new hat or a fine dinner that you are going to have a scandal a month,” Dingell added. “They are running around like a lot of headless chickens.”

Others, even some critics, see tentative improvements. Many defenders acknowledge the FDA is struggling.

“‘Broken’ is the kind of word that’s sort of a fighting word,” said Dr. Frank Torti, the cancer researcher serving as acting FDA commissioner. “We have recognized for a long time that more is needed. Because of a lack of (legal) authorities and inadequate resources, it’s really hard to do the job.”

Restoring the FDA’s reputation will be a major challenge for an Obama administration that strode into town promising competent government.

The decline didn’t happen overnight. There’s no single, simple cause. In 2007, an independent group of science advisers concluded that the FDA was in danger of failing in its mission. “American lives are at risk,” said their report. It wasn’t the first alarm.

As the pharmaceutical and food industries went global in recent years, the FDA fell behind on inspections. Its legal powers failed to keep up with fast-changing industries. Its own scientists said it grew too cozy with drug companies and tuned out signals of safety problems.

Money for research grew scarce. The agency struggled to answer such seemingly simple questions as how far from a cow pasture a farmer should plant his spinach patch to keep out bad germs. Internal computer systems were allowed to decay, although they are essential to monitoring drug safety trends or blocking shady imports.

The FDA drifted. During the Bush administration, it went long periods without a permanent commissioner who could be an advocate before Congress. Lawmakers piled new responsibilities on the agency, often without the funds to carry them out.

This past year’s safety problems — homegrown and imported — illustrate the FDA’s weakness.

Last winter, heparin from China contaminated by a mysterious ingredient prompted an international recall. The blood thinner, used to treat people during heart surgery and kidney dialysis, was triggering life-threatening allergic reactions.

Summer brought a salmonella outbreak blamed first on tomatoes, and later on hot peppers as well.

This winter, it was salmonella again, in peanut products. A small company’s apparent disregard for basic sanitation led to the recall of more than 2,800 foods that used its ingredients.

More than 2,100 people were sickened in these incidents. At least nine deaths have been blamed on tainted peanuts alone.

Last week, another problem surfaced. Federal prosecutors in North Carolina obtained guilty pleas from two employees of AM2PAT, a company that manufactured syringes in unsterile conditions and covered it up with phony paperwork.

Prosecutors say hundreds of patients were sickened and five died. The FBI is looking for the company’s owner, who may have fled the country.

Different products were involved in the incidents, but some of the same FDA shortcomings: inspections, legal authority and technology.

The pharmaceutical plant in China that made the heparin was never inspected by the FDA, partly because the agency confused its name with a similar name belonging to another factory. It was unclear how many foreign drug facilities fall under the FDA’s jurisdiction because one government database lists about 7,000 and another, 3,000.

Sending inspectors to China used to involve first waiting for permission from the Chinese government. The situation has improved, under a U.S.-China agreement that led to the opening of FDA offices there.

The tomato outbreak last summer underscored other kinds of gaps. Produce companies are not required to have a food safety plan. And the FDA lacks legal authority to require a system for tracing foods back to the farm. Investigators had to sift through piles of paper records as losses mounted for tomato growers. Dingell said the FDA looked like the Keystone Kops.

In the peanut butter outbreak, the FDA has been slowed because of the length of time it takes to identify positively a strain of salmonella. The agency wants to replace current lab tests that can take a week or more with technology that cuts the wait to a day or two.

FDA inspectors quickly descended on the small Georgia facility at the center of the peanut outbreak. But they didn’t get the whole story immediately. The FDA had to invoke bioterror laws to get lab reports that ultimately showed the company shipped tainted peanuts. Meantime, the agency had no authority to order a food recall.

“The FDA has been trying to do so much with so little for so long that they really have lost the vision of what would make an effective food safety program,” said Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, which wants to set up a separate food agency.

Congress has been pumping more money into the FDA the last couple of years. And the Obama administration seems willing to consider big changes, especially on food safety.

The two leading candidates for FDA commissioner are physicians from outside the agency. One is Baltimore health commissioner Joshua Sharfstein, a pediatrician who has taken on the FDA over risks in children’s cough and cold drugs. The other is Margaret Hamburg, a bioterrorism expert who served in the Clinton administration and as New York’s health commissioner.

“One area where we could see bipartisan cooperation might be the strengthening of the FDA,” said Dr. Paul Stolley, a former department head at the University of Maryland medical center who had a stint as a visiting scientist at the FDA. “I don’t think ideological differences should interfere.”

___

Baker reported from Raleigh, N.C.

___

On the Net:

FDA Science Board report — http://tinyurl.com/yvnk28

Copyright 2009 The Associated Press.


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

Counterfeiting not an Unforeseeable Problem in Imported Heparin

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Posted on 30th May 2008 by gjohnson in Uncategorized

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The issue of counterfeiting imported drugs is neither new or unique to the Heparin disaster. In fact, this may be one of the biggest problems facing the pharmaceutical industry, worldwide. The FDA has devoted considerable resources to this issue for some time, including an entire portion of the FDA website, http://fda.gov to the issue of counterfeiting. See http://www.fda.gov/importeddrugs/

For example, at http://www.fda.gov/importeddrugs/chart071304.html the FDA reports its findings on three of the leading selling drugs that are being brought in from Canada: Ambien, Lipitor and Viagra. On all three of these drugs, the concentration level or purity (the same issues as with Heparin) are problems. For example, the above page says this about the safety of Viagra, a drug taken orally:
The sample tablets may be less clinically effective because of their reduced potency and poorer dissolution profile.
The sample tablets may also be less safe due to the elevated impurities.
This comment was made about a drug with only .7% impurities, unlike the up to 20% impurities in the contaminated heparin.

Clearly, both Baxter and SPL should have been on notice of the risk factors of contaminants and counterfeit in the raw material imported from China. With a drug intended for the human blood stream, that notice should have required the absolute utmost care.


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 Obtains Permanent Injunction Against Scientific Laboratories, Inc.

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Posted on 17th May 2008 by gjohnson in Uncategorized

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From the FDA:

Company manufactures and distributes unapproved and adulterated drugs
The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

Scientific Laboratories is a contract manufacturer and distributor of various prescription cough and cold products. The government’s complaint, filed by the U.S. Department of Justice, alleged violations of the Federal Food, Drug, and Cosmetic Act (FD&C; Act). The company failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements (CGMP).

“The FDA will not allow a company to put the public’s health at risk,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”

The unapproved new drugs manufactured and marketed by Scientific Laboratories as prescription cough and cold products include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. Because these drugs have not undergone FDA review nor received approval, their safety and effectiveness have not been established. Additionally, the FDA has not reviewed the adequacy and accuracy of the directions and warnings in their labeling.

The FDA had warned Scientific Laboratories against violating the FD&C; Act and about the risk of enforcement action if it failed to take corrective measures.

“The FDA will take action against companies and their executives who violate the law and endanger public health,” said Margaret O’K. Glavin, associate commissioner for Regulatory Affairs. “The FDA will carefully monitor the provisions of this injunction as well as investigate and take action against other marketers of unapproved drugs.”

The consent decree bars the defendants from manufacturing and distributing any drug until they obtain required FDA approval and fully comply with CGMP requirements. The defendants must destroy their illegal drugs. The consent decree also allows the FDA to order the defendants to shut down in the event of future violations. It also subjects the defendants to liquidated damages in the amount of $5,000 per day if they fail to comply with any of the provisions of the decree, and an additional sum of $5,000 for each violation, up to $1 million per year.

If patients have these products in their homes, they should discuss with their health care provider whether to discontinue use of the products and to find alternative therapy. Pharmacies should discontinue dispensing these products.

In June 2006, the FDA issued a guidance document titled, “Marketed Unapproved Drugs—Compliance Policy Guide” (CPG). This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective. The CPG also explains that FDA may take action against manufacturers and marketers of unapproved drugs that violate other provisions of the FD&C; Act, including CGMP requirements.

The decree was signed Thurs., May 8, 2008 by Judge William D. Quarles, Jr., in the U.S. District Court for the District of Maryland


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

Banks v. Baxter International – Federal Court Heparin Survivor Case

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Posted on 6th May 2008 by gjohnson in Uncategorized

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Below is the full text of the Federal Court case filed in the Northern District of Illinois by Nolan Law Group against Baxter and Scientific Protein Laboratories, LLC last week.


UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION

ARTEMUS BANKS, )
)
Plaintiff, )
)
vs. ) Case No.
)
BAXTER INTERNATIONAL, INC., a )
corporation; BAXTER HEALTHCARE )
CORPORATION, a corporation, and SCIENTIFIC )
PROTEIN LABORATORIES, LLC, a limited )
liability company, ROBERT L. PARKINSON, JR., ) PLAINTIFF DEMANDS
JAMES M. GATLING, and DAVID ROHRBACH, ) TRIAL BY JURY
)
Defendants. )

COMPLAINT

Now comes the Plaintiff, ARTEMUS BANKS, by and through his attorneys, NOLAN LAW GROUP, and for his Complaint states as follows:
PARTIES
1. Plaintiff, ARTEMUS BANKS, is a resident of the State of Kentucky.
2. Defendant, BAXTER INTERNATIONAL, INC. is a corporation organized and existing under the laws of the State of Delaware, with its principal place of business located within the State of Illinois and this District.
3. Defendant, BAXTER HEALTHCARE CORPORATION is a corporation organized and existing under the laws of the State of Delaware, with its principal place of business located within the State of Illinois and this District, and is a wholly-owned subsidiary of Defendant, BAXTER INTERNATIONAL, INC.
4. Defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION developed, formulated, manufactured, marketed, distributed, and sold the pharmaceutical Heparin.
5. Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C., is a limited liability company organized and existing under the laws of the State of Delaware with its principal place of business in the State of Wisconsin, and controls 55% of the interest in a joint venture known as Changzhou SPL Co. Ltd.
6. Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C. manufactures the active pharmaceutical ingredient (“API”) for the Heparin, at its facility in Waunakee, Wisconsin and at its Changzhou SPL facility in China. Defendant, SPL, sells that API for inclusion in Heparin finished at the facilities of Defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION.
7. Defendant, ROBERT L. PARKINSON is a resident of the State of Illinois and is and at all times relevant herein was the Chairman of the Board and Chief Executive Officer of Defendant, BAXTER INTERNATIONAL, INC.
8. Defendant, JAMES M. GATLING is a resident of the State of Illinois and is and at all times relevant herein was Corporate Vice President, Global Manufacturing Operations and Supply Chain Operations of Defendant, BAXTER INTERNATIONAL, INC.
9. Defendant, DAVID ROHRBACH is a resident of the State of Illinois and is and at all times relevant herein was Vice President, Quality of the Baxter Pharmaceuticals and Technologies Division of Defendant, BAXTER HEALTHCARE CORPORATION.

JURISDICTION AND VENUE
10. Plaintiff alleges an amount in controversy in excess of $75,000.00 exclusive of interest and costs. This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1332, because there is complete diversity of citizenship between Plaintiff and Defendants.
11. Venue is proper in the Northern District of Illinois pursuant to 28 U.S.C. § 1391. All Defendants reside in this District and/or are subject to personal jurisdiction within this District, and a substantial part of the events or omissions giving rise to this claim occurred in this District.
BACKGROUND FACTS
12. Plaintiff, ARTEMUS BANKS, seeks judgment against all defendants for compensatory and punitive damages arising from personal injuries he suffered from the use of a pharmaceutical drug commonly known as Heparin manufactured and distributed by Defendants BAXTER INTERNATIONAL, INC., BAXTER HEALTHCARE CORPORATION and SCIENTIFIC PROTEIN LABORATORIES, L.L.C.
13. The active pharmaceutical ingredient (API) in Heparin is sourced from pig intestines and then goes through multiple purification steps to inactivate proteins and viruses and to extract out contaminants before it reaches its final dosage form.
14. On March 19, 2008, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and research for the United States Food and Drug Administration (FDA) announced at a press conference that testing had revealed a contaminant in certain Heparin API known as an over-sulfated chondroitin sulfate.
15. Chondroitin sulfate and heparin are each variably sulfated glycosaminoglycans (“GAGs”) belonging to a group of chemicals known as complex polysaccharides. Chondroitin sulfate is ordinarily purified from animal cartilage and is used in the United States as a dietary supplement to treat arthritis.
16. Over-sulfated chondroitin sulfate is not ordinarily found in nature. Most probably, ordinary chondroitin sulfate was chemically modified to introduce the additional sulfate groups found in the Heparin API during the course of the FDA supervised testing of the contaminated Heparin.
17. Over-sulfated chondroitin sulfate is not a drug approved by the FDA for use in the United States nor should it be present in heparin. Unlike conventional chondroitin sulfate, over-sulfated chondroitin sulfate mimics Heparin’s activities in certain tests, including certain potency assays.
18. On November 19, 2007, doctors at St. Louis Children’s Hospital treated a child who suffered allergic reactions from Heparin, including swollen lips and eyelids and a drop in blood pressure within minutes after dialysis.
19. Defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION, through a spokeswoman has represented that the Defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION, began an investigation when other physicians notified it of problems in late December, 2007.
20. The Centers for Disease Control and Prevention (“CDC”) was first notified on January 7, 2008, by the Missouri Department of Health and Senior Services (MDHSS) of the allergic-type reactions among pediatric hemodialysis patients that began occurring November 19, 2007 at St. Louis Children’s Hospital. The reactions had been reported to MDHSS by a health-care provider at the hospital. A total of eight episodes of acute allergic-type reactions were identified as occurring among four patients at St. Louis Children’s Hospital during the period of November 19, 2007 to January 15, 2008.
21. Government officials at the FDA stated that agency became aware of a potential problem with heparin product in early to mid January through reports it was receiving from Defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION, and the CDC. Review of the FDA’s Adverse Event Reporting system data revealed a spike in the number of reports coming into the FDA related to Heparin toward the end of December, 2007 and an escalation in January, 2008.
22. Defendants BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION issued a first Urgent Product Recall letter on January 17, 2008 relating to certain Heparin products contained in Heparin Sodium Injection 1000 units/mL 10 mL vials bearing lot numbers 107054 and 117085 and Heparin Sodium Injection 1000 units/mL 30 mL vials bearing lot numbers 047056, 097081, 107024, 107064, 107066, 107074, and 107111.
23. On February 29, 2008, the Defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION issued an additional Urgent Product Recall to include all lots of single and multi-dose vials of Heparin Sodium Injection product and another Urgent Product Recall to include recall of all lots of HEP-LOCK (Heparin Lock Flush Solution, USP) and HEP-LOCK U/P (Preservative-Free Heparin Lock Flush, USP) product.
24. The joint venture entity of the Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C., known as Changzhou SPL Co. Ltd. (and sometimes referred to as Changzhou Kaipu Biochemical Co. Ltd. or Changzhou Kaipu) submitted an application to the FDA for approval of the manufacturing of Heparin Sodium USP on May 10, 2002, which application was approved by the FDA in 2004.
25. Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C., manufactures finished Heparin API from raw materials procured in each North America and China. “Product 1060” identifies Heparin Sodium USP finished from Chinese raw materials at the Changzhou SPL facility, “Product 1035” identifies Heparin Sodium USP finished from Chinese raw materials at the SPL facility in Waunakee, Wisconsin, and “Product 1037” identifies Heparin Sodium USP finished from North American raw materials at the SPL facility in Waunakee, Wisconsin.
26. Since the date of approval by the FDA, Changzhou SPL Co., Ltd. has held and continues to hold FDA approval to manufacture Heparin Sodium USP in Jiangsu Province, China in accordance with the provisions of FDA Drug Master File Number 15973.
27. The Changzhou SPL facility was not inspected by the FDA prior to providing its manufacturing approval or at any other time prior to February 20, 2008.
28. The FDA conducted an inspection of the Changzhou SPL plant in China during the period of February 20-26, 2008. The FDA cited Changzhou SPL Company, Ltd. for a number of violations, including a) incomplete manufacturing instructions, b) lack of critical processing steps or annual test results, c) lack of an impurity profile for Heparin, d) incomplete manufacturing instructions for Heparin Sodium USP, e) investigations into failed lots were approved as complete, but no cause was listed, and f) inadequate control of material flow in the processing area.
29. A group of employees and agents of Defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION inspected the Changzhou SPL facility in China in September 2007. At this point in time, if not sooner, Defendants BAXTER INTERNATIONAL, INC., BAXTER HEALTHCARE CORPORATION and SCIENTIFIC PROTEIN LABORATORIES, L.L.C., and each of them, knew of the unsafe and dangerous conditions existing in the manufacturing process of Heparin API at the Changzhou SPL facility and the likelihood that harm to persons would result from these conditions.
FACTS APPLICABLE TO THE NAMED PLAINTIFF
30. At all times herein relevant, the Plaintiff, ARTEMUS BANKS, was receiving home dialysis as treatment for a medical condition and was prescribed Heparin for use during his home dialysis.
31. In or about January, 2008, Plaintiff, ARTEMUS BANKS, was delivered a box containing 25 vials of Baxter Heparin for use during his home dialysis known as Heparin Sodium Injection 1000 units/mL 30 mL bearing NDC 0641-2450-41 and Lot Number 027020 (“Subject Heparin Product”) that was manufactured and distributed by Defendants, BAXTER INTERNATIONAL, INC. and/or BAXTER HEALTHCARE CORPORATION, and containing the Heparin API product (“Subject Heparin API”) manufactured and distributed by the Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C.
32. Plaintiff, ARTEMUS BANKS, used the aforesaid Heparin product as prescribed and indicated, yet during the course of its use, Plaintiff ARTEMUS BANKS began experiencing numerous physical symptoms including suffered wheezing, shortness of breath, coughing, dizziness, increased perspiration and sudden weakness.
33. On or about March 12, 2008, Plaintiff, ARTEMUS BANKS, received a letter entitled “URGENT Baxter Heparin Recall” from Fresenius Medical Care instructing him to discontinue the use of the Heparin product and to make arrangements for return of the product with which he complied.

FIRST CAUSE OF ACTION
Products Liability v. Baxter and Baxter Healthcare

34. Plaintiff repeats and incorporates by reference paragraphs 1 through 33, inclusive, of this Complaint as fully set forth herein.
35. That at the time the Subject Heparin Product left the control of the defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION, and each of them, it contained one or more conditions which rendered it defective and not reasonably safe when used in a reasonably foreseeable manner, including but not limited to the following:
(a) said Heparin product was manufactured, distributed and sold when it contained animal cartilage and/or other impurities that were injurious to the human body;

(b) said Heparin product was manufactured, distributed and sold without proper and adequate warnings and/or instructions to assist consumers and health care providers in identifying adverse reactions arising from the condition of the product; and/or

(c) said Heparin product was otherwise defective by way of its manufacture, distribution, sale, warnings and/or instructions in particulars to be determined through discovery in this action.

36. That as a direct and proximate result of one or more of the foregoing unreasonably dangerous conditions of the Subject Heparin Product, Plaintiff, ARTEMUS BANKS, suffered serious physical, mental and emotional injuries, some or all of which are permanent in nature.
37. That as a result of the aforesaid injuries, Plaintiff, ARTEMUS BANKS, was caused to and will in the future experience great pain and suffering, has suffered and will in the future suffer disability and disfigurement, has been caused to incur and will in the future incur expenses for necessary medical care, treatment and services, has suffered and will in the future suffer a loss of the value of his time, earnings, profits and salaries and has been and will be damaged in his earning capacity, and has otherwise been damaged in a personal and pecuniary nature.
WHEREFORE, Plaintiff, ARTEMUS BANKS, prays that judgment be entered in his favor and against the Defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION, and each of them, in a sum in excess of seventy-five thousand dollars ($75,000), exclusive of interest and costs of this action.

SECOND CAUSE OF ACTION
Negligence – Baxter and Baxter Healthcare

38. Plaintiff repeats and incorporated by reference paragraphs 1 through 33 of this complaint as if fully set forth herein.
39. That it then and there became and was the duty of the Defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION, and each of them, to exercise ordinary care in their conduct so as not to cause injury to the person of the Plaintiff, ARTEMUS BANKS.
40. Notwithstanding, the Defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION, and each of them, breached their respective duty of care to the Plaintiff, ARTEMUS BANKS, through acts or omissions including but not limited to one or more of the following:
(a) negligently and carelessly procured bio-medical products from suppliers in China for use in pharmaceutical drugs in the United States, when the facilities and operations of those suppliers had never been properly or adequately inspected by or on behalf of Defendants, BAXTER INTERNATIONAL, INC. and/or BAXTER HEALTHCARE CORPORATION;

(b) negligently and carelessly failed to properly and adequately inspect and test the said Heparin product for unsafe and dangerous impurities contained therein;

(c) negligently and carelessly failed to employ proper and adequate quality control procedures to ensure that its Heparin product was safe and free from dangerous impurities;

(d) negligently and carelessly failed to properly supervise, monitor and/or oversee the acts and omissions of its Global Manufacturing Operations and Supply Chain Operations;

(e) negligently and carelessly failed to timely recall the said Heparin product or otherwise remedy the danger the product posed to consumers once the defendants, and each of them, became aware that a potential danger to consumers existed;

(f) negligently and carelessly manufactured, sold and distributed said Heparin product containing animal cartilage and/or other impurities that were injurious to the human b ody;

(g) negligently and carelessly manufactured, sold and distributed said product without proper and adequate warnings and/or instructions to assist consumers and health care providers in identifying adverse reactions arising from the condition of the product; and/or

(h) otherwise negligently and carelessly manufactured, sold and distributed said product when it was in an unsafe and dangerous condition by way of its manufacture, distribution, sale, warnings and/or instructions in particulars to be determined through discovery in this action.
41. That as a direct and proximate result of one or more of the beach of duty by the Defendants, BAXTER INTERNATIONAL, INC., and BAXTER HEALTHCARE CORPORATION, and each of them, Plaintiff, ARTEMUS BANKS, suffered serious physical, mental and emotional injuries, some or all of which are permanent in nature.
42. That as a result of the aforesaid injuries, Plaintiff, ARTEMUS BANKS, was caused to and will in the future experience great pain and suffering, has suffered and will in the future suffer disability and disfigurement, has been caused to incur and will in the future incur expenses for necessary medical care, treatment and services, has suffered and will in the future suffer a loss of the value of his time, earnings, profits and salaries and has been and will be damaged in his earning capacity, and has otherwise been damaged in a personal and pecuniary nature.
WHEREFORE, Plaintiff, ARTEMUS BANKS, prays that judgment be entered in his favor and against the Defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION, and each of them, in a sum in excess of seventy-five thousand dollars ($75,000), exclusive of interest and costs of this action.

THIRD CAUSE OF ACTION
Breach of Warranties – Baxter and Baxter Healthcare

43. Plaintiff repeats and incorporates by reference paragraphs 1 through 33 of this Complaint as fully set forth herein.
44. Defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION, and each of them, expressly and/or impliedly warranted and represented that the said Heparin product, including its instructions and warnings, conformed to manufacturing specifications, was proper and safe for the use for which it was manufactured and sold, and said defendants further warranted that the said Heparin product was free from defects.
45. Defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION, and each of them, breached said warranties in that the said Heparin product did not conform to manufacturing specifications, was not proper and safe for the use for which it was manufactured and sold, and further was not free from defects.
46. Plaintiff, ARTEMUS BANKS, by way of his purchase and/or receipt of the said Heparin product, was a beneficiary of the warranties extended by Defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION, and each of them.
47. As a direct and proximate result of the foregoing breach of warranties, by Defendants, BAXTER INTERNATIONAL, INC. and BAXTER HEALTHCARE CORPORATION, and each of them, Plaintiff, ARTEMUS BANKS, suffered serious physical, mental and emotional injuries, some or all of which are permanent in nature.
48. That as a result of the aforesaid injuries, Plaintiff, ARTEMUS BANKS, was caused to and will in the future experience great pain and suffering, has suffered and will in the future suffer disability and disfigurement, has been caused to incur and will in the future incur expenses for necessary medical care, treatment and services, has suffered and will in the future suffer a loss of the value of his time, earnings, profits and salaries and has been and will be damaged in his earning capacity, and has otherwise been damaged in a personal and pecuniary nature.
WHEREFORE, Plaintiff, ARTEMUS BANKS, prays that judgment be entered in his favor and against the Defendants, BAXTER INTERNATIONAL, INC., and BAXTER HEALTHCARE CORPORATION, and each of them, in a sum in excess of seventy-five thousand dollars ($75,000), exclusive of interest and costs of this action.
FOURTH CAUSE OF ACTION
Willful & Wanton Misconduct – Baxter, Baxter Healthcare and Individual Defendants

49. Plaintiff repeats and incorporated by reference paragraphs 1 through 48 of this complaint as if fully set forth herein.
50. That the foregoing acts and omissions committed by the Defendants, BAXTER INTERNATIONAL, INC., and BAXTER HEALTHCARE CORPORATION, and each of them, were committed willfully and wantonly, were grossly negligent, and/or exhibited a conscious disregard for the safety and health of the general public, including the plaintiff.
51. That on numerous occasions prior to issuing the Urgent Product Recall letter on January 17, 2008, and in the period between January 17, 2008 and the issuing of the additional Urgent Product Recall letter on February 29, 2008, the Defendants, ROBERT L. PARKINSON, JR., JAMES M. GATLING, and DAVID ROHRBACH, and each of them had actual knowledge of the significant danger and risk of harm existing and its potential for injury, participated in meetings on behalf of Defendants, BAXTER INTERNATIONAL, INC., and BAXTER HEALTHCARE CORPORATION, in which the risks and dangers were discussed, and nevertheless made the conscious decision to not send an Urgent Product Recall letter prior to January 17, 2008, and withheld the additional Urgent Product Recall until February 29, 2008.
52. The foregoing acts and omissions of the Defendants, ROBERT L. PARKINSON, JR., JAMES M. GATLING, and DAVID ROHRBACH, and each of them, were committed willfully and wantonly, were grossly negligent, and/or exhibited a conscious disregard for the safety and health of the general public, including the plaintiff.
53. That as a result of the willful, wanton, and grossly negligent misconduct of the Defendants, BAXTER INTERNATIONAL, INC., BAXTER HEALTHCARE CORPORATION ROBERT L. PARKINSON, JR., JAMES M. GATLING, and DAVID ROHRBACH, and each of them, Plaintiff, ARTEMUS BANKS, suffered serious physical, mental and emotional injuries, some or all of which are permanent in nature.
54. That as a result of the aforesaid injuries, Plaintiff, ARTEMUS BANKS, was caused to and will in the future experience great pain and suffering, has suffered and will in the future suffer disability and disfigurement, has been caused to incur and will in the future incur expenses for necessary medical care, treatment and services, has suffered and will in the future suffer a loss of the value of his time, earnings, profits and salaries and has been and will be damaged in his earning capacity, and has otherwise been damaged in a personal and pecuniary nature.
WHEREFORE, Plaintiff, ARTEMUS BANKS, prays that judgment be entered in his favor and against the Defendants, BAXTER INTERNATIONAL, INC., BAXTER HEALTHCARE CORPORATION, ROBERT L. PARKINSON, JR., JAMES M. GATLING, and DAVID ROHRBACH, and each of them, for compensatory damages in a sum in excess of seventy-five thousand dollars ($75,000), exclusive of interest and costs of this action, and for punitive damages in the amount of one hundred million dollars ($100,000,000.00).

FIFTH CAUSE OF ACTION
Product Liability – Scientific Protein Labs

55. Plaintiff repeats and incorporates by reference paragraphs 1 through 33, inclusive, of this Complaint as fully set forth herein.
56. That at the time the Subject Heparin API left the control of the Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C., it contained one or more conditions which rendered it defective and not reasonably safe when used in a reasonably foreseeable manner, including but not limited to the following:
(a) the Subject Heparin API was manufactured, distributed and sold when it contained animal cartilage and/or other impurities that were injurious to the human body;

(b) the Subject Heparin API was manufactured, distributed and sold without proper and adequate warnings and/or instructions to assist consumers and health care providers in identifying adverse reactions arising from the condition of the product; and/or

(c) the Subject Heparin API was otherwise defective by way of its manufacture, distribution, sale, warnings and/or instructions in particulars to be determined through discovery in this action.

57. That as a direct and proximate result of one or more of the foregoing unreasonably dangerous conditions of the Subject Heparin API, the Plaintiff, ARTEMUS BANKS, suffered serious physical, mental and emotional injuries, some or all of which are permanent in nature.
58. That as a result of the aforesaid injuries, Plaintiff, ARTEMUS BANKS, was caused to and will in the future experience great pain and suffering, has suffered and will in the future suffer disability and disfigurement, has been caused to incur and will in the future incur expenses for necessary medical care, treatment and services, has suffered and will in the future suffer a loss of the value of his time, earnings, profits and salaries and has been and will be damaged in his earning capacity, and has otherwise been damaged in a personal and pecuniary nature.
WHEREFORE, Plaintiff, ARTEMUS BANKS, prays that judgment be entered in his favor and against the Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C., in a sum in excess of seventy-five thousand dollars ($75,000), exclusive of interest and costs of this action.

SIXTH CAUSE OF ACTION
Negligence – Scientific Protein Labs

59. Plaintiff repeats and incorporated by reference paragraphs 1 through 33 of this complaint as if fully set forth herein.
60. That it then and there became and was the duty of the Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C., to exercise ordinary care in its conduct so as not to cause injury to the person of the Plaintiff, ARTEMUS BANKS.
61. Notwithstanding, the Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C., breached its duty of care to the Plaintiff, ARTEMUS BANKS, through acts or omissions including but not limited to one or more of the following:
(a) negligently and carelessly procured bio-medical products from suppliers in China for use in pharmaceutical drugs in the United States, when the facilities and operations of those suppliers had never been properly or adequately inspected by or on behalf of Defendants, SCIENTIFIC PROTEIN LABORATORIES, L.L.C.;

(b) negligently and carelessly failed to properly and adequately inspect and test the Subject Heparin API for unsafe and dangerous impurities contained therein;

(c) negligently and carelessly failed to employ proper and adequate quality control procedures to ensure that its Subject Heparin API was safe and free from dangerous impurities;

(d) negligently and carelessly failed to properly supervise, monitor and/or oversee the acts and omissions of its global manufacturing operations and supply chain operations;

(e) negligently and carelessly failed to timely recall the Subject Heparin API or otherwise remedy the danger the product posed to consumers once the defendants, and each of them, became aware that a potential danger to consumers existed;

(f) negligently and carelessly manufactured, sold and distributed the Subject Heparin API containing animal cartilage and/or other impurities that were injurious to the human body;

(g) negligently and carelessly manufactured, sold and distributed the Subject Heparin API without proper and adequate warnings and/or instructions to assist consumers and health care providers in identifying adverse reactions arising from the condition of the product; and/or

(h) otherwise negligently and carelessly manufactured, sold and distributed the Subject Heparin API when it was in an unsafe and dangerous condition by way of its manufacture, distribution, sale, warnings and/or instructions in particulars to be determined through discovery in this action.

62. That as a direct and proximate result of one or more of the breach of duty by the Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C., the Plaintiff, ARTEMUS BANKS, suffered serious physical, mental and emotional injuries, some or all of which are permanent in nature.
63. That as a result of the aforesaid injuries, Plaintiff, ARTEMUS BANKS, was caused to and will in the future experience great pain and suffering, has suffered and will in the future suffer disability and disfigurement, has been caused to incur and will in the future incur expenses for necessary medical care, treatment and services, has suffered and will in the future suffer a loss of the value of his time, earnings, profits and salaries and has been and will be damaged in his earning capacity, and has otherwise been damaged in a personal and pecuniary nature.
WHEREFORE, Plaintiff, ARTEMUS BANKS, prays that judgment be entered in his favor and against the Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C., in a sum in excess of seventy-five thousand dollars ($75,000), exclusive of interest and costs of this action.
SEVENTH CAUSE OF ACTION
Breach of Warranties – Scientific Protein Labs

64. Plaintiff repeats and incorporates by reference paragraphs 1 through 33 of this Complaint as fully set forth herein.
65. Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C., expressly and/or impliedly warranted and represented that the Subject Heparin API, including its instructions and warnings, conformed to manufacturing specifications, was proper and safe for the use for which it was manufactured and sold, and said defendant further warranted that the Subject Heparin API was free from defects.
66. Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C., breached said warranties in that the Subject Heparin API did not conform to manufacturing specifications, was not proper and safe for the use for which it was manufactured and sold, and further was not free from defects.
67. Plaintiff, ARTEMUS BANKS, by way of his purchase and/or receipt of the Subject Heparin Product containing the Subject Heparin API, was a beneficiary of the warranties extended by the Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C.
68. As a direct and proximate result of the foregoing breach of warranties, by the Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C., the Plaintiff, ARTEMUS BANKS, suffered serious physical, mental and emotional injuries, some or all of which are permanent in nature.
69. That as a result of the aforesaid injuries, Plaintiff, ARTEMUS BANKS, was caused to and will in the future experience great pain and suffering, has suffered and will in the future suffer disability and disfigurement, has been caused to incur and will in the future incur expenses for necessary medical care, treatment and services, has suffered and will in the future suffer a loss of the value of his time, earnings, profits and salaries and has been and will be damaged in his earning capacity, and has otherwise been damaged in a personal and pecuniary nature.
70. WHEREFORE, Plaintiff, ARTEMUS BANKS, prays that judgment be entered in his favor and against the Defendant, SCIENTIFIC PROTEIN LABORATORIES, L.L.C., in a sum in excess of seventy-five thousand dollars ($75,000), exclusive of interest and costs of this action.

EIGHTH CAUSE OF ACTION
Willful & Wanton Misconduct – Scientific Protein Laboratories

71. Plaintiff repeats and incorporates by reference paragraphs 1 through 33 and paragraphs 55 through 70 of this Complaint as fully set forth herein.
72. That the foregoing acts and omissions committed by the Defendant, SCIENTIFIC PROTEIN LABORATORIESS, L.L.C., were committed willfully and wantonly, were grossly negligent, and/or exhibited a conscious disregard for the safety and health of the general public, including the plaintiff.
73. That as a result of the willful, wanton, and grossly negligent misconduct of the Defendant, SCIENTIFIC PROTEIN LABORATORIESS, L.L.C., Plaintiff, ARTEMUS BANKS, suffered serious physical, mental and emotional injuries, some or all of which are permanent in nature.
74. That as a result of the aforesaid injuries, Plaintiff, ARTEMUS BANKS, was caused to and will in the future experience great pain and suffering, has suffered and will in the future suffer disability and disfigurement, has been caused to incur and will in the future incur expenses for necessary medical care, treatment and services, has suffered and will in the future suffer a loss of the value of his time, earnings, profits and salaries and has been and will be damaged in his earning capacity, and has otherwise been damaged in a personal and pecuniary nature.
WHEREFORE, Plaintiff, ARTEMUS BANKS, prays that judgment be entered in his favor and against the Defendant, SCIENTIFIC PROTEIN LABORATORIESS, L.L.C., for compensatory damages in a sum in excess of seventy-five thousand dollars ($75,000), exclusive of interest and costs of this action, and for punitive damages in the amount of one hundred million dollars ($100,000,000.00).

Respectfully Submitted,

Donald J. Nolan, Esq.
Paul R. Borth, Esq.
Jennifer L. Parker, Esq.
NOLAN LAW GROUP
20 North Clark Street, 30th Floor
Chicago, Illinois 60602-4109
Dated: April 22, 2008 Tel (312) 630-4000


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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Heparin House Hearings Available for Download

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Posted on 2nd May 2008 by gjohnson in Uncategorized

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The entire hearings for the FDA’s Foreign Drug Inspection Program: Weaknesses Place Americans at Risk

Subcommittee on Oversight and Investigations
Tuesday, April 22, 2008, 11:00 a.m.
2123 Rayburn House Office Building

are available for download or webstreaming at
http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042208.DrugInspection.shtml


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 Contaminant Attacks the Most Ill

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Posted on 1st May 2008 by gjohnson in Uncategorized

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This has been an active week on the news front of heparin, with House hearings. Baxter and SPL’s CEO, testified as did officials from the FDA, to the House Subcommittee on Energy and Commerce. But seemingly lost in the shuffle of all the finger pointing is this seemingly insignificant line from the New England Journal of Medicine article:
“Patients undergoing dialysis who are also receiving heparin therapy are already at high risk for hypotension because of their exposure to the dialysis membrane, which can also activate the contact system, and their treatment with angiotensin-converting–enzyme inhibitors, which inhibit bradykinin degradation. Exposure to OSCS-contaminated heparin may further increase the risk and could potentially trigger an adverse event.”
See: The New England Journal of Medicine last week published a study out of MIT which establishes a clear causal link between the contaminant identified by the FDA to have been found in the tainted Heparin and allergic reactions/anaphylactic shock. See the New England Journal of Medicine, April 23, 2008: “Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System” Takashi Kei Kishimoto, Ph.D., et. al. The full text of this research can be found at http://content.nejm.org/cgi/content/full/NEJMoa0803200v2#F2


In jargon of the news media, the NEJM buried the lead. The lead here is that the reason that this entire scandal broke is that the Heparin was contaminated with a product that would likely only kill or injure the very sick. As I understand the research, one third of pigs had a measurable response to the actual Baxter product that was recalled. But pure OSCS had a much more severe reaction. All of the healthy pigs survived the recalled product where there was only about 25% OSCS. It may only be that only 1% of those getting intravenous heparin would have a noticeable allergic reaction to the contaminant. But since dialysis patients are already hypotensive (low blood pressure), they were extremely vulnerable to the OSCS. If it had not been for that extreme vulnerability and the genius of one doctor at the CDC, this contamination might never have been discovered.

Don’t take the FDA’s pronouncement of 82 deaths as representative of the extent of this problem. As dialysis patients are already hypotensive, until the FDA announced the problem, heparin allergic reaction was not part of the hypotensive differential. If all of the people who had low blood pressure events over the preceding 12 months had their medical records pulled and differential reexamined, that number might increase dramatically.

I would like to challenge the NEJM research panel, or those doing collateral research to pull 100 charts from dialysis related deaths between January 2007 and November 2007 and determine what additional percentage could be related to an allergic stimulated hypotensive pathology.


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