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The Risks of Heparin

We are No Longer Accepting Heparin Injury or Wrongful Death Cases.

Actor Dennis Quaid appeared on 60 Minutes to explain the heparin overdose that nearly killed his newborn twins.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.

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.

Baum Hedlund Files Contaminated Heparin Lawsuit

Heparin cases filed all over the country have been consolidated under Chief Judge James G. Carr in federal court in Toledo, Ohio. Judge Carr appointed several lawyers, including Baum Hedlund senior partner, Ronald L. M. Goldman, to the Plaintiffs’ Steering Committee (PSC). The PSC oversees the multi-district litigation (MDL) in the national heparin litigation against Baxter Healthcare Corp. and other heparin manufacturers.

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 in 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.

Attorney Ilyas Akbari Combines Bioengineering and Law in the Case Against Heparin.

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.

Since the recalls, the FDA reported on April 25, 2008 that possibly contaminated heparin is still being used by the public via medical products containing the blood thinner and is urging healthcare facilities and providers to identify and report adverse events related to these products.

The FDA extended its warning of heparin by posting a recall by Medtronic, Inc. on May 7, 2008 , which announced the company's initiation of a voluntary removal of selected heparin-coated products used during cardiopulmonary bypass that may have been contaminated with oversulfated chondroitin sulfate (OSCS), the contaminant found in heparin. These medical devices, featuring the Carmeda BioActive surface and used during heart surgeries, include blood oxygenators, reservoirs, pumps, cannulae and tubing packs.

This recall followed an April 8, 2008 recommendation by the FDA to device manufacturers that heparin supplies be checked for remains of the tainted blood thinner. The FDA also urges the public to report heparin-related adverse effects associated with the use of medical products that may contain or are coated with heparin to FDA’s MedWatch.


Provided by the FDA

November 6, 2008:  FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer

To date, 149 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.

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