Family's suit claims mother died from contaminated Heparin

TEXARKANA, Texas � The family of deceased Debra Spivey has filed suit against the manufacturers and distributors of the blood thinning drug Heparin alleging the drug was contaminated. The family claims that after Spivey was injected with the drug, she suffered a brain hemorrhage and died.

The Spivey family filed the product liability suit against Baxter International, Scientific Protein Laboratories and American Capital Strategies on May 12 in the Marshall Division of the Eastern District of Texas.

According to the court records, Heparin is an anticoagulant used to decrease the blood's clotting ability. Baxter is the one of the largest producers of the drug, with annual sales of approximately $30 million per year. Mainly manufactured in Chinese facilities by Scientific Protein Laboratories, the drug's active ingredient is made from pig intestines.

In February, Baxter announced that it had temporarily stopped manufacturing and suspended the sale of the drug due to reports of serious allergic reactions. The reactions to Heparin included difficulty breathing, nausea, vomiting and rapidly falling blood pressure. By March, the FDA was reporting 21 fatalities and 785 adverse reactions to the drug.

The FDA also reported that "a contaminant had been found in the active ingredient" and that the contaminant was present in large quantities. Further, the report stated that the contaminant was an "inexpensive, unapproved ingredient altered to mimic the real active ingredient."

According to the plaintiffs' complaint, Baxter reported that the "questionable Heparin" was made from a Chinese raw ingredient. The New York Times is reporting that the contaminant is an altered form of a supplement used to treat joint pain, chondroitin sulfate.

The Spivey family is accusing the defendants of product liability, negligence, negligence per se, defective design, manufacturing defect, failure to warn, breach of implied and express warranties and violation of the Texas Deceptive Trade Practices Act.

Specifically, the plaintiffs accuse the defendants of failure in the manufacture, inspection, packaging, and warnings regarding the drug. In addition, the plaintiffs believe the drug's manufacturers failed to disclose or report adverse events, failed to promptly recall or respond to reports, failed to implement post-marketing measures to notify the medical community of Heparin's risks.

The complaint also accuses the defendants of failing to establish or ensure adequate quality controls, failing to ensure compliance with laws and regulations, and otherwise negligence and carelessness.

The plaintiffs are seeking wrongful death and survival damages for the deceased's physical injuries, conscious pain and suffering, medical care and treatment and for the family's pecuniary losses.

The Spiveys are also seeking treble and punitive damages, costs of suit and attorney fees.

Longview attorney Douglas C. Monsour of the Monsour Law Firm is representing the plaintiffs.

According to the Monsour Law Firm Web site, Doug Monsour is currently serving as lead lawyer in a large group of Fen-Phen cases against American Home Products/Wyeth involving heart valve damage and pulmonary hypertension caused by the diet drugs Pondimin and Redux. He is also representing numerous Vioxx victims against Merck, Zyprexa victims against Eli Lilly, and Bextra Victims against Pfizer.

In 2004, Monsour served as lead lawyer in two very significant Fen-Phen cases against pharmaceutical giant Wyeth.

"In the first case, Wyeth hired world famous defense lawyer Dan Webb of Chicago's legal giant Winston & Strawn to defend them," the Web site states. "In the third week of the trial, Wyeth relented and settled for a confidential sum. In the second case, Wyeth retained Houston mega-firm Vinson & Elkins to defend them. Wyeth relented again just before closing arguments, and settled for a confidential sum."

U.S. District Judge David Folsom is assigned to the Spivey litigation.

Case No. 2:08cv00199