Baxter Heparin Recall - Baxter Heparin - Medical Negligence

The Baxter Heparin Recall- Are You At Risk?

The Baxter Heparin Recall is the latest in defective drug scandals to hit the market. Heparin is a blood thinner, often used to prevent clotting after surgery or during dialysis. This usually harmless drug soon hit the headlines when it was discovered that there were deficiencies in the manufacturing of this drug, specifically in the company's plants located in China. The reactions to this drug have been diverse- while some have been lucky enough to just have an allergic reaction, as many as 21 people have died.

If you have just heard about the Baxter Heparin recall and have ingested the drug recently, check if you have the following symptoms. Have you had stomach cramps, nausea, vomiting, low blood pressure, excessive thirst and found it difficult to open your mouth? If so, you could be experiencing adverse reactions to this drug. Furthermore, you should start seeking legal action to gain some medical compensation.

If you or a loved one has been affected by the Baxter Heparin recall, you are in a legal position to sue because the drug that was prescribed was defective. Apart from that, you can also make a case for failure to warn and medical negligence. Another point to keep in mind involves the doctors and medical facilities. Though they have already been officially advised not to use Baxter Heparin, make doubly sure that they don't use it, in case you are undergoing a medical surgery.

Remember that some of the reactions to this defective drug have proven to be fatal so immediate action is required. If you or someone you know has been affected by the Baxter Heparin recall, contact a lawyer immediately.

FDA Fails to Regulate Heparin

Within weeks, a man lost both his wife and son because of tainted heparin.

Both victims suffered from genetic kidney disease and both were being treated with heparin, a blood thinner used in the dialysis they needed to stay alive. These loved ones are among at least 81 people in the United States whose deaths from January 2007 to March 2008 have been linked to tainted heparin from China.

First there was tainted pet food then toys tainted with lead and now contaminated heparin once used to save lives instead of kill them. The FDA has failed to provide necessary protection, but this is every bit as much the responsibility of companies that contract with low-cost Chinese suppliers.

Baxter International, bought the heparin from a company in China but it contained a contaminant, oversulfated chondroitin sulfate, that mimics heparin yet costs 99% less.

During the congressional heparin hearings, it's become know that there was no proper inspections from either the Chinese version of the FDA or the U.S. FDA.

Baxter says that even with a rigorous inspection, it could not have detected the fake ingredient. Perhaps but it could have discovered, as the FDA did, that the Chinese plant, among other things, did not have control over its raw-materials suppliers.

Someone has to take responsibility and it's not the victim. If you or a loved one has been seriously ill or died from contaminated heparin, it is advisable to contact a lawyer to determine if you are eligible for a heparin lawsuit.

Source: USA TODAY

Suit Against Tyco Healthcare Alleges Tainted Heparin Caused Death

Legal Intelligencer: A Philadelphia lawsuit against Tyco Healthcare was filed on behalf the estate of a Missouri man who died after allegedly suffering adverse reactions to heparin that was made in China.

The plaintiff's attorney alleged that the FDA is investigating 81 other deaths that have been linked to tainted heparin.

Baxter International Doubts Legal Problems over Heparin

Baxter International does not expect issues with the recalled blood thinner heparin to cause major legal problems potential links to patient deaths.

Baxter announced a recall of heparin in February 2008 after numerous allergic reactions and deaths. Baxter said it’s hard to find concrete links between the drug troubles and deaths and doesn’t expect patient litigation. Baxter is thinking wishfully.

Baxter claims that only four deaths may be related to heparin when in fact there have been 62 deaths. So far dozens of lawsuits have been filed. If you or a loved one has experienced life threatening allergic reactions or death because of the heparin recall, please contact Anapol Schwartz law firm located in Pennsylvania and New Jersey so we may evaluate your options.

Despite the high-profile nature of the heparin troubles, the drug is not a major or high profit-margin product for Baxter. The stock declined by 1.1 percent.

Baxter hasn’t decided whether or not it will bring heparin back to the market, Heparin has a complex supply chain, with an active ingredient derived from pig intestines. Baxter needs to learn more about the cause of heparin problems and supply-chain controls before deciding how to proceed.

The FDA said that some heparin sourced from China was tainted with a certain product made from animal cartilage that is chemically similar to heparin's active ingredient but is considered cheap filler.

Baxter believes the contamination occurred at the crude level before it reached Scientific Protein Laboratories Chinese facility that processes the crude material into the active ingredient.

Red Flags Ignored for Heparin Contamination Problem

The price of crude heparin exported from China rose from $629 per kilogram in January 2007 to $1,507 per kilogram in December 2007. The cost of refined heparin exported by China rose at about the same rate as that of raw heparin—strongly suggesting that the increase was driven by the price of the raw material rather than by processing problems.

The FDA was aware that the price of raw heparin increased dramatically but did not necessarily see it as a signal of potential quality problems. The rise apparently was the result of the blue ear disease. The FDA is looking at other possibilities.

The highly unusual increase of the price within a quarter of a year should have been a red flag to drug makers that something significant—and perhaps dangerous—was happening. Heparin contains a substance that is extracted from the intestines of pigs and is collected in slaughterhouses and on farms.

See: http://www.chicagotribune.com/business/chi-heparin_for_businessapr14,1,64884.story

Scientific Protein Laboratories said the price doubling did not raise any safety concerns but pharmaceutical industry experts say that a sudden increase in a stable price should have raised concern. Last month, the FDA discovered through chemical testing that heparin made in China had been contaminated with inexpensive over-sulfated chondroitin.

Was Baxter Heparin Intentionally Contaminated?

During a senate hearing the FDA commented that they suspect that the blood thinner heparin was contaminated with cheap filler instead of heparin’s active ingredient to increase profit. The FDA failed to specify who added the contaminant. Baxter International said it happened before the product reached the company's supplier.

Later the FDA reneged on the statement saying there was no evidence that the heparin contamination was intentional.

Since January 2007, 62 people died after suffering allergic reactions or low blood pressure, from heparin. Heparin was recalled January 2008. Heparin prevents blood clots during dialysis and heart surgery.

The FDA hasn't concluded where in the supply chain the tainted material was introduced. See: http://www.boston.com/business/healthcare/articles/2008/04/16/fda_fears_heparin_tainted_on_purpose/

Heparin Sodium Recalls - Lawsuits

Heparin Recall

If you have been injured by heparin sodium, you can contact our legal team with experience handling cases invovling dangerous medical devices and defective medications. The lawyers at www.anapolschwartz.com may help you to get the compensation that you deserve for the pain and suffering that you have endured as a result of your defective heparin sodium dose.

The U.S. Food and Drug Administration is investigating the New Jersey Baxter facility along with the Chinese facility that produced the heparin raw product to determine how the contaminate, oversulfated chondroitin sulfate, which does not occur naturally, got into the heparin batches. As much as half of the main ingredient in suspect Heparin supplies was found to actually be the contaminant. This chemical appears similar to the main ingredient in Heparin and produces the same results as Heparin during routine quality testing.. As a result of FDA investigations, China's drug safety agency has ordered local authorities to tighten controls on production. Baxter issued its own statement that also attributed the contamination to the Chinese suppliers.