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The many extracts on these pages are from copyright material. They are owned by the reference given or its owner. They are reproduced here for educational purposes and to stimulate public debate about the provision of health and aged care. I consider this to be "fair use" in the common interest. They should not be reproduced for commercial purposes. The material is selective and I have not included denials and explanations. I am not claiming that the allegations are true. The intention is to show the general thrust of corporate practices as well as the nature and extent of any allegations made. Any comments made are based on the belief that there is some substance at least to so many allegations.

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Introductory page
This corporate web site addresses the issues of corporate health care within a broad framework. A web page describing this broad context should be considered as an introduction to each page on the web site. If you have not yet read it then CLICK HERE to open it in another tab or web page.

Content of this page
Baxter is a large US multinational provider of intravenous fluids, infusion equipment.and dialysis machines. It has diversified into several other areas including dialysis clinics. By comparison with the rest of the sector in the USA, Baxters track record for fraud is quite good. There have however been some serious problems with its dialysis products with a large number of deaths resulting. Baxter now operates dialysis services in Australia.

US section

Baxter

  

CONTENTS


Businesses

Baxter is a US based multinational.  It was founded in 1931 to make intravenous solutions.  It expanded internationally in 1954 and built the first artificial kidney in 1956.  It listed as a public company in 1961.  It has continued to grow by acquisitions and to develop products for intravenous therapy, renal care and cardiac care.  For a detailed account see the Wikipedia link below.  Baxter's own web page describing its products and services is at http://www.baxter.com/

Aug 2008 Baxter
Baxter International Inc. (NYSE: BAX), is a global healthcare company with 48,000 employees and 2006 sales of US$10.4 billion. Its headquarters is in Deerfield, Illinois.

The company offers a diversified line of specialized medical products, generally categorized as BioScience (US$4.4 billion in blood collection products and pharmaceuticals derived from blood plasma), Medication Delivery (US$3.9 billion in products for intravenous therapy, and Renal (US$2.1 billion in products for peritoneal dialysis and hemodialysis). About 80% of its revenue comes from the U.S., Canada and Europe, with the rest primarily from Asia and Latin America.
The company has enjoyed strong growth through much of its history, and has been an innovator in many medically-related fields.
Baxter International  Wikipedia http://en.wikipedia.org/wiki/Baxter_International Accessed Aug 2008

Like Corning, Baxter spun off the infusion therapy subsidiary that was being investigated for fraud in the USA in 1992.  This became Caremark. Caremark paid a US $161 million fraud settlement and this is described elsewhere.  This was a Baxter subsidiary but Baxter avoided the flak when the fraud became public.

Baxter provides dialysis and other renal care services in the USA and internationally. Baxter has been a major global manufacturer and provider of intravenous infusion fluids, and of the devices used to administer them.  It is involved in the drug business and in other health care enterprises.

A 2001 article on Renal Web did not include Australia in the list of countries where Baxter operated Dialysis clinics. It now does so.

May 1996 Caremark's tawdry past

Caremark is a 3 1/2-year-old company that resulted from a November 1992 spinoff by Baxter International Inc.
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Caremark has had a stormy existence even from the time it was part of Baxter. Caremark previously operated a home-infusion business in which it administered intravenous antibiotics, medicines and nutrition to patients at their homes.

That part of Caremark's business was the focus of a criminal investigation by the Federal Bureau of Investigation and the inspector general's office of the U.S. Department of Health and Human Services that dealt with alleged payoffs to doctors for steering business to the company. Ultimately, Caremark pleaded guilty to federal felonies in connection with the inquiry and agreed to pay civil damages and criminal fines of $161 million to settle the case.
MedPartners Proposed Buy of Caremark Would Be the Latest in a Series of Acquisitions The Wall Street Journal Europe May 15, 1996

Nov 1996 Nature of Baxter's operations - A new division becomes more clinical in the USA

Baxter Healthcare Corporation announced the launch of a new affiliate, Renal Management Strategies Inc. (RMS), a renal disease management organization dedicated to creating nephrologist-led renal care networks around the country.
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The Renal Division, which also includes the company's $1.3 billion core business of products and services to treat kidney disease, is one of Baxter's four key businesses. Baxter has been an innovator and leader in the renal industry for the last 40 years, playing a pioneering role in the development of therapies for hemodialysis and peritoneal dialysis.
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Baxter International (NYSE: BAX) is a global medical-products and services company that is a leader in technologies related to the blood and circulatory system. Through its subsidiaries, Baxter has market leading positions in four businesses: biotechnology, which develops therapies and products in transfusion medicine; cardiovascular medicine, which develops products and services to treat late-stage cardiovascular disease; renal, which develops products and services to improve therapies to fight kidney disease; and intravenous systems/medical products, which develops technologies and systems to improve intravenous medication delivery, and distributes disposable medical products.

Launch of New Renal Disease Management Organization Doctors Guide Nov. 5, 1996 http://www.pslgroup.com/dg/D7F2.htm

1998 Operates dialysis clinics outside USA

The Company's Renal segment provides products and services for kidney dialysis--the primary treatment for end-stage renal disease, or kidney failure. This business is a leading manufacturer of products for peritoneal dialysis, a home-based renal therapy, and it also manufactures products for hemodialysis, a treatment administered in a hospital or clinic.

In selected international markets, through its Renal Therapy Services unit, this business operates dialysis clinics. Through Renal Management Strategies Inc., it also works in concert with United States nephrologists as a kidney-disease management company.
Baxter International 1998 10-K Report http://buck.com/10k?tenkyear=98&idx=B&co=BAX&nam=DEMO&pw=DEMO

Aug 1999 More dialysis services across the USA

Renal Management Strategies has inked a three-year contract with Humana to manage care of the HMO's patients suffering from irreversible kidney failure. Under the deal, McGaw Park, Ill.-based RMS, an affiliate of Baxter International, will apply intensive disease management techniques to care for an estimated 800 Humana health plan enrollees with end-stage renal disease in 16 U.S. markets. RMS will roll out the program Oct. 1 in Chicago, Kansas City, San Antonio and South Florida. Louisville, Ky.-based Humana's other 12 markets will be added by the first quarter of 1998. Financial terms were not released.
Baxter affiliate, Humana in deal MODERN HEALTHCARE Aug. 27 1999

Jan 2001 Dialysis clinics in 12 countries across the world but not Australia

Baxter, the Renal Therapy Services (RTS) operates dialysis clinics in 12 countries outside the United States, while Renal Management Strategies Inc. (RMS) partners with U.S. nephrologists to provide a kidney-disease management program to health-care payers. RTS began the year 2000 with more than 160 clinics in Argentina, Brazil, China, Colombia, France, Indonesia, Korea, Malaysia, Singapore, Spain, Taiwan and the United Kingdom.

From Renal Web January 9, 2001 http://renalweb.groupee.net/eve/forums/a/tpc/f/5711014023/m/4041044023

 


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Fraud

I have not come across many reports linking Baxter with fraud  but it is on Crime Reporter's list of the top 100 Corporate Criminals in the 1990s  in the USA

2004 On list of top 100 corporate criminals

To compile The Top 100 Corporate Criminals of the 1990s, we used the most narrow and conservative of definitions -- corporations that have pled guilty or no contest to crimes and have been criminally fined.
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THE TOP 100 CORPORATE CRIMINALS OF THE 1990's
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87)(tie) Baxter International Inc.
Type of Crime: Illegal Boycott
Criminal Fine: $500,000
7 Corporate Crime Reporter 13(7) , March 29, 1993
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Baxter International Inc. pled guilty to a criminal felony for violating the Anti-Boycott Statute by providing information about the company's business dealings with Israel to Arab League boycott authorities.

The company paid $6 million in civil penalties and a $500,000 criminal fine.
Top 100 Corporate Criminals of the Decade  Corporate Crime Reporter http://www.corporatecrimereporter.com/top100.html Accessed 2004

 

Allegations of fraud in its Brazilian operations were squashed on appeal in 2007. The appeal court would not accept the testimony of anonymous confidential witnesses or grant them protection.

Aug 2007 Allegations of fraud in Brazil
The Higginbotham lawsuit was filed after Baxter International announced in July 2004 that it would restate its earnings for the preceding three years due to allegedly fraudulent practices at its Brazilian subsidiary, which included the premature reporting of sales contracts and the reporting of fictitious sales to convey the illusion of growth.
THE SEVENTH CIRCUIT TIGHTENS THE REINS ON SECURITIES FRAUD PLAINTIFFS Securities Litigation and Enforcement FULBRIGHT BRIEFING August 2, 2007 http://www.fulbright.com/images/publications/BRIEFSevenCircuitSecuritiesFraud.pdf

 


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Quality of Care

Canadians in British Columbia in Canada protested loudly about plans to outsource renal services to Baxter.  The objection was based on studies showing a higher mortality in for-profit dialysis services as well as an investigation into an excess number of deaths in those using Baxter's dialysis  machines.   The company had already settled law suits in Europe and the USA.

Mar 2003 Canadian's oppose Baxter because of failings in care
Nurses are demanding that BC health authorities break off talks with a US health care giant, following revelations that the US Justice Department is investigating the deaths of patients who had used the companyÕs kidney dialysis machines.
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The revelations follow a study published in the Journal of the American Medical Association last November showing that people with kidney disease are more likely to die in a for-profit clinic than if they are treated in a not-for-profit facility.
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But in a filing with the US Securities and Exchange Commission March 13, Baxter revealed that the US Justice Department has subpoenaed documents in a probe into the deaths of 53 patients who had used its dialysis machines. The company also disclosed that it has reached settlements with a number of families of patients who died in Spain, Croatia and the United States after undergoing treatment on the Baxter Althane series of dialyzers.
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In the Journal of the American Medical Association study, P. J. Devereaux of McMaster University in Hamilton, Ont. found the overall death rate for kidney patients was 8 per cent higher in for-profit facilities. Dr. Devereaux said for-profit dialysis clinics tend to cut corners such as using technicians, rather than Registered Nurses, and the time patients spend on dialysis is shorter than in not-for-profit facilities.
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" Deerfield Ill.-based Baxter is already a defendant in six civil lawsuits seeking damages from the company and, in a filing with the US Securities and Exchange Commission, it warned that it may face more lawsuits and claims in the United States and elsewhere"
Nurses demand halt to talks with US health giant linked to patient deaths NEWS RELEASE British Columbia Nurses Union  Globe and Mail March 24, 2003

 

In 2003 there was an outcry because Bayer had continued to sell blood clotting medicine for haemophiliacs, that had not been treated to kill the AIDS virus, to 3rd world countries during the 1980s.  Many developed AIDS.  Apparently Baxter was one of a number of companies alleged to have unloaded contaminated old stock in this way.

May 2003 Sold AIDS contaminated blood products to 3rd world during the 1980s
Officials from the three other American-based companies that continued to sell unheated concentrate 'Armour Pharmaceutical, Baxter International and Alpha Therapeutic' either declined to be interviewed or denied wrongdoing, in some cases citing the same reasons Bayer did for its decisions.

Still, what is not in dispute is that by the spring of 1985, few researchers doubted the connection between AIDS and unheated concentrate.
2 Paths of Bayer Drug in 80's: Riskier Type Went Overseas The New York Times May 22, 2003

 

In 2007 a law firm's web site alleged there were concerns about serious problems with infusion pumps and also a failure to repair damaged pumps.

Jul 2007 Problems with Baxter's pumps
In the span of a just few days, the Food & Drug Administration (FDA) ordered two separate recalls for the pumps;  and in one instance, patients treated with these  pumps may have been endangered because of fraud committed at the company's Phoenix service center.
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In a press release, Baxter said that during routine quality control inspections it was discovered that the pumps could have been returned to customers without ever having been repaired.  During the inspection, Baxter found that repair, testing and inspection data sheets for the pumps had been falsified.  The company said that it had dismissed three employees implicated in the fraud.  Baxter did not say how this fraud was allowed to occur.
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The announcement of this recall came just days after the FDA announced a Class I recall of more than 4500 Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps.  Ironically, these pumps had been distributed to replace infusion pumps recalled by the company in 2005.  These upgraded pumps were recalled because of a software glitch that caused the pumps to alarm, display an error code and stop infusion.  Prior to the recall, Baxter had received reports of 16 serious injuries linked to the malfunctioning pumps in the US.
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In light of the poor performance of so many models of Baxter's infusion pumps, questions are being raised about company's quality control programs.   That so many patients could have been endangered because of falsified repair records and shoddy design is inexcusable.  What steps Baxter and the FDA will take to prevent such occurrences in the future still remains to be seen.
Baxter Infusion Pumps: Fake Repair Records, Shoddy Design Endanger Patients, Spark Recalls Parker Waichman Alonso LLP  -- law firm Jul 30, 2007 http://www.yourlawyer.com/articles/read/12940

 

In 2008 there was another crisis when many patients died after an allergic reaction to the blood clot inhibitor, heparin, supplied by Baxter.  While Baxter was blamed for this it subsequently transpired that its Chinese suppliers had supplied it with a slightly different and cheaper product without disclosing this.

Apr 2008 Contaminated heparin causes deaths
The US Food and Drug Administration (FDA) believes that the contamination of Baxter's blood thinner heparin, which has been linked to 62 deaths in the US, may have been due to the deliberate replacement of some ingredients with cheaper alternatives.

Analysis by the agency recently established that the drug lots in question contained oversulfated chondroitin sulphate, which is a less-expensive, animal cartilage-derived alternative to raw heparin that is not approved for use in medicine. Oversulfated chondroitin sulphate has been implicated in causing the hypersensitivity reactions associated with contaminated heparin.
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In response, Baxter and its active pharmaceutical ingredient (API) supplier, Scientific Protein Laboratories, said that the contamination occurred before the material had reached either company. Baxter, which initiated a product recall in February this year, is still investigating the issue.
FDA suspects heparin contamination due to fraud April 17, 2008 http://www.in-pharmatechnologist.com/news/ng.asp?n=84723-fda-baxter-heparin-contamination-china

Apr 2008 Problem resolved
AN international team of researchers have figured out how tainted batches of the blood thinner heparin slipped past safety screens to kill dozens of patients in the United States and Germany.
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"The FDA has already moved to put screening methods in place to detect contaminated heparin,'' said (Professor) Sasisekharan.
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US health authorities said Chinese companies had also supplied contaminated heparin to Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands and New Zealand.
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Using new technology developed for analysing complex sugars, the researchers developed a way to screen for the toxin.

"Our findings suggest that a simple bioassay (chemical test) could help protect the global supply chain of heparin,'' Sasisekharan said.
Link to Chinese factories Answers to killer meds Townsville Bulletin April 25, 2008

 


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Baxter in Australia

Baxter has operated in Australia for many years but only recently started operating dialysis services in this country.

Click Here to examine Baxter in Australia.


Baxter's web page is http://www.baxter.com/

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This page created August 2008 by Michael Wynne