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Baxter Heparin Lawsuit History

Defective Heparin lawsuits, a blood thinner manufactured by Baxter Healthcare, will finally go on trial in November 2010. According to the FDA, the recalled batches of Heparin killed at least 81 people from late 2007 to early 2008, and they caused injuries and sickness to hundreds more.

The drugs caused severe allergic reactions because one of the component ingredients was replaced by over-sulfated chondroitin sulfate. That ingredient mimics the properties of Heparin. It was obtained by Baxter from a Chinese supplier, and that supplier’s facilities were determined to be deficient by the FDA. Furthermore, evidence obtained in discovery shows that the chondroitin sulfate was intentionally used as a cheaper alternative, despite the life-threatening injuries it can cause.

The Heparin lawsuits are consolidated in an MDL in the U.S. District Court for the Northern District of Ohio, and case selection will start around May 2010.

This post – some of it written in 2023 – is a look back on the Baxter heparin lawsuits and what came out of this tragedy and this litigation.

History of the Baxter Heparin Lawsuits

In early 2008, reports began to emerge that patients who had been administered Baxter’s heparin were experiencing severe allergic reactions and even death. An investigation revealed that the heparin had been contaminated with a substance called oversulfated chondroitin sulfate (OSCS), which can cause severe reactions in patients.

What Is Oversulfated Chondroitin Sulfate?

Oversulfated chondroitin sulfate (OSCS) is a synthetic form of chondroitin sulfate, a substance that is found in the connective tissue of animals, including cows and pigs. OSCS has a similar molecular structure to heparin, a naturally occurring anticoagulant used in medical procedures to prevent blood clots.

In the case of the Baxter heparin contamination scandal, OSCS was used as a cheaper substitute for heparin in the production of the drug. However, oversulfated chondroitin sulfate has been found to cause severe allergic reactions and even death in patients who are administered the drug. It is believed that the oversulfated chondroitin sulfate was intentionally added to the heparin in China, where much of the heparin used in the United States was produced.

Oversulfated chondroitin sulfate is not approved by the FDA for medical products, and its use in producing heparin was a significant contributing factor to the contamination of the drug. As a result of the contamination scandal, the FDA has implemented more rigorous testing and oversight procedures for producing and distributing heparin and other anticoagulants.

Baxter Heparin Recall

Baxter recalled its heparin products in February 2008, and the company faced many lawsuits from patients and their families affected by the contaminated heparin. The lawsuits alleged that Baxter was negligent in its production and testing of the heparin and failed to warn patients and healthcare providers about the risks associated with the contaminated heparin.

DOJ Settlement

In addition to the lawsuits, Baxter also faced investigations by the FDA and the DOJ over handling the heparin contamination. In 2012, Baxter agreed to pay $67 million to settle a lawsuit brought by the DOJ over its marketing and distribution of the contaminated heparin. The settlement included $46.5 million in civil fines and forfeiture, as well as $20 million in criminal fines. Baxter did not admit any wrongdoing as part of the settlement. But c’mon.

Chinese Pharma Under a Microscope

There have been growing concerns about the safety and quality of pharmaceutical products produced in China, which is one of the world’s largest producers of active pharmaceutical ingredients (APIs) and finished pharmaceutical products.

The heparin contamination scandal increased scrutiny of the pharmaceutical industry’s manufacturing practices, particularly in China, where much of the heparin used in the United States was produced. The incident highlighted the need for greater transparency and oversight in the global pharmaceutical supply chain.

China is a prominent supplier of crude heparin because – besides being a big supplier of most everything – it has a vast supply of pigs. Chinese pig farms extract and process the intestines collected by consolidators who, in turn, sell them to manufacturers.

The Chinese government is with us on this.  They want safe products coming to the U.S., too. The Chinese government has introduced new regulations for the production and distribution of APIs and finished pharmaceutical products after this debacle and has also established a national drug regulatory authority to oversee the industry.

Baxter Heparin Lawsuit Settlement

n 2011, the federal judge overseeing the consolidated class-action lawsuit against Baxter International over the contaminated heparin rejected a proposed $50 million settlement, ruling that the amount was inadequate. The judge also criticized the proposed settlement for not providing enough money to compensate individual plaintiffs and failing to provide an adequate plan for distributing the settlement funds.

After the rejection of the proposed settlement, the case continued to move forward in the court system, where some cases went to trial and most settled.