Author Topic: Foreign Hemophiliac Lawsuits Proceed in U.S. Against - Cutter / Bayer  (Read 8802 times)

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Online TahoeBlue

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See also: HN51 'accidentally' mixed in Flu Vac - Baxter

http://www.baumhedlundlaw.com/drug2_press/taiwanese_hemophiliacs_lawsuits.php
Foreign Hemophiliacs’ Lawsuits Can Proceed in U.S. Against Makers of HIV-Infected Medicine

Los Angeles, California, January 16, 2009 -- U.S. lawyers for Taiwanese hemophiliacs are pleased that their clients’ cases can now proceed in California. Since the same judge had ruled against the United States as a legal venue for similar cases for other foreign HIV-infected hemophiliacs, the lawyers say this is a step in the right direction. This is the first positive ruling for foreign claimants bringing a claim for HIV-contaminated anti-hemophilia factor concentrate (AHF) exported from the United States.

Cutter, now part of Bayer Corp., knowingly dumped HIV-contaminated hemophilia medicine in the Far East. And the reason they continued to market it in the Far East was because ‘AIDS hysteria’ hadn’t yet reached the Far East,” according to attorney Michael L. Baum. “They continued selling their cheaper HIV-contaminated blood clotting medicine in order to make a profit from it and deplete their inventory.”

The U.S. District Court of the Northern District of Illinois, Judge John F. Grady, who issued this favorable ruling, had previously dismissed lawsuits brought by hemophiliacs in foreign countries such as Argentina, Israel and the U.K. Bayer Corp. and Baxter Healthcare Corp. were hoping for the same forum non conveniens ruling in the Taiwanese cases. Grady ruled that at present the circumstances in the Taiwan cases differed enough to justify continuing the suits in the U.S., for now.

The law firm of Baum, Hedlund, Aristei & Goldman, which also represented victims in the domestic U.S. cases, was approached by the Taiwanese hemophilia community after attorney Michael L. Baum was interviewed by the New York Times regarding documents Baum Hedlund had found regarding Cutter’s continuing to sell non-heat- treated AHF after their heated product was approved.

Baum was also invited to present to the Taiwanese Ministry of Health, Baum Hedlund’s smoking gun documents showing that the U.S. manufacturers of hemophilia medication were, in fact, committing a fraud on Taiwan by knowingly urging doctors to prescribe HIV-contaminated medication to their hemophilia community.

The firm has been working towards getting U.S. jurisdiction for about 40 Taiwanese. After the cases were filed in the California courts, they were transferred to multidistrict litigation, MDL-986, in the U.S. District Court for Northern District of Illinois to follow other similar cases filed by other foreign infected hemophiliacs. Over 2,000 cases were filed by foreign hemophiliacs from more than a dozen countries. The Taiwanese cases are back in U.S. District Court, Northern District of California.

The Baum Hedlund lawyers contend that pharmaceutical manufacturer Bayer intentionally placed sales above lives by choosing to sell AHF to hemophiliacs in Taiwan when it had a safer heat-treated product that could have been used instead. Their “Far East Region marketing plan” shows they wanted to get as much of their cheaper HIV-contaminated medicine sold before the “hysteria over AIDS” reduced their sales. Because they had excess inventory of their unheated product and wanted to maximize their profits on it, they decided to unload their contaminated supply by “dumping” it in foreign countries.

Frances Phares, a Baum Hedlund attorney who has been handling these cases since 1995 stated, “Our clients want their cases heard in front of a jury in the United States. The jury needs to hear about the fact that the manufacturers knowingly dumped HIV-contaminated hemophilia medicine in Taiwan for profit.”

Excerpts from the 1985 Cutter Far East Region Marketing Plan:

"What Koate business Cutter had left in New Zealand as of 1982 was terminated when AIDS became an issue there.

"AIDS has not become a major issue in Asia. Perhaps it is because the region has so many other health hazards of greater, more common concern. The hepatitis risk of American-made concentrates is not of such great concern in a region where hepatitis B is so prevalent. In Taiwan, for instance, where 16% of the population are carriers of Hepatitis B, a hemophiliac is apt to suffer as much risk routinely using cryoprecipitate or blood as with American-made concentrates. With these considerations in mind, we have no immediate plans to introduce Koate-HT or Konyne-HT.

"If we see need for a heat-treated product in the Far East, we will react to the demand swiftly. Otherwise, we will try to continue to dominate the markets with low-cost standard Koate and Konyne.

"Continue with lower-cost standard Koate and Konyne until such time that heat-treated products are required to compete."

Background:

In 2003 the New York Times ran a story about Cutter’s continuing to sell non-heat treated AHF in Hong Kong and Latin America for about a year or so after a safer product became available, and the article discussed some of the documents Baum Hedlund had obtained in litigation.

Thousands of hemophiliacs from the United States and around the world became infected with HIV after administering blood clotting medicine, which unbeknownst to them, was contaminated with HIV. Since then many hemophiliacs have died from AIDS, and others are still living with the disease. Hundreds of personal injury and wrongful death lawsuits in the U.S. were resolved several years ago against Baxter, Cutter/Bayer, Alpha Therapeutic and Armour Pharmaceutical Co. Some of these same companies had also shipped their HIV-contaminated hemophilia medication to other countries where people are still suffering and dying from AIDS after getting HIV from their blood clotting medication.

Hemophilia is a rare inherited bleeding disorder in which a person lacks certain proteins necessary to normally clot blood. Hemophiliacs require blood clotting medicines that contain factor VIII and IX.
Behold, happy is the man whom God correcteth: therefore despise not thou the chastening of the Almighty: For he maketh sore, and bindeth up: he woundeth, and his hands make whole ; He shall deliver thee in six troubles: yea, in seven there shall no evil touch thee. - Job 5

Offline Dig

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Re: Foreign Hemophiliac Lawsuits Proceed in U.S. Against - Cutter / Bayer
« Reply #1 on: March 02, 2009, 07:16:37 pm »
"Cutter, now part of Bayer Corp., knowingly dumped HIV-contaminated hemophilia medicine in the Far East"

How is this shit even possible, I mean WTF?  I heard the news report about this years ago and it is still shocking.
All eyes are opened, or opening, to the rights of man. The general spread of the light of science has already laid open to every view the palpable truth, that the mass of mankind has not been born with saddles on their backs, nor a favored few booted and spurred, ready to ride them legitimately

Online TahoeBlue

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Re: Foreign Hemophiliac Lawsuits Proceed in U.S. Against - Cutter / Bayer
« Reply #2 on: March 02, 2009, 08:04:57 pm »
Quote
Thousands of hemophiliacs from the United States and around the world became infected with HIV after administering blood clotting medicine, which unbeknownst to them, was contaminated with HIV. Since then many hemophiliacs have died from AIDS, and others are still living with the disease. Hundreds of personal injury and wrongful death lawsuits in the U.S. were resolved several years ago against Baxter, Cutter/Bayer, Alpha Therapeutic and Armour Pharmaceutical Co.

Some history... litigate, settle, rinse and repeat...

http://www.aegis.com/news/wsj/1996/wj961008.html
Health: Hemophiliacs With AIDS Join Lawsuit Settlement
The Wall Street Journal - Friday, 25 October 1996.

CHICAGO -- Hemophiliacs who contracted the AIDS virus from blood-clotting products have overwhelmingly opted to join a tentative $650 million class-action settlement of litigation over the issue, the companies involved said.
About 6,500 eligible Americans with hemophilia have decided to participate in the settlement plan, of whom about 800 had previously filed lawsuits against the companies. Meanwhile, about 550 eligible people with hemophilia decided to opt out of the class-action deal, of whom about 380 have filed lawsuits.

The companies in the proposed settlement, however, said they still will take a month to decide whether to stay in the settlement plan. A court hearing on the matter is set for late November in U.S. District Court in Chicago. The corporations tentatively participating in the settlement are Baxter International Inc., Bayer AG, Rhone-Poulenc Rorer Inc.'s Armour division and the Alpha Therapeutic unit of Green Cross Corp. of Japan.

Also see: http://www.hemophilia-litigation.com/

Plaintiffs' Allegations
After 1978, there were four major companies in the United States engaged in the manufacture, production and sale of Factor VIII and IX: Armour Pharmaceutical Company, Bayer Corporation and its Cutter Biological division, Baxter Healthcare Corporation and its Hyland Pharmaceutical division and Alpha Therapeutic Corporation, which have been or are defendants in certain lawsuits.  
The plaintiffs allege that the companies manufactured and sold blood factor products as beneficial "medicines" that were, in fact, contaminated with HIV and/or HCV and resulted in the mass infection and/or deaths of thousands of people with hemophilia worldwide.  

It is believed that three of these companies, Alpha, Baxter and Cutter, recruited and paid donors from high risk populations, including prisoners, intravenous drug users, and blood centers with predominantly homosexual donors, to obtain blood plasma used for the production of Factor VIII and IX. Plaintiffs allege that these companies failed to exclude donors, as mandated by federal law, with a history of viral hepatitis. Such testing could have substantially reduced the likelihood of plasma containing HIV and/or HCV entering plasma pools.  
Plaintiffs futher allege that the defendants fraudulently misrepresented to government officials and the public that Factor VIII and IX were safe to use and that the companies had undertaken serious, timely and effective efforts to reduce the risk to persons with hemophilia of developing AIDS and HCV.
Plaintiffs charge that from July 1982, when the first evidence that people with hemophilia had died from AIDS surfaced, through 1985, the defendants acted in concert to avoid recalling Factor VIII and IX; to avoid warning patients of the risks of HIV and HCV infection posed by their products; to continue to market the products as safe; to avoid implementing testing of Factor VIII and IX for the presence of hepatitis, which would have served as a surrogate for testing for HIV and HCV; to avoid developing and implementing simple methods of viral inactivation that would have eliminated all or most of the infections; and to issue public statements minimizing the risk of contracting AIDS and HCV from their blood factor products and overpromoting the benefits of those products.  


Now Baxter makes the Factor8 from re-combinant human DNA in Hampster cells....

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/01-07-2002/0001642881&EDATE=

Baxter Produces Record Levels of Recombinate rAHF Hemophilia Therapy in 2001

Company's Continued Investments in Production Expansion, R&D Expected to Yield
                Further Increases in Supply in 2003 and Beyond


    DEERFIELD, Ill., Jan. 7 /PRNewswire/ -- Baxter Healthcare Corporation
announced today that it shipped more than one billion units of Recombinate
Antihemophilic Factor (rAHF), the company's recombinant Factor VIII (rFVIII)
therapy, in 2001 from its BioScience facility in Thousand Oaks, California.
  
  This milestone was achieved as the result of significant investments that
the company has made over the last several years to expand production capacity
at this state-of-the-art manufacturing facility.  Baxter began construction of
its Thousand Oaks facility in late 1992 and the facility was licensed in 1996.
Since then, the company has invested more than $200 million in its continued
expansion and has produced more than 4.5 billion units of Recombinate in
total.
 
  Recombinate (rAHF) is a clotting factor produced by recombinant DNA
technology as a therapy for people with hemophilia.  To produce Recombinate
(rAHF), the human gene responsible for producing the Factor VIII protein is
inserted into the DNA of a hamster cell line
.  The information encoded on the
gene instructs the cells to produce the Factor VIII protein.  These
genetically modified cells are placed into 2,500-liter (660 gallon) stainless-
steel tanks, where they are nourished with water, nutrients and oxygen. The
recombinant Factor VIII is then harvested from the tanks, purified and
packaged.

 ...

http://www.coagulife.com/productssupplies/Baxter/pdfs/Recombinate.pdf
6. What are the possible side effects of Recombinate rAHF?
The most common side effects are flushing, nausea, fever, chills, mild fatigue, nose bleeds, and hives.


http://www.drugs.com/newdrugs/advate-baxter-healthcare-corp-hemophilia-a-261.html

(FDA) has approved Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method) rAHF-PFM for the prevention and control of bleeding episodes in people with hemophilia A. Advate is the first and only factor VIII made without any added human or animal plasma proteins and albumin in the cell culture process, purification and final formulation, thereby eliminating the risk of infections caused by viruses that may be carried in these proteins.

Advate Clinical Data
Side effects with the use of Advate are uncommon, with no serious adverse events related to treatment with Advate reported to date. Non-serious, moderate or mild adverse events related to Advate include: a strange taste, itching at the infusion site, dizziness, headaches, catheter-related infections, chills, hot flashes, diarrhea, lower limb edema, sweating, nausea, pain in the upper abdomen or lower chest, prolonged bleeding after post-operative drain removal, decreased red blood cell count, joint swelling and shortness of breath. Non-serious, but severe related adverse events include: fever, headache and decreased coagulation factor VIII levels.

Behold, happy is the man whom God correcteth: therefore despise not thou the chastening of the Almighty: For he maketh sore, and bindeth up: he woundeth, and his hands make whole ; He shall deliver thee in six troubles: yea, in seven there shall no evil touch thee. - Job 5

Offline dissident99

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Re: Foreign Hemophiliac Lawsuits Proceed in U.S. Against - Cutter / Bayer
« Reply #3 on: March 05, 2009, 03:48:10 pm »
I bet tomorrow's lunch money that they get off with a slap in the hand.
"The only thing necessary for the triumph of evil is for good men to do nothing" -Edmund Bourke

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a little temporary safety deserve neither liberty nor safety"
- Benjamin Franklin

Online TahoeBlue

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Re: Foreign Hemophiliac Lawsuits Proceed in U.S. Against - Cutter / Bayer
« Reply #4 on: February 05, 2012, 04:55:46 pm »
bump - AJ mentioned

http://openjurist.org/484/f3d/951/in-re-factor-viii-or-ix-concentrate-blood-products-litigation-domenico-gullone-et-al

http://www.baxter.com/downloads/investors/reports_and_financials/annual_report/1997/bax97ar_t.pdf
...
Factor concentrates litigation

Baxter currently is a defendant in a number of claims and lawsuits brought by individuals who have hemophilia, all seeking damages for injuries allegedly caused by anti-hemophilic factor concentrates VIII or IX derived from human blood plasma
(factor concentrates) processed by the company in the early and mid-1980s. The typical case or claim alleges that the individual was infected with the HIV virus by factor concentrates, which contained the HIV virus. None of these cases involves factor concentrates currently processed by the company.

As of December 31, 1997, Baxter had been named in 486 lawsuits and 410 claims in the United States, Canada, Ireland, Italy, Taiwan, Japan and the Netherlands.

All U.S. federal court factor concentrate cases have been transferred to the U.S.D.C. for the Northern District of Illinois for case management under Multi District Litigation (MDL) rules (MDL Docket No. MDL-986). The company also has been
named in eight purported class actions. None of these class actions has been certified, and five have been transferred to the MDL for discovery.

In most states, Baxter’s potential liability is limited by laws that provide that the sale of blood or blood derivatives, including factor concentrates, is not covered by the doctrine of strict liability.

As a result, each claimant must prove that his or her injuries were caused by the company’s negligence.

IN RE FACTOR VIII OR IX ) MDL 986
CONCENTRATE BLOOD PRODUCTS ) LIABILITY LITIGATION - ELI ASHKENAZI, et al.,v. BAYER CORPORATION, et al - Ruling on Israel


...according to plaintiffs, an important part of the defendant’s conduct occurred in Israel, in that they committed fraud upon the government of Israel and Israeli healthcare providers by failing to disclose that the products they were delivering to Israel were contaminated.
Behold, happy is the man whom God correcteth: therefore despise not thou the chastening of the Almighty: For he maketh sore, and bindeth up: he woundeth, and his hands make whole ; He shall deliver thee in six troubles: yea, in seven there shall no evil touch thee. - Job 5