Heparin Lawsuit & News Blog

More Heparin Recall Lawsuits Filed

Tue, 29 Apr 2008 14:56:37 -0400

In Toledo, Ohio, four more people are filed heparin recall lawsuits against Baxter Healthcare.

The complaints state that these individuals were given heparin during their hemodialysis to avoid blood clotting while the blood passed through the dialysis machine. One of the individuals was looking forward to celebrating his 60th birthday when he slipped into a coma and died.

These four people began experiencing severe and unusual reactions after receiving dialysis. According to the lawsuits, the reactions that were experienced were as those who had adverse reactions to the contaminated heparin, so it is their belief that the drug is the cause of death.

In the Toledo area alone, the number of heparin recall lawsuits is up to seven with many more lawsuits filed throughout the United States including Pennsylvania and New Jersey. If you have a heparin recall lawsuit in Pennsylvania and New Jersey, please contact Anapol Schwartz to determine what your legal options are. The four deaths in the Toledo area have been reported to the FDA by the law firm representing their family so that they can be investigated further.

There have been some cases found that showed that the active ingredient in heparin was replaced with the substance over-sulfated chondroitin sulfate.

It is estimated by the FDA that over one-million vials of heparin are sold every month in the United States and Baxter makes about 50 percent of those doses, according to the lawsuits. As for damages, the damages exceed $75,000.

see: http://www.lawyersandsettlements.com/articles/10466/heparin-four-additional-toledo-lawsuits.html
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FDA, China, and Heparin

Mon, 21 Apr 2008 14:23:12 -0400

The FDA told a Senate panel that heparin from China is most likely tainted for economic reasons. Some of the heparin contained oversulfated chondroitin sulfate, an altered version used as a dietary supplement made from animal cartilage.

Oversulfated chondroitin sulfate is chemically similar to the active ingredient in heparin and is cheaper to make. The active ingredient used to make Baxter's heparin was supplied by Scientific Protein Laboratories LLC, of Wisconsin. SPL has centers in China and Wisconsin, but the contaminated heparin has is only linked to China.

Both SPL and Baxter said they believe the contamination occurred at the crude level before it reached the Chinese facility that processes the crude material into the active ingredient. In February, Baxter first it was recalling certain heparin products after receiving several hundred reports of allergic reactions and a handful of deaths.

The FDA has received 62 reports of deaths from allergic-type reactions to Baxter heparin as well as other companies since January 2007. The FDA is trying to open three offices in China by October 2008 in order to improve inspections of Chinese plants that supply many of the active ingredients used in drugs sold here.

The FDA has been under fire from some congressional lawmakers for more than a year over various food and drug-safety problems linked to China. More than 40% of the active ingredients used in drugs sold in the United States are from China or India.

The FDA is not required to re-inspect foreign plants, unlike domestic plants where re-inspections are required every two years. Along with China, the FDA hopes to open offices in India, Europe, the Middle East and South America.

The FDA is funded by a combination of annual appropriations from Congress and user-fees charged to drug and medical device companies.

See: http://money.cnn.com/news/newsfeeds/articles/djf500/200804151702DOWJONESDJONLINE000731_FORTUNE5.htm

The Severity of the FDA Baxter Heparin Recall

Mon, 7 Apr 2008 16:37:48 -0400

It is critical to note that the FDA does not warn people about recalls flippantly. There is good reason for this. If the FDA were to send people into panics about various drugs people would feel uneasy about taking medicine that could prove helpful as well as having a ripple effect on the economy via a backlash against pharmaceutical companies. This is why when a recall is issued people must take it seriously as in the case of the Baxter Helparin recall which occurred after 300+ patient reported serious adverse reactions to the drug. Clearly, such a high number of negative reports would indicate the seriousness that sponsored such a recall.

Heparin Recall

Fri, 4 Apr 2008 14:27:36 -0400

There were a number of reasons why Baxter recalled Heparin from the market as this medicine had a number of adverse problems associated with it. The most adverse of all the reactions was refactory hypotension which brought with it the potential to be fatal. No, this does not mean, however, that those "minor" adverse reactions are outside the realm of liability lawsuits. If you are taking a product such as heparin and you suffer any level of adverse reaction you may have the basis for a lawsuit. As such, seeking legal advice on the matter would be wise if you have been taking the product and suffering from any adverse effects.

More Heparin Recalls: Heparin Pre-Filled Syringes

Wed, 2 Apr 2008 13:57:07 -0400

MANSFIELD, Mass. - March 28, 2008 - Covidien, formerly Tyco Healthcare, was recently notified by its supplier, Scientific Protein Laboratories LLC, of a nation-wide recall of Heparin Sodium USP active pharmaceutical ingredient.

The voluntary recall affects 32 lots of Lock Flush Syringe manufactured and distributed by Covidien in the United States.

Covidien began recalling the lots as a precautionary measure due to a notification received from the supplier, Scientific Protein Laboratories, disclosing that two lots of Heparin Sodium USP Active Pharmaceutical Ingredient acquired by Covidien had a heparin-like contaminant.

Covidien has not received any adverse event reports related to this issue. Although a very small product line for Covidien, the Company is committed to following the FDA's lead regarding the heparin recall.
The FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products from other companies whose heparin products contained this contaminant.
As indicated in the notification issued by the Scientific Protein Laboratories, typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea, and abdominal pain.

If you or a loved one have been the victim of contaminated heparin and experienced life threatening side effects, stroke or death, please contact Anapol Schwartz law firm so they can evaluate what happened and determine if you/your family are a candidate for a heparin recall lawsuit.

http://www.fda.gov/oc/po/firmrecalls/covidien03_08.html

The Danger of Heparin

Tue, 1 Apr 2008 16:30:49 -0400

When one looks at the specifics of the FDA Heparin recall that pulled this Baxter produced drug off the market it can send chills up and down the spine of anyone who is taking prescription medication. While many of the adverse effects of this drug appeared benign on the surface (nausea, cramps, and abdominal pain) it was later discovered that the drug also caused refractory hypotension which has the potential to be a life threatening condition. This made Heparin one of the most dangerous products to reach the marketplace and that is why it was quickly removed from pharmacy shelves and this is also why a number of lawsuits have been initiated against the manufacturer of this drug.

Looking at the Baxter/Heparin Recall

Mon, 31 Mar 2008 15:29:06 -0400

How common are recalls such as the Baxter/Heparin recalls? When one looks at the totality of the various drugs on the market it becomes obvious that the vast majority of the products are the market remains excellent products that greatly help people. In short, most drugs are 100% safe but there are those exceptions and heparin is one such exception. Worst of all, it is a very dangerous exception as it has been known to cause severe adverse reactions. Additionally, that is the reason why there have been so many lawsuits against the product and, perhaps, many more lawsuits to come.

B. Braun Recalls Heparin in Canada

Fri, 28 Mar 2008 16:27:56 -0400

Health Canada testing of heparin products marketed in Canada has identified a contaminant in products from manufacturer B. Braun Medical Inc. The Department is working with the company on its recall of the affected Canadian products from the market.

Adverse reaction reports to Health Canada do not show an increase in adverse reactions, including allergic reactions, related to heparin. There was one report of an allergic adverse reaction related to heparin from January 1, 2007 to March 6, 2008.

The contaminant, oversulphated chondroitin sulphate, has also been found in heparin products in the United States and Australia.
On March 11, 2008, Health Canada requested that all suppliers of heparin for sale in Canada test their heparin products using the same methodology that uncovered the contamination in the United States.
Health Canada is continuing its testing of heparin products from all Canadian companies and will continue to update Canadians as needed.

Heparin acts as a blood thinner, preventing the formation of clots, and is used after surgery and in dialysis, among other uses. Health professionals should only use heparin where it is medically essential after careful weighing of the risks and benefits for each individual patient. Patients should be monitored during and immediately following heparin administration for signs of allergy or anaphylactic reaction.

Consumers requiring more information about this Advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

See: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2008/2008_49_e.html

Canadian Heparin Recall

Fri, 28 Mar 2008 16:26:30 -0400

The following is to update Canadians on the recall of contaminated lots of heparin products from B. Braun Medical Inc., and the ongoing testing of the heparin supply in Canada.

The contaminant found in the B. Braun products, oversulfated chondroitin sulfate, and has also been found in heparin products in other countries, including the United States.

Health Canada has been in contact with all distributors and manufacturers of heparin products in Canada since March 11, 2008, when the department asked them to confirm that all lots currently sold in Canada have been tested and are free of the identified contaminants. Company results are due by this week.

Heparin primarily acts as a blood thinner, preventing the formation of clots, and is used after surgery and in dialysis. Heparin is used when medically necessary after careful weighing of the risks and benefits for each patient. Patients should be monitored during and immediately following heparin administration for signs of allergy or anaphylactic reaction.

The presence of a contaminant in the active pharmaceutical ingredients of certain lots of B. Braun heparin products was first identified by Health Canada and communicated to Canadians on March 20, 2008.
This contaminant has been found in the following specific products and lots, which are being recalled:

Lot number: J7D580, J6N438, J6J492, J5P643
Description: Heparin Sodium 20,000 units in 5% Dextrose Injection, 500 mL
Drug Identification Number (DIN): 02209713

Lot number: J7E577 J6L669 J5S669
Description: Heparin Sodium 25,000 units in 5% Dextrose Injection, 500 mL
Drug Identification Number (DIN): 01935941

Lot number: J7E420, J6K645, J6H487
Description: Heparin Sodium 25,000 units in 5% Dextrose Injection, 250 mL
Drug Identification Number (DIN): 02209721

Lot number: J7D485, J7C477, J6L453, J6K639, J6K567, J6J613, J6H716, J6H630, J6B493, J6A679, J6A422, J5N567
Description: Heparin Sodium 1,000 units in 0.9% Sodium Chloride Injection USP, 500 mL
Drug Identification Number (DIN): 01935933

Consumers requiring more information about this Information Update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

see: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2008/2008_52_e.html