Heparin Injury Attorney Serving New York and New Jersey
In July of 2008, the FDA formally acknowledged the connection between the contaminants found in the Heparin manufactured by Baxter International Inc., and the serious, even deadly side effects experienced by patients who used it. Beginning in November of 2007, an unexplained spike in adverse events related to Heparin worried the medical community, but it was only in January 2008 that the number of incidents forced a recall of Heparin products. It was determined that all adverse events reported up to that point had come from Heparin manufactured and distributed by Baxter International Inc. Since then, investigations have found that the Chinese factory which supplied raw material for Baxter’s Heparin was substituting oversulfated chondroitin sulphate for raw heparin. Oversulfated chondroitin sulphate mimics the function of heparin, but is NOT approved for use in medications. Chinese officials have denied any contamination took place and are blocking FDA investigations to determine exactly where and how the contaminant entered into the production process.
The “FDA’s working hypothesis is that this was intentional contamination, but this is not yet proven” said Dr. Janet Woodcock, Director of the Food and Drug Administration. Testing has shown that in some batches of recalled heparin, up to 1/3 of the material was a contaminant. As the contaminant was approximately 99% cheaper than raw heparin, it is possible that production costs played a part in the substitution.
Eleven other countries including Canada, France, Germany, Denmark, Italy, the Netherlands, Australia, New Zealand, Japan and China have reported contaminated heparin within their markets. Germany and Japan have also decided to recall all heparin products made with raw active ingredients sourced from China.
Heparin Side Effects
Nearly all reported adverse reactions have occurred in three specific areas of product use – kidney dialysis, invasive cardiovascular procedures and apheresis procedures. Patients receiving a dose of contaminated Heparin may experience:
- hypotension (blood pressure so low that there is insufficient blood flow to bodily organs)
- allergic reactions such as hives, swelling of the skin, or swelling of tissues beneath the skin
- nausea, vomiting, diarrhea
- stomach pain or discomfort
- chest pain
- dizziness or fainting
- shortness of breath
- the feeling of a strong or rapid heartbeat
- drug ineffectiveness
- burning sensation
- redness or paleness of skin
- abnormal sensation of the skin, mouth or lips
- increased sweating
- decreased skin sensitivity
- watery eyes
- throat swelling
- tendency to bleed
- difficulty opening the mouth
If you or someone you know has experienced any of these side effects, the attorneys at Oshman & Mirisola can help you evaluate your claim and seek compensation for any suffering or loss you have experienced.
Recalls and Public Health Advisories
On January 17, 2008 Baxter International Inc., which produces half of all Heparin products sold in the US, voluntarily recalled nine lots of heparin sodium injection multi-dose vials. Until then, all adverse events reported had been associated with those lots. In February, production of the heparin product was stopped at the factory in China where it was made, and on February 28, 2008 Baxter recalled the remaining supply of its heparin multi-dose, single-dose, and HEP-LOCK heparin flush products on the US market. By this time, the FDA had urged hospitals, medical care facilities, and other health centers to use non-Baxter heparin whenever possible.
Heparin Is a Life Saving Medicine
Now known as Heparin Sodium Injection, the heparin molecule was first discovered in 1916 at Johns Hopkins University. Researchers returning to it in the late 1920s spent many years developing its possibilities and creating a drug that could be produced in large quantities, inexpensive to buy, and safe for humans. More than safe, by the 1930s heparin was becoming an essential part of any serious surgery and had made breakthrough procedures such as open-heart surgery and organ transplants possible. The production process to produce the cheapest and most potent form of heparin was patented in 1949 and ever since then, Heparin has saved countless lives.
What Does Heparin Do?
Heparin is a powerful anticoagulant that works to stop dangerous blood clots from forming. Many people who receive Heparin suffer from a medical condition with a high risk for blood clots, or are undergoing a procedure for which it is critical that the blood be as thin as possible. Many catheters and other medical devices use coatings of heparin as well, to minimize the chances of clots forming inside them. Heparin is typically used for patients undergoing kidney dialysis, certain types of heart surgery, and other medical procedures in which there is a high chance that blood clots will form. It is these patients who have experienced the greatest number of serious reactions to the contaminated drug.
If You Have Been Hurt…
If you or someone you love has suffered from adverse side effects you believe were caused by contaminated Heparin, our qualified New York drug attorneys at Oshman & Mirisola can help you evaluate your legal options. A FREE CONSULTATION with one of our experienced litigators can make the difference between bringing responsible parties to justice or not. Please do not hesitate to call for a consultation today.