Back to Pharmaceutical Liability

Dennis Quaid and wife Kimberly recently filed a lawsuit against the a blood-thinner manufacturer Baxter Healthcare, saying the labeling and design of the product led to a massive overdose of their newborn twins last month at Cedars-Sinai Medical Center.

The Quaids' babies twice were given 1,000 times the intended dosage of heparin on November 18.

Nurses twice mistakenly administered heparin with a concentration of 10,000 units per milliliter instead of 10 units per milliliter, the family's lawyer said. Another newborn was also given the wrong dose of the medication, often used as a flush to prevent blood clots around intravenous catheter sites.

All three children have since been released from the hospital, which said they suffered no adverse health effects.

In a prepared statement, the hospital said a pharmacy technician took the heparin from the pharmacy's supply without having a second technician verify the drug's concentration, as hospital policy requires. Then, when the heparin was delivered to a satellite pharmacy that serves the pediatrics unit, a different technician there did not verify the concentration, as required.

Finally, the nurses who administered the heparin to the patients violated policy by neglecting to verify that it was the correct medication and dose beforehand.

Heparin is one of the most frequently used medications in the U.S., according to Pharmacopeia, which operates a medication error and adverse drug reaction reporting program. Between 2001 and 2006, more than 16,000 heparin errors were blamed on incorrect dosing, according to Pharmacopeia.

In their pharmaceutical liability lawsuit the Quaids contend that Baxter Healthcare Corporation knew that other babies had died as a result of similar errors involving heparin, but did not recall the high-concentration vials. The lawsuit also faults Baxter for using similar background colors on the labels of both the high and low concentration vials, despite the possible confusion of dose amounts.

Baxter Healthcare would not comment on the lawsuit because it had not been served.

Last year, three infants in Indiana died after a heparin overdose nearly identical to that at Cedars-Sinai. Months later, Baxter issued a warning, citing "the potential for life-threatening medication errors involving two heparin products."

In October, Baxter altered the label on high-concentration heparin vials, changing the background color, increasing the font size, and adding a "red alert" label. Cedars-Sinai was still using the old vials when its errors occurred.

Baxter is one of several companies that make heparin. Given the confusion over the similar heparin vials, the drugs probably should have been recalled, said Kasey Thompson, director of the patient safety and quality division at the American Society of Health-System Pharmacists.

The drug error involving the Quaid twins was identified after one of the babies started to seep blood from a puncture site. Through blood tests, Cedars-Sinai staff found that three had been given excessive doses of heparin.

The Quaids have not sued Cedars-Sinai at this time.

Reference:

"Dennis Quaid files suit over drug mishap," LA Times, Charles Ornstein, December 2007.