TEXARKANA, Texas -- While in Bowie County, Tracey Underwood believes she was given multiple vials of contaminated heparin and as a result developed superior vena cava syndrome.
Alleging the drug was intentionally contaminated to raise profits, California residents Tracey and Brian Underwood filed suit against Baxter Healthcare Corp., Baxter International Inc. and Scientific Protein Laboratories on Sept. 28 in the Texarkana Division of the Eastern District of Texas.
The suit states that the Underwoods are citizens of the state of California, and that between Oct. 27, 2007, and March 7, 2008, plaintiff Tracey Underwood was administered multiple vials of heparing while in or near Bowie County, Texas.
Heparin is an anticoagulant used to prevent the formation of clots and expansion of existing clots.
Baxter produces heparin using the active pharmaceutical ingredient manufactured by Scientific Protein Laboratories in North America and China.
According to the complaint, Baxter began recalling lots of its heparin sodium injection in January 2008. In February 2008, Baxter was notified of additional adverse patient reactions related to other non-recalled lots of its drug.
By the end of that month, Baxter had recalled all remaining lots its heparin products. Shortly thereafter, it was discovered that the drugs were contaminated with a "heparin-like molecule," identified as over-sulfated chondroitin sulfate.
The contaminant is not ordinarily found in nature, is not a U.S. approved drug and should not be found in heparin, according to the lawsuit.
"Upon information and belief, the contaminant was intentionally introduced to dilute or to substitute the active pharmaceutical ingredient for heparin for the purpose of profit," the complaint states.
The plaintiffs allege that the contaminant was used to dilute or to substitute heparin's active pharmaceutical ingredient because it has heparin-mimicking characteristics.
Tracey Underwood claims that because the substituted drug did not provide her the same health benefit as heparin, she developed superior vena cava syndrome, a condition caused when a large vein in the chest is compressed resulting in restricted blow flow. The increased pressure in the veins causes fluid build-up in the face and arms.
The lawsuit alleges that the defendants are negligent for failing to disclose the test results of the contaminated heparin, failing to act reasonably to recall the drugs and failing to act as a reasonably prudent drug manufacturer.
Causes of action filed against the defendants include negligence, manufacturing defect, and design defect, breach of implied and express warranties.
The plaintiffs are seeking damages for medical expenses, loss of consortium, physical pain and suffering, mental distress, lost income and loss of earning capacity, punitive damages, pre and post judgment interest.
Attorney Maria Wormington of the Wormington Law Group PLLC in McKinney is representing the Underwoods.
The plaintiffs are requesting a jury trial.
U.S. District Judge David Folsom will preside over the litigation.
The case will be transferred to multidistrict litigation- 1953 in the Northern District of Ohio for pretrial proceedings.
Case No 5:09cv00139