Questions are being raised as to the adequacy of the Food and Drug Administration’s handling of the contaminated blood thinner Heparin earlier this year. It is thought that the FDA misreported deaths tied to the product and didn’t thoroughly investigate the problem. It appears that the FDA released conflicting statements to the public and Congress about the number of deaths tied to contaminated Heparin.

The FDA said it linked three deaths to the defective drug in May, but last month claimed that only two of the deaths were possibly linked to Heparin when reporting to congressional staff.

Baxter International Inc., a company involved in the scandal, did its own investigation of the deaths and concluded that Heparin was not the likely cause in the three cases. Their investigation included obtaining medical records from patients, visiting a hospital where one of the patients had gone before dying, and interviewing pharmacists and nurses.

The FDA didn’t follow up with a clinical staff at the hospitals, talk with Baxter to find out further information about deaths, or access other medical databases it uses to evaluate drug safety problems.

The Associated Press is reporting the number of serious drug reactions and deaths reported to the government shot up in the first three months of this year, setting a record.

According to the report, the Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including reports of more than 4,800 deaths.

Two drugs accounted for a large share of the latest reports. One was the blood thinner heparin. Most of the drug’s problems were prompted by tainted heparin imported from China.

The other was Chantix, a new kind of anti-smoking drug from Pfizer.

The 20,745 cases reported from January through March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, the report said.

The number of deaths, 4,824, was a nearly threefold increase from the last calendar quarter of 2007. The FDA said contaminated heparin was largely to blame.

The FDA and Congressional investigators are fighting over its refusal to release information on which Chinese companies supplied a tainted blood thinner that has led to at least 81 deaths in the United States.

Heparin is a widely used blood thinner, frequently given in large doses to patients in order to prevent clotting during complex medical procedures such as kidney dialysis or heart surgery.

Most of the heparin sold in the United States is manufactured from ingredients made in China, a major supplier of drug ingredients to the United States.

The FDA suspects that the deadly heparin originally became contaminated in a Chinese factory, but has refused to tell Congress which companies supplied heparin ingredients to the United States from China. The agency says that confidentiality agreements with the producers bar it from revealing any of their names.

The FDA claims that it does not have the legal authority to prevent the importation of Chinese-manufactured drugs, citing a Memorandum of Agreement that regulates relations between the FDA and China. The memorandum was signed in order to speed the process of allowing FDA inspection of Chinese drug factories in the first place.

Instead, the FDA is relying on companies to voluntarily test their heparin ingredients before distributing them in the United States. Yet such testing failed to reveal the tainted ingredient between January 2007 and February 2008.

Baxter, the country’s major manufacturer of the drug, has developed a new testing method that can distinguish between pure heparin and oversulfated chondroitin sulfate.

One of the plants that the FDA has inspected was Changzhou SPL, a supplier for Baxter. The factory is majority owned by Wisconsin-based Scientific Protein Laboratories Inc. (SPL), the world’s major supplier of heparin’s active ingredient.

At least 12 lawsuits have been filed against Baxter by patients and their family members who claim they were harmed by the tainted drug.

According to an Associated Press story, the families of two newborns who died after they were inadvertently given massive doses of heparin have sued an Indianapolis hospital and the Illinois-based company that makes the blood thinner.

The suit filed recently in Marion Superior Court against Methodist Hospital and Deerfield, Ill.-based Baxter Healthcare Corp. doesn’t specify damages.

The suit was filed by an defective drug attorney for the parents of two of the three newborns who died in September 2006 following injections of heparin 1,000 times greater than the recommended dose for infants. Also suing are the parents of two infants who were overdosed but survived.

The error occurred in part because of a mix up over labeling.

A Baxter spokeswoman said the deaths were tragic but preventable, and it is vital that clinicians always read the name and dose of a drug before giving it to a patient. Baxter changed the labeling on its heparin vials in October 2007.

A spokesman for Clarian Health Partners, of which Methodist is part, said the company did not have all the details of the litigation and had no comment.

Actor Dennis Quaid and his wife sued Baxter last year after their newborn twins got massive doses of the blood thinner at a hospital.

These families aren’t the only ones battling drug companies over wrongful deaths due to defective drugs or defective labeling. It is advisable to locate an experienced defective drug attorney in case legal advice is necessary for a heparin lawsuit or settlement .

The California Pharmacy Board is working towards citing and fining 94 California hospitals and their corresponding head pharmacists for not complying with a recall of the contaminated blood thinner Heparin.

In February, drug manufacturer Baxter Healthcare ordered a full recall of Heparin after concerns that the medication was contaminated. They stated that the drug was to be removed from circulation and not administered to patients.

However, in at least 29 of the California cases investigated, hospital pharmacies were thought to still be using the tainted Heparin. While the amounts of the fines are yet to be determined, the hospitals may face fines from both the California Pharmacy Board and the Department of Public Health.

Contaminated heparin is suspected in nearly 100 deaths and many hundreds of injuries over the last year. Several patients have file heparin lawsuits in order to begin recovering damages.

According to a July 30 story published in the Chicago Tribune, the U.S. Food and Drug Administration, for the first time, has conclusively linked deaths of patients to specific lots of contaminated heparin made by Baxter International Inc.

In an interview, the FDA said it completed its review of 93 death reports related to heparin that the agency received from Jan. 1 to March 31, a period when there was a dramatic spike in potentially deadly allergic reactions from patients who had been injected with heparin. The popular blood thinner is used widely in large dosages, often before patients have dialysis or heart surgery.

Of 10 reports of death from severe shock known as anaphylaxis or hypotension, three of those could be traced to lot numbers of Baxter products that tested positive for an animal-like substance known as oversulfated chondroitin sulfate. Heparin lot numbers were not known for the other seven deaths from anaphylaxis or hypotension, so the FDA could not determine whether those seven patients received heparin contaminated with the substance.

“We have what looks like a cause and effect in some patients,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in an interview, referring to the three deaths linked to contaminated heparin. “We know that they got contaminated heparin, and they died subsequently. This is one of the final links in the chain.”

Baxter recalled its heparin products in February in the wake of the spike in the number of the allergic reactions. In recent months, federal health officials and Baxter believe the oversulfated chondroitin sulfate was intentionally put into the product from suppliers in China

Several wrongful death lawsuits have already been filed against Baxter and other manufacturers who allowed contaminated heparin onto the market.

On May 12th, Atrium Medical Corporation recalled specific lots of Hydraglide Brand Heparin-Coated Thoracic Drainage Catheters. The Heparin-Coated Catheters are being recalled because of concerns about contaminated Heparin.

The Heparin-Coated catheters are used during heart bypass surgery for autotransfusion.

Heparin was recalled in January because of contamination. Since 2007, Heparin has been linked to about 100 fatalities. Many of those fatalities, in addition to hundreds of adverse reactions, have been linked to contaminated Heparin. Baxter International recalled almost all lots of Heparin in order to prevent further illnesses and death.

The contamination was traced to a manufacturing facility in China. The adverse reactions were caused by over-sulfated chondroitin sulfate that could not be detected during testing because of its similarities to Heparin.

Atrium is voluntarily recalling its Heparin-Coated catheters because it was discovered that they were manufactured with contaminated Heparin.

The manufacturers of prescription drugs can be found liable if the products are found to be defective because of negligence. Defective drug attorneys are working on cases in which serious illness or fatality has resulted from faulty prescription medications.

On April 14, 2008, the United States Pharmacopeial (USP) Convention announced that it is working closely with the United States Food and Drug Administration (FDA) to develop new testing that is more sensitive to contaminants in Heparin.

This announcement came after a major recall of Heparin in January. About 19 deaths and hundreds of adverse reactions are being attributed to a contaminated main ingredient manufactured in China. The contaminant was not immediately discovered during testing because of it’s similarity to the main ingredient of Heparin.

The contaminant is over-sulfated chondroitin, which is used to treat joint inflammation. It is assumed that the contaminant was used because it mimics the blood-thinning abilities of Heparin and is cheaper than the main ingredient in Heparin

The FDA asked the USP to assist them in reviewing the current quality tests of Heparin and to help develop new methods of contaminant detection.

Defective drug attorneys are working on cases in which serious illness has developed because of exposure to contaminated prescription drugs.

A personal injury lawsuit was filed against Baxter Healthcare in the federal court of New Jersey. The announcement was made on April 3, 2008.

The lawsuit concerns a near fatal adverse reaction that is attributed to contaminated Heparin that was manufactured and marketed by Baxter Healthcare. The lawsuit seeks damages for medical expenses, physical pain and punitive damages.

The lawsuit comes after the U.S. Food and Drug Administration reported that hundreds of severe reactions have occurred due to a contaminant in Heparin. The contaminant has been traced to a Chinese manufacturing facility where a chemically altered form of chondroitin sulfate was introduced to Heparin. Chondroitin sulfate is used as a dietary supplement use to treat joint pain from arthritis.

Defective drug attorneys are currently working on similar cases in which serious illness has occurred due to manufacturer neglect.

The Food and Drug Administration (FDA) has stated that the chemical that contaminated the blood-thinner Heparin was a version of a compound that is commonly used to treat arthritis. The chemical is over-sulfated chondroitin sulfate and it is not approved for use in prescription drugs in the United States. The FDA says that it is not an ingredient in Heparin.

Investigators are now trying to determine how the substance was introduced into Heparin and if it is the cause of over 700 adverse reactions to Heparin. Investigators do not know if the substance was introduced to Heparin intentionally or not.

In the tested quantities, over half of the main ingredient was found to be the contaminate substance. The substance was overlooked during quality testing since it looks and acts like Heparin.

The FDA is currently working with Chinese authorities to determine how the substance was included with the main ingredient, which is imported from China.

About 19 Americans were killed by contaminated Heparin.

Defective drug attorneys are currently working on cases that involve serious or fatal illness caused by defective prescription drugs.