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Heparin Lawsuits Not Expected Says CEO

Posted by Jane Akre
Thursday, April 17, 2008 12:55 PM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Defective Products, Defective Drugs, Medical Devices, Wrongful Death

Heparin's CEO does not fear lawsuits from the contaminated drug.

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IMAGE SOURCE: FDA image of heparin vials

Baxter International attributes four deaths to use of its blood thinner heparin. The Food and Drug Administration counts 103 deaths following the use of heparin (though all may not be due strictly to heparin) and the number is rising.

That disparity doesn’t disturb the chairman and chief executive of Baxter International, Robert L. Parkinson, Jr. who spoke to investors about Baxter’s first quarter earnings today.

Parkinson says Baxter International Inc. (BAX) does not expect a rash of lawsuits to be filed despite the deaths and allergic reactions attributed to heparin, used in heart surgery, dialysis and outpatient procedures.

So far the FDA says 62 of the reports of death involved one or more allergic symptoms or symptoms of hypotension.

Baxter recalled lots of heparin in February after the initial reports of allergic reactions, which include dizziness, nausea and trouble breathing.

So far a dozen lawsuits have been filed.

Heparin does not represent a high profit maker for Baxter, Parkinson said who notes that the heparin recall has cost the company $11 million in the first quarter.  

Meanwhile the FDA is continuing to investigate the contaminant found in vials of heparin.  

Oversulphated condroitin sulphate is similar chemically to heparin but is made from animal cartilage and is a cheaper alternative to raw heparin from pigs’ intestines.   

FDA commissioner Andrew von Eschenbach told Senators this week that the motive was “by virtue of economic fraud” and likely committed intentionally to increase profit.

The contaminant has been found in Baxter’s heparin supplied by Scientific Protein Laboratories (SPL) LLC of Wisconsin and China. The source of the contamination is believes to be SPL’s Chinese facility that processes the crude heparin from pigs’ intestines obtained from local cottage industries.

Baxter and its supplier, Scientific Protein Laboratories say the contamination occurred in the raw material before it reached them. The Chinese are charged with investigating the motive.

Baxter is not sure when it will begin again manufacturing heparin.

The company’s shares were recently 1.1 percent lower at $59.75. #


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