Federal Probe to Examine Unsolved Heparin Contamination

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Federal investigators are requesting documents from a number of drugmakers in an attempt to identify the source of a 2008 heparin contamination incident believed to have killed nearly 150 people. Despite the fact that Baxter recalled Heparin shortly after the spike in adverse event reports was realized, the source that placed counterfeit ingredients in the medication still has not been identified. Side effects linked to Heparin include serious and potentially life-threatening allergic reactions, hypotension and drug ineffectiveness.

What’s the problem?

On June 29, 2011, the U.S. House of Representatives Committee on Energy and Commerce sent letters to a number of Heparin manufacturers requesting any documents that could help identify where the adultered ingredients could have originated. The letters were sent to the following pharmaceutical manufacturers, who were given until July 29 to respond:

  • Amphastar Pharmaceuticals
  • APP Pharmaceuticals
  • Drug Source Company LLC
  • Global Pharma Sourcing LLC
  • Momenta Pharmaceuticals
  • Pacific Rainbow International
  • Sagent Pharmaceutical
  • Sandoz
  • Sanofi Aventis
  • Siegfried USA, Inc.

It has long been rumored that the source of the contamination was most likely Chinese suppliers who were attempting to cut corners, but the House Committee has indicated that it demands more proof than that:

“There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain and pose a continuing threat to pharmaceutical products imported to the U.S.,” the letter warns. “It is important to determine how the adulteration happened so that industry and government can take more effective proactive measures to reduce the risk of such adulteration in the future.”

In January 2008, the U.S. Food & Drug Administration (FDA) announced that Baxter was recalling Heparin after a huge increase in severe allergic reactions were reported. Hundreds of cases of adverse events – including nearly 150 deaths – were reported to the FDA in connection with the contaminated Heparin.

The congressional inquiry comes on the heels of the first heparin lawsuit to go to trial in the United States. The claim resulted in a $625,000 claim for the family of Steven Johnson, who died in December 2007 after being treated with contaminated heparin. Johnson’s case was the first of some 300 similar cases consolidated under multi-district litigation (MDL) in Cook County Circuit Court.

Side Effects of Heparin

Heparin is a naturally-occurring anticoagulant produced in the lungs and liver. It may be administered as a medication to address blood clotting disorders such as thrombosis, typically in a hospital setting. Heparin can be extremely dangerous if it is used improperly or without supervision, and a number of precautions need to be observed when administering it to ensure that the drug does not cause complications in the patient. Individuals receiving a dose of contaminated Heparin may experience the following side effects:

  • hypotension (blood pressure so low that there is insufficient blood flow to bodily organs)
  • allergic reactions
  • hives
  • swelling of the skin
  • swelling of tissues beneath the skin
  • nausea
  • vomiting
  • diarrhea
  • stomach pain or discomfort
  • chest pain
  • dizziness
  • 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
  • flushing
  • increased sweating
  • decreased skin sensitivity
  • headache
  • restlessness
  • watery eyes
  • throat swelling
  • thirst
  • tendency to bleed
  • difficulty opening the mouth

The Heparin injury lawyers at Schmidt & Clark, LLP are currently investigating potential lawsuits on behalf of people who have been injured by Heparin. If you or someone you know has experienced any of the side effects listed above, our attorneys can help you evaluate your claim and seek compensation for any suffering or loss you may have experienced.

Do I have a Heparin Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Heparin lawsuits. We are handling individual litigation nationwide and currently accepting new Heparin cases in all 50 states.

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