Heparin is widely used as an injectable anticoagulant. It is used for preventing the formation of clots and extension of existing clots within the blood. It is used to treat conditions including:
- Acute coronary syndrome, e.g., myocardial infarction
- Atrial fibrillation
- Deep-vein thrombosis and pulmonary embolism
- Cardiopulmonary bypass for heart surgery
In March 2008, major recalls of heparin were announced by the U.S. Food and Drug Administration (FDA) due to concerns about contamination of the raw heparin stock imported from China. The FDA received reports of serious reactions, including deaths, in patients who were undergoing dialysis.
An FDA investigation revealed that batches of heparin used during the dialysis process manufactured in China were contaminated with oversulfated chondroitin sulfate (OSCS).
Pharmaceutical grade heparin is derived from mucosal tissues of slaughtered meat animals, such as pig intestine or cow lung. While heparin goes through extensive processing from the raw stage before it is cleared for medical use, if there’s a problem with the final medication, it can be nearly impossible to trace the raw heparin back to the source.
In 2009, largely as a result of the heparin scare, the FDA began developing programs in response to concerns that many drug manufacturing companies in developing countries are not inspected, which increases the risk that dangerous or ineffective drugs may be imported into the United States.
The FDA has taken measures to keep dangerous versions of heparin out of the United States, including banning some Chinese manufacturers and asking all FDA-approved makers of heparin to test for OSCS. The agency also opened satellite offices in other countries so that regular inspections of these plants could be conducted.
In August 2013, the FDA implemented a new pilot program designed to crack down on the import of contaminated, misbranded or unapproved drugs into the United States.
The Secure Supply Chain Pilot Program will help ensure the safety of drugs manufactured outside the country, but will also help qualified drug companies in the program by expediting their approval processes so that the agency can focus on drugs not in the program that may need closer inspection to ensure safety.
Beasley Allen’s team of dedicated mass torts attorneys handles cases involving dangerous drugs, like heparin, and defective medical devices, on behalf of individual plaintiffs who suffered injury or lost a loved one as a result of these products. We have successfully handled thousands of defective drug and device claims, and recovered more than $21 billion in verdicts and settlements for our clients.
If you have suffered a serious injury or lost a loved one as a result of a dangerous drug or defective medical device, we would like to talk to you. Fill out the brief questionnaire or call us toll free at 1-800-898-2034 for a free, no-obligation legal evaluation of your claim.