Baum, Hedlund, Aristei & Goldman is representing victims for their injuries caused by the anticoagulant drug heparin, a blood thinning drug commonly administered intravenously. Serious injuries and deaths have been associated with the use of heparin, which contains an active pharmaceutical ingredient (API) from China. The adverse reactions have included allergic or hypersensitivity-type reactions, with symptoms such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea, and abdominal pain.

 

Contact Baum Hedlund today for a free consultation about your Heparin case.

 

Heparin is used to prevent blood clots among patients who have certain medical conditions. Heparin is commonly used before certain types of surgery, including coronary artery bypass graft surgery, and in kidney patients before they undergo dialysis. In some situations, heparin treatment is initiated using a high bolus dose given directly into the bloodstream (intravenously) over a short period of time, usually less than one hour.  Also, heparin pre-filled syringes are used to flush peripherally inserted central catheter lines (“PICC lines”) and implantable ports, sometimes called portacaths or subcutaneous ports.  The reported adverse events occurred in patients who were given heparin in this form of administration.

In February 2008, Baxter Healthcare Corporation recalled multi-dose and single-dose vials of heparin sodium for injection as well as HEP-LOCK heparin flush products after a reported 19 deaths were linked to the drug.  Since then, the death toll associated with Heparin has increased to 131, with over 80 of the deaths directly associated with the same side effects that prompted the recall. 

Baxter was not the only manufacturer to voluntarily recall heparin products.  Throughout March of 2008, a number of manufacturers, including American Health Packaging, B. Braun Medical, Inc. and Covidien, Inc, recalled the contaminated anticoagulant. 

After launching a far-ranging investigation, FDA scientists identified the contaminant as a modified form of chondroitin sulfate.  This chemical, a compound normally used to treat arthritis, was never been approved for use in prescription medication sold in the US.  The chemical eluded discovery since it so closely mirrored the main ingredient found in heparin, sharing some of the same blood-thinning properties.  By mimicking the appearance and properties of the rightful ingredient, the contaminant was able to pass routine quality tests. In an unrelated and strangely coincidental incident, a bacterial contaminant was found in AM2PAT pre-filled heparin syringes.  These syringes were distributed and subsequently recalled by AM2PAT, Sierra Pre-Filled Inc., and B. Braun.

Tainted heparin has been found in more than a dozen countries since Baxter's recall.  Regulators have said they don't know how the contaminant was introduced, but they now believe that Baxter’s heparin lots were intentionally contaminated to increase profit.
           
Regulators believe the contaminant originated China, where the raw material used to make heparin is found. The Chinese production plant, owned by Scientific Protein Labs (SPL) in Changzhou, China, has recently come under fire since it was never certified by China’s drug regulators.  The facility was also never inspected by the FDA, an oversight that caused heavy criticism amongst lawmakers and warranted an overdue inspection of the facility by the agency.

The heparin saga is one of many high-profile safety lapses by the FDA and lawmakers are taking notice.  During an April 29 hearing of the House Energy and Commerce subcommittee on oversight and investigations, testimonies from experts, Baxter, the FDA, Chinese authorities and family members of those killed by the contaminant were heard.  Many concluded that the FDA is underfunded and mal-equipped to properly inspect foreign facilities.

To date, 81 Americans have died because of the contaminated blood thinner and as many as 1,000 have suffered injuries.

Baum, Hedlund, Aristei & Goldman has experience litigating personal injury and wrongful death cases against Baxter Healthcare Corporation, one of the manufacturers of heparin. Considered at the time, one of the worst drug-related medical disasters in history, Baum Hedlund represented more than 100 families of hemophiliacs against several pharmaceutical companies, including Baxter, who were infected with the AIDS virus by their contaminated blood-derived medications.