Dennis Quaid Sues Baxter Healthcare over Heparin OverdoseDec 5, 2007 | Parker Waichman LLP
A heparin overdose that endangered the lives of Dennis Quaid's infant twins has prompted the actor and his wife to sue Baxter Healthcare for negligence. The Quaid twins were two of three children who were mistakenly given 10,000 units of heparin instead of the normal 10 units given to babies while they were patients at the Cedars-Sinai Medical Center in Los Angeles in November.
Heparin comes in 10 unit vials for babies and vials up to 10,000 units for adults. The babies were dosed from 10,000 unit vials twice and began to bleed out before being transferred to the Cedars Sinai neo-natal intensive care unit where they were given protamine sulfate to reverse heparin's effects. The Cedars-Sinai hospital's protocol is to keep the different units separated, but a technician accidentally put the 10,000 unit vials in the drawer where the 10 unit vials were stored.
The Food & Drug Administration (FDA), in collaboration with Baxter Healthcare Corporation, issued a two-page safety alert last February warning of the fatal dangers of mistaking the high 10,000 unit and low 10 unit dose vials of heparin. The memo advised hospitals to double-check their inventory to ensure dispensing errors do not occur. Cedars-Sinai Medical Center was among the recipients of the FDA alert.
The 2007 alert was issued after three infants died in Indiana after they were mistakenly given adult doses. In addition to the Quaid twins, at least six newborns and two other patients are known to have received an overdose of heparin since 2001. The mother of one of those children has said that her child is still suffering long-term affects from a heparin overdose and, at 15 months, is not doing everything other children his age are and should be doing. An attorney representing two families affected by previous overdoses as a result of labeling mix-ups says that these are not new problems and will likely continue, as human error is inevitable given the similar labeling on the two sizes of heparin vials.
The Quaid suit accuses Baxter Healthcare of failing to put clear distinguishing labels on its 10-unit and 10,000-unit vials of heparin, and failing to recall the product after the three other infants died because of a mix-up. The complaint filed in Cook County Circuit Court, Illinois, said both the small and large doses of heparin had similar blue background labels. It also accused Baxter Healthcare of failing to recall or repackage the 10,000 unit vials "when it had actual knowledge that prior infant deaths had occurred as a result of medication errors." The Quaids are seeking at least $50,000 in damages.