Heparin Recall and Litigation

Problems with heparin have prompted an FDA recall and numerous lawsuits over the anticoagulant drug.

By , Attorney

The anticoagulant drug heparin made by Baxter Healthcare has been plagued by problems over the past few years. In 2008 the U.S. Food and Drug Administration (FDA) ordered a recall of heparin after finding that contaminants in the drug caused severe injury and death in a number of patients. Lawsuits also allege that Baxter's confusing packaging led to heparin overdoses in infants and small children, also causing injury or death.

Here's what you need to know about the heparin recall and litigation.

What Is Heparin?

Heparin (also known as heparin sodium) is an anticoagulant, or blood thinner. Because blood thinners make it harder for blood to clot, doctors use them to treat and prevent blood clots in veins, arteries, and lungs.

Heparin comes in liquid form and is usually injected into a vein, under the skin, or by way of an intravenous catheter. In some instances, doctors use large multiple-dose vials of intravenous heparin (called bolus doses) in order to thin a patient's blood over a short period of time. Heparin is also used to coat some medical devices, such as lock flushes (used to clear IV lines and catheters), catheters, and oxygenators.

Prior to 2008, Baxter Healthcare manufactured about half of the heparin available in the United States. The other big heparin manufacturer is APP Pharmaceuticals.

The FDA Recall of Baxter's Heparin

Beginning in around 2006, patients and physicians reported an increase in severe allergic-type reactions to bolus doses of Baxter's heparin. Those reactions -- which caused a number of patient deaths -- included:

  • extreme nausea
  • vomiting
  • breathing difficulty
  • excessive sweating, and
  • decreased blood pressure.

In January and February 2008, Baxter and the FDA recalled almost all Baxter heparin products from the market. Later investigation revealed that Baxter's heparin contained a contaminant that caused the adverse reactions in patients. The contaminant, known as oversulfated chondroitin sulfate, was supplied by a Chinese firm, Changzhou SPL. Oversulfated chondroitin sulfate mimics the biological activity of heparin, but is less expensive.

According to some reports, the contaminated heparin killed 81 people and sickened hundreds more.

Litigation Regarding Contaminated Heparin

Even before the FDA ordered the heparin recall, plaintiffs were filing lawsuits against Baxter Healthcare because of patients' adverse reactions to bolus doses. The FDA recall served to spur on new heparin litigation. The lawsuits allege that heparin bolus doses caused some patients to get sick or die. The lawsuits raise several theories of liability:

Negligence. Plaintiffs argue that Baxter had a duty to ensure that heparin was safe and failed to fulfill that duty by not adequately monitoring or testing the drug for contaminants or adverse side effects.

Product liability. Plaintiffs argue that Baxter knew or should have known that the heparin was defective, but manufactured, marketed, and supplied it anyway. (To learn more about the elements of a product liability claim, see Nolo's article Product Liability Claims Involving Pharmaceutical Drugs.)

Strict product liability. In strict liability, a manufacturer is held liable for injuries caused by a defective drug regardless of how careful the manufacturer was in producing or marketing the drug. Plaintiffs in the heparin lawsuits argue that Baxter's heparin was defective because of the contaminant and because it caused such severe side effects.

Fraud. Plaintiffs argue that Baxter or Changzhou SPL knew the contaminant might be dangerous, but used the cheaper ingredient to dilute heparin sodium in order to increase profits. Plaintiffs allege that Baxter misrepresented the safety of heparin in its marketing of the drug.

Breach of warranty. Plaintiffs allege that Baxter's heparin was not fit for its intended purpose.

For in-depth information on any of these legal theories, see Nolo's article Defective Product Claims: Theories of Liability.

Multidistrict Litigation for Heparin Contamination Lawsuits

In the summer of 2008, all of the federal heparin lawsuits (more than 50 in number) were transferred to the U.S. District Court in Toledo, Ohio, becoming part of multidistrict litigation (MDL) coordinated by Judge James G. Carr. In multidistrict litigation, cases involving similar issues of fact are transferred to one court for pretrial and discovery proceedings (the process where each side finds out everything they can about the other side's case). Once that process is finished, attorneys will try the heparin cases in Judge Carr's court or in the court where the case was originally filed. The first trial coming out of the MDL is scheduled for November 2010. (To learn more about multidistrict litigation, see Nolo's article Multidistrict Litigation (MDL) for Drug Lawsuits and Other Cases.)

Heparin Overdoses in Children

In the last four years, a number of children have died or been injured because hospitals unintentionally gave them massive overdoses of heparin. Some parents sued Baxter, alleging that it was at fault for the dosing errors because it packaged adult and pediatric versions of heparin in vials of the same size and with nearly identical blue backgrounds, so that hospitals had difficulty distinguishing between the two. Parents also claimed that although Baxter agreed to change the labeling, it did not recall the existing stock of pediatric heparin.

In addition to suing Baxter under product liability theories, plaintiffs in these types of lawsuits over heparin might also sue the doctor, hospital, or pharmacy for medical malpractice.

Getting Help

The legal and medical issues in heparin cases are usually sophisticated and complex. Depending on your case, you may want to hire a lawyer who specializes in products liability cases. You may also consider joining an existing class action lawsuit, if there is one. (To learn more about class actions, see Nolo's article Product Liability Claims Involving Pharmaceutical Drugs.) For help with choosing a good personal injury attorney, read Nolo's article Finding a Personal Injury Lawyer or go to Nolo's Lawyer Directory for a list of product liability attorneys in your geographical area.

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