The maker of cardioplegia, a drug used in heart bypass surgery, has agreed to settle four wrongful death lawsuits for more than $5.5 million. The lawsuits, involving patients who were administered tainted cardioplegia at Mary Washington Hospital in Fredericksburg, VA, were actually settled last year, but Central Admixture Pharmacy Services and its parent company, B. Braun Medical, had fought in court to keep the settlement amounts confidential.
Cardioplegia is a drug solution that paralyzes the heart during cardiac surgery. Over an eight-day period in the summer of 2005,three cardiac surgery patients who had been administered the drug at Mary Washington Hospital developed a dangerous inflammation within hours of their operations. One of the patients would die on September 3.
The hospital shut down its cardiac surgery program the next day and called state health officials, who brought in the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC). Within days, the FDA and the CDC confirmed the presence of several types of bacteria in opened and unopened bags of cardioplegia.
The hospital later determined that at least 11 cardiac surgery patients were stricken during a 10-month period from the end of December 2004 to September 2005, and three died.
In March 2006, the Maryland State Board of Pharmacy reported that the Lanham, Md. Central Admixture plant were the cardioplegia had been manufactured was contaminated by bacteria. The report described “significant” violations of U.S. pharmacy regulations at the facility, and said “there was no assurance of sterility” of any of the products manufactured at the plant.
In all, 10 patients or their families filed lawsuits against Central Admixture and B. Braun in Spotsylvania Circuit Court, beginning in 2006. Nine of the cases have been settled, and one is pending.
Last year, a judge in Spotsylvania County Circuit Court approved four of the settlements, but the terms were not disclosed. But the Fredericksburg Free Lance-Star and the Richmond Times-Dispatch successfully filed suit requesting that the terms be made public.
According to the Times-Dispatch, the unsealed documents showed that the four settlements ranged from $1.15 million to $1.9 million. One involved a $600,000 payment and then a series of payments over the next 12 to 20 years to three survivors totaling an additional $652,000.
These, combined with earlier payments, push the total paid by Central Admixture Pharmacy Services and its parent company, B. Braun Medical, to more than $6 million. Two settlements were disclosed earlier and were not among the settlements revealed this week. Those payments, in the amount of $249,000 and $108,000, went to survivors of deceased patients. The company also made undisclosed payments to three patients who survived their surgeries but claimed injuries.
Despite the settlements, neither Central Admixture nor B. Braun has admitted any wrongdoing in the cardioplegia contamination.
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