Working against consumers

Sunday, May 18, 2008 | 2:08 a.m.

The lawsuit filed by actor Dennis Quaid and his wife, Kimberly, after a hospital unintentionally gave their newborn twins the wrong dosage of a blood-thinning drug is being contested by a drug maker on the grounds that it is immune from liability.

Owing to rules that have been or are being rewritten by the Bush administration, any person filing a similar product liability lawsuit could face the same argument, greatly increasing the chances his suit would be lost or dismissed outright.

In articles last week, the Associated Press disclosed that federal agencies are quietly rewriting the language used in regulating consumer products.

Before the rewrites, the language included this sentence: “The final rule is not intended to preempt state tort civil actions,” meaning a company can be sued if its products are claimed to be flawed.

After the agencies’ rewrites, however, the language says federal preemption questions can indeed arise for a number of reasons.

The Quaids’ case is an example of how companies can use the new language.

The couple sued Baxter Healthcare Corp. because vials containing the prescribed dosage were very similar in size and labeling to vials containing a much stronger concentration of the drug. Baxter produced the vials, which got mixed up at the hospital after the twins were admitted late last year.

Baxter, citing the “doctrine of preemption,” is seeking to have the case dismissed because the federal Food and Drug Administration approved the design of the vials. The Quaids argue that Baxter should have redesigned the vials after the same type of mix-up at another hospital left three premature babies dead in 2006.

The Associated Press reports that since 2005 preemption language has been added to rules governing “just about everything Americans use.”

Testifying before Congress on Wednesday, Quaid said taking away the right to sue pharmaceutical companies would turn consumers into “uninformed and uncompensated lab rats.”

Congress should pass legislation clarifying that product liability lawsuits should be decided in court on their merits, not by obscure regulatory language about federal preemption.