|Death toll, lawsuits mount over tainted heparin. Source: Zaz Report|
Baxter Healthcare, a Baxter International company, is facing at least five personal injury or wrongful death lawsuits over a patient's reaction to contaminated heparin, and more are sure to follow as the FDA reports that the number of deaths attributed to the tainted product have reached 103.
On its website, the FDA said that from January 2007 through March of this year, it received 107 reports of deaths in patients who had taken heparin, 91 of which were reported to the agency on or after Jan. 1 of this year. Of those deaths, 62 reports of death that included one or more allergic symptom(s) or symptoms of hypotension, 56 were reported to FDA on or after Jan. 1, 2008. Karen Riley, an agency spokesperson, noted that the regulator raised the total number of deaths reported from 19 last month, after reviewing new information.
Riley also said that the symptoms seen in the 62 deaths were consistent with those that led Baxter to recall its heparin product in the U.S. earlier this year. Yet, the agency cannot say how many of the deaths occurred in patients who took Baxter's version of heparin, and added that the FDA has not yet concluded whether the deaths were due to a contaminant recently identified in Baxter's product.
In the meantime, a personal injury suit, filed in a New Jersey federal court by law firm Lieff Cabraser Heimann & Bernstein, alleges that a patient experienced a “near fatal reaction” from the drug. The complaint charges Baxter with selling a defective product due to contamination and inadequate inspection. The suit asks for damages for physical and medical expenses, as well as punitive damages to deter Baxter from future wrongdoing.
The Chicago Tribune reported that a wrongful death suit was filed in Cook County Circuit Court by Mark Scott of Davenport, Iowa, whose wife died at home on Nov. 30, 2007 during kidney dialysis. Scott is accusing Baxter of selling defective heparin that caused his wife’s death.
“No patient deaths have been confirmed by medical or epidemiological evaluation by Baxter or [the FDA] to have been caused by the allergic-type reactions associated with the current heparin recall," Baxter spokesperson Erin Gardiner told the Chicago Tribune. "None of these suits includes any credible medical information to allow the company to medically evaluate these claims."
Baxter said it will defend itself against the five new lawsuits by plaintiffs, which allege that they have been harmed by the Deerfield, Ill.-based company’s heparin.
The FDA is investigating whether heparin is connected to deaths and serious illnesses since Jan. 1, 2007, according to the Chicago Tribune. Baxter said that only four deaths may be connected to adverse reactions to heparin.
The suspect active ingredient originated at a plant in Changzhou, China, owned by Scientific Protein Laboratories, a Baxter supplier based in Waunakee, Wis. Last month, the FDA disclosed that low-cost animal cartilage made its way into Baxter's heparin but has not determined a specific link to allergic reactions, according to the Chicago Tribune.
Heparin is administered to millions of U.S. patients to prevent blood clots during medical procedures.