Dozens of people have filed a class-action lawsuit against the maker of the popular blood thinner Heparin, accusing the company of using a new, unapproved ingredient in the drug, causing widespread patient deaths and serious injuries.
Baxter International, the maker of Heparin, is accused of substituting the typical active ingredient for the drug derived from enzymes found in pig intestines with over-sulfated chondroitin sulfate (OSCS), a molecule which can mimic the enzyme and is far cheaper to make. The switch occurred sometime during 2007, the lawsuit alleges.
Beginning in January 2008, after reports of deadly, adverse reactions to people being administered Heparin were received, the Food and Drug Administration ordered recalls of the drug. More than 100 deaths and hundreds of injuries have been linked to adverse allergic reactions to the counterfeit Heparin.
Attorneys for the 28 plaintiffs now suing the company allege Baxter put earning higher profits on the drug ahead of ensuring patient safety.
Cheaper Ingredient Led to Injuries
Baxter made Heparin using enzymes collected by cooking intestines from slaughtered pigs. Once the cooked intestines are dried, a granular substance called crude Heparin can be harvested from the intestines and processed into the drug.
However, Baxter eventually discovered that a molecule called OSCS was a far cheaper ingredient which could mirror the actions of crude Heparin. About 3,500 pig intestines were needed to produce 2.2 pounds of crude heparin at a cost of about $900, but the same amount of OSCS could be produced for just $9, according to the lawsuit.
OSCS is not approved for use in the United States and led to the severe adverse reactions in people who suffered serious injuries or died after using Heparin containing the ingredient, the lawsuit alleges.
Chinese Manufacturing Firm Blamed
While Heparin is manufactured in China and in Wisconsin, the contaminated active ingredient is suspected of having been supplied by the Chinese facility. That facility was not properly inspected or regulated by the FDA, allowing the counterfeit active ingredient to be included in Heparin doses.
When inspectors did visit the plant after the Heparin injuries had been reported, they found inadequate record-keeping, manufacturing standards, and other problems, the suit alleges. Baxter is accused of allowing the contaminated Heparin to be used in the United States, in violation of laws and FDA regulations.
“The Recalled Heparin was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended uses,” the suit states. “Baxter placed tens of thousands of patients, including the Plaintiffs, at unnecessarily risk of serious injury and/or death.”
The class-action plaintiffs are seeking unspecified damages in excess of $300,000 plus costs and other relief deemed proper. The suit is filed in St. Clair County (Illinois) Circuit Court.