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.

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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.

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Baxter CEO Admits Responsibility for Heparin Disaster, Irrespective of Wrongdoing in China

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Posted on 13th May 2008 by gjohnson in Uncategorized

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Robert Parkinson, CEO of Baxter International, Inc. admitted in Congressional testimony on April 29, 2008 that because of the vulnerable patient population that receives Baxter’s products, that Baxter and he are responsible for this disaster, regardless of how and when the contaminant OSCS got into the Heparin. Parkinson, testifying in front of House Oversight and Investigations Subcommittee, under oath, at 3:46 into the Hearing stated the following:

“Baxter has built its reputation over 75 years by consistently preparing quality products for critically ill patients.

“We deeply regret this has happened and I feel a strong sense of personal responsibility.

“I feel this because of who we are and what we do.

“Each day there are over 6 million infusions of Baxter products around the world to patients with life threatening conditions..

“We are not a traditional, pharmaceutical company. We don’t make pills or tablets. We don’t do direct to consumer advertising. And we don’t make lifestyle drugs.

“We develop and manufacture products that are injected, infused or inhaled, by patients who need them to stay alive. They have to be safe and effective each and every time.

“Because our products are used in critical care environments, they have to be safe and effective every time, no matter what the reason.

“This is my responsibility because Baxter’s name was on the product.”
These statements form the fundamental basis of the lawsuit claims against Baxter International. Since the target patient population for all of Baxter’s products are so medically vulnerable, Baxter had to take all precautions to assure safety.   According to the FDA, the precautions being taken in China were insufficient to identify contaminants or impurities.

With all that is known in the pharmaceutical industry about counterfeiting, Baxter should have been doing   more sophisticated testing for counterfeit or contaminant ingredients. Frankly, considering the now publicly apparent problems in regulating anything made in China, nothing that Baxter produces should be made from Chinese raw materials.


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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Hubley’s Tell of Family Heparin Tragedy

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Posted on 8th May 2008 by gjohnson in Uncategorized

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Yesterday’s blog was about the emotional investment it takes for my staff to listen to the tragic stories that people have as a result of the Heparin contamination. Today, I thought it might be important to focus in on one such story, not on one of our clients, but on the tragedy of Randy Hubley , as told to the House of Representatives in testimony last week.

Colleen Hubley, a dialysis nurse for 7 years, testified about her emotional experience from the contamination of heparin that caused the death of her husband. Her husband was a dialysis patient whose kidney transplant rejected in May 2006. Her prepared statement said that they were the first couple in Toledo area to do “home hemodialysis” (which is the provision of hemodialysis in the home of people with stage 5 chronic kidney disease). For the full prepared statement of Colleen Hubley, click here.

Two years later he had a surgery that he needed to start “in-center dialysis” and he started that at the Toledo Fresenius Clinic in Ohio. Later he was sent home to continue his hemodialysis routine. That is when Colleen says he began to get worse:
“This was the last week of his life. I wish I could tell you that at least the last few days of his life were good for Randy. I could take solace in that. However, the weekend prior to his death was awful.”
Colleen tells about January 11, 2008, the day her husband’s condition worsened:
“Randy [began to have] low blood pressure, severe diarrhea, abdominal pain, jaw pain, his throat was sore and felt “tight” to him, making him feel he needed his inhaler to breathe easier, something he didn’t normally need too often. Because of this, he barely could make it to the restroom.”
That night, she decided to sleep next to him on the couch. She was awoke to find him clutching is abdomen, unable to breathe and grabbing his chest. Colleen called 911 before he collapsed. She gave him CPR while her son helped her. When the paramedics arrived, they were barely able to get a breathing tube in his throat due to the swelling. Randy was taken to the ER and Colleen says,”[she was] notified that even if they got him back, it was hopeless.”

She watched her husband die right in front of her eyes and there was nothing that could be done. Later she found out that his death might have been due to heparin contamination.
“As a nurse, I thought I would be there to save my husband from any errors, but I guess I was naive. I never thought that the lifesaving medication we were relying on might be contaminated.”
Colleen Hubley asked that Baxter and the FDA take more responsibility to make sure that every drug that is given is free from contamination. Her sole purpose for sharing this tragedy, “to make sure this doesn’t ever happen to anyone else. Please do not let his death be in vain, We, as a family, need to know that some good can come of this tragedy”.

A tragic story, a story that puts a face on the statistics that the FDA has been publishing for months. But the Hubley family tragedy didn’t start with Randy. His mother, Bonnie Hubley, also died of a Heparin reaction, a month earlier. For the Prepared Statement of Leroy Hubley, Randy’s father, click here. Yes, a mother and son, under the same suspicious circumstances.

Why is it one family might have been struck twice by the same contaminant? Because both deaths occurred before the CDC and the FDA alerted the world about the recall on January 17, 2008. If it were just this family that was shattered by this poisoned, it would be a murder investigation centering in Ohio. But the coincidence isn’t forensically relevant when potentially thousands of others nationwide have been poisoned as well.

Bonnie Hubley’s death is not the first nor the last case where the diagnosis wasn’t understood, until this catastrophe became known. Until the extent of the contamination is fully disclosed by Baxter and other makers of Heparin, the real human cost of Baxter’s penny shaving decision to import intravenous drugs from China will not be known.


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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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