Public Citizen

Photo by Bridgette Blair

Taking a mislabeled drug or using a defective medical device is a dangerous thing. Just ask actor Dennis Quaid and his wife, Kimberly.

In November 2007, their newborn twins were given a massive overdose of Heparin, an anticoagulant drug. The twins were supposed to receive another drug that would ease the intravenous administration of antibiotics. Why were they given the wrong medication? The two drugs’ labels were similar. Baxter Healthcare Corp., the manufacturer of both drugs, was aware of the problem – in 2006, the same confusion over the labeling of Heparin caused the death of three infants at an Indianapolis hospital. Baxter relabeled Heparin to avoid this confusion before the Quaid twins were born. But here’s the shocker: The company didn’t recall the drug stock with the confusing label, so it remained on pharmacy shelves and was eventually injected into the twins.

The twins survived, barely.

Dennis Quaid made his way to the Hill this morning to tell his and his wife’s story at a Congressional hearing, and Public Citizen attorney Brian Wolfman accompanied them as part of their legal counsel. (Wolfman, director of the Public Citizen Litigation Group and a preemption expert, has written an article about preemption and why its proponents are wrong in TRIAL Magazine.)

The FDA, along with drug and medical device manufacturers, claim that if a drug or device has received market approval, it’s preempted from lawsuits, even if it’s defective or mislabeled. Essentially, the companies think FDA approval cuts off Americans’ access to the courts, regardless of how negligently companies design their products or whether doctors and the public receive information on product hazards. The Supreme Court is about to decide whether to side with these companies, or whether to allow lawsuits over drugs and devices.

The Quaids are not alone in their story. About 100,000 U.S. patients die each year because of medical errors in hospitals.

“If [people] are denied access to our courts, they will have no compensation for their injuries, and society will lose one of the most effective incentives for safer drugs,” Quaid said in his testimony.

Read the full transcript of Quaid’s testimony on Public Citizen’s Web site. You can also get more information on unsafe and ineffective drugs, as well as rules for safer drug use, at www.worstpills.org.