The family of an east Texas man who allegedly died after taking a contaminated blood thinner has filed a lawsuit against the drug's manufacturers and the medical facility where the drug was administered.
According to the suit filed Dec. 30, Lloyd James Robinson was administered heparin during treatment at the Lufkin Dialysis center. Robinson then suffered a hypersensitivity-type adverse reaction and died, the suit claims.
Heparin is an anticoagulant, commonly referred to as a blood thinner, which is 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.
Alleging that the facilities in China where the drug was manufactured did not meet U.S. regulations, Fabiree Robinson, individually and as estate representative of Lloyd James Robinson, and his heirs, Cassandra Robinson, Deanna Brooks and Leona Runnels, filed a product liability lawsuit in the Beaumont Division of the Eastern District of Texas.
Other defendants include Changzhou SPL Co., American Capital, B. Braun Medical, Tyco Healthcare Group, Covidien Inc., Medefil Inc., Becton, Dickinson and Co., Rental Treatment Centers-Southeast and Davita Inc.
According to the complaint, the defendants began recalling only lots of its heparin sodium injection in January 2008 due to reports of reactions. After an additional notification of adverse patient reactions in February 2008, Baxter recalled all remaining lots of its varying heparin products.
Shortly after the recall, the U.S. Food and Drug Administration discovered that the drugs were contaminated with a "heparin-like molecule," identified as over-sulfated chondroitin sulfate. The contaminant accounted for 5 to 20 percent of the total mass of the each sample tested.
Defendant Changzhou SPL Co. operated a facility in China for manufacturing the active ingredient in heparin and obtained its crude heparin from two Chinese wholesale suppliers. In turn, those suppliers obtained the crude heparin from multiple small family owned workshops that process and extract crude heparin from pig intestines.
Although required by U.S. law, the Chinese plants and workshops were not inspected or approved by the FDA.
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 strict liability, fraudulent concealment, negligence, breach of implied and express warranties, intentional and negligent infliction of emotional distress, health care liability claim, wrongful death and survival action claims.
The plaintiffs allege that the DaVita Lufkin Dialysis center, where Robinson was treated prior to his death and where he was administered the allegedly contaminated heparin, had an "immediate jeopardy" situation, putting patients at risk as determined by the Texas Department of State Health Services.
The complaint states the center was closed down as a result of this finding and ordered to comply with corrective actions. After making changes in patient care and regulatory compliance, the center reopened after being closed more than nine weeks.
The plaintiffs are seeking damages for medical and hospital expenses, loss of income, physical and mental pain and suffering, loss of enjoyment of life, funeral and burial expenses, pecuniary losses, loss of advice and counsel, loss of services, loss of inheritance and loss of companionship and society.
Houston attorneys David J. Van Susteren and Veronica H. Foley are representing the plaintiffs.
The case will be transferred to multidistrict litigation 1953 in the Northern District of Ohio for pretrial proceedings.
The plaintiffs are requesting a jury trial.
U.S. District Judge Thad Heartfield will preside over the litigation.
Case No 1:09cv01037