Dennis Quaid and his wife sued the makers of heparin Tuesday after their newborn twins were inadvertently given massive doses of the blood thinner at a hospital.
The product liability lawsuit, filed in Chicago, seeks more than $50,000 in damages. It claims that Baxter Healthcare Corp., based in Deerfield, Ill., was negligent in packaging different doses of the product in similar vials with blue backgrounds. The lawsuit also says the company should have recalled the large-dosage vials after overdoses killed three children at an Indianapolis hospital last year.
The lawsuit was first reported by CelebTV.com, which obtained the court documents.
The company had not been served with the lawsuit and could not comment specifically on it, spokeswoman Deborah Spak said.
However, "this is not a product issue. The issue here is about improper use of a product," she said.
"While we strive to clearly differentiate our products and dosages, no amount of differentiation will replace the value of clinicians carefully reviewing and reading a drug name and dose before dispensing and administering it," she added.
This fall, the company changed its heparin packaging by adding a red caution label that must be torn off before the vial can be opened.
The Quaids' children, Thomas Boone and Zoe Grace, and a third patient were at Cedars-Sinai Medical Center on Nov. 18 when they were mistakenly given vials of heparin that were 1,000 times stronger than the usual dosage.
Cedars-Sinai said Tuesday the mistake occurred when two pharmacy technicians failed to verify the vials' concentration before placing them in the pediatrics unit where the lower-concentration heparin is kept. The nurses who administered the drug also failed to check the dosage, the hospital said in a news release.
The issued an apology to the patients' families and said it has made a series of changes to prevent a recurrence, including providing more training to staff and requiring four pharmacy workers to verify a "high-alert" medication before putting it in a patient care unit.
The twins were home Tuesday and "appear to be doing well," said Susan E. Loggans, the Chicago attorney who filed the lawsuit. "The Quaids are a religious family, and they really believe the prayers of the public saved their kids."
"Apparently, they're going to be fine now," she said but declined to otherwise comment on the children's medical conditions.
"The point of this case is to save other children from this fate. They're not looking for money," Loggans said of the lawsuit.
The Quaids didn't sue Cedars-Sinai, which acknowledged after the news broke that a "preventable error" had resulted in three patients receiving vials containing 10,000 units per milliliter of heparin instead of vials with a concentration of 10 units per milliliter.
The patients were receiving intravenous medications and the heparin was used to flush the catheters to prevent clotting.
Two of the patients needed a drug that reverses the effects of heparin, the hospital said at the time.
The hospital issued an apology to the patients' families, and said it would take "all steps" to prevent a recurrence.
The heparin was "unreasonably dangerous" as it was packaged and sold because both the small and large dosage vials had labels with blue backgrounds when the vials "should have been completely distinguishable (by) size and shape," the lawsuit argued.
A similar dosage error killed three premature infants at an Indianapolis hospital last year. Three others survived overdoses.
In February, Baxter Healthcare Corp. sent a letter warning health care workers to carefully read labels on the heparin packages to avoid a mix-up.
But the lawsuit by Quaid and his wife, Kimberly, argues that the company didn't do enough.
The company failed to recall the large-dosage vials after the infant deaths and repackage the drug, the lawsuit contends.
It said the manufacturer also should have issued an "urgent" warning to health care providers that required them to educate nurses and others about the problems and implement safety procedures.